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Hearing summary15th November 1999 The Bristol Royal Infirmary Inquiry oral hearings this week focus on the Directorate of Cardiology, United Bristol Healthcare NHS Trust (UBHT). The week begins however with evidence from Mr Robert McKinlay CBE, Chairman, UBHT 1994-1996. Members of the Inquirys Group of Independent Experts will be in attendance in the Inquiry Chamber throughout the week to comment on the evidence presented. Mr McKinlay told the Inquiry about his executive management experience within the aerospace industry and described his appointment as Chairman of UBHT in 1994. He commented on his limited knowledge of the NHS prior to 1994 and gave his impression of what senior managers and clinicians thought of his appointment. He described the management structure he found within the Trust and changes he wished to make, which he decided to postpone until the appointment of the new Chief Executive in October 1995. He went on to focus on the development of clinical audit and circulation of clinical outcome data within the Trust Board. He then spoke about his awareness, from August 1994 onwards, of concerns being expressed about paediatric cardiac surgery, he outlined his response to those concerns and recalled his discussions with colleagues about concerns relating to the neo-natal switch programme. He said he spoke directly with John Roylance, UBHT Chief Executive, in December 1994 regarding the setting up of an independent investigation to establish whether a problem existed. Mr McKinlay then told the Inquiry about the handling of the Hunter/de Leval report publication, his concerns regarding its content and subsequent alterations made following legal advice to the Trust. He then commented on a protocol drawn up to define the paediatric cardiac surgical practice at the BRI. He concluded by commenting on the appointment of the new Chief Executive, Hugh Ross to UBHT in October 1995. The next witness was Dr Robin Martin, Consultant Cardiologist, UBHT. He began by outlining his training and experience. He then described his referral patterns for patients with congenital heart defects, listing the procedures he would refer outside of Bristol, such as complex pulmonary atresia. He went on to comment on the introduction of the arterial switch operation in Bristol for non-neonates (above 28 days) in 1988 and neo-nates (under 28 days) in1992, stating that Bristol established the technique later than other centres in the UK. Dr Martin then discussed the role of the paediatric cardiologist and the methods of diagnosis used to define the anatomy of babies and children requiring complex cardiac surgery. He concluded the days hearings by discussing the monitoring of outcomes and the evolution of audit by referring to individual cases. Dr Martins evidence continues tomorrow morning at 9.30 a.m. Dr Eric Silove, Consultant Paediatric Cardiologist, Birmingham Childrens Hospital and Mr Philip Deverall, retired Consultant Paediatric Surgeon, attended todays hearing as members of the Inquirys Expert Group. |
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FULL TRANSCRIPT
1 Day 76, 15th November, 1999 2 (10.35 am) 3 THE CHAIRMAN: Good morning, everyone. Good morning, 4 Mr Maclean. 5 MR MACLEAN: Good morning, sir. The witness this morning is 6 Mr Robert McKinlay, formerly the Chairman of the UBHT. 7 Would Mr McKinlay take the witness chair, please? Would 8 you stand, please, to take the oath, Mr McKinlay? 9 MR ROBERT McKINLAY (SWORN): 10 Examined by MR MACLEAN: 11 Q. Could you tell us your full name, please? 12 A. Robert Murray McKinlay. 13 Q. You were for two years the Chairman of the United 14 Bristol Healthcare Trust? 15 A. Two and a half years. 16 Q. That is quite right, from 1st July 1994 until the end of 17 1996? 18 A. The end of November 1996. 19 Q. If you look at the screen in front of you, please, at 20 WIT 102/1, if we just scan down that page, that is the 21 first page of the first of two formal written statements 22 that you made to the Inquiry, is it not? 23 A. Yes, it is. 24 Q. If we go to page 17, can you identify the signature for 25 me, please? 0001 1 A. Yes, that is mine. 2 Q. That is the end of your first written statement to the 3 Inquiry? 4 A. Yes. 5 Q. I think you have seen the comments that have come in on 6 that statement, have you not, from Mr Durie, if you go 7 to page 18? 8 A. Yes. 9 Q. You have seen those? 10 A. Yes. 11 Q. And from Mr Wisheart at page 20? 12 A. Yes. 13 Q. You made a second statement then more recently, 14 WIT 102/23. That is the first page of that one. 15 A. Yes. 16 Q. And page 33, that is the end of the second statement. 17 A. Yes. 18 Q. You may not have seen a very short letter which came in 19 from Mr de Leval, which I fear has not been scanned in 20 but perhaps I could read it to you, dealing with your 21 second statement. It is a letter dated 4th November 22 1999, to the Inquiry, and he says: 23 "I have no response to make. Mr McKinlay's 24 description of my involvement in the Bristol affair is 25 accurate and correlates closely with the statements 0002 1 I have made in writing and verbally to the Inquiry, 2 "Yours sincerely, Marc de Leval". 3 So there is no substantive comment there other 4 than agreement. 5 I think this morning you have seen some comments 6 from Mr Wisheart, WIT 102/37, which deal with the second 7 statement? 8 A. Yes. 9 Q. We want to come back to some of those in due course, 10 but first of all, have you had a chance to read through 11 those two statements of yours recently? 12 A. Yes, I have. 13 Q. Is there anything in them you now wish to change or 14 alter in any way? 15 A. No. 16 Q. You understand we are not going to go through those 17 statements paragraph by paragraph. The Panel have them 18 and I know the Panel have read them. 19 A. I understand. 20 Q. You set out in your first statement your background in 21 industry, and your background was for many years in 22 aerospace industries? 23 A. Yes. 24 Q. At the end of your career in that industry, you were 25 Chairman of British Aerospace Airbus Ltd? 0003 1 A. Yes. 2 Q. In what circumstances did you come after your retirement 3 from British Aerospace to become the Chairman of the 4 Trust? 5 A. I was approached by Peter Durie, who is a friend, to see 6 if I was interested in succeeding him as Chairman of the 7 UBHT. 8 Q. And you were? 9 A. I was interested. I was concerned a little about the 10 amount of time that it would take, but I was interested, 11 so I spoke to Peter and I also spoke to Rennie Fritchie, 12 the Chair of the regional organisation at that time. 13 Q. What was the mechanism by which you were appointed? 14 A. Having said that, I spoke to Peter Durie and Rennie 15 Fritchie. The next mechanism was a letter from the 16 Secretary of State stating I was appointed from 17 1st July. 18 Q. Was there any interview process or anything like that? 19 A. No. 20 Q. So far as you are aware, was there anyone else Mr Durie 21 had in mind to suggest for the job? 22 A. I know there was at least one other person who was 23 interested, which Peter Durie passed on to me, but 24 I think I was the person that Peter Durie put forward. 25 Q. So you got the letter from the Secretary of State and 0004 1 took up your post on 1st July 1994. 2 What sort of knowledge of the Health Service did 3 you bring to your role as Chairman? 4 A. Really, very little, just that of an occasional 5 patient. I knew little about the Health Service, little 6 about its organisation. I felt I was joining a Trust 7 which was in good shape and I had had a briefing from 8 Peter Durie, but I had no background knowledge of the 9 NHS. 10 Q. We will come back to the conversations that you had with 11 Mr Durie a little later, but taking a broader view to 12 begin with, what was your overall impression that you 13 obtained when you became the Chairman and had a little 14 time to soak up the atmosphere of the Trust, if you 15 like, in terms of the organisation and culture of the 16 Trust compared to your background in industry? 17 A. It took me quite a time to grasp the organisation of the 18 UBHT. It is geographically a big Trust. There is 19 a large number of directorates, so it took a long time 20 to go and talk to people and understand the 21 organisation. 22 I think that probably the watershed was in 23 November when I had an away-day with the directors where 24 I talked about what I thought I had grasped from my few 25 months in the Trust, and there I think I could summarise 0005 1 by saying I thought the organisation of the Trust into 2 individual directorates was sound; that the directorates 3 being headed by Clinical Directors was sound, but I felt 4 that there was a lack of co-ordination; there was 5 a deliberate very light hand exercised from the centre. 6 Q. That was something you wished to see corrected? 7 A. Yes, in my background, I wanted to see that corrected. 8 I was used to having devolved organisations, but I was 9 not used to having organisations which did not have 10 a fairly proactive monitoring system at the centre. 11 Q. I say "corrected"; perhaps a pejorative "correction". 12 Something you would like to see changed? 13 A. "Correction" is probably the wrong word. It is probably 14 something I would like to see evolve. 15 Q. You made some proposals, I think, about the 16 reorganisation of the central management structure of 17 the Trust a few months after you became Chairman in 18 terms of the reorganisation of some of the committees, 19 did you not? 20 A. Yes, as I recall, that was following the away-day in 21 November, not at the away-day but following it, and 22 I made some proposals for revamping what had been 23 Advisory Groups into board committees, with more what 24 I thought were clearer terms of reference. 25 Q. Can we look at UBHT 21/699. Can you help me with what 0006 1 this document is, Mr McKinlay? 2 A. This was a document to board members. It was the 3 proposals that I was putting forward for changing the 4 organisation of the advisory groups into committees, and 5 what I thought was -- what is the right word -- 6 stiffening up their terms of reference. 7 Q. If we scan down the page, we have lost the heading which 8 is "Board Mission". Does this and succeeding pages of 9 this document set out your own proposals which you had 10 developed over the five months you had as Chairman? 11 A. Yes, these were my proposals: I did not have much 12 discussion with them with anybody else. 13 Q. We see set out at the bottom of the page the Board's 14 committees. There are three of them I want to dwell on: 15 "Patient care standards", "medical audit" and "audit". 16 What was the distinction between "medical audit" 17 and "audit", at that time? 18 A. The Audit Committee was then, and may well be now, 19 a committee that was essentially concerned with the 20 financial situation within the Trust. It looked at the 21 overall accounts of the Trust and then, in company with 22 the National Audit Office, it looked at various aspects 23 of the financial control of the Trust. It was not then, 24 nor was it my intention, that that committee should 25 widen its brief into anything but financial and 0007 1 management matters. 2 Q. Before we come to the Medical Audit Committee, can we go 3 to page 700, at the bottom of the page? There should be 4 a heading "Patient Care Standards Committee." 5 A. Yes. 6 Q. These are your words? 7 A. Yes. 8 Q. "This committee would be expected to oversee all 9 [underlined] aspects of patient care. Provided we can 10 establish a satisfactory set of definitions it would 11 need to enter into the field of medical outcome in as 12 much as this affects the performance of the Trust as 13 a whole but steer clear of medical audit. I believe the 14 answer lies in studying medical outcome on a statistical 15 basis while leaving the underlying clinical factors to 16 the Medical Audit Committee." 17 One might detect a tightrope between entering the 18 field of medical outcome but steering clear of medical 19 audit? 20 A. I think there was a tightrope of a sort. There was no 21 tradition or culture in UBHT that the Board or the 22 committees of the Board should be involved on outcome, 23 medical outcome, even on a statistical basis. I felt 24 that that is something that should evolve. 25 To be more specific, I thought that was something 0008 1 that was wrong. I thought the Board should have some 2 knowledge of statistical outcome, but there was 3 a tightrope to be trod to find a way of easing it into 4 place. 5 Q. If we go to your first statement, WIT 102/11, 6 paragraph 39, the second sentence: 7 "A yearly audit report covering clinical 8 performance was produced by the Medical Audit Committee 9 under a senior consultant. In my time it was not 10 practice in UBHT for this report to be seen by the Board 11 or the Board committees." 12 That was the situation when you took up your post? 13 A. Yes. 14 Q. Was that something you were happy with? 15 A. As I took up my post, it took me some time to find out 16 what the processes were, and I do not think I tracked 17 down the process within the Medical Audit Committee and 18 the production of the report until quite a few months in 19 my time in UBHT. 20 When I found there was a report, I was not happy 21 that it did not come to the Board in some form, not 22 necessarily in the form that was being prepared at that 23 time, but that in some form a medical audit report 24 should come to the Board. 25 Q. We have dealt a little with the Patient Care Standards 0009 1 Committee and you deal with this in the same statement 2 at paragraph 23, page 7. 3 What was the overlap to be between the Medical 4 Audit Committee, the Clinical Audit Committee as it 5 became, and the Patient Care Standards Committee? 6 A. This was something that was not worked out in 7 a definitive way in my time. I had the vision that the 8 Medical Audit Committee would very much treat the 9 individual situations and that the Patient Care 10 Committee would promote the creation of benchmarks and 11 then that it would monitor performance against 12 benchmarks. But it had not progressed to that stage, in 13 my time. 14 Q. Who chaired the revamped committees of the Board which 15 you put in place through this paper and subsequent 16 decisions? 17 A. Richard Dixon chaired the Patient Care Committee. 18 Q. All the committees save one were chaired by 19 non-executive directors, were they? 20 A. That is correct, so far as I recall, yes. 21 Q. The exception was which committee? 22 A. The Medical Audit Committee was not chaired by 23 a non-executive director. 24 Q. It was solely clinicians? 25 A. It was. It was at that time chaired by Jill Bullimore. 0010 1 Q. You mentioned the Audit Committee annual reports. If we 2 go to UBHT 65/263, this is the audit report for 1994/95, 3 so this would be the one that would cover the first part 4 of your time as Chairman. 5 In your statement at paragraph 24 on page 3 6 [WIT 102/24] you say "The only report which I saw in the 7 second quarter of 1995 at my request lacked preset 8 standards." 9 Is that the report you were referring to, for 10 1994/95? 11 A. It was an annual report. I cannot remember whether it 12 was that report. I cannot remember what time a year's 13 report would be produced. 14 Q. If we can just bear with that report in the meantime and 15 go to UBHT 65/267, part of the same report I have shown 16 you the front page of, these particular terms of 17 reference of the Clinical Audit Committee for 1994/95. 18 What I want you to do, Mr McKinlay, is to look at these 19 terms of reference and tell me to what extent those 20 terms of reference would be met, in your opinion, in 21 your early months as Chairman of the Trust. Tell me 22 when you want to scan down the page. 23 A. Could we move on? (Pause). As a generality, sections 24 1 to 4 were being discussed and were in hand, although 25 I think in my statement I described them as being in 0011 1 their infancy. I think item 5, in the first 6 months in 2 the Trust, in my view, was not moving. 3 Q. And you wanted to get it moving? 4 A. Yes. 5 Q. If we go to page 314, this is the very back of the same 6 document, we will see the people who were on this 7 committee. We mentioned Dr Bullimore a moment ago. She 8 by this time had become the Chairman. You say amongst 9 others on the committee Mr Wisheart was the Medical 10 Director, Dr Laszlo was by then Chairman of the HMC. 11 Mrs Maisey was an Executive Director of the Trust? 12 A. Yes. 13 Q. And Drs Black and Bolsin, both of whom were 14 anaesthetists. 15 There was a period when Mr Wisheart was the 16 Chairman of the Medical or Clinical Audit Committee? 17 A. I understand that there was, but I think that was before 18 my time. 19 Q. If we go to UBHT 35/76, we see this is a meeting of the 20 Trust in July 1994, so right at the very beginning of 21 your period. If we just scan down the page a little, we 22 see it was your first meeting? 23 A. Yes, indeed. 24 Q. If we go to page 80, please, still in the minutes of the 25 same meeting, if we go over the page -- I will not waste 0012 1 time trying to find the reference. 2 The point is that Mr Wisheart at this time was the 3 Chairman of the Clinical Audit Committee and 4 Dr Bullimore took up her post as Chairman of that 5 committee with effect from January 1995. 6 I can show you the documents which demonstrate 7 that. 8 A. I am sure you are right. 9 Q. Mr Wisheart explained that he was the Chairman for six 10 months originally was the plan, pending the appointment 11 of a new Chairman who turned out to be Dr Bullimore, 12 because Dr Thomas, the previous Chairman of the Audit 13 Committee, had left the post and there was no-one else 14 willing to step into the breach other than Mr Wisheart. 15 Do you remember being aware of those 16 circumstances? 17 A. No. 18 Q. Can we go to UBHT 16/4, please? We have moved on a bit 19 now. We will come back in time, but we are still 20 dealing with audit. This is the Patient Care Standards 21 Committee, 7th November 1995. We see amongst those 22 present are both yourself and Dr Bullimore. 23 If we go to page 6, paragraph 7, Dr Bullimore 24 introduced the annual audit report. She made a number 25 of comments, and you can see the comments she makes. 0013 1 A. Yes. 2 Q. If we go over the page, please, to page 7, there is 3 a comment from you, in the second paragraph. You ask 4 a question there about identifying relevant standards 5 and comparing local performance. "Few of the audits 6 concerned outcome". Was there any answer provided to 7 that question? 8 A. No. 9 Q. Did you ever form a view as to how that question could 10 have been answered? 11 A. I think the answer could have been that it was not the 12 tradition or culture in UBHT to publish in any open way 13 outcome results. 14 Q. Did you understand that to be a less open approach than 15 other comparable Health Service organisations? 16 A. The people that I talked to within the Trust, which 17 would be probably largely Dr Roylance, but some others, 18 I gathered the impression that they felt they were not 19 really any different from other Trusts. But I did not 20 have any independent way of verifying that. 21 Q. If we go to UBHT 16/148, this is a letter from 22 Mr Wisheart. We see his initials in the top left-hand 23 corner, "JDW", to Professor Dixon, Chairman of the 24 Patient Care Standards Committee. This is February 25 1995. 0014 1 Mr Wisheart sets out some proposals: 2 "... representing a constructive response to the 3 Chairman's suggestion that the Patient Care Standards 4 Committee should oversee all aspects of patient care and 5 the remit should enter into the field of medical 6 outcome. The terms of reference proposed would be ..." 7 Is it right, first of all, that you did propose 8 that change? We have seen that. 9 A. I think that was contained in the proposals that I made 10 at the end of the year which we looked at earlier this 11 morning. 12 Q. And at this stage, Mr Wisheart was responsible for 13 taking those forwards? 14 A. Yes, I felt as Medical Director he should take the 15 initiative on it. 16 Q. Was that something he undertook willingly? 17 A. Yes. 18 Q. And to your satisfaction? 19 A. I thought progress was slow. I know that Mr Wisheart 20 started and he asked the various divisions for their own 21 views on what outcome measures could be used. I know 22 that he moved fairly promptly on that, but I think it 23 took a long time before they were argued, collated, 24 co-ordinated. I am not sure that that arrived in my 25 time. 0015 1 Q. You say progress was slow. Is that merely a description 2 of the fact as you saw it, or was it intended to be 3 a criticism that it was slower than it might have been? 4 A. No, it is possible that it could have been quicker than 5 it had been because Mr Wisheart was a busy man in other 6 areas, but I think it is really a reflection of the 7 sheer difficulty of arriving at outcome measures which 8 can in fact be used reliably. I am an engineer, not 9 a medical man, but it is not easy to come up with a set 10 of medical outcome measures that you can use 11 consistently and reliably, and it was certainly, by any 12 standard, going to take time for these to be 13 established. 14 Q. If we go over the page in this letter, if we just scan 15 down the page a little, we see in that last paragraph: 16 "The role of the Clinical Audit Committee is most 17 crucial. I believe that the proposed development would 18 assist in achieving further progress towards cultural 19 openness about outcomes throughout the Trust and would 20 involve changing development over a number of years." 21 Do I take it from your evidence that you thought 22 this progress towards a culture of openness about 23 outcomes throughout the Trust had a significant way to 24 go at this time? 25 A. At the time that this memo was written? Yes. 0016 1 Q. Before we turn to something else, can I just ask you 2 briefly about the role of the non-executive directors? 3 When you became Chairman, what did you see their role as 4 being? 5 A. I first of all asked what their role had been. It was 6 the first thing that I did. 7 Q. What was the answer to that? 8 A. They had been involved in chairing Advisory Groups and 9 they had been involved in hospital visiting, and 10 generally in supporting the business of the Trust. 11 I felt that that was, you know, a perfectly proper way 12 for the non-executives in a Healthcare Trust to behave. 13 Q. Did you know the other non-executive directors? 14 A. No. Round about that time, and I think perhaps just 15 before that time, I knew Mr Sherwood, but I did not know 16 the others. 17 Q. That would be Louis Sherwood? 18 A. Louis Sherwood. 19 Q. We have had a statement to the Inquiry from someone who 20 was a non-executive director before your time as 21 Chairman, Mr Woolley. Let me show you WIT 357/1. We 22 see that Mr Woolley, if we scan down the page a little, 23 was a non-executive director -- this is paragraph 3 -- 24 from 1st April 1991 until October 1993, so before your 25 time as Chairman. 0017 1 If we look at page 6, paragraph 21, just go back 2 a page to pick up the start of the paragraph, we see 3 what he says about the Patient Care Standards Committee, 4 that they were at times overwhelmed by issues about 5 waiting time, "... generally I did not feel I had any 6 role to play in clinical issues such as how well 7 operations were carried out. I felt that quality of 8 care/outcomes should be left to those who are expert and 9 understand them. Medical audit was not something the 10 Board had any knowledge of. The Medical Audit Committee 11 did not report to the Board. The Board did, however, 12 know that medical audit was taking place." 13 Before we go over the page, to what extent would 14 your attitude differ from that paragraph? 15 A. I feel that a Board has to be aware of the measures by 16 which its business will be judged. If we were building 17 aeroplanes, you have to build good aeroplanes that 18 provide the service that the customer expects, and 19 operate within safety limits. I think the Boards have 20 to have the measures that allow them to be confident 21 that is happening. I think in the Health Service 22 medical outcome is a measure that the board should take 23 an interest in. 24 Q. So it is not satisfactory for the Board simply to know 25 that in another part of "the jungle" medical audit is 0018 1 taking place? The Board ought to see the fruits of that 2 medical audit and be in a position to judge for itself? 3 A. That is my view. I believe that quality within medical 4 performance can only be provided by those who are the 5 providers, the experts, but the Board should be able to 6 assess as to whether the standards which they think are 7 relevant are being met. 8 Q. If we go over the page, please -- I do not think there 9 is anything else there we need to comment on. 10 When you became the Chairman, the Chief Executive 11 was Dr John Roylance? 12 A. Yes. 13 Q. What did you know about him and his attitude to his work 14 and his role when you became Chairman? 15 A. I did not know anything about Dr Roylance; I had not met 16 him or known of him before I joined. What I learned was 17 that he was a man of great experience in the Health 18 Service. He of course was a doctor in his own right, 19 but my understanding of John Roylance started when 20 I joined the Trust. I had no previous knowledge. 21 Q. Mr Durie had no doubt identified who Dr Roylance was? 22 A. Mr Durie had identified the executive management team, 23 so I knew the positions held by the various executive 24 directors, but he did not give me a briefing on the 25 characteristics of John Roylance. 0019 1 Q. He left you to form your own impression? 2 A. Yes. 3 Q. If we go to your first statement, WIT 102/3, 4 paragraph 11, we have touched on this really already, 5 but you say: 6 "The management structure had been done 7 deliberately by Dr Roylance to allow the Trust to start 8 working without disruption." You explain you were 9 seeking a more inquisitive role for the Board. 