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Hearing summary

9th February 2000

Today the first Phase on the Inquiry concluded in Bristol with final oral submissions presented on behalf of organisations and individuals who have previously given oral and written evidence to Phase One of the Inquiry. The following submissions were made:

  • Harry Trusted and Peter Skelton on behalf of the Bristol Heart Children’s Action Group
  • Christopher Sharpe QC on behalf Bristol Surgeons Support Group
  • Rohan Pirani on behalf of the Department of Health
  • Angus Moon on behalf of Mr James Wisheart
  • Michael Brook QC on behalf of Avon Health Authority
  • Robert Francis QC on behalf of Dr John Roylance
  • Stephen Miller QC on behalf of United Bristol Healthcare NHS Trust
  • Hugh Ross, Chief Executive United Bristol Healthcare NHS Trust

Copies of all full written closing submissions can be found on the Inquiry’s website – submissions

 

FULL TRANSCRIPT

 

   1                     Day 99, 9th February 2000
   2   (9.40 am)
   3   THE CHAIRMAN: Good morning, everyone. Good morning,
   4     Mr Langstaff.
   5   MR LANGSTAFF: Good morning, sir.
   6         INTRODUCTION BY MR BRIAN LANGSTAFF QC,
   7             COUNSEL TO THE INQUIRY
   8   MR LANGSTAFF: Sir, today, which is the 99th day on which
   9     this Inquiry has sat in public, is a day on which
  10     interested participants who have asked to do so will
  11     make their closing submissions to you, to close what is
  12     Phase I of the Inquiry.
  13        I will say a little bit at the end of today about
  14     continuing work that goes on.
  15        It is right that I should put in context before
  16     the representatives make their closing submissions by
  17     way of public advice to you what you should take from
  18     the submissions.
  19        If I can first put it into context, it is for you
  20     and for you alone to make the findings which you may
  21     think you should make from the evidence which you have
  22     received. That evidence is every bit as substantial as
  23     we anticipated at the outset of the Inquiry. There have
  24     been, in total, 815,364 documents, 4,672 files
  25     containing those documents, and a figure which may be
0001
   1     surprising to those who attended the oral hearings,
   2     522 witnesses.
   3        That in itself makes an important point, because
   4     not all of those 522 have come to give evidence orally;
   5     indeed, the majority have not, but what they have said
   6     in writing is evidence, and the documents that have been
   7     produced, they too are evidence.
   8        We have, in addition, 12 written submissions
   9     which, in many respects, are detailed, amounting to
  10     570 pages, and it is those submissions which you will be
  11     considering today, but there is one fundamental
  12     difference, perhaps, which I will come to in a moment
  13     between submissions on the one hand and evidence on the
  14     other, because submissions are those arguments which
  15     representatives address to you; they are not in
  16     themselves evidence, even although they may help you to
  17     resolve matters which you feel you should resolve.
  18        You have indicated that you will produce two
  19     reports: an interim report on the vexed issue of tissue
  20     retention and later this year, a final report dealing
  21     with your terms of reference.
  22        Perhaps to focus today, it is advisable that
  23     I simply remind you of those terms of reference. They
  24     are to enquire into the management of the care of
  25     children receiving complex cardiac surgical services at
0002
   1     the Bristol Royal Infirmary between 1984 and 1995 and
   2     relevant related issues; to make findings as to the
   3     adequacy of the services provided; to establish what
   4     action was taken both within and outside the hospital;
   5     to deal with concerns raised about the surgery and to
   6     identify any failure to take appropriate action
   7     promptly; to reach conclusions from these events and to
   8     make recommendations which could help to secure high
   9     quality care across the NHS.
  10        So far as recommendations are concerned, they
  11     obviously will flow from whatever you make of the facts
  12     and the context. So far as making findings as to
  13     adequacy, to establishing what action was or was not
  14     taken, to identify failures to take action promptly,
  15     you have to determine that upon the evidence, which is
  16     what is said to you, what is written. It is not -- and
  17     I will come back to it -- what may have been said in
  18     another place. For instance, you know that you have
  19     not received in evidence the full scope of the GMC
  20     transcripts. Reference has been made at various stages
  21     to some matters which were referred to in the GMC
  22     hearings, and if those help, so be it. You will see
  23     that there is reference in some of the submissions made
  24     to you to further matters, which of course you receive
  25     on the same basis. If they help, they help. In so far
0003
   1     as you can receive those as evidence, you do so.
   2        The further work which is under commission will in
   3     due course add to the evidence and if that raises issues
   4     which individuals may wish to comment on, they will be
   5     given the opportunity to do so further at that stage so
   6     that all the evidence that comes before you may be
   7     commented upon by any interested party. Comments
   8     themselves, the submissions you will hear today, are of
   9     course not in themselves evidence.
  10        It is for you and you alone to decide what the
  11     facts are and if you find arguments about those facts
  12     helpful, no doubt you will accept them. If you find
  13     that they are not helpful, you will of course be
  14     obliged under your terms of reference to reject them.
  15     But it is also right, I think I should say, it is
  16     a point which is made quite rightly, for instance, by
  17     Dr Roylance in his advocate's submissions, that you do
  18     not have to resolve every disputed issue of fact; only
  19     those disputes of fact which may assist towards
  20     resolving the terms of reference which I have reminded
  21     you of. Only such findings as are necessary and
  22     material.
  23        It is also I think right that I should comment
  24     specifically upon what is said in their submissions,
  25     submission 6 at page 2, and of course it will not be
0004
   1     necessary for anyone to read out those submissions
   2     because they are in writing, in which it is suggested,
   3     putting it shortly, that adversarial cross-examination
   4     is the only way in which the truth may properly be
   5     tested. That is a staggering submission to make,
   6     particularly when many systems of law in the world are
   7     used to resolving criminal guilt on an inquisitorial
   8     system, and it fails to recognise the way in which this
   9     Inquiry has gone about its business. It is not
  10     a trial. You have said from the outset you do not
  11     intend to conduct these proceedings as though it was
  12     a trial or a claim for compensation. It is an Inquiry
  13     into the facts.
  14        I invite you to reject as entirely erroneous what
  15     is said about potential unfairness to Dr Roylance, or
  16     indeed to any witness, in coming to conclusions of fact
  17     where there has been no -- I use the words again --
  18     adversarial cross-examination.
  19        You have seen witnesses and it is up to you to
  20     make what you will of them, and you will remember that
  21     the procedures that you have adopted have enabled all
  22     interested participants in the Inquiry to see every
  23     single bit of evidence that goes to you, because nothing
  24     that has gone to you is hidden from the public -- this
  25     is a Public Inquiry. Everyone has been free to comment
0005
   1     upon the evidence of others, and indeed, this Inquiry
   2     has taken the step of circulating in advance to those
   3     who might, it was thought, be affected by the evidence,
   4     evidence before it was published.
   5        Any adverse comment that we, Inquiry Counsel, have
   6     had has been put to witnesses. What appear to be
   7     disputes of fact have been tested when we have been
   8     asked to test it, and I have not heard any criticism of
   9     us in failing to put those matters, even though they may
  10     not have been put in precisely the same way as others
  11     might have done themselves.
  12        However, it has to be said that there is what one
  13     might call a long-stop to ensure, in any event, that
  14     there is fairness, which you yourself mentioned to the
  15     Inquiry when you opened this Inquiry back in October
  16     1998, and it may go some way to assuage the doubts and
  17     fears of Dr Roylance, or indeed others who may have
  18     listened to this, when you pointed out that once you had
  19     prepared a further draft of the report, the final report
  20     I think and the interim report no doubt too, you would
  21     write to the witnesses briefly setting out intended
  22     criticisms, if there are any, with notice of the
  23     evidence on which they are based, giving them a fixed
  24     period of 21 days to respond, subject to an appropriate
  25     undertaking as to confidentiality. Where the Panel
0006
   1     considered it appropriate to do so in fairness to
   2     a witness, a statement or representation by a witness in
   3     response to proposed criticism might be included in the
   4     report, either wholly or in part, in the text or as an
   5     appendix.
   6        From the beginning, I would hope the procedures
   7     which you have adopted have endeavoured to identify the
   8     facts properly and fairly, and I would urge that that
   9     remains your approach.
  10        There is only one matter which perhaps I should
  11     say in relation to the facts, because the facts are not
  12     for me -- you have seen all the evidence. I do not
  13     comment upon it. It would be inappropriate for me to do
  14     so, save in one respect where I think there is such
  15     common ground that it may not be reflected directly in
  16     anything which is said to you today. It is this: that
  17     what may have seemed to many at the outset as a matter
  18     which involved two surgeons and one Chief Executive,
  19     appears from all the written submissions that have been
  20     received to be much more complex than that, and to
  21     involve the whole system at Bristol. It would be wrong,
  22     therefore, to imagine that the scope of this Inquiry was
  23     in some way limited by the history of events that gave
  24     rise to it particularly at the GMC.
  25        I hope that the submissions which you will hear
0007
   1     today, which are a matter for others and not for me,
   2     will focus on what is going to be Phase II of the
   3     Inquiry -- it has already started as Phase II of
   4     the Inquiry -- the process leading to recommendations,
   5     the last matter you were asked to consider as part of
   6     your terms of reference, recommendations for the
   7     future of the NHS, and will not engage in recrimination
   8     which may be unhelpful. A distinction, perhaps, has
   9     to be made between recrimination and resolution of
  10     disputed fact which, if it is a matter which you feel
  11     you should resolve, then plainly it is your duty to
  12     do so.
  13        However, although there is much that is common
  14     ground in the submissions, quite apart from that which
  15     I have already mentioned, it is entirely a matter for
  16     you whether you accept the common ground made to you in
  17     these submissions, and you have to remember that those
  18     who are making the submissions are only a small number
  19     out of the very large number of people who have given
  20     statements, many of whom would have their own personal
  21     views, many of whom have not chosen to express
  22     themselves other than in the written statement which
  23     they have given to the Inquiry, many of whom may not
  24     share, one way or the other, the views which are given
  25     to you.
0008
   1        Where there is common ground between the
   2     participants, you will give it weight, I have no doubt,
   3     but it does not have to be conclusive and you are free,
   4     within the evidence and those conclusions that can
   5     properly be drawn from it, to decide what you will in
   6     honouring your terms of reference.
   7        The procedure for today is this: that we will
   8     begin with the submissions of each of the parties.
   9     Because the parties have given evidence at considerable
  10     length in some cases, each of the --
  11   THE CHAIRMAN: Mr Langstaff, we have rather avoided the word
  12     "parties". On this last day, perhaps we should
  13     continue to do so.
  14   MR LANGSTAFF: As you have observed several times, this is
  15     not a trial, and if between December 17th and now I have
  16     on occasion been indulging in trials elsewhere, I more
  17     easily slip into the jargon. Those making submissions
  18     to you will speak each for half an hour; they will be
  19     reminded towards the end of that period by a flash on
  20     the screen, and I mention this so no-one else is
  21     distracted by it, that they have five minutes to go. In
  22     the best tradition of courts elsewhere and now beginning
  23     in this country, submissions may properly be
  24     time-limited, and all the more may be so when they have
  25     already been given in writing and it is essential points
0009
   1     or comments or responses to other persons' submissions
   2     which need to be made orally to you, for your help.
   3        There is one matter I should mention and that is
   4     that one of the submissions came in in great detail but
   5     very late, and I understand, sir, that you have agreed
   6     that you will receive comments on that in writing rather
   7     than engage today in matters of detail which may not be
   8     particularly helpful and are better put in writing.
   9        If anyone is affected, therefore, by the Heart
  10     Action Group's submission, which is lengthy and speaks
  11     for itself very well, then they may have a further two
  12     weeks in order to respond to it, as had been the
  13     intention in the first place.
  14        Sir, that is all I should say. Mr Trusted, on
  15     behalf of the Action Group, will be the first of those
  16     to make submissions to you.
