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Daily transcripts
Hearing summary
23rd November 1999
The Bristol Royal Infirmary Inquiry oral hearings this week centre on
the evidence of Dr Stephen Bolsin, former Consultant Anaesthetist, United Bristol
Healthcare NHS Trust (UBHT) and currently Director of Anaesthesia, Geelong Hospital,
Geelong, Victoria, Australia.
Dr Stephen Bolsin continued his evidence today by discussing his
presence at an audit meeting attended by cardiac surgeons, cardiac anaesthetists and
cardiologists in 1991. He explained that the minutes of the meeting he produced, which
noted the contribution of anaesthetic staff in recording mortality rates, were
subsequently withdrawn at the request of colleagues and he was asked not to produce
minutes of such meetings in future. He then commented on the records of specific audits
undertaken within paediatric cardiology, which recommended various courses of action to
improve outcomes for surgical procedures. Dr Bolsin, together with Dr Ted Sumner,
Consultant Anaesthetist, Great Ormond Street Hospital, and member of the Inquiry’s
independent expert group, discussed the case of Melissa Clarke, who died following complex
cardiac surgery in 1991. They concentrated their debate on the post operative management
of care in the Intensive Care Unit at the Bristol Royal Infirmary. He concluded by telling
the Inquiry about contact he had in 1992 with Dr Phil Hammond, then a trainee GP, one half
of the satirical comedy double act "Struck off and Die" and columnist with
Private Eye Magazine. He confirmed that he discussed his concerns about mortality rates
for paediatric cardiac surgery with Dr Hammond.
Today’s hearing was attended by Dr Ted Sumner, Consultant
Anaesthetists, Great Ormond Street Hospital and member of the Inquiry’s independent
expert group.
Dr Bolsin’s evidence continues tomorrow morning at 9.30 a.m.
|
FULL TRANSCRIPT
1 Day 81, Tuesday, 23rd November 1999
2 (9.40 am)
3 DR STEPHEN BOLSIN (RECALLED):
4 Examined by MR LANGSTAFF:
5 THE CHAIRMAN: Good morning, everyone. Good morning,
6 Mr Langstaff.
7 MR LANGSTAFF: Good morning, sir. Good morning, Dr Bolsin.
8 I am sorry for the slight delay in starting this
9 morning. By way of explanation, there are two reasons
10 for this: one is that there were discussions between
11 legal representatives and myself and, as you know, this
12 is part of the process by which we are informed as to
13 matters that a witness may wish to be put or people may
14 wish to have put to a witness. I mention it simply to
15 remind those who may not be legal representatives that
16 they of course, too, have the right to catch the ear of
17 Miss Grey if there is a particular matter which concerns
18 them which we feel we might wish to ask about.
19 The second reason was that Dr Sumner who now has
20 come and sits to my right, is someone who was
21 unfortunately delayed by the absence of a Great Western
22 train this morning and as a result did not arrive in
23 Bristol from London at the time he had anticipated.
24 With that introduction, Dr Sumner, perhaps we had
25 better ask you to take the oath in the usual pattern.
0001
1 You have been here before.
2 DR EDWARD SUMNER (SWORN):
3 THE CHAIRMAN: Good morning also to you, Dr Sumner.
4 MR LANGSTAFF: It is likely I think that Dr Sumner's
5 involvement will become much greater after the break
6 which this morning I anticipate we shall have at 11.00
7 for about a quarter of an hour, 20 minutes, when we will
8 continue until round about 1.00 when today's hearing is
9 scheduled to close.
10 Can we begin, Dr Bolsin, by picking up where we
11 were yesterday. May we have on the screen, please,
12 UBHT 61/146. Can we scroll down please. This is the
13 meeting of 28th July 1991 at Mr Wisheart's house with
14 a "Paediatric Cardiac Surgical and Anaesthetic Group"
15 is what it is labelled. Your minutes of the meeting.
16 You have referred there to tables. You have had
17 a chance overnight to look at the tables. Were those
18 tables to which reference was made at this meeting?
19 A. I think they were, yes. There are two sets of tables,
20 one for 1990, the summary here, and I think some for
21 1989 and I think probably the 1990 were the data
22 presented.
23 Q. Can you help me with the words in the first paragraph:
24 "Mr Wisheart said that he thought the tables
25 demonstrated that the problem which had been thought to
0002
1 have been reaching crisis proportions in the Bristol
2 unit, when put in context, was actually not as serious
3 as had been thought."
4 You are there reporting what Mr Wisheart was
5 telling the meeting. Is that as you recollect it,
6 prompted by your own notes here, what he said?
7 A. Yes, what that refers to is that in 1989 the results for
8 that year demonstrated that for open heart surgery under
9 1 year we had a mortality rate of 33 per cent which was
10 twice the national average and that was data which you
11 showed us yesterday on the screen.
12 Q. I think to be fair to you, Dr Bolsin, what we had seen
13 for 1989 was that the data for that year was
14 37.5 per cent. What you are now referring to is the
15 period 1984 up until 1989 inclusive, is it not?
16 A. The column I am looking at is headed "1989".
17 Q. In that case I must stand corrected.
18 A. But it is the handwritten note of Mr Dhasmana, so I am
19 not sure. I am probably more willing to be corrected by
20 you than you by me.
21 Q. The broad figures make the point?
22 A. Yes.
23 Q. Let us go on.
24 A. I think what that was referring to was the fact in the
25 preceding year there had been this very clearly
0003
1 expressed concern which had got to the level of the
2 District General Manager about a national average
3 mortality in the under 1 years -- mortality at Bristol
4 which was twice that of the national average and we now
5 had figures presented at this meeting for the first time
6 in which the mortality rate had dropped down to
7 12.8 per cent, so probably a third really of certainly
8 the figure you gave me just now.
9 This was very reassuring and I think that moves us
10 into paragraph 2 where we are talking about this
11 vindicating the vigilance of the anaesthetic staff in
12 recording their mortality data and Dr Masey and I both
13 recorded our mortality data in logbook form and also
14 minuted there "vigorously pursuing requests for
15 a combined meeting".
16 Q. The third paragraph follows on, does it, in saying "We
17 brought the mortality rate down" -- this seems to be the
18 sense of it from what you are saying?
19 A. Yes.
20 Q. " -- brought the mortality rate down and one of the
21 reasons for this has been first of all looking at the
22 data as the anaesthetist would encourage us to do and
23 secondly the improvements we have made in post-operative
24 management and operative management which have enabled
25 us to do this."
0004
1 There is an element of self-congratulation which
2 one would expect given those results?
3 A. Yes.
4 Q. At this stage in July 1991, looking at the results in
5 general, leave aside particular operations, but the
6 results in general, there was a degree of satisfaction
7 at what had been achieved over the past year, was there?
8 A. There was a degree of satisfaction on my part. I think
9 we come back to the point that these minutes were not
10 accepted by the group, but certainly what I wanted to
11 document was my satisfaction at having identified
12 a problem which may have been of crisis proportions or
13 certainly close to, that vindicated the vigilance of the
14 anaesthetic staff in recording their mortality data and
15 asking for meetings and that this seemed to have
16 improved the mortality rate.
17 Q. Tell me, was it phrases such as "vindicated the
18 vigilance" and "vigorously pursuing" that perhaps led to
19 this record not being accepted in the form it was
20 offered?
21 A. It is a very long minute, it goes over three or four
22 pages and I am not sure what it was about the minutes
23 that were particularly offensive to the people who
24 objected to it to me, which were Mr Wisheart and
25 Dr Masey. What I was trying to do was encapsulate
0005
1 a meeting that probably went over three or four hours
2 and I felt they were useful phrases in encapsulating the
3 feelings that certainly I was expressing and I thought
4 I was capturing in other people at that meeting.
5 Q. What if any objection did you hear expressed to
6 "vindicated vigorously" and phrases of that sort?
7 A. I do not think any particular phrases were picked out,
8 I think it was "We do not want this minuted and we do
9 not want you to take minutes in future", that was the
10 message that I received from Dr Masey and Mr Wisheart.
11 Q. The comment might be made, and I make it for you to
12 respond to, that by the way in which this is drafted,
13 although it may reflect a discussion it may nonetheless
14 be seen by those who read it to have an element of the
15 provocative about it; do you want to comment or not?
16 A. I do not think it is particularly provocative in view of
17 the historical context in which the data that was
18 presented at the meeting was placed. If you say "Here
19 is a mortality rate twice the national average, here is
20 a mortality rate that is a lot better", certainly
21 something has to be vindicated in bringing down that
22 rate and if it happens to have been the anaesthetists
23 who believed that their data collection has helped them
24 to achieve that fall in mortality rates along with other
25 changes in management, which are discussed later in the
0006
1 minutes, then I would not see that as being provocative,
2 I would see that as what you said earlier on, as being
3 self-congratulatory and I would allow that group to be
4 self-congratulatory.
5 Q. Can we go on to UBHT 61/149. Before I do, can I look at
6 WIT 80/319. It is not your statement but it is a
7 comment on it. Go to the foot of it. This is
8 Mr Wisheart's recollection:
9 "I do recall the unease with which his minutes of
10 the meeting of the 28th July 1991 were received ... At
11 the subsequent meeting as I remember it, this was
12 expressed by his anaesthetic colleague or colleagues but
13 not by me, although I did not agree with them. The
14 reason for unease was that the minute contained
15 a partisan element which had not been present at the
16 meeting. To describe this incident as a 'rebuff'
17 leading to the conclusions referred to above, is to
18 magnify a minor incident out of all proportion."
19 What is your comment on that?
20 A. Mr Wisheart obviously has a good memory for minor
21 incidents and I think that being asked not to take
22 minutes again of that type of meeting is more than just
23 a minor incident, that is actually a major change in
24 policy and I think that to me could be interpreted as
25 a rebuff.
0007
1 I think we are moving into the area of semantics
2 but here we have the senior paediatric cardiac surgeon
3 saying that he remembers there was some unease at that
4 meeting about the taking of minutes or the future taking
5 of minutes and I think that confirms what I said, which
6 was that I believe I was seriously ordered not to take
7 minutes of future meetings.
8 Q. Can we move on to UBHT 61/149. This is part of your
9 minute. It is under the heading "problem operations".
10 What we see, looking at the minutes as a whole, is two
11 problem operations: tetralogy of Fallot and AVSD were
12 looked at some detail, were they not?
13 A. It would appear so.
14 Q. So far as this is concerned, the problem that seems to
15 be identified by Mr Dhasmana in the second paragraph is
16 that some of the specific deaths which had occurred, it
17 appears, if what Mr Dhasmana said is faithfully
18 reported, "the information provided was just not good
19 enough with specific reference to the pulmonary artery
20 anatomy and the coronary anatomy".
21 If we go on down the page, six lines down in the
22 last paragraph. Three lines below that we see "He also
23 went on to say that, in his experience, deaths had been
24 associated with low cardiac output, renal failure and
25 pulmonary insufficiency, probably related to coronary
0008
1 artery anatomy not being well demonstrated" and the
2 suggestion made that the cardiological investigation
3 should improve.
4 That was the general conclusion, was it, so far as
5 tetralogy of Fallot was concerned?
6 A. Yes. Can I say that Mr Dhasmana never disagreed with
7 these minutes so that in the paragraph that we have
8 scrolled past I was never told by Mr Dhasmana that he
9 believed they did not represent what he had said.
10 Q. I think the suggestion is not that the minutes were
11 wrong, but that the minutes were partisan or they
12 descended to hyperbole, whereas minutes are
13 conventionally fairly anodyne records of what has
14 occurred; that I think is the suggestion?
15 A. The suggestion from --
16 Q. From Mr Wisheart, as I read it.
17 A. (Witness nodding).
18 Q. There is no challenge as I understand it to the
19 accuracy, just the expression of the minutes; that is
20 the point. The suggestion that is made is that the way
21 that this is put is not helpful as minutes.
