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Hearing summary11th May 1999
Today the Inquiry heard evidence from Sir Michael Carlisle, former Chairman of the Supra-Regional Services Advisory Group (SRSAG) from April 1989 until October 1994. He said that concentration of services in limited units benefited patients because clinical teams could only develop and maintain expertise if the units treated conditions on a regular basis. He said that the number of children being treated at several units designated to provide infant and neonatal cardiac services was an area for concern for a very long time but maintained strongly that he had never been aware of any quality issues being raised at meetings of the SRSAG. He said the roles of the medical and administrative secretaries were to visit units for information about performance in terms of activity and outcome. However, he stressed the difficulty of obtaining clinical data, which he said was common to the NHS as a whole, saying that the NHS has always been stronger on measures of volume than outcomes. He said he relied on his medical colleagues to advise him of any problems relating to clinical competency. Had any such concerns been raised with him, he said he would have instigated an inquiry led by representatives from the Royal Colleges. He placed great emphasis on clinical governance, and said that had it been more prominent during the period under investigation it could have made it significantly easier to access information relating to quality issues. He outlined the SRSAG discussions surrounding the designation and de-designation of infant and neonatal cardiology.
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FULL TRANSCRIPT
1 11th May 1999. 2 (9.40 am) 3 MR LANGSTAFF: Sir, good morning. This morning we have the 4 advantage of hearing from Sir Michael Carlisle, who was 5 Chairman of the Supra Regional Services Advisory Group 6 from April 1989 until October 1994. 7 Sir Michael, would you come forward, please? Sir, 8 Sir Michael is represented, as were the other Department 9 of Health officials from whom we heard, and we have also 10 in the hearing chamber today representatives of the 11 Children's Heart Action Group. 12 Sir Michael, would you stand to take the oath, as 13 is our custom? 14 SIR MICHAEL CARLISLE (Sworn) 15 Examined by MR LANGSTAFF: 16 Q. To your right is the screen upon which I hope we will 17 now be able to show you the first page of a witness 18 statement. It is WIT 41/1. 19 May I, sir, by way of background say, as 20 I mentioned yesterday evening, it was not possible, 21 because of the short notice at which Sir Michael was 22 able to provide the statement, to circulate it widely in 23 advance beforehand, but may I also pay tribute to those 24 who have, from their various perspectives, actually 25 given me input into what they might wish me to ask for 0001 1 the benefit of the Inquiry in respect of the statement, 2 and emphasize, as I did I think yesterday evening, that 3 it should not be thought that simply because people are 4 present in the hearing chamber without saying much, that 5 they are not contributing. 6 Sir Michael, this is the first page of a statement 7 which you have made for the benefit of this Inquiry? 8 A. Yes. 9 Q. Would you please look at the screen as it goes through 10 to page 41/7; is that your signature at the end? 11 A. It is. 12 Q. And the contents are, I take it, true? 13 A. The contents I have seen are true. 14 Q. You were, as you have already foreshadowed, the Chairman 15 of the Supra Regional Services Advisory Group from April 16 1989 until October 1994? 17 A. That is so. 18 Q. And it follows that you were the Chairman at a time when 19 the continued designation of Bristol Royal Infirmary and 20 Bristol Children's Hospital as a supra-regional centre 21 for neonatal and infant cardiac surgery came under the 22 spotlight? 23 A. The whole service of neonatal and infant cardiac surgery 24 had been under review since before my tenure as Chairman 25 and throughout it. 0002 1 Q. As we know from other evidence which we have heard and 2 reviewed in public, the service was de-designated before 3 you finished your term in office as Chair? 4 A. Indeed, it was. 5 Q. You make the point in your statement of telling us that 6 you were the Chairman who produced the first annual 7 report of the Supra Regional Services Advisory Group. 8 A. That is correct. If I can draw your attention to the 9 fact that it was at a time when there were major reforms 10 in the National Health Service and the process of 11 contracting, whether you like that term or not, was 12 taking place. I insisted, personally, on the production 13 of an annual report for the year 1992, I think it is, 14 1991/92, which was produced in 1993, because it actually 15 helped the rest of the NHS to understand what 16 supra-regional services were about, the amount of money 17 that was spent on them, and to try and give some 18 feed-back about the policy behind their work. 19 I also wished to insist upon annual reports of 20 each of the services or units being prepared annually, 21 because whilst local management had a very substantial 22 input into the way those services were conducted 23 professionally, as a contractor, the Department of 24 Health obviously had an accountability as well. 25 Q. Just on that last point you mention, I wonder if we can 0003 1 have on the screen, please, DOH 2/214? 2 You identify the document. Can we go back to the 3 page before, 213? This is perhaps your first meeting as 4 Chairman, was it? 5 A. I cannot recall, but it was about that time. 6 Q. In September 1989. These are minutes of the Supra 7 Regional Services Advisory Group for 28th September 8 1989. 9 If we go back to page 214 where I started, we can 10 see, in the paragraphs that we have there, there was 11 a need for some mechanism, if you have a look at that 12 and read down. Then in the next paragraph: 13 "The Chairman noted that the White Paper reforms 14 raised large issues for the supra-regional services. He 15 felt that the current method of assessing bids for 16 additional funding left a good deal to be desired; the 17 broadbrush approach would need to give way to a system 18 of contracts. The Group needed to know much more about 19 the costs of providing supra-regional services ...." 20 That resulted in members agreeing you should 21 convene a small group to consider the best way forward. 22 Then this is said: 23 "When the principles were resolved, there would be 24 a need for reliable accounting data as well as 25 information on outcomes of treatment." 0004 1 So we may take it, may we, that in general, 2 looking across all the supra-regional services, it was 3 realised in 1989 that there was a need for information 4 on outcomes of treatment? 5 A. The whole of the NHS has been weak on outcomes of 6 treatment. I would refer you to a recent paper in 7 respect of clinical governance, where weakness is 8 acknowledged of the outcome measurement data in the 9 whole of the NHS, and one of the reasons why the 10 National Institute of Clinical Effectiveness has been 11 established. 12 Q. I will ask you about that in a moment. 13 A. I am trying to say, I was, if you like, in advance of 14 thinking in putting that point forward at my first 15 meeting. 16 Q. You had a management perspective, I think, because you 17 came from management, not necessarily the National 18 Health Service, but from management generally? 19 A. But I had also had 20 years involvement in the NHS by 20 1989 as well. 21 Q. There, at any rate, we see the Supra Regional Services 22 Advisory Group itself saying, "We are going to need 23 outcome data"? 24 A. True. 25 Q. And if we can just look at UBHT 64/44, and again if we 0005 1 put this into context, we can go back, please, to 64/43, 2 and go back again before that, please. The bottom of 3 the page. That is to help to identify the tables. 4 These are documents which we understand were put forward 5 for the purpose of obtaining funding for information, 6 reports to the Supra Regional Services Advisory Group, 7 in this case as it happens from Bristol. As we can see, 8 it is dealing historically with 1989 to 1990, and 9 looking for the funding for 1990 to 1991. 10 Can we go back, please, to the page we started 11 at? 12 The information which was given formally to the 13 Supra Regional Services Advisory Group was workload; it 14 was volumetric. Your nod does not go down on the 15 transcript; I hope you do not mind my saying that. 16 A. I think I have said in my statement that the NHS has 17 always been strong on volume measurement, rather weak on 18 outcome. That remains the case. One of the briefs of 19 the National Institute for Clinical Excellence, of 20 course, is to improve that and it is going to be 21 a 10-year programme to do it, because it is difficult 22 and complex; it is easier in some outcomes than it is in 23 others. 24 Q. You mentioned the White Paper, and the new NHS was 25 probably what you had in mind, I suspect. May we, 0006 1 please, go to that? We have it at SLD 3. 2 We can look at SLD 3/11. This of course is a 1997 3 document so it is outside our terms of reference, but 4 I think it does what you said a moment ago: it sheds 5 light on the past. 6 A. Yes. 7 Q. We can see that, can we, looking at paragraph 6.8, for 8 instance: 9 "There will be a new focus on quality in NHS 10 Trusts ..." 11 Overleaf, at 3/12, dealing with the concept of 12 clinical governance. 13 Paragraph 6.12, if we look at what it says there: 14 "Professional and statutory bodies have a vital 15 role in setting and promoting standards, but shifting 16 the focus towards quality will also require 17 practitioners to accept responsibility for developing 18 and maintaining standards within their local NHS 19 organisations. For this reason, the government will 20 require every NHS Trust to embrace the concept of 21 clinical governance so that quality is at the core both 22 of their responsibilities as organisations and of each 23 of their staff as individual professionals. 24 "6.13: This new approach to quality..." 25 One accepts this is a White Paper and therefore 0007 1 the cynic might think there is an element of propaganda 2 from the authors. Is it right, is it consistent with 3 your view that in fact the approach is a new one in the 4 sense that it puts quality at the core of what 5 NHS Trusts are required to deliver, rather than volume? 6 A. Quality has always been at the forefront of everybody's 7 mind in delivering clinical services. I do not think 8 there is any doubt about that. The problem has been 9 measuring that quality. I think I strongly endorse the 10 present government's move in the Paper to which you are 11 referring in carrying this forward, because you cannot 12 manage services centrally and it combines very clearly 13 the establishment of clear standards of service at 14 national level and national service frameworks at 15 national level, with dependable local delivery, which is 16 professional self-regulation, clinical governance, 17 lifelong learning, those aspects, backed up by those 18 standards being monitored. The monitoring of those 19 standards will be done by the Commission for Health 20 Improvement, using patient and user surveys, using 21 national performance framework criteria. So I very 22 strongly endorse what the government is doing in 23 measuring quality. Quality has been pre-eminent, but 24 a number of academic efforts have been made over the 25 years, but there is no consistent comparable 0008 1 benchmarking, or in very few cases. 2 Q. Just looking down at 6.13, under the internal market, 3 NHS Trusts' principal statutory duties were financial. 4 "The government will bring forward legislation to give 5 them a new duty for the quality of care." 6 Just pausing there, is that sentence, in your 7 view, a fair reflection of the context in which you 8 operated in the Supra Regional Services Advisory Group? 9 A. Well, you are comparing a slightly different situation 10 with the Supra Regional Services Advisory Group, because 11 the Advisory Group, as I indicated in my statement, is 12 an Advisory Group, not a management group. 13 Q. You misunderstand. I was asking you about the context 14 of the NHS at the time. 15 A. At the time, the context of the NHS, I would quarrel 16 with that only in one statement. "NHS Trusts' principal 17 statutory duties were financial"; I do not agree with 18 that. It was delivering value for money. That is 19 a different thing. 20 Q. Paragraph 6.15, if I could ask you about that. What is 21 said in the White Paper, the second from last sentence: 22 "NHS Trust boards will expect to receive monthly 23 reports on quality in the same way as they now receive 24 financial reports, and to publish an annual report on 25 what they are doing to assure quality." 0009 1 The implication from that is that at least in many 2 NHS Trusts, before 1997, before the White Paper at any 3 rate, there were no monthly reports on quality, but 4 there were on finance. 5 A. There was a heavier emphasis on finance than on 6 quality. If quality issues had arisen, they would 7 probably have arisen in the early clinical audit setup 8 that was established in many hospitals. That was the 9 precursor of the White Paper, but it was not by any 10 means a heavily developed science. It did, of course, 11 enable local clinicians to peer group review, sometimes 12 with external help, what went on locally, and normally 13 there would be a Medical Director at the hospital and 14 there would be a responsibility for the Medical Director 15 to report any exceptional situation to the local Trust 16 board. 17 Q. Linking this in with what you yourself say in your 18 statement, WIT 41/5, it is halfway down the page, 19 beginning with: 20 "However, the introduction of contracting ..." 21 We see there the sentence: 22 "The entire NHS has always been stronger on 23 volumetric measures than outcomes." 24 You note the efforts which we have been talking 25 about to remedy this by the introduction of clinical 0010 1 governance which is to be taken as seriously as 2 financial governance, and the National Institute to 3 which you have already made reference. 4 So again, what you are saying here, I think, is 5 that the numbers of operations done, the amount of money 6 spent, were obvious measures which the NHS was stronger 7 on than outcomes. Is that what you are saying? 