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Hearing summary1st December 1999 The Bristol Royal Infirmary Inquiry oral hearings this week centre on the evidence of Mr Janardan Dhasmana, former Consultant Cardiothoracic Surgeon, United Bristol Healthcare NHS Trust (UBHT). Mr Dhasmana began his evidence this morning by discussing the working relationships between clinicians involved in the diagnosis, treatment and aftercare of babies and children born with congenital heart defects. He commented on the collection of data relating to surgical outcomes and identified the sources of data used during the 1980s and 1990s. He spoke about responsibilities for completing data entries and commented on the suitability of the data sources for recording information about paediatric cases. He related the audit data collected in Bristol to figures published in the UK Cardiac Surgical Register. He commented on the use made of this comparative data when the Bristol service was reviewed by the Welsh Office following concerns raised about the Bristol mortality figures by Welsh cardiologists in the mid 1980s. Mr Dhasmana confirmed that he was unable to compare case mix between Bristol and other centres providing a complex paediatric cardiac surgical service. He went on to focus on the development of audit and the co-ordination of audit activity between surgeons and cardiologists in the late 1980s and early 1990s. He discussed the issue of communications between surgeons and anaesthetists and discussed concerns raised about the switch programme by his anaesthetic colleagues stating that he was not aware of their dissatisfaction until mid 1994, several months after he had stopped performing neo-natal switches. Mr Dhasmana concluded by saying that following his appreciation that concerns were being expressed about his practice he agreed not to schedule future switch operations without discussing the case with the cardiac anaesthetists. Mr Dhasmanas evidence concludes tomorrow. Tomorrow afternoon the Inquiry will hear from Mr Stephen Willis from Devon and Mrs Rachel Ferris, General Manager, Cardiothoracic Services, UBHT. Dr Eric Silove, Consultant Paediatric Cardiologist, Birmingham Childrens Hospital, attended todays hearing in his capacity as a member of the Inquirys Expert Group. |
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FULL TRANSCRIPT
1 Day 86, Wednesday, 1st December 1999 2 (9.40 am) 3 THE CHAIRMAN: Good morning, everyone. Good morning, 4 Mr Langstaff. 5 MR LANGSTAFF: Good morning, sir. 6 MR JANARDAN DHASMANA (RECALLED): 7 EXAMINED BY MR LANGSTAFF (CONTINUED): 8 MR LANGSTAFF: Mr Dhasmana, yesterday when we went through 9 the three cases we have looked at so far, we will come 10 to the case of Joshua Loveday rather later today, you on 11 a number of occasions were making the point that the 12 cardiologists were not present as often as you would 13 have wished in the Royal Infirmary either 14 preoperatively, postoperatively or for that matter, 15 although you did not say it, I suspect intraoperatively? 16 A. That is correct, sir. 17 Q. That would make it difficult, I suspect -- tell me if 18 this is right -- for the service to operate as a team as 19 you would most wish? 20 A. Looking back, yes. 21 Q. Can we have a look at a letter sent by Mr Wisheart? It 22 is UBHT 195/2. It is dated 3rd April 1992. Before 23 I come to the text, yesterday we spoke about your going 24 to Birmingham and how you wanted to take along members 25 of your team and you took an anaesthetist on each of the 0001 1 two occasions you went. You encouraged Dr Bolsin to go 2 but he said "I am not doing this operation, it is 3 Dr Underwood, Dr Masey". You took along nurses and 4 a perfusionist? 5 A. I did. 6 Q. Did you ask any cardiologist to go? 7 A. Yes, I did. I did and they said, "What we will do, we 8 will make telephone calls and we will find out. We know 9 from our own experience and what I talked to others that 10 nothing different is being done in these patients than 11 what we are doing, but I would make telephone calls and 12 I will let you know if there was any change". 13 I believe they did, but I did not get any 14 information that they did go and visit that centre just 15 for this reason. They may have visited their colleagues 16 in the course of meetings and various things, but I -- 17 Q. It might be right to say that they, the cardiologists, 18 made no special effort in the way that the 19 anaesthetists, the nurses and the perfusionists had done 20 and you had done? 21 A. I think that sounds as if, you know, there was any 22 drawback on their part but I was quite happy with their 23 answer and I thought they must know what they are doing. 24 Q. This is a letter on the screen which Mr Wisheart was 25 writing to Professor West, the Medical Postgraduate 0002 1 Dean. It arose in the aftermath I think of a visit by 2 Dr Shinebourne dealing with the accreditation of Bristol 3 for a Senior Registrar post? 4 A. Yes. 5 Q. He was suggesting that there should not be such 6 accreditation following his visit. 7 What Mr Wisheart wrote -- can we scroll down? 8 "Paediatric cardiac surgery is carried out by 9 Mr Dhasmana and myself. I would like to make a number 10 of points: (1) the cardiologists and cardiac surgeons 11 work in the closest co-operation in the assessment, 12 decision making and management of the children both 13 before and after surgery. The development of the 14 paediatric cardiological services both medical and 15 surgical have progressed in the last decade on the basis 16 of the closest possible co-operation." 17 The first sentence suggesting that cardiologists 18 and cardiac surgeons "work in the closest co-operation" 19 in preoperative and postoperative management both before 20 and after surgery is not the picture that you were 21 giving us yesterday, is it? 22 A. I think one has to really look at the context in which 23 this letter was written and I know very well why it was 24 written and when it was written. I think one should 25 also see that what I am talking about now is looking 0003 1 back, comparing with centres like GOS, Birmingham and 2 other places but of course we were running the service 3 at that time, as somebody would say, and what we were 4 looking at, that no decision in the cardiac surgery was 5 being made without talking to cardiologists. They were 6 part of the decision making. They were in a way 7 involved with management. 8 But of course because of the physical problems of 9 distance and also their number, one has to remember at 10 that time the paediatric cardiological service in 11 Bristol was only consultants, there were no other staff, 12 they did not have junior staff, they had a rotating 13 SHO -- 14 Q. Can I ask you to stop there for a moment? What you said 15 to me in answer so far I think is two things: first, you 16 began by saying -- these are my words but I think 17 reflecting what you are saying, "This may not be 18 strictly accurate but you have to look at the purposes 19 for which this letter was written"? 20 A. That is correct. 21 Q. The second point you were making is: "Well, it is not so 22 badly inaccurate because ..." and I think you were going 23 to say "every surgical decision involved a cardiologist 24 and people were doing the best they could in the 25 circumstances" and at that stage you had no measure of 0004 1 comparison because you did not know until you looked 2 back on it how that compared with elsewhere. 3 Have I reflected your answer thus far? 4 A. I think you have, yes. 5 Q. The first point, "it is not strictly accurate but one 6 has to look at the purposes of the letter" may mean, may 7 it, that Mr Wisheart here was putting forward a view 8 which was inaccurate or exaggerated a point because it 9 suited the purposes of the unit to do so? 10 A. I would say it was not inaccurate because we were, if 11 you look at it you could compare paediatric service with 12 the adult service. We definitely had a better 13 co-operation from paediatric cardiologists in every 14 aspect of the patient management. The purpose was quite 15 right really because both Mr Wisheart and I were really 16 worried that we do not have that much paediatric 17 cardiologist cover for our patients and we knew it would 18 be possible only if we had another human being in that 19 speciality to help us. 20 Q. Is this why, if you look at point 4, you are doing your 21 best to try and get a Surgical Registrar to help so you 22 have a bigger cardiological presence; is that the aim? 23 A. Not Surgical Registrar, Paediatric Cardiology Registrar, 24 yes, Senior Registrar. 25 Q. The point of the letter is to achieve an object? 0005 1 A. That is correct. 2 Q. And the object was to relieve the difficulties that you 3 were experiencing, you and Mr Wisheart? 4 A. Yes. 5 Q. Really is it fair or unfair to say that point 4, the 6 purpose of the letter to obtain a Senior Registrar 7 appointment in paediatric cardiology, is because without 8 it one could not say or continue to say what is said in 9 paragraph 1, that there was close co-operation before 10 and after operations? 11 A. If one looks at that sentence again, it is not exactly 12 saying it is in Bristol, it is giving you a type of 13 principle of paediatric cardiac service really that 14 paediatric cardiologists and cardiac surgeons everywhere 15 work in close co-operation and probably that is what we 16 need more. I think that letter should be interpreted in 17 both ways. It points out the deficiency and it also 18 really says what we should have. 19 There is a background there because I know 20 Dr Shinebourne, when he came in he was very upset that 21 he could not meet us and that was physical presence 22 really, he was taken by car from one place to another so 23 he got the impression that they are two distinct 24 hospitals. So we were very disappointed that we did not 25 meet Dr Shinebourne but we were trying to in a way now, 0006 1 we felt, correct what was a shortcoming from our part 2 really to help in this venture. 3 Q. The second point I want to pick up from yesterday, 4 moving on from this letter, is in relation to equipment 5 because you on a number of occasions were commenting 6 upon the equipment that was or was not available. 7 We heard from nurses in this Inquiry, the 8 reference is Day 32, page 80, that there was no 9 maintenance or renewal programme for equipment on BRI 10 Ward 5. Are you able to comment on that or not? 11 A. I think I can comment on a bit of it because I was 12 actually Chief Director during part of this. UBHT did 13 or does, I am sure it still has, a department called 14 "MEMO". As the name says, medical equipment 15 maintenance organisation. I had a feeling they were 16 going round and looking at this but one thing one has to 17 really take into perspective: every piece of equipment, 18 whatever you are seeing today, 10 months from now would 19 be considered -- well, we should have better. There was 20 that feeling going on all the time and of course if you 21 had more money you could always replace them. So MEMO, 22 they were there but probably you could say there was not 23 uniform satisfaction about the standard of equipment 24 which I am not going to question too much about because 25 I know that was there. 0007 1 Q. The third and perhaps the last set of issues I need to 2 pick up with you from yesterday is the question of your 3 idea of the team which operated on children as part of 4 paediatric cardiac surgical services. Who in your view 5 was part of the team? Who constituted the team? 6 A. You asked me a question at the Children's Hospital; do 7 you mean Children's Hospital or do you mean the BRI? 8 Q. In the services in both hospitals. 9 A. As I mentioned before, any child with cardiac services 10 or with a cardiac problem would be admitted by the 11 cardiologist so they were the first part of the team 12 really, the cardiologists. Then of course 13 investigation, then the radiological department was 14 playing a role quite strongly until the cardiologists 15 took over quite a bit of it themselves really. 16 Third, in a way anaesthetists. Fourth our own 17 junior staff on both sides and then nurses and 18 supporting team of physiotherapists and other people who 19 helped these patients recover. 20 There was trouble on both sides because, as 21 I mentioned in one of my statements, we had a split 22 service not just between BRI and Children's Hospital but 23 also in the cardiac surgery itself, that we were doing 24 closed cardiac work at the Children's Hospital and open 25 heart surgery at the BRI. So if you were doing closed 0008 1 cardiac -- do you want me to go on? 2 Q. Please. 3 A. Closed cardiac work we were doing at the Children's 4 Hospital, as far as surgeons were concerned I was the 5 only surgical person there, there was no junior cover 6 there for me to call it my own team but of course I used 7 to get help from cardiologists. That was possible once 8 they had more of their junior staff in the form of 9 Senior Registrars and some SHOs. 10 Q. But not possible while there was not a Senior Registrar? 11 A. Exactly. So I used to sometimes say -- well, most of 12 the time -- take my own Registrar, I would say to the 13 Surgical Registrar from the BRI who was not at that time 14 involved in theatre, "Could you please come and give me 15 a hand with this operation?" In a way that was the 16 shortcoming there, that surgical staff was not there. 