10 Do we take it you understood and could see good 11 reason for the management structure being as it was in 12 1981, the original Trust structure Dr Roylance was 13 a part of setting up? 14 A. Yes, as I understood the situation, I thought 15 Dr Roylance had provided a structure which kept the 16 confidence of the consultants, kept the support of the 17 consultants, in the move into Trust status. I think, 18 particularly in the setting up of individual 19 directorates, with a consultant as a Clinical Director 20 was probably the strongest move. I felt that he had 21 done that for reasons at the time that were perfectly 22 sound and the Trust from what I could see, what I could 23 read, had started on a fairly even keel and was on an 24 even keel when I joined it in relation to this aspect. 25 Q. If we go to page 7, I think this is the same point, 0020 1 paragraph 22. This is dealing with you turning the 2 Board's Advisory Groups into committees. We see in the 3 middle of the paragraph: 4 "Originally the groups had been set up to have 5 a largely advisory role, primarily to present 6 a non-threatening face to the clinical body." 7 A. These are essentially the -- not exactly the words, but 8 the feelings projected by Dr Roylance. He did not want 9 Advisory Groups that were too inquisitive. 10 Q. Because that would present a threatening face to the 11 clinical body? 12 A. Yes. 13 Q. And that might lead to trouble? 14 A. It might have done. 15 Q. Because the doctors would feel threatened? 16 A. Yes. 17 Q. And would see the Trust as being, if you like, the 18 triumph of the managers over doctors? 19 A. I think that is what Dr Roylance was trying to protect 20 against, that in some way a move to the Trust and the 21 development of the Trust was the victory of the managers 22 over the clinicians. 23 Q. But it follows, does it not, from what you say in this 24 paragraph, by the time you took over you felt there was 25 an inappropriately light touch from the centre? 0021 1 A. Yes. 2 Q. And that needed sorting out? 3 A. I think that needed to evolve into a balanced system 4 where authority was devolved to the divisions, to the 5 directorates, but there was effective monitoring from 6 the centre. 7 Q. We need not go back to it, but do you remember the 8 paragraph I showed you a moment ago from the same 9 statement, paragraph 11. You said there you felt it 10 would be unreasonable to try and change the structure 11 before John Roylance's planned retirement. Why? 12 A. We were talking in a time-scale as I recall where I had 13 some fairly definitive views of what the organisation 14 ought to evolve to, probably in about January 1995, and 15 Dr Roylance was going to retire in October 1995. These 16 things take time. 17 Q. But you were only going to be the Chairman until the end 18 of 1996? 19 A. At that time, that was the period of the appointment, 20 but it was not unreasonable I should carry on. To the 21 end of 1996, I thought there was plenty of time, but to 22 October 1995, I thought the time was short. And I did 23 think that trying to persuade Dr Roylance to change his 24 style was not the best way to proceed. 25 Q. Did you see it as a problem that the Chief Executive of 0022 1 the hospital was himself an experienced doctor? 2 A. Not in its own right. My view was that the leadership 3 of the Trust, the Chief Executive, had to be a good 4 manager, but the fact he might also be a doctor, I do 5 not think was an intrinsic problem. 6 Q. Your second statement this time, still on the same 7 theme, WIT 102/25, paragraph 7: 8 "It took me a little time to realise that the NHS 9 is very wary of industrial people since they think that 10 we can only prosper by hiring and firing with no thought 11 for the human consequences." 12 That rather sceptical, not to say hostile 13 attitude: is that one that you found in the UBHT? 14 A. Yes. I do not think it was hostile, but it was pretty 15 sceptical that -- the way it was considered that we 16 behaved. 17 Q. Where did that come from? 18 A. In what sense? 19 Q. Who was it? Was it the managers, the doctors, the 20 nurses, who seemed to think that you as an industrial 21 man would be somebody who only prospered by hiring and 22 firing? 23 A. I think that would come from the executive directors 24 and the senior managers that I was fairly consistently 25 in touch with. 0023 1 Q. And the executive directors at that time would be 2 Dr Roylance and Graham Nix, the Finance Director, and 3 Margaret Maisey, and Mr Stone? 4 A. Yes. 5 Q. I think Mr Boardman -- 6 A. He had left by then. And Mr Wisheart. 7 Q. And Mr Wisheart as Medical Director? 8 A. Yes. 9 Q. Were there any of those you would exclude from this 10 categorisation? 11 A. I think I would exclude Ian Stone as a professional. 12 I think he knew we were not quite as black as we were 13 painted. 14 Q. And Mr Nix is a finance man. What was his attitude? 15 A. I think that largely these people that I was dealing 16 with, the executive directors, and the senior managers, 17 were people who had only been in the National Health 18 Service. They had not been outside in industry. So 19 there was an in-built feeling about industry, perhaps 20 even to some extent a fear of the way that an industrial 21 chap might behave. 22 Q. So did that attitude, the scepticism, if you like, mean 23 that you had to tighten your sails a little on how you 24 dealt with the executive directors? 25 A. No, I do not think in practice it did. I am fairly used 0024 1 to moving into new situations, and I try and take it 2 gently so I understand what I am talking about before 3 I make any move. So I do not think it had any 4 significant effect. I think I tried to explain that the 5 days of hiring and firing in industry were long gone. 6 Q. At the time you first became Chairman, when did you 7 first become aware of the fact that paediatric cardiac 8 open-heart surgery was conducted in a different building 9 from the rest of the care of children? 10 A. Some time within the first three months. I probably 11 could not be more specific than that. One of the 12 earliest things I did was go and talk to all the 13 clinical directors and walk their particular area within 14 the group of hospitals. I did that of course in the 15 Children's Hospital and in the BRI, so within that 16 process I realised that there was a split between 17 closed-heart surgery and open-heart surgery. It would 18 certainly be in the first three months, but no more 19 specific than that, I do not think. 20 Q. Had Mr Durie discussed this matter with you at all? 21 A. Yes, he had talked about the plan to move all the 22 children's operations to the Children's Hospital. 23 I think at that time I was not aware that there was any 24 heart surgery in the Children's Hospital at all, so it 25 took that little time to sort out that there was in fact 0025 1 some heart surgery in the Children's Hospital, and 2 open-heart in the BRI. 3 Q. Can we look at UBHT 61/246? Tell me if you remember 4 seeing this letter, Mr McKinlay? It is from Professor 5 Vann Jones to Mr Durie, dated 12th May 1994. 6 A. No, I have no recollection of that letter from my time 7 in the Trust. 8 Q. You have seen it, I think, recently? 9 A. I have seen it since. 10 Q. Apart from not having seen the letter itself, do you 11 remember any discussion of the substance of that letter 12 of Mr Durie? 13 A. No. 14 Q. Did Professor Vann Jones, or Professor Angelini, ever 15 approach you when you became Chairman and ask you 16 specifically what Mr Durie or yourself had done in 17 response to this letter? 18 A. No. 19 Q. When you became Chairman, did you understand that the 20 decision to move paediatric open-heart cardiac surgery 21 to the Children's Hospital had been taken, or was still 22 under consideration? What was the precise status? 23 A. I understood from Peter Durie that it was a plan, but it 24 was not yet a formal decision. As I recall, as a Board 25 we took that formal decision at some point in the autumn 0026 1 of 1994. 2 Q. What did you understand the reason to be for ending the 3 so-called split site? 4 A. To create more space and capacity for adult surgery. 5 Q. Did you understand the decision to be taken because 6 there was any concern that the split site was positively 7 damaging to the children operated on at the BRI? 8 A. No, I did not understand that. There was some 9 discussion in presenting the case to the Board, that it 10 would benefit the Trust and possibly benefit the 11 children by creating a one-site situation, but that was 12 at the point of making the formal decision that we were 13 going to do it. There was no lead-up to it on that 14 point. 15 Q. Can we look at UBHT 275/131? This is a Working Party 16 report, "Options for development of adult and paediatric 17 cardiac services in UBHT." 18 This was produced, as luck would have it, on the 19 same day as a letter to Mr Durie from Professor Vann 20 Jones, so before you became Chairman on 12th May 1994. 21 If we go to the second paragraph, please, the one 22 beginning: 23 "UBHT is fortunate ... It is a long-held view of 24 all the professions concerned that paediatric cardiac 25 open-heart surgery should be located in the BCH as part 0027 1 of an integrated paediatric cardiac service." 2 When you did become Chairman and gain an 3 understanding of issues, did you ever understand there 4 to be any opposition to ending the split site from the 5 clinicians involved in the cardiac care? 6 A. Not as presented to me as Chairman. It was presented to 7 me as a plan that released capacity for adult cardiac 8 surgery. It probably would benefit the children by 9 being on one site, but no, I had no knowledge of any 10 clinicians who stood against it. 11 Q. If we go to page 139, still in the same report, under 12 the heading "Threats", look at the first of those. 13 Were you ever conscious of paediatric cardiac 14 surgery having been, before your time, a designated 15 supra-regional service? 16 A. No, that is a term that I became aware of round about 17 the time of the de Leval/Hunter report. 18 Q. The second paragraph deals with the question of 19 numbers. You can see what it says. It concludes: 20 "If services at UBHT do not expand, there is 21 a danger that the total service could be lost." 22 Did you understand that there was a threat hanging 23 over paediatric cardiac surgery in Bristol because of 24 the small number of throughput? 25 A. No. I did not. 0028 1 Q. If we scan down again, please, to 3 and 4, what did you 2 understand was the position vis-a-vis the surgeons 3 themselves when you became Chairman? Who was going to 4 do the paediatric cardiac surgery? 5 A. When I became Chairman, I did not know who did the 6 paediatric cardiac surgery. I may have known that James 7 Wisheart did the paediatric cardiac surgery through the 8 fact that our wives are friendly, but I did not know 9 that Janardan Dhasmana was the other paediatric cardiac 10 surgeon. 11 Q. When did you become aware of the proposal that there 12 should be a new or another paediatric cardiac surgeon? 13 A. There was a listing just in the diaries that there would 14 be an Appointments Committee for a new paediatric 15 cardiac surgeon. The date for the paediatric cardiac 16 surgeon Appointments Committee was in September, so it 17 would probably be listed at some time in August, 18 possibly the middle to end of August. 19 Q. You have told us that Mr Durie explained to you, perhaps 20 in general terms, that there was a proposal to move the 21 paediatric open-heart surgery to the Children's 22 Hospital. Did he, before you became Chairman, explain 23 to you that there was also a proposal that there should 24 be a new paediatric cardiac surgeon? 25 A. Not that I recall, no. 0029 1 Q. You mentioned there in passing, in one of your answers, 2 that you may have known that Mr Wisheart was 3 a paediatric cardiac surgeon because, you said, your 4 wives knew each other. 5 When you became Chairman of the Trust, of the 6 consultant body, the senior managers, how many of those 7 people did you know personally? 8 A. I did not know any of them personally. I think I had 9 met James Wisheart a couple of times at church, because 10 we go to the same church. He is a much better attender 11 than I am, but our wives were friendly through the 12 church. 13 Q. So when you became Chairman, you knew of James Wisheart 14 and you knew he was a consultant and you knew he was 15 Medical Director? 16 A. Strictly not: I think his position as Medical Director 17 was explained to me by Peter Durie in the briefing 18 before I joined. 19 Q. If we go to your second statement, WIT 102/27, 20 paragraph 15, you refer to your briefing from Mr Durie. 21 You say that you knew there were concerns about whether 22 the duration of operations on very young children as 23 performed by Mr Wisheart had a negative impact on the 24 outcome. 25 When did Mr Durie tell you that? 0030 1 A. In the briefing before I joined the Trust. 2 Q. There was one briefing? 3 A. There was one briefing which spanned two or three days. 4 Q. You say "within my first three months I discussed this 5 point with Dr Roylance and Mr Wisheart". 6 Why three months? Does that indicate that this 7 was not, perhaps, put as a very urgent concern? 8 A. It was not put as an urgent concern. It was put as 9 a statement. I am saying the "first three months" 10 because I cannot pin it down, but I cannot recall 11 discussing it with a great urgency. 12 Q. So you did go and discuss it with Dr Roylance and 13 Mr Wisheart. Do you remember that clearly? 14 A. I do remember discussing it -- yes, I do remember it 15 clearly, yes. 16 Q. Did you discuss it with both of them together or 17 separately? 18 A. No, separately. My practice was to have sessions with 19 the executive directors on a regular basis where we 20 would discuss matters of interest at the time, and 21 I recall discussing it separately. 22 Q. You tell me: the paragraph can perhaps be read in one of 23 two ways. Which of them, or was it both of them, stated 24 that within the profession there was no firm conclusion 25 and that meticulous work was inclined to take longer 0031 1 which was regarded by some as a positive factor? 2 A. I think both of them, Mr Wisheart stated it as 3 a personal statement of his conviction. I think 4 Dr Roylance stated it, but more as a general statement. 5 Q. So that would be a positive reason why the work that 6 Mr Wisheart was doing would be beneficial, good? 7 A. Yes. 8 Q. The next sentence says: 9 "They reiterated that the plan remained to move 10 all paediatric cardiac surgery to the Children's 11 Hospital and that Mr Wisheart would then concentrate on 12 adult cardiac surgery." 13 A. That was said at the same time, and that Mr Wisheart 14 would concentrate on the growing workload on adult 15 cardiac surgery. 16 Q. If Mr Wisheart's meticulous work was inclined to take 17 longer was recorded as a positive factor, if that 18 hypothesis were true, then why should he want to give it 19 up and concentrate on adult cardiac surgery? 20 A. Just as a matter of fact, I think the adult cardiac 21 workload was growing, and I think Mr Wisheart's part in 22 the paediatric surgery was by far the smallest part. 23 Q. Did you know how many paediatric cardiac surgeons there 24 were, by this time? 25 A. I am sure by that time I would have known there were 0032 1 two. 2 Q. Did you know who the other one was? 3 A. I knew who he was by name, for sure. 4 Q. But you had not by this time met Mr Dhasmana? 5 A. Within the first three months, I probably did, yes. 6 Q. Can we look at UBHT 61/271? I think you have seen these 7 letters recently, in the preparation of your statement 8 and evidence today? 9 A. Yes. 10 Q. This is a letter from Dr Doyle of the Department of 11 Health to Professor Angelini of 21st July 1994. 12 Do you remember having any contemporaneous 13 knowledge of Dr Doyle's concerns as set out here? 14 A. No, not at that time, no. 15 Q. Professor Angelini wrote to Dr Doyle in reply on 16 19th August. That is page 273. I think again, you have 17 seen this letter more recently? 18 A. Yes. 19 Q. Did you see that one at the time? 20 A. No, I do not recall seeing that one at the time, no. 21 Q. Do you recognise the manuscript writing? 22 A. No, I do not recognise it as such. I think you could 23 guess who the two gentlemen are, but I do not recognise 24 it as such. 25 Q. You would suppose they were whom? 0033 1 A. James Wisheart and John Roylance. 2 Q. The Inquiry has seen, I know, some written comments from 3 Mr Wisheart to Dr Roylance at about this time. Did you 4 ever discuss the matter with either James Wisheart or 5 John Roylance before a reply was produced to Dr Doyle? 6 A. No. 7 Q. Dr Doyle wrote back to Professor Angelini on 8 30th August, page 275. Did you see that one at the 9 time? 10 A. Not at the time, no. 11 Q. Then there was a letter from Dr Roylance. This may be 12 of more relevance, 12th September 1994, page 278. The 13 second paragraph: 14 "I felt I should write to confirm the Trust 15 Board's awareness of this problem, for which reason we 16 are seeking to appoint another full-time consultant 17 paediatric cardiac surgeon and the Appointments 18 Committee is due to meet on 20th September. 19 "The decision has already been taken by the Trust 20 Board and plans are in hand to move paediatric cardiac 21 surgery into the Children's Hospital. I have every 22 confidence this move and the appointment of the new 23 surgeon will resolve the situation for the future." 24 Do you remember seeing that letter at the time? 25 A. No, I do not. 0034 1 Q. That letter is proposing to set out the awareness of the 2 Trust Board as a whole? 3 A. I do not think the Trust Board were aware of this 4 problem at that time. 5 Q. What problem do you take it is being referred to? 6 A. I think the problem is the concern that Peter Doyle was 7 expressing about performance, and that goes back to the 8 perception of poor performance on complex operations. 9 Q. If we go back to Dr Doyle's letter, 271, you see in the 10 second paragraph he says it has been brought to his 11 attention that there were concerns about mortality rates 12 for paediatric, especially neonatal and infant cardiac 13 surgery performed at the BRI and that some sort of audit 14 had been carried out. 15 Do you think that this type of letter from the 16 Department of Health is something that you would have 17 liked to have known about? 18 A. Yes. 19 Q. At this time, in August/September 1994, did you have any 20 knowledge of there having been some sort of audit 21 carried out which confirmed the greater than expected 22 mortality for certain procedures? 23 A. No. 24 Q. Had you ever heard of Dr Bolsin in those terms? 25 A. Not at that time, no. 0035 1 Q. So those are the concerns that are expressed to 2 Professor Angelini. If we look in more detail at his 3 reply, 273, in the third paragraph, he makes a reference 4 to looking for the new full-time consultant and so on. 5 He says: 6 "I can assure you we will do our best to appoint 7 a suitable candidate. It is our desire to find somebody 8 familiar with the surgical procedure for which our 9 results have been least satisfactory." 10 Did you know at that stage that there was any 11 particular procedure or procedures that were the subject 12 matter of particular concern? 13 A. The date of this letter was ... 14 Q. This was 19th August 1994. 15 A. No. 16 Q. We are going to come shortly to a meeting you had with 17 Professor Farndon and Professor Angelini in September 18 1994, before Mr Pawade was appointed. 19 A. Yes. 20 Q. Was that the first time that you became aware of 21 particular procedures that were the subject matter of 22 concern? 23 A. Yes. 24 Q. If we go to Dr Roylance's letter, then, 278, you did not 25 have any input into this letter, so far as you remember? 0036 1 A. No. 2 Q. Are you sure you did not have? 3 A. I am sure. 4 Q. What was the knowledge of the Trust Board in the latter 5 part of August 1994 and early September, about outcomes 6 of paediatric cardiac services? 7 A. I think as a board, as a group, the knowledge was -- 8 there was no knowledge. As individuals, I cannot answer 9 for individuals. 10 Q. If there were concerns floating around the BRI at that 11 time, how would you expect those to reach the Board 12 ultimately? 13 A. I think I would have hoped they would reach the Board 14 through the procedures, through the Clinical Director or 15 the Medical Director, the Chief Executive to the Board. 16 That is what I would have hoped to have happened. 17 Q. So if there were serious concerns raised with the 18 Clinical Director, the consultant for example goes to 19 the Clinical Director and raises on the face of it 20 a serious concern, the Clinical Director would do what? 21 A. I would have envisaged that the Clinical Director would 22 go to where the source of the problem lay. We are 23 talking here about consultant anaesthetists having 24 concerns, so the Clinical Director in anaesthesia, in 25 a very logical system, goes and talks to the Clinical 0037 1 Director in paediatric cardiac surgery. 2 Q. And if there remains a problem, that having been done, 3 what would happen then? 4 A. Then I think the logical next step is to the Medical 5 Director. 6 Q. If, by chance, the Medical Director should himself 7 already be involved in the expression of concerns? 8 A. The Chief Executive is the next step, possibly with the 9 Chairman of the Hospital Medical Committee being 10 somebody that might be consulted on the way. 11 Q. As a substitute, if you like, for the Medical Director? 12 A. Yes. 13 Q. And from there to the Board? 14 A. From the Chief Executive to the Board. 15 Q. Let us turn to the meeting with Professor Farndon and 16 Professor Angelini. That, I think, was before 17 Mr Pawade's interview? 18 A. Yes. 19 Q. What was the purpose of the meeting? 20 A. They asked for a meeting. There was no subject 21 expressed. In the meeting, they wanted to explain why 22 their favoured candidate, Mr Pawade, might apparently 23 have some problems of accreditation. At that time -- 24 and I still think -- they may have felt that I had shown 25 a certain amount of annoyance at a previous Appointments 0038 1 Committee where the process of sorting out 2 qualifications had been somewhat untidy, and I did not 3 favour that being brought to the committee; it should 4 have been sorted out beforehand. They had come to show 5 me that even though there might be some twists and turns 6 in the accreditation of Mr Pawade because he had been 7 working in Australia, that he in fact was a candidate 8 who could be accredited and was in their view the best 9 man for the job. 10 Q. How did you react to that? Was that an appropriate 11 matter for them to bring to you? 12 A. Yes, I think that is an appropriate matter. It was not 13 really all that common at that time, because I think 14 I had only run two appointments committees before that 15 time, but it was quite common beforehand for candidates 16 and interested parties to come and lobby the Chairman. 17 Q. Was there anything else discussed at the meeting, other 18 than Mr Pawade's accreditation? 19 A. They obviously were very keen that a new paediatric 20 cardiac surgeon should be appointed, so I asked why was 21 there so much importance to this and the quality of the 22 gentleman they were talking about, and Professor 23 Angelini said that there were problems in paediatric 24 cardiac surgery in the BRI and that a new cardiac 25 surgeon was needed to improve the situation. 0039 1 Q. Did they descend into particulars about procedures? 2 A. They then went into particulars about the arterial 3 switch operation, which was the first time I had heard 4 that term, and that there had been an unacceptable 5 number of deaths. 6 Q. Did you which surgeon performed the switch operations? 7 A. No, I did not, but thinking back on it, I think 8 I believed that it was not James Wisheart, therefore by 9 fairly simple deduction, it was Mr Dhasmana. 10 Q. How did you react to this? 11 A. I was extremely concerned. I was being told that 12 something we should do well we were not doing well. 13 There was a strong statement from Professor Angelini 14 that children had died who need not have died. I had no 15 knowledge as to whether that was an accurate statement 16 or not, but it was a firm statement, and in order to 17 protect the children, that the operation had been 18 suspended. I was very concerned. 19 Q. The Inquiry has heard evidence from Professor Farndon, 20 who was shown a comment by you, I think, on his 21 statement, in which an aerospace analogy was used. Do 22 you remember that? 23 A. I can remember that. I probably did use aerospace 24 analogies every now and again, because one leans on 25 one's background. 0040 1 Q. What was your recollection? 2 A. My recollection is that in aerospace if you do a series 3 of events which give an unsatisfactory outcome, you stop 4 doing it, think it out and come up with a solution, but 5 my analogy was drawn about the paediatric cardiac 6 surgery, the specific procedure of the arterial switch, 7 that if that was unsatisfactory then it should be 8 stopped. Professor Angelini said it had been stopped. 9 Q. So there was nothing, as you understood it, left to stop 10 in terms of the switch procedure, because this 11 procedure, for which the results were poor, had already 12 been suspended? 13 A. The emphasis at that meeting was on neonates and that 14 the operation had been suspended. I did not make a link 15 at that time as to whether there was any linking with 16 older children where the situation might be different. 17 The emphasis was on very young children, the term 18 "neonates" being an introduction to me of that term. 19 Q. So is it right that the impression you were left with 20 was that this particularly troublesome procedure, as far 21 as Professor Angelini and Professor Farndon had it, had 22 been suspended, so that procedure at least was not going 23 to recur in the immediate future? 24 A. That is correct. 25 Q. So there was nothing immediately to be done about that 0041 1 procedure? 2 A. The understanding I had was that the patients were being 3 safeguarded by this procedure not taking place. 4 Q. In paragraph 17 of your statement, WIT 102/28, you refer 5 to concern being expressed in the discussion that 6 Mr Wisheart might block the appointment of Mr Pawade. 7 Who expressed that concern? 8 A. It was probably Professor Angelini. It was the 9 impression that I gained at the time. 10 Q. Why on earth should Mr Wisheart want to block the 11 appointment of Mr Pawade? 