Annex A > Chapter 28 - Concerns 1993 > Concerns
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Concerns
The data produced by Dr Bolsin and Dr Black
1 Dr Bolsin stated that the results of his data collection were available in early 1993. Dr Bolsin's evidence was:
`... [Dr Black] subjected the data to simple statistical analysis. The numbers were small but gave an indication of potentially significant differences between the results of Bristol and the national average comparative data. The indications were that for two operations (Tetralogy of Fallot and A-V canal) the mortality in Bristol was higher than the rest of the country. The initial data also indicated incorrectly that there was a higher mortality for VSD procedures in Bristol than in the rest of the country. When the error in the VSD data was pointed out to Dr Black and myself we withdrew the comparison. The Fontan procedure mortality was the same in Bristol as the rest of the country.' [1]
2 Dr Bolsin continued to collect data on the Arterial Switch programme and showed the initial results to Professor Prys-Roberts, Professor of Anaesthesia at the University of Bristol. Dr Bolsin also went to see Professor John Farndon. Dr Black also showed the data to Dr Sally Masey, consultant anaesthetist. [2]
3 Professor Farndon was appointed as Professor and Head of the Division of Surgery at the University of Bristol in 1988. He indicated in his written evidence to the Inquiry that he was not an expert in cardiac surgery:
`My understanding of cardiac surgical procedures in general and their associated morbidity/mortality and, in particular paediatric cardiac surgery, was and is very limited. I would not have known the benchmarks that the cardiac surgeons should have been achieving. Few other surgical sub-specialties have mortality and morbidity to match that of cardiac surgery, ... I knew that the cardiac surgeons were submitting data to a national audit where comparisons with other units would be made. The process should have identified problems and corrections to allow closure of the audit loop. When reporting to the Medical Audit Committee I informed them that cardiac surgery were submitting externally. I felt that this national arena was the most appropriate way of dealing with cardiac surgery and provided a secure mechanism.' [3]
4 Professor Farndon was asked in oral evidence about his knowledge of paediatric cardiac surgery in Bristol in the early 1990s and whether he had heard anything about Bristol's performance. He replied:
`It is a very difficult question to answer, because I suppose in hospital settings, one gets a buzz or a ring and some departments are totally quiet and one hears of no reputation or repute, and in others one hears of some anxieties, general anxieties. I cannot honestly recall when I first became aware of others' concern in that area.' [4]
5 Professor Farndon became aware of concerns about the Bristol service early in 1993 when Dr Bolsin came to see him:
`In the early part of 1993, Dr Bolsin came to see me to express concern about the results of the treatment of children with congenital heart disease. His main concern focused on mortality rates. I cannot recall clearly now, but I believe that Dr Bolsin declared at that meeting that he had compiled some data. I cannot remember the exact details of the conversation but I would say that the data would need to be validated, shared and owned by all doctors involved in the process of the care of children and a joint decision made as to its validity. I cannot recall whether I saw the data at that time.' [5]
6 Dr Bolsin stated in his written evidence to the Inquiry that he left hard copies of the data with Professor Farndon and that he remembered Professor Farndon saying he would look into the matter. [6]
7 On the data itself, Professor Farndon told the Inquiry:
`I find it very difficult to remember exactly what the nature is, and contrary to his [Dr Bolsin's] statement with regard to my own, I do not have and do not remember receiving a folder of data.' [7]
8 Professor Farndon described his meeting with Dr Bolsin in the following exchange:
`Q. When I asked you why Dr Bolsin came to you, whether you thought he was coming for general advice or whether he was bringing you particular problems with particular surgeons in particular operations, you said you presumed he was coming for two reasons: (1) that you would be the audit co-ordinator for surgery, and hence I assume would be in a position to give some general advice about the carrying out of audit; and (2) that he had some idea that your stance might be one of equity, and might be one of providing some help in a situation that he found difficult.
`What "help" were you referring to?
`A. The advice that he needed to be sure that everyone could agree his data, and then to benchmark and see whether there was a problem.
`Q. So the help you provided was to tell him, give him general advice about benchmarking his audit?
`A. About the process - advice about audit in general.
`Q. And then telling him to discuss it with the other people involved in the care of children?
`Q. Which bit of that was the situation, as you put it, that Dr Bolsin found difficult?