  17   THE CHAIRMAN: Perhaps just to clarify that last point,
  18     which you helpfully reminded us of, it is proper that
  19     there should be an opportunity to respond in writing,
  20     but that will be as it were the end of that process of
  21     iteration; it will not go backwards and forwards
  22     thereafter; it will be one final opportunity to make
  23     observations.
  24   MR LANGSTAFF: Sir, as far as the Action Group are
  25     concerned, I am told that Mr Trusted will begin, and he
0010
   1     will be followed with particular reference to the
   2     interim report by Mr Skelton. They will be the only
   3     participants for whom two persons will speak, but I have
   4     taken the liberty of indicating to them that that would
   5     be a procedure to which you would accede.
   6        Beyond that, it only remains for me to say that so
   7     far as timetabling is concerned, I invite you to be
   8     rigorous so far as the time limits go, so that the
   9     matters which you have to hear may be most expeditiously
  10     and usefully conducted within a programme which will
  11     last, I think, the whole day.
  12   THE CHAIRMAN: Thank you, Mr Langstaff, and of course, so
  13     that we may be fair as between all those who wish to
  14     talk to us today.
  15   MR LANGSTAFF: Absolutely. Sir, Mr Trusted.
  16          CLOSING SUBMISSIONS BY MR TRUSTED
  17               on behalf of
  18         BRISTOL HEART CHILDREN'S ACTION GROUP
  19   THE CHAIRMAN: Good morning, Mr Trusted.
  20   MR TRUSTED: Good morning, sir. Sir, the Bristol Children
  21     Heart Action Group was formed by a group of parents who
  22     wanted to find out why their children died when they
  23     were treated at Bristol. The increasing realisation on
  24     their part was that there had been very grave
  25     incompetence and mismanagement, amounting to them to
0011
   1     a sense of real betrayal of them and of their children.
   2     They feel that they were misled into trusting their
   3     children to a substandard medical service. The
   4     inevitable outcome of that service was that too many of
   5     those children died or suffered permanent disability,
   6     which we say was avoidable.
   7        The parents whom I represent have to live for ever
   8     with those consequences. In some cases, the emotional
   9     impact of what has happened has been too great for them
  10     to bear.
  11        I say this to you, sir, not so much in a spirit of
  12     confrontation but because this is the background against
  13     which I speak and which, alas, this Inquiry has been
  14     summoned.
  15        We want to be positive. We want to make
  16     a contribution and to help you to make recommendations
  17     for the future of the National Health Service, but
  18     I have to say to you, sir, that some of those we
  19     represent feel that the future for them has already been
  20     blighted and that what has happened has been a terrible
  21     toll, an irreparable toll, on their own lives.
  22        I should also say that there are two groups of
  23     people for whom the Inquiry still does not entirely
  24     address their concerns. First, there are parents who
  25     are not formally within the scope of your Inquiry, that
0012
   1     is to say, that perhaps their children were treated at
   2     Bristol before 1984. I mention them expressly because
   3     I know that you do have their concerns in your mind, and
   4     I must stress that for those parents who feel very much
   5     that they are part of the history of what happened at
   6     Bristol, they follow these events with the greatest
   7     interest and concern and the more in which you feel that
   8     you are able to meet that in your final reports, the
   9     better for them.
  10        The second point I want to stress as a preliminary
  11     matter is that there is still concern that morbidity, by
  12     which I mean children who survived but with
  13     disabilities -- and in some cases devastatingly serious
  14     disabilities -- that subject has still not been the
  15     subject of sufficient review.
  16        We were grateful for Mr Langstaff's comments which
  17     were heard in the autumn, and we still await with great
  18     interest any further evidence and submissions which the
  19     Inquiry may receive on that subject.
  20        I cannot emphasise too strongly that for those
  21     parents and children who are dealing with disability, it
  22     is the most devastating thing and they follow what you
  23     say and what you hear with the greatest possible
  24     interest and concern.
  25        Sir, the allegations that I made at the outset,
0013
   1     that of substandard care and mismanagement, amounting to
   2     a sense of betrayal for the parents whom I represent, is
   3     based not merely on flimsy assertion but first of all on
   4     the direct evidence of the parents themselves; and
   5     secondly, importantly, on the statistical evidence which
   6     this Inquiry has itself collated.
   7        Sir, in our submission, the statisticians went out
   8     of their way to be as fair as possible to the doctors,
   9     surgeons and administrators whose work ultimately they
  10     had no option but to criticise. Their voluminous and
  11     serious and well constructed reports speak for
  12     themselves and I will not amplify what they have said,
  13     but to choose a few key conclusions is sufficient to
  14     show us the scale of the problem.
  15        The Aylin report identified that at Bristol
  16     mortality in children under the age of 90 days who
  17     required open-heart surgery was four times higher than
  18     it was at comparable centres elsewhere in England.
  19        The same report identified that at Bristol
  20     mortality in children aged between 90 days and one year
  21     requiring open-heart surgery was three times higher than
  22     elsewhere in England.
  23        The Spiegelhalter report found that on the CSR
  24     data alone, between 1988 and 1995, 47 children died at
  25     Bristol who probably would not have died had they been
0014
   1     treated elsewhere. Of course, that figure was an
   2     extrapolation, but we say it was a convincing
   3     representation of what really happened.
   4        We are further supported in that submission by the
   5     conclusions of the clinical case reviewers, independent
   6     men and women, thoroughly specialised, well respected,
   7     who looked at 80 children and 100 procedures. In half
   8     of the cases they examined, the care was substandard.
   9     30 per cent of the children they looked at had an
  10     outcome which was possibly or probably worse than it
  11     should have been because of that substandard care.
  12        13 of those 80 children had care which was
  13     graded 1, that is to say, substandard care which
  14     probably led to a worse outcome than would otherwise be
  15     expected. Of those 13 children, 11 died and one is left
  16     with permanent disabilities. That is the background
  17     against which this Inquiry has been summoned.
  18        We will never know exactly how many children died
  19     at Bristol because of the mismanagement and bad care,
  20     but we say, with confidence, that that figure is
  21     probably between 50 and 100, and in our submission, that
  22     is in itself the justification for this Inquiry and for
  23     its very grave concerns.
  24        It is even more difficult to be precise about the
  25     number of children who have been left with permanent
0015
   1     brain damage, tetraplegia and other very serious
   2     complications, but we do know that there were at least
   3     several children in that position, and several in this
   4     context is enough.
   5        Why did this happen, and how can we make sure that
   6     it never happens again?
   7        It was Mr Stark, sir, who commented here on
   8     Day 50, page 17 of your note, that for paediatric
   9     cardiac surgery everything needs to be right: the detail
  10     needs to be right, the management needs to be right, the
  11     surgery needs to be right, and all too often at Bristol,
  12     far too many things were wrong.
  13        Let us begin with diagnosis. There was
  14     insufficient use of such techniques as echocardiography
  15     and TOE. It was widely criticised, particularly when we
  16     looked at individual cases and heard those, such as
  17     Dr Silove, pointing out that the absence of that
  18     diagnostic technique was a key problem.
  19        It was also apparent that in some cases even when
  20     the right techniques were used, the cardiologist
  21     misinterpreted the diagnosis.
  22        The surgeons themselves gave evidence that one of
  23     the reasons that their results were sometimes poor was
  24     that the diagnosis was wrong and that when they opened
  25     up the child, the anatomy was not as they had been led
0016
   1     to expect.
   2        Sir, of course we do criticise the cardiologists,
   3     but we also criticise the surgeons because we say that
   4     they should have alerted the authorities; they should
   5     have protested more about the poor diagnosis. Had they
   6     done so, the rates would have improved.
   7        The lessons, in our submission, are clear: any
   8     hospital offering paediatric cardiac surgery must ensure
   9     that diagnosis is at the forefront of its care. Every
  10     modern technique must be applied as accurately as
  11     possible, and just as the results of the surgery itself
  12     should be monitored, where there is anxiety that
  13     diagnosis is too frequently wrong, that should be the
  14     subject of urgent action and investigation.
  15        The next area is that of the surgery itself. Sir,
  16     as you know, a great deal of concern has focused on the
  17     surgeons themselves and on their record. We accept that
  18     the surgeons are not the only people whose work must be
  19     criticised and examined by this Inquiry. We accept that
  20     to focus solely on Messrs Wisheart and Dhasmana gives
  21     a misleading picture of what went wrong, and we would
  22     not be serving the interests of those parents we
  23     represent if we ignored that.
  24        But, sir, we have to say that there is compelling
  25     evidence that the surgeons had poor technique
0017
   1     themselves. There were such relatively minor matters as
   2     being late for surgery, indicating a kind of laxity
   3     which was unacceptable. There was the fact, noticed by
   4     more than one witness, that the quality of the stitching
   5     was often not as good at Bristol as it was in other
   6     places. There was the fact that during surgery, far too
   7     often cross-clamp times were too long, cardioplegia was
   8     inadequate, acid levels in the blood became unacceptably
   9     high. Again and again, when they looked at the detail,
  10     the experts whom you heard giving independent evidence
  11     corroborated the concerns of parents that that need was
  12     simply not being properly met.
  13        You will also recall, sir, Dr Sumner's evidence,
  14     talking about the failure to monitor urine output using
  15     a catheter. In our submission, that was a classic
  16     example of something which, at a relatively early stage,
  17     was identified as a life-saving technique. It was not
  18     applied at Bristol and it should have been. There was
  19     no excuse for the failure to do so, and in some cases,
  20     that failure, we say, may have made the difference
  21     between life and death.
  22        Again, the conclusions of this are clear: to
  23     achieve optimal results in cardiac surgery, the highest
  24     standards must be maintained. Consultants doing this
  25     work must be expected to keep up with advances in
0018
   1     medicine; to be aware of information about such things
   2     as blood acid levels in cardioplegia, and to ensure that
   3     they give their patients the best possible chance of
   4     survival and of good recovery.
   5        The final key area of a failure of care which we
   6     identified was in the Intensive Therapy Unit. We say
   7     that nowhere was the split site more disastrous than in
   8     the case of intensive care. At a time when there was
   9     something like 70 nurses working in the Bristol Royal
  10     Infirmary on that ward, only two of them were qualified
  11     to look after paediatric cases. In some instances, that
  12     meant that they were entirely ignorant of such basic
  13     matters as the reference intervals applicable to babies
  14     and small children. One parent was told by a nurse,
  15     "Sorry, I don't understand babies". That nurse was
  16     looking after a critically ill child recovering from
  17     open-heart surgery.
  18        We were told that the reason that they had
  19     difficulty recruiting paediatrically trained nurses was
  20     that it was a mixed ward and that most such nurses are
  21     not willing to work with adults as well. Well, perhaps
  22     they are not, but in our submission, the overwhelming
  23     conclusion must be that any such unit in the future must
  24     be dedicated, specialised and staffed only by nurses who
  25     are properly and fully trained to bear the
0019
   1     responsibility of looking after those children.
   2        The split site also meant there was far too little
   3     contact between children in ITU and physicians. The
   4     cardiologists who gave evidence were quite frankly
   5     saying that because of the hill separating the BCH and
   6     the BRI they were not as involved in the post-surgical
   7     care as they should have been. In our submission, that
   8     was simply not good enough; they should have made more
   9     effort to have come to see the children and in any
  10     event, this sort of split site is always going to invite
  11     that sort of approach.
  12   THE CHAIRMAN: Mr Trusted, can I ask you a question to
  13     help me? Just to take you back to the staffing and the
  14     helpful submission you made about qualifications of
  15     nurses, what does one do, would you argue, if those
  16     nurses in sufficient numbers are simply not available?
  17   MR TRUSTED: In that case, I would say if there is any
  18     risk to the children, the children should not be
  19     referred to that centre for surgery until such time as
  20     the ITU care is good enough. We say that what happened
  21     at Bristol simply was not acceptable, and that it should
  22     not have been a designated centre at all. I think that
  23     is the only answer I can give you.