12 A. Both then and now, I do not really know that Mr Wisheart 13 ever dreamt of doing such a thing. 14 Q. We have seen Mr Wisheart's comments on your statement. 15 A. Yes. 16 Q. He says that Mr Pawade was the first choice and his 17 first choice. 18 A. Yes, and there were no problems whatsoever in the 19 Appointments Committee. 20 Q. You were a member of that Appointments Committee? 21 A. Do I remember -- 22 Q. You were a member? 23 A. I was the Chairman. 24 Q. Mr Wisheart as Medical Director would have sat on it? 25 A. In fact he was sitting there as I recall in place of 0042 1 Dr Roylance; he was on leave. 2 Q. Because I think Mr Nix explained that Mr Nix would 3 deputise for Dr Roylance on clinical matters and the 4 Medical Director for clinical matters? 5 A. Yes. I have seen that explanation. 6 Q. At this meeting with Professor Farndon and Professor 7 Angelini and yourself, was there anyone else present? 8 A. No. 9 Q. Had anyone else come into the meeting during its course? 10 A. No. 11 Q. Dr Roylance? 12 A. No, he did not attend. 13 Q. I think you have seen the evidence that has been given 14 to the Inquiry by Professor Angelini -- the references 15 are various, but Day 61, pages 97, 107 and 170 -- that 16 you called Dr Roylance into the meeting? 17 A. No, I did not call Dr Roylance in. I am not sure 18 exactly of the timing, but this was at a time when 19 Dr Roylance was going on leave and that was the reason 20 he was not going to be at the Appointments Committee. 21 I have a specific recollection of talking to Dr Roylance 22 at some time after he returned about the fact that there 23 was this meeting with Professors Angelini and Farndon. 24 Q. We will come to that. Was there any discussion at the 25 meeting with Professors Farndon and Angelini in carrying 0043 1 out some external assessment or audit? 2 A. No, not that I recall. 3 Q. Did those two Professors come to you wanting you to do 4 anything about paediatric cardiac surgery, other than 5 make sure there was no accreditation problem with 6 Mr Pawade? 7 A. No, I think what they wanted me to do was to make sure 8 there was no accreditation problem with Mr Pawade and of 9 course to express their support for Mr Pawade as being 10 the right candidate. 11 Q. If we go to your statement, 102/28, where we are, 12 paragraph 19, this is a point you just made to me: when 13 Dr Roylance returned from holiday you raised the points 14 with him. You see the next paragraph goes on to discuss 15 where you had got to by Christmas 1994. 16 To what extent are you able to be precise about 17 the dates and timings of discussions with Dr Roylance 18 and Mr Wisheart in the wake of the meeting with Farndon 19 and Angelini? 20 A. I am not able to be very precise. One of the 21 characteristics that I have is that when I retired in 22 1994, I made a plan for a fairly substantial amount of 23 holidays during the year, including sailing my boat up 24 to Scotland and travelling and sailing in America, and 25 I know that for a fairly significant amount of the end 0044 1 of September into October I was not in the Trust, so 2 I cannot pin down the date when I talked to Dr Roylance. 3 It was pretty soon after he and I got back 4 together, but I cannot be any more precise than that. 5 Q. So it would be the autumn of -- 6 A. It is more likely to be October than September. 7 Q. In paragraph 19, you say you began to hear from 8 Dr Roylance for the first time that the anaesthetists 9 had concerns, the name "Bolsin" and the name "Peter 10 Doyle". So Dr Roylance mentioned those three factors to 11 you, did he? 12 A. Yes, he did. 13 Q. At about October 1994? 14 A. Yes. 15 Q. So if it was suggested that Dr Roylance did not know of 16 Dr Bolsin's connections with the Department of Health or 17 with Peter Doyle until later -- 18 A. I am not suggesting that. I am just saying that the 19 names "Bolsin" and "Peter Doyle" came to me in that 20 period. 21 Q. So there was no suggestion to you that there was a link, 22 necessarily, between Bolsin on the one hand and Doyle on 23 the other? 24 A. I am not sure that I understand. 25 Q. You mention in the paragraph first of all Dr Roylance 0045 1 telling you that the anaesthetists had concerns? 2 A. Yes. 3 Q. That is the first point; the name Bolsin is the second 4 point; and the name Peter Doyle? 5 A. Yes. 6 Q. There was in fact a link between Dr Bolsin and 7 Dr Doyle. That's why Dr Doyle had come to Bristol in the 8 first place in July 1994, which then gave rise to the 9 letter to Professor Angelini, so there was a link 10 between those two? 11 A. In the first discussions with Dr Roylance after we got 12 together about what Professors Farndon and Angelini had 13 been saying, I do not think that a link came out at that 14 time. 15 Q. That is the point. 16 A. I think that the link between the two arose later, 17 between October and the end of the year. 18 Q. To the extent it arose between October and the end of 19 the year, how did you first know about the link between 20 Dr Bolsin and the Department of Health? 21 A. Dr Roylance and I had many discussions about many 22 subjects. I am sure he was the one who said that 23 Dr Bolsin was keeping Dr Doyle informed of his concerns, 24 and that matters had -- you know, concerns that 25 Dr Bolsin had about the results had been passed directly 0046 1 to Dr Doyle. 2 Q. Might it not have been Professor Angelini who was 3 keeping Dr Doyle informed? 4 A. That is possible, but I do not think that is what was 5 said at the time. 6 Q. You see, if we go back to Professor Angelini's reply to 7 Dr Doyle, if we just go back briefly to UBHT 61/273, 8 over the page, you see at the very end Professor 9 Angelini says to Dr Doyle: 10 "I will keep you informed all the way along." 11 A. It could have been. I think Dr Roylance felt that 12 Dr Bolsin was involved, but pinning down the timing of 13 that I find difficult in retrospect. 14 Q. You say that you had a discussion with Dr Roylance when 15 you returned from your lengthy holiday and Dr Roylance 16 returned from his holiday. Are you sure that 17 Dr Roylance was on holiday at that time? 18 A. I know he was on holiday at the time of the Appointments 19 Committee because it was the reason that Mr Wisheart was 20 standing in for him; as I recall, he was on two or three 21 weeks leave or something at that time. 22 Q. The appointments committee, I think, was on 20th 23 September? 24 A. So I believe. 25 Q. We were dealing with what you discovered then in the 0047 1 latter part of 1994. When you heard that the 2 anaesthetists had concerns and the Department of Health 3 were involved in some way with this chap Doyle, how did 4 you react to this information that the concerns were 5 widely held among other clinicians? 6 A. Fundamentally, talked to Dr Roylance about it. 7 Q. What was the nature of the discussion? 8 A. He knew of these concerns; he knew Dr Doyle was 9 concerned; and at some period October, November, 10 December, there was a letter to Dr Roylance and a letter 11 from Dr Roylance which I remember. 12 Q. I am sorry? 13 A. Correspondence between Dr Doyle and Roylance at some 14 point in that period. 15 Q. You saw that? 16 A. Yes. 17 Q. The stuff we have already seen this morning? 18 A. No. 19 Q. Other correspondence? 20 A. As I recall, yes. 21 Q. In paragraph 20 of your statement, page 28, you say: 22 "By Christmas 1994 I had reached the point where 23 I told Dr Roylance that I wanted an independent inquiry, 24 and he agreed." 25 A. Yes. 0048 1 Q. I do not think we have seen any correspondence, memos or 2 notes from you to him or from he to you dealing with 3 such an agreement. 4 A. No. We were positioned about 30 feet apart, so we had 5 these very regular discussions. I can remember going 6 away for the Christmas break and saying, "John, I think 7 we need to have an inquiry". 8 Q. That would have been into what, precisely? 9 A. Into whether there was or was not a problem. It would 10 have been an inquiry to try and put on the table in an 11 analytical way what the situation was. 12 Q. Dealing only with the neonatal switch operation, or -- 13 A. No, I think at that time the concerns must have been 14 broader; they really had to cover the behaviour of the 15 unit as a whole. At that time I thought that the centre 16 of problem was the neonatal switch, but it really should 17 be a wider inquiry. 18 Q. May I finish this point off, and then it will be time 19 for a short break. 20 If you and Dr Roylance had agreed that by 21 Christmas, why was one not set up by Christmas, or early 22 in January? 23 A. I thought that Dr Roylance agreed with me but he had to 24 go off and think about it. I thought that in January he 25 started the mechanism for setting up an inquiry, to find 0049 1 the people to actually do the job. 2 Q. Before any question of the Joshua Loveday operation? 3 A. I thought so, but I cannot -- 4 Q. You are not sure about that? 5 A. No, I cannot pin that down. 6 Q. We know there was an inquiry subsequently and 7 Marc de Leval and Stewart Hunter's report was produced. 8 Was that the type of inquiry which you say you 9 Dr Roylance had agreed upon by Christmas 1994? 10 A. There are probably two or three questions within that 11 one. 12 Q. I am sorry, could you repeat that? 13 A. I think within that there are two or three questions. 14 I thought that there should be an inquiry to find out 15 whether we had a problem, to pin that down as a series 16 of facts, an analytical inquiry. It is a fact that 17 there was an inquiry by Mr de Leval and Dr Hunter in 18 February. 19 Q. Yes. 20 A. Was that investigation what I had expected? In 21 principle, yes, independent experts coming in and 22 looking at the situation. 23 MR MACLEAN: We will explore the circumstances in which they 24 did come in in a little more detail perhaps after 25 a short break. 0050 1 THE CHAIRMAN: Yes, shall we take a break, then, until 2 12.05? Thank you. 3 (11.50 am) 4 (A short break) 5 (12.10 pm) 6 MR MACLEAN: Mr McKinlay, just before we move on, can I go 7 back to this question of the Trust Board's awareness of 8 the problem? You remember the letter from Dr Roylance 9 to Dr Doyle. We know that you had a meeting with 10 Professor Farndon and Professor Angelini before 11 Mr Pawade's interview. That interview was on 20th 12 September. 13 Can you be any more precise as to how far before 14 the interview the meeting with Farndon and Angelini was? 15 A. I think it was like "the Appointments Committee is next 16 week". That is the recollection that I have. So we are 17 talking somewhere in the region of seven or eight days. 18 Q. In fact the letter from Dr Roylance to Dr Doyle was 12th 19 September, that is eight days before the Appointments 20 Committee. The meeting with Angelini and Farndon, do I 21 have this right, was the first time that anyone 22 descended to particulars with you about concerns, about 23 specific procedures and so on? 24 A. Yes. 25 Q. You did not discuss that meeting, those concerns that 0051 1 were expressed to you with Dr Roylance until some time 2 after the appointments committee meeting which appointed 3 Mr Pawade? 4 A. That is my recollection, yes. 5 Q. On 12th September 1994 when Dr Roylance wrote his letter 6 to Dr Doyle talking about the Trust Board's awareness of 7 the problem, you for your part either were not aware 8 because you had not had the meeting with Farndon or 9 Angelini or were only just aware but had not discussed 10 with Dr Roylance the particulars of the concerns? 11 A. That is correct. 12 Q. So what was the Trust Board's knowledge of problems with 13 paediatric cardiac surgery; where were the problems? 14 A. The Trust Board were not aware of problems in paediatric 15 cardiac surgery associated with procedures in the way 16 that Professor Angelini spelt it out on arterial switch, 17 they were not aware of that. The Trust Board would only 18 be aware there was a plan to move all paediatric cardiac 19 surgery to the Children's Hospital. 20 Q. And perhaps there was a plan to appoint a new surgeon? 21 A. Yes, I think they would be aware of that. Probably not 22 as specifically as I was, I was going to chair the 23 committee. Yes, they probably would be aware of that. 24 Q. They would be aware of those two steps being "in the 25 offing", if you like? 0052 1 A. Yes. I think the Trust Board looking at the history, 2 they probably would have been aware of the appointment 3 of the new surgeon because they would have been aware of 4 the attempt to appoint a new Professor of Cardiac 5 Surgery at an earlier date, they would have had that 6 knowledge. 7 Q. Do you remember specifically any discussions with 8 Mrs Rachael Ferris about paediatric cardiac surgery or 9 the culture in which cardiac services were delivered? 10 A. I can remember discussions with Rachael Ferris, yes, 11 both as part of walking around the hospital and talking 12 to people, but also by Rachael Ferris coming to talk to 13 me, on at least one if not two occasions. I cannot 14 speak to a particular date, but Rachael was concerned 15 about the organisation of cardiac services. I think 16 that was primarily the subject we talked about. 17 Q. She referred in her statement and I think in her 18 evidence on 10th June 1999, Day 27, page 97, about the 19 "culture of fear and blame", as she put it, of the 20 Trust. She said she had discussions with you 21 specifically. Do you remember her bringing that type of 22 general concern about the atmosphere of the place to 23 you? 24 A. Using the terminology "fear" and "blame", no, but 25 concern about the atmosphere and the need to improve, 0053 1 yes. 2 Q. What was her concern specifically so far as you 3 remember? 4 A. I think it could be summed up as being the efficiency of 5 the cardiac services unit. 6 Q. Let us go to your statement, WIT 102/29, please, 7 paragraph 21. We dealt with this just before the break, 8 you may remember, about the business of the inquiry. 9 "My recollection is that here Mr Wisheart had 10 started to explore with the Royal College of Surgeons 11 the identification of experts who might conduct the 12 inquiry". 13 You have seen what Mr Wisheart says about this, 14 I think, have you? 15 A. I think I have seen that he started on or about 12th 16 January. 17 Q. You will see that he says that he first sought advice 18 about the identity of experts for the inquiry from 19 Mr Parker. He did that shortly after the Joshua Loveday 20 operation? 21 A. Yes, I thought he also said something about discussions 22 with Dr Roylance about it. 23 Q. He says, if we go to WIT 102/40. There is specific 24 reference to paragraph 21, it is there under the heading 25 "Comment", do you see? 0054 1 A. Yes, I see that reference. I thought there was another 2 one. 3 Q. There is, if you go back to page 39, when he deals with 4 your paragraph 20, the very bottom of the page: 5 "My first recollection of proposals for an 6 inquiry re conversations I had with Dr Roylance prior to 7 the Joshua Loveday operation." 8 A. That means it was prior to 12th January, which 9 is not very long after Christmas 1994. 10 Q. No. Look back to your statement, please, page 29. In 11 paragraph 22 you refer to knowledge of a switch 12 operation of Joshua Loveday. The second sentence: 13 "I learned about it a day or two after the event 14 from Dr Roylance". 15 By the time you knew about Joshua Loveday, the 16 child had unfortunately already died? 17 A. Yes. 18 Q. You set out in that paragraph what you learned. The 19 last sentence: 20 "I did learn later from Dr Roylance that the 21 urgency of operating the next day had possibly not been 22 fully justified on clinical grounds." 23 What were you told about the urgency of the 24 operation? 25 A. I asked Dr Roylance, did the operation have to take 0055 1 place that day, 12th January and he said that he 2 understood that it did. I gathered the impression from 3 Dr Roylance later, obviously there were more discussion 4 on it, that perhaps the next day was an exaggeration. 5 Q. Dr Roylance, the initial impression he gave you was that 6 it was a matter of operating the next day? 7 A. I think to be quite clear it was that he had been 8 informed that it was a matter of operating quickly. 9 Q. Yes, because he himself had not been at the meeting the 10 night before? 11 A. No. 12 Q. He reported to you his understanding that it was 13 a question of the next day, but subsequently -- 14 A. Subsequently I felt that he had moderated that somewhat. 15 Q. Do you know why that moderation should have come about? 16 A. No. 17 Q. When he did modify it, as you put it, to not being 18 a question quite of the next day, how urgent did you 19 understand the modified position to be? 20 A. That the child needed attention, the child needed 21 procedure. But it might not have been as urgent as the 22 next day. 23 Q. Did you have any idea of when the long-stop was? 24 A. No. No, I felt that the whole impression was that the 25 need was still pressing. 0056 1 Q. Did you ask whether or not the need was such that 2 something had to be done before Mr Pawade was going to 3 arrive in May? 4 A. I do not recall asking that question. This after all 5 was in January and Mr Pawade was not arriving until May, 6 so that was a long wait. 7 Q. Your impression was, that is the reason you did not ask 8 the question, that there was no question of the child 9 waiting for Mr Pawade? 10 A. That is certainly the impression I got. The information 11 I was given immediately after the operation was that the 12 situation was urgent. I gathered it may not have been 13 the next day, but it remained a pressing requirement. 14 Q. What about the possibility that the operation might have 15 been done the next day or within a few days somewhere 16 else? 17 A. Did I discuss that with Dr Roylance? 18 Q. Yes. 19 A. I do not recall specifically discussing that with 20 Dr Roylance. 21 Q. Other patients who perhaps were going to need a neonatal 22 switch operation which had been suspended from October 23 1993, were presumably being referred elsewhere? 24 A. Logically. 25 Q. Did you have any details of where the substitute centre 0057 1 was for those patients? 2 A. No. At some time the Brompton Hospital was mentioned. 3 At some time Birmingham Hospital was mentioned, but 4 I had no sort of collated view of where these children 5 might be going. 6 Q. At all events, you did not raise the question with 7 Dr Roylance nor he with you of whether Joshua Loveday 8 could have been sent elsewhere? 9 A. No. I asked why an arterial switch operation had taken 10 place at all because it was my understanding that 11 arterial switch operations had been suspended. That is 12 when I was introduced to the point, obviously it was 13 quite a substantial point, that the statistics for older 14 children were better than those for neonates and the 15 suspension talked about previously was specifically for 16 neonates. I had not tied all that up in my mind at that 17 time. 18 Q. That point having been explained to you, you accepted 19 the apparent wisdom of the operation? 20 A. I think I accepted the fact that the operation had taken 21 place and that the child had died. It made me even more 22 sure that we had to have an inquiry because there were 23 still concerns around senior people. 24 Q. What did you know about the meeting that had taken place 25 the night before the operation? 0058 1 A. Only by a report from Dr Roylance that such a meeting 2 had taken place. 3 Q. What was your view of the fact of that meeting having 4 taken place? 5 A. I am not sure neither then nor now whether that is 6 unusual that there was a meeting taking place. I was 7 not sure then what the content of that meeting had been, 8 but it had taken place. I knew that Dr Roylance had 9 been consulted because he told me so and he had left the 10 decision with the clinicians. 11 Q. At this stage you yourself had not had any contact with 12 the Department of Health? 13 A. No. 14 Q. Can we have a look at UBHT 61/253. Looking down the 15 page to the bottom, we see you were copied into this 16 letter amongst others? 17 A. Yes. 18 Q. I am not sure it is correctly spelt, is it, there? 19 A. It is fairly consistently spelt wrongly. 20 Q. If you go to the top of the page, this is the 16th 21 January. This is four days after Joshua Loveday's 22 operation. Professor Angelini says to Dr Roylance: 23 "It is sad we have failed to resolve the issues 24 of the paediatric cardiac surgery work internally. In 25 view of this, I share your opinion that an inquiry 0059 1 should be held on the paediatric work carried out in the 2 Department of Cardiac Surgery from 1988 to the present 3 day. I think this is the minimum requirement given the 4 recent circumstances and the bad feeling present in the 5 unit". 6 Then he goes on to suggest two names. The fact 7 Dr Roylance should have an opinion that an inquiry 8 should be held already by that time would be consistent 9 with the fact that you and he had agreed that by 10 Christmas 1994? 11 A. Yes, logically. 12 Q. Professor Angelini when he gave evidence suggested, and 13 I hope I summarise it fairly, that this letter was 14 effectively trying to put Dr Roylance on the spot by 15 stating that he, Professor Angelini, shared an opinion 16 that an inquiry should be held. Angelini was not 17 actually sure that Dr Roylance did hold that opinion, he 18 was trying to manoeuvre Dr Roylance into holding an 19 inquiry. 20 A. I cannot speculate on that. I have taken it at face 21 value since it ties up with what I felt that Dr Roylance 22 and I had agreed. 23 Q. You clearly remember you and Dr Roylance at about 24 Christmas agreeing that an independent inquiry of some 25 sort should be held into paediatric cardiac surgery? 0060 1 A. I remember that, yes. I remember going home for 2 Christmas thinking, you know, we had reached that point. 3 Q. How did you react when you got this letter? 4 A. I suspect not in any particular way. This was 5 a confirmation of something that I thought was 6 established and here he was talking about people that 7 were presumably perfectly suitable, but I did not know. 8 Q. If you go to 282, the same file, 61/282, this is 9 a letter from Dr Doyle to Dr Roylance. If we go over 10 the page you will see that you are copied into this one? 11 A. Yes. 12 Q. So is Professor Angelini. 13 A. Yes. 14 Q. We can see from the top of that page that Dr Doyle is 15 suggesting that all reasonable steps be taken to 16 expedite the proposed inquiry. 17 A. Yes. 18 Q. Do you remember seeing this letter? 19 A. I remember this letter, yes. 20 Q. What did you do when you got this one? 21 A. I do not remember any specific action, but generally 22 speaking at that time I had been asking Dr Roylance, you 23 know, "How is it going, setting up the inquiry?" and the 24 answer was, "It is being set up". 25 Q. Dr Roylance replied the next day, if we go to 284. 0061 1 Again you are copied into this reply: 2 "The Trust had decided not to perform complex 3 neonatal infant open heart surgery until there has been 4 resolution of the conflicting professional advice." 5 Then reference to "the assistance of external 6 experts" in the middle of the next paragraph. 7 "Mr De Leval was already on board and approaches 8 were being made to paediatric cardiologists. If it was 9 possible to find a suitable third person we shall do 10 so." 11 A. I remember this letter, yes. 12 Q. To what extent did that reflect your thinking at the 13 time? 14 A. It reflected it in as much as that it said we were 15 setting up an inquiry. 16 Q. If you go over the page, you see in that first paragraph 17 just below the middle of the paragraph, do you see the 18 sentence beginning "The bold steps"? 19 "The bold steps which were taken last year in 20 appointing a new paediatric cardiac surgeon and deciding 21 to move the children's work to the Children's Hospital 22 was primarily in relation to a specific problem of 23 a particular operation, a problem which we fully 24 acknowledge and no neonatal switch operation has been 25 carried out since." 0062 1 What do you make of that sentence? 2 A. I think that the plan to move the children's work to the 3 Children's Hospital, as I understood it from Mr Durie 4 and from what I gathered there, that had been around for 5 some time as both a wish and as a plan and it was 6 primarily driven by creating more space for adult 7 cardiac surgery. I do not personally relate that as 8 "a bold step" which was primarily in relation to the 9 specific problems of particular operations. 10 Q. It might be thought to be slightly odd, if you have 11 a specific problem with a particular operation, that one 12 would react to that by appointing a new surgeon and 13 moving the work to another hospital rather than simply 14 desisting from that particular operation? 15 A. I think as I understood it then that that operation had 16 been suspended and that they were looking for a new 17 paediatric cardiac surgeon who would be capable of 18 carrying out that operation. That to my mind is 19 uncoupled to moving the open heart surgery to the 20 Children's Hospital. 21 Q. For the reasons you have outlined? 22 A. For the reasons I have said. 23 Q. If we look down Dr Roylance's letter a little more, the 24 paragraph beginning "There was no discussion, statement 25 or understanding ..." There was an area of controversy 0063 1 over what had or had not been agreed. What was your 2 impression, can you add to what he told us earlier about 3 stopping infant cardiac surgery from September 1994? 4 A. I do not know what the reference is to "last 5 September". Dr Roylance seemed to be saying to Dr Doyle 6 that nobody from the Trust had said that they were 7 stopping infant cardiac surgery. But I am sure that at 8 least Professor Angelini, if not perhaps Dr Bolsin as 9 well had told Dr Doyle that neonatal arterial switch 10 operations had been stopped. I was not aware that 11 anybody had said anything beyond those specific 12 procedures. 13 Q. And Joshua Loveday, as we know, was not a neonatal case 14 at all? 15 A. That child as I understand it was older, was more than 16 one year old. 17 Q. The Hunter/de Leval report where inquiry wheels were set 18 in motion, there were in fact only two people on that 19 inquiry team, not three as suggested might have been the 20 case. Why was that, do you remember? 