8 A. I would say across the whole of the NHS, that was the 9 case. I think that is acknowledged in the paper that 10 you have just referred to as well. There is a sentence 11 somewhere that actually makes that statement. 12 Q. For your part, you say, at the bottom of page 41/5, that 13 you hoped that the Supra Regional Services Advisory 14 Group would begin to gather more comprehensive data from 15 the annual reports of units? 16 A. Yes. 17 Q. So the position is, is it, that in 1992 the units in the 18 various different services were not giving very detailed 19 information about outcomes to the Group? 20 A. I, of course, did not see much evidence of that. It may 21 be that Dr Halliday and others -- not others, 22 Dr Halliday in particular -- who had strong liaison with 23 units, may have seen more information than I did, but 24 I do not think it is wrong to say there was more 25 emphasis on the volumetric than the qualitative data. 0011 1 Q. Could I just unpick that last answer? Are you saying 2 that when the Supra Regional Services Advisory Group 3 met, that it did not in general consider the quality of 4 performance of the units and services with which it was 5 concerned? 6 A. Absolutely not. You can see from the 1989 paper that 7 I was very keen that some outcome information should be 8 brought forward to complete the total picture, so that 9 our judgment as a group in the corporate sense could be 10 better informed. So we have an interest in it. What we 11 did not have was the information. 12 Q. So you called for the information in 1989, as we have 13 seen, with reference to the return which Bristol put in 14 looking for funding in the early 1990s. The return was 15 not structured to ask for outcome data; it asked for 16 throughput data, volumetric data, number of operations? 17 A. Yes. 18 Q. You are saying, are you, in the bottom of page 5 of your 19 statement, that you were looking for material which 20 would give you a focus for your interest in quality? 21 A. Yes, indeed. This was nothing to do with designation or 22 de-designation; it is about running good services. 23 I should like to have seen, this was the very first 24 step, the annual report and the annual report of the 25 units, leading up to a situation where I hoped that 0012 1 there would be periodic performance reviews of the units 2 and services within the Supra Regional Services Advisory 3 Group. We could not do every service and every unit 4 every year, but we could start to commence that process, 5 hopefully -- well, definitely -- with the unit where 6 that service was housed, in this case in the Bristol 7 Royal Infirmary, because it is quite clear, and I cannot 8 emphasize it strongly enough, that the Advisory Group 9 was an advisory group; it was not a management group. 10 But from 1991, it was letting a contract through the 11 Management Executive of the NHS. The partners in that 12 and the signatories of that agreement were the local 13 Trust. 14 So, just as on the White Paper, the 1997 White 15 Paper we have been talking about, the Commission for 16 Health Improvement will be the body that will expect to 17 visit these units and see that they have proper clinical 18 governance arrangements in place. I had hoped -- of 19 course not having knowledge that any of this would 20 happen -- that we could adopt, perhaps by proxy, 21 a similar system. We were using the Royal Colleges and 22 the consultants on the Committee; we were using the 23 local hospital. What there was not was the formal 24 linkage between the two. I was hoping through reports 25 and performance reviews to establish some process 0013 1 whereby the total picture of what is going on could be 2 more evident, not just for management purposes but also 3 so we could advise the Secretary of State that continued 4 investment in these services was appropriate or not. 5 Q. So you were looking for, in effect, sufficient data 6 which you did not have, in order to make an assessment, 7 a proper reasonable assessment of the quality of 8 service. Is that a fair summary? 9 A. The totality of the picture: quality, quantity, yes. 10 I was distressed, I have to say, that the annual report 11 to which you refer was the only annual report produced 12 by the Supra Regional Services Advisory Group. 13 I finished, relinquished my position as Regional 14 Chairman the following year, and I was subsequently 15 disappointed to find that that process had not been 16 repeated. I hope you can see, without being immodest, 17 my personal wish to drive this programme forward, and 18 I could not be more delighted that the arrangements that 19 are now in place will formalise that in the interests of 20 patients and staff. 21 Q. I hope if you do not mind if I ask you some questions 22 around that. You have agreed with me, I think you meant 23 to do so, but I want to check and make sure I am right, 24 that in 1992 you did not have the data which you would 25 have wished to have in order to get the whole picture of 0014 1 both quality and quantity of services, in order properly 2 to advise ministers and to discharge the functions of 3 the Advisory Group? 4 A. We were just the same as much of the rest of the NHS. 5 I know that is not the answer you were seeking, but the 6 answer is no, we did not have the quantity and quality 7 of information that I would have liked. 8 Q. You personally -- 9 A. I personally. 10 Q. -- wanted to get better data? 11 A. Yes. 12 Q. You personally, therefore, felt that the links which you 13 had with the Royal Colleges and with the units through 14 the Medical Secretariat were not sufficiently providing 15 you with information? 16 A. When contracting began, we did begin to get a little 17 better information because Alan Angilley insisted that 18 the returns to the cardiac surgical register were 19 included in the monitoring returns of the contract. So 20 that was one little step forward, but it was 21 retrospective. We got, I think, three years all at 22 once. Those were steps in the right direction, but we 23 had very heavy reliance on the Royal College of Surgeons 24 and of course, the make-up of the Group was heavily 25 populated by some of the most experienced and 0015 1 knowledgeable doctors in the country. 2 Q. Not quite the question, I think, I asked. I was 3 suggesting to you that it was implicit in your own 4 approach, looking for sufficient information, and your 5 acceptance that you did not have it, that the formal and 6 informal links with the Royal Colleges and the units 7 were not providing sufficient? 8 A. Well, the answer is, they could not provide sufficient, 9 but it was the only reliance we had, and I would not 10 like in any way to diminish the quality of those 11 dialogues. 12 Q. Are you saying, is it better than nothing? Or quite 13 a lot better than nothing? Where does it fall? 14 A. It is not what I would call hard management information, 15 but it is all we had and I think we got a reasonable 16 feel for most things except outcome. 17 Q. You, for your part, make the point, I think, a number of 18 times in your statement, that it may not always be easy 19 for a manager to judge an outcome without professional 20 input and advice? 21 A. That is true. I would not presume to do so. 22 Q. Is it or is it not right that one can at least get some 23 measure of outcome by measuring outcome against targets, 24 no doubt set with the benefit of professional advice? 25 A. It is very dangerous to interpret data, particularly 0016 1 with small samples, and I placed every reliance on the 2 clinical representatives and the Medical Secretary, 3 Sir Terence English in particular, for that sort of 4 position. One might pose questions, or see the subject 5 was aired, but it was a question that we referred to 6 them for advice. 7 Q. Again, really, exploring what you have been saying about 8 the way in which you hoped that data, information, would 9 give you the full picture, you say at the bottom of 10 page 41/5, and we have it on the screen, that you hope 11 that all the material would have provided some, you use 12 the expression "key audited data, by which the 13 Department of Health, through the Management 14 Executive...", that is the NHS Management Executive, 15 I take it? 16 A. Yes. 17 Q. ... could have engaged in a programme of performance 18 management of the SRS units." 19 "The emphasis would be on key issues and not be 20 overwhelmed with detail." 21 It is a process you introduced in the Trent 22 region? 23 A. Yes. 24 Q. What you are saying here is that, rather than have 25 a mass of data which might be difficult to interpret, 0017 1 one way of at least cutting through the problem and 2 getting an idea of the picture is to focus on one aspect 3 you can get management data on, you can analyse and no 4 doubt set targets in, and see how you go. 5 From a lay perspective, have I put it about right 6 or not? 7 A. I would disagree, actually. I think it is very 8 dangerous to take just one sort of indicator and give 9 the illusion of business, it is a little like saying 10 "The sales have gone up, everything must be all 11 right". I think one needs the distillation of a number 12 of facets to be brought to the appropriate level, so 13 that you can have an effective dialogue and highlight 14 some actions to be taken in the ensuing period. 15 Q. So what did you mean by "key issues" here? 16 A. I am back to outcomes and back to cost and back to 17 benchmarking with other similar units, and I am back to 18 investment plans. It was those bigger issues boiled 19 down into some sensible data. 20 Q. When you came to write the first report, can we have 21 a look, now, at the Foreword to that? It is DOH 2/2. 22 A. It is "Foreword" not "Forward". 23 Q. Perhaps "forward" was the direction you wanted to go. 24 The second paragraph: 25 "It is generally accepted that since their 0018 1 creation in 1983, the supra-regional services 2 arrangements have led to continually improving levels of 3 patient care with outcomes which, in many cases, compare 4 favourably with those obtained elsewhere in the world; 5 concentrated the delivery of designated services in 6 a small number of centres likely to produce good 7 results ..." 8 Then we can go down to the fifth of the 9 highlighted points: 10 " ... meant that quality of service is constantly 11 monitored and improvements sought." 12 What you have been saying to us, I think, is that 13 you did not actually have the objective data which would 14 support those claims? 15 A. Which one are you referring to? 16 Q. I think the first and the last. Let me put it this way: 17 the layman might say, and I really put it to you for 18 comment, how can it be said that there are continually 19 improving levels of patient care with outcomes which 20 compare favourably on the one hand, and how can it be 21 claimed that the quality of service is constantly 22 monitored when the fact is that the Supra Regional 23 Services Advisory Group did not have satisfactory data 24 to deal with the quality of the service provided? 25 A. There is evidence, when you look nationally and 0019 1 internationally, about some of the excellent work that 2 the Supra Regional Services Advisory Group have done: 3 heart transplantation, liver transplantation, there were 4 cases, I am old enough to remember, when people were 5 flown across the Atlantic for operations, and I think 6 there is enough evidence to support that statement. 7 What there is not is the hard aggregated data throughout 8 the whole of the services. There is sufficient 9 evidence, I think, for that claim to be realistic. 10 The quality of service being constantly monitored 11 and approved sought, just because we did not have the 12 hard data in terms of numbers that we were striving to 13 achieve, did not mean that quality was ignored. The 14 visits made by the Medical Secretary and the 15 Administrative Secretary on a regular basis to these 16 units, discussions were held with not only consultant 17 surgeons but nursing staff, managers and others in those 18 units, so there was a very heavy reliance on the 19 feed-back from those meetings. 20 We also had the Royal College of Surgeons where 21 these centres, like many others, are used as training 22 experiences for more junior doctors. They are 23 supervised by the Royal College of Surgeons, and it is 24 my experience there is a very strong set of information 25 that passes, perhaps informally, at that level. There 0020 1 was every effort made to monitor the service, and 2 improve it. What we did not have was the hard evidence, 3 the hard data, to which I have alluded earlier. 4 Q. So is it fair to say that the claims are impressionistic 5 rather than empirical? 6 A. "Impressionistic" is a word I -- I think it was 7 confirmed verbally rather than empirically, I could 8 perhaps accept. 9 Q. So at any rate, you go this far: it was not 10 empirically-based? 11 A. No. 12 Q. Not being empirically-based, it had to be based on 13 something else, and then you are relying here on verbal 14 information and the various sources, the various strands 15 you picked upon. You have people coming across the 16 Atlantic for treatment, which may say something about 17 the way the service is regarded elsewhere. You have the 18 Royal College of Surgeons, their formal and informal 19 input. You have reliance upon whether the certified 20 place, if you certify loosely, is fit to continue as 21 a training centre. Those are the various strands that 22 you pick upon? 23 A. The other one, of course, was local medical audit, 24 because that was certainly around at this time, and 25 I would not have thought it unreasonable for the local 0021 1 Trust, if it was properly into medical audit, to have 2 ensured there was some peer group review of the service 3 locally. That is what normally happened. They were 4 responsible, if you look at the contracts, for 5 performing to quality standards, as far as they were 6 able, and after all, I may be wrong but I think there 7 were other cardiothoracic surgeons in the locality, in 8 the region, so it would not have been unreasonable to 9 have empanelled some of those people to deal with 10 constructive medical audit. It has been -- this 11 practice has been in progress for some years, to various 12 degrees of sophistication, I have to say. 13 Q. So what perhaps may be said to be the vital word in what 14 you have just said to us is the word "if". If the unit 15 was into medical audit and proper peer review? 