17 Of course at BRI there was a problem with medical 18 staff, cardiological staff. So we had a problem on both 19 sides. 20 Q. If one focuses upon surgical services, both closed and 21 open, the surgeon plainly is a central figure because 22 I suppose that unless the surgeon is willing to do the 23 operation it will not take place. Is it, looking back, 24 the position that the surgeon would take overall 25 responsibility for the patient under the team? Would 0009 1 somebody else as you see it take responsibility for 2 that? Was it shared and if so, how? There are three 3 questions in that. Let me break them down and ask you 4 each individually. 5 A. I can answer them one by one, if you like. 6 Q. Please. 7 A. One, I would say a cardiac surgeon is different from 8 other surgeons because other surgeons can get a case 9 directly from a patient's GP. You do not need to have 10 anybody else to make a decision and you can really just 11 take a patient on and it is you who is responsible. 12 In cardiology, in both sides, adult and paediatric 13 but more important paediatric, the surgeon does not get 14 the case directly. Cases are referred to the 15 cardiologist. He is investigating, he is examining; he 16 knows what service he has; he has one or two surgeons he 17 can refer the case. That is why joint cardiological 18 meetings are important and a decision then is made what 19 are we going to do and who is going to do it and when 20 you are going to do it. 21 After that decision is made then the case is 22 really referred on to the surgeon or the surgeon takes 23 over. But the primary decision for the management of a 24 patient, I would feel and strongly believe, is a joint 25 decision of everybody concerned with the child's 0010 1 welfare. 2 Q. If one looks at the preoperative period, as you see it 3 that is partly the responsibility of the cardiologist 4 until one comes to the question of what operation should 5 be performed; that is a discussion between the 6 cardiologist and the surgeon, is it, a joint 7 responsibility at that stage? 8 A. Yes, sir. 9 Q. The surgery itself, is that, would you say, a joint 10 responsibility between those involved or is that really 11 the responsibility of the surgeon, the surgical phase? 12 A. Then again here cardiac surgery is different from other 13 forms of surgery because in other surgery once the 14 patient leaves the theatre and is extubated you have 15 really just the surgeon and nobody else. But in cardiac 16 surgery, right at the time of surgery there are three, 17 four distinct teams involved in the patient's 18 management. 19 Somebody is looking after perfusion. Somebody is 20 looking after anaesthesia, which is not just putting the 21 patient to sleep but also making sure that the patient 22 really is being looked after during perfusion in the 23 same way by keeping an eye on drugs and various 24 management and also these patients are not immediately 25 extubated so the patient is still recovering from 0011 1 anaesthesia, is still requiring breathing support and 2 various things, so anaesthetic cover continues in the 3 postoperative period. 4 Q. I had, I hoped, restricted the questions I was asking to 5 the operation itself. 6 A. Yes. 7 Q. It is difficult I know because the one shades into the 8 other. I will ask you in a moment about postoperative, 9 if I may. So far as the operation itself is concerned. 10 A. I have talked about perfusionists, I have talked about 11 anaesthetists and I also talked about the nurses because 12 they play a very important role here. Operations are 13 varying, it is not a similar type of operation, 14 especially in paediatrics. 15 You do not have a huge number of one particular 16 type of operation going on and on and on every day. You 17 could have one day ASD, another day VSD or the same day 18 a tetralogy and ASD or some other combination. So 19 nurses are also quite an important part of this group. 20 Q. Does any one of those disciplines coordinate the 21 activities of all those particular parts of the overall 22 team? 23 A. It is very good on paper really that somebody should 24 coordinate but it just functions without somebody taking 25 the role of coordinator. What you do, you publish the 0012 1 list, the list goes to theatre or the sister in charge 2 and then it is taken and then the list is also 3 publicised so the anaesthetists know, the perfusionists 4 know from there and it is taken as if it is coordinated 5 that way. 6 Q. The individuals who would work with you on a particular 7 case would be on a rota which may or may not coincide 8 with your rotas, you may be working with different 9 people on similar operations over the weeks? 10 A. Yes, that is correct. 11 Q. Within the operation itself, we heard as you will have 12 seen from the transcript, some concern in one case about 13 the replenishment of cardioplegia, there being in that 14 particular case no note that cardioplegia had been 15 replenished after half an hour and the time on, when it 16 was needed, was about an hour and a half long. 17 A decision such as that, we were given to believe 18 the anaesthetist might say to the surgeon "Shall I give 19 some more cardioplegia?" or the surgeon might call to 20 the anaesthetist "Can I have some more cardioplegia?" 21 What is your perception of how that worked? 22 A. Thank you for giving me that opportunity because I saw 23 that transcript and it made me feel very uncomfortable. 24 I could not believe that I would have had a patient on 25 the table without cardioplegia for one and a half 0013 1 hours. There is something missing somewhere. Either an 2 entry has not been made -- most probably an entry has 3 not been made because I do make a point of giving 4 cardioplegia at frequent intervals. 5 One has to make a little observation here: 6 a 30 minute rule applies to the heart, which is almost 7 at normal temperature. It is mostly with the adult 8 patients who are treated at 32 degrees or 37 degrees 9 Centigrade. Most of the paediatric patients, they are 10 cooled down to 25 to 20 degrees Centigrade so you do not 11 necessarily need to stick to the 30 minute rule, but 12 definitely not 65 minutes, as you have mentioned. It 13 would not be exactly on 31 minutes that cardioplegia 14 would be going, but some time around then. Because 15 there is no real time known, a lot of work has been done 16 but there is still no clear-cut ruling on this except 17 for the general arbitrary line that after 30 minutes you 18 must start looking for a region to give cardioplegia. 19 In the paediatric practice anaesthetists used to 20 give cardioplegia. In a lot of centres, perfusionists 21 give it in the machine and in a way in both of these 22 situations, both of these groups, they ask the surgeons, 23 after about 30 minutes gone, 35 minutes gone, "Do you 24 want me to give cardioplegia?" I am sure, the surgeon 25 at that time is just concentrating on that and time 0014 1 sometimes you do not notice at that time. 2 Q. Again asking you to pause, if you do not mind, what you 3 are saying I think is that because of your focus upon 4 the intricacies of the surgery, you would expect to be 5 reminded by the anaesthetist, that would be essentially 6 his job, or the perfusionist, to tell you "The time is 7 now ready for a fresh cardioplegia" and no doubt if that 8 reminder came you would say "Yes, go ahead" or whatever? 9 A. That is correct. What they would say, to give 10 cardioplegia you have to stop at that time, do nothing 11 else until cardioplegia has been given. So they would 12 ask you and of course you are not going to put a big 13 argument up at that time, and you say "Yes, please give 14 it". Though I do know that -- 15 Q. Is that the way it usually worked with you at any rate, 16 that they would suggest and you would then find a quick 17 and convenient moment to stop, cardioplegia is applied 18 and then you continue? 19 A. Both anaesthetists who have worked mostly with me on 20 paediatric, they were very particular about that and 21 I am quite surprised there is no mention in the notes 22 about cardioplegia. I would feel there is some omission 23 in an entry but it is not possible and I can really say 24 that for a person not to be given cardioplegia for one 25 and a half hours, I just cannot believe it. 0015 1 Q. On the face of it, it is very surprising and one would 2 certainly expect an anaesthetic record in surgery to be 3 complete, would one not? 4 A. I cannot complain about others' records because I found 5 the surgical records are not very good sometimes, so 6 I am afraid record-keeping is not a very good thing in 7 human nature unless you are doing auditing or accounting 8 or some other job like that. 9 Q. When surgery is being conducted the anaesthetist has not 10 the same hands-on role as the surgeon and is expected to 11 enter the charts as he goes along, is he not? 12 A. It should be. 13 Q. I have not yet asked you about the postoperative phase, 14 let me do that now. 15 You were going to say until I cut you short that 16 the anaesthetists had a part to play post-operatively. 17 We have seen that from various sources, as well as the 18 surgeon. Very much later on in Bristol anyway the 19 intensivist who might be an anaesthetist by training -- 20 and I think the way the intensivists began in Bristol 21 was by an expansion of the anaesthetic sessions to cover 22 the ICU, was it not? 23 A. That is correct, sir. 24 Q. Apart from the anaesthetist and the surgeon and the 25 intensive care nurses, did anyone else have 0016 1 a responsibility as you recollect it for the 2 postoperative phase? 3 A. I think you have counted the major groups. 4 Q. The anaesthetist would be concerned with matters such as 5 fluid levels, drug administration, ventilation 6 primarily, would he? 7 A. They would be concerned -- I think fluid management was 8 a type of joint concern really and from my previous 9 experience at other centres and my training, I was a bit 10 more on restricting fluid so I used to control the fluid 11 regime as much as possible, but of course anaesthetists 12 would be really a very guiding influence on that and 13 also the drugs. 14 Q. What was the dividing line between the responsibilities, 15 if there was one, of the anaesthetists on the one hand, 16 the surgeon on the other and perhaps the nurses in the 17 third corner? 18 A. There was no clear-cut demarcation line except that as 19 being a surgeon of the patient concerned I used to 20 always take myself as providing some type of continuity 21 for that patient to make sure things are moving in the 22 right direction. 23 Q. Looking at the input from the various different teams, 24 what if any measures did you take or did the unit take 25 to make sure that each part of the team responsible for 0017 1 the ultimate outcome for the patient was performing 2 adequately? 3 A. I thought I was trying to get the communication right 4 but it appears it was not very good, communication 5 amongst the staff. As a result I used to put in a lot 6 of presence there just to make sure that what we talked 7 about in the morning was being carried out during the 8 day. What we are talking about in the evening would be 9 carried out in the night; what we left in the night was 10 carried out for the remaining part of the night because 11 the rest of the staff were moving or changing. So the 12 communication was not very good and I used to find that 13 sometimes that could create confusion especially amongst 14 nurses really because it is possible a different set of 15 doctors may have advised differently on the same line 16 because, as you know, for any management there could be 17 more than one way of dealing with the problem. 18 Q. So far as the nurses are concerned, in the Intensive 19 Care Unit at Ward 5 of the BRI was there from time to 20 time a shortage of paediatric trained nurse cover? 21 A. The problem with the BRI, because it is a place in the 22 hospital where it is mainly an adult service, so 23 whenever we wanted to recruit a paediatric trained nurse 24 in the cardiac surgery, we were not very successful 25 because nurses who were trained in children's care, they 0018 1 are in high demand everywhere and there is a shortage in 2 almost all hospitals so obviously they get absorbed 3 there quickly. If somebody lives, say in Bristol or 4 other places and having been trained in paediatric, they 5 did not feel that they wanted to look after adults when 6 a child is not being looked after in ITU. 7 So we had a very real problem in recruiting a pure 8 paediatric trained children's, intensive care nurse in 9 our cardiological department. However, we had some very 10 good, very dedicated nurses. They by their own effort, 11 by their own experience and by going to the Children's 12 Hospital, they doubled up their expertise as to get my 13 confidence that I was always happy for them to look 14 after my patients. 15 But because of this we had a core group and there 16 were a small number of nurses who I would feel happy to 17 leave my patients with, and that used to cause some 18 problems and that is where the term 'shortage' really 19 comes, because of course you know sickness or illness, 20 nobody can really foresee those things. 