  24   THE CHAIRMAN: Thank you.
  25   MR TRUSTED: The other aspect of ITU care which we identify
0020
   1     as a key failure was the lack of management and
   2     responsibility. On too many occasions one doctor would
   3     give one order medically which would then be
   4     countermanded by another. The parents had a sense of
   5     mismanagement throughout the entire unit, which meant
   6     that their children were not receiving the quality of
   7     consistent care which they needed. Far too often
   8     a relatively junior doctor was left in charge and was
   9     quite unable to cope, if for example a child developed
  10     a tamponade after a major operation.
  11        Again, we say that the Clinical Case Review
  12     clearly bears out the fact that ITU care itself was
  13     a major cause of mortality and morbidity, that is to
  14     say, children who survived and had had successful
  15     surgery, died ultimately because they were not given the
  16     care and intensive therapy that they so badly needed.
  17        In our submission, in the future, only the highest
  18     standards of intensive care are acceptable when dealing
  19     with children in these circumstances.
  20        Moving away briefly from the detailed clinical
  21     picture, I want to look at the way in which the parents
  22     feel about some of the other things that went wrong in
  23     Bristol. Not all of these criticisms are necessarily
  24     matters of life and death in themselves, but they are
  25     a part of the picture. They are a part of what went
0021
   1     wrong and they are a part of why those we represent feel
   2     such a deep sense of alienation and betrayal by the
   3     medical establishment, as they saw it.
   4        To begin with, children, when they were born,
   5     often exhibited to their parents abnormalities. The
   6     parents brought those abnormalities to the attention of
   7     paediatricians and general practitioners. In an
   8     astonishingly large number of cases, those concerns were
   9     ignored. We have heard evidence from a number of
  10     parents who told us they had to pester continually even
  11     to get their child referred to a cardiologist. This,
  12     I know, is not directly a criticism of Bristol, but we
  13     submit that it is very much within the ambit of this
  14     Inquiry that if children are born with congenital
  15     defects, they are promptly and properly referred to an
  16     appropriate specialist.
  17        In our submission, one of the lessons from Bristol
  18     must be a greater awareness of these conditions and
  19     a sense that they should be referred promptly, and that
  20     the concerns of parents should not be treated with the
  21     disdain that they too often were.
  22        So far as referrals themselves are concerned,
  23     I should say that there is a real sense of grievance
  24     that whether or not a child was referred to Bristol or
  25     to a better hospital was really a complete lottery from
0022
   1     the parents' point of view. They had no knowledge that
   2     what was going on was substandard care. They were quite
   3     unaware that there was anything wrong with Bristol at
   4     all, but some of the referring doctors were aware of
   5     that and did not refer patients to Bristol.
   6        Alas, what those doctors did not do was to alert
   7     the medical establishment to what was going on and to
   8     ensure that the care at Bristol itself improved. The
   9     reality was, from the parents' point of view, an almost
  10     random separation between those children referred to
  11     Bristol and those referred elsewhere.
  12        When they were referred, parents were generally
  13     referred to the cardiologist who would take them
  14     straight to the Bristol surgeon. Again, we say in
  15     passing that there came a point when the cardiologist
  16     should have realised that the care offered by Bristol
  17     was not good enough. However, once they were referred
  18     to Bristol, they were then given a misleading impression
  19     of the risks involved. Parents were not told that risks
  20     at Bristol for their children were higher than they were
  21     elsewhere; they were not told that the local risk was
  22     significantly worse than the national figures.
  23        Sir, in relation to risk, we say this: of course
  24     generally a patient should be given the national risk
  25     because those statistics will probably be more reliable
0023
   1     because they are based on a bigger sample, but where the
   2     local risk is in fact very different, in particular
   3     where it is much worse, which we say it clearly was at
   4     Bristol, the parents or patients should be made aware of
   5     what that risk is so that they can form their own
   6     informed judgment about whether or not they consent to
   7     the surgery.
   8        Many of the parents that we represent still live
   9     with a sense of guilt that they signed consent forms.
  10     They did so, we say, because they were misled about the
  11     true position, but it is one thing for me to stand here
  12     and say that and it is another thing for them who have
  13     to live every day with the consequences of having made
  14     that decision.
  15        I want to look briefly at the way in which the
  16     internal monitoring system at Bristol did not work --
  17   THE CHAIRMAN: Mr Trusted, it is your submission that the
  18     true position was known, or knowable, in, let us say,
  19     1988 and 1989?
  20   MR TRUSTED: Sir, yes. I think what I would say is this:
  21     during the period with which you are concerned, there
  22     was a growing awareness that care at Bristol was
  23     substandard. I would say even before 1988 or 1989 there
  24     were clear signs -- for example there was the BBC Wales
  25     programme; there was Professor Henderson's concerns --
0024
   1     which were expressed to those in authority. However,
   2     I certainly say that by 1990, at the very latest, there
   3     was a clear body of evidence which justified concern and
   4     investigation, both internally and externally.
   5        Another example of that, for instance -- one could
   6     give many, but another example would be Professor
   7     Berry's report, which illustrated the weaknesses in
   8     diagnosis, and the Supra-regional Cardiac Surgical
   9     Report which was first produced in July 1989. There was
  10     that sort of evidence which was evolving, in parallel
  11     with the concerns of referring doctors and patients
  12     being treated.
  13        So far as the medical and surgical staff within
  14     the Bristol hospital, we have heard clear evidence,
  15     indeed, in many cases evidence from the people
  16     concerned, that they knew that the split site was
  17     unsatisfactory, we know Mr Dhasmana thought that,
  18     certainly in the mid-1980s.
  19        There were, of course, far too few specialised
  20     nurses on ITU. Again, that was known to anybody who
  21     bothered to ask the question. We knew from Professor
  22     Berry's paper that the diagnosis was wrong. It was
  23     clear that the referral rate was low, and it was also
  24     clear that in so far as there were national statistics
  25     available, Bristol was at the bottom of virtually every
0025
   1     table we looked at -- not quite absolutely every one;
   2     yes, there were occasions when it managed to move up
   3     here and there, but in general we say there was a clear
   4     body of evidence which supported the concern that
   5     Bristol care was weak.
   6        Sir, I am not in these submissions going to go
   7     through the detail of the Bolsin and Black audit and all
   8     the things that happened thereafter, but what I do say
   9     is this: everybody in the Bristol Royal Infirmary knew
  10     that there were substantial problems certainly by July
  11     1992. The reality was that it was not until the tragedy
  12     of Joshua Loveday's operation in January 1995 that any
  13     sort of external auditors were called in to look at and
  14     account for what was going on. Even then, those in
  15     charge at Bristol did their utmost not to face up to
  16     what had happened, and we say that it is a dreadful
  17     tragedy that that was not done much sooner than it was.
  18     In our submission, the failure of the internal
  19     management at Bristol to deal with this problem was
  20     a major aspect of the whole thing.
  21        Having said that, it is also our submission that
  22     just as important was the failure of any sort of
  23     external monitoring system. Of course, there was the
  24     lack of audit, of course between 1984 and 1995 there was
  25     not really an agreed system of presenting figures
0026
   1     nationally; there were not really agreed standards of
   2     audit; there were not really easy ways of even ensuring
   3     that accurate figures were submitted or analysed
   4     reliably. But nonetheless, we submit that those in such
   5     bodies as the Department of Health, the Royal Colleges,
   6     the District Health Authority, the UBHT, the SRSAG, had
   7     a duty which they woefully failed to discharge.
   8        The concerns of men such as Henderson, Crompton,
   9     Zorab and Ross about what was going on at Bristol were
  10     known to them and they ignored it.
  11        Sir, in our submission, one of the most
  12     distressing aspects of the evidence which you heard was
  13     that not one of the people in charge of those bodies was
  14     prepared to come to this Inquiry and say, "Yes, it was
  15     us. We should have done something and we did not. We
  16     should have looked at something and we did not. We
  17     should have listened and we did not". None of them said
  18     that. They all said, "It was them". They were all
  19     anxious to blame the other guy somewhere else along down
  20     the line.
  21        In our submission, it was all of them. They all
  22     had a responsibility and all of them failed to discharge
  23     it. Of course, we say in the future there should be
  24     proper standards of national audit and of course we say
  25     that in the future those in charge of these things
0027
   1     should have a clear chain of responsibility, but we must
   2     observe that for the past it is a calamitous thing that
   3     none of those people did, at the time, recognise they
   4     had any such responsibility, and how regrettable that
   5     none of them, even now, are willing to acknowledge that.
   6        Sir, before I reach the end, I would like to say
   7     on a personal note how grateful I am to the BHCAG and
   8     particularly to its committee members, for their
   9     tremendous hard work in assisting us as their lawyers,
  10     and I hope in assisting you. I have nothing but
  11     admiration for their courage and selflessness in dealing
  12     with what has been, for all of them, the most acutely
  13     painful series of events. It has been an inspiration to
  14     work with them. I pay tribute to the committee and to
  15     all the parents who have helped us for their selfless
  16     work.
  17        The events that this Inquiry are considering may
  18     properly be described as a tragedy. It is an over-used
  19     word, but here, just for once in modern life, it must be
  20     applied. This was a tragedy for the families whose
  21     children died; it was a tragedy, too, for the children
  22     who have survived but with terrible disabilities; and it
  23     was a tragedy, I have to say, for those parents who have
  24     not been able to accept their terrible sense of guilt
  25     and grief and outrage at what has happened.
0028
   1        The tragedy, I think, extended beyond the parents
   2     and the children to the doctors, surgeons and the
   3     administrators whose lives have also been blighted by
   4     this. They will have to live with it. We have to say
   5     that, in our submission, those men and women were the
   6     victims of their own folly and their own incompetence
   7     and their own mismanagement, but nonetheless, they are
   8     victims. There was a wider culture of a closed,
   9     secretive, defensive medical world which was the real
  10     cause at the very bottom of this disaster.
  11        The greatest single improvement which this Inquiry
  12     could achieve is an open, clear medical establishment
  13     involving parents, patients, doctors and administrators,
  14     in a clear commitment to a fairer more open, better
  15     managed service.
  16        If that can be achieved, the National Health
  17     Service will have come of age.
  18   THE CHAIRMAN: Thank you very much, Mr Trusted. We will
  19     hear now, if we may, from Mr Skelton. We are greatly
  20     obliged to you, thank you very much.
  21        Mr Skelton, we are very content to hear from you,
  22     bearing in mind the time constraints that Mr Langstaff
  23     has made clear.
  24   MR SKELTON: I am grateful, sir. I will be as quick as
  25     I can.
0029
   1          CLOSING SUBMISSIONS BY MR SKELTON
   2               on behalf of
   3         BRISTOL HEART CHILDREN'S ACTION GROUP
   4   MR SKELTON: The BHCAG accepts the potential value of
   5     autopsy as a means of determining how a person died,
   6     assessing methods of investigation or treatment and
   7     providing data by which regional and national trends of
   8     mortality can be identified. However, in our view, the
   9     evidence relating to the practice of pathology at
  10     Bristol is indicative of a national failure of
  11     clinicians, pathologists and coroners to take account of
  12     the wishes of parents who have lost children.
  13        Removing, retaining and disposing of tissues or
  14     organs from children without parental permission is
  15     morally repugnant. Those who have allowed such
  16     a practice to continue unregulated for so long must take
  17     responsibility for the enormous distress they have
  18     caused, and continue to cause. They must also accept
  19     that had a policy of openness and discussion been
  20     adopted in place of one of paternalistic secrecy, this
  21     distress could easily have been avoided.
  22        Many parents who have lost children would agree to
  23     donation if such an act would contribute to future care;
  24     some would not. But it is a fundamental duty of the
  25     medical profession to ensure their wishes are first
0030
   1     sought and then respected. We hope that this Inquiry
   2     will recommend the introduction of enforceable standards
   3     which will regulate the practice and procedure of
   4     pathology.
   5   THE CHAIRMAN: You expressed in it the form of a duty.
   6     Would you not wish to express it in the form of a right
   7     in the parent or patient?
   8   MR SKELTON: I do, sir, and I do so at the end of my short
   9     speech.
