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Opening statements

 

   1     Day 1, 16th March, 1999
   2   (11.00 am)
   3          OPENING STATEMENT BY THE CHAIRMAN
   4   THE CHAIRMAN: Good morning. Shortly, I will invite Counsel
   5     to the Inquiry, Brian Langstaff QC, to set these
   6     proceedings in motion. Before I do, may I say just
   7     a few words.
   8        Today, as you realise, we reopen the hearings we
   9     adjourned last October. Let me start by repeating and
  10     emphasising what I said last October: this is a Public
  11     Inquiry; it is here to inquire. So the procedure which
  12     we have adopted, and will adopt and the range of issues
  13     which we are focusing on, will be those suitable to an
  14     Inquiry and its terms of reference. This is not
  15     a trial. We are not a court. There are no parties.
  16        Some organisations and groups are legally
  17     represented. Their representatives are here. We had
  18     an opportunity to hear from them in October, and are
  19     grateful. There is no need to hear from them further
  20     now. I remind you that Mr Langstaff will question
  21     witnesses on behalf of the Inquiry.
  22        As regards cross-examination, re-examination and
  23     otherwise addressing the Inquiry by legal
  24     representatives, I refer to the procedure which I set
  25     out in October. I expect this procedure to be observed
0001
   1     by everyone.
   2        May I also say a word to the representatives of
   3     the press and the media. We are grateful for your
   4     interest and my team will work closely with you to aid
   5     you in your role. Equally, we would expect you to
   6     observe the dignity and the privacy of witnesses both
   7     inside this building and away from it.
   8        Since October there are a couple of things which
   9     I should report to you. First, the Secretary of State
  10     has appointed a medical member to complete the Inquiry
  11     panel. He is Professor Sir Brian Jarman, Emeritus
  12     Professor of Primary Health Care at Imperial College
  13     School of Medicine and recently retired as a GP in an
  14     inner city London practice. Professor Jarman is
  15     a distinguished doctor with wide experience of
  16     medicine. We will range over a wide area, looking at
  17     a large number of areas of expertise. No single person
  18     could embody all this expertise, so what we have devised
  19     will give us the best of both worlds. Professor Jarman,
  20     with his breadth of knowledge and experience, experience
  21     supplemented by a group of experts knowledgeable in the
  22     various areas into which we must inquire.
  23        Just for the sake of completeness, I remind you
  24     that the other two members of the panel are Rebecca
  25     Howard and Mavis Maclean, and that I am Ian Kennedy, the
0002
   1     Chairman.
   2        The second matter I wanted to report to you
   3     concerns the Inquiry's group of experts. When I spoke
   4     in October, much had still to be done. Mr Langstaff
   5     will set out what has been done. All that I say here is
   6     to remind you that in keeping with the approach adopted
   7     by the Inquiry, all experts will be experts to the
   8     Inquiry. After wide consultation, we have identified
   9     areas of expertise as regards which the Inquiry will
  10     need and be able to have access to advice. The group of
  11     experts will contain a number of experts in each area.
  12     By this procedure, not only do we expect to derive great
  13     assistance for the Inquiry, but we will also avoid the
  14     often unhelpful spectacle of pitting expert against
  15     expert in an adversarial contest.
  16        In this phase of the Inquiry, we will be hearing
  17     oral evidence. For the sake of clarity, I emphasise
  18     again that this oral evidence is intended to supplement
  19     the much larger amount of documentary evidence and
  20     written statements on which the Inquiry will rely.
  21        We will call as witnesses only those who can
  22     assist the Inquiry further by their oral evidence.
  23        Witnesses will be invited to give their accounts
  24     and tell their stories. They will be taken through them
  25     by the Inquiry's counsel who will also ask them
0003
   1     questions. I make it clear I do not ordinarily
   2     anticipate the need for questioning by others. That
   3     said, there may be occasions from time to time when
   4     someone wants Mr Langstaff to ask a question or raise
   5     a matter which he might otherwise not ask. I am anxious
   6     that nothing be overlooked. I know that Mr Langstaff
   7     will ensure that there is always freedom of access, such
   8     that any matters can be put to him or to other members
   9     of the Inquiry team.
  10        I am going to turn to Mr Langstaff, but before
  11     I call on him, may I invite the various legal
  12     representatives to introduce themselves now?
