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Hearing summary11th November 1999 The Bristol Royal Infirmary Inquiry oral hearings this week will focus on the Directorate of Anaesthesia within the Bristol Royal Infirmary (BRI). The witnesses will give evidence regarding the management and organisation of the directorate and also comment on any concerns that were raised regarding the paediatric cardiac services in Bristol. Todays witness was Dr Susan Underwood, Consultant Anaesthetist, BRI, since October 1991. She began by telling the Inquiry about her previous experience in paediatric cardiac anaesthesia prior to joining the BRI. She then discussed the standard and appropriateness of equipment used at the BRI and commented on protocols applied within the cardiac intensive care unit (CICU). She highlighted the establishment of intensivist sessions in the cardiac intensive care unit and her impression that, as a result, improvements in communication and management of care post-operatively occurred. Dr Underwood then discussed the raising and presentation of concerns and procedures for dealing with complaints. She then commented on the introduction of the surgical switch programme at the BRI. She went on to discuss operative issues such as by-pass times and undiagnosed abnormalities. Dr Underwood then gave her recollections of how concerns about paediatric cardiac surgery emerged, including the circulation of data, how the concerns were discussed within the directorates of anaesthesia and cardiac surgery and what action was taken in respect of the concerns. She concluded by commenting on her involvement in the operation performed on Joshua Loveday in January 1995 and her subsequent responsibility for paediatric cardiac anaesthesia at the BRI and the Bristol Childrens Hospital. Dr Michael Scallan, Consultant Anaesthetist, Royal Brompton Hospital, attended todays hearing as a member of the Inquirys Expert Group. |
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FULL TRANSCRIPT
1 Day 75, Thursday, 11th November 1999 2 (9.30 am) 3 THE CHAIRMAN: Good morning, everyone. Good morning, 4 Mr Langstaff. You will know that, it being 5 11th November, we shall, of course, at 11 o'clock take 6 two minutes' silence. I just put everyone on notice of 7 that at this point. 8 MR LANGSTAFF: Sir, would it perhaps be convenient for the 9 first session of the morning then to finish with the two 10 minutes' silence immediately before the break, and if we 11 were to postpone our usual morning break until 11.02? 12 THE CHAIRMAN: That would be very helpful. Thank you. 13 MR LANGSTAFF: Sir, before Miss Grey calls Miss Underwood 14 to give her evidence, may I just say a few words about 15 a matter of concern which has reached the ears of the 16 secretariat and legal team, not least from Mr Lissack on 17 behalf of the Heart Action Group. That is the concern 18 that in the focus which is inevitable upon mortality, 19 that morbidity should not be overlooked. If reassurance 20 is necessary, I give it that throughout the Inquiry it 21 has not been overlooked, nor will it be overlooked, and 22 it is perhaps appropriate that I should say that those 23 who have looked closely at the statistical report which 24 was published last week will have seen that the Inquiry 25 has done what it can to investigate such indications as 0001 1 there may be that may help you, the Panel, to resolve 2 the questions that arise in respect of morbidity. 3 For instance, it is apparent that there is 4 a difference between Bristol, when compared with the 5 rest of the country and other centres, on the basis of 6 the hospital episode statistics as to the incidence of 7 neurological problems and to an extent renal and 8 respiratory problems following surgery. As we 9 explained, it is difficult on the basis of those 10 statistics alone to know whether those problems arose 11 before, during or consequent upon the operation, or were 12 indeed consequent upon the underlying condition, but the 13 difference is there and, of course, remains in part to 14 be explored. It will not have escaped, I hope, notice 15 that the clinical case note review was divided as to 40 16 cases of those who had sadly died and 40 who had 17 thankfully survived, but of those who survived, it was 18 expected that there may be some, and indeed there are 19 some, who have complications of one or other sort, which 20 may be described as morbidity. Inevitably some of those 21 cases will be used in the weeks that come in the 22 evidence of the clinicians involved in those cases to 23 explore those issues that arise. 24 But perhaps again more fundamentally if I may 25 simply say that we have a lot of evidence, some of which 0002 1 will never be given orally by parents, because it has 2 been put in writing, about their particular children, 3 and that evidence is evidence to the Inquiry. It may 4 not look like it, because the parents themselves have 5 not come and given their evidence here, but I know and 6 they should know that you have and will read again that 7 evidence, and where it deals with a child who we are 8 told appeared untroubled before surgery but was troubled 9 afterwards by one or other complications, then you, the 10 Panel, will not lose sight of the message that is 11 contained in it. 12 It is right that I should say, because it is 13 obvious, because it seems to us to be accurate, and we 14 should be grateful if anyone were to put us right if we 15 are wrong on this, that inevitably mortality is sadly 16 easy to identify and morbidity may not be. There are 17 problems of definition, problems of degree that arise, 18 and thankfully the incidence is not as obvious nor as 19 great, it appears, as is mortality, but that does not 20 mean to say that you cannot draw such conclusions as are 21 available on the evidence and will expect to do so and 22 will expect in due course to be addressed by those who 23 have an interest in the report of this Inquiry as to 24 what findings should be made in that respect. 25 Sir, I have gone on at some length, in essence, 0003 1 I hope, to provide reassurance to those who may need it, 2 because of the focus that this inquiry inevitably has, 3 particularly on this day of all days, on death rather 4 than on survival with complications. 5 THE CHAIRMAN: Mr Langstaff, I am very grateful to you and 6 indeed to others who have raised the matter. We have 7 never lost sight of that as an issue, but we recognise 8 that it is an immensely complex issue. We shall 9 continue to do what we can to unravel what can be 10 unravelled as best we can. I give that assurance to 11 everyone. I gave it at the outset and I repeat it 12 here. Our obligation is to get to the bottom of 13 things. We will seek to go as deeply as we can, but 14 some matters are very, very complex, as you yourself 15 indicated. 16 MR LANGSTAFF: Sir, yes. I hope, as I have said, that the 17 investigation of those cases which are selected to put 18 to the various clinicians which arise from the case note 19 review may help to elucidate some of the problems that 20 there are. I should perhaps say, and I shall say more 21 about it on Monday, that when cases are selected -- 22 there will inevitably be a selection made to put to 23 clinicians -- they will be essentially to explore and to 24 illustrate the themes which have arisen thus far from 25 both the statistical review and the case note review, 0004 1 and it is not intended that there will be the sort of 2 exploration that there might be were the case one of 3 seeking compensation or clinical negligence. It is not 4 the purpose, as you have often said, for this Inquiry to 5 hold a trial of individual cases, but rather to 6 establish the adequacy of care as an overall view and 7 come to conclusions which are truly across the board 8 rather than deciding in any individual case why it was 9 that a particular child died or, for that matter, 10 survived. 11 THE CHAIRMAN: Yes. Just to add to that, which is very 12 helpful, Mr Langstaff, to say that it is not just the 13 statistical review and case review which serve as 14 indicators of adequacy, but also the evidence we have 15 gleaned from a variety of other sources, not least the 16 evidence we have heard from parents, around certain 17 themes which have begun to emerge, and it is those 18 themes that we need to explore and explore and explore, 19 and to the extent that we will be assisted in so doing 20 by referring to any case, it is in that context and only 21 in that context that we do, in fact, refer to it. So 22 thank you. 23 Miss Grey? 24 MISS GREY: Sir, this morning we shall be hearing from 25 Dr Underwood. Dr Underwood is represented, as was 0005 1 Dr Masey, by Miss O'Rourke. We also have the benefit 2 today of Dr Scallon's presence. Again he was of 3 assistance to us earlier this week. 4 THE CHAIRMAN: Yes. Good morning. 5 MISS GREY: Dr Underwood, would you like to stand, please, 6 to take the oath? 7 DR SUE UNDERWOOD (SWORN): 8 Examined by MISS GREY: 9 Q. Thank you. Now, Dr Underwood, you have provided two 10 statements to the Inquiry. If we could look at the 11 first of those, please. This is WIT 318/1. That is 12 a statement concerning your anaesthetic log; is that 13 correct? 14 A. Yes. 15 Q. If we turn over the page, we should see your signature 16 there. Is that your signature? 17 A. It is, yes. 18 Q. And are the contents of that statement true to the best 19 of your knowledge and belief? 20 A. They are. 21 Q. Now if we could look, please, at the second statement 22 you have provided, which starts at page 3, is that the 23 first page of your second statement? 24 A. Yes, it is. 25 Q. If we look, please, at page 7 and scroll down a little, 0006 1 please -- can you go up just a little and look at 2 paragraph G4 there? There are two corrections you want 3 to make to that? 4 A. There are please, yes. The Intensive Care sessions 5 began when the intensivists arrived. There were 6 initially three and later five mornings a week. 7 Q. Going on, please, to page 12 of the statement, the copy 8 we have has not been signed. With the two corrections 9 you have just made, are you happy to adopt that as your 10 evidence to the Inquiry? 11 A. Yes, I am. 12 Q. Are its contents true to the best of your knowledge and 13 belief? 14 A. They are. 15 Q. Now if we could go, please, on to page 14 of the 16 statement, you do, in fact, append a CV? 17 A. Yes. 18 Q. And you have told us in the statement that you took up 19 post at the Royal Infirmary in October of 1991. If we 20 scroll down the page, we can see your previous 21 experience. In particular -- can we go down a little 22 further, please -- we can see that from October 1987 to 23 November 1988 you were an anaesthetic research fellow at 24 the London Chest Hospital? 25 A. I was. 0007 1 Q. Was your work there exclusively with adult patients? 2 A. It was. 3 Q. You then go on to act as a Senior Registrar in 4 anaesthetics at the Royal London Hospital, and you say 5 that you spent one year in paediatric anaesthesia based 6 at the Great Ormond Street Hospital? 7 A. Yes. 8 Q. Were you involved there in paediatric cardiac 9 anaesthesia? 10 A. I was indeed, yes. 11 Q. Can you tell us the extent of your experience there? 12 A. Yes. I had a rotation around the hospital, which 13 included a period in paediatric cardiac anaesthesia, and 14 also, because I knew that my interest lay in cardiac 15 anaesthesia, when there were options to go for extra 16 days, I would go for extra days as well. So I spent 17 a fair proportion of my time that year in the cardiac 18 theatre and Intensive Care. 19 Q. You may need to try to slow down your evidence a little 20 bit for the sake of those on your right, who, as we all 21 know, are perhaps the most vital members of our team. 22 So if I ask you to pause occasionally, it will be 23 because of that. 24 You say quite a considerable proportion of your 25 time. Can you just help us a little bit more as to what 0008 1 proportion that might be? 2 A. It is a long time ago. It is very difficult to 3 remember, but I would imagine it is in the area of three 4 months out of the year. 5 Q. Three months out of the year. When you went on to act 6 as a lecturer under Professor Strunin, whom the Inquiry 7 has already heard from, did you have any continuing 8 exposure to paediatric cardiac anaesthesia there? 9 A. Not at the London Hospital, no. 10 Q. At Great Ormond Street were you active both in the 11 theatre and in post-operative care? 12 A. Yes. 13 Q. What sort of a basis for comparison with other centres 14 then or perhaps more accurately with Great Ormond Street 15 did you think you had when you arrived in Bristol in 16 October 1991? 17 A. I had a recent experience in working in a large 18 paediatric hospital. Although I have tried to summarise 19 because you pressed me, for a number of months, my 20 experience was spread over the year. It was not a block 21 just on its own. I felt I had great recent experience 22 of what was happening in another hospital in paediatric 23 cardiac anaesthesia and in intensive care. 24 Q. Now when you came to the Royal Infirmary, were you 25 working -- we will just take the period for this moment 0009 1 up to May of 1995 -- 2 A. Yes. 3 Q. -- so when the children were based exclusively at the 4 Royal Infirmary for open heart operations -- 5 A. Yes. 6 Q. -- did you work at the Children's Hospital to any 7 extent? 8 A. No. I was based solely at the Bristol Royal Infirmary. 