22 A. (Witness nodding). I think I would have to disagree.
23 I think if somebody says at a meeting "This is simply
24 not good enough" I think that is probably a phrase that
25 is worth documenting. I personally do not necessarily
0009
1 support the production of anodyne minutes, I produce
2 minutes which reflect the conclusions and the opinions
3 expressed at the meeting and I think that is just me and
4 my minute taking. I think if you want me to change my
5 minute taking, fine, tell me what you think is wrong
6 with my minutes, but do not say "We do not want these
7 meetings minuted" or "We do not want these meetings
8 minuted by you".
9 Q. It was the latter you told us was the consequence of the
10 discussion of the minutes at the next meeting. I do not
11 know, were you at the next meeting when this was raised
12 and discussed?
13 A. To be quite honest with you, I cannot remember whether
14 I was or not. I thought, this is purely from
15 recollection, that I was approached outside of the
16 meeting by Dr Masey and Mr Wisheart separately.
17 Q. In any event if we go to page UBHT 61/150 on the AVSD,
18 the top of the page:
19 "Mr Wisheart said that, in view of the Melbourne
20 and recent Great Ormond Street experience, these
21 patients should be operated on at a younger age."
22 That proposal it appears was accepted:
23 "Mr Dhasmana reviewed his cases ..." and there was
24 discussion about anaesthetic and post-operative
25 management and so on.
0010
1 If we go down to the bottom of that page, the date
2 of the next meeting and so on and we turn over "The
3 meeting broke up in good spirits".
4 Can we take it that at this stage, which is the
5 middle of 1991, the department, the unit, that is the
6 surgeons, the cardiologists, the anaesthetists, those
7 who took part in this meeting, had a broad consensus as
8 to the way forward to improve patient care given the
9 results they had described and analysed?
10 A. Yes, I think perhaps more important than that, we had
11 established the principle that monitoring outcomes was
12 important in maintaining improvements in outcomes and
13 I bring you back to the fall in mortality from the
14 37 per cent figure you have quoted this morning to the
15 12.8 per cent figure in the data we received here. What
16 we next needed to do was review the next year and see if
17 we were maintaining that improvement.
18 Q. It is the audit cycle you see at work here, is it: you
19 look at results, you say to yourselves "does this
20 indicate a problem?" If so, "What is the problem?",
21 identify the problem, then look for a solution, try the
22 solution and see if it makes a difference to the
23 results. That is the process, is it not?
24 A. Included in that process for me would be monitoring the
25 meetings and recording the minutes.
0011
1 Q. Yes. So long as someone makes a proper record, it has
2 to be an accurate record, that does the job, does it
3 not?
4 A. Accurate, yes, anodyne possibly.
5 Q. What you saw here working in the middle of 1991 was
6 exactly the approach you would have hoped to operate,
7 was it?
8 A. I think I would just correct you in putting the word
9 "not"; what we are seeing not working here is the
10 approach that I was wanting, which was that we had
11 minutes of meetings in the audit cycle. That is exactly
12 what we were not seeing here. These minutes were
13 rejected. I was told never to take minutes again. That
14 is a very very different position to the one that you
15 suggested might have been happening.
16 Q. Let me look at the process: recording apart, the process
17 of looking at results, identifying problems, looking at
18 the problems, trying to identify solutions and testing
19 the solutions was exactly the process that you would
20 have hoped would be carried out?
21 A. Yes, I was claiming we had stimulated that process as
22 paediatric cardiac anaesthetists.
23 Q. That is the process which no doubt you would hope any
24 contemplation of results, poor or good, would lead to?
25 A. Yes.
0012
1 Q. Because that is what is known as the audit cycle, is it
2 not?
3 A. Yes.
4 Q. The only point about which you take issue at this stage
5 of the history, looking now at September 1991 because
6 that is when you produce the minutes which inspired the
7 reaction you have told us about, is whether or not those
8 minutes should be recorded -- that the meetings should
9 be recorded. You told us, and I have to say from where
10 I stand I would agree, that a record needs to be made.
11 A. (Witness nodding).
12 Q. The identity of the person who takes the minutes cannot
13 be of central importance to the process, can it?
14 A. I think it is important to have confidence in the
15 process to know that it is going to be a documented
16 process. That for me was important because if we were
17 going to have mortality rates of the type we had seen in
18 the preceding year it was going to be important to be
19 able to refer back to them and then decide what action
20 needed to be taken.
21 Q. You are missing the point I think.
22 A. Sorry.
23 Q. The question is not whether records should be kept; upon
24 that at the moment you and I are in conversation in
25 agreement. The question is as to the identity of the
0013
1 person who takes and makes those records.
2 A. Yes.
3 Q. The identity cannot matter, can it, provided that the
4 individual makes a faithful record, whether expansive,
5 whether hyperbolic, whether anodyne?
6 A. My concern was that no minutes were being kept of the
7 meetings.
8 Q. I follow that: the question is, the identity of the
9 individual who takes the minutes does not matter, does
10 it, provided he or she does the job properly?
11 A. I would agree with that, sorry.
12 Q. What one looks for is a record of the process partly
13 to indicate that the process has taken place and partly
14 as a point of reference when you next come to look at
15 the next stage in the audit cycle, a year on you look
16 back to a year before and see how you have moved
17 forward; that is the point?
18 A. Yes.
19 Q. By September 1991 do I take it that in terms of
20 paediatric cardiac surgery generally, leave aside the
21 switch operation for the moment, you had no concerns
22 that were not being as you thought properly addressed as
23 to the performance of the unit?
24 A. I think it is difficult to come to that conclusion
25 because what had happened was that we had seen a unit
0014
1 which had produced a performance which was twice or more
2 than twice the national average mortality. We had then
3 had meetings at which we had changed practice and we had
4 seen there was an improvement, as you say, outside the
5 switch procedure.
6 My concern was that we were not, and certainly my
7 experience of the process of getting to this wonderful
8 result of 12.8 per cent had not been a smooth one, it
9 had not been a collaborative one, it had been one in
10 which I had been asked not to write to general district
11 managers and I felt there was a problem with maintaining
12 this kind of performance of low mortality.
13 Q. At this stage, September 1991, which is what I am asking
14 you to focus on, you are putting forward minutes of
15 a meeting which say how useful it was to have had the
16 input, and you are recording everyone as agreeing how
17 useful it was to have had the input of the
18 anaesthetists, to have had discussions on the figures,
19 to have thought of ways of getting round the problems
20 and it appeared at that stage to have produced
21 procedures which were working?
22 A. Yes, it had been hard work but we were getting there --
23 there was evidence we were now getting there.
24 Q. At that stage, may I take it generally, leave the switch
25 aside, you were happy that the right processes were
0015
1 under way in paediatric cardiac surgery?
2 A. Yes, generally, yes.
3 Q. It would also appear from that meeting that the best
4 available figures were being looked at?
5 A. Yes.
6 Q. And, indeed, that there was a willingness so far as
7 the surgeons were concerned to look at the best
8 available figures, broken down not only by operation but
9 also by surgeon?
10 A. If that data had been presented at the meeting and if
11 you tell me that it was, then, yes, I will believe you.
12 Q. From the end of September 1991 until July 1992, it is
13 a matter of nine months. Did anything as you recall it
14 significant happen during those nine months so far as
15 your perception of the services in Bristol were
16 concerned?
17 A. I think, and again it is recollection, but I think there
18 was again a problem with mortality and I cannot tell you
19 any more than that except that my logbook data would
20 have recorded that there was a persistent mortality that
21 concerned me and that probably with a lack of
22 a mechanism for documenting and recording that that had
23 been expressed from September led me to feel that there
24 perhaps was not the will within the unit to deal with
25 poor results if they were to arise.
0016
1 Q. Before I come to the discussions which you may or may
2 not have been party to or recall about the starting of
3 the neonatal switch operation: you will recall around
4 about 1991 perhaps that there was discussion of the
5 appointment of a new cardiac surgeon whom it was hoped
6 would be a paediatric cardiac surgeon?
7 A. Yes.
8 Q. Ultimately, as we have heard, Martin Elliott -- you knew
9 Martin Elliott, did you?
10 A. He came down and I spent several hours talking to him,
11 yes.
12 Q. You knew there were those in the unit who would hope
13 they might recruit Martin Elliott to work in Bristol?
14 A. Yes.
15 Q. His particular expertise being paediatric?
16 A. Yes.
17 Q. It was at that time that Professor Angelini as he now is
18 applied for the Professorship and ultimately we have
19 heard Mr Elliott withdrew and Dr Angelini,
20 Professor Angelini was appointed?
21 A. Yes.
22 Q. He of course was not a paediatric cardiac surgeon even
23 though he was a cardiac surgeon?
24 A. Yes.
25 Q. The unit at this stage, it was still fixed at the end of
0017
1 1991, had sought, had it, to try to improve the
2 performance in the results by the appointment of someone
3 whose principal expertise and interest was paediatric?
4 A. Yes.
5 Q. And who was up-to-date, young and so on in a paediatric
6 field?
7 A. Yes, I think the implication behind that for me was that
8 the surgeons who were currently in post were possibly
9 not up-to-date, young, enthusiastic, possibly capable
10 and that for me it indicated that they should perhaps
11 not be doing some of the operations they were doing.
12 Q. So far as Mr Dhasmana was concerned you have told us
13 what you said to him yesterday at some stage -- I think
14 that must be in 1992?
15 A. Yes.
16 Q. About him being the best paediatric cardiac surgeon in
17 the South West and encouraging him to go on at
18 operations other than the switch operations he was good
19 at, as you put.
20 You felt, did you, that he was a good surgeon,
21 leave aside the switch?
22 A. I encouraged him to do the operations he was good at
23 so I felt he should continue to do the work he was good
24 at without risking patients, that was my message to
25 him. Yes, he was the best. He was the best of two.
0018
1 Q. Would one take the view that a paediatric cardiac
2 surgeon might be appointed as an indication that the
3 surgeons themselves felt that somebody who was dedicated
4 to the paediatric service as opposed to doing both adult
5 and paediatric work would be better for the long-term
6 future of the unit?
7 A. Yes, I think that is true.
8 Q. Do I take it from your answer you would agree this was
9 a development you would welcome?
10 A. Yes, I think I would change the emphasis slightly and
11 say for the long-term interest of the patients in that
12 unit.
13 Q. Yes, I had I think assumed that the long-term interests
14 of the unit and the patients were the same, but
15 I understand.
16 A. I think in Bristol they got divorced and I think that is
17 part of the problem, but that is why I emphasise it.
18 Q. At about this time, perhaps a shade before, had you
19 heard talk of the view that heart operations on children
20 should be performed in a children's environment in the
21 Children's Hospital rather than on the split site at the
22 Royal Infirmary?
23 A. Certainly there were discussions about the mechanisms
24 for achieving that, yes.
25 Q. Did it seem to you, again looking at this at this time,
0019
1 that the general will of those involved in delivering
2 paediatric cardiac services in the unit was to seek to
3 achieve the unification of those services on one site?
4 A. Yes.
5 Q. The problem was, was it, money and will in the
6 management as it were of the Trust to make that
7 available in competition with other demands on money,
8 space, resources and so on?
9 A. I think funding was one of the issues. Reorganisation
10 of the services and on-call rosters for perfusionists on
11 two sites were other issues that needed to be
12 addressed. It was a complex issue.
13 Q. Again, so I know what your view is at this stage, was it
14 your view that that change would or should make an
15 improvement in the results, whatever they were?
16 A. Yes.
17 Q. At some time round about the end of 1991 it must have
18 been or the beginning of 1992 there were discussions,
19 were there, about the expansion of the arterial switch
20 operation so that neonates were operated upon as well as
21 those who were non-neonates?
22 A. They may well have occurred. I cannot remember
23 attending meetings that specifically discussed that, but
24 if you can show me that they occurred, then I believe
25 you.