  10        The evidence given to the Inquiry illustrates that
  11     there was no standardised good practice at Bristol to
  12     ensure that the issues of postmortem and tissue
  13     retention were dealt with sensitively and with
  14     thoroughness. In particular, the possibility of
  15     a postmortem was often first raised by junior staff with
  16     whom the parents had little or no established
  17     relationship. The issue was often dealt with in
  18     a cursory manner with parents being given insufficient
  19     information as to why a postmortem should take place,
  20     what it entailed and the role of the Coroner.
  21        In cases of hospital postmortems, although written
  22     consent was obtained, the retention of tissue was not
  23     explained properly so the parents were not aware that
  24     the tissue they could comprise of major organs.
  25        In cases of Coroner's postmortems, parents were
0031
   1     not given the option of permitting the retention of
   2     tissue or organs and were usually not even told that it
   3     would occur.
   4        We believe that the responsibility for raising the
   5     issue of postmortem retention resides with the senior
   6     clinician, who has an established relationship with the
   7     parents. In all cases, parents should be told at least
   8     in outline what the postmortem will entail and what it
   9     will achieve. They should be given the option of
  10     allowing or refusing organ retention, and this option
  11     should be confirmed in writing with a copy of the
  12     consent form to take home.
  13        Finally, parents should be informed at a later
  14     date which organs or tissues, if any, have been
  15     retained. If, as has been made clear in evidence, the
  16     pathologists had concerns about the legal grey area
  17     surrounding rule 9 of the 1984 Coroners Rules, they
  18     should immediately have ensured that proper consent was
  19     always obtained, or desisted from retention and sought
  20     the formal opinion of the local Coroner and the
  21     Coroners' Society.
  22        Only if they were then informed that retention
  23     without consent was legally acceptable, should they have
  24     continued to retain material, and then with the proviso
  25     that the senior clinician should have provided a full
0032
   1     explanation and justification to parents.
   2        Pathologists have been routinely removing and
   3     retaining material from bodies for decades. This
   4     practice has been facilitated by the paucity of
   5     guidelines, legislation and case law on the subject,
   6     which has allowed the medical profession to use the
   7     powers of the Coroner to pursue its own twin purposes of
   8     education and research, and in the case of Coroner's
   9     postmortems, a deliberate policy of not informing the
  10     deceased's relatives. In our view, it is to the
  11     discredit of the medical profession that they have
  12     ignored the moral rights and feelings of bereaved
  13     relatives and continue to seek to justify their practice
  14     by a lack of clarity in the law.
  15   THE CHAIRMAN: Is it your submission that there was
  16     a deliberate policy, rather than a failure to recognise
  17     that it might be appropriate to seek permission?
  18   MR SKELTON: Sir, from the evidence we heard, it was clear
  19     in the late 1980s that this issue was coming to the
  20     fore, certainly from Professor Green, as we set out in
  21     our written submissions. I think in the minds of both
  22     the coroners and the pathologists by the late 1980s,
  23     there was certainly an unease about the fact that they
  24     were misleading parents.
  25        The public should not need Parliament or the
0033
   1     courts to regulate medical practice. The profession
   2     should have properly assessed and amended its own
   3     procedures many years ago. As the events in Bristol and
   4     Liverpool exemplify, the primary issue is not legal, not
   5     who has legal authority to do what, but ethical: what
   6     duties the medical profession has towards bereaved
   7     relatives and what steps may be taken to ensure that
   8     those duties are met.
   9        It is clear from the Inquiry's brief examination
  10     of the Coroner system that it is in urgent need of
  11     scrutiny and overhaul. In our view, the Coroners in
  12     Bristol were either aware of the practice of retention
  13     and allowed it to continue, or failed to ensure that
  14     their authority was properly exercised by the
  15     pathologists. By allowing the medical profession to use
  16     the powers of the Coronial office for their own
  17     purposes, Coroners abrogate key public duty. It is
  18     therefore essential that they are properly trained,
  19     externally monitored and regulated.
  20        This need was highlighted by the Inquiry's
  21     exploration of the issues relating to retention
  22     following Coroners' postmortems. It was clear that
  23     liaison between Coroners, clinicians and pathologists
  24     was still a matter of local practice and not
  25     a nationwide requirement. In our view, had proper
0034
   1     dialogue been maintained between the Coroners' Society
   2     and the Royal College of Pathologists, the tacit
   3     practice of tissue and organ removal would either never
   4     have developed or have been the subject of public
   5     scrutiny and amended.
   6        Coroners have daily contact with bereaved
   7     families. They are and should be sensitive to the
   8     emotional turmoil which retention without consent can
   9     cause. They and their pathologists must now be alert to
  10     the growing emphasis on the rights of bereaved
  11     relatives.
  12        Thank you, sir.
  13   THE CHAIRMAN: Mr Skelton, thank you. That was very
  14     helpful.
  15   MR LANGSTAFF: Sir, we now have Mr Sharp, who will make the
  16     closing submissions on behalf of the Surgeons Support
  17     Group. May I suggest that when he finishes, perhaps
  18     would be the opportunity to take a short morning break?
  19   THE CHAIRMAN: Thank you. Good morning, Mr Sharp.
  20           CLOSING SUBMISSIONS BY MR SHARP
  21               on behalf of
  22           BRISTOL SURGEONS SUPPORT GROUP
  23   MR SHARP: Good morning, sir, we are grateful for the
  24     opportunity you indicated we have to comment on the
  25     submissions that have been made in writing and received
0035
   1     rather late, which opportunity we plan to avail
   2     ourselves of.
   3        I am also grateful that Mr Langstaff has indicated
   4     what he sees, and I hope the Inquiry will share his
   5     view, as common ground, that is to say, that this
   6     Inquiry, which perhaps in the public mind started as an
   7     inquiry into the practice of two surgeons and the Chief
   8     Executive, has spread and has needed to spread its
   9     enquiries much wider than that.
  10        Sir, I represent, as you know, the Surgeons
  11     Support Group, a large group, 750 members or so.
  12        We wanted to use this opportunity to address the
  13     Inquiry as an opportunity to focus upon the positive,
  14     and to focus upon the future, and I propose to do that,
  15     and we have sought in our written submissions to do
  16     that.
  17        There are two points I need to address first, one
  18     which deals with the past and one which deals with
  19     a matter which concerns our group very much and which we
  20     hope, although it is slightly outside your terms of
  21     reference, you may feel able to give some
  22     recommendations about.
  23        The first point is that it would be wholly
  24     inappropriate, given the vast fund of material which our
  25     members have provided, if I were not to stress the
0036
   1     message which they have sought to deliver in their
   2     statements and in the answers to the questionnaires
   3     which you have seen, and the expression of which was the
   4     spontaneous trigger for the formation of the group,
   5     a socially disparate group, a geographically widely
   6     spread group, but a group of patients, parents and
   7     professional colleagues which was brought together by
   8     the way in which these surgeons had touched their lives,
   9     brought together by a common experience that these
  10     surgeons were men of the utmost integrity, care and
  11     compassion.
  12        On Day 70 of this Inquiry, Mr Langstaff reminded
  13     us that in approaching this task of assessing the
  14     adequacy of care at Bristol, the Inquiry would have to
  15     consider the written and oral evidence, for instance, as
  16     to the way in which parents and children were treated.
  17        As he said at that time, figures and statistics
  18     cannot answer this question, but the experience of real
  19     people can provide the Inquiry with an insight into the
  20     reality of the interaction between surgeons and the
  21     cardiologists and the nurses on the one hand and the
  22     parents and the children on the other and in that way,
  23     inform the Panel of one important way in which parents
  24     and children were treated.
  25        The evidence of this group as a whole, that is to
0037
   1     say, not only the statements that you have received and
   2     the oral testimony that you have reached, but also those
   3     questionnaire replies, covers a wide period of time, and
   4     as Mr Trusted said a moment ago, although your terms of
   5     reference may be limited, you have indicated
   6     a willingness to spread your eyes, as it were, beyond
   7     that narrow horizon.
   8        What we say is this: that that broad picture
   9     provides a picture of the character of these surgeons of
  10     such consistency over such a long periods period of time
  11     that you must necessarily take it into account when you
  12     are considering the way in which they dealt with and
  13     reacted to the traumas and the tragedies of the families
  14     with whom they were concerned.
  15        That evidence consistently is marked by
  16     descriptions of compassion, of care, of sensitivity, of
  17     empathy with patients and concern. It is impossible, we
  18     suggest, to imagine these same men, so described over
  19     20 years or so, were capable of some form of
  20     schizophrenic change of character that could explain the
  21     suggestions that have been advanced that they were less
  22     than caring, dismissive or impatient. There may be
  23     other reasons for that view expressed by some, and
  24     I will return to that in a moment.
  25        I make also no apology for repeating what we have
0038
   1     already highlighted in our written submissions, that in
   2     almost every statement or questionnaire of reply we have
   3     received, the words that stand out about both of these
   4     surgeons relate to their honesty, their realism and
   5     their integrity, in particular, those objections relate
   6     to the care and the patience with which the risks and
   7     complications of surgery were explained to the parents.
   8        Even the GMC -- and, sir, you will have seen at
   9     least some of the evidence before that hearing -- was
  10     clear in its recognition and I quote, of the extensive
  11     evidence before it of the care and dedication the two
  12     surgeons had shown to their patients over many years.
  13     There was no evidence before that inquiry, and certainly
  14     there has been none before this, that they had any
  15     intention of acting other than in the interests of their
  16     patients. These are men who, quite simply, dedicated
  17     their lives to their profession and to their patients,
  18     and it is vital to acknowledge that fact.
  19        Sir, the Clinical Case Note Review has
  20     demonstrated, we suggest, that the probable influence of
  21     any failings in the surgeons' procedures looked at in
  22     isolation was actually minimal in effect and in terms of
  23     outcome. Comments have been made elsewhere, and
  24     previously this morning, on statistics. I do not
  25     propose to explore that, it is far too deep a subject
0039
   1     for a short submission, but I do say this: a lot of
   2     those statistics are capable of, shall we say,
   3     differential analysis, and no doubt, sir, you, with the
   4     benefit you have had of much expert input, will take
   5     that into account.
   6        It is also essential to remember that the conduct
   7     of procedures in a fast moving area of medicine that is
   8     appropriate in 1999/2000 is not the same thing in 1984
   9     to 1995.
  10        Sir, we have seen how procedures that have been
  11     criticised represented a very small proportion of these
  12     surgeons' work. We have seen how in other areas they
  13     had good and even excellent results; we have seen what
  14     the 1995 report of the Hunter/de Leval report, described
  15     in terms of Mr Dhasmana's work, other than the neonatal
  16     arterial switch, was very likely to compare very
  17     favourably with the best UK institutions.
  18        I mention all this as material with which the
  19     Panel is very familiar, for this reason, and it is the
  20     second point that I make by way of preliminary
  21     observation: the Surgeons Support Group has very great
  22     concern that these elements, these positive elements,
  23     and many more, which are apparent from the evidence,
  24     have not been properly or fully reported in the press.
  25     I said in opening that we wanted to concentrate on the
0040
   1     positive, and we do, but we have very great concern for
   2     the irresponsibility, and I use that word advisedly, the
   3     irresponsibility of some sections of the press and
   4     media, and the way in which it has reported and
   5     commented upon these proceedings frequently it would
   6     appear to us from a position which portrays an ignorance
   7     of the evidence, a failure to read the evidence,
   8     a failure to research the background of the evidence.
   9        By way of example only, last Sunday you may be
  10     aware that there appeared in one of the Sunday papers
  11     from a writer who should have known better from his
  12     political origins, a comment about Mr Wisheart which was
  13     insensitive to Mr Wisheart's patients, wrong as a matter
  14     of fact, and frankly offensive in its entirety.
  15        Sir, I am not going to, as I was, cite that,
  16     because it is so offensive, but what it does do is it
  17     demonstrates an irresponsibility not only on the part of
  18     the author, but on the part of the editor who allowed
  19     that to appear in a national newspaper. It was not
  20     true. It was unjustified, an unjustified attack on
  21     a man who had dedicated himself to helping these
  22     children, but also, this type of journalism, we fear,
  23     has an effect on a further and unrepresented group of
  24     parents and children, of former patients and also, we
  25     fear, future patients, because of the way it attacks and
0041
   1     undermines trust in a system on which they all depend.