9 I did do some paediatric cases at the Dental Hospital 10 during the general anaesthetic part of my week, but in 11 terms of cardiac, it was all at the Bristol Royal 12 Infirmary. 13 Q. So you did not carry out any general paediatric 14 anaesthesia up at the Children's Hospital? 15 A. Not at the Children's Hospital, but one list a week at 16 the Dental Hospital. 17 Q. If we can go back, please, to your statement at page 4, 18 page 2 of your second statement, and scroll down 19 a little, please, to your treatment of issue B1e, you 20 talk there about equipment and you mention, firstly, 21 that the ventilators were not ideal for patients with 22 difficult respiratory requirements. Did those include 23 children on occasion? 24 A. Yes, indeed. 25 Q. And what sort of difficulties would that give rise to? 0010 1 A. We would more frequently than you would nowadays need to 2 use the hand ventilation method. 3 Q. Well, you say in the next sentence that all children 4 were hand ventilated until preparation for theatre was 5 complete until a ventilator was borrowed from the day 6 surgery unit by the ODA? 7 A. Yes. 8 Q. When did that take place? 9 A. The reason I did not write a date was I could not 10 remember it. The ODA arrived about 1993, I think, so it 11 would have been after that time. 12 Q. What sort of difficulties, if any, did hand ventilation 13 give? 14 A. It would have been a problem if we had not had 15 sufficient anaesthetists, but in practice the 16 anaesthetic was provided by a consultant and always 17 a senior anaesthetic trainee was present as well, 18 obviously as part of their training, but they were well 19 able to assist with the hand ventilation. So in 20 practice there were enough pairs of hands in the room to 21 provide the ventilation. It obviously became easier 22 when equipment was available too but it was quite 23 feasible with two anaesthetists to do it in that 24 fashion. 25 Q. How did that situation compare with your experience at 0011 1 Great Ormond Street? 2 A. I cannot honestly remember if there was a ventilator in 3 the room or not. It is quite common when setting up 4 a child for complex surgery to have a period of hand 5 ventilation. You are in complete touch with the 6 patient. You can feel the stiffness of the lungs and so 7 on. So it would not be unusual to use a hand 8 ventilation method for some time. So it did not strike 9 me as a major difference in a sense, but it was a sign 10 perhaps that the theatre was coping with paediatric and 11 adult cases and in that respect some of the equipment 12 had to be suited to both, and it may have been chosen 13 differently if it had been suited to one or the other 14 group of patients. 15 Q. (To Dr Scallon) Dr Scallon, could I ask you to come in 16 on this? Do you find this description of the state of 17 affairs until some time in 1993 or thereafter at all 18 surprising? 19 DR SCALLON: No. I think the comments that have been made 20 are absolutely fair, that hand ventilation can be as 21 good as mechanical ventilation in the anaesthetic room, 22 and, as Dr Underwood said, there is a period during the 23 setting up of the anaesthetic when even if there is 24 a ventilator, there will be a period of hand 25 ventilation. 0012 1 I think that the general comment that it is 2 perhaps a symptom that the facilities were not geared 3 towards paediatric anaesthesia is a fair one. It may 4 also point to the criticisms that we have heard 5 elsewhere of the lack of equipment and the lack of 6 a ventilator may be another one. Whether it follows 7 from this that the standard of care in the anaesthetic 8 room was inferior is, I think, incorrect. A standard of 9 care using hand ventilation in the anaesthetic room can 10 be as good as that when using the ventilator. 11 Q. So the staff may have to work a little harder perhaps on 12 occasion, but the children in no way would suffer from 13 that? 14 A. That is right. The point is that with the second 15 anaesthetist present, this is not a problem. A solo 16 anaesthetist would clearly have problems. 17 Q. (To Dr Underwood) You go on to say in the statement 18 that the transfer of patients to ITU at the end of 19 surgery was sometimes a long and difficult journey. We 20 heard from Dr Pryn on Monday that there was a serious 21 problem with back-up batteries for transport monitors. 22 Can you help us on the nature of that problem, if indeed 23 you perceived there to be one? 24 DR UNDERWOOD: Yes. Again, it is a long time ago and it is 25 difficult to remember exactly what we had then, but 0013 1 there was certainly a period when we relied on 2 a battery, which was a physically large piece of 3 equipment in those days, hanging on the end of the bed 4 or the cot to provide us with electricity for the 5 journey. We needed the electricity to run the 6 monitoring and equipment we were using on the journey. 7 That equipment was essential to the child. So there was 8 always a worry when you heard that someone else or 9 somebody had been concerned that the battery might not 10 last that that would be a feature of the journey. 11 So the journey was stressful, because we were 12 concerned that something may happen. I do not think it 13 would be fair to say that I can remember an actual 14 incident when that happened, but I do remember that 15 patients who were needing a lot of support, you would be 16 concerned when you set out for the journey, because you 17 knew that there was a possibility -- the journey seemed 18 long, because it included a lift journey. It was not 19 physically very far. 20 Q. So to the best of your recollection you can remember 21 concerns that something might arise, but no incident in 22 which actually problems did arise because of this 23 particular problem? 24 A. Exactly, yes. Yes. 25 Q. Can you remember then any occasion in which the journey 0014 1 or length of the journey from theatre to ITU did, in 2 fact, compromise the health or safety of any patient? 3 A. No, I do not think so specifically. I think because we 4 knew that the journey was long and potentially 5 hazardous, we would not embark on it until the patient 6 was quite stable, so that in moving a sick patient from 7 the operating table to the cot or the bed, there may be 8 some instability in a very sick patient, but then you 9 would not move out of the theatre until you had overcome 10 that period and then you would move to the Intensive 11 Care Unit. There was never any pressure to press on 12 with the next patient if the patient was not fit to make 13 the journey, because everybody understood that you must 14 not set out on the journey unless it was going to be 15 made as safe as possible. 16 Q. Did you move directly from theatre to the ITU or was the 17 room immediately outside theatre where you would 18 stabilise the patient after surgery? 19 A. No, you would stabilise in the theatre and then move up 20 to the Intensive Care as one journey. 21 Q. If we look at UBHT 297/69, this is the list of equipment 22 that was drawn up by Dr Pryn in December 1994, major 23 equipment that is, required by cardiac services. 24 Firstly, what was the system for review of equipment 25 before Dr Pryn started his overhaul? 0015 1 A. The anaesthetic part of the equipment was dealt with by 2 the Anaesthetic Department, who always had an equipment 3 officer, one of the consultants nominated to do that 4 job, in the department, and I was never that officer and 5 never particularly involved in that sense with the 6 equipment. 7 Q. Now we have a record there of requirements of updating 8 to Intensive Care ventilators. Can you describe the 9 situation with ventilation before the replacements were 10 purchased? 11 A. We always had, to my memory, ventilators that were 12 suitable for use on the children, but there used to be 13 separate paediatric ventilators or adult ventilators up 14 in Intensive Care. If I remember rightly, and as I say 15 it was not my primary responsibility to do that, this 16 was to introduce more modern ventilators. In fact, they 17 would be useful for the adults or the children. 18 Q. The particular concern set out there is there are no 19 servicing or spare parts available, so if anything went 20 wrong, it was difficult to do anything about it. Again 21 can you remember any incident where this potential 22 problem became an actual one? 23 A. No, but I do remember that we only had a limited number 24 of paediatric ventilators and we used to ask for them to 25 be set up before we started the case or during the start 0016 1 of the case. So they would be prepared on Intensive 2 Care before we arrived there and again I can picture in 3 my mind the ones we had and they were ones I had been 4 used to using in GOS. I knew the problem was they would 5 not be sustainable. I think that is why Dr Pryn made 6 a concerted effort to do that. 7 Q. If there are only a limited number of paediatric 8 ventilators, did that ever function as a limitation on 9 the throughput of children through the ward, or were 10 there other more critical issues, such as nursing or 11 indeed availability of consultants to perform 12 operations? 13 A. I do not remember the ventilators themselves being 14 a limiting factor in the throughput of children, but the 15 beds on Intensive Care were to some extent labelled as 16 paediatric and adult in that there was a maximum number 17 of children that could be coped with on Intensive Care 18 from the nursing and medical point of view. So that was 19 really a much more limiting feature, and I do not 20 remember the ventilators on any particular occasion 21 being a limiting feature. 22 Q. Can I ask you just to speak up a little as well? 23 A. Yes. 24 Q. From the point of view of factors limiting the number of 25 children that could be operated upon, what were the most 0017 1 significant? 2 A. There was a limited number of beds available for 3 children in the Intensive Care, and at this stage 4 I cannot remember if it was three or four, but we 5 usually had two or three children on the Intensive Care, 6 but I do not know exactly what it was that caused that 7 to be the number. My understanding would have been that 8 it was related to ability to provide a suitable 9 paediatric experienced nursing staff in the Intensive 10 Care, but also probably related to the requirement to do 11 a certain amount of adult cardiac surgery through the 12 same unit. So there would have had to be a balance and 13 there was a limit on the number of beds in Intensive 14 Care that could be filled with children at any time. 15 Q. Going back to this page, if we scroll down, please, we 16 can see there the reference to replacing the patient 17 monitoring system, and Dr Pryn picked out in particular 18 the problem of electrical interference with diathermy. 19 Was that a problem that you recognised? 20 A. Yes, indeed. That was the problem with older monitors 21 particularly obviously in the operating theatre and 22 during the use of diathermy which at some stages in the 23 operation is quite continuous, it would be difficult to 24 monitor the child or indeed the adult. 25 Q. I think if we went to Dr Pryn's list of minor equipment 0018 1 or more minor equipment, which would be at UBHT 84/101, 2 he picked out the necessity for new syringe pumps. What 3 was your experience of syringe pumps' adequacy before 4 they were replaced in this round of reviews? 5 A. Again I think that things were developing gradually bit 6 by bit and we were all becoming more aware of the fact 7 that there were better syringe pumps than the ones we 8 had. Some of the variation in the condition of patients 9 we could ascribe to the pulsing nature of the syringe 10 pumps. When the pumps became available that provided 11 a smoother action, it was obviously sensible to try to 12 obtain some, if we could. 13 Q. So you had had experience of problems with pulsing of 14 inotropes? 15 A. Yes, I think we had. We had certainly seen variations 16 in the patients' condition, some of which we put down to 17 the possibility of that being a cause of it, so that you 18 would think that if a better equipment became available, 19 if it was possible to have it, that would reduce that 20 aspect of variability at least. 21 Q. Again, did that ever cause a serious compromise to any 22 significant extent to the condition of a patient? 23 A. I do not recall any specific incidents where the syringe 24 pump was at fault, although I do know that it was 25 considered in the unit that the syringe pumps had caused 0019 1 on occasions difficulty. 2 Q. Generally, Dr Underwood, in looking at the availability 3 or function of equipment, if the Inquiry is looking to 4 explain outcomes at Bristol, to what extent do you think 5 that equipment failure or deficiencies in equipment 6 should be regarded as an actual or potential cause of 7 any problems? 8 A. I think it is very difficult to single out equipment 9 from the rest of the procedure really. Obviously it is 10 easier to do a procedure better with better equipment, 11 but it is a balance between being able to do the 12 procedure with the equipment you have or saying that you 13 must have better equipment, and although this is 14 a one-off document that you have picked out here, in 15 fact, the procedure is a much more on-going, rolling 16 programme. It does have occasional boosts ahead when it 17 is possible to change syringe pumps or get a completely 18 new set of ventilators, but in general it proceeds bit 19 by bit. I think I would find difficult to pick out what 20 part that plays in the whole picture, but I think it is 21 fair to say that it does play a part in the whole 22 picture. 