21 A. No, I did not take any part in setting up the 22 investigation. I actually thought at the time there 23 would be a button you could press in the National Health 24 Service which was marked "investigation" and the 25 procedures would follow and I thought that something 0064 1 fairly normal would be put in place. I did not 2 interfere with how the inquiry would be set up. 3 Q. You thought that somewhere in the Health Service there 4 would be an investigative unit, something of that sort? 5 A. Not necessarily an investigative unit. I think I knew 6 enough then that that was possibly unlikely. But there 7 would be an accepted procedure. 8 Q. Professor de Leval and Dr Hunter visited Bristol on 10th 9 February 1995? 10 A. So I believe. 11 Q. We know that Dr Roylance definitely was on holiday at 12 this time. If go to UBHT 7 52, this is a meeting of the 13 Executive Committee of the Board. Go to page 53. That 14 is 24th February this meeting. 15 "Dr Roylance reminded the Board he would be on 16 three weeks leave in Australia from the coming weekend." 17 24th February 1995 was I think a Friday. 18 Dr Roylance is going on holiday for three weeks more or 19 less from then. 20 Can we go to UBHT 58/65. This is a meeting of the 21 Executive Committee on 17th March. If we scan down the 22 page. Go up to see who attends this meeting. We see 23 from that that Dr Roylance is not at this meeting? 24 A. Right. 25 Q. If we go down to letter F: 0065 1 "An independent report has been produced by 2 Mr Marc de Leval and Dr Stuart Hunter and was received 3 by the Trust on 25th February 1995. The recommendations 4 for UBHT in the report were felt to be acceptable, but 5 a number of comments were incorrect and in some cases 6 extremely damaging to the Trust and to individuals if 7 taken out of context. A group chaired by Mr McKinlay 8 had considered the report in detail and there had been 9 a meeting with Miss Rennie Fritchie [which we will come 10 to] and Dr Scally. The chairman and Mr Nix had held 11 three evening meetings with all interested parties: 12 cardiac surgeons, anaesthetists, radiologists and 13 cardiologists to consider the report." 14 Before we go to the details of this, what was your 15 overall impression of the Hunter/de Leval report when 16 you first saw it as an investigation into the matters 17 that needed investigating? 18 A. I thought it drew very powerful conclusions on what had 19 obviously been a very limited investigation because by 20 that time I knew they had spent very little time in the 21 hospital. So I thought that the conclusions were 22 surprisingly strong and to my recollection there was no 23 quoted statistics in the report. They obviously had 24 received the statistics but they were not quoted in the 25 report. 0066 1 A further discussion which took place in the 2 meetings cited here with the consultants, it was obvious 3 there was confusion between two sets of information that 4 had been presented to the two independent investigators 5 and it was not clear on which set of information they 6 were drawing their conclusions. I got confused and 7 annoyed that we had ended up with a report on something 8 which was obviously very important but not very 9 satisfactory. 10 Q. I am asked to say that Dr Roylance was there when 11 Professor de Leval and Dr Hunter made the visit but not 12 at the later meeting. I hope I have made clear from the 13 minute of the meeting of 24th February he was going on 14 holiday from that weekend and therefore would not have 15 been on holiday from 10th February. If that was not 16 clear, I hope it is now. 17 What you have just told us about the report, 18 Professor de Leval and Dr Hunter were apparently eminent 19 people in their field and eminently qualified to produce 20 such a report, to conduct such an inquiry, I should say? 21 A. Yes. 22 Q. Yet you said that they had only spent a limited period 23 of time in the hospital in order to do their on the 24 ground research. Did you think it had all been done in 25 rather a hurry? 0067 1 A. I did not really know the lead-up to Mr De Leval and 2 Dr Hunter coming into the hospital in any detail. 3 I only knew subsequent to the production of the report 4 that they had spent a very short time in the hospital, 5 one or one-and-a-half days, something of that order, and 6 I thought that that was a bit limited for the importance 7 and complexity of the subject. 8 Q. The report had been delivered to the Trust on 25th 9 February which was just a little over a fortnight after 10 the two men had been to visit? 11 A. That is correct I believe, yes. 12 Q. And they were practising clinicians who were no doubt 13 busy in the interim? 14 A. No doubt. 15 Q. So it had been produced fairly quickly, this report? 16 A. I think it had been produced very quickly, yes. 17 Q. You first learned about it from Mr Nix, I think you said 18 in your statement? 19 A. Yes, I think he was standing in for Dr Roylance and he 20 actually collected the copy of the report. 21 Q. When you first physically saw it, it was from Mr Nix? 22 A. I believe, yes. 23 Q. Can we go to WIT 102/30? This is your statement again, 24 paragraph 27. You say: 25 "The draft and how it should be handled was 0068 1 discussed with Mr Nix, Dr Laszlo [who was Chairman of 2 the HMC] and Mr Wisheart." 3 Why was a discussion as to how it should be 4 handled with Mr Wisheart who was himself in part the 5 subject of it? 6 A. That is true, but he was also the medical director of 7 the Trust at that time, that is what happened in my 8 recollection. 9 Q. Do you think it was a wise idea that Mr Wisheart should 10 be responsible for discussing the handling of a report 11 which was in part concerned with his own surgical 12 performance? 13 A. I do not think that Mr Wisheart being involved at that 14 stage in the discussions did any damage of any sort to 15 the way the report was handled. If we had our time over 16 again, which is not given to all of us, but if we had 17 our time over again it probably would have been better 18 if Mr Wisheart had not been effectively a client for the 19 report, if he had stood further away from the report. 20 Q. You have seen what Mr Wisheart says about this in his 21 comments on your statement. He says in answer to this 22 paragraph: 23 "I was not part of nor had I any input into the 24 discussions and plans to which Mr McKinlay refers ..." 25 I think in fact a memo was produced, was it not, 0069 1 for you dealing with the report from Dr Laszlo and 2 others? 3 A. Yes, a commentary. 4 Q. A commentary? 5 A. Yes. 6 Q. Before we go to the commentary can we go to PAR1 5/141? 7 This is a copy of the Hunter/de Leval report, yes? 8 A. Yes. 9 Q. If we scan down the page, there is manuscript 10 annotations on this. Can you tell me if any of it is 11 your writing first of all? 12 A. No, that is not my writing. 13 Q. If we go over the page? 14 A. No, that is not my writing. 15 Q. Do you know whose writing it is? 16 A. No, I do not. No, I do not. 17 Q. Top of the page, for example the words "highly 18 disorganised". That is, I think, regarding the 19 intensive care unit and the suggested replacement is 20 "could be better coordinated"? 21 A. Yes. 22 Q. Go down the page again some more alterations; none of 23 that is your hand? 24 A. No, that is not my handwriting. 25 Q. Over the page again? 0070 1 A. No. 2 Q. When you received this report with whom did you discuss 3 it yourself? 4 A. Mr Nix and Dr Laszlo, these were the primary contacts. 5 Q. Dr Laszlo has said in his statement, we do not need to 6 go to it but the reference is WIT 100/22 at 25, 7 paragraph 14, and he prepared the memorandum. The 8 memorandum is UBHT 52/271. This was prepared for your 9 consumption, I think? 10 A. Yes, it was. 11 Q. It was prepared following a meeting, as we see from the 12 top of the page, involving Dr Joffe, Monk and Laszlo 13 with Professor Vann Jones? 14 A. Yes. 15 Q. Whose writing do we see here? 16 A. That writing is mine. 17 Q. If we scan down the page and over the page down to the 18 bottom, please, 7.5: 19 "We strongly disagree with the conclusion on the 20 last line of page 4 ..." 21 The last line of page 4, the Hunter/de Leval 22 report was the reference to a "higher risk surgeon"; do 23 you remember that? 24 A. Yes. 25 Q. "No data are presented to show how this surgeon is 0071 1 ranked nationally. In the tables provided there is no 2 significant difference between the mortality figures of 3 the two surgeons. The total number of deaths in 1992-5 4 was very similar..." 5 That writing which would appear to be the same as 6 on the previous page, which would be yours: "This para 7 is not easy to follow". 8 Did you ask for some clarification of the 9 memorandums dealing with the reference to "higher risk 10 surgeon"? 11 A. Not as such on that commentary. That, as I recall, was 12 produced effectively in parallel with the discussions 13 which we had with the consultants where we went through 14 the report line by line, so that I do not recall asking 15 a specific question on that to get it clarified on that 16 commentary. I think I probably took the effective 17 answer from the discussion with the consultants. 18 Q. Did you ever speak to Professor de Leval? 19 A. No, I have never spoken to Mr de Leval. 20 Q. Or Dr Hunter? 21 A. No. 22 Q. Can we go to WIT 100/26, please? This is Dr Laszlo's 23 statement to the inquiry which I mentioned earlier. Let 24 us scan up the page and put it in context for you, 25 Mr McKinlay. He talks about attending a meeting at the 0072 1 Regional Health Authority. That was on 9th March, we 2 will come to that. You were at that meeting with Rennie 3 Fritchie? 4 A. Yes. 5 Q. If we go down the page to 17: 6 "Subsequently Mr Nix and Mr Wisheart showed me 7 a few amendments to the report which they hoped to have 8 made in the event of the Trust being asked to publish 9 the document. These were only minor and in one or two 10 places they asked for some of the phrases 11 to be softened and made less colloquial. The version 12 I was shown for approval was not changed in any material 13 way. I was surprised later to see that the second 14 version submitted by Professor de Leval did not contain 15 the reference to a 'high risk surgeon'. I had not 16 expected our comment on this to be transmitted to the 17 reviewers. I was assured that Professor de Leval 18 himself had made the major changes, on the basis that he 19 had not expected the original report to be made public." 20 Can you comment about any suggested changes that 21 Mr Nix and Mr Wisheart should have made? 22 A. Not from a recollection at the time. I have seen the 23 report with some recommended changes on it as you showed 24 a few minutes ago, but at the time I did not know that 25 they had put forward recommendations for change. 0073 1 Q. You are not able to tell us from any direct evidence who 2 did or did not speak to Professor de Leval? 3 A. I know that I spoke to Dr Roylance when he came back and 4 said that I was concerned that if we released the report 5 as it was written then de facto the Trust would be 6 endorsing a report and no amount of fine print would 7 avoid that and I was very unhappy that the quality of 8 the data that had been used was suspect and would he 9 communicate that to Mr de Leval. 10 The only thing I know is that he did talk to Mr de 11 Leval and that he took legal advice. I am not aware of 12 any comments by Mr Wisheart or Mr Nix that were fed into 13 that discussion. 14 Q. Who took legal advice? 15 A. Dr Roylance. 16 Q. On behalf of the Trust? 17 A. On behalf of the Trust. 18 Q. If we go to UBHT 332/1 and scan down the page. This, as 19 it says from the second paragraph: 20 "Is intended to record the legal advice and the 21 practical views on the way forward expressed this 22 morning." 23 This is the legal advice Dr Roylance got about the 24 contents of the Hunter/de Leval report? 25 A. I did not see it at the time, I only saw it this 0074 1 morning. 2 Q. And it was obtained following a conversation between the 3 solicitor and Graham Nix and meetings with Graham Nix, 4 Mr Wisheart and Dr Roylance, so it would seem? 5 A. I have no reason to dispute that. Certainly Graham 6 would be involved because after the meetings with the 7 consultants Dr Roylance had not immediately returned 8 from holiday, there was a period when Graham Nix was 9 still effectively in charge. 10 Q. You were not a direct consumer of this legal advice? 11 A. No. 12 Q. But you knew that legal advice had been sought? 13 A. I knew that Dr Roylance had sought legal advice, yes. 14 Q. What did you understand the thrust of the advice to be? 15 A. The same as my feeling, that we must not be endorsing 16 a report which had suspect data. 17 Q. So what would happen; what were the appropriate steps? 18 A. The point that the report was going to be made public 19 should be made to Marc de Leval and that he should be 20 asked did he want to amend it. I was not aware that he 21 was asked to amend it in any particular way, but just to 22 be informed that it was going to be made public. 23 Q. Did you expect the version that would be made public to 24 be toned down? 25 A. Did I expect that? In a sense I could have expected 0075 1 anything, I think Mr de Leval could have stuck to his 2 views. In the event what he came back with was toned 3 down, yes. 4 Q. Did you understand the substance of what he came back 5 with to be different from the substance of the first 6 report? 7 A. It was significantly different in that there was no 8 reference to a "higher risk surgeon" and that part of 9 the report had been toned down very substantially. 10 Q. You wrote to the Regional Health Authority on 3rd March: 11 UBHT 52/260. You say, the first bullet point: 12 "To protect Mr Wisheart I have requested him not 13 to deal with media queries, leave it to 14 Gabriel Laszlo..." and so on. 15 "This does not mean that the Trust agrees with 16 the statements made in the report concerning 17 Mr Wisheart." 18 Did it mean that the Trust disagreed with the 19 statements? 20 A. No, talking for myself I thought the situation was open, 21 that comments had been made about Mr Wisheart but the 22 data was suspect. 23 Q. Why should the Chairman of the Trust be writing to the 24 Chair of the Regional Health Authority, what was its 25 role in all of this? 0076 1 A. They were to some extent representing the views of the 2 National Health Service executive in London. We had 3 contact with the headquarters in London, it was through 4 the regional chair. 5 Q. A meeting took place on 9th March 1995, UBHT 61/293. We 6 see who all is present. 7 A. Yes. 8 Q. There is no representative here from the purchaser, the 9 Avon Health Authority? 10 A. No. 11 Q. A point Mr Brooke made in re-examination of Dr Baker. 12 Was there any reason to expect the purchaser to be at 13 this meeting? 14 A. Certainly the purchaser might well have been at that 15 meeting, but the invitations came from Rennie Fritchie 16 and we responded. 17 Q. If we look down the page, paragraph 3: 18 "Mr McKinlay said that the Trust was facing 19 a complex issue. Mr McKinlay acknowledged that the 20 concern had been expressed for some time... Believed 21 that the Trust had the situation under control from the 22 middle of 1994 but ..." and so on. 23 What is that a reference to? 24 A. That is really a reference to the arterial switch 25 operation being suspended. 0077 1 Q. That is what you understood to be the key controlling 2 mechanism in the middle of 1994? 3 A. Yes. 4 Q. Nothing else? 5 A. No, not I think anything else at that time. 6 Q. If we go to paragraph 9 over the page, please: 7 "There was general agreement that the external 8 experts had done a remarkably efficient job in the short 9 time available to them." 10 Is that an accurate reflection of your feeling now 11 about the Hunter/de Leval report? 12 A. I am not really quite sure about the dates here. You 13 said that was dated 9th March, I think. 14 Q. 1995? 15 A. The consultants' meetings that took place were -- 16 Q. They were on 13th and 14th March, thereabouts. 17 A. Yes, my view of the report changed substantially after 18 the meeting with the consultants. 19 Q. And the change was for the worse? 20 A. Yes, it was. 21 Q. In that same paragraph there is reference, towards the 22 end: 23 "Mr Nix said because of the wording of parts of 24 the report, wider circulation within the Trust was not 25 desirable..." 0078 1 That is for the reasons we have already discussed, 2 is it? 3 A. Yes. 4 Q. Then the next thing that happens is 296, you write to 5 Rennie Fritchie on 15th March. You see from this letter 6 that you met with the cardiac surgeons, anaesthetists 7 and radiologists on Monday and Tuesday evening of this 8 week", and that is how I am able to date those meetings 9 to before this letter was written but after the meeting 10 we have just looked at, is that right? 11 A. Yes. 12 Q. By this time the protocol had been agreed? 13 A. Yes. 14 Q. The protocol, I need to find the reference, HA(A) 15 146/113. That is the protocol? 16 A. Yes. 17 Q. Please scan down the page. We see that at: 18 "1.3 Mr Wisheart will continue to operate on 19 children over 1 year of age for all conditions excluding 20 the AV canal. He will continue to see new paediatric 21 referrals up to 1st May 1995." 22 Over the page, the reference to Mr Pawade 23 arriving? 24 A. Yes. 25 Q. By this time these evening meetings had taken place; 0079 1 there was another meeting, was there not, an initial 2 meeting where the Hunter/de Leval report was discussed 3 in the presence of some of the clinicians involved? 4 A. Yes, I think that is right, yes. 5 Q. Bits of the report were shown on overhead projectors? 6 A. In the evening meetings we also showed the report page 7 by page on the overhead projector, as I recall but 8 I think on the first meeting, yes, you are right. 9 Q. The evening meetings were a reaction to the hostile 10 reception that the initial presentation of the report 11 had got from some of the clinicians? 12 A. No, I do not think they were. I think, speaking again 13 for myself, they were to try and understand the 14 situation. We had a report that was very firm on some 15 points and I needed to understand where that information 16 was coming from as to whether the Trust would simply 17 endorse the report or not. I think Graham Nix felt the 18 same, but I certainly felt quite strongly that we could 19 not accept a report like that without understanding it. 20 Q. There was some reference in the evidence of 21 Professor Angelini to the fact that he and Dr Bolsin 22 were victimised by you and by others present at some of 23 these meetings discussing this report for having, as he 24 put it, "dragged the Trust into this situation"? 25 A. No, I think that Professor Angelini is being a little 0080 1 sensitive there. I was certainly annoyed that the Trust 2 -- and clearly with some history behind it which was 3 gathering in my mind all the time -- had set up an 4 investigation and the results were confused. That is 5 what -- the quality of the investigation and the report 6 certainly annoyed me at that time. 7 Professor Angelini had a slight tendency to ignore 8 some of the statistics, but I do not think the Trust 9 could do that. I think the Trust had to understand what 10 it was being told. It was important from the point of 11 view of the Trust and the individuals involved. 12 Q. After the immediate aftermath of the Loveday operation 13 and the protocol and so on, there was a process of 14 conciliation which was entered into involving 15 Mr Wisheart, Mr Dhasmana and Dr Bolsin. You wrote to 16 Dr Bolsin on 5th May 1995. This is UBHT 61/394. You 17 see you are asking there for "urgent supply of detailed 18 evidence". 19 Did you receive any "detailed evidence" from 20 Dr Bolsin at that stage? 21 A. Yes, I received the -- not a report, I received what 22 I thought were extracts from the report of the 23 statistical evidence as he saw it on three particular 24 procedures, three or four, I cannot remember exactly. 25 Q. As you understood it he supplied you with the same 0081 1 information as he had supplied to Hunter/de Leval? 2 A. Yes, I understood that. 3 Q. Coming towards the end, Mr McKinlay, Mr Ross was 4 appointed as a new Chief Executive of the Trust towards 5 the end of 1995? 6 A. I think October. 7 Q. Were you on the interview panel? 8 A. Yes, I chaired the panel. 9 Q. There were a number of internal and a number of external 10 candidates? 11 A. Yes. 12 Q. And the internal candidates included Mr Wisheart and 13 Mr Nix? 14 A. Yes, they did. 15 Q. Mrs Maisey told the inquiry that Dr Roylance made no 16 secret of the fact that he thought having a doctor as 17 a Chief Executive was a good thing for the Trust. I may 18 have asked you this I think in passing earlier: what was 19 your view about the necessity or otherwise of 20 a medically qualified Chief Executive? 21 A. My view expressed then and quite often was that 22 I thought the primary requirement for being a Chief 23 Executive is that the person was a very good manager and 24 if he also happened to be a doctor that was fine. 25 Q. Do you ever recall being informed of a case in which 0082 1 Dr Bolsin was at some risk of criminal or civil 2 proceedings as a result of a procedure carried out at 3 the hospital? 4 A. Yes, at some point in -- I think in early 1995, yes. 5 Q. Can we have a look at UBHT 52/182, please? This is an 6 extract from a report which Dr Bolsin sent to you on 4th 7 November 1995. He also sent it to Mr Ross at the same 8 time; do you remember? 9 A. I remember. 10 Q. I do not think I need take you through much more of the 11 detail of it with you. He is referring here to 12 a discussion with Dr Roylance. Go to the bottom, can 13 I ask you to read the last two paragraphs there, please, 14 Mr McKinlay? 15 A. Yes. 16 Q. Let us go over the page. I think you only need to read 17 the first paragraph there. 18 A. Yes. 19 Q. Did anyone ever have to prevent you from applying the 20 rules of the aerospace industry? 21 A. No. 22 Q. Either to Dr Bolsin's case or anyone else's? 23 A. No, Dr Roylance was using some analogy which, I doubt if 24 I had ever been specific in trying to tie that analogy 25 with Dr Bolsin's case. We are pretty firm in the 0083 1 aerospace industry, we try to make sure mistakes are not 2 repeated, but I had not applied -- tried to apply 3 aerospace philosophy. 4 Q. Go back over the page, please, to 182. Again highlight 5 that bottom half of the page. This is Dr Bolsin's 6 report. It is a matter we can go into with Dr Bolsin 7 next week, but it may not be entirely accurate in every 8 respect this report, but this is his report to you and 9 to Mr Ross. 10 Do you ever remember a discussion between yourself 11 and Dr Roylance to the effect that he, Dr Roylance, 12 would have to protect Dr Bolsin from sanction by you? 13 A. No, I do not remember such a discussion. We did discuss 14 what might be appropriate for Dr Bolsin because there 15 was obviously a problem, that he was unhappy and there 16 was not a very great atmosphere in the operating 17 theatres. But, no, Dr Roylance did not have to hold me 18 back from taking some drastic action with Dr Bolsin. 19 I did not feel then or now that the right action 20 with Dr Bolsin approached anything like dismissal or 21 separation in any way from the Trust. 22 Q. If we go to your statement at WIT 102/14, paragraph 50, 23 you say: 24 "I believe that the difficulty in paediatric 25 cardiac surgery lay in the concerns being centred on 0084 1 senior members of the clinical team." 2 Who is that a reference to? 3 A. The medical director. 4 Q. "Coupled with being unable to convince the Chief 5 Executive to look into the concerns himself." 6 What is your evidence as to the reason why there 7 was an inability to convince the Chief Executive; is it 8 that the case made to the Chief Executive was not 9 persuasive enough, or was it that the Chief Executive 10 inappropriately failed to investigate the concerns 11 himself? 12 A. For whatever the reasons were I think that the problem 13 should have been investigated substantially earlier than 14 it was. 15 Q. What direct evidence can you give us about attempts made 16 by whoever to convince the Chief Executive to look into 17 the concerns himself? 18 A. I can give little direct evidence on that because 19 I entered into the frame effectively in September 1994. 20 I am aware of activities that took place before then, 21 and I have seen letters since that were interchanged, so 22 I cannot really pin down an answer to your question. 23 I was convinced then and I am now, that it should 24 have been investigated earlier and it should have been 25 investigated analytically without a predrawn conclusion, 0085 1 it should have been investigated just to find out 2 whether there was a problem. 3 Q. You were succeeded as the Chairman by Mr Jeffrey 4 Williams with effect from 1st December 1996? 5 A. Correct. 6 Q. You had been the Chairman for a little under two and 7 a half years. During your time as Chairman, was there 8 ever any discussion either formally or informally by 9 board members of articles about Bristol's cardiac 10 services in Private Eye? 11 A. There were discussions about articles in Private Eye 12 round about the time of the Hunter/de Leval report. 13 Q. So after the inquiry wheels were in motion? 14 A. Yes, that is when I became aware of them, that there had 15 been articles in Private Eye. 16 Q. Was that the first time you were aware of those 17 articles -- 18 A. I think so. 19 Q. -- which dated back to 1992? 20 A. Yes. 21 Q. Are you or have you ever been a Mason, Mr McKinlay? 22 A. No. 23 Q. When you left the Chairmanship of the UBHT, in what ways 24 do you think it was different from the organisation you 25 became Chairman of and why? 0086 1 A. We had a Chief Executive who was more of my way of 2 thinking, that we should be quite analytical in our 3 approach to medical outcome, that there should be 4 a statistical approach and that the board should be 5 involved, in some way still to be defined as part of the 6 control system on medical outcome. 7 On the management side, the same Chief Executive 8 had set up a central organisation which had a much more 9 proactive view of monitoring what was going on in the 10 hospitals, not speaking specifically about medical 11 outcome in that, but everything that was going on. So 12 there was more central control, more central monitoring. 