  13   MR LISSACK: My name is Richard Lissack QC and I appear on
  14     behalf of the Bristol Heart Children's Action Group
  15     together with my learned friend Mr Harry Trusted and
  16     Mr Peter Skelton, instructed by Mr Lawrence Vick of
  17     Tozers and Mr Mervyn Fudge of Toller Beattie.
  18   MR EASTWOOD: My name is Simon Eastwood, a solicitor from
  19     Winckworth Sherwood. I am instructed by the Medical
  20     Defence Union and the Medical Protection Society on
  21     behalf of Drs Jordan, Joffe, Monk and Martin.
  22   MR MILLER: I am Stephen Miller QC. Mr Gregory Chambers
  23     sits on my right. We are instructed by Julie Austin of
  24     Wansboroughs Willey Hargrave representing the United
  25     Bristol Healthcare Trust.
0004
   1   MR CHEN: Good morning. Simon Chen, solicitor,
   2     Le Brasseur J Tickle. I act for the Medical Protection
   3     Society.
   4   MR SHARP: My name is Christopher Sharp, counsel instructed
   5     on behalf of the Surgeons' Support Group. I am
   6     instructed by Mr Ed Allingham of Sims Cooke and Teague.
   7   MS STOCKLEY: I am Jo Stockley, senior officer, Royal
   8     College of Nursing. My colleague is Helen Fovarge.
   9   THE CHAIRMAN: Thank you. Now Mr Langstaff.
  10             OPENING BY MR LANGSTAFF
  11   MR LANGSTAFF: Professor Kennedy, Mavis Maclean, Rebecca
  12     Howard, Professor Sir Brian Jarman, ladies and
  13     gentlemen. The Chairman has already described who I am
  14     and my task at this Inquiry. It is my role to give
  15     independent legal advice to the Inquiry, and to present
  16     the evidence. In this I have the great advantage of
  17     being assisted by two other counsel: Eleanor Grey and
  18     Alan Maclean.
  19        You may not hear quite so much from them as you do
  20     from me during the course of this Inquiry, but they are
  21     in no sense silent partners. It is essential in an
  22     Inquiry such as this that the work of analysing,
  23     presenting and examining the evidence is shared between
  24     the three of us, so no-one should read any particular
  25     significance into the fact that Miss Grey or Mr Maclean
0005
   1     asks questions of a witness rather than me, or vice
   2     versa.
   3        Let me give you an overview of what I hope to
   4     achieve within the next hour or so. It is to explain
   5     where this Inquiry starts from, how it came into being,
   6     and in particular, what it proposes to do and the
   7     processes by which it will do it.
   8        In doing this, I shall develop four main themes.
   9     These are, first, that this Inquiry starts its
  10     investigation afresh. Secondly, that the Inquiry will
  11     be comprehensive and inclusive. Thirdly, it is a very
  12     public process and fourthly, the Inquiry's analysis of
  13     data will be careful and cautious.
  14        The first theme needs to be emphasised at the
  15     outset and it is this: we start this Inquiry with
  16     a clean sheet. When conclusions of fact come to be
  17     drawn and recommendations made of future advantage for
  18     the National Health Service, the panel will do so on the
  19     basis of the material which has been presented as part
  20     of this Inquiry. We do not start with a case to be
  21     accepted or rejected. We do not begin with any
  22     conclusions. Conclusions may be where we end up, but
  23     they never make a good starting place. Preconceptions
  24     have no place in this Inquiry. If it is to inquire
  25     fairly and rigorously, it must assume nothing and be
0006
   1     prepared to question even that which seems most obvious.
   2        Chairman, as a barrister yourself, you will know
   3     that counsel are often accused of repetition. However,
   4     repetition is one of the best ways of ensuring that
   5     a message is heard and understood. I hope, therefore,
   6     that I shall be forgiven for repeating, perhaps in
   7     a number of different ways during the course of this
   8     opening, that this Inquiry does not begin with a view or
   9     a bias which it seeks to justify. As part of the legal
  10     team, I do not present a case; I am not here to
  11     prosecute any surgeon or cardiologist or any other
  12     health professional, any more than I am to put a case
  13     for them. We have both the luxury and the
  14     responsibility of taking no side, and of having merely
  15     a determination to present the evidence and to question
  16     it in a way which we hope will enable the panel to get
  17     to the bottom of things.
  18        As if to emphasise that this is not a trial, you
  19     will notice that this is not a courtroom. The Inquiry
  20     has gone out of its way to organise the rooms and
  21     facilities to allow as many as possible to follow the
  22     proceedings without being intimidated by the
  23     surroundings.