23 THE CHAIRMAN: Can I just interrupt? It is very important 24 we hear everything you say and capture everything you 25 say, and sometimes you are going quite quickly, not for 0020 1 my ears, but for the fingers of the lady to your right. 2 A. Sorry. 3 THE CHAIRMAN: So before we see blood emerging from her 4 fingers, remember to slow down sometimes, because it is 5 so important that we have a full transcript. 6 A. I do apologise. 7 THE CHAIRMAN: No apology is called for. 8 MISS GREY: Dr Underwood, your answer suggests that 9 equipment might have made some difference? 10 A. Yes. 11 Q. Can you help us a little bit more as to the nature of 12 any difference that it might have made? 13 A. I think if there is better equipment, everything is 14 easier. Everything flows more smoothly. One piece of 15 equipment which is not actually highlighted here but 16 which made a big difference to my mind, and I think to 17 my colleagues' too, is a difficultly in keeping 18 particularly very small children warm during the 19 procedure of setting up for an operation. 20 Certainly I remember that when I first arrived 21 there was no equipment to help us with that. We used to 22 turn the temperature up in the anaesthetic room but it 23 was very difficult to keep small babies warm. I did 24 manage to procure an overhead warming device from the 25 Maternity Hospital, in fact, which we borrowed for some 0021 1 time, and later tried to get some more equipment to keep 2 babies warm. 3 So there are things like that which are important 4 and relevant in the care of the child, but I would not 5 -- it would be hard to say exactly what part they play. 6 Q. Not every hospital will necessarily have 7 state-of-the-art equipment at any one time. In your 8 judgment how did Bristol compare with your experience of 9 what had been available to you at Great Ormond Street? 10 A. The biggest differences I saw were in the heating 11 arrangements for keeping children warm and in the 12 monitoring, and I knew that there was effort to change 13 the monitoring in theatre and in the Intensive Care, and 14 I was pleased. I think it helped my practice when it 15 did change. 16 Q. Warming you have told us about, in preparing children 17 for theatre? 18 A. Yes. 19 Q. Are you also talking about the situation in the ITU? 20 A. In the Intensive Care there were some cots with heaters 21 over the top, but they were operated by the nurses 22 rather than the more modern servo-controlled. So again 23 there were some -- less than the most modern at that 24 time. 25 Q. You have reminded us that the monitoring was changed. 0022 1 Can you date that? 2 A. No. No more clearly than Dr Pryn. 3 Q. It is something that arose out of Dr Pryn's review of 4 equipment, is it? 5 A. I believe that is what made it actually happen. 6 Q. (To Dr Scallon) Dr Scallon, you came and helped us on 7 Monday and indeed were sworn in on that occasion and so 8 I should perhaps remind all for the sake of the wider 9 audience that you remain on oath. 10 Is there anything you would like to comment on on 11 the general availability of state-of-the-art equipment 12 or the most modern equipment within hospitals within the 13 NHS across this period? 14 DR SCALLON: It varies enormously from hospital to 15 hospital. As Dr Underwood said, equipment is acquired 16 as a continuous programme, but there are times when it 17 can be extremely difficult to get money for equipment 18 because the money is simply not available or because 19 other people are competing for it. 20 My own hospital was fortunate in that we moved to 21 a new building about ten years ago and we were able to 22 get, as part of the package, a whole new set of 23 equipment, but that is unique in a new hospital. Old 24 hospitals do not have that luxury. 25 Q. Thank you. 0023 1 A. Can I just come in on another point, on the issue of 2 heating in the anaesthetic room? It is correct to say 3 that in general terms children and small babies need to 4 have their heat conserved, because during exposure they 5 can lose heat very quickly, but babies and children 6 undergoing cardiac surgery will be cooled as part of the 7 process of the operation. So I would say a modest 8 amount of cooling in the anaesthetic room is not 9 necessarily a disadvantage. Indeed, many people in the 10 field deliberately leave the children exposed during 11 that period as part of the cooling process. So one has 12 to balance the degree of cooling. It is not necessarily 13 in all situations a bad thing. 14 Q. So it would follow from what you are saying that the 15 lack of temperature controls or inadequate, limited 16 systems to warm children in the pre-theatre room would 17 not necessarily be a factor that concerned you? 18 A. Provided it did not lead to excessive cooling, the 19 answer to your question is yes. 20 Q. (To Dr Underwood) Excessive cooling, Dr Underwood, was 21 that a problem? 22 DR UNDERWOOD: I think I would be in agreement with 23 Dr Scallon on this that moderate cooling was fine. Our 24 theatres were old and frequently very cold in the 25 morning. I think we are actually talking about the same 0024 1 thing, about maintaining a reasonable temperature but 2 not the normal body temperature. Now we are in a newer 3 theatre, we have much less trouble controlling the 4 ambient temperature and we see the difference. 5 THE CHAIRMAN: May I come in with a question that would 6 help me? You referred back a little while ago to 7 monitors, for example, being less than modern, as 8 I think your words were. One has that impression of 9 some of the other equipment. Do you think it is a cause 10 for, let us say, concern, without putting any strong 11 value on that word, that one is engaged in surgery which 12 is extremely modern, at the leading edge of what is 13 possible, and yet one's equipment is not at that same 14 degree of development? 15 A. I think it would be impossible to keep the monitoring 16 always at the leading edge, and when we are looking at 17 this time at the monitors that we had in theatre and the 18 Intensive Care, we are looking at the end of their 19 period ready for the start of the next monitor. So this 20 is as bad as the monitor can ever get before it is 21 replaced. Over a period of years that would not 22 represent the average, if you like. So I think that is 23 very difficult. We had to press to keep updating things 24 as much as is feasible, but these monitors that we were 25 replacing were at the end of their useful life from our 0025 1 point of view, and we were pressing to have them 2 replaced. We were organising to have them replaced. 3 THE CHAIRMAN: But just for the sake of clarity, when you 4 say "as bad as they get", do you mean, and I do not seek 5 to put words into your mouth, within the cycle of them 6 being serviceable to the need, they go from being very 7 good at that to less good at that but remain 8 serviceable, or do you mean they had ceased to be 9 serviceable? 10 A. I believe they were still serviceable. As a practising 11 anaesthetist they provided me with the measures 12 I needed. They were not as clear as the more modern 13 ones were. You could not attach them to a central 14 station, as you could with the newer ones and so on and 15 so forth, but the monitoring that I needed minute by 16 minute for the patient was available on the screen, 17 though harder to discern from the screen perhaps than 18 the more modern ones. 19 MISS GREY: Dr Underwood, if we could go back to your 20 statement, please, 318/4, and scroll down a little 21 further, please, you give us at B1(e), the second 22 sentence of the paragraph there, the statement that: 23 "In the Intensive Care Unit adults and children 24 were nursed alongside each other". 25 What significance do you think that fact had 0026 1 firstly from the point of view of parents of children? 2 A. I should imagine it was very difficult, particularly as 3 a parent. I think the children in Intensive Care 4 generally were sedated and, even if they were not 5 sedated, probably do not have a lot of recall for that 6 period, although once they become high dependency 7 patients rather than intensive care, that would be 8 different. I would imagine that a parent in 9 that setting would find it very difficult. 10 Q. From the point of view of an anaesthetist concerned in 11 the post-operative care, what were the disadvantages of 12 this set-up? 13 A. I think it can be quite difficult to be concentrating on 14 one aspect of your work one minute and another aspect 15 another minute, but they were all cardiac patients and 16 my training was in cardiac anaesthesia for all age 17 groups, so that I think the problem for me personally, 18 when I first arrived, was probably less than it was for 19 the parents and children themselves. 20 Q. I asked you what the disadvantages were. Do you think 21 they were significant? 22 A. In terms of my anaesthetic input for the children 23 I think probably maybe not, but I think in my part as an 24 intensivist -- I am not a trained intensivist as folk 25 are now, but I had training in Intensive Care and looked 0027 1 after the patients on Intensive Care. In that role 2 I think it was difficult, because the back-up in other 3 specialities for children was not physically present in 4 the hospital. 5 Q. We will come back to this in greater detail later. You 6 have just said you draw a distinction between training 7 as intensivist and your own training as anaesthetist 8 involved in post-operative care. 9 A. Indeed. 10 Q. Can you help us a little more on the distinction you are 11 drawing there? How would an intensivist be trained 12 first? 13 A. In these modern times it is set out quite clearly how an 14 intensivist would train, but in the time when I was 15 appointed, if I had been interested in an intensive care 16 post, I would have had to show more training and 17 experience in the Intensive Care field itself, but, as 18 I spent a lot of training doing cardiac and thoracic 19 anaesthesia, then that is where I spent my specialist 20 experience, if you like, in that field, rather than in 21 Intensive Care, but obviously anybody who is trained in 22 anaesthesia for major operations has some training in 23 post-operative care of those patients on the Intensive 24 Care Unit. 25 Q. If we can go over the page, please, and look at 0028 1 paragraph B6, you say you do not remember seeing any 2 written protocols or guidelines before the arrival of 3 the intensivists in 1993. We have heard from Dr Pryn 4 about the protocols that he was instrumental in 5 developing. If we could look, please, at WIT 341/60, 6 these are Mr Wisheart's comments on Dr Pryn's 7 statement. Can we scroll up again, please? Thank you. 8 I am sorry. We should turn back, to give it the 9 context, to page 59 first, where we can see that Dr Pryn 10 had been commenting on the red book that he had seen 11 called: "Guidelines for the Care of the Cardiac 12 Surgical Patient", and he said a number of features were 13 out of date. 14 If we look over the page, page 60, we can see 15 Mr Wisheart's comments on that. He says that the book 16 had been written in 1988, or this edition had been 17 produced in 1988 with a number of contributors helping 18 him. He had started the book in 1976 in his first year 19 in Bristol, and that it contained comprehensive 20 guidelines. He said that he felt it was important that 21 the authorship of these guidelines should pass to new 22 hands, but that nobody took up this opportunity, and 23 that when Drs Pryn and Davies were appointed as 24 intensivists or with intensivist sessions it naturally 25 fell to them to do so. 0029 1 Were you aware of the red book? Did you see it 2 when you arrived in October 1991? 3 A. When I wrote my statement, I had completely forgotten 4 about the red book. When I saw mention of it in my 5 reading in the last few days, I do recall there being 6 a red book. I do not remember reading it myself. 7 I remember that my understanding was that it had been 8 written by the surgeons, and that it was generally aimed 9 at the surgical SHOs who were working hour by hour on 10 the Intensive Care Unit. I did know later on that some 11 updating was needed, and I seem to remember that before 12 Dr Pryn started writing protocols which he put in an 13 orange book, that actually one or two even of the senior 14 registrars in cardiac surgery had started to make some 15 updates to the book. 16 Q. So you were aware of it? 17 A. Yes, I was. 18 Q. Did you actually see a copy of it? 19 A. I do not now recall that I saw a copy of it. 20 Q. Can you remember when you became aware of it, roughly in 21 relation to -- 22 A. No, except I do remember discussion standing around in 23 the intensive care, discussion about updating it, and 24 I do recall that a Senior Registrar was reported to be 25 doing that updating. So I was obviously aware of it at 0030 1 that time, and that was before Dr Pryn wrote protocols, 2 I believe. 3 Q. Why not read it yourself and satisfy yourself that it 4 was a proper and adequate guide? 5 A. I think because I considered it to be part of the 6 surgical arrangements on Intensive Care, and my vague 7 memory of it is that it was something written by the 8 surgical seniors for the surgical juniors. I would have 9 been more concerned with teaching people on the ground, 10 if you like, particularly the anaesthetic trainees in 11 our aspects of Intensive Care, although obviously the 12 surgical SHOs were frequently with us at the time. 13 Q. So when Mr Wisheart says that he felt it important that 14 the authorship of those guidelines should pass to new 15 hands, but no-one took up this opportunity, was it ever 16 suggested to you that that might be a useful way in 17 which to spend your time? 18 A. I do not remember it ever being suggested to me 19 personally. 