13 Q. Mr McKinlay, those are all the questions I want to ask 14 you. There may be some questions from the panel. I am 15 told there is no re-examination from Mr Miller. Thank 16 you very much for giving your evidence. I am sure the 17 Chairman will remind you of the opportunity to put in 18 further written submissions later. Before he does that, 19 is there anything else that you want to add now to the 20 evidence you have already given? 21 A. I think the only thing I would like to say is that I did 22 not come into UBHT to sort out an identified problem in 23 paediatric cardiac surgery. If somebody had said come 24 in and do that I probably would have run a mile. It is 25 not a very good role for an engineer. Therefore, it 0087 1 took time for me to appreciate that there was 2 a problem. 3 Perhaps if I had my time again, but we do not get 4 that, some things might have moved for positively, but 5 I still came in with a view that the Trust was operating 6 quite satisfactorily. I had no mission to sort out 7 a problem in paediatric cardiac surgery. 8 MR MACLEAN: Thank you very much. Are there any questions 9 from the panel? 10 EXAMINED BY THE PANEL: 11 PROFESSOR JARMAN: Mr McKinlay, you stated in your witness 12 statement at page 10 that: "the board and executive 13 management required that the Trust provided a high 14 quality, safe treatment and care". 15 Then later on, page 23, paragraph 2 you say that: 16 "Standards against which questions could be posed 17 and followed up did not exist in this systematic 18 fashion." 19 You have said a number of times that you thought 20 there should be analytical data available to analyse 21 problems. Did you see any of the reports, and I will 22 give you an example, which is UBHT 55/68, which is the 23 paediatric cardiac surgery BRI. If we go to page 81 of 24 that -- 25 A. I have not seen that report, no -- sorry, let me see 0088 1 that. This is the report that was produced in January 2 1995, is that correct? 3 Q. No, this is an example of the reports of the paediatric 4 cardiac surgery of the BRI, the annual reports; they are 5 widely available. 6 A. No. 7 Q. If we go to page 81 to give you an example. This is 8 earlier than you were there, but these were available to 9 you, in line 6: "Under 1 year". Do you see where it 10 says "under 1 year. If you go along to the fourth 11 column the percentage death is 37.5. That is compared 12 with the last column on the same row for the UK of 18.8? 13 A. Yes. 14 Q. Reports of that type were freely available and you 15 wanted reports of that type; did you request them? 16 A. No, I did not, I did not know that reports of this type 17 were available. What I had asked for as an audit report 18 did not have this kind of information in it. 19 Q. What would you say to the suggestion that the 20 information that you wanted did actually exist? 21 A. It possibly existed. It did not exist in a form that 22 was put through to the board. 23 Q. But you wished to get this information and it was 24 available; did you request it? 25 A. No, I primarily wanted a system put in place where 0089 1 standards were set and performance against those 2 standards were measured. At the time when I was 3 projecting that view in the Trust, we are talking about 4 November 1994, I was not aware that there was a problem 5 in mortality in paediatric cardiac surgery. I was 6 putting forward something to me that was perfectly 7 normal. 8 Q. When you became aware, did you request that type of 9 information? 10 A. I requested the audit report, I did not request this 11 information because the audit report did not track you 12 through to this information. This information, by the 13 time I was asking for the audit report, was the content 14 of the information that Hunter and de Leval had produced 15 and which was produced by the Trust in January 1995 -- 16 January 1996. 17 THE CHAIRMAN: I have no questions. 18 Mr McKinlay, thank you very much for coming to 19 speak to us this morning and some part of this 20 afternoon. As Mr Maclean has made clear, if there are 21 other matters which come to your attention or you think 22 might help us, we would of course be glad to hear from 23 you, but for the moment at least thank you very much 24 indeed. 25 MR McKINLAY: Thank you. 0090 1 MR MACLEAN: If I could prevail upon Mr McKinlay for 2 a second, it may be appropriate to have a lunch break 3 until 2.00, perhaps? 4 THE CHAIRMAN: I think a rather shorter lunch break, but you 5 put me on the spot with my mathematics here. Let us say 6 1.50, shall we? 7 (1.10 pm) 8 (Adjourned until 1.50 pm) 9 (1.50 pm) 10 MR LANGSTAFF: re CLINICAL CASE REVIEW 11 MR LANGSTAFF: Sir, this afternoon we continue with the 12 evidence of Dr Martin. Before he is called to affirm, 13 can I just mention, again, something which I touched on 14 briefly last week? 15 Now that we are dealing with the clinicians 16 centrally involved in the provision of complex surgical 17 services in Bristol, and now that we have had presented 18 to us the results of the 80 cases reported on as the 19 Clinical Case Note Review, there will be occasions 20 during the evidence in the days to come when some of 21 those cases will be used in the chamber. 22 I think it is important, in particular for the 23 wider audience, that there is an appreciation of the way 24 in which we propose to present the evidence to the 25 Panel, which arises from the use of those cases. 0091 1 I think essentially, what I would like to do is to 2 make six points. The first is, of course, essential, 3 fundamental. It is that this Inquiry has to answer the 4 questions posed in its terms of reference. That is to 5 take a view as to the adequacy of care in the years 1984 6 to 1995. That necessarily supposes a view which is 7 general or broad, rather than particular, even although 8 we must never lose sight that the general is of course 9 composed of a number of particular instances of surgery 10 upon particular children, all of whom deserve an 11 identity of their own and have an identity properly of 12 their own. 13 Secondly, that it is important to use the clinical 14 cases from the case note review to have a broad 15 overview, a perspective, on care. 16 Thirdly, it follows that the cases will be 17 referred to not in order to determine each one of them 18 as though it were the subject of a clinical negligence 19 case. 20 There are a number of reasons for that: one of 21 them, of course, is that if we were to deal with one or 22 two cases -- and we have necessarily to be selective or 23 we would be here well into the next millennium -- it may 24 seem to be offensive to others that we were resolving 25 the dispute, if there is a dispute as to the quality of 0092 1 care in respect of their son or daughter, and not in 2 respect of others, and some people may feel disappointed 3 if we were to take that approach. 4 Secondly, of course, we are not a court of law 5 awarding compensation. Therefore, it is important that 6 the lessons to be learned which are in many ways more 7 subtle than they might be in a clinical negligence case 8 are learned from using the clinical cases in a proper 9 and effective way. 10 The next point which I make is that the Case Note 11 Review is, of course, itself a sample; it does not 12 pretend to be an exhaustive examination of each and 13 every one of 1,860-odd cases. Because it is 14 representative, views of what it shows may be 15 generalised from the sample to the whole, although due 16 allowance has to be made for matters such as statistical 17 variability, for reliability and it has to be 18 accepted -- although it may be difficult, one 19 appreciates, for some parents in some circumstances -- 20 that experts may themselves disagree as to how to 21 evaluate the adequacy of care in any particular case. 22 We are fortified by knowing that each of the 23 review teams has itself had a number of clinicians who 24 have been invited to say whether they could or could not 25 reach a consensus, and in no case have they failed to do 0093 1 so, although in a couple, as you know, there has been 2 some controversy as to whether it should be a 2 or a 3. 3 We are fortified, I think, in knowing that 15 of the 4 cases, in order to moderate the results, have been 5 checked through second panels with results which show 6 a striking degree of consistency, but not entirely 7 consistency. To the extent there is inconsistency, you, 8 the Panel, will have to evaluate what those cases show. 9 So essentially, the use of the cases will be as 10 exemplars, to illustrate points or themes which the 11 experts have, in the evidence that we heard a couple of 12 weeks ago, traced as running through the cases which 13 they dealt with, to illustrate particular facets that 14 make up the overall picture of adequacy of care so far 15 as the Clinical Case Note Review can show us. 16 One comes, of course, to the sixth point: that it 17 is only part of the jigsaw; it may be an important 18 piece, but then lots of other pieces also are important, 19 and I am certain that in the weeks to come those pieces 20 will play just as much a part as the Case Note Review. 21 I hope I have said enough to demonstrate that the 22 purpose in referring to such cases as will be referred 23 to is not to resolve on a "Yes" or "No" basis whether 24 the care was or was not below the standard that a court 25 of law might apply in determining whether to award 0094 1 compensation or not. 2 THE CHAIRMAN: Thank you, Mr Langstaff, save only that 3 I would add that they are used as exemplars of themes 4 concerning adequacy which have not only arisen from the 5 case review itself, but from the totality of evidence 6 gained from a variety of other quarters, which have 7 suggested or made observations about adequacy which we 8 can then, as it were, condense to another theme. 9 MR LANGSTAFF: I apologise for keeping Dr Martin with those 10 words, but if you would like to come forward now, 11 please. Dr Martin, would you stand, please, to affirm? 12 DR ROBIN MARTIN (AFFIRMED): 13 Examined by MR LANGSTAFF: 14 MR LANGSTAFF: Sir, we have with us two experts: Mr Deverall 15 and Dr Silove. Dr Silove needs no introduction, but 16 Mr Deverall, once he is sworn, will tell us a bit about 17 himself. 18 MR DEVERALL (SWORN): 19 DR SILOVE (SWORN): 20 MR LANGSTAFF: Mr Deverall, can you tell us a bit about 21 yourself and your claim to be here and sitting at our 22 expert table? 23 MR DEVERALL: Thank you, sir. Just briefly, I qualified in 24 medicine in the year 1960, at University College in 25 London and after a career in medicine and then general 0095 1 surgery, I began my training in cardiothoracic surgery 2 in 1965, when I became Senior Registrar in Leeds. In 3 the next five years, I received training there at the 4 Hospital for Sick Children in London and in Leiden, 5 Holland, which was one of the recognised centres for 6 paediatric cardiac surgery in Europe at the time. 7 I then, subsequently, worked as a research fellow in the 8 University of Alabama in Birmingham, which was a centre 9 at which the majority of surgeons of that era were 10 trained. 11 I was appointed as a consultant to the University 12 and regional cardiothoracic centres in Leeds while I was 13 in the United States and took up a position in Leeds in 14 July 1970, my main brief being to develop a paediatric 15 cardiac centre at Killingbeck Hospital in Leeds. That 16 I sought to do, and was then approached round about 1976 17 and asked whether I would be willing to consider moving 18 to Guy's Hospital in London, to repeat what I had done 19 in Leeds and to assist in the further development of the 20 adult cardiac programme. I did, indeed, move to Guy's. 21 Strangely, it was like coming home, since my grandfather 22 had owned a pub next to where the hospital now stands. 23 I worked there from 1978 and became Head of the 24 Department of Cardiac Surgery in 1989 when my senior 25 colleague became terminally ill. 0096 1 I remained in that position until 1996, when 2 I retired from the National Health Service, when the 3 institution was merged with another major teaching 4 hospital. 5 During the 19 years at Guy's, we developed 6 a paediatric programme which started with virtually no 7 surgery and by the time I left, we were doing of the 8 order of 300 open-heart operations per year, with 9 a strong emphasis on surgery in the neonatal and infant 10 population. 11 During that period in time, I served for six years 12 on the Higher Specialist Training Committee of the Royal 13 College of Surgeons, and I served for two terms, eight 14 years in all, on the Funds Committee of the British 15 Heart Foundation. 16 Since I retired from the National Health Service 17 some three years ago, I have had a variety of roles and 18 duties clinically, in that I have accepted and carried 19 out a series of overseas travelling fellowships and 20 visiting professorships in a variety of countries around 21 the world where trainees from our Guy's programme are 22 now working. I continue to do that, but I am not 23 practising in the United Kingdom in any capacity. 24 Q. I think one of your recent commitments has been to look 25 at a number of cases which have come to you as a member 0097 1 of one of the Clinical Case Note Review teams set up by 2 this Inquiry? 3 A. That is correct. I was approached I think when 4 Mr Christopher Lincoln found his programme of work too 5 heavy and I was asked whether I would take over from him 6 in the group chaired by Dr Silove and in that capacity 7 I helped to review five case reports. 8 MR LANGSTAFF: Dr Martin, I would normally ask you to 9 identify your statement and confirm its contents, but we 10 have no statement from you, do we? 11 A. No. 12 Q. Can you tell us why it is that you have not seen fit to 13 give the Inquiry a written statement? 14 A. That is on legal advice. 15 Q. Are you here under subpoena? 16 A. I am not sure exactly the mechanism involved there. 17 I believe my solicitor had an instruction that I should 18 attend. 19 Q. You have, I think, given evidence in respect of some of 20 the aspects of care relating to Bristol at the General 21 Medical Council, have you? 22 A. Yes. 23 Q. Did you provide a written statement to the General 24 Medical Council? 25 A. Yes, I did. 0098 1 Q. May we have, please, on the screen, GMC 14/124? Is that 2 the first page of that statement? 3 A. Yes, it is. 4 Q. If we go through to page 131, is that the last page of 5 the statement you made to the GMC? 6 A. Yes, it looks to be. 7 Q. The signature is there recorded in print. When you 8 signed it, were you satisfied that the statement you 9 provided to the GMC was the truth? 10 A. Yes. 11 Q. Were you invited to provide a further statement to the 12 GMC? 13 A. I was asked also by the defence team whether I would be 14 prepared to supply a statement and that was discussed, 15 but I did not supply any additional statements, other 16 than that one. 17 Q. So may I again ask you briefly why was it that you 18 failed to, or did not, at any rate, provide any further 19 statement to the GMC? 20 A. That again was on legal advice. 21 Q. Did you attend the GMC to give evidence under compulsion 22 in the sense of a subpoena? 23 A. I believe everyone did. 24 Q. Because we have no statement given to the Inquiry as 25 such, you will appreciate that we have been unable to 0099 1 send out what you would otherwise have given us as 2 a statement to participants in the Inquiry who may be 3 interested in what you have to say. 4 I mention this at this stage not so much for your 5 benefit, because you know this, but for theirs, simply 6 to say that I have had some input from others, it may be 7 that there are matters which you and I discuss in the 8 course of questioning which individuals may wish to 9 comment upon. If so, they should, of course, feel free 10 to do so. 11 It may be, Dr Martin, that if they do so, it may 12 call for a further response from you in writing, and 13 I hope that if that happens, you will feel able to give 14 it. Obviously you will have to take legal advice on 15 it. May I make it clear, so everyone knows where we 16 are, that if we do have comments which come in after 17 your evidence, in writing, and you are invited to 18 respond and fail to respond in writing, then the Panel 19 will only have the comment of others and not your 20 response to it. 21 Do you understand? 22 A. I do, yes. 23 Q. You gave evidence, did you, over some time to the GMC, 24 and you were asked questions by a number of counsel. 25 Taking it broadly, is the evidence which you gave to the 0100 1 GMC the truth? 2 A. I certainly gave as truthful answers based on the 3 information I had at that time, yes. 4 Q. So true to the best of your knowledge and belief? 5 A. Yes. 6 Q. Would you please forgive me for taking a little time to 7 go through something of your background, because, as 8 I say, there is no formal statement to the Inquiry as 9 such. 10 You were appointed to the Bristol Children's 11 Hospital in 1988, were you? 12 A. Yes. 13 Q. You began work, I think, in February 1989 in the cardiac 14 unit? 15 A. Yes. My official employment started in the middle of 16 1988. I did some initial work in general paediatrics, 17 neonates, to fulfil my full training requirements prior 18 to commencing cardiological work in February 1989. 19 Q. You had to spend some six months or so in paediatrics? 20 A. Yes. 21 Q. Before you could take up the cardiac duties as 22 a paediatric cardiologist? 23 A. Yes, indeed. 24 Q. Before that, had you been in a number of places? You 25 had been, I think, in Liverpool, in training? 0101 1 A. Yes. 2 Q. You had been in Guy's and you had been in Harefield? 3 A. Yes. 4 Q. Whilst at Guy's and Harefield, you occupied a research 5 position, did you? 6 A. Yes and no. When I was at Harefield initially I was 7 employed as a cardiological registrar. That work 8 covered both adult and paediatric cardiological 9 practice. I was in that post for a little over two 10 years, if I remember correctly, and after that 11 I undertook a research post which was jointly funded -- 12 jointly held between Harefield Hospital and Guy's 13 Hospital. 14 Q. Whilst you occupied your research post, did you take 15 part as a team writing a number of articles involving, 16 amongst other things, the long-term results of children 17 who had had the arterial switch operation? 18 A. I wrote a number of papers in conjunction with others. 19 Whether or not you would call it long-term results, 20 I would use perhaps the term medium-term results, 21 because it was still relatively early in the experience 22 of that operation. 23 Q. Nobody knew what it was? 24 A. No, they still probably do not. 25 Q. Looking at what the information was as to the way they 0102 1 survived and had continued to survive that operation, 2 and amongst other things I think contrasting that with 3 the way that children had survived or not over the 4 medium term for the Sennings operation? 5 A. I did one paper looking at different functional aspects 6 in the two different groups of patients, those that had 7 intra-atrial repair and those who had the switch 8 operation and anatomical correction. I did not focus 9 particularly on mortality. 10 Q. May we assume from this three things: first of all, that 11 you had an interest in figures and statistics; secondly, 12 that you had an interest in the arterial switch as an 13 operation; thirdly, that you had seen such an operation 14 performed perhaps on a number of occasions? 15 A. I certainly had seen the arterial switch operation 16 before, I think on two occasions by Mr, now 17 Professor Yacoub. I had an interest in evaluating the 18 results of what was a new operation because I thought it 19 was an important ability to contrast it to the 20 historical treatments, the intra-atrial repair 21 operations, so I thought that was of interest. 22 I would not claim to be a statistician by any 23 means, but whenever you are writing a report, it does 24 involve some statistical analysis, albeit perhaps of 25 a not very complex nature. 0103 1 Q. But at least enough to give other fellow professionals 2 a reliable idea of outcomes or results so far as they 3 can be established? 4 A. Yes, and I had input from people with statistical 5 expertise to help me with that. One of the papers had 6 somebody who had an interest in statistics specifically 7 help me with that project. 8 Q. Could I just go through with you a series of 9 propositions and see how far you agree or disagree with 10 them? As a cardiologist, as a doctor, the care of the 11 patient is that which should predominate in any 12 decision-making about that patient. Is that 13 a proposition you would agree with, or not? 14 A. You have to look for the best interests of each 15 individual child, if that is what you are suggesting. 16 MR LANGSTAFF: That is a better way of putting it. 17 THE CHAIRMAN: Forgive me for interrupting, Mr Langstaff, 18 but we are not able to hear very well. I do not know 19 whether the microphone is placed wrongly, Dr Martin: 20 your jacket may be interrupting it. (Microphone 21 adjusted) 22 MR LANGSTAFF: Secondly, as a cardiologist, although you may 23 work in and from hospital, you are free to refer your 24 patient to whichever consultant you wish, wherever that 25 consultant may practice? 0104 1 A. Yes. I think it is a general rule, if I felt the 2 patient had a particular paediatric problem that I did 3 have not the expertise to deal with, I would refer it to 4 Professor Yacoub to deal with it. If I felt that 5 a child's problem might need, say, surgical input, then 6 I would discuss that with one of my surgical colleagues. 7 Q. The choice of surgeon you would recommend to the patient 8 or the patient's parents, to do the operation, would be 9 essentially your choice and your recommendation, would 10 it? 11 A. I would normally suggest what I felt was the appropriate 12 course of action if -- again, it is something that is 13 dependent both on the person you are referring to's 14 view, so I would not refer a patient to someone if 15 I knew they would not want to take that patient on for 16 surgery, or for other treatment while I was involved. 17 Also, it would depend on the parents' wishes, so if they 18 expressed a preference, I certainly would be happy to go 19 along with that preference, as long as I felt that was 20 in the child's interests. 21 Q. When you were at Bristol in the 1990s, you had a number 22 of patients who were suffering from AVSDs. Am I right 23 in thinking that as a matter of preference, you referred 24 such patients to Mr Dhasmana rather than to 25 Mr Wisheart? 0105 1 A. I referred most of my patients with AVSD to Mr Dhasmana, 2 not exclusively, but the majority. I think as I have 3 explained previously, I had a feeling that Mr Dhasmana 4 joined in the operation. I felt, based on what I could 5 see the patients I referred, his results seemed to have 6 a good functional result afterwards, and that dictated 7 my practice. 8 The other factor that we were looking at, perhaps, 9 in the sort of 1990s, was to try and concentrate 10 experience, particularly in the perhaps more complex 11 operations, in one surgeon; it does not mean 12 exclusively, but to try and concentrate experience. 13 That was certainly done with the arterial switch 14 operation. The decision was made that Mr Dhasmana would 15 only do those operations. That was not the case with 16 the AVSD, but there is a general feeling that the 17 majority of those cases probably ought to go to him. 18 Q. The first reason you gave for preferring Mr Dhasmana to 19 Mr Wisheart on the AVSDs was that you thought 20 Mr Dhasmana enjoyed doing the operation. 21 If the criterion was the best interests of the 22 patient, then the choice of surgeon does not come into 23 it, does it? 24 A. Fair comment, no. There are some operations where you 25 get the impression -- it is only an impression because 0106 1 I cannot speak for whether Mr Dhasmana really enjoyed 2 doing it or not -- that it was an operation he, as 3 I say, enjoyed the technical aspects of it. It does not 4 mean to say he did not enjoy other operations so far as 5 I am aware, but that was the impression I gained at that 6 time. 7 Q. Let me put the same point in perhaps a slightly 8 different way. 9 Suppose you had the impression Mr Wisheart hated 10 doing AVSD operations but in fact produced much better 11 results than Mr Dhasmana did. It is a hypothetical 12 situation, you understand. To which of the two surgeons 13 would you then have referred your AVSDs? 14 A. Undoubtedly I would be guided by the results. At that 15 stage, also, I was not aware of any surgeon-specific 16 data for that particular operation. 17 Q. Did you have a feeling that Mr Dhasmana was better at 18 it? 19 A. Not really. I could not really judge that, based on my 20 own experience, as I say, because the majority of them 21 went to Mr Dhasmana. 22 Q. The second reason you gave -- I think it was the 23 second -- was the idea that there was an advantage in 24 concentrating work of a particular sort in particular 25 hands. 0107 1 The idea of that is, is it, that experience, 2 practice, makes perfect, or at least, better? 3 A. I think there is a general thrust that most people would 4 accept that the more -- in our specialty we are dealing 5 with a lot of diverse operations, relatively small 6 numbers of patients in each patient group and there are 7 advantages in certain groups in perhaps sub-specialising 8 so that one person takes on more of one thing than 9 another. 10 That was the thrust behind that referral practice. 11 Q. The central point is correct, is it: that the idea was 12 along the lines of "practice makes perfect"? That 13 experience counted? 14 A. Yes. I think that is true. Yes, I would agree with 15 that. I am not sure I would agree it makes perfect. 16 I do not think perfection is achievable, but I think 17 there is a general feeling that the more you do of most 18 procedures, be you a surgeon or somebody like myself, an 19 interventional cardiac catheteriser, the more likely you 20 are to achieve high quality results. 21 Q. So the very fact of steering one's work to a particular 22 surgeon is likely obviously to give that particular 23 surgeon a greater experience than the one to whom you do 24 not steer the work? 25 A. Yes. 0108 1 Q. And in turn, should justify the selection? 