  24        Why the Inquiry? In one sense, it is easy to say
  25     why we are here. The Secretary of State for Health made
0007
   1     a statement to Parliament on 18th June 1998. He
   2     provided the terms of reference which are to inquire
   3     into the management of care of children receiving
   4     complex cardiac surgical services at the Bristol Royal
   5     Infirmary between 1984 and 1995, and relevant related
   6     issues; to make findings as to the adequacy of the
   7     services provided; to establish what action was taken,
   8     both within and outside the hospital, to deal with
   9     concerns raised about the surgery, and to identify any
  10     failure to take appropriate action promptly; to reach
  11     conclusions from these events and to make
  12     recommendations which could help to secure high quality
  13     care across the NHS.
  14        Two observations: first, this is no usual
  15     Inquiry. It is not a case of a single incident with
  16     tragic results. If a ferry sinks, if an airliner
  17     crashes, if a tube station or an oil rig goes on fire,
  18     then there is an incident to inquire into. Secondly, in
  19     any such case, you can be confident from the beginning
  20     of the Inquiry that something has gone badly wrong.
  21        But this is not a case of a single incident. We
  22     are asked to examine a process. Cardiac surgical
  23     services were provided to many children of many
  24     different ages over a 12 year period. All those
  25     children required treatment; they were ill. The
0008
   1     survival of any one child cannot, on its own, show that
   2     the care given to others was adequate. The tragedy of
   3     any child's death -- and I use the word "tragedy"
   4     deliberately, because I defy anyone to maintain that the

   5     death of a child is not a tragedy, however unlikely it
   6     is to have happened. The tragedy of any child's death
   7     cannot on its own demonstrate that the services provided
   8     were inadequate.
   9        One of the focuses which has emerged from the
  10     witness statements which have been submitted to the
  11     Inquiry since it opened last October has been a concern
  12     expressed by many parents about the quality of care
  13     their child or children had at Bristol. Some who were
  14     content in the belief that doctors had tried their best
  15     for their son or daughter, have watched the TV reports
  16     and have read the papers, and have come to question
  17     whether that belief was justified. I hope that the
  18     evidence that we shall produce will enable those parents
  19     to know, if for nothing else, for their own peace of
  20     mind, whether there was anything they might reasonably
  21     have done which could have secured a better outcome.
  22        I said at the outset that we have no answers. The
  23     first question may, however, seem startling. Bear in
  24     mind that an Inquiry such as this must start without
  25     preconceptions if it is to do its job properly, with
0009
   1     integrity, and if it is to carry conviction. The first
   2     question is whether there was indeed a problem with the
   3     treatment provided in Bristol. Did the care provided at
   4     Bristol, taken either overall or individually, match the
   5     standards of care provided elsewhere in the UK?
   6        There may be those who think that imposing that
   7     basic question was Bristol in fact significantly
   8     different from any other hospital carrying out cardiac
   9     surgery on children, that we are merely paying lip
  10     service to the need to appear unbiased and open in
  11     approach? This is not so. If my first theme is that at
  12     this stage of the Inquiry there are no answers, merely
  13     questions, the second theme must be to emphasise the
  14     comprehensive nature of the Inquiry upon which we are
  15     engaged.
  16        At the General Medical Council, I will call it the
  17     GMC for short, 29 deaths were examined in detail,
  18     a series of 53 cases was studied. Two operations -- two
  19     operations alone -- were central: the arterial switch to
  20     repair the transposition of the great arteries, and the
  21     operation to repair the atrial ventricular septal
  22     defect, AVSD for short. The time-frame was much more
  23     limited than the breadth of this Inquiry, which is far
  24     greater. By contrast with the GMC, we will draw
  25     statistical conclusions from over 2,000 cases of
0010
   1     surgery, both open heart surgery and closed heart
   2     surgery.
   3        I say over 2,000: the Trust has been unable to
   4     tell us from its own records the precise number of such
   5     cases, but once the necessary cross-checking has been
   6     done to ensure there is no duplication, we shall be able
   7     to supply it. We shall deal with a range of
   8     procedures. We shall consider surgery over 12 years.
   9     Every case, to a greater or lesser extent, will form
  10     part of that consideration. We shall look at all
  11     paediatric cardiac surgery and at all outcomes, not only
  12     death but also morbidity such as brain damage. Let me
  13     lay to rest once and for all that this Inquiry is into
  14     the death of 29 babies. If it were, it might imply that
  15     the death of any other baby were of lesser importance.