20 Q. Going back then to your statement at page 5, please, and 21 scrolling down to B7, you say: 22 "In the ITU note-keeping was more difficult but 23 started to improve with the arrival of the 24 intensivists". 25 Can you explain what it was like before they 0031 1 arrived? 2 A. Of course it is only my perception, but before they 3 arrived there would be more people passing in and out of 4 the Intensive Care, and there was not a senior person 5 allocated to the Intensive Care, so that, as decisions 6 were made through the day, they may or may not have been 7 written in the patients' notes. I think it is the 8 nature of the Intensive Care and the changing of the 9 plan as the day goes by that partly made it difficult to 10 make a consistent record. That is made much easier if 11 one person is in the Intensive Care for a prolonged 12 period and can either summarise what has happened during 13 the day or add to the records as the day goes by. 14 Q. But surely even the trainees on the ward must have 15 appreciated the importance of documenting changes in 16 care or condition as the day went on? 17 A. I think once the intensivists arrived, this was more 18 strongly stressed, that it was left to the junior people 19 to make a note in the notes, and if they did not do it, 20 it probably was not checked. Certainly I did not check 21 myself when making the evening ward rounds that 22 something had been written in the notes. 23 Q. So it would be your practice to make a ward round and 24 discuss with the trainees on the ward at that time what 25 changes in management needed to be made but not to 0032 1 document it yourself? 2 A. That is right. We used to make an evening ward round 3 after the theatre list with the people that were going 4 to be available for the Intensive Care for the evening 5 and night, and if there were instructions to nurses, 6 they would be written on the charts at the head of the 7 bed, so that they were visible all night for the nurse 8 to follow. 9 Q. They would be written by whom? 10 A. I remember writing quite a lot myself. They may be 11 written by someone else on the ward round. Actions that 12 required carrying out that evening would be written down 13 on the Intensive Care page rather than in the patients' 14 notes. The arrival of the intensivist brought a new 15 page to be filled in each day, which made it easier for 16 the trainees to understand that that is where the 17 information should go, and try to coordinate it, but 18 I think even that was sporadically completed probably. 19 Q. Well, Dr Pryn's evidence was that that was seen as 20 being, as it were, something, if I may put it that way, 21 owned by the intensivists rather than being something 22 which necessarily concerned the surgical trainees. Is 23 that evidence which you would agree with? 24 A. I think it is, and I think that the reason that is now 25 becoming quite clear is we have not addressed the issue 0033 1 of who was physically present in the Intensive Care. 2 There was no intensivist or anaesthetist allocated to 3 the Intensive Care for the day when I first arrived. 4 Q. Until the arrival of Dr Pryn and Dr Davies? 5 A. After the arrival of Dr Pryn and Dr Davies, who had 6 between them three morning sessions on a consultants' 7 basis, and then also managed to re-arrange the trainee 8 rota so that an anaesthetist of a junior level was 9 available in the Intensive Care during the day as well 10 as being on-call for the night. 11 Q. I will come back, if I may, to the question of who was 12 present when, but looking down a little this page, still 13 on the subject of note-keeping, we can see at B12d that 14 you found communicating with other staff relatively 15 easy, but it depends on conversations in theatre, office 16 and Intensive Care with little written down. So it is 17 informal discussions, is it, with colleagues? 18 A. They could be described as informal, though often they 19 were very useful and often they would be clinically 20 relevant and clinically based. If I had a question to 21 ask a surgeon about the patient, I would seek out the 22 surgeon, because they would generally not be far away, 23 discuss the question and then one or other of us would 24 take the action that we had decided on. So they may 25 have been about clinical issues and the running of 0034 1 actual patients' care and so on. 2 Q. If you had had a discussion with another member of 3 staff, a colleague, would you document the fact that 4 this change had been made with the agreement of, say, 5 Mr Wisheart and Mr Dhasmana, or would you simply record 6 the change? 7 A. I would more likely record the change itself, because it 8 is very common in Intensive Care that a decision to 9 change is made by a group of people rather than an 10 individual. 11 Q. If we look at the Clinical Case Review, the preliminary 12 report from the Inquiry, which is INQ 16/23, we can see 13 the overall comments on post-operative management issues 14 at 5.11, where it says: 15 "It was difficult to determine who took either 16 medical or nursing responsibility for directing the 17 management of patients on the ITU and particularly as 18 applied to the management of paediatric patients". 19 Were you clear who was taking medical 20 responsibility for directing the management of patients? 21 A. The patients were always under the care of the 22 consultant surgeon under whom they were admitted, but 23 their medical care would be a matter of discussion 24 between the anaesthetists and the surgeons, and they may 25 have a certain amount of input, depending on the nature 0035 1 of the problem being addressed. For example, a problem 2 of ventilation, I would assume that my decision would be 3 satisfactory to the surgeon, and if I was going to make 4 a major change, I would probably speak to the surgeon 5 about it, but I would expect that change would be 6 satisfactory to them and indeed it generally was. 7 Q. So what do you mean by "a patient was always under the 8 care of the consultant surgeon"? Is that a question of 9 ultimate authority or what? 10 A. I do not think in the day-to-day life on Intensive Care, 11 looking after the patients that we had, that that was 12 something that came to my mind particularly. I was more 13 concerned in dealing with the adjustments to medical 14 care to try to improve the condition of patients and 15 obviously to make them better and out of Intensive 16 Care. So I was concerned with communicating with the 17 surgeons in assisting the patients in progressing 18 through the unit, and at that point I would not have 19 said that either one or other of us was superior to the 20 other. We would be having a discussion in the usual way 21 of Intensive Care with how to proceed with a certain 22 problem. 23 Q. So if you were confident in your role in managing in 24 particular the anaesthetic or ventilatory side of the 25 patient care, what does the fact that the patient was in 0036 1 the care of the surgeon mean to you? 2 A. Only that I think, because the patient is not actually 3 separate units of ventilation and heart and kidney and 4 so on, it is a whole patient, that something that I do 5 to the ventilation may make a difference to the patient 6 in general. So it would be unhelpful to wander into an 7 intensive care and change the ventilation of the patient 8 without due regard to the rest of the patient. So if 9 I was making a major change in ventilation, for instance 10 I was going to take a patient off the ventilator because 11 they no longer required it, I would like to mention that 12 to the surgeon some time in the next few hours, so they 13 are aware of that situation with their patient, but 14 I would still expect to be responsible for the 15 ventilatory aspects of what I was doing. 16 Q. But if the care in ITU is at any time in danger of being 17 fragmented, disorganised, because of, say, the 18 management or junior people on the ward, difficulties of 19 communication with more senior people, to paint 20 a hypothesis, for instance, who is responsible for 21 sorting out that problem and ensuring that proper 22 communication does take place? 23 A. I would say that that was a reason that intensivist 24 sessions were so helpful to us, and why we were so keen 25 to have them, because it is more a coordinating role 0037 1 than a supervisory role, I would suggest, in getting the 2 right information together and that somebody who has 3 time allocated for that purpose is much more able to 4 achieve that than people who have duties elsewhere. 5 Q. But, with respect, that is to say that you can solve the 6 problem by appointing someone to coordinate. If you 7 cannot appoint someone to coordinate, because you do not 8 have the resources to do it, say, or there is not 9 agreement that it is necessary, who is responsible for 10 controlling the problem or eradicating it at an earlier 11 stage? 12 A. Before the arrival of intensivists I would always work 13 on the premise that it would be a team effort because 14 anybody with something to add in that sphere for that 15 patient, and I would consider that we would be working 16 together to do that. 17 Q. Are you saying then that if you observed difficulties in 18 communication on the ward or problems of inadequate 19 cover whilst very junior people were present, that you 20 would think it would be an equal responsibility between 21 yourself and the surgeons, the other consultants, to 22 sort that problem out? 23 A. Yes, I think you covered a lot in there. Some of it 24 I could agree with. I personally did not find 25 communication particularly difficult, because there were 0038 1 a smaller group of us in those days, which makes 2 communication easier. It was easy to locate people you 3 wanted to speak to, because they would be in the 4 Intensive Care or in the theatre or perhaps in the 5 office opposite, and so there was a lot of communication 6 about the patients and what progress they were making 7 and how they could be assisted to make more progress 8 between the parties involved, and as an anaesthetist, 9 I thought that that was an appropriate way to go about 10 it before the arrival of intensivists, as you say. 11 Q. Well, we may be at cross-purposes, because we are 12 talking about two different things. If we remain on the 13 subject of management, as it were, management of the 14 ITU, if there are difficulties in communication, and 15 I will put that as a hypothesis for the moment, that 16 people are not talking to each other, there are problems 17 with junior staff not being able to get a hold of more 18 senior staff, for instance, when they need to make 19 changes in management, this sort of problem, who is 20 responsible for taking a look at the ITU and seeing 21 whether or not those problems are real and, if they are, 22 sorting them out? 23 A. I do not know if I am qualified to answer that question, 24 but I would say that because the Anaesthetic Department 25 has a big input into Intensive Care, that the 0039 1 anaesthetists or perhaps the Director of the Anaesthetic 2 Department had some responsibility in helping to resolve 3 those kind of issues, but I do not know if I am the 4 right person to answer the question, unless I have 5 misunderstood your question. 6 Q. Why not, with respect, because you were working on an 7 ITU? You must have some idea of who to go to if there 8 are difficulties in management of the ITU or whether it 9 was something that you yourself would have 10 responsibility for sorting out? 11 A. I think some confusion may arise because in my mind 12 it would depend a lot on the problem. If there was 13 a problem with anaesthetic trainees having difficulty 14 contacting anaesthetic consultants, then I would have 15 a responsibility to try to investigate that and assist 16 in resolving it. If it was a problem with a surgical 17 trainee having the difficulty, then I would envisage 18 that coming under the aegis of the surgical team. So 19 I think it depends on the sort of problem. It is in 20 Intensive Care where all these things meet together and 21 it is quite difficult to unpick when it is run by 22 a group of people. 23 Q. Going back then to paragraph 5.1, the comment there is 24 that it was difficult for the reviewers to determine who 25 was taking -- and we will stay with medical -- 0040 1 responsibility for directing the management of patients 2 on the ITU. Do you think that is a fair comment? Is 3 that a confusion you ever had? 4 A. I think it is a fair comment for someone from outside to 5 make. I do not remember it being a problem from 6 personally looking after an individual patient on the 7 Intensive Care, although I do think they are two 8 separate questions. 9 Q. Going on to the second sentence: 10 "In general Intensive Care appeared to have been 11 fragmented and insular in approach". 12 Do you think that is a fair comment? 13 A. Again in the day-to-day sense from my perspective 14 I think it was a less fragmented than it would have 15 appeared to an outsider trying to piece it together 16 now. So I do think that is a fair comment made by an 17 outsider, but my perspective at the time was starting 18 from me and looking around myself, communication was 19 quite easy, though very time-consuming, when nobody was 20 based on the Intensive Care and I was not based on the 21 Intensive Care myself. 