21 Q. Did nurses have to be recruited from the bank from time 22 to time for ICU work? 23 A. Unfortunately, yes. 24 Q. And you say "unfortunately" because? 25 A. Because sometimes what we would do, we would get nurses 0019 1 who are intensive care trained but probably in 2 a different field, not even cardiac surgery. So when 3 they come in we would move them to look after the HDU 4 side and some suitable nurse from HDU would be moved 5 into ITU, so it still needed adjustment of nurses in the 6 unit but that was in a way the best we could really do 7 rather than postpone the case and postpone again. 8 Q. Going back to the question of the teams or the groups 9 that formed part of the overall team -- 10 THE CHAIRMAN: Mr Langstaff, I wonder if we could ask 11 Dr Silove whether experience of bank nurses and so on 12 was common in his experience, whether in Birmingham or 13 elsewhere. 14 DR SILOVE: I think there has always been a very major 15 problem in recruiting nurses for intensive care. It is 16 common -- it has been common throughout the country for 17 intensive care beds not to be fully staffed and I am 18 sure bank nurses have had to be recruited from time to 19 time in most places. 20 May I just say something else, may I go back to an 21 issue that Mr Langstaff was raising a little earlier on 22 this morning: you were focusing on the word 23 "co-operation" between cardiologists and cardiac 24 surgeons and I wanted to say that from the perspective 25 of doing the clinical case note reviews, the teams of 0020 1 experts considered there was good co-operation between 2 the surgeons and the cardiologists, the cardiologists 3 were not being unco-operative by not going to the BRI, 4 we perceived there being geographical constraints which 5 might have made this extremely difficult. 6 In a number of comments coming from the teams of 7 experts about the management of patients at the 8 Children's Hospital, they actually praised the 9 management on the Intensive Care Unit and there was 10 a perception that the cardiologists were much more 11 closely involved with the management of patients at the 12 Children's Hospital, presumably because that is where 13 they were. 14 But I do not think we should start getting the 15 feeling that the cardiologists were being 16 unco-operative. Mr Dhasmana said earlier on in this 17 hearing that when he asked cardiologists to come to the 18 BRI they came. 19 A. Yes, they did. 20 DR SILOVE: But it was difficult to find them. 21 MR LANGSTAFF: I think one of the points that you said 22 earlier to us arising out of the Clinical Case Note 23 Review was that a number of teams had commented upon the 24 absence, not the lack of co-operation but the absence of 25 cardiologists on the ICU at the BRI and a number of them 0021 1 had said "where is the cardiologist?" 2 DR SILOVE: That is absolutely right and I agree with that 3 point and we commented on that in a number of cases 4 yesterday. The only word that I am trying to have 5 removed from this is the word "co-operation". 6 MR LANGSTAFF: You are concentrating on attitude rather than 7 performance? 8 DR SILOVE: Yes. 9 MR LANGSTAFF: That is a fair point, is it, Mr Dhasmana: 10 that the attitude was entirely right, performance in the 11 way one would hope and expect was lacking? 12 A. This letter itself shows really that the problem was 13 identified and we were all working together to move to 14 that direction. We had all accepted and agreed that 15 there should be a more physical presence of paediatric 16 cardiologists by themselves in a way and they themselves 17 realised that, the only thing was it was not possible 18 a number of times. 19 Q. I was going to ask you about how the component parts of 20 the team were able (if they were) to evaluate their own 21 contribution to the overall outcome. The first question 22 that arises: we know the anaesthetists had audit 23 meetings of their own, was there any form of review so 24 far as you know of the cardiologists as a separate 25 group, the perfusionists and the nurses? 0022 1 A. I cannot follow the question, you said "separate 2 group"? 3 Q. We have identified a number of component parts: nurses, 4 anaesthetists, perfusionists, cardiologists, surgeons in 5 creating an overall outcome for the patient in cardiac 6 surgery. The unit as a whole looked at its figures and 7 we will have a look at that in a moment or two. Before 8 we get to that stage, I am just asking how the 9 performance of the separate groups was assessed, if it 10 was; was there any process of doing so? 11 A. There were audit processes in every group really. We 12 cardiac surgeons had our own audit which we used to call 13 monthly morbidity/mortality meetings. We had our yearly 14 audit where we would present a whole year's figure. We 15 would have a teaching session during which our junior 16 staff would present, say, a periodical audit for 17 a particular problem. 18 Similarly when you use the term "cardiology" I was 19 a bit confused whether you meant adult or paediatric 20 really because both of them had a separate group really, 21 but paediatric cardiology also had their audit which -- 22 we were a part of it, paediatric cardiac surgeons used 23 to really go to that periodic cardiology audit meeting 24 which became more formalised once they increased their 25 consultant number from two to three when Dr Martin came 0023 1 along, and it was supposed to be a monthly audit 2 meeting. It did carry on. Somehow it lapsed somewhere 3 in 1990 and 1991 sometime and then he got it back again 4 in 1992. So there was a cardiology audit which was a 5 combined paediatric cardiac services audit. 6 Perfusionists by themselves did not have any audit 7 but they used to in a way -- I think it became more 8 formalised once the children moved to the Children's 9 Hospital but before that there was no real audit in the 10 name of perfusion because they did not take perfusion by 11 itself as separate from cardiac surgery, if you are 12 auditing cardiac surgery you are auditing the whole 13 thing. 14 Q. When you came as surgeons, either separately or with the 15 paediatric cardiologists, to look at your results what 16 available data was there to you, first of all to 17 establish your own results and, secondly, to compare 18 them with the results of any other group or centre? 19 A. In the beginning it was all, you have to collect data 20 yourself from registers, books, make your own -- I mean 21 we all from our training really have had a logbook which 22 we continued with that. So we used to keep a record 23 there. 24 Q. Can I identify the sources and then we will ask about 25 each of them in turn if I need to. The first is logs? 0024 1 A. Yes. 2 Q. Surgeons' logs; what else? 3 A. Then I -- and I am not sure whether my colleagues, but 4 I am sure some of them did -- also had a record of the 5 whole year's work really in a way in a folder which 6 would have an operation note, discharge summary and 7 relevant cases, postmortem findings in patients where 8 unfortunate events has taken place. So that I would 9 have, which I used to call a year book but probably not 10 everybody called it that way, but they were there 1985, 11 1986, 1987, like this. 12 Of course the hospital had its own medical record 13 and sometimes we had to really go back to them to get 14 things verified. So that was the case mostly during the 15 1980s. I am not sure at that time there was any 16 computer in true form. 17 Q. In the 1990s? 18 A. In the 1990s we started computerising things and I think 19 there was one system, we tried it but it failed because 20 it was a very complex system, METASA source it was 21 called. We then change to the PATS system which was 22 more compatible with cardiac surgery because in way 23 Americans, they were well advanced and they had 24 developed it. So we took it from there. 25 Our society accepted it so in a way to us it felt, 0025 1 you know, it would be reasonable really to adopt this 2 system and then we do not have to really separate or 3 make an extra effort to fill in the UK register really. 4 Q. In the 1990s, did you continue to keep your logs? 5 A. Yes. 6 Q. Did you continue to keep your year books? 7 A. Yes. 8 Q. And you had in addition the PATS system; that is the 9 Patient Analysis and Tracing System? 10 A. Yes. 11 Q. Which replaced the METASA system? 12 A. Yes, I do not know the full form now, I have forgotten. 13 Q. Did you have any other source of data for your own 14 figures? 15 A. For my own figures? 16 Q. For the figures, the surgical figures of the unit? 17 A. It is not coming to my mind at the moment, but ... 18 Q. We have heard from cardiologists that they kept 19 a register which they called the South Western 20 Congenital Heart Register? 21 A. Yes. 22 Q. Was that something they kept to themselves? 23 A. I knew that Dr Jordan -- this was known to be 24 Dr Jordan's brain child and he was very keen on it and 25 almost all children would have a type of sheet in the 0026 1 case notes saying "South West Congenital Heart Surgical 2 Register" or some type of that name. 3 Q. I think I do not need to ask you about the details of it 4 because we have those. Did you use that particular 5 register to produce your own figures at all? 6 A. No, I did not use that. 7 Q. I want to look at each of those to some extent in 8 a little more detail. The second part of the initial 9 question I asked was: what (if any) comparison data was 10 available to put Bristol's figures, results, outcomes in 11 context? 12 A. The only comparator which I can really name is the UK 13 Cardiac Register. 14 Q. The surgeons' logs, looking at those first; they would 15 be completed by you personally, your own log that is? 16 A. Yes. 17 Q. You would put in to the log, the record: the name of the 18 patient, the hospital number? 19 A. Yes, I think it must. 20 Q. Date of the operation? 21 A. Can I just explain that, it probably would come better? 22 Q. Please. 23 A. I did not want it to be too complicated, I simply wanted 24 a type of what I have done and what was the outcome in 25 this patient. So in a way I can quickly fill in and get 0027 1 the quick glance back type thing, what I have done in 2 the past. 3 I would ask my secretary to type in the 4 demographic data which I used to call, the patient's 5 initials or name would be there. Initially date of 6 birth was not there, she used to put in the age at that 7 time in months or the year and the hospital number. She 8 would just put in the diagnosis as we have got it from 9 the cardiologist and sometimes she would put down 10 a little bit more on haemodynamic data which I told her 11 not to bother because most of the time I thought they 12 were not correctly put in. 13 So they were the typed part you know in the 14 beginning. She would also mention the operation that 15 was carried out and after that I used to fill in and 16 I used to really -- I was interested in what was 17 happening, whether they were discharged or not 18 discharged, what had happened and then follow the 19 information which I would get from the cardiologist, 20 a copy letter and I would just summarise that. So that 21 is how it was. 22 Q. The logbook was actually compiled by your secretary? 23 A. The initial entry, just the demographic data, the rest 24 of it was in my own hand. 25 Q. When you say you were looking at the outcome, were you 0028 1 able in every case, and did you in every case follow-up 2 whether there had been survival or mortality within 3 a 30-day period? 4 A. That is a very good question and I cannot answer that in 5 every case I have that answer. 6 Q. So far as the 30-day figure itself is concerned, did you 7 yourself regard that as being of significance or not? 8 A. Yes. 9 Q. Why? If, for instance, someone died following surgery 10 at 31 days, they would not be within a 30-day mortality 11 obviously. Did you regard it nonetheless as important 12 for your own figures to have a cutoff at 30 days? 13 A. I think here 30-day mortality came from the UK Cardiac 14 Surgical Register because that is what they were asking 15 for so we had to in a way put in an entry from our 16 logbook or whatever information we had to satisfy that 17 one. 18 To me personally, if a patient died in hospital, 19 whether the BRI or the Children's Hospital, it was 20 a hospital death and that did matter to my own record. 21 Q. Whenever it happened? 22 A. Whenever it happened, if it happened in hospital, yes. 23 Q. Suppose that a child had stayed in hospital for 6 weeks 24 after operation, a prolonged stay on ICU, and then had 25 finally succumbed; would that be in your log as a death? 0029 1 A. It would be in my log as a hospital death, yes. 2 Q. What (if any) note did you make about apparent morbidity 3 following operation? 4 A. I am afraid morbidity is not very well recorded because 5 as I said before the logbook was not supposed to be 6 a detailed note really, otherwise I would have been in 7 the same trouble like any record now because they are 8 not completely filed you have to really then have 9 a check point at every entry point, so there was no 10 entry point for morbidity. At that time mortality was 11 the thing which I was looking for. But in some patients 12 who stayed in hospital longer and there was a problem in 13 the hospital I was concerned about, I have listed as 14 much as I could. 