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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

   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.

   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

   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."

   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

   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,

   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

   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

   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."

   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

   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.

   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

   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

   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

   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

   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

   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,

   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

   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

   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

   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

   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?

   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?

   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

   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?

   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

   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

   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,

   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?"

   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

   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

   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."

   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

   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

   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,

   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

   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

   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.

   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

   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

   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.

   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

   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

   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)

   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

   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

   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

   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

   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

   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

   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

   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

   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

   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

   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

   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

   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

   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?

   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

   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

   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

   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

   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

   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

   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:

   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

   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

   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.

   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

   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

   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

   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

   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

   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

   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?

   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.

   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

   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

   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

   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,

   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?

   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

   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