2 A. Well, you would hope so. 3 Q. When it came to certain Fontan cases, and certain cases 4 of complex pulmonary atresia, was it the practice in 5 Bristol to refer outside Bristol? 6 A. There were some patients that were referred outside of 7 the unit. They would very often be the sort of patients 8 that you described, but not exclusively. Patients that 9 required transplantation certainly were all referred 10 outside because we were not a transplant centre, so they 11 were referred mainly to Harefield and Great Ormond 12 Street for transplantation. There would be a group of 13 patients where usually I would say we had discussed them 14 at our joint meetings with the cardiac surgeons, 15 cardiologists and cardiac surgeons, and had taken the 16 view that it would be wise to get another opinion as to 17 the best way forward, perhaps if there was some 18 discussion over the best treatment strategy for that 19 particular patient, and some of those certainly would 20 have been referred out and taken on surgically by other 21 centres. Principally we mainly referred at that stage 22 to Great Ormond Street. 23 Q. When Mr Dhasmana, if I use the very loose expression, 24 "got into problems" with the arterial switch programme 25 with neonates, he went to Birmingham, not once but 0109 1 twice. 2 Why Birmingham? 3 A. I think Mr Brawn, the surgeon there, certainly had 4 a reputation for being an authority on that particular 5 condition. He had published previously on it, and 6 certainly he published when he was in Melbourne, prior 7 to going to Birmingham, on the condition, the surgical 8 practice of it and surgical results. I presume that 9 Mr Dhasmana had some contacts with him at surgical 10 meetings and forged a link there. 11 Q. So it was recognised, was it, that so far as that 12 operation at any rate was concerned, Birmingham might 13 merit the description "centre of excellence"? 14 A. I think Mr Brawn was recognised as an expert on that 15 particular operation. I have to say, I have no idea, 16 and still have not to this day, of the surgical results 17 in his hands. One hears occasional tittle-tattle at 18 meetings, talk at meetings where surgical results are 19 discussed, but I have still not seen any results from 20 that unit. 21 Q. When you say "no idea" as to the results: not, I think, 22 quite right, because you have yourself given a figure, 23 at least in 1995, for the mortality that you would 24 expect the Birmingham unit to produce over a series? 25 A. I think I have given an estimate, but as I say, that is 0110 1 based on no knowledge, no factual knowledge, no 2 documentary knowledge. As far as I was aware, they had 3 a low mortality for that operation. I had no more 4 information, and I still do not. 5 Q. The cases that you referred out, whether they be 6 transplants or cases of the sort that I mentioned, some 7 Fontans for complex pulmonary atresia, or other ones 8 where a second opinion was needed, again, what was the 9 guiding principle in referring out of Bristol to another 10 centre? 11 A. I think often there is not. If we were dealing with 12 a situation where the surgeons felt that they either 13 were not sure of the treatment strategy or felt it was 14 an operation they would not want to take on, they would 15 suggest another opinion, and suggest a referral to 16 a different surgeon at another unit. 17 Q. The referral would presumably not be for a second 18 opinion, but for the operation to be conducted if there 19 was an operation? 20 A. Sometimes cases were referred just for an opinion, 21 asking "What do you think the best strategy would be?" 22 in the particular case. Sometimes they would come back 23 and maybe our surgeons might follow that strategy, or 24 sometimes they might not feel comfortable with that 25 strategy themselves in their hands, because it has to be 0111 1 an individual decision what operation you do for that 2 particular surgeon. If they did not feel comfortable 3 with that, then they might say, "Well, please could you 4 take this on?" 5 Q. Could we have a look on the screen at UBHT 275/139? 6 Perhaps I had better identify the document to you. Can 7 we go back a page? And again? And again, please. 8 [UBHT 275/131] These are the options for development of 9 adult and paediatric cardiac services in the UBHT. 10 Can we go back, having seen what the document is, 11 to page UBHT 275/139, please? 12 In the first paragraph, where threats are 13 outlined, this is said: 14 "There is a perception that the quality of 15 paediatric cardiac services in UBHT does not match the 16 standards of the Trust's major competitors and it is 17 imperative that the Trust demonstrates continued 18 commitment to improved quality in waiting times and 19 outcomes which will have an impact on mortality and 20 morbidity in specialist areas." 21 Was there a perception, then, that the quality of 22 paediatric cardiac services, in 1994, did not match the 23 standard of the major competitors? 24 A. I think we had areas that we felt needed to be improved 25 and one of the main thrusts of this document was to 0112 1 unify open-heart surgery and closed-heart surgery on the 2 Children's Hospital site. We viewed that as an 3 important objective, and we hoped -- no evidence, but we 4 hoped that would improve logistics, hopefully outcomes, 5 of this group of patients. 6 We were also conscious that the waiting list times 7 for patients, often on what we called the "priority 8 list", was no longer. I believed, and I do not know 9 what data we had to support that, that the waiting times 10 were longer than for some of our surrounding centres. 11 For that reason we felt we should use that as an 12 argument to try and unify our service on the Children's 13 Hospital site. 14 Q. Concentrating for a moment on outcomes rather than 15 waiting times, what appears to be said in this internal 16 document is that there was a perception that paediatric 17 cardiac services in UBHT were not up to the standards of 18 what are called the "major competitors". 19 Who would you be thinking about in terms of major 20 competitors, do you suppose? 21 A. Surrounding units. I suppose Birmingham, Cardiff, 22 Southampton would be the nearest ones. 23 Q. So there was a perception, was there, that Bristol's 24 quality of paediatric cardiac services was not up to 25 those in Cardiff and Southampton? 0113 1 A. I am not sure we had that data, to be honest with you. 2 I did not write this document, so I do not know whose 3 perception this is referring to. I can only speak for 4 my perception, but I have a perception that there are 5 areas we certainly needed to improve, and as I have 6 already said, one of those I felt was very important was 7 to try and unify the service on the Children's 8 Hospital's site. I do not know that we had any 9 comparative outcomes or waiting list data for other 10 centres to really say whether that perception was based 11 on fact or whether it was speculative. 12 Q. You have given me the answer I expected you would, but 13 without having comparative data, on what basis was it 14 that the operations we have been talking about -- the 15 transplants may be in a separate category, but the 16 transplants, Fontans, complex pulmonary atresias that 17 were referred out; on what basis were they referred to 18 other centres? 19 A. I think we have already said, if we were uncertain about 20 the treatment strategy for that particular patient, or 21 if the surgeons felt either uncertain about the strategy 22 or if they wanted another opinion as to whether 23 a different strategy which perhaps was performed by 24 someone else would be better for that patient. 25 Q. How would they know that Southampton or Cardiff or 0114 1 whoever down the road would have a better idea than you 2 did? 3 A. We would have no idea. 4 Q. Before 1992, what happened to any neonate who required 5 an arterial switch -- I should say, I think, to be 6 strictly accurate, who came into the unit diagnosed as 7 suffering from a transposition of the great arteries? 8 A. Up until 1992, those patients would have been managed 9 along the lines of a Sennings operation, certainly for 10 the period I was involved in the unit. I think the 11 Senning operation was used exclusively in those 12 patients. 13 I believe earlier, prior to my commencing work, 14 the Mustard operation was used by Mr Wisheart in some 15 patients. 16 Q. Between 1988 and 1992 Mr Dhasmana had been developing 17 his own skills in dealing with the arterial switch 18 operation for those children who were not neonates. 19 Bristol, we have been told, was rather late 20 amongst centres in adopting the arterial switch as an 21 operation of choice for children who suffered from 22 transposition of the great arteries. 23 Is that right or is that wrong? 24 A. As far as I was aware, I think when I was at Guy's 25 Hospital, I think, intra-atrial repair was still being 0115 1 performed rather than the switch operation. At 2 Liverpool -- I would have been there until 1988 -- 3 I think the arterial switch operation was just coming in 4 at that stage. I think there were other centres still 5 using intra-atrial repair at that stage, but I think the 6 majority of centres by that time had moved to the 7 arterial switch operation. 8 Q. So if that is the position in 1988, by 1990, let us 9 suppose, would it be right to think that most centres in 10 the country, although some may still have been 11 performing Sennings or Mustard, would have been doing 12 the arterial switch? 13 A. Certainly by 1991/92, the majority were using the 14 arterial switch operation. I cannot say whether that is 15 exclusive. I have no date on that. 16 Q. Up the road in Birmingham was Mr Brawn, whom you tell us 17 was developing a reputation in the trade, as it were, 18 for being very good at that particular operation. 19 When children under the age of 30 days came into 20 the unit in Bristol requiring an operation in respect of 21 transposition of the great arteries, was there a habit 22 or a practice at all of any consideration with their 23 parents as to whether the operation should be the 24 Sennings performed in Bristol, or the other operation, 25 the arterial switch which was available as the preferred 0116 1 operation in most other centres? 2 A. I think the first year or so I was there, I do not know 3 that we would necessarily have been discussing the 4 arterial switch operation as an alternative in those 5 patients. I think possibly as you get towards 1991, 6 that was probably discussed at that stage, although I am 7 not absolutely sure. I would not necessarily have been 8 directly involved with those discussions; I might have 9 discussed it in passing with the family, "Your child 10 needs surgery for transposition". Usually what we would 11 do is discuss that at one of our joint meetings. 12 Q. So I am clear as to your role and how you performed it, 13 as one of the paediatric cardiologists, you would see 14 a child who was referred to you or identified as having 15 a problem which was likely to be cardiac and requiring 16 investigation? 17 A. Yes. 18 Q. You are nodding. I have to say that so it gets on the 19 transcript. You would carry out such investigations as 20 you needed to in order to identify as best you could the 21 nature of the condition if there was one, which the 22 child was suffering from, or to exclude it, for that 23 matter? 24 A. Yes. 25 Q. If you found that the child had what seemed to you to be 0117 1 a congenital abnormality of the heart, you would then 2 have to decide whether that required conservative 3 management or closed operation or some form of open 4 operation, would you? 5 A. Well, the cardiologist certainly has a significant input 6 into that process. For most patients you would do that 7 in discussion with your cardiac surgical colleagues. 8 Q. So if it comes to an operation, whether it is closed or 9 open, you are going to talk about that with the 10 surgeons? 11 A. Yes. 12 Q. And reach a joint decision? 13 A. Discuss the options and -- it has to primarily be the 14 decision of the surgeon if they are going to take the 15 child on for surgery, what operation they are going to 16 do, what they feel in their hands is likely to give the 17 best results for that child. 18 Q. So back to the hypothetical example that I was posing to 19 you, a child in 1990, let us suppose, requiring some 20 surgical intervention because they had a transposition 21 of the great arteries: would you discuss with the 22 parents the options, the Sennings on the one hand; the 23 switch on the other? Would you involve one or other of 24 the surgeons, presumably Mr Dhasmana, in those 25 discussions? How would you go about it? 0118 1 A. I would certainly, in brief outline, talk about the 2 potential treatment plan, as I saw it, with the family. 3 Whether or not I would list that as a series of options, 4 I am not sure I necessarily would. I would perhaps keep 5 that initially fairly brief. I would then usually 6 discuss that child at a joint meeting. 7 For the period you are talking about, 1990, 8 I think it would probably still have been generally 9 accepted in our unit that the intra-atrial repair was 10 the method to proceed with with that group of patients, 11 so I may not have involved the surgeon necessarily at 12 that stage. But obviously I would do at a later stage. 13 The reason I may seem slightly hesitant about 14 that, I know that Mr Dhasmana, when he discussed 15 surgical options with the families, on the outpatients 16 usually at a later date, he would usually discuss those 17 two options, but it was not usually one I would be 18 discussing prior to him taking that discussion on. 19 Q. The switch operation began in the hands of Mr Dhasmana, 20 we are told, in 1988 on those who were not non-neonates, 21 so anyone over the age of a month old would fall within 22 the category that he might -- might -- perform the 23 operation on. 24 If such a person came as a patient of yours, you 25 would have to decide whether you referred the patient on 0119 1 to Mr Dhasmana for surgery of that sort, would you? 2 A. Yes, I think all of those patients would have had 3 transposition with a ventricular septal defect, plus, 4 often, other abnormalities, such as coarctation or 5 interrupted aorta coarct, so they would generally fall 6 into that category of patient. It was reasonably well 7 accepted, I think, that the arterial switch operation 8 was likely to be the better approach in that group. 9 Q. Were you present in Bristol when discussions took place 10 as to whether to begin an arterial switch operation at 11 all for the non-neonates -- any arterial switches? 12 A. No. 13 Q. There must have been such a discussion, presumably, some 14 time around 1987/88? 15 A. Possibly. I was not working in the unit then, so I do 16 not think I can comment on that. 17 Q. Let me ask you to have a look, please, on the screen at 18 UBHT 54/84. Can we look at the early results of the 19 non-neonatal switch programme? 20 THE CHAIRMAN: Mr Langstaff, I am just seeking to redact 21 some dates, if you would bear with me just a moment, 22 please. We have also dates on the left-hand side which 23 may arguably be taken out of this. 24 MR LANGSTAFF: I think they are acceptable. 25 THE CHAIRMAN: I am not quite sure they are acceptable to 0120 1 me, yet. (Pause). Thank you. 2 MR LANGSTAFF: Can I explain for a moment the delay, which 3 is to ensure we take every step to preserve 4 confidentiality, which you will understand. 5 A. I appreciate that, yes. 6 Q. What we have here are the dates of operations, given the 7 month and the year, the diagnosis and the result. If we 8 look down from that page, from 1988 to 1989, you might 9 like to keep in your head that of the first nine, it 10 would appear that five sadly died and four survived the 11 operation. 12 Can we go over to the next page, down to 13 number 14? 14 THE CHAIRMAN: Again, we are just making some adjustments, 15 Mr Langstaff. (Pause). 16 MR LANGSTAFF: If we go down to January 1992, number 17 14 -- do you have that on your screen now? 18 A. Yes, I have that now, thank you. 19 Q. Of the first 14, it would appear, given the death that 20 we have in December 1991, that there had been six deaths 21 out of 14 cases. That is just a bit over 40 per cent as 22 a matter of mathematics, is it not? 23 A. Yes. 24 Q. So at this stage, very nearly, not quite, half of the 25 patients going for this operation did not survive it. 0121 1 What had the results for the Sennings been like? 2 A. I think, from what I was aware, and certainly from some 3 of the early papers I was given when I joined the unit, 4 the results of the Sennings operation seemed good, but 5 I do not know how many patients there would have been 6 during that time period that had Senning operation plus 7 VSD closure, which you have to compare if you are going 8 to compare those two groups. 9 I think generally speaking, other series have 10 shown that that group also has a very high mortality for 11 that approach. 12 I would not have had these figures -- I do not 13 think I saw this list of data until much later on so my 14 perspective would be, joining in 1989, that -- if we can 15 go back to the previous page, is that possible? 16 Q. Let us not go back to the previous page, because we have 17 to go through the process of redaction again. If you do 18 it from memory, we shall -- 19 A. I cannot be precise but I think it was the fifth or the 20 sixth patient, the first five I would not have been 21 aware of. Whether I was aware of the sixth patient, 22 I am not sure. It would be very shortly after I joined. 23 Q. So February 1989, the first patient you might have been 24 aware of died? 25 A. Possibly. 0122 1 Q. The one after that, May 1989, died. The next one, July 2 1989, survived. 3 A. The next patient, I think, was one that I referred who 4 did very well initially after the surgery and appeared 5 to have a good result, and yet sadly developed -- I am 6 not absolutely sure, actually. I think he developed 7 a septicaemic illness post-operatively. If you go over 8 the page, if that does not cause too many problems 9 [UBHT 54/85], if you look at the 11 patients there was 10 one who died, so 10 survivors and one death out of 11. 11 So in effect, from when I started I think there 12 would have been three or four deaths out of 15 or so. 13 That, to me, at that stage certainly seemed to compare 14 favourably with both historical data and what I had 15 experienced in other centres. 16 Q. I want to draw a line -- I will explain why in 17 a moment -- under the fifth on that sheet, which is 18 January 1992. The reason I do that is because it was at 19 about this time that it was decided to begin the 20 neonatal switch programme. 21 A. 1992? Yes. 22 Q. The first operation followed only a matter of a few 23 weeks after, January 1992. 24 A. Yes. 25 Q. There were discussions, were there, about whether to 0123 1 begin a neonatal switch programme? You are nodding 2 again. 3 A. Yes. I am sorry, yes, there were discussions leading up 4 to that time about whether we should be moving to the 5 neonatal arterial switch operation. I think, based on 6 the more recent results with the arterial switch 7 operation plus VSD closure, I think most of us felt that 8 that is a treatment that we should be offering. 9 Q. So if one takes the results to this stage, 6 out of 14, 10 just over 40 per cent, that, I suspect, might have been 11 regarded, if looked at in those terms, as a pretty poor 12 record, might it? 13 A. In that group of patients the mortality is known to be 14 high. I had my own historical data from Harefield, 15 which I do not think was ever published, of a 30 16 plus per cent mortality in that group when I was doing 17 my research, so I was aware that mortality for this 18 condition was potentially quite high. I think there was 19 a general feeling that the high numbers of deaths 20 clustered in the either part of the series might 21 represent what has been termed the "learning curve", 22 which I think has been discussed, and certainly was 23 discussed quite extensively at the GMC. 24 I think we felt, based on the trend that we 25 thought we could see in those results at that time, that 0124 1 the results with the switch plus VSD were improving and 2 that therefore it was a reasonable option, if you like; 3 that some of the technical aspects of the operation had 4 been dealt with and therefore that it would be 5 appropriate to move on to the neonatal switch operation. 6 Q. So can I look at it in this way, then: that the 7 technical aspects of the operation itself are pretty 8 much in common, are they, as between neonates and those 9 who are non-neonates? 10 A. There are differences and there are similarities. 11 Q. You were saying -- this is why I picked you up on it -- 12 that the technical aspects of the programme seem to have 13 been overcome and therefore it was appropriate to go on 14 to neonates; so there is a corpus of similarity is 15 there? 16 A. There are some similarities, yes. 17 Q. Are the similarities, do you think, greater than the 18 differences? 19 A. I think it is very difficult to say. The need to 20 transfer the coronary arteries as part of the operation 21 is certainly one part of it. It is common to both 22 operations. The coronary artery patterns that one comes 23 across in transposition of VSD compared to neonatal 24 switch are often different. Children with VSD often 25 have a different great artery arrangements, so it is not 0125 1 identical but there are similarities. You have an 2 additional ventricular septal defect to close in the 3 patients with a ventricular septal defect. You may have 4 other problems such as great artery problems that have 5 to be dealt with. All of these things mean that there 6 are some differences, but, if you like, the core of the 7 actual coronary artery transfer is similar; the 8 reconstruction of the pulmonary arteries has some 9 similarities, although again there will be differences 10 between older patients and younger patients for that. 11 Q. Perhaps this is an appropriate moment, if I may, just to 12 bring in our experts to comment. It may be, 13 Mr Deverall, that you want to comment from the surgeon's 14 point of view on the differences and similarities of 15 operating on neonates and those who are not? 16 MR DEVERALL: Yes. I have been trying to think what the 17 correct answer to your question is. It is very 18 difficult. If I may comment on the neonatal operation 19 first -- and I am assuming that you mean neonatal 20 operation without any other complicating lesion, the 21 so-called simple transposition of the great arteries 22 performed in the first days of life, as it had to be for 23 physiological reasons -- yes, the technical elements of 24 the operation are similar but the margins for error are 25 a great deal less. I am talking about margins for error 0126 1 as a surgeon: I am talking in terms of halves 2 of millimetres as opposed to millimetres. 3 Children having an arterial switch procedure in 4 association with other lesions is a different 5 operation. There is the access to and management of the 6 usual ventricular septal defect, and that in itself 7 means very little as there are many different types of 8 ventricular septal defect requiring different surgical 9 exposures. Each of those types of ventricular septal 10 defect would in itself carry different mortalities, even 11 without the arterial switch operation. 12 Many of the children having an arterial switch 13 operation plus a complicating lesion would already have 14 had another operative procedure in order that they 15 survive long enough to be a candidate to come forward 16 for that operation in the first place. 17 I have not reviewed the data and I do not know how 18 long the time intervals were in this group of children. 19 As with any congenital heart lesion, who receives 20 multiple treatments, there is a selection process that 21 has gone on throughout those treatments which makes that 22 group of children different from another group of 23 children who have not undergone that sequence. You 24 cannot compare two groups without knowing that the 25 sequence is identical. 0127 1 If I might just refer to this, I notice that 2 several of these children had had the procedure of 3 pulmonary artery banding, which is a surgical manoeuvre 4 where the pulmonary artery is deliberately surgically 5 narrowed to reduce the flow of blood to the lungs, 6 usually in the neonatal or infant period. You have 7 therefore created a new disease. You may or may not 8 have modified a disease which may progress within the 9 lungs. So the manipulation of the coronary arteries and 10 the rejoining up of two major arteries is only a small 11 part of what is essentially a complicated operative 12 procedure and any two operations would be completely 13 different. 14 So I think for most surgeons, and certainly in the 15 first 20 times of, shall we say, operating on children, 16 at this point in time you probably would not be 17 repeating yourself as a surgeon. Each new experience 18 with complicated transposition would be a new 19 experience, whereas in the transposition in the neonatal 20 group, providing you have the basics of the margin for 21 error and other issues under control, then most of the 22 operations are in fact rather similar to each other. 23 You mentioned the coronary artery pattern. 24 I think most of us have come to realise that a majority 25 of the children have similar coronary artery patterns. 0128 1 Once you have learned a technical manoeuvre to do that, 2 you find yourself encountering the same technical 3 experience the next time you do the operation, so you 4 have learned what to do and what not to do and you can 5 relatively readily repeat that manoeuvre. 6 I would say with complex transposition, even after 7 many years one never feels that, because however skilled 8 the pre-operative diagnostic process that your 9 colleagues have, you are never sure what you are going 10 to find with some of these very complex situations, and 11 it would take a very long time to have experienced all 12 the possibilities. 13 MR LANGSTAFF: Dr Silove? 