15 Q. At some stage you did I think indicate a figure as to 16 your expectation of the morbidity following operations. 17 In fact it is in your statement, if we look at 18 WIT 84/53. You say: 19 "As regards to morbidity, there was no data 20 available to me from any other centre in the country to 21 be used as a comparator. At some of the courses ... 22 incidence of neurological changes following open heart 23 surgery... were discussed and wide ranges were 24 mentioned, for example, psychiatric and behaviour 25 changes in as many as 25-30 per cent of cases and gross 0030 1 motor changes in 5-15 per cent." 2 The only comparator you say you had was locally 3 with your colleague Mr Wisheart although no comparative 4 figures were collected and you believe you did not 5 compare unfavourably against Mr Wisheart? 6 A. That is just an impression. 7 Q. If you were to estimate now -- and it is a question you 8 may want to think about overnight, and tell us if you do 9 -- if you wish to estimate now what you think the 10 percentage of neurological complications, renal 11 complications respiratory complications may have been in 12 the cases in which you dealt, what sort of percentage do 13 you think you would put on it, appreciating you have no 14 detailed data to make the estimate? 15 A. That is why I am saying neither can I estimate at this 16 time nor tomorrow because I do not have any data with 17 me. 18 Q. You cannot give a rough figure? 19 A. I cannot really unless somebody sat with all those 1800 20 cases and looked at the notes and compiled it because 21 that data is not there. 22 Q. Going back to the first of the data sources you mention, 23 your log; turning to the second, the year book: you kept 24 a year book, did Mr Wisheart? 25 A. I cannot comment on that. I believe I have followed his 0031 1 practice so if I was doing it I am sure he was doing it, 2 whether he continued to do it I am not sure. 3 Q. At some stage Mr Wisheart kept a year book, whether he 4 went on doing it you do not know? 5 A. No. 6 THE CHAIRMAN: Stepping back one moment to the reference to 7 morbidity, Mr Langstaff. I know you are going to say 8 something tomorrow about this, but I wondered whether we 9 could ask Dr Silove to comment on Mr Dhasmana's answer. 10 DR SILOVE: I think Mr Dhasmana's experience is probably the 11 same as most other centres, in that figures for 12 morbidity have not really been well collected. The only 13 figures that seem to be collected are those of mortality 14 and I am not really sure how well those figures are 15 collected, but morbidity is something which people have 16 begun to write about more in the last 5 years or so, but 17 there is very little information available 18 unfortunately. 19 THE CHAIRMAN: Would you like to tell us why that may be the 20 case? 21 DR SILOVE: I suppose it is a matter of having somebody to 22 do the work of writing it down and people have not 23 actually bothered in the past to consider that to be 24 a factor that needed to be written down. I do not 25 really know the explanation, sir, it is so difficult 0032 1 going back in time. We are aware that many patients in 2 the immediate postoperative period have minor 3 neurological problems, some have more major problems, 4 there does not appear to be any significant audit method 5 of finding out how many patients actually have 6 neurological or renal problems or any other morbidity 7 problem. 8 MR LANGSTAFF: I wonder if I may push you a little on that: 9 in some textbooks would one find an estimate of the 10 extent to which there might be, for instance, 11 neurological damage following operation? 12 DR SILOVE: There will be information in some textbooks 13 which will be drawn from published articles and you will 14 see a great range in figures. I cannot quote you 15 precise figures at the moment, I do not have them in my 16 head but you will see figures ranging from 5 per cent 17 right up to 25 per cent for morbidity and it is very 18 difficult to know what reliance one can place on various 19 figures. 20 MR LANGSTAFF: Is any attempt made in the articles from 21 which those percentages (wide as they are) are drawn, to 22 attribute those percentages to any particular cause? 23 For instance, it appears to be generally accepted -- and 24 tell me if this is wrong -- that the period of time on 25 circulatory arrest or time on bypass has an adverse 0033 1 implication in terms of morbidity; is that a matter 2 which the articles -- from where the figures come? 3 DR SILOVE: There are attempts to link it to length on 4 bypass and I do not believe there is any strong 5 correlation. Again, I must plead some ignorance on 6 this. I have not studied that particular subject 7 carefully. 8 MR LANGSTAFF: Dealing with that issue for a moment, if 9 I may. You were accepting yesterday that the length of 10 an operation probably had an adverse effect. The longer 11 the operation the more likely there would be some 12 adverse effect on the child concerned. First of all -- 13 A. Can I just? 14 Q. Yes, please. 15 A. I am not sure we did talk on this yesterday, did we? 16 Q. You mentioned the view that the length of time in 17 operation might have an adverse impact. If necessary 18 I can look back at the transcript and pick it up. What 19 I am exploring with you is that concept anyway, is it 20 right? 21 A. I think it has been -- I do not know whether I can put 22 a little philosophical view on something the Chairman 23 asked me before, forgive me. 24 Because this has also bothered me for a long time, 25 that in a way we get mortality but we do not get too 0034 1 detailed morbidity from different centres. I asked that 2 question to a great mentor of mine for whom I have a lot 3 of regard, Dr Kirklin. He told me the way he sees it, 4 that the cardiac surgery developed a great deal. The 5 initial question in everybody's mind was to get that 6 patient better, survive the operation. It is only 7 recently that we have come to a stage because we are 8 using a cardiopulmonary bypass, a different machine 9 which itself causes damage to the blood cell, you do not 10 use this device in any other type of surgery. That 11 machine itself causes a problem. 12 So in a way you are adding a problem or the 13 machine may be causing a problem. It is now, with 14 modification, with further advances the machine is 15 getting safer and safer. So now because the machine is 16 getting safer and safer we should now be looking at 17 whether now the surgery itself is adding something 18 because until now we had a machine to blame. 19 So that is why morbidity, in my mind -- and I may 20 be wrong -- is late in coming, but it is coming now 21 because now people are reporting almost, you know, 22 a very acceptable mortality from cardiac surgery, even 23 sometimes no different than major general surgery. So 24 this is the time to look for morbidity. So that I feel 25 is probably the cause in late appearance of morbidity 0035 1 data. 2 Most of the morbidity data which is appearing is 3 now appearing in the same way, first, in the most major 4 problem which is neurological and that is why a lot of 5 research is now being undertaken. Until now very much 6 -- research was more on correcting the problem but not 7 looking into the complication. Now they are looking and 8 they are doing research and that is where the figures 9 are coming. 10 About the length of operation and association with 11 bypass: there is a general feeling, because you have 12 a patient on drugs or anaesthesia for a longer period so 13 obviously a person probably would have a problem. But 14 we have all seen that sometimes after a long operation 15 a patient makes a miraculous recovery, and sometimes a 16 straightforward operation, a very short bypass, we have 17 a series of problems. 18 So there is an impression that probably a long 19 operation and a long bypass leads to the problem, but at 20 the same time people do have views that a long operation 21 and a long bypass, unless it is unduly long, probably 22 does not have any significant effect on outcome this way 23 or that way. 24 DR SILOVE: I agree with everything that Mr Dhasmana has 25 just said and I do not believe there is any clear 0036 1 evidence, there is no clear evidence that length of 2 bypass is definitely related to morbidity. It is an 3 impression, as he says. 4 Just to take this a step further: many of the 5 cases where there is a long bypass because I think -- 6 I am not a surgeon -- but I think the surgeon is 7 deliberately prolonging the bypass time after having 8 done the operation to give the heart a rest, to allow 9 the heart to recover before taking the patient off 10 bypass and letting the heart take over. 11 To take it just a stage further than that, there 12 is a form of bypass called -- which is a sort of 13 a partial bypass really -- ECMO which is Extracorporeal 14 Membrane Oxygenation where the patient is connected to 15 a bypass machine often for weeks and weeks and I do not 16 believe there is any strong evidence that that prolonged 17 period of perfusion, using the oxygenator is responsible 18 for morbidity. 19 MR LANGSTAFF: When was ECMO introduced? 20 DR SILOVE: I suppose probably about 7 or 8 years ago, I am 21 not sure about that. 22 A. The mid 1990s, 1994/1995. 23 MR LANGSTAFF: Did they use it in Bristol? 24 A. Now they are using it, they did not have it before. 25 Q. Not in the period with which we are concerned in the 0037 1 Inquiry? 2 A. No, it is very recently. 3 Q. So far as the cardiopulmonary bypass is concerned, you 4 agree then with what Mr Dhasmana was saying: it does 5 damage the blood inevitably as part of the process? 6 DR SILOVE: Yes, it does. 7 MR LANGSTAFF: Intuitively, I think is what you are saying, 8 the view is that the longer the machine is used the 9 greater the damage is likely to be? 10 DR SILOVE: Yes, perhaps more important than the length of 11 bypass, though, might be the cross-clamp time of the 12 aorta when there might be -- mind you that really 13 affects the myocardial function more than anything 14 else. When there is total circulatory arrest for a long 15 period of time that could cause neurological damage but, 16 as Mr Dhasmana was pointing out, these babies and 17 children are usually cooled down to about 20 to 25 18 degrees Centigrade which should protect the brain quite 19 significantly for periods of, say, an hour of 20 circulatory arrest. 21 MR LANGSTAFF: The words you are using are "protect 22 significantly", it would suggest that -- 23 DR SILOVE: There is great anxiety that prolonged 24 circulatory arrest can cause neurological damage, that 25 prolonged bypass might cause neurological damage but 0038 1 there is no very hard evidence. 2 MR LANGSTAFF: The intuitive feeling that length of time on 3 bypass -- the length of circulatory arrest may cause 4 damage, the longer it goes on the more the problem might 5 be -- has that been a general view of cardiologists and 6 cardiac surgeons since surgery on bypass was introduced? 7 A. Paediatric cardiac surgery, especially paediatric 8 cardiac surgeons have been very much interested in this 9 field, really. Yes, they have always kept an eye on 10 this and know what Dr Silove has just said. 11 MR LANGSTAFF: Is there anyone who expresses the view that 12 it does not matter? 13 DR SILOVE: No, I do not believe there is. 14 MR LANGSTAFF: We have rather gone out of the way of my 15 asking you about the sources of data in a discussion 16 which was necessary and followed from the Chairman's 17 question. It is perhaps appropriate, then, to have 18 a break before we return to the question of data sources 19 and analysis. 20 THE CHAIRMAN: 15 minutes until 11.00. 21 (10.45 am) 22 (Adjourned until 11.00 am) 23 (11.05 am) 24 MR LANGSTAFF: The year books, Mr Dhasmana: what additional 25 information, over and above your logs, did your year 0039 1 books give you? 2 A. It had a copy of the operation note, so it would have 3 the detail of the operation, the findings, what I have 4 done, who anaesthetised and the usual data there, and it 5 would have a discharge summary which I used to write 6 myself in the 1980s, but of course once the computer 7 came in it became a bit more regimented. So that would 8 have more information, and it would have some mention of 9 morbidity, because I always wanted to give that 10 information to the GP, so if I had done the discharge 11 summary myself, I would have mentioned that. 12 Q. The METASA system you say essentially was not 13 satisfactory and it was replaced? 14 A. Well, only I could complete it; nobody else could, 15 really, because it needed a lot more information, and it 16 was very time-consuming, so I and sometimes, you know, 17 my other consultant colleagues if they had time, they 18 could do that. But if you relied on juniors to do it, 19 it did not work out. 20 Q. So do I take it from that that the information contained 21 in it would be to an extent unreliable and to an extent 22 inconsistent? 23 A. That is correct. 24 Q. The patient analysis and tracing system: that, I think, 25 related to operations from April 1992 to January 1996, 0040 1 so far as we are concerned. 2 A. I think that is right. 3 Q. It was a spreadsheet? 