22 Q. You say very time-consuming. I think Dr Pryn identified 23 one of the problems he was dealing with was simply one 24 of delay. It was getting hold of the relevant people to 25 discuss a change in management when they were busy 0041 1 people. I am talking in particular now of the 2 Consultant Surgeons, who had responsibilities in 3 theatre, who had perhaps administrative responsibilities 4 as well. Was that something you would endorse? 5 A. Yes, I think that is a fair comment. It might be quite 6 easy to know where they were but if they were in the 7 middle of doing a complex operation, that was not the 8 time to discuss management of a patient on Intensive 9 Care. So some delay could have arisen in that form, 10 yes. 11 Q. The next sentence points to delayed response to 12 post-operative problems. Would that be a problem that 13 you had encountered in practice? 14 A. Yes. My involvement with Intensive Care was necessarily 15 patchy during the daytime, because I was involved in the 16 theatre. There were times of day in theatre when it was 17 not possible for me to go to Intensive Care. Although 18 somebody would go if there was a crisis and a trainee 19 would go to help with practical procedures so long as 20 they were able to do that, longer-term decisions could 21 only be made when you had time to be on the Intensive 22 Care and think them through. So I think it is fair to 23 say that because we were -- well I , as an anaesthetist, 24 was only physically present in the Intensive Care for 25 part of the day, it could result in delays in responding 0042 1 to problems. 2 Q. The first part of that sentence: 3 "There was a failure to anticipate clinical 4 problems ..." 5 Is that again something you observed? 6 A. I cannot remember any particular instances but I was 7 very aware that it is stressful to be working in an 8 operating theatre on one floor and to be anaesthetically 9 responsible for patients two floors up. 10 Q. The front-line care, if I may call it that, was provided 11 by a Senior House Officer, who was a cardiac surgical 12 trainee, and there was, I think, on-call cover from 13 another cardiac surgeon trainee, this time a Special 14 Registrar? 15 A. Yes. 16 Q. Would either of those two perhaps have had problems on 17 occasion in anticipating clinical problems? 18 A. The cardiac surgery SHO is naturally a relatively junior 19 trainee, and I would not expect them to have any 20 experience in anaesthesia or anaesthetic-related issues 21 and unless they had worked on another Intensive Care, 22 probably very little experience of ventilation. So that 23 the anaesthetic aspects of Intensive Care, if I can call 24 them that, were not covered by somebody physically 25 present on the Intensive Care Unit in the first months 0043 1 and years after I arrived. 2 Q. If we could go back then, please, to your statement at 3 page 5 still, you say at the bottom that you believe 4 that complaints were investigated with the involvement 5 of the clinicians concerned. I think this is in 6 response to a question of management of complaints from 7 patients. 8 A. Yes. 9 Q. Can you recollect any instances where complaints were 10 received about paediatric cardiac services? 11 A. I do not think that I was involved in any personally. 12 Q. Do you know of any complaints being made? 13 A. Not specifically, no. 14 Q. So when you say that you believe that complaints were 15 investigated with the involvement of the clinicians 16 concerned, on what experience is that evidence based? 17 A. Well, that is based on my recollection of the 18 arrangements within the Trust for such complaints to be 19 dealt with. 20 Q. Can you actually remember -- I think it is implicit that 21 you cannot -- when complaints about the paediatric 22 cardiac services were successfully brought through to 23 any conclusion, an instance of that? 24 A. No, I could not, no. 25 Q. Turning over the page, please, you say at the top there 0044 1 that: 2 "The fact that a person had to seek outside 3 publicity to air a concern was seen as a failure of the 4 system to resolve that problem early and completely." 5 When you wrote that, did you have any example in 6 mind? 7 A. I was thinking of Dr Bolsin in particular. 8 Q. Well, in relation to that, is that an accurate statement 9 of the chronology of events? Would Dr Bolsin not say 10 that he did not seek or attain any outside publicity 11 until the matter had already broken in the media? 12 A. I could not say obviously from his perspective, but from 13 my perspective and my recollection I thought that we had 14 failed in some way if any of this became so notable to 15 the public because we had failed to note something or to 16 change something or to look into something 17 satisfactorily and to reach a good conclusion. So 18 I would consider that it should not have been necessary 19 for information to get into the public domain, because 20 if there was something of concern, it should have been 21 investigated and satisfactorily concluded amongst the 22 people for whom it was a concern. 23 Q. So we should read this sentence, should we, not as 24 direct commentary, still less than attack on Dr Bolsin, 25 but rather self-criticism directed at the organisation; 0045 1 is that right? 2 A. I always thought, and still think, that it is very sad 3 that problems could not be investigated more completely 4 and to the satisfaction of everybody locally concerned, 5 and that they had to come to a bigger audience for 6 resolution. 7 Q. Who in the Trust should have been responsible for 8 achieving an earlier resolution of these difficulties? 9 A. The concerns are expressed at the shop floor, if you 10 like, and I think that, as they are expressed and people 11 make responses to them, so I would hope that before they 12 had gone through many cycles, they would be resolved, 13 and I think that now our audit system provides some of 14 that facility, but that was not in place in the time 15 that we are talking about. 16 Q. Well, can you be a little more specific? You have 17 talked about the failure and sadness. Who failed? 18 A. That is a more complex question than it sounds, 19 I think. If somebody expresses a concern, then they, in 20 my opinion, should provide suitable evidence for the 21 concern to be considered properly by peers, and then by 22 the next level of the seniority, and so on, until it is 23 resolved. I think it would be possible that there are 24 some concerns which would have to go right up the 25 system, but there are some concerns which can be 0046 1 resolved at a more local level, but the concern must be 2 aired in such a way that it can be understood by the 3 other people and clearly identified, so that it can be 4 addressed. So it could be said that there was a failure 5 in a lot of areas, or it could be said that the concern 6 was not clearly expressed. That is why I say to me it 7 is a complex question, quite difficult. 8 Q. If we stay at the level of the peer group, and we will 9 come to that in more detail -- 10 A. Yes. 11 Q. -- that is your first line of analysis, as it were? 12 That is the first point at which concern should be 13 aired? 14 A. To my view, yes. 15 Q. You have really identified two possible failures there: 16 one, the way that the concern was aired and, two, and I 17 am not sure about it, the response of the peer group. 18 First of all, taking the first one, are you making any 19 direct comment or criticism of the way in which 20 a concern was expressed or ventilated by Dr Bolsin? 21 A. I think it might be a bit clearer somewhere later in my 22 statement too, but my recollection is that he voiced 23 concern quite frequently to me, and therefore 24 I understood that he had a concern, over the mortality 25 in the paediatric cardiac surgery, to clarify, but that 0047 1 my recollection and my understanding at the time was 2 that he was not producing for me any data which helped 3 to substantiate that, and again my recollection is that 4 on several occasions at meetings where I had hoped that 5 data about the paediatric cardiac surgery outcomes may 6 be presented it was not, and I found that difficult, 7 because I then was unable to have a view on whether this 8 concern was real or not. So I think that some of the 9 difficulty arose quite near the beginning of the process 10 in that respect, but I am only one anaesthetist and I do 11 know he showed some things to some other people. 12 Q. That is then the comment on how Dr Bolsin presented his 13 data, at least to you. What then on the other side of 14 the coin, the response of the group of Cardiac 15 Anaesthetists? Do you, with the benefit of hindsight 16 admittedly, now question the adequacy of that response, 17 of the response to it? 18 A. If exactly the same were to happen again, I think it 19 would still be difficult to respond without clearer 20 data, and one difficulty was that the surgeons had 21 produced data and Dr Bolsin had apparently produced some 22 data. So my understanding from talk among people, but 23 not from any meeting, was that these were not always the 24 same. I think that then the discussion became focused 25 on how to compare these data, and which were correct, 0048 1 rather than on the issue which was whether there was 2 a problem with the mortality in paediatric cardiac 3 surgery, so that the focus was tending and the talk 4 around the place was tending to be on whose data was 5 correct and who had collected what, and that actually 6 the issue was a different issue, and it was difficult to 7 get to the issue itself, which should have been the main 8 cause for debate. 9 Q. You have described the response of the institution, at 10 least at the level of the peer group, to Dr Bolsin's 11 data and the audit prior to, if I may take this as 12 a watershed, January 1995. What about the response of 13 the UBHT as an organisation after that date? If we look 14 at Dr Bolsin's statement, WIT 80/129, we can see -- can 15 we scroll down, please -- his account of the changes in 16 his anaesthetic sessions after this had all become 17 public, and in particular a change in his work 18 arrangements, cutting down his paediatric cardiac 19 surgery sessions. Did you have any knowledge of that? 20 A. In that I worked in the cardiac theatre and in the 21 cardiac section of the Anaesthetic Department, I saw 22 that that occurred, but I had no personal knowledge of 23 the arrangements that had been made. 24 Q. Did you have to change your theatre sessions in order to 25 accommodate this change? 0049 1 A. Not to my recollection. 2 Q. Can you help us on the working arrangements or 3 atmosphere between Dr Bolsin and, firstly, Mr Wisheart 4 after this had occurred, after January 1995? 5 A. I would never have been present when the two of them 6 were working together. 7 Q. And the same arises with Dr Dhasmana? 8 A. Indeed. 9 Q. So in general can you help us on the manner in which the 10 UBHT responded to Dr Bolsin's concerns and the events of 11 January 1995? Was it proper? Was it adequate? 12 A. I do not know that I can shed any light on that, because 13 I was not part of those arrangements. 14 Q. Going back to your statement then, and in particular you 15 treat very briefly the fact that you were not, I think, 16 particularly conscious or involved with the financial 17 arrangements for children who were under 1s, if we look 18 at UBHT 84/129, we can see there that it is a minute of 19 a Cardiac Services Management Board which you attended, 20 25th April 1994. If we scroll down a little, we should 21 see that under the "Contract Report" there is a note 22 there of you saying that the reduction in under 1s could 23 be a cause for concern. 24 A. Yes. 25 Q. Can you remember what the concerns were at the time when 0050 1 designation for Supra Regional Services was removed? 2 A. I had nothing to do with the fact that we were a Supra 3 Regional Centre or not or whatever from that management 4 point of view, if you like, but, as an anaesthetist, 5 I was very concerned, particularly because my work was 6 split between paediatric and adult anaesthesia, that in 7 order to maintain my clinical skills, I would need to do 8 a certain amount of each type of anaesthesia. I was 9 concerned that the number of patients under 1 year of 10 age was very small, and with the Anaesthetic Department 11 gradually growing over the years, this may spread the 12 cases to such a degree that none of us would feel 13 skilled enough to do it, and certainly I would not have 14 felt skilled enough to do it. So I was concerned that 15 we should either do sufficient cases under 1 to make 16 that a reasonable option or to say that we could not 17 maintain skills if we did not do sufficient cases. 18 Q. Well, it is fair to say that the link in the removal of 19 Supra Regional Services' funding from the 1st April 1994 20 is one that I have made rather than one that you have 21 put, according to this minute, but more generally can 22 you tell us: was there a perception at this time, as is 23 suggested by this minute, that the number of under 1s 24 was or could reduce in the future? 