0020
1 Q. We have no record, no written record -- it goes perhaps
2 back to a point you were making -- of those discussions
3 but at some stage Mr Dhasmana began to operate upon
4 neonates. The first operation was in early 1992. We
5 have been told this was after some considerable
6 discussion as to whether it was appropriate to carry out
7 the operation on neonates?
8 A. I see.
9 Q. You operated quite a bit with Mr Dhasmana. You were
10 associated with anaesthetists, your expertise was in
11 part in paediatric anaesthetics. Did you know there
12 were discussions, or talk at any rate, of providing the
13 arterial switch operation for neonates?
14 A. I cannot specifically remember any discussions, but
15 that does not mean that they did not necessarily occur.
16 Q. What was the view -- I do not know if you recall it --
17 at the end of 1991 and the start of 1992 as to how the
18 programme (as it was perhaps called) of operations on
19 the non-neonates for the arterial switch had gone?
20 A. I cannot remember that there was any specific conclusion
21 or tabling of information about the early programme, to
22 be quite honest with you.
23 Q. Yesterday when we looked at your own tabulated results
24 we saw that four out of five of the operations at which
25 you provided anaesthetic in the non-neonate group had
0021
1 unfortunate outcomes?
2 A. Yes.
3 Q. You were saying "This is because I did quite a lot of
4 the early operations"?
5 A. Yes.
6 Q. When you looked at your own logs you would have seen,
7 I do not know whether it was four of the very first
8 five, but you would have seen certainly a high rate of
9 fatality/mortality in those operations where you had
10 been the anaesthetist?
11 A. Yes.
12 Q. Do you remember whether that caused you any particular
13 concern or not?
14 A. Yes, it did cause me concern.
15 Q. Did you speak to Mr Dhasmana about it?
16 A. I cannot remember speaking to Mr Dhasmana specifically
17 about it.
18 Q. Because he was the only surgeon I think doing --
19 A. No.
20 Q. Mr Wisheart did three, did he not?
21 A. Mr Wisheart did four. Two of them died. I remember
22 one of them being anaesthetised by me for Mr Wisheart.
23 I remember Mr King's comments to me and to
24 Mr Wisheart --
25 Q. I think we will leave people's comments out of it unless
0022
1 they are a necessary part of the story.
2 A. What he said was "The arterial switch is a young man's
3 operation and I do not think you should be doing it,
4 James" and James actually only did four and then
5 stopped.
6 Q. There was Mr Dhasmana, the younger man of the two, going
7 on and doing the operation. He was the person it was
8 proposed would carry on doing the operation on neonates,
9 as we know?
10 A. As I said, Mr Dhasmana did most of his paediatric
11 operating on a Tuesday and I was not in cardiac theatres
12 on a Tuesday and if he did operate with me on a Thursday
13 it was almost invariably on adults and we might not
14 necessarily then have the paediatric programmes at the
15 forefront of our minds, we would be concentrating on the
16 adult work we were doing on the Thursday.
17 Q. How much involvement did you have, do you think, at the
18 end of 1991, the beginning of 1992 in the paediatric
19 work?
20 A. I was working with Mr Wisheart in paediatrics on
21 a Monday, but that would not have involved any switch
22 operations apart from possibly the four that he did, but
23 I do not think he did them all with me. So my switch
24 operating, given that I was not working with Mr Dhasmana
25 doing paediatrics on a Tuesday, would have been mostly
0023
1 in the older age group and some with Mr Wisheart.
2 Can I say that by the end of 1991 when the minutes
3 of the meeting that we are just looking at the end of
4 here were, we are now looking at a new annual data
5 collection and our logbooks would have been flagging the
6 mortality rates pertinent to that year and by the end of
7 1991 my logbook, with Sally Masey's logbook, would have
8 been flagging mortality rates which now returned to
9 twice the national average.
10 So if you take these in sequence we have
11 37 per cent, as you said this morning, followed by
12 12.8 per cent, followed by the 1991 figures which were
13 back up to 36 per cent I think, but I cannot remember
14 exactly.
15 Q. Realisation began to dawn no doubt in coffee room
16 conversations?
17 A. It would probably have been present at the time these
18 minutes were rejected in September 1991 and would have
19 led me to believe that, yes, the blip had occurred, but
20 the blip was the 12.8 per cent not the 37 per cents that
21 were either side of the 12.8 per cent and that the
22 attempt to not minute those meetings may well have been
23 an attempt to suppress a year in which the mortality
24 rate was back up to twice the national average.
25 Q. Can we have a look at UBHT 61/161. This a pro forma, it
0024
1 appears. It is a common form for one or two audit
2 meetings. The anaesthetists themselves had anaesthetic
3 audit meetings I think which were recorded on a form
4 such as this. We have seen some when Dr Monk gave his
5 evidence.
6 A. Yes.
7 Q. This is described as "paediatric cardiology" and the
8 date of the meeting 25th March 1992. You see the
9 attendance at the top of the page, although it appears
10 that there is no anaesthetist there. There is no
11 anaesthetist there, is there?
12 A. No.
13 Q. We have been told that anaesthetists were invited to,
14 and did on occasions come to, these meetings. You
15 confirm for me whether that is right to your
16 understanding; there may be difficulties in getting
17 there but I think you were invited?
18 A. Probably, yes.
19 Q. We can see what is the audit topic reviewed "Paediatric
20 cardiac surgical mortality for 1991 in comparison with
21 previous years". This is now looking back to see
22 whether the 12.8 per cent has been maintained?
23 A. Yes.
24 Q. If we look down, "Findings and observations. Increasing
25 infant open heart surgery workload." It sets out the
0025
1 increasing workload. "For the last three years
2 mortality for infant VSD 3/37", none it says out of 12
3 in 1991. AVSD, 20 per cent over the last three years.
4 Transposition 3 per cent, and notes that is good
5 results. It then notes "poor results" in totally
6 anomalous pulmonary venous drainage and in truncus.
7 They are on the face of it poor results or appear to be,
8 do they not?
9 A. (Witness nodding).
10 Q. They appear to be specifically noted here as "good
11 results" or "poor results". This is a much briefer
12 record of discussions than your own minutes but what it
13 appears to record is a discussion as to the results and
14 as to whether they should be classified as "good" and
15 therefore acceptable although one would obviously want
16 to improve them, or "poor" which means in great need of
17 attention and improvement?
18 A. Can I ask: is this all the operating for the unit? Does
19 it include the arterial switch data?
20 Q. Let me come to that because you will want to see the
21 actual figures themselves, will you not?
22 A. Only if they are relevant.
23 Q. They are not actually relevant to my question at this
24 stage. Perhaps I can come back to that.
25 A. Yes, do.
0026
1 Q. If we look at "Inferences and hypotheses", the need to
2 increase infant and neonatal open workload. Good
3 results in infancy should aim to increase the infant and
4 neonatal workload. High mortality in TAPVD, needs
5 further detailed review at the next audit meeting.
6 A. Yes.
7 Q. What appears to be the approach here is: "We have got
8 poor results. We need to look at that specially, we
9 need to see what we need to do to improve it"?
10 A. Yes.
11 Q. Is that an appropriate reaction to results such as this
12 in TAPVD?
13 A. Yes, I think I would be looking at a detailed review to
14 try and find out what the causes were and whether you
15 could prevent future mortality.
16 Q. That appears to be what this group is considering?
17 A. Yes.
18 Q. 3 identifies the problem of the split site which we have
19 agreed was a problem.
20 "4: Miscellaneous group of patients with high
21 mortality" include infants with complete congenital
22 transposition of the great arteries plus VSD?
23 A. Yes.
24 Q. "Query should consider ..."; that is the switch group,
25 is it not?
0027
1 A. It is the older switch group I think, is it not?
2 Q. There is the non-neonatal switch group.
3 A. Yes.
4 Q. There is obviously a concern being expressed here
5 amongst this group as to the level of mortality and
6 a suggestion as to what might be considered as a means
7 of improving results and improving the care given to
8 patients?
9 A. Yes.
10 Q. Is there anything inappropriate in this approach as
11 documented here?
12 A. I think we are doing exactly the same thing a year on
13 from a year on of bad results and I think that for me
14 what needed to be looked at was the processes that we
15 were undertaking with these children. Could we
16 technically do these operations and could we do them
17 within a time within which we would expect minimal
18 complications.
19 Q. You say what needed to be looked at was the time at
20 which patients came to operation?
21 A. Yes. No, the time the operations took. I think that
22 was one of the important messages Mr Wisheart had
23 received from Mr King about switches being a young man's
24 operation. They had to be done technically proficiently
25 and reasonably quickly to get good outcomes.
0028
1 Q. So speed of operation?
2 A. Speed and technical proficiency.
3 Q. And technical proficiency. Which you would have, would
4 you not, to be a surgeon to be able properly to analyse
5 technical proficiency as a surgeon?
6 A. Not necessarily. I think some of the evidence given to
7 the Inquiry early on from Professor Strunin indicated
8 that actually anaesthetists may be in a very good
9 position to make relative judgments about the
10 proficiency of surgeons that they work with. One
11 anaesthetist may see six surgeons doing the same
12 operation. A senior surgeon may not see other surgeons
13 doing the same operation or he may just see junior
14 surgeons that he is training.
15 THE CHAIRMAN: May I interrupt for my own understanding,
16 Dr Bolsin: there is this reference here at number 2 on
17 your screen to the idea of "detailed review" which you
18 had been urging for some time, I take it. Why would you
19 say that that review ought to be about a specific issue,
20 namely time taken in surgery rather than have an open
21 mind as to what might be implicated beginning from
22 referral and ending in whether the child is discharged
23 from the Intensive Care Unit, in other words have a very
24 broad picture of what needs to be reviewed because
25 arguably that might come up with something which is more
0029
1 sustainable?
2 A. The reason for me saying that is because as anaesthetist
3 we did not have any impact on the presentation of the
4 patients for surgery. We dealt with the patients after
5 they had been listed for surgery and dealt with them on
6 the night before their operation, then during their
7 operation and then on the post-operative course.
8 So that the bit we were most intimately involved
9 in and the only bit we were really technically qualified
10 to deal with were premedication, pre-operative visit and
11 then the operative course and the post-operative
12 course. That is why my concerns were most closely
13 related but I certainly would not have excluded a review
14 of the cardiological diagnosis of the anatomy and also
15 the presentation of the patients prior to them getting
16 to us.
17 MR LANGSTAFF: What the figures give you is an overview of
18 what is a collective responsibility?
19 A. Yes.
20 Q. As part of the collective, with responsibility for those
21 results you would want to see that the proper solution,
22 whatever it was, whether it was referral patterns,
23 whether it was cardiological investigation, whether it
24 was surgical competence, whether it was post-operative
25 management --
0030
1 A. Whether it was anaesthetic.
2 Q. -- whatever it was was sorted; that I think is the point
3 the Chairman was putting to you?
4 THE CHAIRMAN: I am sure you are going to understand this
5 further, Mr Langstaff, but I am just seeking to
6 understand as a scientist why you would as it were focus
7 on one particular matter without asking yourself what
8 range of matters might be implicated and let us look at
9 all of those?
10 A. Yes, I was doing it from my specialist viewpoint and
11 probably wrongly restricting --
12 THE CHAIRMAN: Forgive me, your specialist viewpoint is as
13 an observer of the process of audit and audits requiring
14 a review and seeing the review arguably as a scientist
15 as being all embracing?
16 A. Yes.
17 THE CHAIRMAN: Not embracing only that which an anaesthetist
18 could understand?
19 A. Certainly, yes, yes.
20 MR LANGSTAFF: Perhaps if I bring in Dr Sumner at this
21 stage, if I may: doctor, from your perspective looking
22 back at 1992 what would you expect the anaesthetist's
23 contribution to an audit discussion looking at how to
24 improve general results would be, what particular
25 perspectives would you expect him to be able to bring to
0031
1 bear.