`A. I do not know.' [8]
9 Professor Farndon told the Inquiry that he was not competent to comment on the data itself:
`... I had nothing with which to benchmark. The concept of some of the operations, the complexity, the outcome measures, are totally unknown to me in my own practice. It does not come across to me in any professional reading or continued education. I have no idea where to benchmark any such data.' [9]
10 Professor Farndon said that his advice to Dr Bolsin at the time would have been:
`... that this data has to be owned and shared and you need to look at what is the mechanism of any problem, if there is a problem, if you are able to benchmark, is there a problem? What are the likely contributory factors?' [10]
11 Professor Farndon took the view that the data should be shared with the surgeons and:
`Not only that; that everyone, before the data gathering had begun, was aware that this was a process of audit and knew that they were contributing to the data and its analysis, so that the data is gathered with everyone knowing, looking at the risk management of patients so that the data can be meaningful.' [11]
12 Once Dr Bolsin had raised his concerns, Professor Farndon stated in his written evidence to the Inquiry that he then heard of concerns that other consultants had:
`Once Dr Bolsin had come to see me I remember speaking with colleagues (in passing) about the concerns he had raised. I cannot remember the dates or exactly to whom I spoke. I certainly spoke to Professor Angelini, perhaps two to three times, and these were informal "corridor conversations".
`Other colleagues approached me with concerns about paediatric cardiac surgery. Mr Bryan, Dr Monk, Professor Prys-Roberts and Dr Willatts talked to me. [12] These are the only names I can now recall. I cannot remember the exact details of their conversations. My stance then, as now, was to advise them to produce agreed audit data that everyone could own. This should have allowed discussion on whether there were "problems" or not.' [13]
13 Dr Bolsin told the Inquiry that:
`... I showed people the data and said "this is the data that Andy Black and I have collected, what do you think of this?"' [14]
14 Dr Bolsin indicated that Dr Masey was the first of the paediatric cardiac anaesthetists to see the data:
`... because Andy [Dr Black] had literally got it hot off the printer and Sally [Dr Masey] was in the department and he asked her for her comment on it, unsolicited, which I think gives a measure of the openness with which we were doing it in that Andy got the data. His first contact was not "Steve, do you think you ought to show this to your colleagues?" it was "Sally, what do you think of this?'' ' [15]
15 Dr Bolsin said that he thought that this occurred in `the spring of 1993'. [16]
16 In her written statement to the Inquiry, Dr Masey confirmed this account:
`In the spring of 1993, I discovered by chance about the "confidential audit" being conducted by Dr Bolsin when I was shown, in passing, by Dr Andrew Black, some preliminary results of analysis of mortality in paediatric cardiac surgery. I immediately felt that if this information was being collected that it needed to be accurate. I felt concerned that if it was being collected "confidentially", that this could lead to collection of inaccurate data. I do not recall the exact years to which the figures Dr Black showed me referred, but do recall that they included some data on Tetralogy of Fallot that included the 1990 figures. This was the year that I knew that the results had been unexpectedly, and unusually, high. There were also data on closure of ventricular septal defects, but I did not study these closely.
`Dr Bolsin arrived in my office while I was discussing these results with Dr Black and I again asked Dr Bolsin, if he had concerns, why he was not involving his cardiac anaesthetic colleagues, as I had done in 1990 after he had written to Dr Roylance. I expressed the opinion to him that it would be advisable to involve us, his cardiac anaesthetic colleagues. I suggested it would be easier to make sure that information was accurate if all of the cardiac anaesthetists were involved, and also the paediatric cardiac surgeons, and that if genuine concerns were highlighted it would be easier to address these as a group rather than as an individual. The only reason I recall that Dr Bolsin gave me that day as to why he was reluctant to approach the paediatric cardiac surgeons was that he thought that if they knew he was collecting this information they might prevent his access to information. I stated strongly to him that I considered it was inappropriate to collect this information in secret. However, Dr Bolsin continued to say that he felt this was the only way he could get information, as he felt that the paediatric cardiac surgeons did not produce these results themselves, or, if they did, they did not show them to anyone else. I commented to him that I had always been shown the results, but did agree that I could not recall having seen recent results. I said to Dr Bolsin that I had no doubt that if I asked Mr Dhasmana for the recent figures that he would give them to me immediately. Dr Bolsin showed some doubt as to whether the figures would be forthcoming. To test my hypothesis, I approached Mr Dhasmana the following day, and without explaining why I wanted them, I asked to see the most recent surgical results. He apologised that I had not received them earlier, and explained that the reporting date had been changed from the year-end to the end of March, and this had led to a delay in their preparation. He then went on to say that he had just completed the figures, and, as I had predicted, he showed them to me immediately. However, he did ask me not to show them to Dr Bolsin.