25 A. I do not remember that. I do remember that I personally 0051 1 -- when I first arrived, I think I was probably doing 2 at least as much paediatric anaesthesia as anybody else, 3 or perhaps more in the first year, because of the nature 4 of the days on which I worked, but I was concerned that 5 I was doing only just enough to maintain my skills 6 anyway, and I would have been very concerned to do much 7 less than that. 8 Q. What you are minuted as saying, accurately or 9 inaccurately, is that you feel that the reduction in 10 under 1s could be a cause for concern. It is minuted as 11 a fact. 12 A. I do not recall that fact. I presume it would refer to 13 a reduction which had recently or was about to occur. 14 Q. Can you help us as to what the expectation was for the 15 service for under 1s from the 1st April 1994? 16 A. No, I do not recall that at all. 17 Q. In general, what was the perception, if you can 18 recollect any, on the importance of funding for the 19 under 1s from the Supra Regional Services? 20 A. I do not remember ever being involved in or 21 understanding the issue between the funding and the 22 patients as such. Obviously in this kind of meeting the 23 funding is mentioned and so on, and I realised that it 24 is something that is important, but I would have been, 25 and still am, because of the position that I work in, 0052 1 interested in the patients coming through from 2 a clinical point of view and in what service we can 3 provide for them and what is a feasible number of 4 patients to provide this service for. 5 Q. We will come back to it in greater detail later, but 6 I think it is right that you were one of the two 7 anaesthetists who did most of the anaesthetising for the 8 switch operation? 9 A. I think that is true, yes. 10 Q. And, as such, you were involved in a considerable number 11 of discussions with Dr Dhasmana and others on the 12 continuation of the switch programme, both for neonates 13 and non-neonates; is that right? 14 A. Yes. Mr Dhasmana. 15 Q. I appreciate the switch programme for non-neonates 16 started before you arrived in Bristol. 17 A. Yes. I think it started in 1988. I arrived in October 18 1991. 19 Q. The neonatal switch programme started in January 1992, 20 so after your arrival; is that right? 21 A. I think that is correct, yes. 22 Q. So you must have been involved in general on discussions 23 on both neonatal and non-neonatal switch programmes? 24 A. Yes, in general. 25 Q. If we go to Dr Bolsin's statement, please, WIT 80/1, we 0053 1 can see there that he says that during 1989 the unit 2 commenced arterial switch operations, and he says he 3 believed it was to maintain a favourable comparability 4 with other supra-regional and non-designated paediatric 5 cardiac surgical centres. 6 I think, Dr Underwood, we have reached an 7 appropriate moment for a break. We have mentioned 8 already that we will be breaking to observe the two 9 minutes' silence. 10 THE CHAIRMAN: We will save that question until after the 11 break. May I ask you to rise with us and observe two 12 minutes' silence in the memory of those who have fallen 13 in war? 14 (Two minutes' silence observed) 15 MISS GREY: Until 11.15, sir? 16 THE CHAIRMAN: Yes, until 11.15. 17 (11.02 am) 18 (Short break) 19 (11.20 am) 20 MISS GREY: Dr Underwood, I was asking you about discussions 21 about switch procedures generally, and I think you 22 answered that you had been involved in discussions. 23 Does that need qualification in any way? 24 A. It might do to confirm that as an anaesthetist doing the 25 switch procedures, particularly with Mr Dhasmana, 0054 1 I would have multiple conversations with him and 2 discussions about individual cases, but I was not 3 involved in a management sense in planning a switch 4 programme. 5 Q. We will come back to that in later detail, but for the 6 moment can you look at WIT 80/1 on the screen, where 7 Dr Bolsin suggested that the unit commenced arterial 8 switch operations, which he believed was to maintain 9 a favourable comparability with other supra-regional and 10 non-designated paediatric cardiac surgical centres. 11 He dates that to 1989. You were not involved in 12 any of those discussions? 13 A. No, I arrived in 1991. 14 Q. If we go on, he says at (b) that he believes that to 15 have suspended the arterial switch operation or 16 programme in the competitive environment would have cost 17 the unit a considerable amount in top-sliced funding and 18 that this put considerable pressure on the unit to 19 continue to provide the arterial switch procedure, 20 amongst others, he suggests, and he thinks may well have 21 contributed to the excessive mortality in the operations 22 undertaken. 23 Leaving that last part of his evidence aside, the 24 excess of mortality, are you aware of any discussions 25 which linked continuation of the switch programme, after 0055 1 October 1991, after you arrived, to factors relating to 2 funding? 3 A. No, I am not aware of any discussion involving funding 4 and the switch procedures. 5 Q. If such a discussion had taken place you necessarily 6 have been aware of it? 7 A. No, I would not necessarily have been aware of it. 8 Q. I have asked about discussions. At any time in your 9 discussions with Mr Dhasmana on particular switch 10 procedures, did you gain any impression that issues 11 related to funding or the prestige of the centre might 12 be important in continuing the arterial switch 13 programme? 14 A. My discussions with Mr Dhasmana would have been, were 15 indeed, purely clinical. They were discussions that an 16 anaesthetist has with a surgeon about many cases. But 17 did not ever refer to funding. 18 Q. What about issues of prestige or the importance of being 19 able to do procedures that other centres were known to 20 be doing? Was that ever a factor in discussion? 21 A. I do not think that was a factor in discussion. The 22 discussion was purely clinical and would be a discussion 23 about a particular patient with what lessons we may have 24 learned from such a patient and how we might proceed 25 with the next individual patient. 0056 1 Q. Going back to your statement, then, please, at page 6, 2 scrolling down, please, to issue C4, you talk about the 3 difficulties of making comparisons when looking at small 4 groups of patients in the paediatric cardiac surgery 5 group, and you say that because they are small, it is 6 difficult to make comparisons with the national 7 register. 8 If you just hold in your mind that part of your 9 evidence, and then go on, please, to page 10, issue M6, 10 you say there you vaguely recall on two occasions being 11 shown, in the Anaesthetic Department, your paediatric 12 cardiac surgery data alongside national data. This was 13 not in a regular audit meeting. 14 Were those the only occasions when you saw data 15 for the paediatric cardiac service as a whole set 16 against national data? 17 A. I believe that they were, yes. 18 Q. So if we turn back to issue C4, page 6, you make 19 comments on the difficulty of these sorts of 20 comparisons. Is it right that you saw an attempt to 21 make them only on two occasions? 22 A. I think that on two occasions I saw the annual return 23 figures. 24 Q. Were there any other attempts that you are aware of, 25 prior to the arrival of Dr Hunter and Professor de Leval 0057 1 in January or February 1995, to collect figures for the 2 unit as a whole and to make comparisons with national 3 averages? 4 A. I was aware that Dr Bolsin was collecting some data on 5 paediatric cardiac patients. 6 Q. But you did not see it, you say? 7 A. I did not see it. 8 Q. So attempts that you yourself were involved in are 9 restricted to two that you have spoken of under issue 10 M6; is that right? 11 A. They were occasions when I saw the data from the unit, 12 yes. 13 Q. Before January 1995, you had been in the unit for 14 something in the region of 3 and a half years? 15 A. Yes. 16 Q. Is that an adequate assessment or evaluation of outcomes 17 to be involved in? 18 A. I think I was not in any way in charge of audit. I did 19 not have any responsibility to the unit as a whole in 20 that sense, so that what I saw was only at an individual 21 level, if you like. 22 I used to attend the audit meetings and you will 23 know from my statement they developed over the years, 24 but -- 25 Q. The audit meetings for the Anaesthetic Department? 0058 1 A. I was going to say, they were at the same time as the 2 Cardiac Department and in my first years I would attend 3 the Anaesthetic Department audit meetings. 4 There were no minutes that I received of the 5 meetings that occurred in the Cardiac Unit. 6 Q. In the first years; what about the later years? 7 A. The much later years I attended the cardiac surgery audit. 8 Q. What do you mean by "much later"? 9 A. More recently, and I am trying to think whether that 10 would be before 1995. I think maybe not. 11 Q. Mr Bryan seems to recollect your attending such 12 meetings, the cardiac surgical audit meetings, in 1994 13 or thereabouts. Do you have any recollection of that? 14 A. It is possible that I went to something because when 15 there was audit afternoon set aside by the hospital for 16 audit, I would always attend one or the other. I would 17 try to find out what was to be discussed and make 18 a judgment which would be the more useful for me to 19 attend. 20 Q. But going back to the previous answer, you said that on 21 an individual level, you were aware of some outcome data 22 for the unit as a whole being seen by you on two 23 occasions? 24 A. Yes. 25 Q. You have made the point that you had no formal 0059 1 responsibility for audit. But you have told us earlier 2 that you were aware that concerns were being expressed 3 about outcomes in the unit? 4 A. Yes. 5 Q. Was seeing the data on those limited number of occasions 6 adequate? 7 A. I would have preferred it if we had had one database to 8 collect all the data and indeed, that is what we have 9 now, but it is an extremely time-consuming and difficult 10 job to set that up, and not one which an individual 11 anaesthetist at that time was probably able to do. 12 I remember that when concerns were expressed, 13 particularly by Dr Bolsin on one occasion, which 14 I mention later in the statement, that the cardiac 15 anaesthetist present, including myself, pressed him to 16 bring some data for us to look at. 17 Then when I later knew that he was collecting 18 data, I kept assuming that he would present it in 19 a forum where it was free for everybody to see, and 20 I think that month by month I kept thinking that that 21 would be soon appearing. 22 Q. Going back to C4, you point out the difficulties in 23 making comparisons when numbers of patients in each of 24 the neonatal and paediatric groups was small? 25 A. Yes. 0060 1 Q. When you saw data, on two occasions you say, leaving 2 aside Dr Bolsin's audit, was the data broken into groups 3 that were small? How was it broken down? 4 A. My recollection is that it was broken down into the 5 categories of -- possibly of the Cardiac Surgery 6 Register, but there were few numbers in each group, yes. 7 Q. So was the result that you could never tell whether the 8 results were acceptable or not? 9 A. I think it meant that we, or perhaps it is fairer to say 10 "I" felt that Bristol would not have been the top 11 performing centre in the country, but it was not clear 12 from the data that I saw that it would be outwith the 13 group, centres within the country. 14 Q. Where did the data come from on those occasions? Was 15 it from the surgeons? 16 A. I do not recall who showed it to me on the first 17 occasion, but I think on one occasion Dr Monk had some 18 papers, including this particular piece that I have in 19 mind, and that he showed me, and he sat down and looked 20 down the columns at the operations to have a look at 21 it. 22 I think he probably brought it from the surgeons, 23 but I do not know. 24 Q. Can you help us on the date of that incident? 25 A. No, I racked my brain when I was writing my statement to 0061 1 try to do that, but I cannot. 2 Q. Does that apply to the other incident as well? 3 A. I think the other incident was prior to it, but again, 4 I cannot recall when it was. 5 Q. The second incident you have told us was a discussion 6 between yourself and Dr Monk? 7 A. Yes. 8 Q. Was there anyone else there? 9 A. Not to my recollection, no. It was in the Anaesthetic 10 Department. 11 Q. And the other occasion, possibly earlier: who was there 12 on that occasion? 13 A. I do not recall who was there on that occasion. 14 Q. So you remember data being seen by you? 15 A. Yes. 16 Q. Can you not remember whom you got it from on that 17 occasion? 18 A. No, I cannot. 19 Q. You have pointed out the difficulties of data analysis. 20 Can you remember any discussion on how the data you did 21 see on those two occasions was presented and whether it 22 could be examined in a more meaningful way? 23 A. No. I think because it was presented in the way that 24 the Cardiac Surgery Register apparently required it, 25 that that was the only point, really, about the 0062 1 presentation of the data. 2 The audit meetings that developed would have 3 included discussion on morbidity and mortality of 4 individual patients, but I do not remember it being 5 until much later that statistics of the whole unit's 6 performance were presented in an audit meeting. 7 Q. You are saying in effect there that any data that you 8 did see did not allow meaningful comparison; is that 9 correct? 10 A. It puts our data alongside such national data as was 11 available at the time. In that respect, the fact that 12 my memory was that in some categories our figures were 13 worse and some better, in that sense it seemed 14 a reasonable comparison at the time. 15 Q. Was that a comparison which related to the results for 16 one year only, or were the groups being aggregated over 17 a longer period? 