2 DR SUMNER: I think anaesthesia is obviously a member of the
3 team of workers who would do this type of work in
4 infants and small children. I think we are in a very
5 good situation to provide an overview for a lot of the
6 care that takes place, both pre-operatively,
7 intra-operatively and post-operatively. Some of it we
8 have no control over, but we can observe it.
9 I would say that we would be observing the
10 preoperative management which may be in our hands to
11 a degree if we are involved in the Intensive Care Unit
12 (as I happen to be), so we could optimise patients. The
13 clinical state of the patients as they came to the
14 operating theatre, we would be able to observe the
15 technical and efficiency aspects of the procedure.
16 I agree with Dr Bolsin that we are in a very very
17 good situation to compare the technical aspects of
18 surgery, after all, surgery tends to be a technical
19 exercise and if one person is better at it, then, in my
20 view, they are more likely to have better results.
21 I think it is a technical exercise and that is the prime
22 reason for patients going to theatre, to have their
23 procedure.
24 Then of course we are in a very good situation to
25 oversee what happens post-operatively too, so I think we
0032
1 are in a strong position to judge others and be judged.
2 MR LANGSTAFF: Could I move on from 61/161 to 61/164. This
3 is a meeting which is obviously two months later, six
4 weeks later. It is the same group. The results of
5 previous audit interventions we see recorded. High
6 mortality and TAPVD group, identified at an audit
7 meeting 25/3/92, so there is a reference back to the
8 previous record as you would expect in a properly
9 organised audit system.
10 The topic and criteria reviewed. Here apparently
11 the promise appears to be honoured to look at the TAPVD
12 results which have been identified as particularly poor
13 in March.
14 Can we scroll down. The observations "mortality
15 high", "2 In two patients diagnostic error and/or
16 surgical approach inappropriate", so there is no
17 shrinking from criticism within the unit there of these
18 results?
19 A. No.
20 Q. "In some patients delay in diagnosis prior to referral
21 to cardiac centre may be important."
22 Does one get a perspective from these points that
23 most aspects of care are actually being looked at and
24 examined to see why it is the results are bad?
25 A. Yes, I think so. I am not sure if I can see surgical
0033
1 technical aspects being addressed. Surgical approach
2 may not deal with the full technical aspects of surgical
3 repair.
4 Q. Can we scroll down. It appears as though the surgeons
5 have been looked at, at any rate. Here Mr Wisheart and
6 Mr Dhasmana in attendance are prepared to consider that
7 they may have taken the wrong approach, whichever one it
8 was or whatever is being said, that stands out from the
9 words?
10 A. Yes.
11 Q. The action taken and the changes instituted. We see
12 what is said, that: "There is need to operate within 48
13 hours of presentation unless if there is evidence of
14 obstruction"?
15 A. Yes.
16 Q. One would understand the clinical reasons for that?
17 A. Yes.
18 Q. Dealing with diagnosis which is a cardiological
19 question. Then looking at "low age not being
20 a contra-indication to successful repair" which must,
21 I suppose, be taken together with point number one;
22 essentially the idea is get the patients early and you
23 have a better chance of success?
24 A. Yes.
25 Q. Is this what you would expect to see in a properly
0034
1 organised audit cycle as a response to the annual
2 figures looked at in the meeting in March?
3 A. Yes, this is the follow-up of the TAPVDs that was
4 mentioned in March. There is no mention of other
5 operations here, this is a specific meeting we are
6 dealing with TAPVD. I would like to know what the
7 background data was for the 1992 year to see if there
8 were any other problem operations that needed to be
9 addressed early to nip problems in the bud.
10 Q. Could we have a look at 165 because it is the next
11 meeting in the series. There the attendance is rather
12 wider, you actually have a nurse and a liaison sister in
13 attendance in addition to surgical and cardiological
14 staff.
15 Can we scroll down. Results of the arterial
16 switch operation by Mr Dhasmana and the findings:
17 "Mortality for TGA plus VSD switch similar to
18 reported results, particularly if, consider his early
19 experience, higher mortality for multiple VSDs and when
20 in hospital for a long time prior to switch."
21 The results are looked at because plainly they
22 have been a matter of concern?
23 A. Yes.
24 Q. One saw that at the March meeting, the very last item
25 was: "we have to look at what was described then as
0035
1 CCTGA plus VSD" if you remember?
2 A. Yes.
3 Q. This appears to be where it happens. Again as a matter
4 of approach -- leave aside for a moment whether they got
5 the conclusions right -- as a matter of approach this is
6 what you would endorse, is it?
7 A. Yes, I am not sure what the results are here, it is not
8 clear from the minute what the actual results of the
9 programme at that time were.
10 Q. We can have a look I think at GMC 8/22. This appears to
11 be the data presented to the meeting. "Anatomical
12 correction", the group at the top "Complex TGA, double
13 outlet right ventricle" and it deals with what is
14 obviously TGA plus VSD?
15 A. Yes.
16 Q. And the number, February 88 to April 92, hospital deaths
17 and the percentage. We can see scrolling down the
18 figures broken down by year. The two blanks on the
19 right-hand side are because we honour our obligation as
20 best we can to ensure patient confidentiality. They are
21 patient names.
22 One can see here a pattern of results. That is
23 the basic data which the meeting it appears had?
24 A. Yes.
25 Q. And were looking at in respect of the operations,
0036
1 looking at over a period of four years and a bit. If we
2 go back to 61/165, that appears to be the basis for the
3 findings and observations. The findings and
4 observations, I do not know, do you say that they are
5 (at least on one view) justified by the results?
6 A. Yes, I am not sure what the "reported results" refers to
7 and it would not have been difficult at that stage to
8 have rung round other units to find out what their
9 experience was, certainly at some stage (and I cannot
10 remember when) I picked up the telephone and rang
11 Cardiff to find out what their experience was. I think
12 they had one death in their first twelve. I telephoned
13 Southampton, Tom Abbott and when I spoke to anybody
14 about the results that I was accumulating in Bristol
15 there was a general consternation that we were not down
16 at, I cannot remember if the 5 per cent level was not
17 the level that was acceptable.
18 Q. We have to be very careful not to confuse epochs because
19 we are looking of course from 1984 to 1995 here.
20 I think we will find, and I will have it checked
21 over the break we are about to come to, that at this
22 stage Cardiff did not have a surgical presence. Again
23 there may be a difference between the conversations you
24 are talking about which you cannot place in time and
25 when these conversations occurred?
0037
1 A. Certainly.
2 Q. Because our understanding is that the results for the
3 switch operation improved generally and in particular
4 throughout the 1990s in, if I can say, other centres
5 because I want to keep Bristol out of the picture here
6 for a moment?
7 A. Yes.
8 Q. That is the general picture which I think has been
9 painted by the evidence we have had in the Inquiry.
10 Unless you can help us with specifically when you
11 telephoned to ask individuals, it does not necessarily
12 help to resolve what would have been the comparison
13 here?
14 A. In 1991 when I was appointed the national audit
15 coordinator of ACTA, the meeting was in Southampton and
16 I spoke to Tom Abbott who then posted me the results for
17 the preceding 10 years in Southampton and I compared
18 them with our results and there was a considerable
19 difference in mortality rates which concerned me.
20 Q. That I will pick up with you later.
21 Looked at thus far what we have seen is the 1992
22 review, two specific operations looked at. On the face
23 of it, subject to the query you have about what results
24 the mortality in Bristol was compared with in June --
25 A. Can I just clarify: the 1992 review was, what?
0038
1 Q. That is the March meeting?
2 A. That is a review of 1991 figures.
3 Q. That is right, that is what it says it is?
4 A. Was that the tables that came at the end of the 1991
5 annual report?
6 Q. They would be identical?
7 A. That is twice the national average mortality in the
8 under ones.
9 Q. That may need to be clarified, but the figures which
10 I said I will come back to --
11 A. Yes.
12 Q. -- again, if I may to keep the points as it were short
13 and to enable you to make the points that you wish,
14 shall I ensure that during the break you are supplied
15 with what we think are the 1991 figures?
16 A. Yes, please.
17 Q. Then we can resume this part of the conversation after
18 the break.
19 The point I am on at the moment and which I think
20 you are agreeing with, is: subject to the query about
21 the identity of the results elsewhere with which
22 a comparison was made, that it would appear to you
23 looking at these documents that they document a process
24 which is what you would expect as a proper process of
25 reviewing results, looking at the reasons for under
0039
1 performance and seeking ways of improving that under
2 performance, an appropriate process?
3 A. Yes.
4 Q. One which you would encourage?
5 A. Yes.
6 Q. One which you would hope that any worrying figures would
7 give rise to?
8 A. Yes. I think if I could just add to that: if I had been
9 present at these types of meetings and with the
10 information that was being made available and with the
11 information that was available from colleagues around
12 the country, I might have been adding in (and I cannot
13 say that I would because I was not there and because of
14 possibly the influences I was under) but I might have
15 been saying "should we stop any of these high risk
16 programmes, should we actually consider not doing this
17 operation or going to a centre and finding out how to do
18 it properly"; that may have been one of the things that
19 it would have been necessary to have, at a stroke,
20 maintained the improvement or sustained an improvement.
21 Q. The suggestion you are making there is: what may not
22 have been considered was putting an end to the programme
23 rather than seeing if you can improve it while the
24 programme continues?
25 A. Yes, not one programme but a series of programmes,
0040
1 possibly the TAPVD programme, possibly the switch
2 programme, possibly other programmes should have been
3 examined with a view to seeing if there was anything we
4 could learn from centres that we believed had a better
5 record for those procedures.
6 Q. When was it that you recall talking to Dr John Zorab?
7 You tell us about this in your statement at page 110,
8 the foot of the page. Was this in 1991 after the
9 minutes of September, was it in early 1992 at the time
10 that these meetings were taking place which you did not,
11 as it happened, go to; when was it?
12 A. To be quite honest with you I cannot accurately date
13 that meeting. I do not know when Dr Burton retired but
14 he was certainly still working at the BRI when I spoke
15 to Dr Zorab so it was before Dr Burton retired.
16 Q. It would have to be before mid-1992 because that is when
17 Dr Zorab wrote to Sir Terence English?
18 A. Yes, there was a considerable delay between me
19 approaching Dr Zorab and Dr Zorab actually writing to
20 Sir Terence English, and the reason for that was --
21 Q. That is his recollection and it has to be his reason.
22 A. Yes.
23 Q. We can leave your evidence out of this because it was
24 only reported to you.
25 A. No, he wrote to me --
0041
1 Q. Yes, it is only reported to you.
2 A. Sorry.
3 Q. We have his letter.
4 Can you help any more about the precise timing?
5 A. No, I am sorry I do not think I can. It was a casual
6 meeting in one of the private hospitals in Bristol and
7 it was fortuitous. Andrew Dunn had obviously spoken to
8 him and said "if you get a chance speak to Steve
9 Bolsin".
10 Q. You have since, in I think what you have written and
11 certainly what you have said, claimed that you told the
12 Royal College of Surgeons of England of your concerns?
13 A. No, that is not true.
14 Q. That is the way it has come across. The route was
15 indirect, was it, by telling Dr Zorab? You happened to
16 know from what he has told you since that he spoke to
17 Sir Terence English, that is how the Royal College of
18 Surgeons of England got to know?
19 A. Yes, I think I knew the Royal College of Surgeons had
20 known about it.
21 Q. What I am going to move on to is a discrete topic and
22 perhaps it is convenient if, although we are a shade
23 before 11.00, we take a break. May we begin again at
24 11.10?
25 THE CHAIRMAN: You place me in my usual mathematical
0042
1 dilemma, but I make quarter of an hour on my watch to be
2 11.05; is there a compromise?