`As far as I am aware, apart from seeing the initial data in early 1993, I was never formally shown the results of Dr Bolsin's "confidential audit", although I did ask Dr Bolsin on a number of occasions to inform us, his cardiac anaesthetic colleagues, as to what he was doing, again for the reasons given above.' [17]
17 Mr Dhasmana indicated in a written response that he did not recall this conversation with Dr Masey. [18]
18 Dr Sheila Willatts, consultant in charge of the Intensive Care Unit (ICU) at the BRI since 1985, stated:
`I had prolonged discussions with Dr Stephen Bolsin in 1993 regarding the potentially adverse outcomes and the course of action he might reasonably take. I advised as follows ... "the issue was principally an audit one, namely that the results needed to be scrutinised, validated and agreed. During 1993 and 1994 I spoke to Professor Prys-Roberts, Professor Farndon and Chris Monk expressing my concerns that the data needed to be verified. I hoped that the results could be examined by a joint meeting of the surgeons and anaesthetists. It was my hope that the surgeons would bring their results to the meeting and the results should be discussed in an open forum. Professor Farndon volunteered his services as a potential chairman for such a meeting as he was not a cardiac surgeon".' [19]
19 In relation to the collection of data by Dr Bolsin and Dr Black, Dr Willatts stated:
`I believe that the surgical procedures reviewed and the sources of information were appropriate. If this audit could have been conducted openly with agreement between surgeons and anaesthetists it would have been a much stronger audit as the data would have been openly agreed. However, I do believe that it was impossible to obtain the necessary conditions for such a joint discussion to take place at that time as the strong personalities in cardiac surgery did not agree that this was necessary.' [20]
20 Mr Wisheart was asked about what he knew of the collection of data:
`Q. ... did you at any time see any data or figures or analyses, however one describes them, which were produced by Dr Bolsin in respect of paediatric cardiac surgery, at any rate before April 1995?
`A. Not before April 1995.' [21]
21 Dr Stephen Jordan retired in May 1993. He stated: `I was unaware of Dr Bolsin's audit of cardiac surgery until sometime after my retirement.' [22] In his oral evidence to the Inquiry he said:
`A. I saw no data at all. I was unaware at the time, up to the time of my retirement, that he had actually ever produced any data.
`Q. And you do not recall anyone mentioning such data existing to you during your time in post?
`A. As I have put in my statement, the only possible connection with this is the fact that I think it was Dr Bolsin introduced Dr Black to me and said he understood that I had some information on a computer at the Children's Hospital; could Dr Black have a look at it. I think I took Dr Black up and showed him what the information was. I am not aware of Dr Black ever having used this. That is the only possible connection that I can recall between myself and Dr Bolsin in terms of collecting data and auditing data.' [23]
22 Dr Jordan agreed, however, in the following exchange that he was aware of `some problems' in Bristol:
`Q. (the Chairman): Just one question from me, Dr Jordan. If an observer having heard your evidence formed a picture that you were someone who, recognising that there were some problems in Bristol, fought within Bristol to effect change while outside quietly suggested or warned people off; would that observer have any right to hold that view?
`A. There is some truth in it. I will perhaps give you an example: shortly before I retired I had discussions with cardiologists in South Wales, I think this has sort of been obliquely referred to. Basically they were obviously considering whether they should continue to send patients to Bristol and take on a new cardiologist from Bristol, there was going to be a change anyway and they were being offered, in fact being encouraged to use the service in Cardiff instead. The thing I said to all of them, and I used very similar words but not necessarily identical ones were "You have asked my advice and what you are asking is really what is best for our patients. If I thought that the centre in Bristol was absolutely the best centre in the UK and there was no way that anyone else was going to produce comparable or better results, I would say to you, `Do not try an untried unit in Cardiff'. Frankly, I do not think I am in a position to say that to you and therefore you will have to make up your mind whether you want to try a new unit or stick with Bristol." I think that is the sort of, if you like, comment I made which indicated that I was not going to go around blindly saying "Bristol is wonderful, keep on sending your patients there".' [24]
23 Dr Susan Underwood, consultant anaesthetist at the UBHT from 1991, stated in her written evidence to the Inquiry:
`I was aware that Steve Bolsin was undertaking an audit of the paediatric surgical work because he told me. He did not discuss details with me or show me the results.