14 DR SILOVE: What strikes me about the cases you have listed 15 here is that they are not really truly a homogeneous 16 group of patients. You have patients with multiple VSDs 17 which must immediately increase the risk of an 18 operation, and you have some patients with left 19 ventricle outflow tract obstruction, and, of course, the 20 patients Mr Deverall has referred to with pulmonary 21 artery banding. 22 So it really -- it is not just straightforward 23 transposition with ventricular septal defect, if that is 24 straightforward; it is certainly not simple 25 transposition where there is no VSD, but even where you 0129 1 have VSDs here, they are quite complicated. So I would 2 regard this list, actually, as a list of fairly 3 complicated problems with transposition. 4 I do not know what Mr Deverall would feel about 5 moving from an experience with those then to tackle 6 transposition without ventricular septal defect, even 7 though the patients are much smaller and younger. 8 It might be a reasonable move to make. 9 MR LANGSTAFF: Dr Martin, do you want to comment on that 10 which Dr Silove or Mr Deverall have said, before we take 11 a short break? 12 A. I really could not put things better than my colleagues 13 have put it, really. I think that there are many 14 differences and some similarities and we had to work on 15 that basis, but I would agree that they are, as you see, 16 quite a complex group of patients, this particular 17 group. 18 MR LANGSTAFF: Sir, would that be a convenient moment? 19 THE CHAIRMAN: Yes, thank you. Shall we take 15 minutes, 20 until 3.25? 21 (3.10 pm) 22 (A short break) 23 (3.30 pm) 24 MR LANGSTAFF: Before the break, Dr Martin, we were looking 25 at the factors which gave rise to the start of the 0130 1 neonatal switch programme; do you remember any 2 discussions about whether it was or was not appropriate 3 to begin such a programme at Bristol? 4 A. I remember the subject being discussed and the general 5 feeling that we should be proceeding with a neonatal 6 arterial switch programme. 7 Q. Because? 8 A. I think there was gathering evidence from long-term 9 follow-up data that the late complications of the 10 intra-atrial repair rate was quite concerning and 11 therefore that anatomical repair, the arterial switch 12 operation was likely to be preferable. We do not have 13 totally comparable long-term data for the two groups by 14 definition because they have been done in different 15 historical periods which makes it difficult. But 16 I think there was enough evidence gathering that that is 17 likely to be the better option and I think current 18 evidence still would support that. Who knows what the 19 future will hold on that? 20 Q. It is decided that Mr Dhasmana will go ahead and perform 21 the neonatal switch operations, which as we have heard, 22 have some similarities but certainly some differences to 23 the non-neonatal operation. 24 Can we have a look, please, at UBHT 54/81, it will 25 have to go up on your screen first, sir. I see it has 0131 1 already been redacted, so that can go. This is how the 2 programme began? 3 A. (Witness nodding). 4 Q. We look at the date of the operation in months. If we 5 come down to the fourth, the fourth was a patient of 6 yours? 7 A. I believe so, yes. 8 Q. So you would look at the experience; you would know, 9 would you, of the three neonatal operations that had 10 been performed beforehand? 11 A. Yes, I would have known of those patients, yes. 12 Q. You would know of the outcome which we see here? 13 A. I am not absolutely sure whether the third patient was 14 alive or not at that stage, so that does not say the 15 dates for sure. 16 Q. It does not, but I can tell you, it was a matter of 22 17 days before the fourth operation. 18 A. Okay. Yes, I would have been aware, yes. 19 Q. When you came to discuss what operation might be 20 appropriate, you had in mind that the arterial switch 21 might be a better operation for the reasons you have 22 mentioned, because of the general proposition, the 23 long-term prospects were likely to be better than those 24 for the intra-atrial switch? 25 A. Yes, I think the argument was that it was probable that 0132 1 the neonatal arterial switch operation perhaps had 2 a higher initial operative mortality compared to 3 intra-atrial repair. Certainly that was the experience 4 at most people's hands but that the long-term benefits 5 are likely to outweigh that higher initial mortality. 6 Q. You knew that the operation was not an easy operation, 7 that is plain just by looking at the first three 8 results, and the nature of the operation, it was 9 properly called complex, was it not? 10 A. I am not a surgeon, so it is difficult for me to say. 11 I think the general feeling would be it is one of the 12 more technically demanding and complicated operations. 13 Q. Given that you decided or formed a view that this 14 operation might be appropriate for your client, the 15 fourth on the list, why did you decide to refer your 16 patient to Mr Dhasmana rather than, for instance, refer 17 the child to Birmingham to Mr Brawn? 18 A. I think, as I already said, I had no information on 19 Mr Brawn's results other than passing comments that one 20 might have heard, and knowing a little bit about his 21 previous work, we had brought it with others from 22 Australia. 23 We had carefully looked at these patients both at 24 our pathology meetings and I think we also had an audit 25 meeting some time after the second case, looking at any 0133 1 lessons that might be learned from these individual 2 cases and I think we felt there were lessons we could 3 learn from those patients that could be put into 4 practice. Therefore, whilst I agree that the first 5 three patients dying was not as we had hoped, we felt we 6 had a reasonable expectation that that would not 7 continue. 8 Q. You have described there lessons you might learn from 9 the three cases where there had not been survival. What 10 I was asking about was why the decision was not taken to 11 refer the child to someone else at some other centre 12 where the lessons might already have been learnt? 13 A. There are lots of reasons why one might favour one's own 14 unit, you know, I may well have been in a position that 15 I have already had contact with the families, built up 16 a relationship. They would usually have come from an 17 area we visit therefore I would have local contact with 18 paediatricians, we would also presumably be in a 19 position then to offer follow-up after successful 20 repair. So you have the opportunity of building up 21 a relationship, perhaps saving sending families off all 22 around the country. You might say, "Why not send 23 a patient to Melbourne" where the results were very 24 good. That is in practice not feasible. 25 We would normally offer surgery within our unit 0134 1 for a whole variety of potential reasons, hopefully 2 benefits for the family and we also hoped benefits for 3 the child. 4 Q. Jumping ahead on the point of feasibility, when in fact, 5 as we have heard, the Loveday operation effectively put 6 an end to switches for a while at Bristol, any case 7 needing a switch was referred down the road to 8 Birmingham, were they not? 9 A. They were for a period, yes. 10 Q. There is no question of that not being feasible? 11 A. It is feasible. Whether that is in the best interests 12 of patients as a group is another issue, yes. 13 Q. Let us put feasibility on one side. We are talking 14 about the best interests of the patients and you are 15 making the point to me that geography and hence contact 16 with the parents and contact with the patient after 17 operation is facilitated if it is a local hospital. 18 That must have more force, I suspect, with parents 19 who live in the immediate vicinity of the Bristol 20 hospitals and those who are generally in the Wessex 21 area? 22 A. I think we developed very good links with the local 23 paediatricians and I do not think one should belittle 24 their contribution to the care of these patients. You 25 know many patients after they have had cardiac surgery 0135 1 will take a little while to get going again afterwards, 2 they may have feeding problems, they may have a number 3 of other problems that need special attention and the 4 input of the local paediatrician is potentially quite 5 important in that setting and we have a well established 6 clinic network throughout the southwest region that we 7 felt was very important to help in that general 8 supportive role. 9 Q. Perhaps the main point is this: if you had said to the 10 parent, who perhaps is the best judge of the child's 11 interests "You may stay here in Bristol where it is good 12 and it is local and where we have only done three 13 operations of this sort on children at this age and they 14 have all died, or we can, if you wish, send you to 15 Birmingham where there is a risk, we cannot deny the 16 risk but there appears on what we know about the figures 17 to be a better chance of survival"; how do you suppose 18 a parent would react from your experience to a choice 19 put in those terms? 20 A. That predisposes I had that information. As I have 21 already said, I did not have information from other 22 units. The only crude data I would have would be that 23 from the Surgeons' Registry, the Society of 24 Cardiothoracic Surgeons' Registry which gave very broad 25 data for different groups, but it was not operation 0136 1 specific. We had really no comparable data to be sure 2 about based on that. So whether I should refer patients 3 to another hospital because Joe Bloggs had said their 4 results when I met him at a meeting were good, I do not 5 think that is a basis for making the referral. I would 6 really have liked to see more data than that. 7 Q. I think you jumped the question. 8 A. Have I? Right. 9 Q. You have answered the question which I had not yet 10 asked, which is: why did you not. The question I was 11 asking: suppose the parent were presented with the 12 option in something like those terms, what would you, 13 from your experience, expect the parent to do? We will 14 come in a moment to whether you could have put it in 15 those terms because you may not have had the 16 information. Suppose you had put it in those terms to 17 a parent, what would the parent do you think have said? 18 A. It is very hypothetical. As I already said, that 19 presumes you have the knowledge to put it in those 20 terms. 21 Q. If you had the knowledge to put it in those terms and 22 you said it, what would you expect most parents would 23 say to you? 24 A. I think if you put it in those terms without any riders, 25 I would expect probably the parents to say "I will go to 0137 1 a different centre", most likely. 2 Q. You suspect that because, if those terms are appropriate 3 on that hypothesis, I appreciate, there is really no 4 answer, is there, to the suggestion that the child is 5 probably better cared for in a centre which has 6 an apparently better track record and has a much greater 7 experience of the operation? 8 A. That predisposes you know that information. 9 Q. But on that hypothesis, that must be right, must it not? 10 A. If you tell me so. I think it is very difficult to 11 judge, but there are many reasons why you might favour 12 a referral to your own centre, which is the sort of line 13 you are taking. There is the geographical ideas we have 14 already discussed. The patients you are talking about 15 may be only a relatively small proportion of your 16 overall work so you build up a working relationship with 17 your surgical colleagues. You certainly come to rely on 18 their experience and expertise and listen to their 19 advice. Any patient that is being assessed for surgery, 20 it is not something I am saying this is what has to be 21 done, it is something you discuss as a group and -- I am 22 not sure whether you have seen yet, but the joint 23 conference data notes that would be done for most 24 patients mean that opinions are canvassed from different 25 areas, so my cardiological colleagues, my surgical 0138 1 colleagues all would have input into that 2 decision-making process. 3 So deciding what treatment is right for that 4 particular patient is a complex one; it is a complex 5 interaction between many individuals of a team. 6 Q. As part of that answer you have said to me that the 7 building up of a relationship with the surgeon in your 8 centre is a matter of importance? 9 A. You inevitably build up a working relationship with 10 colleagues and to an important degree you do listen to 11 other people's advice, you know, within your unit. So 12 building up a relationship per se is not the "be all and 13 end all", but it is an important part of how 14 cardiologists, cardiac surgeons work, they work as 15 a team. 16 Q. Do you think it would prejudice the relationship of any 17 cardiologist at Bristol with the surgeons at Bristol to 18 have said "In this case we are going to refer this child 19 to another surgeon for an operation which can be done 20 here, but we think it can be done better there"? 21 A. It is very difficult to say. I think you would have to 22 ask other colleagues, you know, particularly the 23 surgical colleagues, whether they would have done. 24 I think there would have been a danger it could do so. 25 Q. The reason for my asking you is you have put it forward 0139 1 as part of the advantages of having a child treated 2 within the unit because it is a unit, because you have 3 relationships with the surgeons. That is what I am 4 exploring with you. 5 When we come in practical terms to the fourth on 6 this list you have no information, no hard information 7 I think you told us, that the situation is actually any 8 better elsewhere; is that the case? 9 A. Yes, I think that is true. 10 Q. Was there at this stage anything in the way of what you 11 would see as a learning curve taking place at Bristol? 12 A. Certainly we looked at the first few cases and looked to 13 see if there were any lessons there. Now whether that 14 constitutes the learning curve or not I think it is very 15 difficult to say. I think if you look, you know, just 16 looking at the individual cases there were, the first 17 case there was unsuspected coarctation of the aorta 18 which we felt was a contributing factor. 19 The second case, there were problems with 20 thrombosis and infection and we were concerned there may 21 be other factors that were important, if you like, other 22 than the surgical expertise of doing the operation. 23 So I think we looked at these cases individually. 24 If we found what we thought was a reasonable reason for 25 that patient's death then, if you like, that colours 0140 1 your view as to whether it is appropriate to carry on 2 later. 3 Q. I think the question I asked was whether you thought 4 there was something of a learning curve or not. Did 5 you? 6 A. I think we thought that possibly was part of our 7 learning curve, yes. 8 Q. You did not think, did you, that the results were very 9 good, of the switch series at this stage? 10 A. I do not think we could have said that about the 11 neonatal switches. As I said, we were basing our move 12 to this on our experience with the older switch patients 13 which I think at that stage we certainly felt our 14 results were adequate. 15 Q. Forgive me, if we go to GMC 19/119, the question begins: 16 "Explain exactly what you mean by that phrase, I 17 do not want to put any words in your mouth." 18 You say: "not as regards the general community. 19 "What do you mean about Bristol in terms of 20 neonatal switches in 1992, how were they seen by you?" 21 Your answer: "As I say, when you undertake a new 22 procedure, I do not know whether the term has been used 23 before, it has been recognised that you might have what 24 is called a 'learning curve', that is the mortality in 25 the first period of a certain operation might be higher 0141 1 than it is later on. I certainly was not clear at that 2 stage whether what we were seeing was related to that or 3 whether we had a bad run of patient anatomy. There were 4 a number of factors that were not completely clear at 5 that stage." 6 What in summary you were saying to the GMC in that 7 answer is: you did not know whether it was anatomy; you 8 thought it may well be a learning curve? 9 A. I think, as I have said, we thought that was 10 a possibility. There were lots of factors we thought 11 could have been, you know, important in poor outcome. 12 Q. May I put a rather crude question to you: why should the 13 patient take the disadvantage of the risk that there 14 might be a learning curve at work here? 15 A. With any new treatment when you start it you do not know 16 whether you are going to see an immediate improvement in 17 results. For instance, we might have done those first 18 three and seen no deaths and been delighted, say "we 19 have a 0 per cent mortality". That may not necessarily 20 have been a true reflection of the overall quality, if 21 you like, of the service we were offering. 22 I am sorry, I have lost my thread. 23 Q. Let me ask you another question and see if I can get you 24 back on track. I was asking you why it was that 25 a patient should take the risk that there might be 0142 1 a learning curve at work. You were saying I think words 2 to the effect "Well, a learning curve is inevitable if 3 you start a new procedure and we might very well have 4 had the experience that it was very successful". As it 5 happened, in neonatal switches you did not? 6 A. Yes. 7 Q. I understand what I think is the answer you are giving 8 me in terms of a completely new procedure, a new 9 development which is tried for the first time in a 10 particular centre. But it might be different, might it 11 not, if the procedure is actually an established 12 procedure in the country even though it may not be an 13 established procedure in that unit; do you follow the 14 point? 15 A. Surely any time you make a change in management strategy 16 for a group of patients you encounter this system, you 17 know this problem to a certain degree. I think the term 18 "learning curve" for that reason is not necessarily 19 a good one. We were hopeful that, based on the, as you 20 have already heard, fairly complex group of switches and 21 VSDs that the learning curve for the basics of the 22 surgery had been performed, but when you are operating 23 on the neonates maybe there are other factors that 24 become important that we had not, you know, appreciated. 25 So any time you make a treatment strategy there is 0143 1 a risk of a learning curve, a change in outcome for that 2 group. That may be for the better, it may be for the 3 worse. What you are dealing with here still is a 4 relatively small group of patients compared with to rest 5 of our throughput. So while all this was going on 6 I would be seeing patients going through having a whole 7 variety of complex operations with perhaps better 8 results than I had seen before. You see fluctuations in 9 different groups at any one time. That makes it I think 10 always difficult for us to analyse exactly what is 11 happening with individual groups of small patients. 12 Q. Knowing there might be a learning curve at work here, 13 what steps did you take to protect any of your patients 14 against the adverse effects of such a curve? 15 A. I think, as I have already said, we looked at the cases 16 individually at our meetings. These were at some 17 pathology meetings. 18 Q. At pathology meetings? 19 A. Yes. 20 Q. That is after the event? 21 A. Yes. 22 Q. So before the operation, what if any steps did you take? 23 A. The first few cases, we tried to see what lessons we 24 could learn from that. We talked as a group about it, 25 we looked at the ultrasound assessment, the 0144 1 echocardiographic assessments of the patients. The 2 first patient, as I said, had coarctation of the aorta 3 which had not been suspected pre-operatively and we made 4 a particular point of looking for that. 5 A little bit later, I think after the fifth case, 6 we had further discussions and decided to institute 7 a practice of limited angiographic study to look at the 8 coronary artery anatomy in a little bit more detail. 9 Sorry, have I answered that question then? 10 Q. I am not sure. Shall we have a look at UBHT 61/165? 11 This is an audit meeting. I am going to ask you a bit 12 more about audit and put it into a pattern later on. 13 This is a meeting of 3rd June 1992. It is chaired by 14 Mr Dhasmana. We can see you were there. Can we scroll 15 down, please? The results it seems of the arterial 16 switch operation are reviewed? 17 A. (Witness nodding). 18 Q. Under "Findings and Observations": 19 "Mortality for TGA plus VSD switch, similar to 20 reported results", then these words, "particularly if 21 consider his early experience". 22 Pausing there for a moment, were the results 23 themselves presented? 24 A. I think Mr Dhasmana chaired that meeting and I think he 25 presented the data for the switch VSD patients. We have 0145 1 looked at the data to a certain extent, but I think he 2 would have produced figures to show at that meeting and 3 I think the observations noted there "higher mortality 4 for multiple VSDs", I think that is something was well 5 recognised in most series and we felt perhaps patients 6 that had been in hospital for a long time prior to the 7 switch, based on a review of those cases, ran into 8 problems. 9 Q. Shall we have a look at GMC 8/22? This is the switch, 10 I think. Top right-hand corner of the group we can see 11 which it is if we just put that on to the screen: 12 "Double outlet right ventricle with subpulmonary", it 13 must be -- "the VSD"? 14 A. "subpulmonary VSD", I think it has just missed off 15 the D. 16 Q. It sets out the number and the death rate, 17 37.5 per cent. Shall we scroll down? We have there the 18 rate set out, the results up until April 1992 which is 19 summarised by the 37.5 per cent figure we saw at the 20 top, not quite the mathematics which I had worked out 21 with you earlier when we looked -- 22 THE CHAIRMAN: I have taken it off for a moment because 23 I suspect there may be a name, two names on the 24 right-hand side. 25 MR LANGSTAFF: Yes. 0146 1 THE CHAIRMAN: I do apologise, Dr Martin, we are very 2 anxious to observe our obligations to maintain 3 confidence. 4 MR LANGSTAFF: My apologies for not spotting that. I am 5 grateful for the eagle eye of our Chairman. 6 The overall mortality of 37.5 per cent? 7 A. Yes. 8 Q. Shall we scroll down and see the other figures that were 9 produced. Could we go overleaf, please? The comparison 10 which is made, top of the page, please, with the English 11 experience appears to be 1977/1984. I do not know if 12 that rings a bell with you? 13 A. I do not remember this document. It is a long time ago 14 now. It may have been what Mr Dhasmana presented at 15 that meeting; is that what you are presenting? 16 Q. This is what we understand he presented at that 17 meeting. Tell me if you think it is right or wrong? 18 A. I do not recall it but it looks to be the right era, so 19 it could well be. 20 Q. Do you recollect having seen this or not before? I am 21 asking you about it as though you had and it may be 22 unfair to do so. 23 A. I do not recollect seeing this before. If you are 24 telling me that was presented at the audit meeting, then 25 -- 0147 1 Q. Let me deal with it hypothetically, I think it is fairer 2 to you to do so. Can we go back to the page before. 3 Suppose the rate there being considered was 4 37.5 per cent overall for the mortality rate in the 5 non-neonatal arterial switch up until April 1992. That 6 would be relatively high, would it not, by comparison 7 with what one might expect from other hospitals at that 8 time? 9 A. I think, as we have already heard, this group of 10 patients is a complex and challenging group and 11 certainly my experience based on Harefield was that was 12 very similar to the mortalities achieved in that patient 13 group. 14 Q. Before 1988 when you were at Harefield? 15 A. Yes, the data I would have had would have been from that 16 era. I did not have any up-to-date data from Harefield 17 to compare it to. 18 Q. If we go back to the page we were on, UBHT 61/165. 19 MR DEVERALL: Could I interrupt, I think we should clarify 20 we are talking about two totally different conditions. 21 The group with the 37.5 is a condition that used to be 22 called the Taussig-Bing syndrome which is the great 23 arteries are not normally connected, they both arise 24 from the right ventricle and there is a ventricular 25 septal defect immediately underneath that and that is 0148 1 specifically designated as that condition. The data 2 from the United States referring to 1977/1984 is from 3 the University of Alabama in Birmingham from Pacifico 4 and Kirkland in Kirkland's book. That was specifically 5 transpositioned with a single ventricular septal defect 6 but without this connotation of double outlet and so 7 they are different conditions. 8 MR LANGSTAFF: The two sets of data quoted are very 9 different, that is what you are saying? 10 MR DEVERALL: They are not only different, but they are 11 different conditions in a different time period. 12 MR LANGSTAFF: So no comparison really could be drawn 13 between those two, let alone those two and local 14 results. 15 MR DEVERALL: In my opinion not. 16 DR SILOVE: I agree with Mr Deverall, yes. I was thrown by 17 seeing that one lot with "UAB" and then Mr Deverall 18 reminded me that that is University of Alabama, 19 Birmingham, a different Birmingham. 20 MR DEVERALL: Birmingham, Alabama. 21 MR LANGSTAFF: Let us focus on the words which summarise it 22 here: 23 "Particularly if considers early experience" ; 24 what was actually being said at the meeting that 25 reviewed the switches? Was it being said, as those 0149 1 words might suggest, "We have not done as well as other 2 centres, but we are in a learning curve or we are 3 gaining experience" or words to that effect? 4 A. What I tried to do I think would be to summarise the 5 general feeling of everyone at the meeting and I think 6 they were listed above. I think we felt that for this 7 complex group of patients the mortality that was 8 observed was within the realms that we might expect and 9 what we were trying to do was to see if any lessons 10 could be learnt, you know, to improve care for further 11 children coming along in this complex group of patients 12 and one observation there is that high mortality for 13 multiple VSD, and I think that is reasonably well 14 recognised, if the defects are multiple then the 15 mortality outcome is going to be higher in that group. 