3 MR LANGSTAFF: I refrain from negotiating in public with my
4 Chairman.
5 THE CHAIRMAN: Shall we say 11.05?
6 (10.50 am)
7 (Adjourned until 11.05 am)
8 (11.10 am)
9 MR LANGSTAFF: Sir, my apologies for keeping you waiting.
10 THE CHAIRMAN: No apology called for, Mr Langstaff.
11 MR LANGSTAFF: Dr Bolsin, we have, as you know, got
12 Dr Sumner here, and as I have indicated almost on the
13 first day of the Inquiry, there are questions which
14 arise from a particular case which it may be useful to
15 the Inquiry to have put to you.
16 That is the case of Melissa Clarke. We have, of
17 course, full consent and we have been through Tracey
18 Clarke's recollection of what happened in some detail.
19 She was in fact our first witness.
20 The points that arise in respect of Melissa Clarke
21 arose from Melissa's records, if we can have on screen,
22 please, MR 175/2. Full copy records are at your feet,
23 should you need them. If we can look at 1752/120, we
24 can scroll down to 18th October 1991, it fits in with
25 the period that we have just been discussing in broad
0043
1 terms as to the development of your concerns about
2 progress in the unit.
3 Can you tell me, were you the anaesthetist during
4 the operation which Melissa Clarke had?
5 A. No, I was not.
6 Q. Were you an anaesthetist with responsibility at least
7 for part of the time during which Melissa Clarke was in
8 ITU after operation?
9 A. My contact with Melissa Clarke started, I think, on the
10 25th October.
11 Q. Can you, nonetheless, help us with an entry we have for
12 18th October, because you are familiar with intensive
13 care?
14 A. Yes.
15 Q. We see for the entry 18-10 that many "ABG", arterial
16 blood gases, is it?
17 A. Yes.
18 Q. "A problem, as fighting the ventilator"?
19 A. Yes.
20 Q. We miss the next line. "Ventilation adjusted, tubes
21 split".
22 A. Yes.
23 Q. If we can also pick up a reference to "tubes split",
24 please, at 1752/152, can we turn this sideways? If we
25 look at the top right-hand note, it is appropriate to
0044
1 display, the top right-hand as we now have it on the
2 screen makes reference to "tubes split". It is under
3 the column to the right-hand of "Action" in the first
4 box. "Tubes now split". It goes on in the next entry,
5 "Gases now better, tubes split."
6 What is "tubes split" a reference to?
7 A. This was a technique that we used in Bristol for
8 reducing the amount of dead space in the ventilating
9 circuit. The standard ventilating circuit that they
10 came back from theatre with included a short length of
11 dead space between the endotracheal tube and the wide
12 piece of the ventilator connection. If we had a problem
13 with a child's ventilation -- and obviously in Melissa's
14 case there was a problem -- then we would take out the
15 dead space and connect the tubes directly on to the
16 endotracheal tube in what is described as a "Cardiff
17 connector" type of approach and that is what we called
18 "splitting the tubes".
19 MR LANGSTAFF: I think, Dr Sumner, it is not a term you had
20 come across before?
21 DR SUMNER: No, I did not know what it meant. I got the
22 impression from reading the notes it was a beneficial
23 thing to do rather than an inadvertent splitting of
24 a ventilation tube which would lead to severe
25 hypoventilation. I am glad to hear it explained.
0045
1 Q. What Tracey Clarke told us about was her understanding
2 from what she had been told that there had been some
3 incident during Melissa's stay on intensive care, as
4 a result of which she had suffered some injury or
5 additional injury to her central nervous system.
6 Effectively, she became brain dead. But her
7 complaint is in part that that is something that it took
8 some time for those in charge of the ICU or in charge of
9 Melissa to tell her?
10 A. Yes.
11 Q. Part of the importance, perhaps, of this case as an
12 exemplar of the process by which children were cared for
13 in Bristol is therefore to look and see how Melissa's
14 problems may have arisen with what they were and how
15 they may have been dealt with.
16 Dr Sumner, as you interpret the notes, do you take
17 the view that Melissa had suffered some cerebral injury
18 during the course of her operation?
19 DR SUMNER: My understanding of this little girl's case is
20 that it is very likely that she sustained some cerebral
21 insult during the surgery. The circulatory arrest time
22 is 65 minutes which is a very long circulatory arrest
23 time. We know the animal work and clinical work was
24 starting in those days, I do not think they could have
25 been expected to know all of it, but we know that
0046
1 periods of circulatory arrest longer than 30 minutes are
2 setting the stage for cerebral damage.
3 This little girl, she was 10.9 kilos, and I just
4 wonder why Mr Dhasmana would consider using circulatory
5 arrest in this situation, since the little girl was big
6 enough to have a bicaval venous drainage, and therefore
7 could have been kept on bypass for the whole length of
8 the procedure.
9 Q. Could I just ask you to pause there? "Bicaval venous
10 drainage: was that done for operations which you
11 anaesthetised on children who were big enough?
12 DR BOLSIN: I think it was, yes. I would not be in
13 a position to comment accurately on the weight we would
14 go down to, to do bicaval operation, but it would be
15 easy to check from the operative records.
16 Q. Was that a matter of protocol or the surgeon's choice or
17 the anaesthetist's choice?
18 A. It would probably be the surgeon's choice.
19 Q. In discussion with the anaesthetist, or not?
20 A. I do not think we would have much input into that. That
21 is a technical aspect of the operation and it depends on
22 the anatomy you observe at operation.
23 Q. You have heard what Dr Sumner has said. How did you
24 respond to the times of circulatory arrest which you
25 have seen in this case, because you have seen the review
0047
1 of the notes?
2 A. Yes, I have looked briefly through the notes. I agree
3 with Dr Sumner. I would say there was evidence in the
4 literature at that point. I can remember working at the
5 Brompton in 1986 which Chris Lincoln and Frank Wells
6 produced a paper in which they said that every minute
7 over 45 minutes of circulatory arrest time leads to
8 a one point drop in IQ, on the basis of follow-up data.
9 Barrett-Boyes had produced data and Tom Treasure was
10 producing data from an animal model, in which they were
11 all suggesting that there was an upper limit and it was
12 around 40 minutes.
13 Q. I think there is nothing between you and Dr Sumner on
14 the availability of literature at the time. You were
15 going to go on I think and make a point, were you, about
16 cardioplegia?
17 DR SUMNER: I think the cross-clamp time is also a very long
18 time, 1 hour and 45 minutes, and I could see only one
19 note of administration of cardioplegia, which -- it is
20 usual to give cardioplegia every 30 minutes during aorta
21 cross-clamping to provide the myocardium with continuing
22 ice cold solutions to keep the metabolic rate down and
23 potassium to keep the heart from beating. Cardioplegia
24 solutions are given either by the anaesthetist or by the
25 perfusionist depending on the unit. We give it and it
0048
1 is usual for us to remind the surgeons that it is half
2 an hour and it is time to be giving more. I am not sure
3 what happened here but I think it set the stage for
4 post-operative problems of very poor right ventricular
5 function.
6 Q. Can I again stop you there, if you do not mind,
7 Dr Sumner, just to ask, if cardioplegia is not replaced,
8 is there an adverse effect just on the heart and its
9 ability to function after surgery, or is there a wider
10 difficulty with the circulation as a whole?
11 DR SUMNER: Cardioplegia is designed to minimise the damage
12 associated with aortic cross-clamping at which time
13 there are no oxygen nutrients or waste products being
14 taken away from the myocardium via the coronary
15 arteries, and so on, and cardioplegia is ice cold, it
16 contains potassium, which stops the heart so that it is
17 not beating any more, and it cools it right down so that
18 the metabolic demands are minimal. After about half an
19 hour, the effects will have worn off, the heart will
20 start to warm up and then its metabolic demands will
21 increase, but cannot be met because the aorta is still
22 cross-clamped.
23 So it is usual, at around half an hour, to give
24 another dose of cardioplegia to protect the myocardium.
25 Q. You said this may have set the stage for post-operative
0049
1 problems?
2 DR SUMNER: We know that Melissa had a very, very stormy
3 post-operative period from the cardiac output point of
4 view, among others. The echos and the clinical signs
5 showed she had very poor right ventricular function, and
6 the right ventricle in this little girl is of course the
7 systemic ventricle, since she had an atrial repair, not
8 an arterial repair.
9 So the echo shows a dilated right ventricle poorly
10 contractile, with tricuspid valve regurgitation.
11 Tricuspid valve is again the systemic valve in the heart
12 and I think this has caused an enormous amount of
13 problems; it caused the multi-organ failure. There was
14 good evidence in the biochemistry of liver damage, of
15 very, very poorly functioning kidneys, which in fact
16 packed up completely on the 20th, and I think was also
17 contributory to exacerbating an initial cerebral insult.
18 Q. The initial cerebral insult would, as you see the notes,
19 probably have been sustained as a consequence of the
20 long and complex operation that this little girl went
21 through, would it?
22 A. I can see no other well-known cause of cerebral oedema,
23 which I had diagnosed clinically on her post-operative
24 day by the enormous restlessness and impossibility of
25 sedation using normal sedative drugs as a sign of
0050
1 cerebral irritation at that stage. It is absolutely
2 classical and I have seen it so many times.
3 So when one is in a situation of being unable
4 immediately post-bypass, we always give morphine and
5 usually benzodiazepine drugs such as Valium or
6 midazolam. When these normal doses of drugs cannot
7 sedate a baby, then we always think there must be some
8 cerebral irritation at that stage. That is my feeling.
9 Q. Can I pick up on some points, because others may yet
10 wish at a later stage in the Inquiry to speak about
11 Melissa's circumstances and operation.
12 From what you say, seeing this reaction or
13 a similar reaction in a number of babies on a number of
14 occasions, it is, is it, something of a recognised
15 complication to surgery of this sort?
16 A. Yes. Neurological problems are a very well recognised
17 complication of this type of surgery in small infants.
18 Q. Can I move on for a moment to deal with the care in
19 intensive care? Dr Bolsin, perhaps you can help us
20 here. You had care of Melissa's case at a later stage
21 in ICU. In 1991, who was responsible for a child in
22 ICU, as you recall it?
23 DR BOLSIN: It would have been a joint responsibility of the
24 surgeons and the anaesthetists, with the junior staff
25 actually being present on the Intensive Care Unit.
0051
1 Q. Junior staff, we have been told, was the surgical house
2 officer?
3 A. Yes.
4 Q. And that was the resident presence, was it?
5 A. Yes.
6 Q. So very junior member of staff?
7 A. Yes.
8 Q. With consultant surgeons, consultant anaesthetists,
9 perhaps cardiologists?
10 A. Very infrequent attendance by cardiologists, although it
11 is interesting to note that Dr Jordan did get involved
12 latterly in Melissa's stay in the Intensive Care Unit.
13 Q. No intensivist at this stage?
14 A. No.
15 Q. And what would your comment be as to the degree to which
16 surgeon, anaesthetist and if there was a cardiologist,
17 co-ordinated care for babies on the ICU?
18 A. As far as I remember, this was a time when there were
19 probably several different ward rounds occurring of the
20 different specialties at different times, and the
21 co-ordination would have been difficult, I think.
22 Q. Was there a problem, as you have seen the notes, with
23 the ventilation?
24 DR SUMNER: When Melissa came out of theatre, gas exchange,
25 that is, oxygenation and CO2 removal were excellent.
0052
1 There is no doubt about that. But some time during the
2 night, the ventilation became difficult and we saw it in
3 the nursing notes. The chest x-ray taken at that time
4 showed pulmonary oedema, the collection of water within
5 the lungs, within the structure of the lungs, and this
6 is made manifest by pink frothy secretions.
7 When this happens, the lungs become much stiffer
8 and are much more difficult to ventilate, and I think it
9 occurs very often in the notes of Melissa that the
10 tracheal tube was a size 4 mm, which was probably fine
11 for the operation in the theatre. Once the lungs became
12 stiffer, I think it gave a real problem in that air
13 would preferentially come out around the tube and is
14 heard as a leak, rather than ventilating the lungs.