4 A. It was a spreadsheet you needed to fill in, and again, 5 this thing would change. Initially, the SHO at the time 6 of admission was supposed to be filling in demographic 7 data and some of the symptoms and haemodynamic data and 8 the surgeon after he had finished the operation would 9 fill in the rest, but the haemodynamic data was not 10 always filled completely, so some time later it was 11 changed that the surgeon would fill in the haemodynamic 12 data and the operation findings himself. 13 One has to realise that the PATS system was not 14 geared up to deal with paediatric information, except 15 diagnostic information and things like that, it is 16 basically more adult orientated, so even though we 17 adopted it, I still would not call it a very 18 sophisticated technique for data collection in 19 paediatric cardiac surgery. 20 Q. It was supposed to fill in the diagnosis for paediatric 21 cases? 22 A. That is correct. 23 Q. The work done on the PATS system which the Inquiry team 24 has done reveals that there were no entries in respect 25 of diagnosis prior to August 1994; thereafter, only 0041 1 about four entries in the diagnosis field, which 2 suggests a lack of completeness by whoever was supposed 3 to fill in the diagnosis. 4 Was that appreciated? 5 A. It was very well appreciated because in a way the PATS 6 system wanted one diagnosis and it was not easy in a lot 7 of children to put in one diagnosis. Most of these 8 patients had multiple problems. That is why I was 9 saying that, you know, the PATS system was not really 10 geared for the paediatric system. That is why, when 11 I came to know about another system, I applied to join 12 that one. 13 Q. I am told, and you have a chance to agree or disagree, 14 that the completion of some of the items on the 15 spreadsheet was, as described to me, "spasmodic". Would 16 that be a fair description? 17 A. If you are talking of all five surgeons, then yes. 18 Q. So in terms of giving information to you, it was not 19 a very reliable source of information? 20 A. For paediatrics I never considered the PATS system 21 reliable, no. 22 Q. So in terms of preparing the figures for audit, you 23 would be back relying upon your surgeon's log? 24 A. My surgeon's log and the secretary who was keeping the 25 year book and monthly operation in a way, she used to 0042 1 record that. 2 Q. The problem with the comparison, the Congenital Heart 3 Register, is, is it, that you had no idea how it was 4 going to be filled in at other centres? 5 A. That is correct. 6 Q. And am I right in thinking that the data you had for 7 comparison purposes came to you after the year end, 8 after analysis, and therefore you had already produced 9 your own internal next year's figures by the time you 10 got the national figures for the year before? 11 A. That is correct. Most of the time it used to be two 12 years behind. 13 Q. But the general view would be, would it, that the 14 figures, albeit two years behind, looked at over 15 a number of years, would enable one to determine 16 a trend? 17 A. That is what we used to believe, yes. 18 Q. And the figures produced by the national register would 19 be in relation to diagnosis rather than operation? 20 A. That is correct, sir. 21 Q. So you would be able to look at what information you 22 had internally on diagnosis, if you had that 23 information, to compare it with the outcomes for that 24 diagnosis nationally, but the information you had from 25 your surgeon's log was not diagnosis, it was operation. 0043 1 A. Yes. So, I mean, I knew what was the diagnosis, and now 2 I know from my own data what operation I have done, but 3 to fill in, I would fill in as per the diagnosis. 4 Q. So when you made the returns to the national register, 5 you filled in as per diagnosis, and not as per 6 operation? 7 A. That is correct. 8 Q. So we may see, if we look at the figures, a difference 9 between the operations conducted on the one hand and the 10 diagnosis which might suggest a different type of 11 operation on the other? 12 A. That is correct. 13 Q. When you were Associate Clinical Director, did you, do 14 you think, have any responsibility to provide the audit 15 figures then produced -- this would be 1993 onwards -- 16 to the Trust for annual review? 17 A. No. 18 Q. Who did? 19 A. I think initially it was Mr Hutter and then some time in 20 1994 -- around that time, it changed to Mr Bryan. 21 Q. And both of those were adult surgeons? 22 A. Yes. 23 Q. Purely? 24 A. Yes. 25 Q. So who had the responsibility of conveying to the Trust 0044 1 from January 1993 onwards the paediatric figures? 2 A. The paediatric figures were part of the unit figure -- 3 open-heart surgery. 4 Q. So Mr Hutter and Mr Bryan? 5 A. Yes. 6 Q. And they would have to get the figures from you, would 7 they, or Mr Wisheart, or both of you? 8 A. Yes. 9 Q. In 1987, can we have a look, please, at UBHT 194/22? 10 You joined with your colleagues in writing to the editor 11 in respect of a BBC Wales television programme. We can 12 see from the first paragraph that "certain allegations 13 were made about the standard of paediatric cardiac 14 surgery in Bristol". 15 Do you recollect there being such a TV programme? 16 A. You remember, I think the first day you showed me 17 another letter -- 18 Q. I did. 19 A. -- and it is all related to the same thing. 20 Q. The figures that you then had available were at 21 UBHT 55/8. That is the 1984 to 1986 figures. 22 A. That is correct, sir. 23 Q. Tell me, looking at this form -- this is a typed form 24 we have -- when would the figures have been presented in 25 this typed form? 0045 1 A. I am not able to follow your question. 2 Q. What we are looking at is a page, a typed page. It is 3 a document which has come to us in the Inquiry as 4 a typed page. 5 A. Yes. 6 Q. Somebody obviously prepared the figures and produced 7 them -- 8 A. Yes. 9 Q. -- in this form. Do you know who did? 10 A. It is my colleague, Mr Wisheart. 11 Q. Did he type them up personally? Did he have his 12 secretary do it? 13 A. No, he must have a secretary to type it. 14 Q. Did you, in the department, in the unit, see 15 a handwritten version of this before it was typed? Was 16 it presented to the unit in this form, or are we looking 17 at a document which was sent off to somebody else, such 18 as the register? 19 A. I used to do my own mostly in hand and then I would give 20 to Mr Wisheart my figure and he would collate it, so 21 I would not really have an opportunity to see his own 22 hand, unless, you know, he has given it to me, and 23 I would see this typed version coming out at the end, 24 really. 25 Q. So you would go through your own logs, work out your 0046 1 own figures, give your figures to him, he then produces 2 a typed result? 3 A. That is what I would see, yes. 4 Q. So this is what you knew about the unit? 5 A. Yes. 6 Q. If we look across the first line, "open-heart surgery 7 over 1 year", 7.9 per cent is the percentage of deaths 8 in Bristol between 1984 and 1986. The comparison with 9 the UK 1984, 6.9, so Bristol is one percentage point out 10 of 100 higher there. Under 1 year, 26.5 compared to 11 21.8 nationally. 12 We have been through these figures before, a 5 per 13 cent difference or a ratio of 5 to 4 there, and the 14 closed-heart figures show Bristol with a lower mortality 15 in over 1 year and virtually identical in under 1 year. 16 Overall, closed-heart, better than the national average 17 by 5.7. 18 The grand total at the bottom is pretty much 19 identical. 20 Can we go back to the response to the editor, 21 UBHT 194/22? The second paragraph: 22 "The outcome for operations in children in this 23 unit during the period 1984-86 is equivalent to the UK 24 national results in 1984 (latest available data) and 25 better for certain conditions. This is true for both 0047 1 open and closed-heart surgery ..." 2 Again, repeating the question which I asked you on 3 the first day, it is not, is it, entirely accurate to 4 say that the figures for open-heart surgery in the 5 younger children was equivalent to the UK national 6 results for 1984, given the difference between the 7 figure for Bristol and the figure nationally, a ratio as 8 I have said to you, of 5 to 4? 9 A. Well, I said on that day, and I am saying it again: 10 statistically, they are equal. 11 Q. Is it the position, if one saw the same pattern repeated 12 year after year after year, so that year after year 13 after year Bristol were at the 26 per cent level; that 14 the UK was at the 21 per cent level -- make it easier, 15 25 and 20 per cent -- that then the fact of repetition 16 would inevitably make one query why it should be that 17 Bristol was consistently producing a figure less than 18 the national results? 19 A. I would agree with you. 20 Q. So what is essential for small numbers such as this is 21 to see the pattern over a period, is it? 22 A. That is correct, sir. 23 Q. That is the only way, is it, that one can really adjust 24 for the effects of small numbers, because otherwise what 25 one is looking at may simply be that year, that is how 0048 1 the figures work out; the next year it may be very 2 different? 3 A. That is the problem with small numbers, because if you 4 are doing say only 10 to 20 cases a year, then just one 5 case this way or that way could make 10 per cent 6 difference, and you can see the difference is 5 per 7 cent, so you cannot really make any valued judgment on 8 just simple figures. 9 Q. Shortly after this, we have heard that representatives 10 from the Welsh Office -- I think it is actually at the 11 end of 1986 -- came from Cardiff to Bristol -- and 12 Dr Lloyd reported on that visit at Welsh Office document 13 WO 1/263. I will show you the first page of it. That 14 is the first page of her report. It sets out the 15 background. 16 WO 1/265 , 266 is the page I want to ask you about, at 17 the bottom. She has described a visit by herself and 18 others to Bristol. 19 In the middle paragraph: 20 "Both consultant paediatric cardiologists and one 21 of the consultant surgeons accompanied us while 22 inspecting Bristol Children's Hospital ..." 23 It talks about the development of the new 24 paediatric cardiac catheter suite. 25 Were you the consultant surgeon who accompanied 0049 1 her around? 2 A. No, I was not. 3 Q. That was Mr Wisheart. 4 "We were unable to obtain from the DHSS who do not 5 hold figures broken down by units any figures on outcome 6 by centre. We did, however, raise the question of 7 outcome with Bristol staff. They put to us the accepted 8 point that outcome is influenced greatly by case mix. 9 They were quite open in quoting outcomes for some of the 10 commoner procedures they undertake. They see a gradual 11 improvement in these as expertise grows and specialist 12 equipment becomes available. For most of the more 13 commonly occurring conditions their figures compare well 14 with other centres. They acknowledge that surgeons in 15 different centres develop special expertise in rarer 16 conditions and that outcomes may therefore vary greatly 17 for these between centres." 18 At this time, then, what Mr Wisheart and the 19 cardiologists appear to have been saying to Jennifer 20 Lloyd was that the outcome is influenced greatly by case 21 mix. The suggestion, I think, seems to be, if you take 22 some difficult cases, you cannot expect such a good 23 result as you would if you took some easier cases. 24 Was there, as you see it, any particular 25 difference between Bristol and its case mix in 1986/87 0050 1 from the case mix you would have expected in any other 2 centre? 3 A. It is difficult for me to comment, because (1) I have 4 not seen this letter before; (2) I am not the one who is 5 talking; (3) I do not have the detail of the operation 6 results of different types so I cannot really comment on 7 what was the case mix talked about and at that time, 8 I was still working in Bristol when I was Senior 9 Registrar and got the consultant's job in Bristol, so 10 I cannot really comment on what was happening 11 elsewhere. 12 Q. So for your part, you cannot help at all on whether 13 Bristol's case mix seemed, to you, to be unusual, 14 because you had no point of comparison? 15 A. That is correct. 16 Q. Can we then move on from 1986 to 1987. UBHT 126/13. 17 This is the annual report. Is this the first formal 18 annual report that there was? 19 A. Probably you are right, but maybe before I have not 20 seen it. 21 Q. Can we go to page UBHT 126/18? If we look at where it 22 deals with the results, it is the third line. In fact, 23 I will take the whole of the top paragraph: 24 "A summary of the types of surgery performed 25 between 1984 and 1987 and the results are contained in 0051 1 table 3. Mortality is attributed to surgery if it 2 occurs within 30 days of the operation. These results 3 are virtually identical to those obtained 4 nationally ..." 5 If we want to find the results we would go, 6 I think, to page 11 [UBHT 166/11], where the mortality, 7 the over 1 year is 8 per cent, broken down, simple, 8 moderate, complex. We can see there the figures 1.9, 9 6.5 for moderate, 23.7 for complex, and under 1 year 10 27. The total mortality for open operations, 11.3. 11 If we go on to 1988, it is UBHT 126/3 for the 12 report, and that is the covering sheet. Can we look at 13 page 12, please. 14 Here we have the open-heart surgery reviewed for 15 a four year period. This is an attempt, is it, to get 16 a reflection of the difficulty that we mentioned 17 earlier: if we look at it in isolation, there are small 18 numbers and we get no picture of the trend or how the 19 results compare with the national results? 