  16     It might, moreover, suggest that where a child survived,
  17     but left let us suppose brain-damaged or with renal
  18     problems, that that is not to be taken into account.
  19     Because of the way the Inquiry will examine the data
  20     which it has obtained, I can assure the parent of every
  21     child who had heart surgery since 1984 that their
  22     child's case will take a part in the evidence upon which
  23     the Inquiry will base its conclusions. Some cases may
  24     have more immediate prominence. Some parents, for
  25     instance, whose children's treatment raises issues
0011
   1     representative of many, will be asked to give oral
   2     evidence. However, prominence must not be confused with
   3     importance and the fact that, inevitably, many will not
   4     give evidence orally does not mean in any way that they
   5     are being passed over and forgotten.
   6        Over half a million pages of clinical records have
   7     been obtained. Not only has the Inquiry managed to
   8     obtain those clinical records, but has been active in
   9     a number of other fairly unseen ways since last
  10     October. The Inquiry has powers given by Act of
  11     Parliament to require documents to be provided to it by
  12     order of the Chairman, and require evidence to be given
  13     and further, to require that evidence will be given on
  14     oath, as indeed it usually will be. Documents have come
  15     into the Inquiry's offices in London and latterly in
  16     Bristol from a number of different sources. We have had
  17     them from the Department of Health; from the
  18     cardiothoracic register of the United Kingdom; from
  19     a number of parents; from the private papers of the
  20     clinical professionals involved; from various regulatory
  21     bodies from the United Bristol Healthcare Trust and from
  22     several others.
  23        As at this morning, those of you who have had the
  24     luxury of having a printed copy of what I am to say in
  25     advance will need to make some alteration here, because
0012
   1     I can bring you up to the minute. As at this morning,
   2     a total of 28,720 documents other than clinical records
   3     have been provided, indexed and scanned into an
   4     electronic database. Many of those documents consist of
   5     10 or more pages. Of the medical records, we have
   6     3,136. As I have said, more than half a million pages.
   7        At one stage in the process, we estimated that if
   8     one person on his own were to read every page at
   9     a reasonable rate, allowing two minutes for an A4 sheet
  10     of paper, it would take him over 20 years of working
  11     time to read each document just once. That is why
  12     a considerable team has had to be recruited to assist
  13     the Inquiry.
  14        So how precisely have the team coped since last
  15     October in uncovering documents, requiring evidence and
  16     analysis and how can we go about a task which is beyond
  17     a reasonable time-scale for any one person? The answer
  18     is, of course, that not all the documents are relevant,
  19     and that of those which are, the degree of relevance
  20     varies from minimal to very considerable. Every
  21     document has been read by a legally qualified member of
  22     the Inquiry team. Unless obviously irrelevant it has
  23     been re-read by a more senior lawyer checking for
  24     importance.
  25        After this process of review and cross-check,
0013
   1     documents which may assist the Inquiry have been made
   2     part of what we call a core bundle. This forms the
   3     essential data tool for the Inquiry, and it will be
   4     published in searchable form on a series of CDs.
   5        Let me deal for a moment with confidentiality of
   6     those documents, because it is a matter which I think
   7     concerns a number of people. Many of the documents
   8     contain confidential material, or material which was
   9     supplied under an assurance of confidentiality. The
  10     Inquiry undertook not to disclose details which tend to
  11     lead to the identification of a patient, a child, unless
  12     a parent or the patient consents.
  13        We regard this as vitally important. Accordingly,
  14     references which could have the result of identification
  15     are blacked out or redacted, of the documents which are
  16     copied. The database intended for presentation of
  17     documents on screen in this hearing chamber is also
  18     edited in the same way, and both the Chairman and I have
  19     a facility to check at the last moment, even, to ensure
  20     that there is no untoward reference, even if others
  21     missed it. May I say that much of the Inquiry team over
  22     the past fortnight has been checking and double-checking
  23     and subsequently checking again the document base to
  24     ensure that our promises on confidentiality have been
  25     and will be honoured. Thus, every effort has been taken
0014
   1     to ensure that unless a parent consents, a child cannot
   2     be identified. Redaction has proceeded on a next-door
   3     neighbour test: although parents are likely to know that
   4     the information relates to their child, would the
   5     material tend to identify the child to their next-door
   6     neighbour? If so, we have redacted it. If it becomes
   7     permissible to lift the redaction, then we may do so,
   8     but always respecting confidentiality and the parents'
   9     or patients' wishes as a prime concern.