16 A. I am sorry, you will have to ask them that question. 17 Q. That I appreciate. So far as the Supra Regional 18 Services Advisory Group was concerned, from what you are 19 saying, and again, I do not want to paint an unfair 20 picture, just to get life as it was, am I right in 21 thinking that whether the unit was monitored at local 22 level or not, whether the "if" as it were had a tick 23 rather than a cross against it, was not something which 24 necessarily found its way through to the Supra Regional 25 Services Advisory Group for its consideration? 0022 1 A. It was, of course, one of the aspects in an annual 2 report from a unit that I would have been looking for. 3 Q. But did not necessarily find its way through? 4 A. It did not. The process from one year that I commenced 5 was the very first step, and just as we are looking now 6 at the work of the Commission of Health Improvement, the 7 government have said that is a 10-year process, in just 8 the same way what I was starting was the first step on 9 that road. 10 Q. You have said a number of things which I would like to 11 explore with you, as to some of the difficulties in 12 getting data. We have to appreciate that we are looking 13 back here in time and we go back, as you know, as far 14 back as 1984. 15 A. Yes. 16 Q. May I say at once to you, that we appreciate that of 17 course the culture has changed between 1984 and today, 18 and I think very much of your statement acknowledges 19 that, and I think you said yourself, you were one of 20 those who wished to change and still wishes to change 21 the culture for the benefit of the patient? 22 A. Absolutely. 23 Q. You, for your part, were disappointed I think that other 24 people did not follow up your lead in producing a first 25 report of the Supra Regional Services Advisory Group? 0023 1 A. Very, but I have been comforted since in the 2 arrangements that have been put in place in the last 3 year or two, but it distresses me, this is a long, hard, 4 tedious road, because it is always difficult to extract 5 this data, even to define this data is quite difficult, 6 sometimes, to make it comparable. It does distress me, 7 and I have said in my statement one of the penalties 8 will be the slowness of pace, because it is important 9 that this is not an Inspectorate. We really have to 10 encourage a standard of work that we would be happy that 11 our own families used, and we do that by persuasion and 12 development rather than by heavy-handed, aggressive 13 behaviour. 14 The relationships between the medical profession, 15 I have always had good relationships with the medical 16 profession, but we do rely on them to alert us if there 17 are any exceptions to quality. For example, if there 18 had been a major problem, I would have regarded it as 19 totally unsatisfactory if any member of that Advisory 20 Board -- which was a serious body, it was not just 21 a rubber stamp committee -- had not flagged up to me or 22 the Secretariat that there was a major problem. I would 23 have regarded it as a matter of very grave concern. If 24 I had heard of any such matter, I would have instigated 25 enquiry which had nothing to do with designation or 0024 1 de-designation, it was about the care of patients. If 2 that had not been done, I would have seen the Chief 3 Medical Officer, who I saw every two months and I saw on 4 the Medical Research Council as regards that time, to 5 make sure some something was done. 6 I hope that gives some sort of impression of my 7 commitment to this service. It was not a bureaucratic 8 process; it was an honest attempt to develop these 9 services in the way that the government had intended. 10 Q. I was going to ask you about something rather different, 11 but I am going to follow up what you have just said. 12 What you are saying, and I think it ties in with 13 what you say in your statement about whether you 14 personally knew about problems and, putting the word 15 neutrally, at Bristol? 16 A. Absolutely not, emphatically not. 17 Q. Can I put a hypothetical to you and ask for your 18 response. Suppose you had been told when you began as 19 the Chairman of the Supra Regional Services Advisory 20 Group that of the nine or ten supra-regional units that 21 were then funded supra-regionally, that statistically it 22 appeared that one of them was performing very much worse 23 than the others, so much so that it was beyond the 24 bounds of mere chance: what would your reaction have 25 been? 0025 1 A. My reaction would have been, if it was of a serious 2 nature, I would personally have taken steps to ensure 3 some inquiry was initiated professionally to examine 4 facts. It would be equally unwise to jump to the wrong 5 conclusions, but I would have used the position I had, 6 which was, without being immodest, a substantial and 7 respected one in the NHS to ensure something was done 8 about it. I think that goes further than the issue of 9 designation or de-designation; it was about acceptable 10 or unacceptable quality. 11 Q. May we have a look on the screen at DOH 2/231? 12 These are figures which come from a paper produced 13 in July 1989, a Working Party, the interim report of the 14 Working Party set up by the Society of Cardiothoracic 15 Surgeons of Great Britain on neonatal and infant 16 supra-regional cardiac surgical units. It may be just 17 a little before the time that you began as Chairman. 18 We can see, if we go down to the bottom of the 19 page, the second from the left, Bristol, and then we go 20 up to the top so we can follow the box graphs. 21 I apologise, it is difficult to get a large enough view 22 of the whole page. 23 A. I follow you. 24 Q. You can see that the open operation was done on the 25 under 1s in Bristol. The number was 29 in 1988. Then 0026 1 we go down to over 1 year, 89; the next, please, closed 2 under 1 year, 49; closed over 1 year, 50. 3 If we bear those in mind and go to 2/233 and 4 rotate it, please, you will recognise these, I feel 5 confident, as being point figures as to the dot; the 6 number of cases run across the bottom. The dot is the 7 point and the barbells, if I can call them that, around 8 the point, are the confidence intervals, the extent to 9 which one can exclude chance as a variable factor, on 10 the basis of the pure mathematics of it. 11 The second from the left is the figure which 12 corresponds to the position of Bristol. One can 13 instantly see that there are two units, Bristol being 14 one of them, whose mortality rate, because the left-hand 15 figure is percentage mortality, the upright axis, is out 16 of step with the others. 17 May I ask: did you yourself come across this 18 particular figure? 19 A. I do not recall seeing these papers at the Advisory 20 Board. It is a long time ago and you may prove me 21 wrong. It does not look to be in the sort of form that 22 would be presented to the Advisory Group. 23 Q. If we go to 2/234, rotate it, the third from the left 24 there is, as we work it out, going from the bar chart, 25 we think we are right and others can tell us if we are 0027 1 not, the third from the left, we believe to be Bristol, 2 which is the worst as a matter of point figure on 3 mortality. One can see it was actually quite a wide 4 range around it, and although it may be significantly 5 worse than the best, it is not significantly out of 6 step with the others, although it is, it would appear, 7 the worst. Can we just complete the picture for the 8 over 1s, 2/235, and rotate it, please. Second from the 9 left, Bristol, the best, the open operation over 10 1 year. If we go to the fourth, please, 2/236, and 11 rotate it, again, the worst but not beyond the bounds of 12 chance at 50 for closed operations over 1 year. That is 13 Bristol, we think. 14 I put those to you so that the wider audience who 15 listen to these questions do not necessarily draw 16 a wrong conclusion from matters which I am putting to 17 you. 18 The question which arises, really, from this, is 19 that if it had appeared to you personally, from what you 20 have been saying, that there was a problem that the 21 outcome data available, however reliable it may have 22 been, demonstrated, you would have followed it up? 23 A. If it had been presented in such a way that a problem 24 existed, I would have expected this to be a matter of 25 clinical opinion. I really would not like to -- I mean, 0028 1 I take it these are one year figures? 2 Q. Yes. 3 A. I believe a little bit more in trends than I do in one 4 year figures. I know insufficient about the complexity 5 of some of the cases, the case mix, and whereas someone 6 would have asked the question, whether it was me or 7 another member of the Group, if it was presented to it, 8 I think this is very much an issue on which I cannot 9 help you and which I would have referred, or feel would 10 be properly discussed via the Medical Secretary, the 11 President of the Royal College of Surgeons. That sort 12 of interpretation, I would have thought, too, would have 13 been looked at as part of the medical audit in the 14 hospital itself. 15 Q. It is part of the reason that I asked you to look at 16 these charts: to understand how the concerns that you 17 express and emphasize from your own perspective would 18 actually have worked in practice. 19 What you are perhaps telling us, and again, 20 correct me if I am wrong, is that if it occurred to you 21 that there might be serious grounds for concern with any 22 particular unit, leave aside one doing neonatal cardiac 23 infant surgery, that your first port of call would have 24 been to the medical men to say, "Well, look, give me 25 a view on this. What is this all about?" 0029 1 A. Absolutely right. One relied upon them, I suppose in 2 a manner of exception reporting, to come forward if 3 there were known perceived problems in any unit where 4 they had knowledge and expertise. We had a substantial 5 network formally and informally for medical people. 6 I have referred to the President of the Royal College of 7 Surgeons; there were other eminent medical people on 8 that group, and I think there was a sufficiently 9 powerful group of people and network of people to be 10 able to pick up evidence, albeit verbally, of problems. 11 In those cases, those had been brought or raised at the 12 committee, at the group, I would have seen action was 13 taken to do something about enquiring more about it. 14 Q. So you, in wishing to take things forward in the best 15 interests of patients, as you did, you were really 16 reliant upon the input that the medical men had to give 17 you? 18 A. Absolutely so. It is not my area of expertise to 19 interpret medical data. It is dangerous interpreting 20 any data over 1 year as well. 21 Q. What you could have interpreted, as it were -- if, let 22 us suppose medical men had set standards to be achieved 23 in advance and you could see from available data that 24 the standards had not been met, you could have dealt 25 with that. That would be a simple management tool. But 0030 1 the sort of data that you had, the sort of problems that 2 there might have been, you would have had to rely upon 3 the medical men. Have I got it right? 4 A. Yes. 5 Q. You deal in your statement, if we can go back to 6 WIT 41/6, it is the last paragraph of section 7: 7 "Whilst I have always had considerable respect and 8 good relations with consultants and other medical staff, 9 it is difficult to obtain explicit data, particularly 10 when it relates to individuals ..." 11 A. I am sorry, I am not with that -- yes, I have it. 12 Q. We will just highlight it. 13 You have told us already that obviously not 14 everyone saw things the way you did in relation to the 15 way that the Supra Regional Services Advisory Group 16 would handle itself. Again, a nod does not go down on 17 the transcript, but you are nodding? 18 A. Yes. 19 Q. You, from what you have said, I think, were ahead of 20 your time in looking for the greater detail than most in 21 respect of performance and outcome data? 22 A. I like to think so. 23 Q. Do I take it from what you say here that you met with 24 some opposition amongst other people from the clinicians 25 themselves in trying to get empirical data as to what 0031 1 was happening? 2 A. I personally was not involved in gathering data, but one 3 did hear of occasions when it was difficult, and I think 4 there is reference somewhere in the papers you have to 5 the difficulties of obtaining good hard data. Sometimes 6 people were busy; they did not think it was important. 7 I mean, that is now changing, happily. 8 Q. It is not quite busyness or importance which is 9 reflected, I think, in this paragraph here, is it? It 10 is the idea that it might blow the whistle on 11 a particular individual? 12 A. Yes. Getting the key clause here is "particularly when 13 it relates to individuals". I think the medical 14 profession -- I can understand that -- are coy when it 15 comes to publishing information that relates to 16 individual performance. Possibly there is a fear of -- 17 an increasing fear of litigation, and so it is almost 18 easier to get it in a block than it is through an 19 individual, although there are exceptions. 20 Q. If we bear that paragraph in mind and just go back to 21 the page before in your statement, WIT 41/5, the top of 22 the page, the second sentence in the second paragraph: 23 "In the early days there was still a residue of 24 suspicion of managers by some clinicians and there were 25 some occasions when discussions became quite robust." 0032 1 The robust discussions, I think you are talking 2 there about the Advisory Group, are you? 3 A. I am indeed. 4 Q. But the residue of suspicion of managers by some 5 clinicians, was that something which you felt as 6 Chairman of the Advisory Group was taking place, as it 7 were, in front of your eyes in the discussions? 8 A. You mean in the Advisory Group? 9 Q. Yes. 10 A. There were occasions when there was a degree of robust 11 discussion because at the time of perhaps the ill-named 12 "internal market", there was still a number of senior 13 medical people, not all of them by any means, who viewed 14 that with distaste. 