   2        Sir, the local press in this city, last week,
   3     carried a story of the tragic death of a mother of
   4     a child who died some six weeks after an operation in
   5     Bristol. This Inquiry, it was said, had brought back
   6     memories for her with which she could not cope. This
   7     has been the experience of our members as well --
   8   THE CHAIRMAN: Forgive me if I say, if it will help you, you
   9     should know that the Panel will make its own mind up on
  10     the facts, whatever is said in whatever other
  11     environment through whatever other means. That is the
  12     first assurance I give to everybody and I think you do
  13     not need that.
  14        The second, I do not think it is particularly
  15     helpful here, neither to us nor to others, to dwell on
  16     that particular case, as regards which the facts are
  17     still a matter of dispute, as I understand it. Perhaps
  18     we could move on.
  19   MR SHARP: Sir, I am more than happy to move on. What
  20     I would like to point out is this: those whom
  21     I represent have also suffered that same distress by
  22     reason of the repetition of allegations and by the
  23     raising of the issues which this Inquiry necessarily has
  24     had to explore. Those allegations have sometimes been
  25     expressed in public media in unrestrained and emotive
0042
   1     terms and that can have a terrible effect upon a parent,
   2     even where the parent has the support of a group such as
   3     the BSSG, but there are many parents -- you know of
   4     some -- who have not had that support. They are not
   5     members of those groups. They have not had the
   6     opportunity, perhaps, of studying the evidence in
   7     detail; all they have is the public press. When they
   8     thought they had come to terms with their loss, they
   9     then find themselves in this position and they have had
  10     their doubts and their fears raised and for those who
  11     lost children, those doubts will now remain for ever,
  12     clouding and poisoning the memories that they had.
  13        For those whose children survived and perhaps even
  14     worse for the children themselves, they are left with
  15     a fear that there is some unknown problem hanging over
  16     them. We have knowledge of one case in which a former
  17     patient has been told he is a "time-bomb" because of
  18     whose patient he was. What is the effect on that
  19     individual?
  20        Then, for those who have yet to undergo surgery,
  21     what is the effect upon their trust in the system and
  22     the service which has been so publicly decried?
  23        Sir, this Inquiry has quite properly and
  24     understandably committed itself to transparency and
  25     openness. At the same time, it has sought to protect
0043
   1     patient confidentiality. It has involved itself in
   2     a uniquely detailed and comprehensive study of the
   3     issues it has addressed. It may be, sir, you will feel
   4     that you are in a position to consider recommendations
   5     for the manner in which future inquiries are conducted.
   6     That there will be such future inquiries would appear to
   7     be likely, having regard to events in other parts of the
   8     country.
   9        We know that the Inquiry has attempted to promote
  10     and encourage responsible reporting. In a country with
  11     a free press it is impossible, obviously, for you to
  12     control it, but we may suggest that one possibility is
  13     that irresponsible and inaccurate reporting could be
  14     avoided by, for instance, reporters who are assigned to
  15     report upon inquiries such as this being specifically
  16     briefed by inquiry press officers; that perhaps editors
  17     might be encouraged to ensure there is a dedicated
  18     reporter assigned to the proceedings throughout, so that
  19     a full and consistent understanding may be achieved.
  20        By way of example, sir, on 4th February this year,
  21     in the year 2000, after nearly a year of hearings in
  22     this city, the Bristol Evening Post, reporting on
  23     a matter related to this Inquiry, described your Inquiry
  24     as an inquiry into "29 children who died after
  25     undergoing heart surgery". It is difficult to
0044
   1     understand how such ignorance can arise in a local
   2     newspaper.
   3        In order for that ignorance to be avoided, sir,
   4     you may feel that there are some recommendations that
   5     you can make. But it does not stop there.
   6        The distress which has been caused as
   7     a consequence of these issues having to be raised needs
   8     also to be addressed. When those parents who have been
   9     involved have attended at this Inquiry, they have had
  10     the support of the facilities you have made available
  11     and that has been of great assistance, but there are
  12     many people out in the wider world who have not had that
  13     support. By reason of the Inquiry's openness and the
  14     way in which it has spread the issues, it has, we feel,
  15     taken upon itself a responsibility, or should take upon
  16     itself a responsibility to consider the effects upon
  17     those people and we have made the recommendation in our
  18     written submissions and we repeat it now that there
  19     should be a facility for counselling for those people
  20     who are affected and there should be publication of the
  21     facilities that ought to be made available.
  22   THE CHAIRMAN: I found that very helpful, very interesting
  23     in your submission, if I may say so, particularly on
  24     page 24 [subsequently amended to page 27], if that is of
  25     any help subsequently. I just wondered, did you have
0045
   1     any views as to how that might be supported in financial
   2     terms? I get the impression you are thinking of
   3     voluntary networks of support, some of which exist in
   4     the context of other circumstances of illness. Did you
   5     have any thoughts on that?
   6   MR SHARP: There are two possibilities, sir. The first is
   7     that one would hope there would be a sufficient network
   8     within the GP system and within the NHS to be able to
   9     enable referrals to be made. We know however there are
  10     limitations in the funding of many hospitals. Secondly,
  11     having regard to the funding which this Inquiry has
  12     itself inevitably had to attract and having regard to
  13     what we hope would be a fairly limited take-up, there
  14     should be a peripatetic counselling service which would
  15     be accessible through the agency of the Inquiry itself,
  16     and will enable those who are affected, who would be
  17     probably within a reasonably limited geographical area,
  18     to be visited and at least initial counselling to be set
  19     up in that way.
  20   THE CHAIRMAN: I should have said page 28 [subsequently
  21     amended to page 27]. My apologies.
  22   MR SHARP: I do not carry it in my head!
  23   THE CHAIRMAN: You were going to tell me how that was going
  24     to be funded.
  25   MR SHARP: So far as the Inquiry itself was concerned, I was
0046
   1     indicating that I believe that the take-up would be, one
   2     would hope, comparatively limited and therefore
   3     a peripatetic counselling service within the funding of
   4     the Inquiry itself ought to be possible.
   5        Sir, I say that because the implications, and the
   6     examples in the press last week is one, can be very
   7     significant and that sort of funding, if it would help
   8     to avoid that sort of tragedy, is a price that has to be
   9     paid.
  10        So what can one, therefore, say positively for the
  11     future? The building of the new Children's Hospital, we
  12     would hope, would represent a particular token or symbol
  13     of optimism for the future. Hopefully, there will never
  14     again be any question of children having to share
  15     facilities with adults, or receiving nursing care from
  16     non-paediatric trained nurses. In that respect, we
  17     share some common ground with the speaker before.
  18        Hopefully, there will never again be any question
  19     of a split site with all the emotional stress, fractured
  20     communications, lack of co-ordination and potential
  21     disasters that that caused. Hopefully, the new hospital
  22     is a sign of commitment of adequate funding to meet the
  23     special and discrete needs of sick children, and no
  24     doubt this Inquiry will stress the special and discrete
  25     needs of sick children.
0047
   1        The lessons learned from the evidence of this
   2     Inquiry: we can say that communication is the vital
   3     watchword. It is the watchword which should inform any
   4     organisation that hopes to provide first class Health
   5     Service. Communication, we say, is central to
   6     understanding and to trust, and that is true at all
   7     levels: it is true between management and staff; it is
   8     true between various levels of staff and seniority
   9     within staff; it is true between disciplines.
  10     Communication and the failure of communication you may
  11     think lies at the root of the problems involving the
  12     expressions of concern that this Inquiry has had to
  13     consider. If Dr Bolsin had felt as he apparently felt
  14     and had communicated his concerns at an earlier stage,
  15     the situation, you may feel, might have been different.
  16     The split site is an example of problems over
  17     communication. The poor relationship between the
  18     counsellors at different sites: again, a problem of
  19     communication. Some of the antipathy that appears to
  20     have occurred between surgeons and anaesthetists: again,
  21     a problem of communication. But in particular, so far
  22     as concerns the Surgeons Support Group members,
  23     understanding which comes from good communication we say
  24     helps parents to deal with the stress of their child's
  25     treatment and if sadly necessary, to come to terms with
0048
   1     adverse outcomes.
   2        We can draw from the disparate subjective
   3     recollections of those who have gone through these
   4     painful experiences the lesson that stress, personal
   5     isolation, lack of emotional support, socio-economic
   6     circumstances and educational attainment all affect the
   7     efficacy and efficiency of that communication process.
   8     We know that the overall circumstances surrounding an
   9     experience can condition the recollection and that
  10     retrospectively a person can reconstruct recollection of
  11     what he was or was not told and the manner in which he
  12     was told it. We know that many parents denied signing
  13     postmortem consent forms, and yet their signed forms
  14     have in fact been produced. They have no recollection
  15     of being told that tissue or organs would be retained,
  16     and yet the forms themselves are very clear on that.
  17        This is no criticism of the parents, but it is
  18     a reflection on the inadequate means of communication.
  19        Similarly, therefore, recollections of a lack of
  20     the provision of full explanations of risks and
  21     complications of surgery may not be reliable, and we
  22     know that two different individuals may interpret and
  23     recollect differently what they are told at the same
  24     time and it is for this reason that we stress the
  25     consistency of the positive testimony of so many of our
0049
   1     members about the practice of the surgeons in their
   2     dealings with the parents and patients and suggest that
   3     this must reflect the overwhelming majority of cases.
   4        However from this evidence, we can learn that
   5     adequate and informed preparation of the parent before
   6     a consultation, a permanent record of advice given and
   7     consents signed, independent and informed support at
   8     consultations, time and patience in the process of
   9     explanation, and the emotional strength and support of
  10     family, partner or friend, all militate towards
  11     understanding, trust and teamwork and that in turn this
  12     improves the prognosis for the care of the child, but if
  13     there is a loss, it also helps the grieving parent with
  14     understanding and therefore coming to terms with that
  15     outcome. To assist with this, sir, we say that it is
  16     essential that doctors and other health professionals
  17     are all fully trained in the necessary communication
  18     skills.
  19        Sir, we have also learned the importance of the
  20     provision of an adequately funded -- and I stress
  21     that -- and trained and focused counselling staff and
  22     support staff. We have learned the need for empathy and
  23     community of experience in providing that support
  24     effectively. We have learned of the need for postmortem
  25     counselling, and importantly, and in furtherance of the
0050
   1     process of understanding, the need for follow-up, to
   2     ensure that bereaved parents are reminded of the
   3     availability of advice, discussion with clinicians and
   4     the Coroner, and of counselling. That was always
   5     available but rarely taken up, and those opportunities
   6     should be made clear to parents.
   7        Sir, we have also learned that the entire health
   8     service which is provided depends upon the funding that
   9     supports it. It is no coincidence by way of example
  10     that Germany has one of the best outcomes for cancer
  11     care and spends hundreds per cent more than we do on
  12     their Health Service. It is no coincidence that
  13     Bristol, the subject of this Inquiry, was for years
  14     denied the funding which would have provided the
  15     dedicated paediatric surgeon and single site which would
  16     have enabled better care to be offered and which the
  17     surgeons were themselves supporting.
  18        It is not an option, we suggest, simply to
  19     rearrange the deck-chairs or worse still employ managers
  20     to do so. What is required is more doctors. You will
  21     have heard only on the news this morning of the problem
  22     involving cataract surgery. The doctors exist, but the
  23     funding does not exist to employ them. So we need more
  24     doctors, we need more health professionals, we need more
  25     and better education, we need more and better support
0051
   1     services, we need more dedicated and properly funded
   2     centres of excellence.
   3        Obviously money alone will not provide the
   4     service, but without the money, the service cannot be
   5     provided. It is really not satisfactory that the
   6     provision of a dedicated Children's Hospital in this
   7     city was dependent as it was upon public subscription.