  10        Let me return from confidentiality to a second
  11     theme: that the Inquiry intends to be comprehensive. It
  12     has received statements. Any formal statement received
  13     will be published. If, in that statement, anyone is
  14     referred to critically, that is, in a sense relevant to
  15     the Inquiry's issues and of sufficient importance, then
  16     before publication, it will be circulated to the person
  17     criticised for comment. Of course, although we do not
  18     expect it, if there should be any purely abusive or
  19     scandalous material which cannot take the Inquiry any
  20     further, that will be redacted. Statements will come
  21     from a range of sources. This is not just an Inquiry
  22     concerned with patients and surgeons. There is a much
  23     wider range of material to be examined. In particular,
  24     our terms of reference require us to go beyond the
  25     detail of the Bristol Royal Infirmary to the whole of
0015
   1     the National Health Service as a system, including the
   2     build-up to and the impact of the NHS reforms in 1991.
   3        The process of requesting formal statements has
   4     not been conducted randomly. Confidential
   5     questionnaires have been sent out to parents in response
   6     to their requests. 242, and there is a difference to
   7     the figures because overnight we have had 8 more, have
   8     so far been returned. Of those, 156 said they were
   9     members of an action group. 107 identified the action
  10     group as the Bristol Heart Children Action Group; 36
  11     identified the action group as the Bristol Surgeons'
  12     Support Group. I should like, on behalf of the Inquiry,
  13     to thank all parents who have completed and returned
  14     such a questionnaire. The questionnaires have been
  15     extremely helpful to the Inquiry team, and it cannot
  16     have been easy to express their deeply held feelings to
  17     us on paper.
  18        The answer to the questionnaires remains
  19     confidential. They are unseen by the panel. Everything
  20     the panel see is in the public domain. The answers to
  21     the questionnaires therefore form no part of the
  22     material upon which the panel decide whether they can
  23     make recommendations, and if so, what they will be.
  24     People who have sent in the questionnaires have been and
  25     may well be asked to provide written formal statements.
0016
   1     Any statements submitted will be part of the evidence.
   2     Any formal statement, from whoever wishes to submit one,
   3     will be considered. Although we have a mass of evidence
   4     already, there is more to come. In particular, I would
   5     like to encourage everyone, for instance a member of
   6     staff at the Bristol hospitals, if there is anything
   7     they wish to say about what happened in Bristol, good,
   8     bad or indifferent from 1984 to 1985, to come forward
   9     and to speak to a member of the Inquiry staff. The
  10     press here today, particularly local reporters, can
  11     assist by reporting my plea for anyone who feels they
  12     have anything useful to add to the information to come
  13     forward and contact the Inquiry. The Inquiry means what
  14     it says about being comprehensive and inclusive. You
  15     already, I think, have realised that this Inquiry will
  16     be the widest ranging examination of the NHS ever
  17     conducted independently.
  18        What about procedure? The procedure is not that
  19     of a trial. This is an Inquiry. Thus, as the Chairman
  20     explained last October, cross-examination will be
  21     limited. Eleanor Grey, Alan Maclean or I will examine
  22     the witness. After the first few witnesses have been
  23     heard, the written statement which has been published
  24     will be taken as read. There will be an opportunity for
  25     each witness to be re-examined by his or her
0017
   1     representative to ensure they give a fair account of
   2     themselves; a short written statement summarising the
   3     effect and importance of the witness's evidence made
   4     overnight may be published the morning after the witness
   5     has completed his or her evidence. On application, the
   6     Chairman may allow that statement to be given orally.
   7        The purpose of our questioning is to examine the
   8     evidence thoroughly. We would hope that it is fair but
   9     rigorous. What a witness says deserves to be treated
  10     seriously. Witnesses should remember that evidence
  11     which is not carefully examined, not looked at
  12     thoroughly in its important respects, will carry less
  13     weight.
  14        A third theme is the public nature of this
  15     Inquiry. It is unusual. No Inquiry has yet been so
  16     public. The daily transcript will be put on the
  17     Internet. After Easter, the proceedings will be
  18     transmitted live to Barnstaple, Truro and Cardiff. This
  19     is under controlled circumstances for the Inquiry, it
  20     will not be appearing on TV or radio. If anyone should
  21     attempt to use it in this way, sanctions will follow.