15 Q. So there were people on the Advisory Group panel itself 16 whom you felt had a suspicion of managers? 17 A. Well, "suspicion" may be an unkind word, but 18 "interference" of managers might be a better word, and 19 part of my role as Chairman was to create 20 a multidisciplinary atmosphere, to get some freedom of 21 discussion, and I was not at all afraid of those views 22 being ventilated. We were there to do a serious job, 23 but I felt that sort of group needed to have a life of 24 its own, it needed to have a corporate entity so far as 25 possible, so it could deliver its role. I am afraid 0033 1 I am a team player. 2 Q. What I am asking about is the correspondence between the 3 way in which views were expressed by individuals in the 4 course of frank and open discussion in the Supra 5 Regional Services Advisory Group. Views were expressed 6 that were hostile (if I can describe not the manner of 7 the view but the view itself) to interference by 8 managers? 9 A. "Hostile" is too strong a word. "Critical". 10 Q. That ties up with the difficulties that there were in 11 obtaining data particularly relating to individuals, the 12 same sort of approach, is it? 13 A. I would not like to give the impression that there is 14 total hostility between doctors and managers; it is 15 a sensitive area. I have been involved in it a long 16 time, and my experience, it is not easy with some 17 individuals; it is much easier with others. 18 Q. If I can put it this way and see how far it represents 19 the case, you are pushing for what you wanted. You had 20 the sense that some people had to be pushed? 21 A. Not on the Advisory Group, but I think through the 22 Advisory Group we had to push out into the service to 23 get them to understand how important it was to feed 24 through this integrated information of workload, of 25 outcome, of manpower, of finance, because it was in 0034 1 their interests that we had that picture, so that we 2 could, if you like, defend their investment, and to 3 illustrate that it was worthy of additional investment. 4 That was part of the terms of reference of the Group. 5 Q. Your alternative view was not obviously to see it that 6 way? 7 A. I beg your pardon? 8 Q. The view that some had and those that did not share your 9 views, they took a different line, I take it? 10 A. I do not think there were many on the Advisory Group 11 that disagreed with me on that principle. 12 Q. But those beyond the Advisory Group to whom they were 13 talking? 14 A. Clearly that may have been the case, but I think you 15 would have to address that question to those who were 16 seeking the information and actually getting it. The 17 fact we were trying and did not get it I think must be 18 the only answer I can give. 19 Q. I am asking you, really, because of the way in which it 20 was reflected to you. I appreciate you were not 21 actually asking people yourself, but what was reflected 22 to you was a difficulty in bringing the profession with 23 you, was it? 24 A. In some cases. I mean, we did not want sticks with 25 which to beat them, as it were. We had the incentive, 0035 1 or they had the incentive of additional cash. There 2 were instances where there was reluctance to part with 3 information. I mean, returns had not been sent in; they 4 should have sent quarterly returns in and they had not 5 been done. There was a case in Harefield, actually, 6 where I seem to remember there was difficulty in getting 7 figures. I think Norman Halliday went there and got 8 them there and then, but sometimes it just took a little 9 effort to extract it. 10 Q. Was that, on that occasion, a threat that supra-regional 11 funding might be withdrawn if they did not co-operate? 12 A. I hope no threats were issued. 13 Q. A suggestion that it might happen? 14 A. He got the result. How he got it was his business. 15 Q. Again, just taking that forward a little and tying it in 16 with the question of de-designation, about which I will 17 ask you a little more later, ultimately as we know, and 18 we have seen a number of documents, but we have the view 19 that the Supra Regional Services Advisory Group came to 20 the conclusion that the service had to be de-designated 21 because too many units in the country were actually 22 performing the work. That is broadly right, is it? 23 A. That is broadly correct. 24 Q. And there were a number of possible ways out. One was 25 to allow them to go on doing work in the numbers that 0036 1 they were, which the Group did not want to do; another 2 was to de-designate the service, which is what happened, 3 and the third was to reduce the number of units? 4 A. Yes. 5 Q. In order to reduce the number of units, you or the Group 6 turned, did it, to the profession, the medical 7 profession? 8 A. Yes, of course. 9 Q. And in effect said, "Look, you have 10 units who are 10 funded and another couple of units doing the work, that 11 is 12 or 13 units in the country. The ideal is 6 to 8. 12 You tell us which 6 or 8 you want"? 13 A. That is correct. 14 Q. That would rely upon the medical profession co-operating 15 in reducing the 5 or 6 that would be "for the chop", if 16 I put it very bluntly and in lay terms? 17 A. That is so. The Royal College of Surgeons' Working 18 Party was very helpful in producing a paper. 19 Q. It was not very helpful in the result, though, was it? 20 A. No, it was not at all. That is why we had to break the 21 Gordian knot. 22 Q. From your perspective, why did the profession need to be 23 asked to reduce the numbers; why could that not be done 24 centrally or by recommendation of the Group itself, and 25 secondly, why didn't the profession come back and 0037 1 suggest the names for the chop? 2 There are two separate questions there. Can 3 I deal with them in turn? The first: why was it 4 necessary to go to professions to say, "Well, which ones 5 do we cut out; which ones do we keep?" rather than make 6 that decision as part of the Advisory Group itself? 7 A. That was the way we worked, because we want to work if 8 we can with the profession, to resolve and regulate 9 their own proliferation. There were issues of 10 geography. There was the question of critical mass. 11 But we always empanelled or asked the Royal College of 12 Physicians or the Royal College of Surgeons, whoever it 13 was, to set up a Working Party to advise us on that 14 issue as part of a process of proper consultation. 15 Q. So what you have told me thus far is that the Group 16 would consult with the profession to see if the 17 profession could be brought along? 18 A. Yes. 19 Q. Am I right in thinking that the view was taken by the 20 Group that it was in the patients' best interests, 21 generally speaking, that there should be only five or 22 six centres throughout the United Kingdom doing the 23 work? 24 A. I forget the precise figure at the precise time, but 25 probably of the order of seven. 0038 1 Q. That was in the patients' best interests? 2 A. As far as I could ascertain from what was said by the 3 Royal College of Surgeons. 4 Q. And that was something that you, because you relied upon 5 the Royal College of Surgeons, accepted from them, was 6 it? 7 A. We asked them, and I think there had been two reports on 8 this subject; one in 1990 and one in, was it 1992? 9 There comes a point when you consult and take the best 10 advice that you can, when the Group itself had to say, 11 "We have to come to a decision about this", and we have 12 got the professional input and we had to also ensure 13 that our term of reference was being met, and it clearly 14 was not. 15 Q. What I am asking you -- I can show you all the 16 references which we have been through with Mr Angilley 17 and Mr Owen and Dr Halliday, and there are frequent 18 references that we have seen to the view of the Group 19 being, or the acceptance by the Group being that it was 20 in the patients' best interests that there should be 21 a limited number of centres doing the work. 22 A. Fine. 23 Q. But the decision which is taken, having asked the Royal 24 College of Surgeons' Working Party, set up by 25 Sir Terence English, to report back and give you the 0039 1 identity of those units for the chop, does not deliver 2 the goods, the view that is then taken by the Group is 3 to then say, "Well, we will have to de-designate the 4 service". 5 My question, because I want to understand the 6 dynamics at work and the problems that you had in 7 delivering what you wanted to deliver in terms of advice 8 to the minister, is: why it was not possible or 9 desirable for the Group itself to say, "Well, we need to 10 reduce the numbers; the service is in the best interests 11 of the patient. The patients will therefore suffer if 12 we de-designate the service. We ourselves will take the 13 decision to reduce the number of units"? 14 Why did that not happen? What were the problems? 15 A. I think "designation" is in danger of being slightly 16 misunderstood. I mean, I have to take issue with your 17 use of the word "chop". It looks as if it was going to 18 be an extinction. There were one or two services and 19 the clinical freedom where people were starting to do 20 this work. One of the purposes of designation and 21 eventual de-designation was to develop these services to 22 a stage where the expertise and knowledge was at such 23 a level that it could probably be then transferred to 24 a regional specialty. 25 When you had as many centres as we had, there was 0040 1 beginning to be evidence that this was a mature service; 2 it had gone through its early developmental stage and it 3 was now a mature service that was geographically spread 4 pretty well throughout the United Kingdom, and not too 5 long after this the number of regions were reduced to 6 8 from 14, so it was not really the "chop" to say 7 "Perhaps this can become a regional specialty as 8 opposed to a supra-regional specialty". 9 Q. That presupposes the service was actually being 10 well-delivered in each of the regions and you did not 11 know that because you did not have the data? 12 A. Fine, but it was also consuming by far the largest 13 slice, I think, nearly 25 per cent of our total budget. 14 I think the figure was 24 million, the last figure. 15 When there was a very strong view put forward from Guy's 16 Hospital, which was another of the hospitals, if 17 I remember correctly, that was under threat, Newcastle, 18 perhaps Harefield at one time, and there was an increase 19 in interventional catheterisation and the ... I am 20 sorry. 21 So we really felt this was a mature service that 22 was taking rather more of the supra-regional services 23 finances than it should. I mean, it was not a financial 24 decision. 25 Q. That was what I was going to ask you next. 0041 1 A. Of course you were. I mean, we did not get any more or 2 less money, anyway, but I think it was at a stage 3 where -- I recall my point. We were at the beginning of 4 the internal market and there was a case made by Guys, 5 I think, that if the money was put back into the service 6 as part of the NHS allocations, which it subsequently 7 was, anybody who needed that service, of course, would 8 be able to purchase it by what was called an 9 extra-contractual referral. So if the centres were 10 giving good service and they had good referrals and they 11 had a good reputation, they would get the work. It 12 would not necessarily mean the fragmentation of the 13 service, because I would have hoped it would have been 14 developed as regional services, as indeed normal 15 cardiothoracic surgery is. 16 Q. Suppose that Professor Sir Terence English's Working 17 Party had come up with the suggestion that there are six 18 names, six centres, which the Royal College recommended 19 for continuing designation. Do you think that probably 20 the Advisory Group would have said, "Okay, we will 21 retain designation for those six"? 22 A. I think it is highly likely. 23 Q. So it follows, does it, that the real problem or the 24 real cause of de-designation of the service was not the 25 fact that it was a mature service and was not the input 0042 1 from Guys, it was simply a function of numbers? 2 A. It was proliferation. 3 Q. Although there may have been a number of reasons which 4 might have been used to justify de-designation, those 5 given the approach by Professor Tynan of Guy's pointing 6 out the increase in interventional catheterisation of 7 which Guy's were pioneers, he said, and secondly the 8 maturity of the service, that if those had been 9 compelling and overwhelming reasons for de-designation, 10 there would have been no need to set up a Working Party 11 under Sir Terence English in the first place? 12 A. Possibly not, but I would venture to suggest, and it is 13 only a suggestion, that the time would come when that 14 service would have become de-designated as a regional 15 specialty. 16 Q. Because of its maturity? 17 A. Yes. Enough people have been trained and we have 18 critical mass in each centre. I think the Royal College 19 of Surgeons and everybody did not have to see an 20 enthusiastic surgeon doing one of the operations in 21 a remote hospital somewhere because he felt like it. 22 I think that is entirely proper because there is 23 clinical freedom, but I think there is also 24 concentration of expertise, it is shown to work, it is 25 prevailing now in cancer treatment, in the Calman/Hine 0043 1 report. It is in trauma orthopaedics where more and more 2 concentration on centres is done because of evidence now 3 being produced that outcomes are better. 4 Q. Can I come back to the question that I asked about five 5 minutes ago or so, and I just want to understand, and 6 I appreciate you were only the Chairman and the Group 7 was much wider than the Chairman, but given that the 8 position was that it was really a function of numbers, 9 given that there was no other compelling reason at the 10 time for de-designation, why did not the Supra Regional 11 Services Advisory Group itself grasp the nettle and say, 12 "Well, the Royal College has tried to help, they cannot 13 very much; we ourselves will do it"? 14 A. That is exactly what we did in July 1992, because 15 I think, if I remember rightly the guideline, there were 16 no firm numbers. There were something like 400 to 1,000 17 cases per annum, and we were something like 1,500, so 18 hence my reference to maturity. 