15 The additional problem with a tube of those
16 dimensions is that one cannot use what is called
17 "positive end-expiratory pressure", because it is
18 dissipated by the leak. Positive end-expiratory
19 pressure is very, very useful in situations of wet
20 lungs, so they were in a slight problem there.
21 Q. Can you tell me, is that a problem which is relatively
22 easy to resolve?
23 A. The proper thing to do in those circumstances is to
24 change the tube and put a larger one in. That requires
25 a skilled anaesthetist, because the babies are often at
0053
1 this stage quite sick, and to expose them to a change of
2 tracheal tube might not be the most advisable thing to
3 do at that stage and one might wait until there is more
4 stability to do it.
5 The alternative is to put a throat pack in around
6 to prevent the leak, but that is not a very satisfactory
7 way, the best way is to change the tube and put
8 a slightly larger one in.
9 MR LANGSTAFF: Dr Bolsin, in terms of management, do you
10 agree that that is what is or could be done?
11 DR BOLSIN: Yes.
12 Q. So one comes to the question here, appreciating that you
13 were not the anaesthetist then responsible for the case,
14 what would be required for this to be done would be
15 a level of co-ordination, would it, between the health
16 professionals caring for Melissa, so that an
17 anaesthetist was made available, a decision was made, as
18 a consequence of which an anaesthetist was made
19 available and attended and changed the tube for a larger
20 one?
21 A. Yes. I think it is one of those areas where Dr Masey in
22 her evidence earlier on would have said this was an
23 anaesthetic technical thing and the anaesthetist would
24 have been prepared to get on with it without necessarily
25 seeking the consent of the surgeons, but would have
0054
1 informed them that was what they planned to do if
2 Melissa's condition was stabilised.
3 MR LANGSTAFF: You were going to move on to say something
4 further?
5 DR SUMNER: The gas exchange did improve, actually, with
6 treatment, and also they gave paralysing drugs to
7 overcome the difficulty of sedation and the fighting of
8 the ventilator and that did help.
9 MR LANGSTAFF: So we have a picture, do we, of less than
10 satisfactory control of the ventilation?
11 DR SUMNER: Yes.
12 MR LANGSTAFF: You were going to talk, I think, about the
13 other problems which little Melissa faced. Amongst
14 them, you mentioned earlier was a renal problem.
15 THE CHAIRMAN: Before we move on to that, is the fact that
16 it was at night particularly relevant in Melissa's
17 case?
18 MR LANGSTAFF: At night, the problem having first arisen,
19 the presence on the unit would be the house officer, the
20 surgical house officer?
21 DR BOLSIN: Yes. There was an Anaesthetic Registrar on call
22 for the unit at night and obviously consultants on call
23 for the unit at night as well.
24 MR LANGSTAFF: Do we see any evidence in the notes of them
25 having been called?
0055
1 DR BOLSIN: I cannot remember the notes that well, to be
2 quite honest with you, Mr Langstaff.
3 MR LANGSTAFF: If we have a look at 1752/120, are there
4 signatures there that you recognise?
5 DR BOLSIN: This looks like the nursing notes.
6 MR LANGSTAFF: Yes. I am not sure there are names in the
7 notes there that we can pick up. The clinical notes --
8 A. There is, about halfway down, it says "[something] on
9 the bag" and then "anaesthetist called". It is just
10 above the 8 pm line, "anaesthetist in to see Melissa".
11 Q. So it appears that an anaesthetist would have been
12 called in?
13 A. Yes. The reason for that is that they are unable to
14 maintain saturations with the bag; therefore "called
15 anaesthetist in to see Melissa". I am not sure what the
16 time of that is.
17 Q. It does not help much, does it? It is obviously some
18 time after 19.10, I think 02-00, if you look halfway
19 down the nursing notes where the handwriting changes,
20 the temperature goes up and the oxygen saturation goes
21 down.
22 A. Yes.
23 Q. Can I come back to the question of the renal
24 management?
25 DR SUMNER: What I found very interesting and disturbing
0056
1 too, not just with Melissa but in some of the other
2 20 cases that I was asked to look at, was the lack of
3 a urinary catheter, which is routine, I thought, in
4 centres who do this sort of work. It is put in at the
5 beginning of the operation in the anaesthetic room and
6 then provides a minute to minute or hour to hour data on
7 how much urine is being produced, because kidney
8 function is a very sensitive guide to cardiac output,
9 and with other aspects too, but by and large if the
10 urine output goes down, the cardiac output is down and
11 to not be able to know that from hour to hour is
12 a terrible loss of data.
13 In Melissa's case, they were expressing the
14 bladder, pressing on the bladder emptying it, which may
15 or may not fully empty it. We have absolutely no idea
16 what the urine output is, because the urine output must
17 meet the fluid intake, and if the urine output goes
18 down, then we must do things about it. We have to
19 increase the cardiac output, we give diuretics. In
20 spite of all that, we must dialyse the patient. I think
21 it is a serious lack of information that we would be
22 getting from the cardiac output, from the renal status
23 and fluid management of this little girl. She was
24 catheterised eventually on the 20th at 1300, 1 o'clock
25 in the afternoon, when there had been no urine
0057
1 overnight.
2 Dialysis did not take place until 2300 on the same
3 day, that is, she had not really passed any urine worth
4 speaking of for nearly 24 hours. I think that was
5 wrong. In the light of the fact that -- and with the
6 hindsight, of course, which we have, it was very, very
7 damaging to a child who had had a cerebral insult.
8 Cardiac output was very poor, there was, as I have said
9 from the echo, demonstrable poor right ventricular
10 function with tricuspid regurgitation. I do not think
11 that was ever adequately treated.
12 Melissa was on dopamine and then on dobutamine,
13 and she was also on drugs to control supraventricular
14 tachycardia, but reading between the lines, I do not
15 think that she was ever adequately treated for a low
16 cardiac output in terms of stronger inotropes and
17 vasodilating substances to make sure the tricuspid valve
18 would be working optimally, and of course, we see low
19 blood pressures, we see high venous pressures, so again,
20 her brain, which I believe had already suffered, there
21 would be poor venous drainage from the head and
22 inadequate blood flow, so her cerebral perfusion
23 pressure, which is crucial for cerebral well-being,
24 would be very small.
25 Q. Could I break that down and see what generalisable
0058
1 lessons there may be in the state of events that you
2 recount?
3 The first point you are making is that cardiac
4 output needs to be maintained when the little baby is on
5 ICU, because if it is not, then organs, amongst them the
6 brain, are likely to suffer?
7 DR SUMNER: That is correct.
8 Q. But in order to maintain such output, one may use drugs
9 and here I think you are saying, not sufficient were
10 used.
11 DR SUMNER: I think that, with an echo diagnosis of poor
12 ventricular function, and the clinical signs of low
13 blood pressure, high value venous pressure, pulmonary
14 oedema, shut down peripheries -- I am describing what
15 I have taken from the note -- they are really describing
16 a very low cardiac output. They were giving drugs, but
17 I do not believe that they were of the calibre that this
18 child needed.
19 Q. So somebody needed, did they, to get the information
20 together to read the signs and decide on appropriate
21 management?
22 A. Yes.
23 Q. And appropriate management would, as you see it, have
24 involved the administration of more or more appropriate
25 drug therapy. You dealt with the question of renal
0059
1 function, and said here a catheter should have been put
2 in so one could have a measurement to see how effective
3 from hour to hour the heart was being, in pumping blood
4 around the body?
5 A. Yes.
6 Q. Was it the practice, Dr Bolsin, at any stage, that you
7 anaesthetised in the Royal Infirmary, for catheters to
8 be inserted prior to discharge from the operating
9 theatre?
10 DR BOLSIN: I was always keen to have urinary catheters in
11 the paediatric patients I was looking after. One of my
12 particular interests was renal function.
13 Q. So the question is really quite simple: did it happen or
14 did it not, or was it mixed?
15 A. It was mixed. One of the sensitivities was these
16 patients often had long post-operative courses and there
17 was concern about sepsis from urinary catheters.
18 MR LANGSTAFF: Dr Sumner?
19 DR SUMNER: I mean, it is absolutely routine in my practice
20 and in the practice of places I have worked and visited
21 to have a urinary catheter. It is put in in an aseptic
22 way. The patient is always covered initially by
23 antibiotics and naturally, the incidence of sepsis
24 related to a urinary catheter is extremely low.
25 Q. Which is the greater problem, do you think, in intensive
0060
1 care management: the risk of sepsis or the absence of
2 information which a catheter might give him?
3 DR SUMNER: The latter.
4 DR BOLSIN: Could I say, I agree with Dr Sumner. The
5 sensitivity to catheters was from the surgeons, not the
6 anaesthetists or the intensivist.
7 MR LANGSTAFF: You are saying there obviously was some
8 discussion about the practice.
9 DR BOLSIN: If the urinary catheter was not inserted it
10 would be a surgery decision, not an anaesthetic
11 decision.
12 MR LANGSTAFF: Going back to the question of urinary
13 management on the ICU, are you suggesting that
14 catheterisation was really too late in Melissa's case,
15 or the dialysis too late?
16 DR SUMNER: I think that certainly in my practice, I would
17 have seen more clearly the trend of the urine output on
18 the day of the 19th, on the second post-operative day.
19 We would have had a warning that things were likely to
20 be going downhill from that point of view and that we
21 should move quite quickly and if we do not get
22 a response to the measures we take to produce urine,
23 then we have to dialyse them and that would be --
24 I would only wait one hour with no urine.
25 MR LANGSTAFF: There was a stage which we can pick up from
0061
1 the notes at which there was an indication that Melissa
2 had suffered further problems to her central nervous
3 system. Can we put a date on that?
4 DR SUMNER: I could see, on the 22nd, at 6.45 in the
5 morning, the nurses first noticed that Melissa's pupils
6 were unequal.
7 Q. And the significance of that is ...
8 DR SUMNER: The significance of that is that the pressure
9 within the head is rising and on what is called
10 a process of "coning", where the contents of the brain
11 are becoming extruded through the foramen magnum, the
12 hole in the bottom of the skull and this immediately
13 causes a change in the pupils.
14 I think that was understood by the people involved
15 with Melissa. They understood this was a very, very
16 serious cerebral manifestation.
17 Q. So can you tell me what the practice would be in the
18 hospitals with which you have been concerned when
19 a child suffers an event which is demonstrable in this
20 way as to telling parents what has happened?
21 DR SUMNER: I think this is a very difficult question. One
22 always wants to remain optimistic, but one also has to
23 be realistic. Melissa was very poorly, there is no
24 doubt about it, not initially when she first came back
25 from the operating theatre, but some time in the first
0062
1 operative night, she was very poorly from then on. It
2 was not possible, really, to know what was happening
3 inside the head, except retrospectively. I think they
4 were in a difficult situation and they were managing
5 things as they happened, rather than being proactive.
6 I think nevertheless, all the factors that we know would
7 exacerbate a cerebral insult were present in Melissa,
8 low cardiac output, particularly a high venous pressure
9 and we know from the postmortem examination that the
10 cerebral veins were congested. I think that must have
11 been a very potent --
12 Q. But looking at it in terms of observing Melissa there in
13 the ICU and knowing that something has happened because
14 of the way in which the pupils react, as you have
15 described, the parents of a baby like this are going to
16 be in and out and at the child's bedside more often than
17 not. What does one say to parents? Is it a difficult
18 balance? How should one, do you think, as you see it,
19 and bearing in mind yours would be one of a number of
20 views that the Panel will wish to consider of this sort
21 of difficulty, how would you see that the matter might
22 be addressed?
23 DR SUMNER: I have always tried to be very open about the
24 clinical state, as far as the parents are concerned, and
25 our practice was to meet them regularly, and again,
0063
1 whenever necessary. If there had been a major change in
2 the clinical situation.