18 A. My recollection is that on each occasion it was only the 19 annual figures that I saw. 20 Q. Was that enough, therefore, to allow adequate 21 comparisons with the national register? 22 A. In retrospect, and judging by the level of audit that 23 I would now consider suitable, it would have been 24 lacking in that. 25 Q. At the time were you aware of those deficiencies? 0063 1 A. At the time I was pleased to see our figures set against 2 some other figures, because prior to that I only had my 3 diary record and the discussions with anaesthetists in 4 coffee rooms and anaesthetic departments as to what was 5 going on. So I was pleased that I had seen some results 6 from my unit, set aside some other results which had 7 some weight to them. 8 Q. What conclusions did you draw from the comparisons? 9 A. As I said, my recollection is that in some categories we 10 were better, in we were some worse. Because the numbers 11 were very small, it was difficult to know whether the 12 areas in which our results were not as good were 13 a matter of chance or a matter of concern. 14 Q. But what I am seeking to press you on is, if the data, 15 when aggregated for a year only, was not such as to 16 enable you to draw comparisons, did you not say to 17 yourself, "We need to see more data aggregated over 18 a longer period of time in order to see whether more 19 reliable conclusions or wider conclusions can be 20 drawn"? 21 A. I think if I had been in charge of audit, that would 22 have been a reasonable question to ask and a reasonable 23 line to pursue, but in fact, in my daily work as 24 a cardiac anaesthetist, keeping my own record, I felt 25 pleased that there were people in the department who 0064 1 were collecting fuller data. I was reassured by the 2 fact that the surgeons were returning annually their 3 data to the National Cardiac Surgical Register, and 4 I took in audit as it developed in the unit. 5 Q. But this is coming against a background in which, as you 6 say later in your statement, Dr Bolsin expressed 7 concerns about the performance of the Paediatric Cardiac 8 Surgery Unit from the time you arrived in Bristol. 9 In those circumstances, is it enough to say that 10 others had the responsibility for audit and therefore it 11 was enough to have seen these figures? 12 A. I think it has to be set in the context of the whole 13 department, perhaps, as well. If somebody makes 14 a concern, then I would say that they have some duty to 15 try and elucidate that, particularly to gain support, 16 and to either confirm or deny the concern. 17 I was involved in anaesthesia for a number of 18 different procedures in different groups of patients, 19 and I do not think it would be feasible for me to make 20 an audit of all the children in the Dental Hospital and 21 of the patients on my other lists and so on, so I was 22 a supporter of the increasing interest in audit and 23 always completed any audit data that was requested of me 24 in order to try and assist the unit to do their audit 25 procedures, but I was not instrumental myself in 0065 1 producing such an audit. 2 Q. In relation to pre-operative care, turning to later 3 issues in your statement, it was the case that meetings 4 were held at the Children's Hospital to assess the 5 management of children, if surgery would be appropriate 6 and when. 7 Were you able to, or did you ever attend those 8 case conferences? 9 A. No, I never attended those at the Children's Hospital. 10 Q. Dr Scallon, can I turn to you on this? Would it be 11 normal to have anaesthetic input into these sort of case 12 conferences? 13 DR SCALLON: From my experience, most units did not attend 14 these sorts of case conferences. 15 MISS GREY: If we look at UBHT 84/177, it gives us the 16 reference: Cardiac Services Management Board meeting on 17 Monday, 25th October 1993. 18 Over the page, back again, please, we can see 19 there that there is a discussion on throughput through 20 the unit. You are minuted as saying you need to address 21 efficiency issues throughout the whole system and 22 improving entry to the system was important, but it 23 would not work if it resulted in blocked beds in ITU due 24 to case selection. 25 What was the issue of case selection that you were 0066 1 discussing there? 2 DR UNDERWOOD: I am just reading it. (Pause) If I remember 3 rightly, this was the first or one of the first meetings 4 of this group, so I think it was one of the first times 5 that a cardiologist in the form of Dr Pitts-Crick had 6 been present at these management meetings. 7 My recollection is that we were discussing 8 generally throughput through the intensive care and that 9 it was helpful for me to point out that the cardiologist 10 had some influence on the bed situation in intensive 11 care in that if we did a run of emergency or urgent 12 patients, they could be expected to be in intensive care 13 a little longer than the routine patients, and this 14 could result in a blockage in intensive care causing 15 cancellation of other operations. 16 I was keen to explain that, because I felt that 17 the cardiologists may not have appreciated that there 18 were blockages occurring further down the line, and 19 I think it probably followed discussion about the 20 cardiologist passing work to the surgeons and maybe 21 about the balance of urgent and emergency patients and 22 patients who had been waiting in hospital and so on. 23 Q. Was there any concern over case selection in the sense 24 that there was a feeling that cases were being selected 25 for operation which should not have been because, for 0067 1 instance, the case was really too dire to be amenable to 2 surgical correction? 3 A. I think in general their decision about which case 4 should be selected for operation is made between the 5 cardiologists and the cardiac surgeon, and perhaps 6 including the general practitioner, but not the 7 anaesthetist. 8 Q. I appreciate it is not a matter for the anaesthetist to 9 select that, but nevertheless, in general discussions 10 amongst colleagues, had that been an issue of concern in 11 any way? 12 A. I do not think that was a particular issue here. 13 Q. Dr Pitts-Crick is an adult cardiologist? 14 A. Yes. 15 Q. Were there any issues or concerns that you can remember 16 relating to case selections for children? 17 A. No, I do not remember any discussion on children's case 18 selection. 19 Q. If we go back to page 7 of your statement, please, at 20 issue F6 you talk there about your experience of 21 operating as part of a team in theatre. 22 You mention there that your experience had been of 23 shorter operations in cardiopulmonary bypass times, and 24 you were particularly concerned when circulatory arrest 25 times exceeded 45 minutes. 0068 1 Why was that a point at which your concerns would 2 be particularly raised? 3 A. During my training it was emphasised that that could be 4 associated with poorer outcome, and this was the figure 5 that had stuck in my mind from my training time. 6 Q. So it is a rough rule of thumb, is it? 7 A. I would say that is fair, yes. 8 MISS GREY: Dr Scallon, would you like to come in on that? 9 Is there a point at which a concern would be 10 particularly raised? 11 DR SCALLON: I think circulatory arrest is essential in some 12 operations, but it does carry a price. The short answer 13 is that the less circulatory arrest you have, the 14 better. What is considered to be a reasonable period of 15 circulatory arrest? Well, 45 minutes is generally 16 accepted as a reasonable period, but it by no means 17 means that 44 minutes is okay and 46 minutes is 18 unsatisfactory. The risk of damage to various organs 19 increases with the longer duration of circulatory 20 arrest, and the organ most of at risk of damage is the 21 brain. 22 Q. So 45 minutes might be a rough point at which concerns 23 might be triggered as a rough rule of thumb, but it has 24 no particular special magic? 25 DR SCALLON: No special magic, no. 0069 1 Q. If we look at INQ 16/22 we can see at paragraph 5.8 that 2 the reviewers saw relatively long cross-clamp times and 3 circulatory arrest times. "Such times would be unusual 4 in the current era but not necessarily so in the past." 5 What was your perception of the comparison between 6 Bristol and Great Ormond Street at the time? 7 DR UNDERWOOD: I think it is hard -- well, it is impossible 8 to answer without imposing some of the thoughts I had in 9 intervening years, but my memory at the time is that 10 I felt that the operations were longer and that the 11 cross-clamp times tended to be longer than I had been 12 used to at Great Ormond Street. 13 I did discuss that with my colleagues as I have 14 written, and I do understand that the operation must be 15 completed technically very carefully and very well, 16 otherwise obviously a disaster is likely, so that taking 17 a cross-clamp time out of context may be unhelpful. 18 Q. So when you say in your statement that you discussed 19 this with your colleagues, both anaesthetic and 20 surgical, on an informal basis, was that the response 21 that you had firstly from the surgeons? 22 A. Yes. A surgeon would discuss with us anything that we 23 wished to ask about the operation, really, and in saying 24 that I felt that cross-clamp times were a bit longer 25 than I was used to, I do not remember specific 0070 1 conversation, but I recall general conversations in 2 which we would discuss the fact that the technical 3 completion of the operation is of paramount importance 4 and that if that resulted in a slightly longer 5 cross-clamp time, so long as the myocardium was properly 6 protected, that could be a sensible way of proceeding 7 with the operation. 8 Q. Dr Pryn, in giving evidence, was drawing comparison 9 between Mr Pawade and Mr Wisheart and Mr Dhasmana in 10 terms of speed of surgery. 11 Did you have an opportunity to observe Mr Pawade 12 in the operating theatre? 13 A. I did anaesthetise for Mr Pawade on a number of 14 occasions, yes. 15 Q. Did you find him to be a quicker surgeon? 16 A. My general impression would have been that the 17 operations he did were shorter, but I have not compared 18 the types of operations that we were doing at that 19 time. I worked with him only from June until December 20 1995. 21 Q. So you are saying you have not studied the case mix at 22 the time? 23 A. I have not studied the case mix. 24 THE CHAIRMAN: Professor Jarman wishes to ask a question. 25 PROFESSOR JARMAN: Relating to the cross-clamp times, you 0071 1 have said if the myocardium is protected, maybe it is 2 not such a bad thing if they are too long. But what 3 about the point that Dr Scallon has just raised with 4 regard to the effect on the brain? Could a longer 5 cross-clamp time affect the brain while not affecting 6 the heart if it is properly protected? 7 A. The cross-clamp time would not be related to the 8 neurological outcome really, because the circulation 9 would be maintained by the perfusionists to the body, 10 all except for the myocardium. 11 MISS GREY: Dr Scallon, would you like to comment on that? 12 DR SCALLON: The cross-clamp time refers to the time when 13 the heart is not being supplied with blood. It does not 14 follow that the rest of the body is not being perfused 15 at that time, so they are really separate issues. 16 PROFESSOR JARMAN: So it is really only a question of the 17 time of cardiac arrest we are dealing with, circulatory 18 arrest? 19 A. Yes. 20 THE CHAIRMAN: Bypass time. 21 DR SCALLON: The cross-clamp time refers to the period when 22 the myocardium is not getting blood. The circulatory 23 arrest time refers to the time when the whole body is 24 not being perfused. The bypass time is when the heart 25 is being perfused by the cardio pulmonary bypass 0072 1 machine. 2 MISS GREY: So the concern about brain damage relates to the 3 period of circulatory arrest, rather than the period of 4 the time when the heart alone is not being perfused? 5 DR SCALLON: They are independent, yes. 6 MISS GREY: If we look back again at paragraph 5.8, the 7 clinical case reviewers said that such time would be 8 unusual in the current era, but not necessarily so in 9 the past. 10 Dr Scallon, you reviewed the notes as part of the 11 exercise. Can you help us what the "past" meant, 12 because here we are looking at a period from 1991 13 onwards and the comparison is being made with Great 14 Ormond Street. Are you able to help us as to whether or 15 not it might have been felt by the team that by October 16 1991 onwards, the cross-clamp times and bypass times 17 were long in Bristol? 18 DR SCALLON: I think the general impression was that the 19 cross-clamp times and bypass times were much longer in 20 Bristol than elsewhere. 21 "Such times would be unusual in the current era, 22 but not necessarily so in the past"? I am not sure 23 I entirely agree with that. I think as surgery has got 24 better, so it has become better, so operations tend to 25 be faster, but I do not think there is a major 0073 1 difference. 2 Q. Just coming back to your answer, what we have on the 3 transcript was that you said "I think the general 4 impression was that the cross-clamp times and bypass 5 times were much longer in Bristol than elsewhere"; is 6 that correct? 