19 MR LANGSTAFF: I am going to pause there, if I may, 20 Sir Michael, and we will take a break -- I think, 21 Chairman, this will be an appropriate time for a break. 22 Normally it will be about a quarter of an hour. 23 THE CHAIRMAN: Yes. Thank you, Mr Langstaff. 11.15, then, 24 we reconvene. 25 (11.00 am) 0044 1 (A short break) 2 (11.15 am) 3 MR LANGSTAFF: Sir Michael, can I deal now with the issue of 4 Bristol's continued designation throughout the time that 5 you were Chairman, until it became, with other units, 6 de-designated? 7 Can I ask you, please, to have on the screen, 8 DOH 2/22? This goes right back to the start of the 9 supra-regional services, HN(83)(36). It talks about the 10 setting up of the Advisory Group. Can we go down 11 further, please, and overleaf? We have seen here the 12 criteria for the services. It deals with the services 13 themselves, and if we go down to B at the bottom, it 14 deals with the units. 15 Can we go back, please, to the page before. 2/22, 16 the bottom of the page, paragraph 3, identifies the 17 Advisory Group. Terms of reference: "To advise" -- that 18 is a verb you make particular emphasis on in the course 19 of your statement, rather than "to manage": 20 "To advise the Secretary of State through Chairman 21 of Regional Health Authorities on the identification of 22 services to be funded supra-regionally and on the 23 appropriate level of provision ... Each year, the Group 24 will advise ministers, 3 Regional Health Authority 25 Chairmen on which services should be funded 0045 1 supra-regionally in the forthcoming year, which units 2 should be designated to provide them, and what level of 3 funds should be allocated to each designated unit. 4 Authorities will then be notified of the decisions 5 reached on the Group's recommendations." 6 That appears to say that every year one of the 7 issues for the Group to advise the Secretary of State 8 about is whether the service should continue to be 9 designated; is that correct? 10 A. That is correct. 11 Q. It also appears to say that once it has reached the 12 decision that the service should be designated, it has 13 each year to make a fresh decision as to whether each 14 unit providing the service should be designated to 15 provide it; is that correct? 16 A. I would take issue with that. I think "each unit should 17 be designated" is incorrect. I think the service should 18 continue to be designated, yes. 19 Q. So whatever the words may originally have meant to an 20 informed reader, these words in 1983, the position was, 21 was it, that the question of which units were designated 22 as opposed to which services were designated was not 23 something which was necessarily reviewed annually? 24 A. No, it was not. Can I just add to that? There were 25 occasions, if I recall, where there were recommendations 0046 1 that two units collaborate, or unite. 2 Q. If we can move on, please, to 2/24, this is 3 12th September 1988, so again before the time you became 4 the Chairman, EL(88)P/153. It says: 5 "The Supra Regional Services Advisory Group has 6 requested that additional guidance be issued to all 7 Regional and Special Health Authorities which are 8 providing services that may be suitable for designation. 9 "This is attached as a follow-up to circular 10 HN(83)36", which we have just been looking at. 11 If we turn over the page to 2/25, this is the 12 document which comes with it. Under "Supra-regional 13 Services", paragraph 2: 14 "Circular HN(83)36 defines supra-regional services 15 as the small number of ..." one sees the definition, and 16 it is expanded into the following criteria. Again, one 17 can look down the criteria: (f) at the bottom I think, 18 is the only one which is unit specific, but "the units 19 to be designated should be capable of meeting the total 20 national caseload for England and Wales." 21 (3)(i) at the bottom of the page: 22 "The rarity of the condition to be treated must be 23 such that the population served by each unit is 24 a minimum of 5 million and the total national caseload 25 should normally be capable of being treated in fewer 0047 1 than 10 units. In practice --" and this is where you 2 get your 400 to 1,000 operations from, and "(ii) the 3 cost high enough to make the service a significant 4 burden for the providing regions ..." and we see the 5 cost. 6 If we turn over the page: 7 "(4) Units which might qualify for this title are 8 those where a special expertise has been developed in 9 a particular area of medicine". 10 So one can see some of the criteria at any rate 11 that were applied for the designation of a unit as 12 opposed to a service. 13 When Bristol and other units were considered for 14 de-designation later on during your tenure of 15 Chairmanship, it appears to be suggested, and I can show 16 you the particular minutes if you want to have a look at 17 them, the papers, that the only claim that Bristol had 18 for continued designation was what is called 19 "geography". Broadly, does that correspond with your 20 recollection? 21 A. It does. I seem to recollect that Newcastle and Bristol 22 were two places that were regarded, certainly for 23 a considerable time that I recall, as necessary for 24 geographic reasons. 25 Q. We do not see, in this document -- we can go back to 0048 1 page 25 and just check through it again. Just scroll 2 down. It can be difficult, not having the page in front 3 of you, but is there anything said in 2/25 -- let us go 4 down to the bottom of the page, please -- or the top of 5 page 26, about geography? 6 A. Not in that document that I can quickly scan. 7 Q. So why was it that the Supra Regional Services Advisory 8 Group placed plainly a heavy reliance on geography? 9 A. The supra-regional services were a developmental process 10 and it was conscious policy. I cannot put my hand on it 11 and I cannot see in there where that guidance came from, 12 that all the expertise and all the services should be 13 provided, can I crudely put it, in the "golden triangle" 14 of Oxford, Cambridge and London, which would have been 15 the risk. Access of patients, and extremely important 16 in terms of children, was the ability of carers to be 17 supportive and able to be present, so whatever the basis 18 for that interpretation, I think it was a strongly held 19 view. 20 Q. So what the Group were reflecting was a view that it was 21 in the interests not so much of the patient, at least, 22 not directly, but of those who were the parents or 23 carers of the patient? 24 A. It was both. 25 Q. One, I suppose, would conclude that if the carers or 0049 1 parents felt that it was of particular importance that 2 they should be close or they should have a centre close 3 to their home to which their child could go for surgery, 4 that opening up such a centre in their locality would 5 lead to an increase in referrals from those homes or 6 those local homes to the centre. That would fit with 7 the geographical thesis? 8 A. It would indeed. It is not what is being talked about, 9 but we faced a very similar debate for designation or 10 de-designation of psychiatric services for the deaf, 11 which is very specialised, but catchment area had 12 a major part to play in the referral patterns of units 13 such as those. 14 Q. One can tell, looking at service by service, really, the 15 extent to which carers or, in the case of neonatal and 16 infant cardiac surgery, parents, placed a premium upon 17 proximity, because opening up a centre, you would see an 18 increase in referrals? 19 A. That is correct, and in the case of Bristol, the 20 proximity to Wales of course was another feature, which 21 I think was regarded as desirable, although later there 22 was a development in Cardiff, I think, which had the 23 reverse effect. 24 Q. I was going to ask about that. It may be thought, and 25 again, I do not want to take up too much time going 0050 1 through documents which we have seen already with 2 others, but it may ultimately be thought -- I do not 3 know -- that there was no significant number of 4 referrals, save from Gwent, possibly, to Bristol, before 5 Bristol was designated, or when it first became 6 designated. 7 So, not a great number of children on available 8 documents. 9 A. I cannot recall the figures, but I will accept them. 10 Q. What I was going to ask you, it was not to comment on 11 figures you do not have in front of you and have not 12 seen, that would be unfair, but when Bristol's position 13 came up for discussion, was there any actual analysis 14 done that you can recall of the referrals, the number of 15 referrals, to Bristol from Wales or the surrounding 16 area? 17 A. I imagine that that was a subject that the Royal College 18 of Surgeons and maybe Norman Halliday had. I do not 19 recall -- I may be wrong, but I do not recall those 20 figures being presented to the Supra-regional Group. 21 Q. When it came to the question which is reflected in the 22 minutes of the Supra Regional Services Advisory Group, 23 that the opening up of the Cardiff unit might have an 24 impact on Bristol's numbers, was anything more than the, 25 if you like, the impressionistic said, "Because we have 0051 1 a unit across the Severn, it will have an impact"? 2 A. The opening of that unit was clearly significant. 3 I cannot recall any new data, the cause and effects of 4 that you have seen, but maybe it was the cause of some 5 reservation by the Royal College of Surgeons 6 subsequently. 7 Q. To what extent did the Group, the Advisory Group, take 8 into account in dealing with designation of units in 9 England, the proximity of units just across the border 10 in Wales and Scotland? 11 A. Well, certainly they did, in terms of Bristol and 12 Wales. That was certainly a strong argument. That was 13 taken into account and I think explained why Newcastle 14 and Bristol, without being untouchables, were regarded 15 as being key elements in a geographic distribution. 16 Q. Once Cardiff opens, once it is known there is 17 a determined development by the Welsh Office or the 18 Welsh to open up a unit in Cardiff, that is likely, is 19 it, to defeat any continuing claim at that Bristol might 20 have for designation on purely geographical grounds? 21 A. I took it as an explanation of why Bristol's numbers did 22 not increase. There was constant pressure to increase 23 throughput in Bristol, because of the rationale that 24 bigger will bring more expertise and better outcomes, 25 but it never got above the 50 level. That was my 0052 1 understanding of the reason it did not. 2 Q. You knew of this historically, I imagine, but not from 3 direct experience, that ever since the designation 4 began, Bristol had never made the critical mass number? 5 A. It has always been a struggle, yes. 6 Q. And the critical mass to produce the effects of better 7 surgery, if you like, from familiarisation, never were 8 likely to come to Bristol. Simply because of its 9 throughput, you were saying attempts were made to 10 encourage Bristol to have more referrals. How could one 11 manage that? 12 A. I am sorry? 13 Q. Did you yourself play any part in trying to manage an 14 increase? 15 A. Certainly not. I was aware that there was a constant 16 pressure on Bristol to increase its throughput, but 17 I was not involved in any way personally at all. 18 I never had a specialty of any problem within Bristol. 19 From a quality point of view, there was a request for 20 additional capital, if I remember right, because they 21 were working on two sites at one time. 22 Q. I want, without taking too much time about it, because 23 as I say, we have seen some of these documents with 24 others, to go through some of the history immediately 25 prior to de-designation, because I would welcome your 0053 1 comments and input on what was then taking place. 2 May I say, also, and may I say clearly -- this is 3 for the benefit of others who may either be watching or 4 may pick this up on the transcript -- that there are 5 a number of aspects in which the statement you have 6 given, and the evidence of others, may not be entirely 7 consistent. 8 I am not going to deal with inconsistencies 9 because -- 10 A. I am under oath. I have told you the position as I have 11 it. 12 Q. May I make it clear, this is no criticism of you, 13 Sir Michael, please, it is by way of explanation for 14 those who may say, "Why didn't Mr Langstaff say to 15 Sir Michael Carlisle, 'So-and-so said this, what do you 16 say?'" There is a purpose in the pattern, in my 17 questioning, which makes those sorts of questions 18 unnecessary. 19 A. Fine, you are in charge. 20 Q. I am saying it to explain to the wider audience, not to 21 you, and, please, do not take it as a criticism of 22 yourself. 23 A. Thank you. 24 Q. May I ask you, please, to go to DOH 2/204? This is 25 a meeting, 1990, which you chaired. It is the first 0054 1 meeting in 1990. Can we go in that, please, to 206? 2 This, I think, is dealing with the forthcoming NHS 3 reforms and their impact. Mr Malley sets out three 4 principles at the top of the page, 5 " ... believed the Advisory Group should as far as 6 possible uphold three principles, (i) the preservation 7 of some similarity between the treatment of 8 supra-regional and other services under the NHS reforms; 9 (ii) the avoidance of disruption to the provision of the 10 services; (iii) the avoidance of proliferation of 11 non-designated units offering supra-regional services. 12 He strongly supported option 2 which dealt with all 13 three issues". 14 Option 2 concerned Central Funding. 15 If we go on down, in paragraph 4.5: 16 "Sir Anthony Grabham reported that the JCC had 17 debated the principles of agreements on service 18 provision. It had concluded that in some cases it was 19 right to rein in services, although in general they 20 would not seek to restrict activity if there was local 21 support for the provision of a service. Members of the 22 Advisory Group appreciated the difficulties of the 23 profession exercising control over service provision, 24 but some favoured ..." -- and the word comes out as 25 "for", I am not sure whether it should be "for" or 0055 1 "far" -- "some favoured for stronger action to prevent 2 proliferation." 3 First of all, can you help me, is it "for" or is 4 it "far"? 5 A. 9 years ago is asking a bit, for that. 6 Q. You may not be able to say. 7 A. I think it is perhaps -- I cannot say. "Favoured 8 stronger action" I think would infer the meaning 9 correctly. 