`I recall an evening meeting in winter, possibly 1993, where I think all cardiac anaesthetists were present and Steve Bolsin expressed his concern over the paediatric cardiac surgery mortality. The group asked him to produce some data to substantiate it. He did not bring any data to future meetings.' [25]
24 Mr Roger Baird, consultant general surgeon, and Clinical Director for Surgery at UBHT from April 1991 to November 1993, told the Inquiry:
`I was aware that Dr Bolsin had some funding from the Department of Health to enable him to develop audit techniques in cardiac surgery from the anaesthetics point of view. I thought that was a good thing. I did not associate this with anything other than an academic interest in developing audit, at that time. I was not aware of the nature or purpose of the "confidential audit".' [26]
25 Dr Joffe stated that he and Dr Bolsin `never discussed paediatric cardiac surgical outcomes or services, nor was I privy to his secret audit. Indeed my first sight of his figures was in the `Daily Telegraph' and BBC West television, in April 1995.' [27]
26 Dr Roylance was asked when he first knew about the audit:
`Q. When did you first become aware that Dr Bolsin had been collecting, let us call it, "figures" or "data"?
`A. After the visit of Marc de Leval and Stewart Hunter.
`A. No.' [28]
27 Dr Roylance was asked by Counsel to the Inquiry specifically about 1993:
`Q. Did any whisper reach you do you think in 1993 that Dr Bolsin was not only collecting data but analysing it?
`A. No, I did not know about Dr Bolsin's activities until after the external inquiry by Marc De Leval and Stewart Hunter. That is when it emerged and I did not know of his activities before that date.' [29]
28 Professor Gordon Stirrat, Dean of the Faculty of Medicine, University of Bristol 1991-1993, told the Inquiry that no one made him aware of the collection of data and that:
`I would most certainly have expected Prys-Roberts to have done so ... Andrew Black and I have worked together closely for a long time ... I would have hoped that he might have felt able to tell me. But his direct line of responsibility was through Prys-Roberts.' [30]
29 Dr Bolsin, in his written evidence to the Inquiry, stated that Dr Black had told him that Professor Prys-Roberts had telephoned Dr Roylance `and informed him that there was a real and demonstrable problem in the Department of Paediatric Cardiac Surgery'. [31]
30 Professor Prys-Roberts was asked about this in the following exchange:
`Q. ... Do you recollect having any further information from Dr Bolsin or Dr Black about the process they had been engaged in since the summer 1992?
`A. I recollect having a meeting with them during which Steve had to leave and go off and left me to look at the data with Dr Black. I cannot recall the date. I know it would have been mid-1993 but probably not earlier and Dr Black showed me the results in tabulated form from a minute-type analysis that he had done. I do not recall doing anything about it at that stage because my recollection is that Andy Black went away and discussed it subsequently with Dr Bolsin, but they did not ask me to take any specific action at that stage.
`Q. If we go down the page, I think you have already referred to this, we can see that Dr Bolsin there informs us [the Inquiry] of something Dr Black is said to have told him, that you immediately telephoned Dr Roylance; that is not something, I think you have already told us, that you remember doing?
`A. I do not remember doing it. I have discussed it with Dr Black and he does not remember me doing it in his presence.
`Q. You say that Dr Black and Dr Bolsin did not ask you to do anything specific?
`Q. What was your reaction to the data they had given to you?
`A. My reaction was that the data - which were still not what I could call finalised figures, but they were figures which were much more reasonable, I did not look at them in real detail at the time - that these were simply confirming the conclusions we had come to before, that there was a serious cause for concern.
`Q. If there was a serious cause for concern, why not ring either Dr Roylance or possibly Mr Wisheart?
`A. With hindsight I do not know why not. As I have said, at that stage I was not spending a great deal of time in Bristol. I was not involved in the overall process, I knew that others were involved and becoming more involved certainly on the cardiac anaesthesia side and that they were concerned with Dr Roylance.