7 DR SCALLON: Yes. 8 MISS GREY: Dr Pryn in giving evidence -- I am looking at 9 WIT 341/23, paragraph 11, please -- referred to the 10 children needing higher amounts of inotropic support 11 after cardiopulmonary bypass than he was accustomed to. 12 Was that something that you were aware of? 13 DR UNDERWOOD: I do not remember it striking me when 14 I arrived in Bristol. I had seen some children on 15 little support and others on a lot of support in my time 16 at Great Ormond Street and I continued to see that in 17 the BRI, some requiring a lot and some not, so it was 18 not something that struck me in the same way that it 19 appears to have struck Dr Pryn in that statement. 20 Q. Did you ever have any conversations about such a subject 21 with Dr Bolsin? 22 A. I do not remember discussing inotropic support with 23 Dr Bolsin particularly. 24 Q. If we go back to the clinical case review, please, at 25 INQ 16/12, and scroll to "Perfusion", we can see that 0074 1 one of the most frequent comments concerned acidosis, 2 i.e. an unacceptable buildup of acid in the patient 3 during the operation. 4 Dr Scallon, can you help us on the significance of 5 this observation? 6 DR SCALLON: The development of acidosis suggests inadequate 7 perfusion of the tissues and therefore abnormal 8 metabolism. A degree of acidosis is almost inevitable 9 during the course of cardiopulmonary bypass, and again, 10 the longer the bypass, the more likely you are to get 11 this acidosis. Bypass is physiologically an abnormal 12 method of perfusion. Periods of circulatory arrest are 13 inevitably associated with acidosis, as are periods of 14 low flow, although in that situation the degree of 15 acidosis may be less. 16 Q. Does it follow that if the circulatory arrest times are 17 long, the danger of an increased amount of acidosis is 18 greater? 19 A. That is correct. 20 Q. So is there any link, then, between the observation of 21 long bypass times and cross-clamp times and the 22 observation that there was a greater degree of acidosis 23 than might otherwise be expected? 24 A. I think that is a reasonable conclusion. 25 Q. What is the responsibility of the anaesthetist if 0075 1 acidosis has occurred? 2 A. There are two things. One is to try and prevent its 3 development and that is to try and maintain an adequate 4 perfusion, the need for circulatory arrest, the need for 5 low flow may prevent that at a particular time. The 6 other thing is to correct the acidosis when it develops, 7 to give appropriate medication to reverse the acidosis. 8 Q. Dr Underwood, were you aware of perhaps higher instances 9 of the build-up of acid in patients undergoing surgery 10 at Bristol? By that I mean children. 11 A. Yes -- I am sorry, I mean "yes" to the children part of 12 the question. I do not remember it striking me when 13 I arrived, but along with Dr Scallon, I agree that one 14 of its main causes is low flow and so on, and sometimes 15 that is necessary for surgery. 16 I also found that in Bristol, perhaps slightly 17 differently from my experience in Great Ormond Street -- 18 there again, it is a long time ago to be sure -- the 19 perfusionists who were in charge of the bypass machine 20 were, in the earlier days, reluctant to increase the 21 blood flow on bypass machine because of the damage that 22 that causes to the red cells and so on. 23 Later, when new perfusionists arrived, they 24 adopted what I considered to be the more modern approach 25 of increasing the flow further on bypass, and I think 0076 1 that the problem was less common after that. 2 DR SCALLON: That is absolutely fair. I think in the 3 earlier days, when the perfusion machines were more 4 traumatic to blood, there was a reluctance, as 5 Dr Underwood said, to push the flows. The tendency now, 6 it is accepted practice generally to try and maintain 7 high flows during the course of the bypass. 8 Q. Is this an issue, then, about the provision of 9 machinery, or changes of technique amongst the 10 perfusionists themselves? 11 A. It is both, really. I think it is both. 12 Q. If an unacceptable build-up of acid in the bloodstream 13 of a patient had occurred during operation, would that 14 have any lasting effect? 15 A. Perhaps the acid in itself would not, but the 16 implication that there has been inadequate perfusion and 17 therefore low grade damage to the tissues may well have 18 a lasting effect. 19 THE CHAIRMAN: Mrs Howard has a question. 20 MRS HOWARD: Dr Scallon, can I just take you back to the 21 perfusionists? Do perfusionists work autonomously and 22 independently in terms of decisions they make vis-a-vis 23 the discussion we have just been having, or would you 24 expect them to be working under the direct instruction 25 of an anaesthetist? 0077 1 DR SCALLON: A lot of the work of perfusionists is dedicated 2 to him, but he will work with the anaesthetist and will 3 discuss difficulties such as acidosis and what to do 4 about it. The ultimate responsibility must be with the 5 anaesthetist and with the surgeon. 6 MRS HOWARD: So if there were particular changes in the 7 acidotic state of the patient during an operation, would 8 the perfusionist be expected to make those decisions 9 himself as to changing matters, or would he or she be 10 waiting for a prompt from the anaesthetist? 11 DR SCALLON: It would depend largely on the local 12 arrangement. The perfusionist seeing that may well 13 recognise that there is a problem and try to increase 14 perfusion, but it may be in discussion with the 15 anaesthetist. 16 This all has to be taken in the context of the 17 operation and what is required by the surgeon to enable 18 him to do the operation. A higher flow will almost 19 invariably mean more blood in the operative field and so 20 may make the operation more difficult. So there is 21 a balancing act. 22 THE CHAIRMAN: I think Mrs Howard also has in mind that 23 in Dr Underwood's statement -- perhaps I can address 24 this to you, Dr Underwood. You talk in your statement 25 of sometimes, during an operation, going to do a ward 0078 1 round and coming back. Maybe Miss Grey will refer to 2 this later on. During that time, a trainee would be in 3 charge, as it were. 4 Could the sort of monitoring which Mrs Howard has 5 just been referring to, and the exchange between the 6 perfusionist and the anaesthetist, be less as it were 7 successful on those occasions? 8 A. Indeed, you raise a good point. In our department the 9 perfusionists are fairly autonomous, although I agree 10 with Dr Scallon they obviously work along with the 11 anaesthetists in maintaining the perfusion of the 12 patient during the operation. 13 They also receive a lot of instruction from the 14 surgeon who must have certain conditions in order to 15 complete the operation, so that my perception is not 16 that the perfusionist works for the anaesthetist in any 17 sense, but would indeed work with the anaesthetist in 18 many aspects. 19 You also raised the question of the anaesthetist 20 being absent during a period of bypass. This is not 21 ideal and in the climate of the time, meant a choice on 22 the part of the anaesthetist between those patients 23 upstairs and downstairs. On occasion, the ward round 24 did not get done because the patient in theatre needed 25 the anaesthetist, but it was more common, as I wrote in 0079 1 my statement, to do the ward round at that time. 2 MISS GREY: Dr Scallon, it might be an appropriate moment to 3 ask you whether, in your experience, that choice was 4 a common one for an anaesthetist, to have to choose 5 between doing a ward round or seeing a patient who 6 required attention in the ITU, and remaining in theatre, 7 at that time. 8 DR SCALLON: Yes, this dilemma did certainly arise. I have 9 certainly experienced it myself. During the course of 10 cardio pulmonary bypass it is undoubtedly a period 11 when the demands on the anaesthetist are less, because 12 a lot of the responsibility is dedicated to the 13 perfusionist, and the anaesthetist does not leave the 14 patient unattended; if the senior is not there, a junior 15 anaesthetist would be present. But it is symbolic of 16 some of the pressures of trying to run a service in the 17 theatre and to run a service in the Intensive Care Unit. 18 Q. We have touched upon this issue several times already 19 this morning. Perhaps it is an appropriate moment to 20 ask you for your comments on firstly the reasons why 21 intensivist sessions were developed in the late 1980s or 22 early 1990s? What was that a response to? 23 A. I think a lot of the issues that were raised before the 24 break by Dr Underwood outlining the difficulties of 25 management of patients in Intensive Care Unit were by no 0080 1 means unique to Bristol. It was a recognition of these 2 difficulties that undoubtedly played a large part in the 3 push towards dedicated paediatric cardiac intensivists. 4 As you rightly say, it is a relatively recent 5 development, 10/15 years ago we did not have dedicated 6 paediatric cardiac intensivists. 7 Q. So one of the pressures it is responding to is the need 8 to take either anaesthetists, but also perhaps surgeons 9 as well, out of theatre to look at a patient who 10 requires attention in ITU? 11 A. Correct. 12 Q. Dr Underwood, in theatre, was it a common experience to 13 find that the surgeons were confronted with anatomy that 14 they had not perhaps expected or visualised prior to the 15 operation? 16 DR UNDERWOOD: It would not be for me to comment exactly on 17 what they were expecting, what they saw. That would 18 have been more between them and the cardiologist, but it 19 was my impression that on occasion they were surprised 20 by some of the anatomy that they found. 21 Q. On occasion? How often can you remember that happening? 22 A. I would put it in the "from time to time" rather than 23 "regularly". 24 Q. When that happened, was it ever a response to call for 25 the cardiologist to come over and have a look? 0081 1 A. That was rarer; partly the physical problem of coming 2 from one hospital to another, but certainly, 3 cardiologists did come to theatre on occasion. 4 Q. So rarer but on occasion? 5 A. Yes. 6 Q. Can you help us as to how often it occurred within the 7 context of -- 8 A. In my recollection of the cases that I was personally 9 involved in, which would really be the only time I would 10 know if the cardiologists had been physically present, 11 probably a single figure number of times. 12 Q. And that obviously relates to the occasions when you 13 were anaesthetising? 14 A. Exactly. I would not necessarily know if the 15 cardiologist had come when someone else was 16 anaesthetising. 17 Q. You spoke about the split site. Were you aware of the 18 practical difficulties that might be imposed on 19 a cardiologist in coming over to theatre? 20 A. The whole issue of the practicality of the split site 21 was a major feature of the discussion I had with members 22 of the department before I took a job in Bristol, and 23 they were asking if I had any ideas of how to make two 24 hospitals into one even before I arrived. Obviously as 25 a Senior Registrar, I could not solve the problem, but 0082 1 it was already seen as a difficulty in a very practical 2 sense. 3 Q. Who raised it as a difficulty? Did you, or did they? 4 A. I think everybody knew that it was physically two 5 hospitals, and it was a topic around which there was 6 much discussion for a new member thinking of joining the 7 department. 8 Q. So when you discussed it you mean with anaesthetic 9 colleagues; is that right? 10 A. Particularly with anaesthetic colleagues. 11 Q. What was it suggested its effect was on patient care? 12 A. I think at that stage it was in a pre-interview 13 discussion and people were asking me what I would think, 14 whether there were potential difficulties, and those 15 would be of a very practical nature of not being 16 surrounded in a hospital by people with paediatric 17 interests who could assist in backing up if things 18 became difficult. 19 The expertise for cardiac surgery and cardiac 20 anaesthesia was at the BRI, but the other aspects of 21 paediatric care, general paediatric physicians, as well 22 as cardiologists and other paediatric facilities, were 23 based in a different hospital. 24 Q. You gave that answer, then, when you were applying for 25 a job. You could foresee it was a potential problem? 0083 1 A. Yes. 2 Q. After you had been in post for a few years, again always 3 looking prior to January 1995, what was your perception 4 of it as an actual problem? 5 A. I think it was an actual problem. But it was my 6 impression that before I arrived, and certainly from the 7 time I arrived, all debate was on trying to unify the 8 service in one site. In fact, in the period round about 9 the time of my appointment and until 1992, the 10 discussion revolved around the possible appointment of 11 a further paediatric surgeon. 12 Q. Those are, if I may say, the responses to the problem. 13 Can you help us on identifying the nature of the 14 problem? 15 A. I beg your pardon, yes. From my perspective, the 16 problem came particularly in intensive care. If 17 a patient became a long-term patient with multiple 18 problems, then the back-up that you would like was not 19 easily available. It was available by telephoning or by 20 asking colleagues up at the Children's Hospital, but to 21 explain that a bit further, if an adult patient had some 22 difficulty in intensive care and I would like some more 23 information, some more help with that, I can call on 24 a selection of adult physicians who can come readily 25 between their clinics or after their lists to assist me 0084 1 in intensive care and can pop in and out frequently in 2 the following few days. 3 That service is much more difficul