10 Q. What stronger action was under discussion as being 11 a useful way of preventing proliferation? 12 A. It was 1990, but there was every help we could get 13 through the Royal College of Surgeons, which we have 14 been through. There were some who probably felt, if 15 I remember right, that the managed market, the internal 16 market, would help that process. 17 I think at this point I ought to just say a little 18 more about the Advisory Group and its discussions. 19 I mean, you have made a little of sort of suspicions and 20 criticisms. I cannot recall a case when we did not come 21 to unanimity of view, with one exception, but we did 22 have some robust debate, and I think it was a good 23 group, a cohesive group from that point of view, and 24 I would not leave you with the impression that there was 25 one set of people set against another. The only dissent 0056 1 that I ever received in writing was disappointment from 2 Sir Terence English when we had de-designated the 3 service, but apart from that, we had some robust 4 debates. I think it was important to have robust 5 debates, for the reasons that I have talked of earlier, 6 to thrash out these issues. 7 But to get back to your question, we have no 8 directional powers. Much is made of "designation" or 9 "de-designation", but I do not feel we were doing 10 anything else but trying to get the profession to 11 control the proliferation of this service, and others, 12 voluntarily. 13 Q. It is difficult to think back 9 years. What I am asking 14 you to do is, if you can recall any of the suggestions 15 or views expressed by the Medical Director in the course 16 of this robust discussion, as to what the stronger 17 action to prevent proliferation was? 18 A. I think it would be to de-designate and use the 19 extra-contractual referral device, that is what some 20 members there probably had in mind, and I am 21 speculating, so that the successful succeed and the less 22 successful might perish. 23 Q. Market forces? 24 A. Yes. I mean, I do not care for that, but I mean, it is 25 a managed market and there was no experience of it in 0057 1 1990, but I think that was at the back of people's 2 minds. There is a degree of speculation in my answer 3 there. I find it very difficult to recall the substance 4 of that debate, but in the end we reached a consensus, 5 I think. 6 Q. Can I ask you to do this: when you leave here today, you 7 appreciate we will be here for quite some time. If it 8 occurs to you at all what views might have been 9 suggested in 1990, the beginning of 1990, as to what 10 stronger action might have been taken to prevent 11 proliferation, can you write and let us know, please? 12 A. I will certainly do so, because I wish to be 13 constructively helpful to this Inquiry. 14 Q. There may be some clue, I do not know, if we go to 15 page 2/211. It is a slightly different context, so it 16 may not help. It is paragraph 8.1, "Neonatal and infant 17 cardiac surgery". This is Dr Halliday reporting that 18 some units had not participated in NCEPOD, and it is the 19 last sentence: 20 "Members agreed that a tough line was necessary", 21 this is to get the units to send in their data, "and the 22 unit should be informed that it must participate in 23 a national enquiry in order that its funds should not be 24 affected." 25 A. Can I see the date of that document, please? 0058 1 Q. It is the same document. It is paragraph 8 of the same 2 minute. 3 A. I beg your pardon. A tough line was, I think, rhetoric 4 rather than sanctions, just as any other Health Service 5 body needs to make its returns. I would not have 6 thought it would have been unreasonable for a letter to 7 have gone to the unit with a copy to the Chief Executive 8 of the Trust and I think there will be mechanisms 9 whereby the officials in the Supra-regional Services 10 could try and make sure their wishes were met. 11 Q. You saw the Chief Medical Officer every couple of 12 months? 13 A. Yes. 14 Q. Did you see the minister, the Secretary of State? 15 A. I saw the ministers and Secretary of State every few 16 months. I cannot remember discussing supra-regional 17 services particularly. 18 Q. It is a hypothetical again, and answer it, please, as 19 best you can. Suppose that you had gone to the Chief 20 Medical Officer or the Secretary of State and said, 21 "Look, we are not getting data from -- and you name the 22 unit -- to the National Confidential Inquiry into 23 Peri-operative Deaths. As a result, we are recommending 24 de-designation of that particular unit". 25 Do you think the Secretary of State, the Chief 0059 1 Medical Officer, would have said, "Okay, fine", or would 2 they have said "That is not appropriate"? 3 A. I have the very great respect for Kenneth Calman. 4 I think he would have told me to sort it out. I did not 5 trouble ministers with details, important as those 6 were. I mean, there were a successive number of efforts 7 one could make. I could have written as well to the 8 Trust concerned; I could have written to the appropriate 9 Regional Chairman in that region and asked for help. 10 I would have done that rather than troubled busy cabinet 11 ministers. 12 Q. All I am asking about is ultimate sanction. If a threat 13 had been made, what I am asking you for is your best 14 guess, knowing the people, knowing the times, as to 15 whether ultimate sanction of withdrawal of funding would 16 actually have followed? 17 A. I cannot recall any instance when a particular unit, as 18 opposed to a service, has been a candidate for 19 de-designation. I do not say it could not have 20 happened, but I think it is extremely unlikely. I am 21 quite confident that other measures would have succeeded 22 before that was necessary. We were not in the business 23 of prejudicing good services because of bureaucratic 24 inquiries, important though those may be. 25 Q. Your answer to me is that the hypothetical question is 0060 1 too hypothetical, because you would never get to that 2 stage? 3 A. I hope it is not a hypothetical answer, but clearly, you 4 do not know me either. 5 Q. So clearly you would have managed it one way or the 6 other? 7 A. I am sure I would. 8 Q. That was February 1990. Can I take you to the next 9 meeting, which is July 1990, and we see the minutes 10 again at 2/194. So you see what we are talking about, 11 it is a meeting of Thursday, 26th July 1990, and you are 12 there with various others of the Advisory Group. 13 Can we go to 2/196? Paragraph 5, at the top of 14 the page, "Designation issues, neonatal and infant 15 cardiac surgery" and there is a reference to the paper, 16 SRS (90)6, or the minute number. It is obvious from 17 this, as indeed you, I think, accept in summary in your 18 paper, that designation of the service and units within 19 the service was actively under consideration? 20 A. Yes. 21 Q. Just following to see what is said, who is saying it, it 22 is the second paragraph: 23 "The Chairman invited Mr English to give members 24 the views of the Royal College on this service. 25 Mr English considered that this service should remain 0061 1 designated, but with no more than 9 units. It would be 2 helpful to have surgical data from each unit." 3 Just pausing there, you say -- this is just to 4 clarify in your statement, WIT 41/4; we will come back 5 to DOH 2/196 in a moment. If we go to WIT 41/4, the 6 very last sentence under paragraph 6.1: 7 "Dr Halliday was an important channel for clinical 8 advice to the SRSAG when medical issues arose which were 9 outside the experience of other medical members of the 10 Advisory Group." 11 Have I got it right that if you had a medical 12 member of the Advisory Group with any particular 13 experience in heart transplants, infant and neonatal 14 cardiac surgery, liver transplants, whatever it happened 15 to be, they would speak on that issue because they knew 16 all about it, rather than Dr Halliday? 17 A. I think probably Dr Halliday and the person in control. 18 I stimulated a wider debate; it was not a dictatorship. 19 In the end we had to get a corporate view that was 20 acceptable, so there could be questions, there could be 21 information. Normally one would look to a member with 22 particular expertise to give a view, or somebody who 23 represented an organisation such as the Joint 24 Consultants' Committee. There was a wide network of 25 medical people, a variety of Royal Colleges, and 0062 1 information would be within the Department of Health as 2 well. So it was useful, when people had personal 3 professional expertise. It was sometimes difficult in 4 some of the rarer types of service that we were dealing 5 with. 6 I am sorry to return again to the psychiatric 7 services for the deaf, but we had nobody on the Advisory 8 Group who was an expert in that area. So that is why 9 the last sentence about Dr Halliday. He did comment 10 usually on each of those issues. 11 Q. You have already told us that when it came to matters of 12 clinical judgment and evaluation, that was not your own 13 personal experience? 14 A. It was not, indeed. 15 Q. You had to rely upon what the experts were going to tell 16 you? 17 A. Yes, that is right. 18 Q. Do I take it that obviously the first point of reference 19 would be both Dr Halliday and the medical member, if the 20 medical member had the appropriate expertise? 21 A. That is right. I have not indicated here that 22 Dr Halliday was the source of information; he was 23 a channel of information. He had been out to the unit 24 and was usually in a position to reflect the views of 25 the service and other senior doctors with whom he had 0063 1 consulted. 2 Q. So when it came to something like neonatal infant 3 cardiac surgical services, the Group as a whole would be 4 bound to place heavy reliance, do I take it, on 5 Sir Terence English, as well as on the information that 6 Dr Halliday had been able to extract from his various 7 sources? 8 A. Yes, and there were a number of other -- I mean, we had 9 the Post-graduate Dean, we had Sir Anthony Grabham, we 10 had a Regional Medical Officer. We had a number of 11 people that were, although with not professional 12 expertise, had quite often knowledge of some of these 13 services, either in their region or may have had 14 a regional specialty that might not be neonatal and 15 infant cardiac surgery, but might be cardiothoracic 16 services. I think they had a legitimate input into the 17 debate. 18 Q. If we go back to DOH 2/196, paragraph 5, the second 19 paragraph: 20 "The Chairman invited Mr English to give members 21 the views of the Royal College on this service." 22 That would be the Royal College of Surgeons? 23 A. Yes. 24 Q. "Mr English considered that this service should remain 25 designated but with no more than 9 units. It would be 0064 1 helpful to have surgical data from each unit." 2 We dealt with data which you did not have, 3 obviously. 4 "He said of each unit ..." 5 He sets out what is said about Harefield, 6 Brompton, Guy's and Bristol. 7 "Bristol: He recognised that this unit should 8 retain designation, but recommended that they should be 9 pressed to increase the workload." 10 A. Yes. 11 Q. Then we have input from one of the Welsh observers. 12 Do I take it that this is a reflection of the concerns 13 about the throughput at Bristol? 14 A. It is the only concern I ever heard. 15 Q. If we then go on, if we may, to the next meeting which 16 we see the agenda for at 2/166, we can see that on the 17 agenda for the meeting in October 1990 were designation 18 issues, talking about neonatal and infant cardiac 19 surgery, and future arrangements for supra-regional 20 services, at 6, which I think is a response to the 21 National Health Service changes. 22 Can we, in the minutes of that meeting, go to 23 2/168, paragraph 4(a), please, in full. We have 24 Professor Tynan's paper, which was considered as 25 discussed, the first paragraph. The second paragraph: 0065 1 "Members agreed that the service should ideally be 2 concentrated in no more than six or seven centres and 3 that proliferation occurred to the detriment of 4 patients." 5 Just pausing there, if the service had been 6 thought at this stage to have been a mature service 7 rather than one which was on its way towards maturity, 8 the view could not have been taken, could it, that 9 proliferation would have occurred to the detriment of 10 patients? 11 A. I think the reference was intended to convey, as far 12 as I can remember it, that random proliferation in small 13 uncontrolled pockets would lead to the detriment of 14 patients. It was uncontrolled development that was 15 being referred to. 16 It is quite interesting that, if I may point out, 17 whilst it was clear the service was heading towards 18 de-designation, I think -- and in the last line, the 19 service should ultimately be provided as a regional 20 specialty. I had either lost sight of or forgotten 21 that, but I hope it confirms the point I made earlier. 22 Q. You have drawn attention to the other part of that 23 minute, which I would otherwise have drawn to yours. 24 Can we move forward in time now to mid-1991, to 25 RCSE 2/66? This is Dr Halliday writing to Sir Terence 0066 1 English, a letter of 31st July: 2 "The Advisory Group at its meeting yesterday 3 considered ways in which the cardiac surgical service 4 for neonates and infants might be rationalised in order 5 to ensure the continued designation of this service." 6 The first suggestion is to look and find within 7 the service particular procedures which might be 8 designated. 9 The last sentence of that first paragraph: 10 "If this were possible, it would mean that some 11 units presently designated under the existing 12 arrangements could then be de-designated, thus bringing 13 about a rationalisation of the service." 14 That was the objective, to reduce numbers one way 15 by identifying particular surgical procedures? 16 A. Not surgical procedures, I think. It was an effort to 17 get some volunteers to transfer their work elsewhere, 18 and concentrate on fewer sites. 