16 The other thing we observed was that those 17 patients that had been in heart failure for a long 18 period in hospital, we were worried whether that might 19 be a factor in one or two of the patients running into 20 problems. Therefore we wondered whether perhaps trying 21 to repair a little bit earlier than had been done 22 previously if they had not had a pulmonary artery 23 banding might be the way forward. 24 Q. Again, I think you are focusing on a couple of questions 25 which are yet to come. What I was asking you was 0150 1 whether, so far as the meeting was concerned, you were 2 faced with a position where you were saying to 3 yourselves, "We have not done as well as other centres, 4 but it is early days"? 5 A. I do not think they were in a position to say that. You 6 have seen the UAB, University of Alabama data which we 7 were making some comparison to, but we did not have any 8 really good comparable data to make any valid 9 comparisons. All we could do was do our best from the 10 literature with all the limitations that might have. 11 I think it was well recognised that any results in the 12 literature tend to favour those with the better 13 results. I think most people tend to write up the good 14 results rather than the less good results. One always 15 has to bear that in mind for many surgical procedures. 16 There are few exceptions to that, but that is something 17 one has to bear in mind. 18 Q. The lessons you were learning from experience you were 19 then going to deal with. You have dealt with one of 20 them, which is the aim for earlier repair where 21 possible. That is number 3 at the bottom, is it not, of 22 the sheet? 23 A. Yes. 24 Q. Number 34: "Careful search for multiple VSD and 25 coarctation." 0151 1 A. Yes. 2 Q. This was a specific note made at the meeting? 3 A. Yes, it is a note I made. 4 Q. Your writing? 5 A. That is my writing. 6 Q. This is trying to learn lessons to do better in the 7 future? 8 A. Yes. I have already mentioned the point about the first 9 child, the neonatal arterial switch that had 10 coarctation. That can be a difficult diagnosis 11 sometimes to make, particularly with the arterial duct 12 wide open, and we felt that was something we should 13 make, if you like, a particular point to really focus in 14 on. 15 The other issue was to make sure as best one can 16 whether there were any additional ventricle septal 17 defects in those known to have a single defect, look for 18 additional defects, and obviously for the neonates 19 coming forward, to see if we could identify VSDs in 20 those patients. 21 Q. You are making this suggestion in the light of 22 experience? 23 A. In the light of review that we undertook on that day, 24 yes. 25 Q. The experience was, was it, that on occasions those 0152 1 would be missed? 2 A. I think in everyone's experience, certainly ventricular 3 septal defects in the new born can be very difficult, to 4 be sure about particularly small defects. As I have 5 already said, coarctation was not identified in the 6 first patient in the series and that can sometimes be 7 very difficult. It was actually I think very unusual to 8 have simple transposition, if you want to use that term, 9 perhaps not a simple lesion with coarctation. 10 Q. Can I stop you. Again you are giving an explanation 11 without having given an answer. I think the answer 12 which you are assuming to be correct -- I want to check 13 that it is -- is that experience had shown that multiple 14 VSDs and coarctation had been missed. You were going to 15 say that is not surprising because of the difficulties. 16 Am I right in thinking it had in fact been missed? 17 A. Yes. As I have already said, I think coarctation was 18 certainly missed. I really have to look back at the 19 data in a bit more detail about multiple VSDs. I cannot 20 remember what that statement was based on at that time. 21 Q. I have been asked to ask you to slow down. I will give 22 you as much help as I can by giving perhaps a greater 23 break after your answer. It is not so much you as the 24 stenographers, who have to keep pace with what is said. 25 If you leave that to me but answer slower rather 0153 1 than faster, if you can? 2 A. Okay. 3 Q. After this, this is June 1992, as we see, were the 4 results of the switch kept under review to see whether 5 those four items -- it is really I think the third and 6 the fourth were the steps to be taken -- were paying 7 dividends? 8 A. I think we certainly discussed cases as they came 9 along. We know all of the children put forward for 10 surgery would have had their echocardiograms reviewed 11 and that would be something we would be focusing on in 12 that review process. A little bit later, as I said, we 13 started the practice of undertaking angiograms on these 14 patients. That partly was to look for evidence of 15 ventricular septal defects, but mainly to see if we 16 could get a better feel for the coronary artery 17 anatomy. 18 Yes, it was something that was constantly being 19 reviewed after individual cases. 20 Q. Stopping you there for a moment: the introduction of the 21 angiogram was because the echo was not telling you 22 everything that the surgeon later discovered at the 23 operating table; was that the position? 24 A. I think it is well recognised that echocardiography does 25 not identify the coronary artery anatomy in this group 0154 1 of patients certainly with a high level of accuracy and 2 I think most published series I have seen have suggested 3 an accuracy of about 80 per cent, something of that 4 order. 5 We felt that we had encountered certainly in the 6 series a higher number of unusual coronary artery 7 variants than perhaps we might have expected, and felt 8 that we wanted to try and give as much information as 9 possible to Mr Dhasmana and that one way of trying to 10 improve the assessment of the coronary artery anatomy 11 might be to undertake a limited aortogram or 12 ventriculogram. 13 I think we were trying to give Mr Dhasmana as much 14 information as possible, as I understand it. Perhaps 15 this is something perhaps a surgeon might want to 16 comment on. The surgeon has to make their own 17 assessment of the coronary artery anatomy at the time of 18 surgery anyway but if you can forewarn him it might try 19 and make his job a little easier. We were just trying 20 to do our best to improve the accuracy of what is not an 21 easy condition to be sure about. 22 Q. I will invite Dr Deverall and Dr Silove to comment 23 a little bit later, if I can. 24 What I would like to turn to is the question of 25 the review of the measures that you had introduced to 0155 1 combat the difficulties that had been experienced in the 2 arterial switch programme. 3 Can I put that in context: when you came to 4 Bristol, were there regular audit meetings, sort of 5 regular meetings at which cases were discussed in these 6 respects? First of all, before any surgery was 7 undertaken you would discuss as a team, would you, 8 cardiologists and surgeons, perhaps others, what was 9 going to happen? 10 A. I think the setup in Bristol was very similar to other 11 units that I worked in, that you would have a regular 12 joint meeting between cardiologists, cardiac surgeons, 13 maybe other interested parties, junior medical staff, 14 cardiac radiologists, to discuss individual 15 investigations and discuss treatment plans. 16 Q. That is case specific in advance? 17 A. They would be case specific and would also encompass 18 some more general discussion on that patient's 19 condition. 20 Q. If the patient sadly died, there would be 21 a clinico-pathological conversation if there were any 22 postmortem to review? 23 A. Yes. 24 Q. Apart from those two forms of meetings, both of which 25 would be case specific or patient specific, when you 0156 1 came to Bristol was there any regular pattern of 2 auditing results so that one got a general picture as to 3 what was happening? 4 A. I think medical audit probably was perhaps in its -- I 5 do not know if it was in its infancy at that stage, but 6 it was certainly an evolving topic. 7 Q. Can I stop you? 8 A. Yes. 9 Q. Again I think you are giving me the explanation before 10 you have given me the answer. What is the answer? 11 A. It depends on what you mean. When I arrived in Bristol 12 I was aware they had produced a yearly annual report and 13 I was given copies of that when I arrived. I do not 14 think there were any regular group discussions, if you 15 want to term, you know, multidisciplinary type meetings 16 where topics outside of individual cases were discussed 17 and I think towards the end of 1989 I volunteered myself 18 to put forward to try and get that type of audit meeting 19 under way. 20 Q. What you had in mind I think is a letter, UBHT 61/107. 21 Scroll up so we get the date. 18th December. 22 "A recent meeting suggested we ought to hold 23 regular clinical audit meetings", as you say, they are 24 in their infancy at this stage, "and I have set out to 25 coordinate these" and you set out what the purpose is. 0157 1 The implication from that opening paragraph is 2 that so far as you knew they had not been held in that 3 form before? 4 A. I was not aware of any, no. 5 Q. There followed, did there, audit meetings which you 6 coordinated? 7 A. Yes, I did. 8 Q. Roughly how often did they occur? 9 A. Very difficult to be sure looking back now because very 10 often I do not think we always kept a written record and 11 my recollection is not clear. The numbers would vary 12 from time period to time period. 13 I think during 1990 we would have had a few. 14 Again, I cannot be sure of the exact number. In 1991 15 I would imagine we would have had a few. I have more 16 recollection because I had some documents from 1992 -- 17 Q. Can I, with that in mind, ask you to have a look at UBHT 18 61/153? It is the opening words of this, this is the 19 3rd January 1992, your letter: 20 "I think it is very important that we recommence 21 our audit sessions in 1992 and after discussion I think 22 we ought to hold these monthly ..." 23 That might suggest that the audit sessions had 24 fallen away a bit during 1991. Is that -- 25 A. I think that is probably true, yes. 0158 1 Q. There needed to be a fresh breath of life put into 2 them. Why do you think it was that they dwindled away 3 in 1991? 4 A. I think it is difficult in a busy clinical programme 5 sometimes making the time to get people to come to these 6 meetings. Actually I found as an organiser it is quite 7 difficult to get a sufficient group of people together 8 to make the audits useful. That is not to say people 9 were not interested, it is just the pressure of clinical 10 commitments often makes it very difficult. 11 Q. Pressure of dealing with Trust status perhaps in 1991? 12 A. I cannot comment on that. I was not involved in that. 13 Q. I was asking how you perceived it -- 14 A. I would say it was much more likely it was the 15 hurly-burly of clinical work that makes it much more 16 difficult and I am sure it was a problem more clinicians 17 face, to get a regular audit programme going is very 18 difficult. It can be done on your own. It is not 19 a single person doing it. I cannot say "Oh, you must 20 come and do your audit" and turn up and there is only me 21 there. You need a group of people for it to be of 22 value. That is not to say problems were because -- 23 I think people felt that audit was important but 24 logistically it was quite difficult to get people 25 together. 0159 1 There may be many reasons for that in our 2 particular setup. I think it is probably fair to say 3 the switch site arrangement did not particularly help us 4 to get an adequate number of people together. It has 5 been a little bit easier and I carried on trying to 6 coordinate and keep the audit meetings going. Since 7 they moved the open heart surgery up to the Children's 8 Hospital, we have got more people on site and it has 9 been easier to get good consensus and a group of people 10 together, but it is not easy. 11 Q. The audit meetings we are talking about are -- although 12 it is described as audit of paediatric cardiology, these 13 were audit meetings which involved the surgeons? 14 A. Paediatric cardiology -- our service included a whole 15 range of disciplines. There were many things we felt 16 would need auditing. 17 Q. The reason for my asking -- again I am sorry to cut 18 across you, I do not mean to be offensive -- is that 19 this was not something which was just restricted to the 20 BCH? 21 A. No, certainly the cardiac surgeons would come when 22 possible. It was mainly because it was held in the BCH 23 I think it would mainly be staff from the BCH that were 24 attending the meetings I think it is fair to say. We 25 would have encouraged anyone to come along that wanted 0160 1 to. For particular things we might get people who would 2 not come regularly. For instance I think on several 3 occasions I have reviewed the foetal works -- I have 4 particular responsibility for the foetal diagnostic 5 work. We would have got people along from the foetal 6 department to review those figures and participate in 7 that meeting. So we would get along people outside, if 8 you like, the normal group, if circumstances needed it. 9 Q. If we have a look at a couple of the forms that were 10 filled in afterwards. Could we have a look at UBHT 11 61/156? The heading at the top "Hospital Medical 12 Committee, Audit Committee, Medical Audit Meeting 13 Report". This is however a paediatric cardiology 14 meeting; is this one of the meetings you would have 15 coordinated? 16 A. That is one of the meetings I chaired, in fact, yes. 17 I think my preceding letter, I volunteered to do the 18 first one for that month and that would be that 19 particular audit meeting. 20 Q. If we remember what that looks like and flick to have 21 a look at UBHT 63/340, this is not paediatric 22 cardiology, you are not I think in attendance, but the 23 heading at the top of the page is actually the same, 24 "Hospital Medical Committee, Medical Audit, Annual 25 Report of the Audit Committee 1991", "Specialities: 0161 1 Anaesthesia". Date: 3/3/92. 2 It is a very similar format on the page to the one 3 we were looking at. Let us go back to the one we were 4 looking at 61/156. Were these forms then something 5 which, as you saw it, were coordinated as a standard 6 report form developed in that way by the Hospital 7 Medical Audit Committee? 8 A. To be honest, I do not recall how we came to be using 9 those forms. I do not remember anyone giving me them 10 specifically. 11 Q. They must have come from somewhere, must they not? 12 A. They must have done, but I do not recall where they came 13 from, I am afraid. 14 Q. It looks as if a coordinated attempt was being made to 15 record information. You were certainly recording, 16 albeit briefly, on the form what was happening? 17 A. We certainly used those forms for a period. As I say, 18 I was not aware of any particular link myself to the 19 Medical Audit Committee. I do not remember having any 20 particular contact myself with those people. So whether 21 someone else supplied the forms for us to use, I am not 22 sure. 23 Q. For whose purposes were you conducting the audit? 24 A. For ours as a group. 25 Q. The group was the cardiac services, albeit it was not in 0162 1 establishment in that form at that stage; it was 2 surgeons, cardiologists, cardiac anaesthetists, the 3 cardiac counsellor we see here, Helen Vegoda? 4 A. Yes, junior medical staff, nurses. 5 Q. We have these forms for January, February, March, May, 6 June, July 1992. The last one, there are two in July, 7 61/167. It is described as "cardiology" here. I do not 8 know if that is different from the paediatric cardiology 9 we have been looking at. Let us go down. Hypertrophic 10 cardiomyopathy: adult or paediatric? 11 A. That looks to me like Dr Jordan's handwriting. It 12 refers to patients in infancy, so it was a review of 13 patients with hypertrophic cardiomyopathy in childhood. 14 Q. After that we have not, so far as we can see, got any of 15 these forms for the rest of 1992, and for that matter 16 1993. Did anything happen? 17 A. Around that time -- I think it was around July or August 18 1992 -- we were quite concerned about a report that 19 appeared in Private Eye at that stage which seemed 20 appeared to include what appeared to be data from our 21 audit meeting directly. I am sure it had an effect on 22 audits after that, certainly for the surgical results. 23 I think we carried on having some audit sessions for 24 individual catheters, maybe foetal, you know some of the 25 different subspecialties that we also feel important to 0163 1 audit, but I do not remember that same format being used 2 for the surgical results around that time. 3 Q. Do you mean because of the publication in Private Eye 4 the review in these, if I call them "departmental" 5 meetings, I apologise that it may not be absolutely 6 accurate as a phrase -- the review in these sorts of 7 meetings finished? 8 A. Yes, I cannot be sure it finished completely. I know I 9 wrote out a rota for audit in 1993, which you kindly 10 gave me in the bundle of papers, but I am afraid I 11 cannot find any written record of those meetings. I do 12 not know how many of those took place. I do not 13 remember there being the same sort of surgical audit 14 afterwards, though as I say I think we did audit other 15 topics of a non-surgical nature after that. I think the 16 appearance of that audit, what we viewed as confidential 17 audit information in Private Eye, we found very very 18 disconcerting, very disturbing. 19 Q. The review within what I might call the "department" of 20 surgical results as opposed to non-surgical results 21 finished or significantly diminished following and as 22 a consequence of the publication of a Private Eye 23 Article in July 1992? 24 A. I think it certainly modified it. That sort of wider 25 audience multidisciplinary audience which I think we 0164 1 were having very successfully in 1992 largely started -- 2 we carried on reviewing data at other times but perhaps 3 in a slightly different format. For instance, we had 4 evening meetings in individual consultant's houses where 5 the consultant group would meet together, and I know 6 from time to time we would discuss surgical issues in 7 that. 8 So it changed its format from a broader group 9 incorporating nursing staff, technical staff, medical 10 staff to, if you like, a purely senior medical staff 11 group. Does that answer your question, sir? 12 Q. Can we look at SLD 2/5? If we go to the top of the page 13 we will see the date, 3rd July 1992. Can we scroll 14 down, the left-hand page. I do not know if you have 15 seen this before, have you? 16 A. I was shown it certainly at the GMC when I gave evidence 17 there. 18 Q. At the bottom of the left-hand column: 19 "The mortality rate for arterial switch is now 20 0 per cent in America; nearer to home in Birmingham, 21 3 per cent. In Bristol, despite the fact that the 22 operation has been performed since 1988, it is 23 30 per cent. Sadly, consultant cardiologists continue 24 to refer patients to their surgeons to support the local 25 unit." 0165 1 It quotes from a recently retired very emminent 2 cardiac surgeon in Southampton. 3 Those figures are not exact from the meeting that 4 you had in June. We have seen the meeting and I have 5 been through those figures in some detail with you. It 6 is broadly the same message. I do not know about 7 Birmingham, but the 30 per cent is broadly the same 8 figure? 9 A. Yes, as I say, we do not know for sure where they got 10 their information from for this satirical magazine, but 11 we were concerned that the mortality figures presented 12 there were in the order of what we had been discussing 13 only a week or two earlier. 14 Q. So they appeared to have come from the meeting into the 15 press? 16 A. We thought that was a possibility. 17 Q. If those figures are quoted in the press, why was it, do 18 you think, that the reaction was to reveal no more 19 figures rather than "if this is going to be the 20 information put out about us, let us make sure it is 21 accurate and right and do more work rather than less"? 22 A. I think we still felt that you had to review figures, 23 but it was the format of the meeting that we felt 24 perhaps was the issue. I think we were concerned that 25 many other things of confidential nature are discussed 0166 1 at audit meetings and we were concerned that there may 2 be other information which was erroneous appearing. 3 This is not true fact, so I do not know where the 4 mortality for arterial switch operation is 0 per cent 5 and I do not know that we knew the mortality in 6 Birmingham was 3 per cent. So I do not know that that 7 is necessarily data that came from our meeting, but we 8 were concerned that that might be the case. 9 Q. I am going to leave over further discussion with you on 10 this until tomorrow morning, because I am conscious that 11 we still have to bring our experts in and ask them to 12 comment on some of the matters which arose earlier, and 13 I am conscious of the time. I would just like you to 14 ponder overnight, if you would, why it should be that 15 the response to that which you said contained an element 16 of fiction should not be to answer it with fact but to 17 answer it with silence. 18 Perhaps we will return to that tomorrow morning. 19 Gentlemen, we had discussions earlier about the 20 coronary arteries and the imaging of them and the 21 difficulties, perhaps, of identifying the anatomy and 22 the effect that might have upon the success of an 23 arterial switch operation. Would you like to comment? 24 DR SILOVE: It is very difficult to image the coronary 25 arteries with echocardiography. One cannot be certain 0167 1 about the origins of the coronary arteries and the 2 course they run with echocardiography, although you can 3 get a pretty good idea. Perhaps a pretty good idea is 4 not good enough, but I must say that our practice in 5 Birmingham, for what it is worth, has been to accept 6 echocardiography as the standard by which the coronary 7 artery anatomy is presented to the surgeons. If the 8 surgeons find that it is different from what we 9 described on the echocardiogram, they accept that and 10 seem to find a way around it. 11 On the other hand, it is probably a reasonable 12 approach to do angiography because it is certainly our 13 practice, too, to put a catheter into the heart in every 14 baby who presents with transposition and do a balloon 15 atrial septostomy, so at the same time it would not be 16 technically too great an additional procedure to pass 17 a different catheter, the catheter you use for doing 18 a balloon atrial septostomy, that is, tearing a hole in 19 the atrial septum. You would need to use a different 20 catheter to do an aortogram or a right ventricular 21 angiogram, and that would stand a reasonably better 22 chance of showing the coronary artery anatomy and would 23 also exclude or help to exclude the presence of more 24 than one ventricular septal defect. 25 Again, it has not been our practice to do that. 0168 1 I must say that since the advent of colour flow 2 echocardiography from -- not from its inception; I think 3 we probably started doing that in 1989, but I would 4 certainly say that from about 1981 onwards, we had been 5 reasonably confident in defining ventricular septal 6 defects on echocardiography. 7 To cut a long story short: angiography is a useful 8 adjunct to doing a balloon atrial septostomy if one 9 cannot be certain about relying on your 10 echocardiography, but one has to accept that anything 11 additional that you do in a neonate is accompanied by 12 some risk -- maybe not a big risk, but there is some 13 additional risk. 14 MR LANGSTAFF: Mr Deverall, do you want to comment from the 15 surgeon's perspective? 16 MR DEVERALL: A little bit. I would say that there were 17 publications in the literature, both in the peer review 18 journals and in one or two books by the late 1980s, 19 defining the patterns of coronary arterial anatomy which 20 occurred in association with transposition of the great 21 arteries. In this country, Professor Yacoub and his 22 group published from Harefield and there was 23 a particularly good paper from Dr Quaegebeur, who worked 24 in Leiden in Holland, who had written on this particular 25 subject. 0169 1 That posed a bit of a problem. It explained what 2 subsequently happened in that the majority of neonates 3 presenting for the neonatal correction, about 4 80 per cent of them had one or other of two types of 5 coronary arterial anatomy which were the easiest for the 6 surgeon to deal with. 7 The two patterns which were least frequent were 8 the most difficult to diagnose, even by angiography. 9 One particular pattern, where the ostium of the artery 10 lies where two of the valves of the aortic valve come 11 together, is extremely difficult to diagnose 12 angiographically, in my opinion, so much so that we felt 13 that investigation was not of value. 14 We then get on to the question of how a surgeon 15 prepares himself for the unusual. That is another set 16 of questions. 17 MR LANGSTAFF: Dr Martin, until tomorrow morning, if you 18 please, at 9.30. 19 Before we finish for the day, sir, I wonder if 20 I may mention, for the benefit of those behind me and 21 those who are interested in the progress of the Inquiry, 22 that on Wednesday of this week and in addition to the 23 programme which I outlined last Thursday, we shall at 24 9.30 be hearing from Mrs Maria Shortis. 25 THE CHAIRMAN: Thank you, Mr Langstaff. We adjourn until 0170 1 9.30 tomorrow morning. 2 (4.40 pm) 3 (Adjourned until Tuesday, 16th November 1999, at 9.30 am) 4 5 6 7 I N D E X 8 9 10 MR ROBERT McKINLAY (sworn) 11 Examined by MR MACLEAN ....................... 1 12 13 MR LANGSTAFF: re CLINICAL CASE REVIEW .............. 91 14 15 DR ROBIN MARTIN (affirmed) 16 Examined by MR LANGSTAFF ..................... 95 17 18 Mr Deverall (sworn) 19 Dr Silove (sworn) ............................ 95 20 21 22 23 24 25 0171