20 A. I think this was trying to get some type of statistical 21 verification, if we still could get it. That was the 22 idea, yes. 23 I am a bit confused, because I thought the 24 previous one had mentioned 1984 to 1987, and we still 25 have the same year, or am I wrong? It was previously 0052 1 1984 to 1986. 2 Q. We can go back to the previous table which is at 3 UBHT 126/18. I am sorry, that is the wrong reference. 4 Can we go back to the previous table? 166/11, I think, 5 was the sheet I took you to. 6 A. Yes. I think I am right, because I noticed there it was 7 saying 1984 to 1987, so there is some -- I think because 8 this is a year book of 1987, so it should be before 9 1986, here. 10 Q. I think the results are there set out looking at all 11 three years, if I am not mistaken. If one looks at the 12 number of cases just to resolve this, take a like, focus 13 on the under 1 year, for instance. 14 A. These numbers are a little different than the numbers in 15 the other ones. 16 Q. The point is, I think, this must be a three-year period, 17 because of the number of under 1 year cases, so you are 18 quite right; we are looking here at the three-year 19 table. Can we then look, please, at UBHT 126/12? It 20 says "(figures for a four year period, 1984 to 1987, in 21 parentheses)", which may be four years if they are not 22 financial years? 23 A. At that time they were not financial years, so it 24 probably is a four year period. 25 Q. We then have the figures for the year 1988 compared with 0053 1 the figures for the previous years. 2 A. I am sorry, I do not have it. 3 Q. If you look at what it says at the top of the page, the 4 figures for the four year period are in brackets so the 5 four previous years are in brackets; 1988, not in 6 brackets. 7 If you look at the open-heart surgery, 29 8 operations performed in the under 1 age group. If we 9 just put a yellow bar, please, across that line, the 10 29 patients, the number of deaths are quoted, the 11 percentage of deaths is calculated, 37.9 per cent, and 12 the comparison, the previous four years, 27 per cent. 13 Was there, do you recollect, any discussion about 14 those figures? 15 A. I am sure there would have been, but I go on the same 16 way, because here we can see 29 and 11, so just one 17 death this way or that way could make that difference 18 again and that is how probably it could have been 19 explained. Again, probably it could be explained more 20 if individual cases were really looked at. 21 Q. So on the face of it, unless there is an explanation 22 which relates to an individual case, the figures would 23 be disturbing, would they not, because they indicate 24 that the unit was actually performing less well in 1988 25 than it had done for the previous four years, and you 0054 1 would expect an improvement, would you not? 2 A. I have always been uncomfortable with these figures, and 3 I have mentioned a number of times that these figures 4 should always be given with the confidence level, 5 because that is how Dr Kirklin used to tell us, 70 per 6 cent confidence limit. Then you really know where you 7 stand and you can make a value judgment. That is why 8 I would have seen the figure. I would have said it 9 looks high but we need further explanation before we can 10 say anything more. 11 Q. Was there any discussion at the time of how this 12 compared to the United Kingdom's figures? 13 A. I am sure there would have been. I do not have a clear 14 feeling, but I personally would have thought that 15 probably, yes, we did realise that it was slightly 16 higher than the UK Cardiac Register -- this within 17 brackets is not the UK Cardiac Register, really, it is 18 our own figure. 19 Q. It is your own figure for the previous four years. 20 A. Yes, I am sorry. 21 Q. This report tell us you two things: first of all your 22 own results within that particular year, and you point 23 out that there are small numbers, have on the face of it 24 got disturbingly worse? 25 A. Yes. 0055 1 Q. And secondly, one would need to make a comparison of 2 figures like this to see how Bristol related to the rest 3 of the United Kingdom? 4 A. That is correct. 5 Q. One of the difficulties you have told us, of course, is 6 getting the United Kingdom figures for the comparative 7 years. One can only, perhaps, pick that up in 8 retrospect. 9 If we go to UBHT 55/88, this is from your own 10 unit's 1990 report, and it is reporting the figures for 11 UK 1984 to 1988. You have told us that you got those 12 figures really two years after the event, but we can 13 just pick up for a moment 30-day mortality under 1 year 14 of age, 1984 to 1990, within the UK as reported through 15 the register, 21.2 per cent. 16 Can we go back, then, to the previous sheet, 17 UBHT 126/12? 18 A. But before you go back here, this is the year we were 19 really pleased about that, because our result was -- 20 Q. I am going to come to that, by all means mention it 21 now. As it happens, we can see from this sheet, if we 22 go back to UBHT 126/12, please, if the national figures 23 had been available they would have been 21.2 per cent? 24 A. In fact, that was not a national figure for 1988. That 25 is what I was trying to point out at that time, because 0056 1 that was a combination, a four year figure, really, and 2 somehow we got in a UK figure 1984 to 1988 all combined 3 together, so you have a combined mortality of 21.2 per 4 cent mentioned there, which I am a bit surprised at 5 because normally we get annual figures, so I do not know 6 how that figure is mentioned that way. But, yes, that 7 is not a 1988 figure, 21 per cent. 8 Q. No, it is a four year figure, 1984 to 1988, 21.2 per 9 cent. Here, the 27 per cent is a four year figure, 10 1984 to 1987, and we have 1988 added at 37.9. 11 A. But then you can see 27 and 21 will not be much 12 different, if you are looking that way, but 37.9, yes, 13 there must have been some worry amongst us that the 14 mortality is slightly higher. 15 Q. Do you recall any such worry being expressed and 16 discussed at the time? 17 A. I think I expressed in the following year, in 1989, if 18 you look, I was quite worried at that time and I did say 19 that our results on mortalities are higher. 20 Q. Let us have a look at 1989. The report is at 21 UBHT 167/72 and the page we need to look at is 22 UBHT 55/80. 23 So here for 1989, under 1 year of age, 37.5 per 24 cent. And closed 3.4 per cent, open 10.9, closed 2.4. 25 Was that, as you recollect it, at all worrying, 0057 1 given that it came after the 1988 figures that we have 2 just been looking at which you recognise were worse, 3 higher, than the figures for the four years previously, 4 and appear to be quite different from the UK national 5 figures? 6 A. Yes, I did, and I pointed out that it is high and at 7 that time I also said that looking back, our previous 8 results on all these things point that our under 1 year 9 of age group is not doing that well, and we must look 10 into it. It was following that that there was an audit 11 meeting for under 1 years in 1990. 12 Q. Again, so that we can look at the two sides of the 13 service, both over 1 and under 1, that is 1989. If we 14 go to page 81 [UBHT 55/81] there is a comparison made 15 between Bristol on the one hand and the United Kingdom 16 1988 figures on the other. This time, I think, the 1988 17 figures were produced a year after the event, so there 18 is only a year's gap there. 19 If we look at the under 1 line, if we just 20 highlight that, we are looking now at quite a number of 21 patients, are we not, between 1984 and 1988 on the 22 left-hand column, 103 patients, an overall percentage 23 mortality rate of 30.1 per cent. In 1989 we can see 24 another 40 patients, percentage mortality 37.5. The 25 total, 143 patients in the five-year period, giving 0058 1 a mortality rate of 32.2 per cent over that entire 2 five-year period? 3 A. That is correct, sir. 4 Q. Compare that with the United Kingdom for 1988. That 5 should be better than Bristol in 1984, 1985, 1986 and 6 1987, but the percentage from the 708 patients reported 7 through the register is quite definitely lower than the 8 figure for Bristol. 9 A. I agree. 10 Q. How long does one have to have a series, a pattern of 11 figures, for a small unit such as Bristol? 12 A. I felt this was long enough, really, to need to look at 13 what we are doing. That is why we called for that audit 14 meeting. 15 Q. Just summarising, at this stage these figures called for 16 action? 17 A. That is right. 18 Q. If we can just look at the over 1 year group, and just 19 concentrate on the total line, please, the percentage 20 there, 8.9 per cent, comparing with the UK for 1988 of 21 6.9 per cent, is not so much out of step as the 22 under 1s, but the number of patients is rather bigger, 23 is it not? 24 A. Yes. I think it just shows a little bit of a trend, but 25 my concern more was under 1s rather than over 1s. 0059 1 Q. So that being the 1989 figures, there was an audit 2 meeting, was there, in March 1990. We pick that up at 3 UBHT 61/126. 4 We have looked at this before. When the results 5 were produced, you had concern; did others have 6 particular concern? 7 A. I know that I had concern but I cannot really recall if 8 anybody else had said that. I am talking about at that 9 time, I am having difficulty to separate myself from 10 what I know now from what I knew at that time. 11 Q. Shall we look at what the minute says? First of all it 12 deals with VSD. Can we scroll down so "VSD" is at the 13 top? There is an examination of the VSD deaths. Do you 14 recall how long the meeting took? 15 A. It would have taken more than an hour, but probably not 16 longer. You could say people would be going back to 17 their work so the meeting would have started -- it used 18 to be Monday morning. It started at 8 o'clock and then 19 people would start getting a bit restless after 20 a quarter past 9, so it probably would have gone on 21 maximum to half past 9. 22 Q. Then the Senning results, which are reported as being 23 good, and some discussion of that? 24 A. I think on VSD results, that in a way we identified 25 a problem, when we looked at the number of cases 0060 1 together, that the problem appeared to be post-operative 2 pulmonary hypertensive crisis, and somehow we had to 3 really tackle that, so that was one thing identified. 4 Q. Can we scroll down? TAPVD. 5 A. Yes, and that was the next group identified. Under 1, 6 most of the patients who got into trouble had the TAPVD 7 and that is why the in next group tested, 3 patients out 8 of 5 died. 9 Q. The last paragraph on that page: 10 "Agreed there should be a low threshold for 11 cardiac catheter study in children that were relatively 12 well and not in the unstable obstructed group." 13 What is being said there? 14 A. I am trying to remember what we were discussing at that 15 time. I think Dr Martin had just joined so our 16 echocardiographic service was getting in a way more, you 17 could say with an infusion of new blood, more modern. 18 Until that time, we were getting very concerned that 19 sometimes we were not getting the right or correct 20 diagnosis, and obstructions were being missed. 21 Q. So this goes back to something which we demonstrated 22 yesterday as a problem, that it might be that the 23 information available to the surgeon when he came to 24 operate was not as complete as the surgeon would hope. 25 A. Well, yes. 0061 1 Q. Can we go overleaf? Again, scroll down so we have AVSD 2 at the top of the page, please. AVSD was reviewed. 3 "Other operations": there is no reflection there, in 4 the "other operations" as such to the arterial switch 5 programme which you had started, but that is because 6 that was in the over 1s at this stage. 7 A. When we looked yesterday, there were very few under 1s, 8 really, and one is mentioned here, one due to 9 interoperative bleeding in a child having an arterial 10 switch. 11 Q. I am sorry, you do mention it, yes. 12 A. So that is mentioned here, but others have not been 13 mentioned because they were not really ... 14 Q. Future direction: need to review the results, so that is 15 obviously the next step of any audit process, that once 16 you have results, particularly with a small unit as you 17 said, you would need to look back over the previous few 18 years to see and to check enough data to make the data 19 meaningful for comparison purposes. 20 A. Yes. 21 Q. One would need to review where you got to on the various 22 measures that were suggested at this meeting. 23 A. Yes. And also, there are certain things which are not 24 really documented in the way as you could really find 25 out from the spirit of the meeting, that now we have 0062 1 also come to realise that just that yearly figure myself 2 was not really a type of audit. Audit should be like in 3 a group of patients: it could be say of a particular 4 condition and that is what we should be focusing on, so 5 we really said that in a way, in future audit should be 6 on a particular problem and that is why, really, we are 7 saying that we will next time look at the pulmonary 8 hypertensive crisis, how the patients are being managed, 9 or in the future look at a particular group like 10 tetralogy, or a situation like that. 11 Q. The second paragraph under "Future direction": 12 "In patients with coarctation with VSD we should 13 be aiming to perform closure of VSD and pulmonary artery 14 debanding between 6 and 12 months of age." 15 Aiming to perform that operation within that 16 period in that age group suggests you were not presently 17 doing that operation within that age range, or sometimes 18 you were missing it? 19 A. That is correct. 