  22     When documents are referred to in the oral hearing, they
  23     will be part of the core bundle and they too will be
  24     made public. Because the Inquiry is taking evidence
  25     publicly on paper, not everyone will be asked to give
0018
   1     evidence orally; but those who are not called are not
   2     ignored. In many ways, their evidence may count for
   3     more. This is because we shall ask those to give
   4     evidence where we may need to amplify what they are
   5     saying; to put it in context or to challenge it. It
   6     may, for instance, be inconsistent with that which
   7     another witness has said. On the other hand, witnesses
   8     will not be called where their statement is
   9     self-explanatory and there is perhaps little that
  10     questioning could add. For the witness who is tempted
  11     to feel that his or her evidence has been treated as
  12     being of lesser value because he or she has not been
  13     called to sit in the central chair in the full glare of
  14     the cameras and bear public witness to what he or she
  15     has said, I would simply ask, is a statement likely to
  16     be regarded as of greater value if the evidence is
  17     publicly doubted, as may be the case with some
  18     witnesses, rather than accepted as obviously true?
  19     I would ask them, would they think that evidence which
  20     is full enough on paper so there is no need to ask
  21     anything to expand upon it orally, is not likely to
  22     carry more weight because it is seen to be full and
  23     frank in the first place.
  24        We have endeavoured to select witnesses whose
  25     evidence covers a range of issues, which is broadly
0019
   1     representative of the evidence which we have received.
   2     Let me emphasise again, that no-one should feel that he
   3     or she is being treated adversely merely because her or
   4     his evidence has not been selected for oral scrutiny.
   5     Moreover, each week we will publish in advance the names
   6     of the witnesses whom we expect to call in the following
   7     week. Parents who are not called to give evidence in
   8     block 1 may find that they are being asked to give their
   9     evidence in block 3, or 5, or 6. For the parents'
  10     evidence runs seamlessly throughout the issues we have
  11     to consider. Each witness will be invited to see
  12     whichever of the three of us, Eleanor, Alan or myself,
  13     is going to ask them the questions when they do give
  14     evidence. They may, of course, not wish to avail
  15     themselves of this, but it may help to relieve some of
  16     the anxieties which are inevitable about the process of
  17     being a witness, particularly on a stage as public as
  18     this.
  19        May I say that of course, we are happy to see any
  20     witness with or without their representatives in advance
  21     of the evidence.
  22        One category of witness perhaps deserves special
  23     mention, and that is experts. As the Chairman has just
  24     said, the Inquiry will establish a group of experts
  25     containing a number of experiments in each relevant area
0020
   1     of expertise. The expert group will include experts in
   2     the following areas of expertise, first and perhaps most
   3     obviously: paediatric cardiac surgery. Paediatric
   4     cardiology, paediatric cardiac anaesthesia, paediatric
   5     intensive care, paediatric pathology, nursing, both
   6     paediatric care and intensive care, medical education
   7     and training, specialist surgical training, medical and
   8     clinical audit in relation to methodologies, regulation
   9     of the medical profession, NHS management and finance in
  10     the 1980s and 1990s, including the impact of the NHS
  11     reforms, and statistics and epidemiology.
  12        The aim of the Inquiry's group approach is to move
  13     away from the model of expert evidence used in trials,
  14     where expert evidence is presented in an adversarial
  15     setting. As experts to the Inquiry, those in the group
  16     will be asked to give their opinion in the widest public
  17     interest, rather than in support of the case of one side
  18     or the case of the other. As Professor Kennedy has
  19     already made clear, there are no sides; there is no
  20     case.
  21        The Inquiry is very mindful of the relative
  22     scarcity of expertise in a number of areas of interest
  23     to the Inquiry. We recognise that membership of the
  24     expert group may involve a considerable commitment of
  25     time and energy to the expert and to the institution
0021
   1     where the expert works. Thus, to lighten the load on
   2     any one individual, a number of experts will be invited
   3     to serve in each area of expertise. Appointment to the
   4     group will be by invitation only. The Inquiry has
   5     sought and will continue to seek advice from experts as
   6     to those others whose expertise is well recognised, with
   7     a view to ensuring that the expert group first has
   8     sufficient numerical strength to ensure the Inquiry's
   9     demands are met with the minimum of inconvenience to any
  10     one group or institution, and secondly covers any
  11     principal difference of view or emphasis within a given
  12     specialty, and thirdly, is broadly based, both
  13     geographically or otherwise. I know the Chairman is
  14     always content to listen to suggestions for additions to
  15     the group, where it is considered that will be of
  16     assistance to the Inquiry.