   8     Responsible government, we say, involves planned
   9     provision and a suitable and efficient service and if
  10     that involves a greater public cost, then this Inquiry
  11     must not shrink from that recommendation. Increased
  12     taxation is not the only answer, although it may be one
  13     to increase funding in the Health Service, but as we
  14     have said in our written submissions, if this country is
  15     once more to have a health service in which it can be
  16     proud and in which essentially the people can repose
  17     their trust, it is going to have to be funded so that
  18     the results can be delivered.
  19        Ultimately, our society will get the health
  20     service it deserves. If it is prepared to fund the
  21     health service and provide the resources that it needs,
  22     we are confident that the doctors will be able to supply
  23     the product, but at present, too much is expected of too
  24     few doctors, with too little support. The medical
  25     profession cannot and must not be treated as scapegoats
0052
   1     by governments who, in pursuit of lower taxes, and we
   2     suspect electoral advantage, deny those resources and
   3     then seek to deflect attention from the reasons for the
   4     service's failing.
   5        We ask this Inquiry, therefore, not to shrink from
   6     the resources implications of the recommendations we are
   7     confident you will make.
   8        Finally, sir, we say, as we have said in our
   9     written submissions, that we invite you, so far as you
  10     feel able, to invite the GMC to revisit what we say are
  11     its flawed conclusions.
  12        Thank you, sir.
  13   THE CHAIRMAN: Thank you very much indeed, Mr Sharp. As
  14     Mr Langstaff indicated, this may be an appropriate
  15     moment to take close to a 15 minute break and therefore
  16     shall we adjoin now until about 11.20? Thank you.
  17   (11.05 am)
  18               (A short break)
  19   (11.20 am)
  20   MR LANGSTAFF: Sir, we continue with the final closing
  21     submissions on behalf of the Department of Health by
  22     Mr Pirani.
  23           CLOSING SUBMISSION BY MR PIRANI
  24               on behalf of
  25            THE DEPARTMENT OF HEALTH
0053
   1   THE CHAIRMAN: Thank you. Good morning, Mr Pirani.
   2   MR PIRANI: Good morning, sir. Sir, the Secretary of State,
   3     in setting up this independent Inquiry, plays the full
   4     support of his department and we hope that the Inquiry
   5     will acknowledge that the Department of Health has not
   6     flinched in its duty to provide the Inquiry with all the
   7     evidence at its disposal, and its witnesses have given
   8     evidence without any hint of a departmental bias or
   9     departmental agenda.
  10        The Secretary of State has also committed his
  11     department to give full consideration to all the
  12     recommendations of this Inquiry and looks forward to
  13     your report in due course.
  14        However, sir, it was in recognition of the very
  15     great suffering of all the children and their parents
  16     that the Secretary of State set up this Inquiry and they
  17     will continue to have our sympathies, and indeed, we
  18     would like to endorse the expressions of sympathy which
  19     the Department of Health witnesses have made and also,
  20     to express admiration for the courage with which the
  21     parents have approached this Inquiry.
  22        Sir, having put in our written submissions, if
  23     I may make a few general points, first, if we may make
  24     it absolutely clear that we will not decline to accept
  25     criticism when justified; secondly, however, in our
0054
   1     submission much of the evidence, the oral evidence and
   2     indeed some of the written evidence that you have
   3     received, is coloured somewhat by the benefit of
   4     hindsight and this relates to two particular areas:
   5     first, the whole assessment of the issue of quality and
   6     second, the mechanisms of quality audit.
   7        However, sir, the events and systems of course
   8     have moved on dramatically since the time with which the
   9     Inquiry is concerned. It is of course pointless to
  10     attempt to defend the systems and procedures of the
  11     past. The whole purpose of the Inquiry is to try and
  12     ensure that the new systems that are in place have not
  13     inherited the disadvantages of the old ones. It is
  14     therefore crucially important that we assist the Inquiry
  15     in endeavouring to discover where and how the systems of
  16     the past have failed.
  17        If I may move on, sir, to the area of
  18     responsibility and accountability, and make it
  19     absolutely clear again that the Department of Health
  20     accepts that it is responsible and is accountable for
  21     any failings of the systems that were in place during
  22     the period covered by the Inquiry. Ultimate
  23     responsibility rests with the Department of Health and
  24     the Secretary of State.
  25        This is, however, in the context of delegated
0055
   1     responsibility for the treatment of individual
   2     patients. Of course, sir, the sheer scale of the NHS
   3     necessitates that powers have to be delegated downwards
   4     which means that systems of accountability are
   5     established and whilst the NHS, the Executive which is
   6     an integral part of it, has many avenues of influence,
   7     it does not directly manage patient services.
   8        Sir Alan Langlands commented, I think at page 58
   9     of his evidence, that in the complex situation that
  10     exists, not just in the NHS but in every health system,
  11     it seems to be that the key system is to ensure that
  12     roles and responsibilities of individuals, roles and
  13     responsibilities of statutory bodies and roles and
  14     responsibilities of the Department of Health and the NHS
  15     Executive are adequately defined, so everybody can see
  16     the distinctive contribution that each of these players
  17     can make to ensure we have a system that is as risk-free
  18     as possible.
  19        It is against this standard and this background
  20     that the Department's responsibilities must be judged
  21     and assessed by you.
  22        Of course, nothing can detract from the shared
  23     responsibility for clinical outcomes and Sir Alan was
  24     keen in the same piece of evidence to emphasise that
  25     (1) individuals are responsible and accountable and
0056
   1     (2) the Department of Health must be responsible and
   2     accountable for the systems that were in place.
   3        Moving on from the general to the specific, if
   4     I may, it now seems clear that there was confusion and
   5     therefore systemic failings with regard to the way in
   6     which the Supra Regional Services Advisory Group dealt
   7     with the specialty of neonatal infant cardiac surgery.
   8     In particular, sir, may I say it is accepted that,
   9     first, there appears to have been confusion about the
  10     roles and responsibilities of the members of the group.
  11     The Department of Health's expectation that the Royal
  12     College members of the group would provide analysis of
  13     the quality of the data that was presented to the group
  14     was apparently not made clear. For example, there is no
  15     record that medical members were explicitly asked to
  16     comment or give any formal view on the issue of
  17     outcomes. Further, sir, it also appears that there was
  18     confusion about the remit of the group and whether, and
  19     indeed to what extent, it was responsible at all for the
  20     quality of the designated units it provided funding for,
  21     and, sir, you will see that the oral evidence relating
  22     to that matter has indeed been picked up by all the
  23     submissions which have been handed to you.
  24        Fourthly, sir, also it appears that the District
  25     Health Authority was confused as to its role and whether
0057
   1     or not there was any reduction in responsibility they
   2     had for the provision of paediatric cardiac surgery.
   3        Sir, may we say that there is no doubt that the
   4     diligence of the Inquiry team has uncovered this
   5     confusion and the systemic failing which was previously
   6     not known to the department. All these are accepted and
   7     are a cause of great regret.
   8        Sir, that said, in our submission the Inquiry
   9     should be careful not to overlook that in other areas of
  10     its work, the arrangements for supra-regional services
  11     have been more successful. It provided a funding
  12     mechanism for providing highly specialised and generally
  13     high cost medical procedures, the two important effects
  14     of this system of funding were firstly the encouragement
  15     and the concentration and development of expertise in
  16     designated units and secondly, discouraging the
  17     proliferation of smaller units. The system is still in
  18     operation today and provides benefit to patients who are
  19     guided by the premise that expertise is developed in
  20     these particular units and indeed, Sir Alan Langlands
  21     said in his evidence that the discipline of the system
  22     is admired in many parts of the world.
  23   THE CHAIRMAN: Can I ask you a question arising from what
  24     you have just said and from your very helpful written
  25     submission? You said a moment ago that the Department
0058
   1     was anxious to encourage this level of specialisation
   2     and you referred particularly to Dr Halliday saying, "We
   3     hoped we could bring about a rationalisation".
   4        It is that word "hoped" that I think is important
   5     here, so as to understand what powers the Department
   6     thought it had, could have had or would wish to have, as
   7     regards effecting that kind of rationalisation.
   8   MR PIRANI: Indeed, sir, if you remember in Dr Halliday's
   9     evidence he said the only reason why it was so
  10     successful was because we had the best medical
  11     profession in the sense that they were the most
  12     co-operative and they could see the benefit of having
  13     supra-regional services and therefore, although there
  14     was this concept, vague concept, if we may say so, of
  15     clinical autonomy, they were prepared to accept the
  16     fact -- I think Dr Halliday gave specific evidence to
  17     this -- that if services were concentrated, quality
  18     would be improved and indeed, outcomes would be
  19     improved.
  20   THE CHAIRMAN: But was it not the case -- you correct me if
  21     I am wrong -- that the general view was 6 centres rather
  22     than proliferating possibly to 10, and then the whole
  23     thing collapsing.
  24   MR PIRANI: Indeed, that was the general view, and of course
  25     the de-designation of the service.
0059
   1   THE CHAIRMAN: My question to you is, when Dr Halliday, whom
   2     many would regard as one of the architects of this
   3     system, says "We hoped to achieve this concentration",
   4     given that concentration is such a desirable end,
   5     I think accepted by him, is the Department saying it
   6     could do more than hope, or would it wish to be able to
   7     do things rather more than merely encourage and hope for
   8     the best?
   9   MR PIRANI: What we can say, sir, is through the funding
  10     mechanism, they in effect discouraged proliferation, but
  11     certainly with regard to paediatric cardiac surgery,
  12     that in the event failed and therefore, the service had
  13     to be de-designated.
  14        In essence, if there is a degree of flexibility
  15     within the system, the Department of Health could at
  16     least realise that there comes a time when a service
  17     should be de-designated because there is proliferation,
  18     and I think what Dr Halliday was referring to when he
  19     used the term "hope" was that at that time certainly the
  20     Department of Health had no power to stop units
  21     practising in paediatric cardiac surgery. This was
  22     certainly at the beginning of the supra-regional
  23     structure.
  24   THE CHAIRMAN: Would it wish to have that power?
  25   MR PIRANI: I think certainly Dr Halliday would have wished
0060
   1     to have that power, but nevertheless what he wanted was
   2     the co-operation of the medical profession as well.
   3     Without that co-operation, I think he would have
   4     accepted that the supra-regional structure would have
   5     been a failure.
   6        Sir, if I may move on from that point, at the
   7     start of this Inquiry an allegation was made that there
   8     was a cover-up by the Department of Health.
   9     Understandably if true, this would have been a very
  10     great concern to the parents involved in this Inquiry.
  11     In our submission, the Inquiry has clearly established
  12     that there was in no sense whatsoever a "cover-up" or
  13     any suppression of information during the period with
  14     which the Inquiry is concerned, or indeed since that
  15     date. This avenue has been explored by the Inquiry to
  16     the extent that it no longer forms part of the
  17     criticisms and allegations levelled at the Department of
  18     Health by interested groups in this Inquiry.
  19        Therefore, although we accept without
  20     qualification that there were systemic failures, we
  21     reject the suggestion that there were at any time prior
  22     to 1994 -- this is a correction to our written
  23     submission which says July 1995 -- that Departmental
  24     officials were in possession of facts which would have
  25     alerted them to concerns that were apparent. That July
0061
   1     1994 date is when Dr Doyle was contacted by Dr Bolsin.
   2     It seems that several people had fragmentary concerns
   3     about the situation at Bristol, but in our submission,
   4     failed to communicate them in a way which would enable
   5     anyone within the Department to assemble the fragments
   6     and take the action that needed to be taken.
   7        There were not avenues with which concern could
   8     have been brought to the attention of the Department;
   9     first contacting the Chairman of the Supra-regional
  10     Services Group; second contacting any Departmental
  11     official, or indeed any regional health official;
  12     thirdly, contacting Health Ministers; and fourthly
  13     contacting the CMO directly.
  14        Dealing, sir, if I may with specific instances of
  15     concern, Sir Michael Carlisle, the Chairman of the
  16     group, said that at no time did anyone approach the
  17     Supra Regional Services Advisory Group and say that they
  18     had concern about the outcomes at Bristol. He also very
  19     clearly said that if reports were made to that effect,
  20     then he would have instituted an inquiry forthwith.