20 Q. Is that because of the problem with waiting lists that 21 we looked at a couple of days ago? 22 A. Yes. 23 Q. "It was not felt we should be repairing the coarctation 24 and then going on to closed VSD if necessary as 25 a primary procedure. With our particular setup it was 0063 1 felt that this may pose problems." 2 What was it about the particular setup that would 3 pose problems in doing that? 4 A. We are talking of 1989/90, and of course these are the 5 patients you are really seeing in the neonatal period so 6 you really would be starting a neonatal operation, 7 repair the coarctation and then turn the patient back on 8 and do the VSD closer. I am sure now some centres have 9 started doing it, quite a few centres may be now doing 10 it. It was being thought about, but in a way rejected, 11 as I have mentioned that it would carry very high 12 mortality and we are not geared up to do too many 13 neonatal operations because you would be getting a lot 14 more patients with coarctation and VSD than you get for 15 other conditions. 16 Q. When you say "not geared up" to deal with a greater 17 number of neonates, in what way -- 18 A. Open-heart surgery. 19 Q. Why was the unit not geared up to that? 20 A. Because in a way, in 1989/90, we had at that time only 21 one anaesthetist which I could rely on -- of course 22 there were one or two others -- and the facility at the 23 BRI had just been improved, but there was still 24 a waiting list. It would have created more problems to 25 our waiting lists. We were already having a problem, 0064 1 and then there was another new open procedure, and 2 I felt we should not really be doing it until we have, 3 in a way, cleared our waiting list and made it more 4 satisfactory. 5 At least this way we had tackled the patient, 6 tackled the immediate problem, and then we can deal with 7 the VSD as a closed -- as in a routine case -- in a cold 8 environment. Otherwise it becomes a very urgent 9 situation. 10 Q. So what restrained the unit from doing the operation was 11 first of all waiting lists; secondly, staffing, if I can 12 say shortages, I think that covers the anaesthetists 13 point you made; and thirdly, do I get the sense that if 14 you operate on more neonates, there is less room for the 15 non-neonates, given the pressures on bed space and 16 operating theatres caused by the adults? 17 A. Well, it is an emergency operation. You cannot wait for 18 the next period to operate, so you have to -- I mean, if 19 you look in my record of closed cardiac surgery, it was 20 working at night and various things, so almost I was 21 doing open-heart surgery every night and then other 22 surgery next day. So this was adding something new 23 which I do not think we were geared up to, really. 24 Q. You say there was only one anaesthetist you could rely 25 on. There were three who were doing paediatric work, 0065 1 I think, at that stage -- there may have been more, but 2 the names that come to my mind are Mrs Masey, Dr Bolsin 3 and Dr Monk. 4 Which was the one that you had in mind as the one 5 you could rely on? 6 A. Dr Masey. 7 Q. After this discussion in early 1990, you would have been 8 waiting, no doubt, to see the 1991 results? 9 A. Correct. 10 Q. Those we have got, I think, if we look at UBHT 55/82. 11 This is 1990, the next year. This shows a considerable 12 reduction in the mortality rate for the under 1s in the 13 open age group. 14 A. That is correct. 15 Q. Did this come as a relief? 16 A. Yes. It was also obvious that we were happier in 17 managing pulmonary hypertensive crisis much later, 18 because by this time we had introduced a new regime with 19 the drugs and ventilatory management. 20 Q. Did it come as a relief not only to you but, so far as 21 you were aware, to the rest of the unit? 22 A. I am sure it would have been. 23 Q. Before I move to the discussion that there was in 24 respect of these figures, can I just ask that we have 25 a look at UBHT 55/89? This is under 1s, 30-day 0066 1 mortality by diagnosis. Scroll down, please. The 2 figures for the transposition of the great arteries and 3 the Sennings are in the middle there. Can we highlight 4 that across? What the figures consist of is no deaths 5 out of 40 operations from 1984 to 1990 in the under 1s, 6 which compares very favourably with the United Kingdom 7 in its mortality rate. 8 A. Thank you. 9 Q. So the Senning was one of the success stories, was it, 10 of the Bristol unit? 11 A. That was my problem. 12 Q. It was to your credit, was it not, because you persuaded 13 Mr Wisheart to begin operating on the Sennings back when 14 you were Senior Registrar? 15 A. I think he himself was thinking about it. I would say 16 instrumental because I had just written from Alabama 17 where they were doing a lot of Sennings, quite a lot, 18 with very good results, and here Mr Wisheart has started 19 seeing a problem with the Mustard which he was doing 20 before. I mean, he had very good results with the 21 Mustard, but I thought that we should change and he was 22 very seriously thinking of changing. Obviously, when 23 two people talked about the same, then we did change and 24 we went to make the change, yes. 25 Q. The figures for 1990 were discussed, were they, on 0067 1 28th July 1991. You will not remember the date, I am 2 sure. If we look at UBHT 61/146: Mr Wisheart's house, 3 8 o'clock in the evening, and can we scroll down? 4 "By way of introduction to the meeting, 5 Mr Wisheart provided tables of open and closed cardiac 6 surgery results for the Bristol paediatric unit. 7 Comparisons were made in this data for mortality in the 8 Bristol Cardiac Unit in 1990 and the UK national average 9 in 1988." 10 That is the sheet we just looked at. 11 "Mr Wisheart said that he thought the tables 12 demonstrated that the problem which had been thought to 13 have been reaching crisis proportions in the Bristol 14 unit, when put in context, was actually not as serious 15 as had been thought." 16 This is expressing the sense of relief, is it, 17 that the whole unit had that the figures for 1990 showed 18 a considerable improvement, for the reasons you have 19 mentioned? 20 A. It is shown in the third paragraph, if you read it 21 further, that we felt that way. 22 Q. You and he both made the point there had been recent 23 improvements in operative and post-operative management 24 to the BRI site which made meetings like this extremely 25 valuable. 0068 1 "It was noted that the previous such meeting had 2 discussed pulmonary hypertension and this had been very 3 successful." 4 So the success is attributed to the management of 5 pulmonary hypertension? 6 A. Yes, because as we identified before, the two groups 7 which I was more concerned with, VSD and AVSD, and both 8 of them had a problem relating to pulmonary hypertension 9 and hypertensive crisis in post-operative management. 10 That is the group where -- because we knew Senning was 11 all right. TAPVD, we had five cases in three years type 12 of thing, so we were not getting that many, and of 13 course diagnosis was going to be improved, hopefully, 14 but the main group I thought was the VSD and AVSD. That 15 is why we were really saying, it has been minuted like 16 that, but that is the correct impression. 17 Q. Going back to the first paragraph under "Introduction", 18 the feeling that the problem had been thought to be 19 reaching crisis proportions, focusing on those words -- 20 perhaps you will just highlight them -- is it right 21 until the 1990 results came out there had been a sense 22 that there was something of a crisis in the unit because 23 the outcomes were not as good as they should be? 24 A. No, I would not say that. I would say concern, but not 25 "crisis". 0069 1 Q. So you take issue with the words "crisis proportions"? 2 A. I think "crisis" is a little bit of an exaggeration, 3 I would say, but of course there is a concern, and the 4 concern would be there, if you have the mortality which 5 appears to be on the high side, even if you put 6 a statistical range on it. 7 Q. If we look on, the problem, when put in context, missing 8 the words "crisis proportions", was not actually as 9 serious as had been thought. 10 Is the problem referred to there the problem that 11 Bristol's results were out of step with the UK's if one 12 looked at the 1989 data and earlier? 13 A. I would accept that. 14 Q. The context is the context provided by the 1990 results? 15 A. The improvement noticed, yes. 16 Q. The next paragraph: 17 "Dr Bolsin said that he thought that the data in 18 the tables in which the Bristol mortality was higher 19 than the UK average for two years prior vindicated the 20 vigilance of the anaesthetic staff in recording their 21 mortality data and vigorously pursuing requests for 22 a combined meeting. This point of view was supported by 23 Dr Burton, Dr Masey and Dr Monk." 24 What do you recollect being said about the results 25 of the previous meeting vindicating the approach that 0070 1 the anaesthetist has been taking? 2 A. I think this is a personal opinion. I do not think this 3 was discussed in the meeting or agreed in the meeting. 4 Q. You appreciate, this is Dr Bolsin's note or minute of 5 the meeting as he has told us. Subsequently, when in 6 September he circulated the note, there was objection 7 taken to it as a minute. But did you see this minute at 8 the time? 9 A. Yes. He circulated it. I had it. 10 Q. If you saw it at the time, did you think at the time 11 that some of the words used were, as you have told us, 12 exaggerated, like the words "crisis proportions" and the 13 private view expressed in the second paragraph? 14 A. No, I did not look at that critically, as if it was 15 criticising anything, or the system. I thought this is 16 a minute of a meeting which is all aimed to improve the 17 results and performance, and I had no reason to really 18 question anything and therefore I did not. 19 Q. So when you read the minute through, did you think that 20 it was a fairly accurate record of what had been 21 discussed, or not? 22 A. I mean, looking back, what I know now and various 23 things, I am getting into looking very critically about 24 the use of the word "crisis" and the use of the word 25 "vigilance" and things like that. But at that time, 0071 1 I mean, I saw it and I did not really notice any 2 difference, or -- 3 Q. So it did not strike you at the time as being out of 4 place? 5 A. No. 6 Q. That might suggest that those words or something like 7 those words may adequately have reflected the meeting? 8 A. No, but I would not have used the term "crisis". 9 Q. You would not have used it? 10 A. And I did not think anybody was really mentioning 11 "crisis" anywhere. 12 Q. What those three paragraphs, particularly the first two, 13 might suggest, is that the anaesthetists, in particular, 14 had concerns over the mortality figures which had been, 15 in part at any rate, resolved by the 1990 figures. Was 16 that the sense of the meeting? 17 A. I thought that after that meeting everybody was very 18 pleased that we have managed to achieve something. 19 Q. Yes. That is not quite what I was asking. 20 A. No, but I did not get any impression that anaesthetists 21 as a group had some different feeling or were feeling 22 differently before. 23 Q. I am sorry, you misunderstood the question. The point 24 I am asking about is whether the anaesthetists were in 25 effect congratulating themselves for having been 0072 1 particularly concerned? 2 A. No, I did not get that impression at all. 3 Q. If we go down to the bottom of the page, there is 4 a reference to meetings like this being extremely 5 valuable, and the steps which had been taken over the 6 last year in respect of operative and postoperative 7 management. 8 Those steps came, did they, from the minute that 9 we looked at a moment or two ago, where each of the 10 operations was looked at in turn and which was 11 a meeting, if you recall, of 19th March 1990. 12 A. That is correct, sir. 13 Q. Had there been an audit meeting of that type since 14 March 1990? 15 A. You mean like the 1 year age group? 16 Q. In 1990, yes, March 1990. You look at the results of 17 the 1 year age group, these minutes are of a discussion 18 the following July, July 1991, and the figures are 19 reviewed just as the figures had been reviewed in March 20 1990. 21 A. That is what I was talking to you, at the end of that 22 meeting, that we decided from now on we would audit in 23 a group of patients, the condition or particular 24 time-frame that would give us a better idea than 25 presenting a yearly figure. That is why, really, you 0073 1 see the subsequent audit meetings when, if you have the 2 record, they would say an arterial switch or something 3 saying pulmonary valvuloplasty, or balloon atrial 4 valvuloplasty, that is how it was being audited and 5 I thought it was more useful. 6 Q. If we look at UBHT 61/153, this is a letter from 7 Dr Martin to Dr Jordan, audit of paediatric cardiology. 