3 I think if there were pupillary changes as there
4 were, these would be communicated and the implication of
5 them would be communicated to the parents, and I believe
6 should be.
7 Q. On most units, by whom?
8 A. I think the most senior person who is available to do
9 that, really, and who knows what the clinical
10 implication of the findings are.
11 Q. One of the matters Mrs Clarke was telling us about was
12 the way in which the nurses did not say anything to her
13 and as you see the units that you have been associated
14 with, would you expect -- do I take it from your last
15 answer, you would not expect the nurses to deal with it
16 because after all it needs to be dealt with by the most
17 senior person on the ward?
18 A. I think it should be dealt with by as senior a clinician
19 as possible in the presence of a nurse and for several
20 reasons, really: one is that the nurse who is with the
21 child 24 hours a day and who the parents get to know and
22 become quite intimate with, that person must be
23 involved. And also, because it is very difficult for
24 a parent to be told bad news, to take everything in at
25 one interview, the function of the nurse can then be to
0064
1 explain further or reinforce what has been said and the
2 implications of it.
3 MR LANGSTAFF: One of the things about which Tracey Clarke
4 told us when she gave evidence was that throughout the
5 week the staff at the ITU were telling her that things
6 were fine, yet they ought to have known from the notes
7 that there were in fact serious problems.
8 This is perhaps a question of approach, but were
9 you conscious that that approach was at least on
10 occasions taken by staff in the ICU?
11 DR BOLSIN: Are we talking about medical staff, or the
12 nursing staff here?
13 Q. All staff.
14 A. I would take Dr Sumner's approach, which is to --
15 Q. The question I am asking is not the theoretical one of
16 what should happen, but the factual one of what you saw
17 happening as you recall history, so it is a historical
18 question. Was this the sort of reaction that you were
19 conscious sometimes happened?
20 A. It may sometimes have happened. The reason I was going
21 to give my practice was because I was one of the staff
22 on that unit, and I did observe my practice on that
23 unit, so that I can really share my practice best. But
24 I think that there may have been people who would have
25 erred on the side of optimism and perhaps waited for
0065
1 senior clinicians to come and break bad news.
2 Q. I do not know whether you recall or not why it was you
3 became involved in this particular case?
4 A. I was on call for the Intensive Care Unit on the Friday,
5 I believe, and I had a cardiac surgical commitment on
6 that Friday as well, so the responsibility of the
7 patients within the Intensive Care Unit would fall
8 automatically to me. I did the ward round in the
9 morning, and -- I will never forget this ward round --
10 Melissa was the first patient that I saw.
11 It was very obvious to me that she had serious
12 cerebral problems and the most striking feature of the
13 management of the parents had been that the last
14 communication with the parents by a member of the
15 medical staff was that Melissa was making a perfectly
16 normal recovery. That was definitely not true, and my
17 job was now, as a matter of some urgency, to counsel the
18 parents about the actual state of Melissa and what their
19 expectations could and should be, and what we were
20 thinking about Melissa's management. That was going to
21 be a very difficult interview, but a very, very
22 important and necessary interview for the Clarkes.
23 Q. And you had not met the parents before?
24 A. I had not, no. All I knew was that they had last been
25 told that Melissa was making a perfectly normal
0066
1 recovery.
2 Q. So the fact of the way in which the ICU was organised,
3 meant that you as the senior clinician responsible may
4 have to break difficult news to parents who would be
5 very distressed by it, and whom you had had no
6 relationship at all with before?
7 A. Yes. I was fortunate on that day because Helen Stratton
8 was also on duty, and she was the cardiac liaison
9 sister. She had established a relationship with the
10 Clarkes and she was absolutely pivotal in getting
11 together the meeting and being able to act as a common
12 ground for me to establish the relationship to undertake
13 this extremely difficult --
14 Q. I do not want to dwell on matters which are going to be
15 distressing for some to listen to, so I am not going to
16 ask you precisely what you said to the Clarkes, but was
17 it the case that you were not in a position, when you
18 spoke to Tracey Clarke and her husband, to turn the
19 ventilator off at that stage, even though there was,
20 from what you were saying, no useful purpose to be
21 achieved by keeping it on?
22 A. I think that the conversation that we had, as I remember
23 it, was that we looked at a range of possibilities and
24 certainly, for me in dealing with this sudden turnaround
25 of expectation on the part of the parents, you have to
0067
1 present a range of possibilities for the child's
2 condition. I would have expressed a range which varied
3 from, "We will be going on to test Melissa to see if she
4 has actually become clinically dead on the ventilator",
5 through to, "We will need to continue to assess
6 Melissa's cerebral condition to look at the chances of
7 recovery", and I would have expressed a range, because
8 at the time I spoke to them, we actually had not
9 undertaken all of the tests that we needed to come up
10 with firm conclusions.
11 Q. Her recollection of the conversation is that you
12 indicated you could not turn the ventilator off until
13 Mr Dhasmana was there, and he, as it happened, was on
14 holiday that day.
15 A. Mr Dhasmana's presence on the unit would not have been
16 the determinant of whether support of that nature was
17 withdrawn.
18 Q. So you had the full responsibility to make the decisions
19 of that sort?
20 A. Yes.
21 MR LANGSTAFF: I want to leave the particular facts of
22 Melissa Clarke and talk about how they fit in with the
23 picture that you may have discovered, Dr Sumner, from
24 looking at other cases in the Clinical Case Note
25 Review. But before I leave, may I say, sir, to you and
0068
1 to the Panel, that of course what you have heard today
2 is the expression of views of one expert and
3 a consultant anaesthetist; some of those views may touch
4 upon conduct which others will wish to dispute. If
5 I can just simply say, you have not necessarily heard
6 the whole picture yet, and it would be wrong for and for
7 others to draw any premature conclusion from what has
8 been said, although plainly there is evidence which
9 might otherwise be entitled to full respect.
10 Dr Sumner, the pattern that you have told us of,
11 which you indicated in what you were saying you saw in
12 your review of the records in relation to Melissa, was
13 reminiscent of other cases you have looked at in looking
14 at cases in the Case Note Review?
15 DR SUMNER: My group looked at 20 cases, 10 who had died and
16 10 children who had not, and there were patterns. The
17 predominant impression that I gained was of the
18 inadequate cardiology input post-operatively, really,
19 that cardiological investigations which were in common
20 usage in those days, in the 1980s, from the mid-1980s,
21 such as echocardiography, the use at the bedside,
22 non-invasive, a wonderful tool, was late in coming or
23 being asked for on many occasions.
24 When a diagnosis was made, then such as in
25 Melissa's case, the first echo was actually done,
0069
1 I think, on the 18th, the day post-operatively. Having
2 got the information, I did get the impression sometimes
3 that the treatment of conditions was sub-optimal,
4 sometimes; that it would not be -- or late. A residual
5 defect, for example, was not treated, that sort of
6 thing. I got the impression that the fluid management
7 although protocolised, was not as professional as I had
8 been used to, notably, the lack of information from the
9 hour to hour urine outputs, and to be an early warning
10 sign of impending problems.
11 MR LANGSTAFF: So did this, then, strike you, from the cases
12 which you looked at, as being something of a failure to
13 analyse properly the information that might have been
14 available, to either seek more or to decide upon
15 a prompt and appropriate strategy of management?
16 DR SUMNER: Yes. I think that sums it up.
17 MR LANGSTAFF: Dr Bolsin, you were a person with passing
18 responsibility for the ICU -- I say "passing" because
19 you would be responsible when you were there. To what
20 extent are Dr Sumner's reflections on the cases which he
21 has seen as representative samples of the cases that
22 went through Bristol between 1984 and 1995, true of the
23 period that you, from 1988 until 1995, were in part
24 responsible for the ICU?
25 DR BOLSIN: I would tend to agree with Dr Sumner's
0070
1 comments. I was actually only in Bristol from the end
2 of 1988 through to 1996 --
3 Q. That is why I said 1988 to 1995 in your case.
4 A. I had done intensive care in Australia, and was very
5 keen to establish an anaesthetic presence in the
6 post-operative management of the patients. As Dr Sumner
7 points out, the fluid management was protocolised by
8 a surgical book, which was, as far as we anaesthetists
9 and intensivists were concerned, probably out of date.
10 I felt that some of the renal management was also
11 out of date. I think that looking at the specific case
12 of Melissa and also extending it into more general
13 cases, the fact that the paediatric renal physicians
14 were not on site meant that a renal referral in
15 a paediatric case often meant that a renal physician
16 would have to finish their day's work at the Children's
17 Hospital before coming down and seeing patients at the
18 BRI ICU. So there may again be an implication of
19 a split site problem. Certainly we were working to try
20 and improve the protocols, to try and improve the
21 post-operative management through intensive care
22 principals which Dr Sumner sees lacking in his case
23 reviews.
24 Q. So I sum it up by saying that you were conscious as
25 a group of the need for protocols of the desirability of
0071
1 a unified site for, amongst other things, the question
2 of fluid management and the availability of renal
3 physician help?
4 A. The protocols existed. We were trying to improve the
5 protocols. We as anaesthetists and intensivists felt
6 they were out of date.
7 Q. Dr Pryn has told us about the improvements he made as
8 soon as he came in terms of developing protocols,
9 promulgating them and seeking agreement on them.
10 A. Yes.
11 Q. So the picture we have is one of improvement throughout
12 the period, which I think is the picture you are
13 painting, but from what you are saying, appearing to lag
14 behind the practice else where.
15 I am not going to ask you to comment on that
16 unless you disagree, but let me ask Dr Sumner, is that
17 a reflection of the picture as you would see it?
18 DR SUMNER: Yes. I think change of this sort does not occur
19 overnight because we are getting more information all
20 the time, so sometimes we have to decide whether
21 something that other people do is right for our unit,
22 and it is a constant flux, really, of development.
23 MR LANGSTAFF: Did you, for your part, Dr Bolsin, ever offer
24 to update the red book, the surgical book on intensive
25 care management?
0072
1 A. No, I was not aware that the red book existed until
2 I had been there for several years, possibly until Steve
3 Pryn realised it was the basis for post-operative
4 management. I think there was a reluctance on the part
5 of the surgeons to relinquish what they saw as control
6 of their patients in the post-operative phase.
7 Q. The last edition we are told had in fact been written
8 with the collaboration of Dr Jarvis, who was at the time
9 an anaesthetic Senior Registrar, in 1988. I do not know
10 if you remember Dr Jarvis?
11 A. No.
12 Q. So it would have been in existence shortly after you
13 arrived. In ignorance of there being a red book, did
14 you yourself suggest and develop protocols which might
15 be of use to yourself and others in dealing with the
16 ICU?
17 A. We certainly discussed protocols, possibly more on case
18 management lines rather than on generalised conditions.
19 The important point to remember is that a child, for
20 example, that has one condition may require very
21 different protocols to a child that has another
22 condition, sepsis versus low cardiac outputs require
23 very different conditions and I would be looking for
24 protocols on the basis of the disease you are treating
25 rather than every patient gets this fluid replacement,
0073
1 or those kind of things.
2 Q. When you say "we discussed", who is the "we"?
3 A. It would have been discussion certainly amongst the
4 paediatric cardiac anaesthetists, Dr Monk, Dr Underwood,
5 Dr Masey.
6 Q. And yourself?
7 A. Yes.
8 THE CHAIRMAN: May I just interject so I can understand the
9 timing? Your answer a moment ago was that the fluid
10 management was protocolised by a surgical book which
11 was, "as far as we, anaesthetists and intensivists" were
12 concerned, probably out of date.
13 You said a little later you were not aware of the
14 red book. Explore with me how those propositions are
15 compatible.
16 DR BOLSIN: I think when Dr Pryn showed me the contents of
17 the red book, I was aware that it was not current
18 practice at the time and if that had been what had been
19 happening in the unit, then it would not have been
20 up-to-date practice at that time.