`I cannot recollect why at that particular stage I did not take it any further.' [32]
31 Dr Christopher Monk, Clinical Director of Anaesthesia from January 1993 to December 1995, said that he first became aware of the audit: `I believe in September 1993.' [33] He explained that he found out `because I went into the perfusionists' room ... where their data was recorded and one of them, or one of two people, said to me: "Do you know that Steve is looking at the data and trawling through the patients' notes?" or some similar phrase.' [34]
32 Dr Monk described the audit as `clandestine' because: `it did not involve the process of speaking to the consultant anaesthetists providing the anaesthesia or the consultant surgeons who were performing the operations in providing the information'. [35]
33 Dr Monk told the Inquiry that had he known about Dr Bolsin's exercise beforehand:
`I think I would have been sympathetic to his intentions, but I think it should have been open as opposed to private in the way that he did it, because, having got the data, it then becomes difficult to disseminate it.' [36]
34 Putting it in the context of the time, Dr Monk said:
`... you have to look at it in terms of 1992, when audit nationally was only just being introduced. The impressions were that the people who did the work owned the audit.' [37]
35 In his written evidence to the Inquiry, Dr Ian Davies, consultant anaesthetist at the BRI from 1993, stated:
`When I worked at St George's as a Senior Registrar and was applying to Bristol, Mr John Parker led me to believe that the Bristol Cardiac Unit was under threat because of the quality of the services provided at that Unit. As I recall, he told me that if I had been interested in a career in paediatric cardiac anaesthesia, he would advise me not to go there.' [38]
36 Dr Davies referred to a conversation which he had had with Dr Bolsin prior to his joining the BRI in April 1993:
`In the course of my conversation with him, he told me that the Paediatric Cardiac Surgical Programme was unsatisfactory, and that he was particularly concerned about the switch programme.' [39]
`After I started at BRI, Dr Bolsin spoke to me on a number of occasions about his concerns.' [40]
38 At a meeting of the UBHT Management Board on 7 December 1992 it was noted in the minutes that:
`Dr Roylance advised that Julian Le Vay, a member of a Regional working group set up to look at cardiac services in the Region would recommend to Bristol & District the creation of a second site for cardiac services at Derriford. Dissatisfaction had been expressed about the quality and cost of services offered in Bristol. He would discuss this with Mr Wisheart.' [41]
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Footnotes
[1] WIT 0080 0113 Dr Bolsin. See Chapter 3 for an explanation of these clinical terms
[2] WIT 0080 0113 Dr Bolsin
[3] WIT 0087 0003 - 0004 Professor Farndon
[4] T69 p.88-9 Professor Farndon
[5] WIT 0087 0006 - 0007 Professor Farndon
[6] WIT 0087 0032 Dr Bolsin
[7] T69 p.94 Professor Farndon
[8] T69 p.105-6 Professor Farndon
[9] T69 p.95 Professor Farndon
[10] T69 p.96 Professor Farndon
[11] T69 p.101 Professor Farndon
[12] Mr Alan Bryan, Senior Lecturer in Cardiac Surgery, University of Bristol and consultant cardiac surgeon, BRI; Dr Christopher Monk, consultant anaesthetist and Clinical Director of Anaesthesia from January 1993-December 1995; Professor Cedric Prys-Roberts, Professor of Anaesthesia, University of Bristol and Honorary consultant Anaesthetist, UBHT; Dr Sheila Willatts, consultant in anaesthesia and intensive care medicine, BRI, and consultant in charge of ICU, BRI
[13] WIT 0087 0007 Professor Farndon
[17] WIT 0270 0014 - 0015 Dr Masey
[18] WIT 0270 0028 - 0029 Mr Dhasmana
[19] WIT 0343 0002 Dr Willatts
[20] WIT 0343 0002 Dr Willatts
[21] T94 p. 132-3 Mr Wisheart
[22] WIT 0099 0027 Dr Jordan
[25] WIT 0318 0011 Dr Underwood
[26] WIT 0075 0035 Mr Baird
[27] WIT 0097 0169 Dr Joffe
[30] T69 p.32 Professor Stirrat
[31] WIT 0080 0113 Dr Bolsin
[32] T94 p.57-8 Professor Prys-Roberts
[38] WIT 0455 0006 - 0007 Dr Davies
[39] WIT 0455 0001 Dr Davies
[40] WIT 0455 0002 Dr Davies
[41] UBHT 0058 0031; meeting of the UBHT Management Board; 7 December 1992