19 Q. I understood and welcome your comment. You may want to 20 take a moment to think about it, whether this letter is 21 not actually talking about identifying from within the 22 menu of operations on the under 1s particular 23 operations, particular surgical procedures, such as, for 24 the sake of example, the arterial switch procedure, or 25 an operation on a hypoplastic left ventricle, something 0067 1 of that sort. 2 A. I am sorry, you are on ground that I cannot possibly 3 comment upon, as you I am sure will know, so I am sorry, 4 I cannot help you with that. 5 Q. I shall not trouble you further with it, because I think 6 perhaps the letter may speak for itself. Can I, from 7 that letter, take you to the reply which came from 8 Sir Terence, and we have this at DOH 3/3. The third 9 paragraph: 10 "My view at this stage is that it would be very 11 difficult to try and relate designation to specific 12 categories of operative procedures. I do, however, 13 think that appropriate resources and staffing, both 14 medical and surgical, are important considerations and 15 this was touched upon in the July 1989 ... report. 16 "I would also want to see the annual audit data 17 from each designated centre, that presumably you have 18 received over the last few years and which you allude to 19 in your letter. 20 "It is my view that if supra-regional designation 21 is to continue, as I firmly believe it should, it should 22 be related to the annual workload of open and closed 23 operations performed on neonates and infants, so that 24 the misuse of supra-regional funds for treating older 25 children is stopped. 0068 1 "Finally, I believe that any such endeavour would 2 have to accept the possibilities of some of the smaller 3 or less effective units (or indeed units that fail to 4 produce regular audit data) being de-designated in order 5 that the good and responsible units could continue to 6 provide a valuable service." 7 This of course is a letter written to 8 Dr Halliday. I do not know if you ever saw it at the 9 time? 10 A. I cannot remember. 11 Q. But the views in it are plainly the views of Sir Terence 12 English and the Royal College of Surgeons. Those views: 13 were they views which he and the Royal College, through 14 him, were expressing in discussions with the Group at 15 the time? 16 A. I find it very difficult to be specific on that, unless 17 there is a minute that relates to it. I am fairly 18 certain that the issue, as I have just said, about 19 trying to have designation for specific categories of 20 operative procedures, I am fairly sure that issue would 21 be discussed, and also any misuse of supra-regional 22 funds for older children. 23 So it could well have been discussed, or the 24 substance of it, if not a copy of the letter circulated. 25 Q. The next minute I would just like to ask you to look 0069 1 at -- it is part of the continuing chronology of this -- 2 it is DOH 2/33: the first meeting of 1992. If we go 3 across to page 36 in that, paragraph 4.2.2, please. 4 Here we have Sir Terence English giving a view which is 5 recorded in the minutes: 6 "Sir Terence English said that the most recent 7 reports concluded that keeping 90/95 per cent of 8 neonatal and infant cardiac surgery work concentrated in 9 6 or 8 centres was most beneficial to patient care." 10 He speaks about three options which we spoke about 11 earlier and he offers to set up the Working Party to 12 deal with those issues. 13 If we turn to the bottom of the page, 4.2.4: 14 "After discussion, members agreed to Sir Terence's 15 suggestion that he would set up a Working Group to 16 consider the three options for the service. If that 17 group recommended that the number of designated units be 18 reduced, it would name the units to be", I think it 19 should be "de-", rather than "re-" designated? 20 A. Yes. 21 Q. "The Group would produce its findings in time for the 22 July meeting." 23 The July meeting we find at DOH 2/97. It is 24 28th July. If we look and see who was present, and then 25 the apologies. It is plain that Sir Terence was not 0070 1 able to get to that meeting? 2 A. That is true. 3 Q. Page 2/99. "Designation issues". There is a reference 4 there to SRS (92)9. I just wanted to take you to paper 5 (92)9.1, which we find at DOH 2/109. 6 The current position, please. We have spoken 7 about this in broader terms, really, and for the purpose 8 of the question the detail perhaps does not matter, but 9 there were 10 designated centres and Leicester had asked 10 to be added to the list? 11 A. That is correct. 12 Q. Oxford had enquired about being added to the list, and 13 there was going to be Cardiff. So the sentence at the 14 end of the first paragraph: 15 "A situation now exists where there are 13 units 16 providing these services in England and Wales." 17 A. That is correct. 18 Q. A couple of developments are set out there, and the 19 paper concludes: 20 "Those developments serve to strengthen the need 21 to limit the ... centres to the 6 to 8 unit limit 22 discussed by the Advisory Group in February 1992." 23 Page 2/111, there is "Discussion": 24 "The position of the smaller units was last 25 reviewed in 1990 when the Advisory Group decided that it 0071 1 was not possible to de-designate any of them. Attention 2 was then addressed to those units identified by the 3 Society of Cardiothoracic Surgeons, namely Bristol, 4 Newcastle, Guy's and Harefield. 5 "Since then the problems at Newcastle have been 6 overcome and the RCS Working Party's league tables moved 7 from 9th in 1990 to 6th in 1991." 8 Those were league tables of the numbers done? 9 A. Yes. 10 Q. "The position of Bristol must still be considered 11 uncertain, given the expansion of the NICS service in 12 Cardiff. On the league table of activity, Bristol moved 13 from seventh ... in 1989 to eighth in 1990 and ninth in 14 1991." 15 So its activities were dropping by comparison with 16 other centres? 17 A. Or others have gone up and they have remained static. 18 Relatively, you are correct. 19 Q. It says in the second to last paragraph: 20 "Removing designation from units based solely upon 21 their level of activity is therefore an option which has 22 already been considered and rejected by the Advisory 23 Group. It would also not necessarily reduce the number 24 of units overall providing the NICS service." 25 The only criticism apparent in that paper of 0072 1 Bristol is the numbers done? 2 A. Absolutely. 3 Q. Can I go back, having looked at that paper, to the 4 discussion about it at 2/99, the minute we were on just 5 a moment ago? It is paragraph 4.1.2: 6 "Dr Halliday reported that since receiving the 7 Royal College of Surgeons report, he had been approached 8 by Sir Terence English who indicated that since 9 submitting the report, he now had reservations about the 10 continued designation of the Bristol unit." 11 Do you recall the content of what Dr Halliday had 12 to say? 13 A. If I recall correctly, that was the meeting at which 14 Sir Terence English was not present in July, and 15 Dr Halliday had a conversation, I think it was 16 a telephone conversation -- I cannot be absolutely 17 sure -- but he did report in those terms to the Advisory 18 Group, the words, as far as I can recall, that were said 19 there. 20 I have to say, my interpretation, to the best of 21 my knowledge, was that the reasoning behind that was the 22 difficulty in increasing volumes. 23 Q. There is nothing else that you can recall being said? 24 A. I am certain that there was nothing else said. 25 Certain. There was certainly nothing said about the 0073 1 quality of the service. 2 Q. Again, so that we are clear about what information you 3 had or did not have, what I would like you to do is to 4 consider a document which you almost certainly will not 5 have seen at the time, and it is a letter from a man 6 called John Zorab to Sir Terence English. The reference 7 is RCSE 2/188. 8 If we scroll up, it is dated 15th July 1992: 9 "Some time last autumn, I made one or two efforts 10 to get to see you in order to discussion the delicate 11 and serious problem of mortality and morbidity following 12 paediatric cardiac surgery in Bristol." 13 A. I can emphatically tell you, I have never seen that 14 letter until I saw it yesterday evening. 15 Q. I do not suggest that you saw this at the time. I made 16 that clear, I hope, already. 17 A. I hope you did. 18 Q. I mean, it follows from your reaction exactly as I would 19 expect. If you had had knowledge of anything like this 20 at the time, you would have raised it with others? 21 A. I have had nothing to do with designation or 22 de-designation. If there was a risk to a service with 23 which I was associated, I would have pressed for 24 enquiries to be made very urgently indeed, and I think 25 I said to you earlier, that if there had been any 0074 1 reluctance for that to have taken place, I would have 2 taken it right up to the top of the Department of 3 Health, to ministers, if necessary, but certainly the 4 Chief Medical Officer, because I am appalled, if that 5 sort of correspondence was around on 15th July? 6 I cannot remember the date of that Advisory Group 7 meeting. 8 The other point I have to say is that if this 9 sort of information had been around, even on 10 a person-to-person basis, without any member of the 11 Advisory Group, whether he is the President of the Royal 12 College of Surgeons or not, and it was not reflected to 13 the Group, I would take a very strong view about that 14 indeed. 15 I regard it, I have to say, I am sorry, I am 16 trying to retain control of myself -- 17 Q. Do not worry. 18 A. -- I would regard it almost as, forgive the business 19 illusion again, as making investments when your company 20 is insolvent. I think it is appalling. If that was the 21 case. 22 Q. The meeting was 13 days later? 23 A. I am sorry? 24 Q. The meeting was 13 days later, on 28th July, the 25 Advisory Group meeting? 0075 1 A. Thank you very much. 2 Q. That is the meeting at which Dr Halliday is reported as 3 saying that Sir Terence had some reservations? 4 A. Well, I did not know there were these reservations. 5 Q. Can we have a look at 2/189, RCSE 2/189, please. For 6 what it is worth, there had been something in Private 7 Eye and this probably did not get to you at all? 8 A. No. It is not a publication I read, and I certainly 9 never heard, most definitely, I never heard any 10 reference to that, either formally or informally, 11 I promise you. 12 Q. Let us move on from that. What happened, it may 13 appear -- we have yet to hear from Sir Terence 14 English -- 15 A. Forgive me, but it is very interesting and I have only 16 seen this now, an eminent cardiac surgeon in Southampton 17 says "everyone knows about Bristol". 18 Q. And you did not? 19 A. Absolutely not. One of course has to separate gossip 20 from fact. 21 Q. Absolutely. May I say that this simply is a document 22 which was there at the time, and that is what appears to 23 have inspired, or may have inspired Dr Zorab's letter to 24 Sir Terence. 25 May we move, please, to RCSE 2/197. 0076 1 This is a letter which is written by Mr Hamilton 2 to Sir Terence English on 3rd August 1992. If we just 3 look through it, what it may be thought may have been 4 happening is that it may be thought that there was 5 a discussion between Mr Hamilton and Sir Terence as to 6 whether or not to alter the recommendation in the 7 Working Party report to reflect concerns about the 8 quality of performance in the light of the Dr John Zorab 9 letter. 10 Did any of that, even the remotest whisper of it, 11 reach you? 12 A. Not the slightest indication in any of this 13 correspondence, neither verbal or in writing, 14 absolutely, emphatically not. 15 Q. Am I right in thinking that it follows from what you 16 have been saying that with this sort of correspondence 17 around, you would like to have known about it? 18 A. I mean, it is of such fundamental importance, it should 19 have been ventilated, yes. 20 Q. Can I go back to the history. The history, I think, is 21 then that following the meeting in July, or at the 22 meeting in July, a decision was taken to de-designate. 23 Can we go back to DOH 2/99, paragraph 4.1.3, please. We 24 see what the Advisory Group there concluded, the service 25 as a whole should be de-designated and what is said 0077 1 about it: 2 "... a fairer decision in terms of medical and 3 surgical rights of patients than to restrict designation 4 to a few surgical units." 5 One of the difficulties that we have in making 6 sense of what is said there is that the thesis, up until 7 now, and the advice, has been that it is in a patient's 8 best interests that there should be a designated 9 service. It is contrary to a patient's interests that 10 there should be proliferation of services, and it would 11 be desirable to use whatever efforts one could, within 12 obviously the limits of time, to restrict proliferation 13 of services? 14 A. Correct. 15 Q. One appreciates that there may have to be a bowing to 16 the inevitable, but is there any particular reason that 17 you can help us, why is it described as a "fairer 18 decision in terms of the medical and surgical rights of 19 patients" than the continuation of a system with 20 sufficiently few designated units to achieve the objects 21 of the system? 22 A. I have a little difficulty with that, in retrospect, 23 I have to confess. I think it goes back to the 24 proximity of service, the geographical element. I am 25 sorry, I cannot help you more than that. I find it 0078 1 a slightly ambiguous paragraph myself, in retrospect. 2 Q. There is one other matter in the history of designation 3 which I would like to ask you about. Moving aside now 4 from the chronology, if we go on to DOH 2/44. 5 This is a note in relation to SRS (92)2, so this 6 fell for discussion in the February meeting in the year 7 in which designation was finally agreed upon. 8 It is the ideas and the thoughts that fell behind 9 certain phrases that I want to ask, really, for your 10 input on. 11 If we look at what is said here: 12 "At its last meeting, the Advisory Group reviewed 13 the provision of neonatal and infant cardiac surgery and 14 considered whether, in view of the number of units 15 undertaking this work, the service could continue to be 16 designated. Members were in favour of continued 17 designation and asked whether there were any prospects 18 of identifying specific operations rather than units 19 which might be designated, or whether any units might be 20 de-designated." 