21 If it was the law for the surgical SHO that he had
22 to apply the red book, it would explain why the
23 management was not necessarily along the lines that we
24 as intensivists would have recommended for specific
25 conditions.
0074
1 THE CHAIRMAN: So did you know that there were
2 protocols, but you did not know the source of the
3 protocoling, or were you not until then aware that there
4 were protocols?
5 DR BOLSIN: I think it is probably the former. Yes,
6 I think it is probably the former.
7 MR LANGSTAFF: Will you just give me one moment?
8 (Pause). If you knew there were protocols but had not
9 seen the red book, had you ever actually seen the
10 protocols which you were supposed to be addressing in
11 management of the ICU?
12 A. I had seen the protocols written down as fluid
13 replacement prescriptions, but I had not seen the source
14 of the fluid replacement prescription protocols.
15 Q. I am not sure I understand that answer. The red book
16 you had not seen until later. You were aware there were
17 protocols but you had not seen them as such?
18 A. No.
19 Q. Or had you seen them as such?
20 A. They might be written down at the top of a child's
21 prescription chart as "fluid replacement for 24 hours
22 3mls per kilogram clear fluid" or whatever it was, so
23 they would be written down for each patient rather than
24 as a series of protocols that were kept in a central
25 location in the unit.
0075
1 Q. And the only information you would then have that those
2 were protocols would be the similarity of one case of
3 a particular type to another?
4 A. Yes. If I was looking at that, I would say "This child
5 may need more fluid, let us increase the fluid in the
6 protocol", or "This child is overloaded, let us reduce
7 the fluid in the protocol for that child", rather than
8 "Let us change the protocol in the red book or the
9 central location".
10 Q. A protocol, let us be sure we are talking about the same
11 thing: a protocol as I would understand it is a standing
12 instruction to be followed in all cases that fall within
13 the identified parameters, the parameter identified,
14 that is in the standing instruction.
15 Is that a proper and correct understanding of what
16 a protocol is?
17 A. Yes.
18 Q. So the note at the top of an individual child's chart
19 or records would not, itself, be a protocol, it may be
20 a reflection of the protocol?
21 A. Yes.
22 Q. Looking simply at the identity between one child's chart
23 and another child's chart, how do you identify habit,
24 giving the same amount if you are the same person to the
25 same sort of child in the same sort of case, from the
0076
1 application of a protocol which is an agreed standard
2 laid down for application in all such cases that fall
3 within those parameters? How do you distinguish the
4 two?
5 A. I think that in the case in the unit, there would not be
6 the prescription written down or the formula written
7 down. I was not sure whether that formula was taken
8 from a textbook of surgery or paediatric intensive care
9 or whatever textbook it was taken from, or whether it
10 was taken from a protocol. When I saw the prescription
11 written down, I would look specifically at the
12 applicability of that prescription for that child with
13 that condition on that day, and I would not be saying,
14 "Just because a textbook or something else says that
15 this is what a post-operative cardiac patient requires,
16 this is what we write up"; I would say "This child has
17 specific needs and requirements and we must modify
18 whatever the surgical SHO or anybody else has decided is
19 the fluid replacement for the day".
20 Q. So is it the case that you never asked about the
21 protocols that underlay the original prescription, or
22 might have underlain the original prescription?
23 A. I think my assumption was that the SHOs were given some
24 tuition by the Registrars or consultant surgeons when
25 they came on to the unit and had a little piece of paper
0077
1 which they had formally written down. That was the
2 understanding that I had.
3 My management was directed at modifying that in
4 individual cases rather than providing another set of
5 protocols which might be totally inappropriate for half
6 the patients going through the unit.
7 Q. Plainly, you felt free within the scope of your clinical
8 responsibility to modify whatever prescription had been
9 first applied to the child?
10 A. Yes, modify with discussion. I would explain, "This
11 patient is now fluid overloaded therefore this figure is
12 too high, therefore we must restrict" et cetera.
13 Q. Discussion with whom?
14 A. It would be with the surgical SHO, the Surgical
15 Registrar or the Anaesthetic Registrar when there was an
16 Anaesthetic Registrar presence or with the consultant
17 surgeon, whoever happened to be around at the time.
18 Q. And you say that you felt the protocols of which these
19 prescriptions would inevitably be reflective, because
20 you never saw the protocols themselves, were out of
21 date. Did you reach that conclusion never having seen
22 the protocols, or did you reach that conclusion in
23 retrospect with the eyes of 1993/94 or whatever it was
24 when Dr Pryn drew your attention to the red book?
25 A. I think my intensive care training in Australia had led
0078
1 me to believe that each patient has to be detailed on an
2 individual basis.
3 Q. That is not quite what I am asking you. I am asking
4 whether it was that you drew the conclusion that the
5 protocol was out of date without actually having seen
6 it, or whether you drew the conclusion it was out of
7 date in 1993/94 having seen it then, and inevitably
8 looking at it with the eyes of the mid-1990s?
9 A. I think I drew the conclusion that the protocol was out
10 of date originally when I saw it, but I also drew the
11 conclusion that some were inapplicable to certain
12 conditions to which they were being applied within the
13 unit and that was an out-of-date practice.
14 Q. "Practices", because you did not know there were
15 protocols at the time?
16 A. Yes, I think that is a good use of the phrase.
17 Q. What did you do to influence any alteration in that
18 practice?
19 A. I would explain the particular condition and particular
20 needs of that patient to the clinicians who were
21 involved jointly with the care and explain why
22 I believed that that fluid rationing was inappropriate
23 or was appropriate or should be increased.
24 Q. Do you think that made a difference to those cases in
25 which you had been involved?
0079
1 A. I would like to think so, yes.
2 THE CHAIRMAN: May I ask one further question,
3 Mr Langstaff? If you are seeing decisions about
4 management in the intensive care being set down which
5 you surmise are drawn from some as it were
6 "aide-memoire", let us call it that, and where those
7 decisions do not coincide with what you regard as best
8 practice, you change in consultation with others, is
9 there not there, unless that aide-memoire is brought up
10 to date and in consequence was what you understand to be
11 best practice, an in-built recipe for conflict in the
12 management of any patient where there might be
13 a disagreement between and you the other?
14 A. Yes. I think that if the aide-memoire was, for example,
15 a surgical textbook, then it would not be appropriate to
16 say "That is wrong as a source"; it would be appropriate
17 to say "This is an inapplicable patient for the
18 application of that regimen" and that was the way
19 I approached the prescriptions that I saw.
20 Q. You agreed with me by saying "Yes", but then the rest of
21 your answer did not necessarily relate to the
22 possibility of conflict.
23 I have no view about this; I am seeking help. If
24 there is a "recipe book", as it were -- and I use that
25 just colloquially to help us -- which you think is out
0080
1 of date, which you have to change whenever you come to
2 be involved, then there is a recipe for conflict, is
3 there not?
4 I am wondering (a) if you agree with that;
5 (b) does it follow that someone has to do something
6 about that possibility of conflict?
7 A. I think that what I was seeking to do was -- in some of
8 the patients the recipe will apply. In some of the
9 patients the recipe will not apply. I was seeking to
10 try and train the junior staff and possibly the senior
11 staff to decide whether the recipe was applicable or
12 inapplicable, and look at the modification of a recipe
13 from being a rigid application of a protocol.
14 Does that help?
15 THE CHAIRMAN: It may be that we will get no further, but
16 I had understood you to say that you were not aware of
17 the recipe book as such, so it would be terribly ad hoc,
18 would it not, but you might have been aware of
19 continuing disagreement between your approach to
20 management and that of others, which might have provoked
21 a question as to what to be done about it?
22 A. I think that the thing about the protocol -- perhaps
23 just to clarify it -- is that if it prescribes let us
24 say a certain amount of fluid, we can have a situation
25 in which more fluid is required and we would then
0081
1 increase the prescription.
2 There may be a situation in which less fluid is
3 required, in which case we would negotiate and reduce
4 the prescription. The fluid may be appropriate for
5 40, 60, 80 per cent of the patients. To query the
6 protocol and leave the SHOs with nothing as their basis
7 would be a worse situation than having a protocol we
8 could modify according to the condition of the patient.
9 Does that help?
10 MR LANGSTAFF: I wonder if the picture that you are
11 painting is not so much that of protocols which are out
12 of date and therefore inappropriate, as saying, "Well,
13 not every case falls within the strict parameters of
14 a protocol"?
15 A. Yes, certainly.
16 Q. Dr Sumner, can I turn to something slightly different
17 which arises in part out of evidence which we have heard
18 from Dr Bolsin, in part with the case of Melissa Clarke
19 in mind and the general observations that we have been
20 making.
21 It is this: plainly there is a risk of
22 neurological complications, or for that matter, renal
23 complications, arising post-operatively in cardiac
24 surgery of this sort.
25 Is it possible to say whether a unit which has
0082
1 a poor record in terms of mortality is, by virtue of
2 that fact, likely, as one might intuitively suppose, to
3 have a poor record also in morbidity? Or is it the
4 case, perhaps, that those units which have a poor record
5 in mortality, may it be supposed, have a lesser
6 incidence of morbidity generally speaking, perhaps
7 because the more morbid patients are not in that unit
8 saved as they are in others?
9 DR SUMNER: It is not a very easy question to answer.
10 Certainly my, and I think a lot of people's reactions
11 would be that in a unit that has a higher mortality,
12 then you might expect a higher incidence of
13 post-operative complications.
14 There have been some studies on this. I did some
15 homework yesterday, actually, and there have been some
16 studies from the United States -- I could not find any
17 from this country -- relating to cardiac surgery in
18 adults. I think there were more than 50 centres
19 involved in the data collection. It transpired that
20 centres with a low mortality, good centres, had the same
21 complication rate as centres with the higher mortality.
22 But the difference was that the better centres, that is,
23 centres with a lower mortality in adult cardiac surgery,
24 had a better record of rescue of the complications, that
25 is, they recognised them earlier and treated them
0083
1 better, for the same severity score.
2 Those are the only data I can draw on, I am
3 afraid, because my own gut feeling had been more
4 mortality, more complications, but that does not seem to
5 be the case.
6 Q. Is this then something of an open question at the
7 moment?
8 DR SUMNER: It depends on whether you believe the
9 statistics. I mean, it is easy to read and make one's
10 own mind up. The primary author of this work is
11 JH Silver and he works in Philadelphia. I think it
12 makes very interesting reading, but it does also imply
13 that if you are doing the same case mix of adult cardiac
14 surgery and you have a low mortality, even though you
15 get the same amount of complications, you will be better
16 at dealing with them.
17 THE CHAIRMAN: Might it also be explained by the fact
18 that one of the relevant factors for low mortality in
19 the first place would be excellent care throughout, from
20 immediate pre-operative right through to
21 post-operative?
22 DR SUMNER: I am sure that is the case, but I think that
23 American institutions have always been, quite rightly,
24 interested in outcome data, both of mortality and of
25 morbidity related to economic factors, which they and we
0084
1 are interested now, but I think we are behind the
2 Americans in this.
3 THE CHAIRMAN: I did not put my question as well as
4 I intended. One's intuition is that if this is a centre
5 with low mortality, it has very high quality people at
6 all points along the scale of care, and therefore they
7 would be better at rescuing people with a higher
8 morbidity risk otherwise?
9 DR SUMNER: Yes, absolutely.
10 MR LANGSTAFF: Can I explore for a moment the converse of
11 that? If one had a unit in which the pre-operative and
12 operative phases were good, for want of a better word,
13 what crucial difference will the quality of the
14 post-operative management make? Perhaps it is obvious.
15 DR SUMNER: I think the Chairman made the point that the
16 result of the treatment, the end result, the outcome, is
17 related to excellent care throughout. So if at one
18 stage it is suboptimal, it is bound to make a difference
19 to both mortality and to the rescue of the
20 complications.
21 MR LANGSTAFF: I do not know whether there is any comment
22 you want to make arising out of those la