  17        The written opinions of the experts will be made
  18     public. They will be published on the Inquiry's web
  19     site. Although the Inquiry will not necessarily hear
  20     orally from each expert where views differ, it will seek
  21     to take advice and evidence where it seeks to reflect
  22     fairly any divergence of opinion, and where it is
  23     important to explore it. The experts may be called to
  24     give oral evidence in addition to their oral and
  25     published reports. Where they are called to give
0022
   1     evidence, an expert may appear alone, or he may appear
   2     as part of a discussion where two or three experts who
   3     hold what are apparently different views will be invited
   4     to contribute. In the latter case, each will give
   5     evidence at the same time, moderated as it were by
   6     counsel, thus permitting an open panel-type discussion
   7     amongst the relevant experts.
   8        The oral evidence which I have described, both
   9     from lay witnesses and from experts, will be taken in
  10     phases, in blocks. The Inquiry has two phases, and the
  11     oral evidence will be taken in the first phase, Phase I,
  12     of the Inquiry, in six blocks. If the first block
  13     parents will give evidence of their experience of and
  14     the treatment of their children at the BRI and the
  15     Bristol Children's Hospital. It is from their
  16     experience that everything else stems. They will
  17     feature in each of the other blocks of evidence as
  18     well. After setting the scene from their perspective,
  19     we shall move to block 2, to consider the national
  20     scene. Block 3 involves the local scene, the
  21     organisational structure, the staffing side. Block 4 is
  22     the nature of the services provided. Block 5 is their
  23     adequacy, and block 6 the concerns expressed about the
  24     services. Bear in mind that in the earlier blocks we
  25     shall be concentrating on structures, finances and
0023
   1     arrangements. Some witnesses may therefore give
   2     evidence in more than one of the blocks. For instance,
   3     many of you will know that Mr Wisheart, as Chairman of
   4     the Hospital Medical Committee, and later medical
   5     director of the United Bristol Healthcare Trust, had
   6     a central role to play in the administration of the
   7     Bristol hospitals. Accordingly, he will be asked to
   8     give evidence in block 3 about that aspect. He also
   9     will be asked to give evidence in the later blocks.
  10        So there are two phases to the Inquiry: Phase I
  11     divided into the six blocks I have mentioned, and
  12     Phase II, where the wider issues raised by the Inquiry
  13     will be considered; conclusions drawn and
  14     recommendations made.
  15        With such a mass of evidence, with so many
  16     witnesses giving evidence, and with the Inquiry being
  17     into a process rather than one single event, people may
  18     wonder when the Inquiry is going to finish. It will
  19     finish Phase I by Christmas. It has to. If the
  20     recommendations which the panel will make are to be made
  21     at a time when they will have any influence on the
  22     future of the NHS, then they must be made within
  23     a reasonable time-span. It is necessary for parents to
  24     be able to move forward; it is important for the
  25     Hospital Trust to move out of the shadows cast by the
0024
   1     past, so that it gives the service it can to the people
   2     of Bristol. No-one is served by delay.
   3        Remember that the purpose of the oral evidence is
   4     to supplement the written evidence. Because much of the
   5     evidence is in writing, the Inquiry will be able to move
   6     more swiftly to its conclusions.
   7        The timing of Phase II is driven by the same
   8     concerns. We will aim to start it even as Phase I draws
   9     to its completion, with a view to ending Phase II within
  10     the first half of next year.
  11        How shall we manage the evidence? The Inquiry, as
  12     I have said, is not only unusual in being an Inquiry
  13     into a process, into a service delivered over several
  14     years, nor is it only the largest investigation into
  15     practices in the National Health Service for many years,
  16     indeed ever, it is also unique in the sense to which it
  17     will be accessible to any member of the public. I have
  18     emphasised already, it is going to be open,
  19     comprehensive and inclusive.