  21        You also heard that Professor Crompton relayed to
  22     Dr Halliday comments of Professor Henderson in 1987.
  23     These comments were at variance with the rest of the
  24     profession without sufficient detail to take action, in
  25     our submission. Indeed, Dr Halliday commented that
0062
   1     no-one ever questioned outcome in Bristol; no-one was
   2     questioning the clinical standards there; all the
   3     reports we had -- and we had many of them, not only
   4     reports but reports of visits -- all gave Bristol
   5     a clean bill of health.
   6        Allegations were made in Private Eye in 1992 and
   7     it is true that those in the Department, and Sir Kenneth
   8     Calman was one of them who did read it, were not
   9     predisposed to accept its accuracy. Indeed, Sir Kenneth
  10     Calman drew attention to the statistics in one of the
  11     articles which were incomplete and did not make sense,
  12     but in any event, sir, the concerns were investigated by
  13     Alistair Mason, who was a Regional Medical Officer, who
  14     made enquiries of colleagues and they reassured him that
  15     they were unaware that there was any concern at Bristol,
  16     but nevertheless, Sir Kenneth was also clear that had
  17     Dr Hammond approached him directly, he would certainly
  18     have taken follow-up action.
  19        Sir, in our submission, if the intention of the
  20     author was to bring the content of the articles to the
  21     attention of the Department of Health, it was a serious
  22     misjudgment to use this particular avenue.
  23   THE CHAIRMAN: Can I pursue that with you for a moment?
  24     Your paragraph 39: what are you saying there about
  25     Dr Hammond?
0063
   1   MR PIRANI: In our submission, Dr Hammond should have
   2     approached the Department of Health directly and if it
   3     was his intention to bring the content of those articles
   4     which were in a sense inaccurate -- and I have pointed
   5     to the statistical misgivings -- he should have used
   6     a different avenue and indeed one of the examples of
   7     four avenues which I outlined during my submission.
   8        Sir Kenneth Calman made it explicitly clear that
   9     had he been approached directly, he would have taken
  10     action.
  11        Sir, Sir Terence English also said in his evidence
  12     that he phoned Dr Halliday in July 1992 and told him of
  13     concerns that he had about high mortality at Bristol.
  14     Of course, there is the dispute as to the content of
  15     that conversation which has been thoroughly investigated
  16     by the Inquiry. However, what we would say is that the
  17     concern was not documented and that Dr Halliday did
  18     ensure that Sir Terence was present at the next meeting
  19     of the Supra Regional Services Advisory Group in
  20     September 1992 and despite having seen the minutes of
  21     the previous meeting, at which concern was not noted,
  22     Sir Terence failed to correct the minute or to clarify
  23     what those concerns were.
  24        Dr Halliday clearly said that if he had been told
  25     of concerns about quality, he would most certainly have
0064
   1     brought them to the attention of the group.
   2        Sir, that brings us forward to December 1993, when
   3     Dr Bolsin met Dr Ashwell and informed her that he had
   4     concerns about paediatric cardiac surgery at Bristol.
   5        Dr Ashwell raised the issue with the Clinical
   6     Director of the BRI. However, Dr Bolsin subsequently
   7     wrote to Dr Ashwell in February 1993, indicating that
   8     the matter had been satisfactorily resolved.
   9        Dr Ashwell made it clear in her evidence that had
  10     she had continuing concerns, she would have taken the
  11     matter further.
  12        That brings us up to the July 1994 date, whereupon
  13     Dr Doyle took immediate action when he was informed by
  14     Dr Bolsin that there were concerns and that the problem
  15     remained unresolved.
  16        Sir, we would now like to take this opportunity to
  17     refer briefly to a number of other matters, including
  18     that of medical audit in general. The evolution of
  19     clinical and medical audit, which are matters of course
  20     central to the remit of your Inquiry, has been detailed
  21     by Dr Winyard in a statement he provided to the
  22     Inquiry. Unfortunately, the Inquiry has not heard from
  23     him orally, but nevertheless, he explained that prior to
  24     the publication of the White Paper "Working for
  25     Patients" -- and that was in 1989 -- the Department of
0065
   1     Health only had a limited involvement in audit and
   2     outcome assessment. That was because general standards
   3     were set by the GMC and the Royal Colleges, through
   4     general and specialist examinations, the inspection of
   5     training posts and the evolvement of Consultant
   6     Appointment Committees. However, the prime
   7     responsibility at that time in professional practice lay
   8     with the individual. Audit was seen primarily as
   9     a system for analysing local practice.
  10        However, in the mid and late 1980s, there was
  11     a developing interest in medical audit in which
  12     individuals and groups of clinicians would define the
  13     standards they wish to achieve, compare their actual
  14     with those standards and take remedial action where
  15     necessary. That was of course the audit cycle which was
  16     defined and has come to form the basis of all subsequent
  17     clinical audit. It was not until "Working with
  18     Patients" in 1989 that it became a mainstream part of
  19     the NHS.
  20        The proposals at that stage sought to strike
  21     a balance, and indeed still strike a balance, between
  22     the need for audit to be owned by the medical profession
  23     for it to be an effective and stimulating peer review --
  24     that goes back to the supra-regional structure -- and
  25     secondly, of course, the wider interests of quality and
0066
   1     care.
   2        Dr Winyard does suggest in his statement that had
   3     programmes incorporating these principles been
   4     effectively implemented across the NHS, then at least
   5     some of the problems addressed by this Inquiry might
   6     have been prevented.
   7        Dr Winyard does go on to describe the major
   8     implementation programme which the Department of Health
   9     funded to establish, develop and monitor clinical audit,
  10     and that was in 1993/94, with an injection of
  11     œ221 million, and also the work of the clinical outcomes
  12     group established in 1992 which promoted
  13     a multi-professional approach towards it.
  14        Dr Winyard, in his statement, therefore details
  15     both a systemic and cultural change within the
  16     Department, within the NHS as a whole and indeed within
  17     the medical profession and these developments lay the
  18     groundwork for further advancement in recent years, and
  19     indeed, sir, as you will know, plans for the future.
  20        Much has been made of the various statistics
  21     available to the people who were involved in the
  22     time-frame of the Inquiry. The efforts of the
  23     statisticians and experts commissioned by the Inquiry to
  24     analyse this information have introduced new insights
  25     into the way such statistics will be used, and indeed,
0067
   1     sir, the Inquiry must be congratulated for this. The
   2     Department has already undertaken to examine in detail
   3     the significance of this work.
   4        Sir, of course there have been a number of key
   5     changes since 1997 which are pertinent to the Inquiry.
   6     It is hoped the Inquiry will provide insight into the
   7     benefit which these changes will bring and alert the
   8     Department of Health to any potential shortcomings which
   9     there may be.
  10        The most pertinent changes to this Inquiry are in
  11     the area of audit and strengthening systems of
  12     monitoring and accountability. First, setting direction
  13     and standards of performance in national priority
  14     guidance, establishing new clinical governance
  15     arrangements, also the NHS Executive established in
  16     April 199, a performance assessment framework intended
  17     to provide a broad basis for the NHS to plan and assess
  18     its work and that framework has been supported by the
  19     publication in June 1999 of 41 high level performance
  20     indicators and 6 clinical indicators. Also,
  21     specifically relating to quality, there was a government
  22     initiative and drive for improvement set out in the
  23     first class service, which of course you will be aware
  24     of, and that was in 1998. That sets out quality
  25     standards with the National Institute for Clinical
0068
   1     Excellence and the national service framework and that
   2     helps to raise standards of care and reduce unacceptable
   3     variations.
   4        Also, monitoring mechanisms have been put into
   5     place with a new independent Commission for Health
   6     Improvement to assess the development of clinical
   7     governance.
   8   THE CHAIRMAN: Mr Pirani, can I take you to the
   9     paragraph before the one you have just referred to, when
  10     you talk about putting in place voluntary mechanisms.
  11     You talk of the ambition to improve quality by
  12     introducing modern systems of professional
  13     self-regulation. Would you like to tell me what that
  14     might mean?
  15   MR PIRANI: There is a whole raft of measures which have
  16     been implemented and are about to be implemented and
  17     these are contained in our written submissions. If you
  18     would require further detail on any particular one of
  19     those, we would be happy to provide that, and indeed, we
  20     have skipped over them to some extent. I think it would
  21     be inappropriate for me to generalise at this point in
  22     time, but if the Inquiry had any particular concern with
  23     either one of those specific instances listed, or
  24     a concern relating to a group of them, certainly we
  25     would be more than willing to elaborate on those
0069
   1     particular concerns.
   2   THE CHAIRMAN: Thank you very much. I just wondered what
   3     it meant. We will come back to them.
   4   MR PIRANI: Indeed, sir. Sir, of course the position of
   5     whistle-blowers has been advanced and clarified since
   6     1995, and the rights and responsibilities of all NHS
   7     staff when raising concerns about health care issues
   8     were set out in guidance to the NHS in 1993 and the
   9     Public Interest Disclosure Act 1999, which gives
  10     statutory protection to staff who disclose information
  11     in the public interest and are penalised by their
  12     employer.
  13        Sir, it is certainly hoped that the Inquiry can
  14     add to and strengthen some of these bodies and
  15     mechanisms, which all have the purpose of improving and
  16     monitoring the care which is provided to patients and
  17     indeed, sir, if you do have specific enquiries, we would
  18     be grateful for those concerns so that they can be fed
  19     back into your report.
  20        We are grateful for your indication that we will
  21     be entitled to reply in writing to some of the
  22     criticisms from the other interested groups to this
  23     party and therefore I will not address those in my oral
  24     submission, but if I may just deal with one of those
  25     criticisms, because it does do violence, in a sense, to
0070
   1     the body of this oral submission, and that was the
   2     allegation in the submission of the Bristol Heart
   3     Children's Action Group, under Issue L, External audit,
   4     paragraph 2.4.2 and it was that Miss Catherine Hawkins
   5     was told that paediatric cardiac surgery was poor in
   6     Bristol in 1991. The submission then goes on to refer
   7     to a letter which she wrote to Dr Roylance on
   8     20th November 1991.
   9        Sir, we can say that at no time did Miss Hawkins
  10     ever receive any information to the effect that there
  11     was any concern about paediatric cardiac surgery and
  12     this is confirmed, sir, you will see, in the second
  13     statement which she provided and was forwarded to you.
  14        The letter referred to in the written submission
  15     refers to cardiac surgery and indeed the reply from
  16     Dr Roylance deals with waiting lists and therefore there
  17     was no reference at any time to paediatric cardiac
  18     surgery. That was in 1991, because of course, our
  19     submission is that the key date is July 1994.
  20        Sir, there are a number of other various matters
  21     which we wish to deal with, and we will of course deal
  22     with those in our written submission to you.
  23        Sir, in conclusion we fully accept any systemic
  24     failings which the Inquiry finds, but we would also ask
  25     you to take note of the wide-ranging reforms which have
0071
   1     taken place since 1997 which have not only affected
   2     systemic but also cultural changes and have introduced
   3     new institutions to safeguard and improve patient care.
   4     We anticipate, as we say and emphasise, that this
   5     Inquiry will add to and strengthen those changes.
   6        Sir, in closing, primarily in our submission, all
   7     parties of all groups are here to learn and not to
   8     blame. We look forward to your report in due course.
   9        Sir, if there is any particular matter you would
  10     wish to deal with at this stage, I would be happy to --
  11   THE CHAIRMAN: Mr Pirani, thank you very much indeed.
  12     That was most helpful. If there are matters we wish to
  13     take up, we will contact you.
  14   MR PIRANI: We would certainly be grateful for that.
  15     Perhaps they could be incorporated into our further
  16     written closing. Thank you, sir.
  17   THE CHAIRMAN: Thank you very much indeed.
  18   MR LANGSTAFF: Sir, Mr Moon will now address you on behalf
  19     of Mr Wisheart.