8 This is the cardiologists inspired meeting which the 9 surgeons attended. 10 "I think it is very important we recommence our 11 audit sessions in 1992 and after discussion I think we 12 ought to hold these monthly ..." 13 The first line, "important that we recommence". 14 This, to scroll down a bit and remind you of the date, 15 was 3rd January 1992, so Dr Martin is saying to 16 Dr Jordan, "Let us start up again, recommence, the audit 17 sessions"? 18 A. That is correct. 19 Q. Had they slipped away or fallen away for some reason? 20 A. You know the previous audit, when you saw the 1990 21 figure, and under 1 mortality figures, they were started 22 by Dr Martin in 1989 and we went on for a year or so, 23 but then, when the new Trust structure came in and a new 24 audit setup was established, people were a bit confused 25 for a year, what would be the audit. I mean, is it 0074 1 going to be UBHT itself going to organise something 2 centrally? They were having meetings; we were getting 3 circulars, but no real structure was coming out. What 4 we were talking about is the usual audit which we were 5 getting on Monday, we were talking to, you know, 6 presenting our data on various things, but not in 7 a relevant manner, in a format and that is what it is 8 trying to establish. 9 So in a way there was an audit going on but not 10 in a formatted manner and we were waiting for 11 instruction from UBHT to come out, which did come out, 12 but not by the time this letter came out. 13 Q. So if I unpick your last answer, you were saying that 14 during the time that the Trust began, formalised audit 15 stopped or diminished for a while and began again in 16 1992? 17 A. Yes. 18 Q. The exception must be the meeting that we have looked at 19 in March 1990, just before the move towards Trust 20 status, and the meeting that we looked at in July 1991 21 reviewing the results, which obviously is formalised in 22 the sense that it took place and there is a note, albeit 23 not agreed, of what took place at the meeting? 24 A. But all this time, monthly audit meetings at both places 25 were still taking place. 0075 1 Q. Is it part of the audit cycle that first of all one 2 should look at how one has been doing; secondly, discuss 3 how one might improve, the steps that might be taken to 4 improve; and thirdly, review those steps to see whether 5 the improvement has been achieved? 6 A. That is well accepted, but as you know, this all came in 7 after these things became more formalised; before that 8 it was not, really. It was an audit in an old-fashioned 9 manner, sitting in the ward looking at your monthly 10 figures, coming out with what we were doing, good and 11 bad and things like that and what we should do. So we 12 are doing a loop, but not a complete loop, as we come to 13 know in the mid-1990s in that sense. 14 Q. The audit loop, as you described it, means, does it, 15 necessarily that the decision of a meeting should be 16 written down somewhere so that one can refer back to the 17 record, so that we have something written to compare 18 future progress against? 19 A. That is correct. 20 Q. Just exploring for a moment the way it was done in the 21 unit before the audit loop became the accepted idea, you 22 say just looking at the figures and saying "We have done 23 well" or "We have done badly", did that, at that stage, 24 involve discussion, if you felt you had done badly, of, 25 "Well, how can we improve?" 0076 1 A. Yes, very much so. 2 Q. About no particular goals set against which you might 3 measure that improvement? 4 A. That is correct, because there was no goal to compare 5 against. 6 MR LANGSTAFF: Dr Silove, I think, wanted to contribute? 7 DR SILOVE: I did not think of anything in particular, 8 really, except to say that audit in the late 1980s and 9 early 1990s was a very sporadic affair, and I think it 10 has only become much more formalised in the last, say, 11 six or seven years, but it was a very sporadic affair. 12 I think that the Bristol people were actually conducting 13 reasonable audit for that time. 14 MR LANGSTAFF: We have been told, Dr Silove, that one of 15 the impetuses to formalising audit in the audit loop was 16 in fact the development of Trust structures across the 17 country. 18 DR SILOVE: Yes. 19 MR LANGSTAFF: This is a national point, because with 20 the purchaser/provider split, there was a need to 21 demonstrate performance across a range of indicators, 22 and it became part of consultants' contracts that they 23 took part in formal audit? 24 DR SILOVE: That is correct, but it took a long time for the 25 process of audit to be developed properly in each of the 0077 1 Trusts. 2 MR LANGSTAFF: So the point of drawing that or providing you 3 with that evidence that we have had is that it might 4 indicate that ideas as to the way that audit should be 5 conducted were certainly current prior to 1991, and 6 sufficiently current for that to be formalised at the 7 time that Trust status began? 8 DR SILOVE: Yes, they were certainly current at that time. 9 I am just saying that it seemed to take a long time for 10 groups to get together and decide exactly how they were 11 going to audit things. 12 MR LANGSTAFF: Would you expect it to happen more in cardiac 13 surgery, given that the surgeons had collectively 14 established a national register back in the 1970s? 15 DR SILOVE: Yes, and I think there always has been audit of 16 the type Mr Dhasmana has been describing through the 17 1970s and 1980s. There always was the collection of 18 surgical data, number of operations done, types of 19 operations and mortality rates, but that seemed to be 20 the type of audit that are around. 21 The rest of audit and closing the loop, so to 22 speak, had not been formally introduced, I would say, 23 until the Trusts came into being. 24 MR LANGSTAFF: Because if any doctor, any clinician, 25 had a sense that he or she was not doing as well as 0078 1 others, any self-respecting doctor would want to know 2 why, how he or she might address it, and at a later 3 stage, wish reassurance, even if there was no 4 formal target, that that had been achieved? 5 DR SILOVE: That is absolutely right, yes. 6 MR LANGSTAFF: That has always been the position, has it 7 not? 8 DR SILOVE: Yes, it has. 9 MR LANGSTAFF: So audit in that sense had been conducted 10 throughout the 1980s and what we are seeing is a process 11 of formalising what has been called the audit "loop". 12 DR SILOVE: Yes. 13 MR LANGSTAFF: Which necessarily involves, does it, 14 recording decisions? 15 DR SILOVE: Yes, and then following up those decisions at 16 a later meeting. 17 MR LANGSTAFF: And developing standards against which 18 one might actually monitor performance? 19 DR SILOVE: That is right, yes. 20 MR LANGSTAFF: So instead of sitting down and looking back 21 and saying "How well we have done", or "Could we not do 22 better here", or "My goodness, that is worrying", people 23 are setting out in advance saying "This is what we want 24 to achieve and that allows us a year later or 6 months, 25 whatever the period is, to come back and say this is 0079 1 what we said we should achieve, have we done it". 2 DR SILOVE: That is correct. 3 MR DHASMANA: It is well to bear in mind that cardiac 4 surgeons had taken a leading role in this. That is what 5 the UK Cardiac Register is supposed to be doing, to 6 provide a type of target where an individual surgeon 7 would look at his or his unit's results and see if he is 8 falling behind and what steps he has to take to catch up 9 with it. So cardiac surgeons were really working on 10 it. It was not as sophisticated as it is now, but we 11 were doing all of it. 12 THE CHAIRMAN: May I ask a question? We have heard a lot of 13 evidence about audit, of course, and the mention of the 14 notion of the audit loop and closing the loop does not 15 really take account of the fact of how the loop is 16 opened, in other words, what the targets are and how you 17 decide upon those. 18 Mr Dhasmana has just referred to targets. How 19 would these targets begin to emerge? Based upon what 20 data? 21 DR SILOVE: Essentially, one needs to take a careful look at 22 all of the cases over a period of a year, which is what 23 they did, divide them into categories of diagnoses, and 24 look at results. The difficulty, in the early 1990s, 25 was the comparators. The UK surgical register was based 0080 1 on a decision made when it was first set up to collect 2 diagnoses rather than operations, and I think this was 3 a fundamental problem. It was very difficult, for 4 example, comparing transposition operations when the 5 switch operation started. They were all being lumped 6 together as transposition. 7 So I think that each centre, each department in 8 each centre, needed to establish its own information 9 base and needed to look at results and try to determine 10 where there were problems, and then say, "There are 11 these problems; how can we improve on them"? 12 THE CHAIRMAN: Is it not a bit more complicated than that? 13 Not "how we can improve upon them?", but "Can we improve 14 upon them?" How do you answer that question? 15 DR SILOVE: That can be difficult, but that is the 16 fundamental question that has to be asked first, yes. 17 MR LANGSTAFF: Can I come back from the theoretical to the 18 historical and go back to the meeting that we were 19 looking at in July 1991, a different part of the note? 20 Can we go to UBHT -- 21 THE CHAIRMAN: Mr Langstaff, just interrupting for a moment, 22 I understand the distinction, but we have to get the 23 theoretical right as well as the historical. 24 MR LANGSTAFF: I was not suggesting anything -- 25 THE CHAIRMAN: It is important for all who hear us. 0081 1 MR LANGSTAFF: Please, in case the wider audience should 2 misunderstand my comment, it was intended as a link and 3 not in any sense to -- 4 THE CHAIRMAN: It is very important that it is understood by 5 all that there has to be some deep thinking about the 6 questions we are engaged in, and not just reaching 7 conclusions on what might be bandied about here there 8 and everywhere as facts and figures. We have to think 9 deeply of the context in which the figures emerge and 10 what weight to give to them and so forth. It is for 11 that reason that we have to press very deeply before we 12 rise again to reach the sort of answers that people are 13 looking for. 14 MR LANGSTAFF: Thank you, sir. Can we go back to UBHT 15 61/149? You actually looked, in that meeting, as 16 Dr Silove has suggested one should do, at problem 17 operations. Here we have the tetralogy of Fallot 18 patients who were looked at under the heading of 19 "Problem Operations". 20 Was it thought at the time that tetralogy of 21 Fallot patients might be a problem area? 22 MR DHASMANA: I think I wanted to highlight that the 23 pulmonary artery anatomy should be better visualised and 24 that is why, really, I raised the question. I am not 25 sure whether I had thought that it was a problem area or 0082 1 not. 2 Q. But certainly, that is exactly what you are recorded as 3 saying in the second paragraph there. You are recorded 4 as saying, or complaining, that the information provided 5 was just not good enough. That represented your view, 6 did it? 7 A. Well, again, the use of words, really. That is what 8 sometimes -- I would not have said "just not good 9 enough", I am not that way. I would have said "it could 10 be better", you know, if I knew, because I was seeing 11 the film, an angiogram, the two arteries nicely near the 12 hilum and the main pulmonary artery, but what I was not 13 seeing was the bifurcation. I had difficulty in 14 persuading my colleagues, which included radiologists, 15 to use a supine view, the coronal view, which I had seen 16 quite a lot in the US and Alabama. So I was trying to 17 make that point again, and especially as now Dr Martin 18 has arrived. I was very pleased that he agreed with me, 19 and assured me that they were trying to do that and 20 provide me with that information. 21 Q. Can we scroll down? This is dealing with Mr Wisheart's 22 comments. About a third of the way down that paragraph: 23 "He [I think Mr Wisheart] also went on to say that 24 in his experience deaths had been associated with low 25 cardiac output, renal failure and pulmonary 0083 1 insufficiency, probably related to coronary artery 2 anatomy not being well demonstrated." 3 Is that again part of the same point? 4 A. No, again, you know, there was some basis for the 5 discussions which is missing here. I think 6 anaesthetists wanted to use a pulmonary artery catheter, 7 and like any new procedure, you start getting worried 8 about these things, and especially leaving them in very 9 small children in ITU. We knew when these things were 10 being introduced that there were reports of perforation 11 and various other things, so we were really saying that 12 if you want to really put in this pulmonary artery 13 catheter, what information are you looking for? They 14 said, well, (1) PA; (2) we would get the wedge pressure 15 and that would give us some indication of how the left 16 ventricle was coping. I said I can give you a left 17 atrial line, which can give you an indication of the 18 left ventricular performance, and you do not have to put 19 this line in. That was that discussion, really. 20