21 It sets out those which were most at risk. 22 Paragraph 2: 23 "Members had considered a paper ... which provided 24 more information. Bristol and Newcastle were considered 25 to be important on geographical grounds, but officials 0079 1 were asked to discuss with both units ways in which the 2 activity might be increased. 3 Then 3: 4 "Members accepted the conclusion set out in the 5 paper that in general terms, all other factors being 6 equal, there is a strong case for Bristol and Newcastle 7 in terms of geographical spread." 8 We have dealt with geography, and I am not going 9 to go through that again. 10 This follows: 11 "They agreed it would be difficult, if not 12 invidious, to de-designate the centres in question on 13 the basis of surgical expertise, and doubted whether it 14 was possible to do so on the basis of referral pattern. 15 Members agreed that designation should continue but that 16 the situation should be kept under review." 17 "Difficult if not invidious to de-designate on 18 the ... basis of surgical expertise." 19 Can I go through a number of propositions with 20 you? Let us suppose, and it is a hypothetical question 21 which may receive, we do not know yet, an answer by the 22 Inquiry at the conclusion of our hearings in this 23 particular Inquiry, but if one assumes that the concerns 24 expressed by Mr Zorab apparently giving some alarm to 25 Sir Terence English at the time, that we just looked at, 0080 1 that they were well-founded -- let us suppose that; it 2 is pure hypothesis? 3 A. I am sorry ... 4 Q. They were concerns about morbidity and mortality? 5 A. Yes. 6 Q. Proper concerns. Suppose for the moment that it is 7 well-founded. Why would it have been invidious, or 8 would it have been invidious, to de-designate on that 9 basis? 10 A. I think it would have been invidious. 11 Q. That is what I expected you to say. 12 A. My interpretation, for what it is worth, and it is 13 looking at it here, is there was no evidence to 14 de-designate the centre in question on the basis of 15 surgical expertise. It was a non-starter. That would 16 be my interpretation, reading that before I saw that 17 appalling correspondence. 18 Q. This pre-dates the correspondence, you must understand. 19 A. Right. 20 Q. Can I ask you a little bit more about that. The reason 21 why, presumably, it would be difficult or you had no 22 evidence was that there was no evidence on outcome data 23 upon which one could rely? 24 A. Absolutely not. 25 Q. And by "absolutely not", you mean there was none? 0081 1 A. There was none. 2 Q. Therefore, the only basis upon which one could take the 3 decision to de-designate would have to be an 4 impressionistic one? 5 A. Based on dialogues which had taken place between Norman 6 Halliday and, as I have said before, managers, surgeons, 7 anaesthetists, nurses, in the unit. 8 Q. And that would be difficult, if not invidious, to 9 de-designate on the basis of those conversations? 10 A. If there had been evidence, I should have thought it 11 would have come through that group, through that 12 discussion. 13 Q. Suppose those discussions had resulted in the views 14 expressed to Dr Halliday that he picked up, that Bristol 15 was not up to the mark surgically; it was below par and 16 had remained so for some years: again, hypothesis. If 17 that had come through, do you think the Supra Regional 18 Services Advisory Group would have done something about 19 it? 20 A. If it had been reported to the Supra Regional Services 21 Advisory Group, I am sure it would have referred the 22 matter in the first instance as an enquiry to 23 Sir Terence English to say, "Is there substance in 24 this?" Possibly to others as well. I do not think one 25 would jump to conclusions. One would want a pretty 0082 1 speedy response to that sort of enquiry. I have no 2 doubt if that evidence were forthcoming, steps would 3 have been taken to discontinue that service in that 4 unit. 5 Q. Would you give me one moment, Sir Michael? (Pause). 6 Can I tell you what we have on the transcript, because 7 I am not sure it reflects what you want to say. I am 8 grateful to Mr Lissack for pointing it out. The 9 question was, you remember, I put a hypothetical 10 question, suppose there were concerns about Bristol, and 11 suppose they were real concerns. I said "Suppose there 12 were concerns about morbidity and mortality". You said 13 "Yes". "Proper concerns". "Suppose for the moment 14 that they were well-founded. Why would it have been 15 invidious, or would it have been invidious to 16 de-designate on that basis?" You are recorded as 17 saying, "I think it would have been invidious". 18 A. I am sorry, that was incorrect. 19 Q. You meant the opposite, did you not? 20 A. Thank you for correcting me. I am sure it would have 21 been proper to have considered de-designation. 22 Q. Indeed, I think that is how I understood you to mean it, 23 because I went on to say, "That is what I expected you 24 to say". I have to say, what I expected you to say was 25 exactly that, that it would have been proper to 0083 1 de-designate? 2 A. As it is on the record, I would rather it was straight. 3 Q. I am grateful to the input for that. 4 Would you give me one more moment? (Pause). 5 Can I leave the whole question, please, if you do 6 not mind, of designation? 7 Can I ask you, finally, about what you say in your 8 witness statement at page 41/6. This, I suspect, is not 9 so much going to be about de-designation as about the 10 impact of how clinicians work. It is the bottom of the 11 page. You talk about de-designation as an issue: 12 "There was constant discussion at the SRSAG on 13 this matter, and despite helpful efforts by Sir Terence 14 English and the Royal College of Surgeons, the 15 possibilities of closure of several small units 16 was -- ", these words, " -- never likely to gain many 17 volunteers." 18 Is that a reflection of reality? 19 A. I think it is. You have talked earlier about people 20 having the "chop". I do not think many people would 21 volunteer for it. 22 Q. So was it the position, as you saw it -- we have had 23 others' input into it, but was it the position as you 24 saw it that there were difficulties in designating 25 a service such as neonatal and infant cardiac surgery 0084 1 because surgeons, clinicians, could, if they wished, 2 continue performing such operations as and when they 3 wished? 4 A. Yes. That is clinical freedom. I revert to the issue 5 where I started, really, of clinical governance. If 6 there were proper clinical governance arrangements in 7 place, provided there was a well-managed regional 8 service in a discrete number of centres, I think 9 designation or de-designation would have very little 10 effect, actually, on the quality of service once it was 11 a mature service. It was always clear it was going to 12 move towards a regional service, but it had to be backed 13 up by good monitoring on an acceptable basis. 14 I mean, I am sorry that I am going to quote to 15 you -- I meant to earlier: 16 "Clinical governance is part of a national 17 strategy for improving quality in the NHS. A new 18 approach to quality was deemed necessary because the 19 cost of services was being stressed without considering 20 quality. The public has lost confidence in the Health 21 Service and there is unequal access to service and 22 treatments." 23 Those are not my words, those are out of "A First 24 class service 1988." 25 I am very happy to give you a diagrammatic couple 0085 1 of pages which illustrates how clear standards of 2 service, dependable local delivery, which contains the 3 clinical governance area, and monitored services through 4 the Commission of Health Improvement which would ensure 5 that those arrangements were in place, I am certain that 6 that is the way forward, and I hope, too, that the panel 7 will endorse that, if I may make the plea at this stage. 8 Q. Can I just check and see that we may actually have the 9 document? SLD 3/28, please. 10 A. This is an abstract from a paper from a paper that went 11 to my own Trust. That is a diagram that says it, and 12 I am glad you have it on record, but I believe strongly 13 that the government initiative in this area is 14 absolutely correct and if it had been in place in the 15 time we are talking about, the chances of the sort of 16 tragedies that have occurred would have been very much 17 less likely to happen. 18 MR LANGSTAFF: Sir Michael, I am not going to ask you any 19 more questions. May I thank you very much for your 20 evidence. Before you go, there may be some questions 21 from the Panel. For my part, can I invite you to say 22 anything you feel you would like to have covered but 23 have not, and also, if you would like to leave the two 24 pages that you have with you so we can check that we 25 have them and scan them into the database, we would be 0086 1 grateful. 2 Is there anything you would like to add to what 3 you have already told us? 4 A. I think I have covered the ground there adequately 5 through your skilful questioning, and this paper, 6 Mr Pirani has a copy of it, but it is one from my local 7 Trust, so any reference to "CHS" in there is Community 8 Health, Sheffield, just to be clear about it. But it 9 was work in which I was engaged several months ago. 10 MR LANGSTAFF: I can tell you that we have a taxi waiting 11 for you in about 10 minutes time, so it looks as if 12 I have timed my questioning correctly. 13 A. I am here to do the job, not to work to deadlines, but 14 I am grateful. 15 THE CHAIRMAN: There are just a couple of questions from the 16 Panel. 17 Examined by THE PANEL: 18 MRS HOWARD: Sir Michael, just one question. With regard to 19 the role of Regional Health Authority Chairman vis-a-vis 20 the Advisory Group, what influence did the Chairman have 21 on decisions both on designation and de-designation? 22 A. The Regional Health Authority Chairmen as a body had 23 none. The main reason for taking the proposals to the 24 Regional Chairmen's group was to ensure they were 25 content that the amount of top-slicing that was taking 0087 1 place every year, as a first charge on the remainder of 2 the funds of the NHS, met with their general acceptance. 3 MRS HOWARD: Thank you. 4 THE CHAIRMAN: I have one question, which I wonder whether 5 you could help me with. The impression you have given 6 is that of a person very much concerned with 7 management. I understand that. You described the 8 meetings of your group as being ultimately resulting in 9 unanimity, in agreement. 10 It is a question I would value your response to -- 11 I do not have a view; I am just seeking: do you think 12 ever the price to be paid for unanimity might have been 13 one of either, if one can use colloquialisms, "fudge" or 14 "leave something on the backburner", or putting it in 15 more appropriate terms, a lack of clarity as to 16 precisely the action to be taken or the chain of command 17 or whatever, or alternatively, proceed with all due 18 slowness? Do you have any observations on that, as 19 a manager? 20 A. I have an observation in respect of this particular 21 service that we are discussing. It had been on the boil 22 for ten years, pretty well, and it was not a question of 23 "any decision is better than no decision", but it was 24 time that was resolved. There were good reasons to 25 resolve it, because it was no longer meeting the 0088 1 criteria for supra-regional specialties. 2 I must say -- it is in the papers -- that I was 3 stressing the need to resolve this issue. It would be 4 interesting to reflect, since de-designation, what has 5 happened to some of these units. I do not imagine they 6 have all perished. 7 It had been going on for a very long time. We had 8 had a number of these sort of issues. I did not want 9 a fudge, I wanted something that had clarity and also 10 safety and better managed services, in the interests of 11 patients and the staff who worked in the units. 12 Q. If I may press you a little, did you think that you 13 could have unanimity if you did not have a fudge? That 14 was really my question. 15 A. There are times when you will not get unanimity 16 entirely. We did not get unanimity, clearly, on the 17 de-designation, because the only correspondence that 18 I can recall having directly from Sir Terence English 19 was a letter saying he was essentially disappointed with 20 the decision we had taken. 21 So I think consensus management did not work very 22 well in 1974, and I think the time comes when you 23 consult, you discuss and groups of people who have 24 a corporate and individual respect for each other come 25 to a decision. That was actually where I came from. 0089 1 THE CHAIRMAN: I am grateful. Mr Pirani? 2 MR PIRANI: Thank you, Chairman, I have no questions. 3 THE CHAIRMAN: I am grateful. Sir Michael, thank you very 4 much for giving us your time this morning. It has been 5 very valuable to hear from you. As Mr Langstaff made 6 clear, if you have other things that you would wish to 7 bring to our attention, we would be very grateful to 8 receive them, including a copy of the paper you have 9 just referred to. We will be here, as Mr Langstaff 10 said, for a while, so if there are other things you wish 11 to bring to our attention, we would like to hear from 12 you, but for today, thank you very much indeed. 13 I am just now going to refer to Mr Langstaff, if 14 you could sit for one more minute. He will tell us 15 about tomorrow. 16 MR LANGSTAFF: Sir, tomorrow we will hear from Dr Reith, who 17 is the President of the Royal College of GPs, and he 18 will begin his evidence at 11 o'clock in the morning, 19 because he is travelling down from the north, from an 20 area better known to Mr MacLean than most of us, in order 21 to give his evidence. 22 That is what we have tomorrow. If I can 23 foreshadow ahead to Thursday, we will have the advantage 24 of hearing from Sir Terence English, whose name has been 25 much in evidence today, and for that matter, last week. 0090 1 His evidence we expect to begin and to take, indeed, 2 almost all of the Thursday hearing day. 3 THE CHAIRMAN: Thank you very much. So we adjourn and 4 convene tomorrow at 11. 5 (12.49 pm) 6 (Adjourned until 11 am on Wednesday, 12th May 1999) 7 8 9 10 I N D E X 11 12 13 SIR MICHAEL CARLISLE (Sworn) 14 15 Examined by MR LANGSTAFF ...................... 1 16 Examined by THE PANEL ......................... 87 17 18 19 20 21 22 23 24 25 0091