  20   THE CHAIRMAN: Thank you very much. Good morning, Mr Moon.
  21           CLOSING SUBMISSIONS BY MR MOON
  22           on behalf of MR JAMES WISHEART
  23   MR MOON: Good morning, sir. Sir, Mr Wisheart is also
  24     extremely grateful for this opportunity to make a short
  25     oral submission, and for the time, to put in some
0072
   1     supplementary written submissions. The ability to put
   2     in some written submissions will enable me to keep this
   3     much less, I hope, than 30 minutes.
   4        Sir, the way in which Mr Wisheart has structured
   5     his written submissions was very much with the
   6     non-adversarial spirit in mind, which, sir, you have
   7     identified as being the approach which the Inquiry
   8     wishes to take.
   9        The focus of his written submissions were some
  10     tentative recommendations, suggestions, as to the sort
  11     of recommendations you might wish to make in any report
  12     which you write.
  13        However, for quite understandable reasons, those
  14     acting for the Action Group have advanced serious
  15     personal criticisms of Mr Wisheart, a number of which
  16     have not been put to him in cross-examination. It is
  17     only right, in my submission, that Mr Wisheart be given
  18     a proper opportunity of dealing with those criticisms.
  19        Of course, it must be right that the focus of this
  20     debate should be the parents of the children who died at
  21     Bristol Royal Infirmary, but it is right also to say,
  22     and in my submission needs to be said, that when you
  23     come to consider the evidence, you should consider it
  24     fairly and dispassionately. To do otherwise would be to
  25     do injustice, in my submission, to everyone concerned in
0073
   1     this Inquiry and to the wider public.
   2        It is my submission, advanced I have to say with
   3     a degree of sadness and regret, that the submissions
   4     advanced on behalf of the Action Group contain a number
   5     of factual inaccuracies. That is not said in any sort
   6     of adversarial spirit, it is said because the parents
   7     who form part of the Action Group deserve better than
   8     anything short of a full and accurate account of what
   9     happened at the Bristol Royal Infirmary between 1984 and
  10     1995.
  11        Sir, the theme of my oral submission is going to
  12     be the need for factual accuracy. I do intend to seek
  13     to correct not all but some of the misapprehensions
  14     which one might collect from the Action Group's
  15     submissions.
  16        Can I start with the role of the cardiologists
  17     which is described as Issue C in the Action Group's
  18     submissions? It is said that there was insufficient
  19     liaison between the surgeons and the cardiologists
  20     preoperatively.
  21        That submission seems entirely to overlook the
  22     fact that there are written records of meetings between
  23     the cardiologists and the surgeons about almost all the
  24     elective patients, except for those in the very earliest
  25     years in the period under review. No more than
0074
   1     a cursory glance at the medical notes of the patients at
   2     the Bristol Royal Infirmary in that later period will be
   3     enough to demonstrate the inaccuracy of the suggestion
   4     that there was insufficient liaison preoperatively.
   5        Dr Joffe's evidence is quoted in the Action
   6     Group's submission, and Dr Joffe is quoted as having
   7     said that he did not mention Mr Wisheart's figures for
   8     surgery to a Mrs Shortis at a meeting in April 1995
   9     because, and I quote, "Mr Wisheart's results were
  10     significantly worse."
  11        With the greatest of respect, this is an
  12     inaccurate quotation of what Dr Joffe said in evidence.
  13     Dr Joffe actually said the results "with AVSDs were
  14     significantly worse", and it is Day 90, page 112,
  15     line 3. So whilst purporting to quote accurately from
  16     the evidence, the submission leaves out the two crucial
  17     words which change the whole meaning of that sentence.
  18     Mr Wisheart has always accepted that his AVSD results
  19     were worse, if one leaves out of account the additional
  20     risk factors in the particular patients who died as
  21     a result of this operation.
  22        But the point I am making is this: Dr Joffe did
  23     not say that all Mr Wisheart's results were worse than
  24     elsewhere. That is an inaccurate quotation.
  25        Can I move on to preoperative consent?
0075
   1        The submission on behalf of the Action Group
   2     focuses on one child who underwent surgery and on the
   3     evidence of one particular mother of that child. That
   4     evidence is quoted and it is suggested that Mr Wisheart
   5     did not inform that child's mother about the risk of
   6     mortality inherent in her child's operation. None of
   7     that was put to Mr Wisheart in his oral evidence. I am
   8     not making a complaint about that, sir, I am not making
   9     a complaint about the system, but what I do say is that
  10     when you come to consider the evidence compassionately,
  11     because of the absence of cross-examination it is
  12     necessary to look very carefully at exactly what was
  13     said and at the totality of the other evidence which is
  14     available.
  15        What one finds nowhere in the Action Group's
  16     submission on this point is the references in the
  17     contemporaneous medical notes to the full discussion of
  18     risk which Mr Wisheart had recorded in those notes with
  19     those parents. There is, in relation to that particular
  20     patient, both handwritten and a typed note. They are at
  21     pages MR 3432/79 and MR 3432/111 and the typed note
  22     explicitly refers to the risk of not surviving the
  23     operation.
  24   THE CHAIRMAN: Yes. Mr Moon, just to interject, it is not
  25     really a matter of cross-examination; it is really
0076
   1     a matter of your having the opportunity to respond. You
   2     are taking that opportunity now, but it might be that
   3     you would take it more fully when you have the
   4     opportunity to reply in writing, a decision we have
   5     already taken to invite you to do so.
   6        So I do not think you need have any fear that we
   7     will be unaware of circumstances where there are
   8     differences between accounts.
   9   MR MOON: Sir, I understand the force of that in principle,
  10     and in principle, of course, it is a perfectly logical
  11     and understandable way of approaching things.
  12        The difficulty, in my submission, about that
  13     approach is that with the vast amount of written
  14     material which Mr Langstaff has referred to, it is
  15     possible for a human being, reading it, to overlook an
  16     important passage in one of the thousands and thousands
  17     of documents which might cast light on the oral
  18     evidence. Therefore, of course in principle everybody
  19     has the right to respond and that allows fairness in
  20     principle, but as I say, sir, it is difficult to imagine
  21     a single human being being able to read all the
  22     documents and see all the facets of evidence in the
  23     round.
  24   THE CHAIRMAN: Just to reassure you, two points are in
  25     order: if you flag it up as important, that helps us.
0077
   1     Second of all, there is absolutely no reason why we
   2     should be able to remember what fell from the mouth of
   3     each and every witness who spoke to us over the 95 days
   4     any more than we can remember what was written. I give
   5     you my assurance that we do read and we will try to
   6     remember and if you tell us what to remember, we will
   7     seek particularly to take account of that. It is not
   8     a question of cross-examination.
   9   MR MOON: Sir, I am grateful for that. I am glad that you
  10     have given me this opportunity to flag up particular
  11     areas where I say on behalf of Mr Wisheart, there are
  12     areas of inaccuracy that you may need to focus upon.
  13        It is said, again in the Action Group's
  14     submission, that the figures at Bristol were always
  15     worse than the national statistics. Again, it is
  16     submitted that this assertion is quite simply
  17     inaccurate. A quick glance at the tables, at
  18     UBHT 61/477 and 478, demonstrates the inaccuracy. Only
  19     a minority of procedures were in fact less good than the
  20     average, according to those tables and your statistical
  21     review has of course not yet been finalised, but one
  22     point Mr Stark made in evidence was that the national
  23     performance in terms of mortality in 1988 was probably
  24     double that reported in the UKCSR, so seen in that
  25     light, it is almost impossible to understand how the
0078
   1     submission can properly be made that the figures in
   2     Bristol were "almost always worse than the national
   3     statistics."
   4        It does not fit with the evidence, in my
   5     submission.
   6        Can I move on, then, to the issue of surgeons and
   7     their operations, because again, specific criticism has
   8     been made under E in the Action Group's submission.
   9        It is a central contention of that submission that
  10     surgery at the Bristol Royal Infirmary was poorly
  11     carried out and the Inquiry's own independent Clinical
  12     Case Note Review which has not yet been completed, but
  13     that review will, in my submission, demonstrate that in
  14     fact surgery at the BRI generally speaking was not
  15     poorly carried out.
  16        Somewhat extraordinarily, the submission is made
  17     that the Clinical Case Note Review demonstrates that
  18     surgery was poorly carried out. How is that done? In
  19     my submission, and I say this with a sense of regret, it
  20     is done by sleight of hand to imply that the surgeons
  21     were shown to be at fault in 16 of the 80 or 100
  22     procedures.
  23        At page 6 of section E of the Action Group's
  24     submission it says, and I quote:
  25        "For 16 of the procedures, grades 1 or 2 were
0079
   1     given for surgical care. This means that in those
   2     cases, surgical error has probably or possibly
   3     contributed to death or morbidity".
   4        In fact, there were only 9 grades of 1 or 2 for
   5     surgical procedure and at least one of those will need
   6     to be revised to a score of 3 following Mr Mankad's
   7     evidence in relation to one patient on Day 93.
   8   THE CHAIRMAN: That is going a little too far, Mr Moon. It
   9     will be revisited. Whether it is revised will be
  10     a matter not for you or for me, but for our experts.
  11   MR MOON: Sir, I immediately accept that. It will be
  12     revisited.
  13        There were 16 scores of 1 or 2 if one includes
  14     perfusion and anaesthetics, but the surgeons can hardly
  15     be blamed for these, however widely one seeks to cast
  16     the net of blame.
  17        Further, the submission advanced on behalf of the
  18     Action Group does not mention the undisputed views of
  19     Professor Evans, given by way of a report which I think
  20     was introduced on Day 94, which makes it clear that
  21     97 per cent of the whole series of over 1,800 patients
  22     had operations which scored 3 or 4 for the surgery.
  23        Another inaccuracy appears at page 10, section E,
  24     under the heading "Poor surgical technique". It is
  25     alleged there that Mr Wisheart left the operation
0080
   1     theatre during an operation. This allegation was not
   2     put to Mr Wisheart in his oral evidence. Had it been
   3     put to Mr Wisheart, the true nature of this incident
   4     would have been apparent. According to the evidence of
   5     the parent of that child, a nurse told her that the
   6     operation had been delayed because of a crisis on the
   7     ward that Mr Wisheart had to attend. In other words,
   8     her evidence supports the contention -- and this would
   9     have been Mr Wisheart's evidence had he been asked about
  10     it -- that the start of the operation was delayed, not
  11     that Mr Wisheart left the theatre during the operation.
  12     That is a serious allegation which in my submission is
  13     quite unsupported by evidence and it was not put to
  14     Mr Wisheart. It should, in my submission, be withdrawn.
  15        Page 12, section E: the Action Group rely upon the
  16     hypothesis advanced by Mr Mankad that alleged high
  17     mortality might be caused by the procedure of snaring
  18     the common vein. The Panel will recall that was
  19     a question that was canvassed with Mr Mankad. Again,
  20     Mr Mankad in fact withdrew that hypothesis: Day 93,
  21     page 145, lines 16 to 20.
  22        Sir, I am coming to the end of this list of
  23     inaccuracies. The last two relate to post-operative
  24     care and to the suggestion put by my learned friend for
  25     the first time this morning that the medical
0081
   1     establishment at Bristol was closed, secretive and
   2     defensive. I am going to deal with those two to finish.
   3        The point in relation to post-operative care is
   4     a small one in the context of this review, but it may,
   5     nonetheless, add to the sense of growing doubt which
   6     those who read the submissions, and you, sir, may feel
   7     about the reliability of the submissions advanced on
   8     behalf of the Action Group.
   9        At page 7, section F, the post-operative care
  10     section suggests that the BRI Intensive Care Unit lacked
  11     leadership, and there is a longish quotation, I think
  12     from a Mr Mallone's evidence on Day 95, to the effect
  13     that a consultant came to the ward who Mr Mallone had
  14     not seen before, and interfered with his daughter's
  15     treatment. The following morning his daughter had
  16     a punctured lung.
  17        What the writer of the Action Group's submission
  18     seems to have overlooked is that in fact that child was
  19     not being cared for at the Bristol Royal Infirmary; she
  20     was being cared for at the Bristol Children's Hospital.
  21        My learned friend said this morning that the
  22     medical establishment at Bristol was "closed, secretive
  23     and defensive"