  20        In front of you are two sets of screens, black and
  21     grey. On the ones which have a black support, you may
  22     see a little old grey-haired man who thinks he is the
  23     Inquiry's equivalent of Jeremy Paxman. That image,
  24     which will not always be of me, I hasten to add, will be
  25     transmitted after Easter from this hearing room to
0025
   1     Barnstaple, Truro and Cardiff; at the health centre in
   2     each. The Inquiry will place the evidence it has
   3     obtained in public libraries throughout the south west,
   4     and indeed South Wales. At the end of each day, the
   5     evidence, every question, every answer, will be placed
   6     on the Internet and we hope that this will inspire more
   7     people to come forward if they have anything useful to
   8     add or any comment to make. This Inquiry is a Public
   9     Inquiry and it takes the word "public" seriously.
  10        The second screen, the grey one, is used for
  11     displaying documents to a witness for comment. I will
  12     show you how that works when I deal in a moment or two
  13     with the way the Inquiry will navigate through the sea
  14     of information available. If I can take that metaphor
  15     further, you, Chairman, as a barrister yourself, will
  16     know how lawyers love analogies, because they help to
  17     picture a process. In some respects, the Inquiry
  18     resembles some of the explorers of old setting out on
  19     a voyage of discovery. Like them, the Inquiry does not
  20     know how it will end up. It has, however, to start from
  21     somewhere, and it must be aware of currents flowing from
  22     different directions that may take it off course, and it
  23     must have a star to steer by.
  24        How do we propose to make sense of the evidence
  25     which has come in, and which will accumulate, and
0026
   1     navigate our way through it?
   2        Our starting place, perhaps, is matters of
   3     historical record. The Inquiry is into paediatric
   4     surgical services. That covers children under 16. It
   5     also covers infants, that is, those under one year of
   6     age, including neonates, those up to 28 days of age. It
   7     is important to keep in mind the distinction between
   8     children over the age of one and under the age of one.
   9     The reason is this: in 1983 the then Secretary of State
  10     for Health designated a number of clinical services as
  11     supra-regional. They were those services which, in
  12     order to be clinically effective, or economically
  13     viable, needed to be provided by centres, each of which
  14     served a population significantly bigger than that of
  15     a single health service region. There were 14 regions
  16     in England and Wales. The advisory group, the
  17     Supra-regional Services Advisory Group -- you understand
  18     why I call that SRSAG -- designated nine hospitals for
  19     the provision of infant and neonatal cardiac surgery.
  20     They did that in 1983. Thereafter, until 1984, infant
  21     and neonatal cardiac surgery was a supra-regional
  22     service. The distinction between infants and neonates
  23     on the one hand and children over one on the other is
  24     that cardiac surgery provided to the latter group was
  25     not provided on a supra-regional basis.
0027
   1        Supra-regional services received funding direct
   2     from what was then the DHSS. Designation as a centre
   3     thus had important financial consequences. Each centre
   4     was required to make a return each year to the
   5     Department, giving the numbers of operations conducted
   6     in any one year. In 1986 there was a review of the way
   7     in which the system was working. Can we have a look,
   8     please, at document 62, UBHT 62/401? Shall we try and
   9     amplify it so we can see? If we focus, please, on the
  10     second paragraph, can we have that highlighted in
  11     yellow? We can see there that in the report it records
  12     that the need was confirmed for a limited number of
  13     centres to perform a complex surgery, and there was
  14     a case for a possible reduction in the number of centres
  15     which were designated. The supra-regional centres are
  16     as follows ... can we scroll down, please? We can see
  17     that the hospitals are listed. If we go down to the
  18     bottom of what is now on the screen, we see the Bristol
  19     Children's Hospital and Royal Infirmary.
  20        We then read this:
  21        "The Bristol centre is one of the smallest centres
  22     in terms of throughput. The total number of operations
  23     on children aged under one year increased from 50 in
  24     1984 to 55 in 1985 .... It has, however, been seen as
  25     having a legitimate claim for development on
0028
   1     geographical grounds and the consideration of this has
   2     included its proximity to the South Wales population."
   3        May I add, for those of you who may be aware of
   4     some of the figures that have been bandied around, that
   5     the figure of 50 and 55 is a combined total of both open
   6     heart surgery and closed heart surgery.
   7        As this document really demonstrates, the
   8     documents we have received have been scanned into an
   9     electronic database. One of the advantages of the
  10     research which had been done by the staff of the
  11     Inquiry, the advantage of the electronic database, is
  12     that documents which may be far-removed in different
  13     files can be matched, displayed to you in a coherent
  14     manner, they can be highlighted, and indeed sometimes
  15     relatively indistinct old documents can be made, by the
  16     use of modern technology, to look rather better than
  17     they did originally.
  18        Returning to the history of the supra-regional
  19     services, in 1992 the Secretary of State, the then
  20     Secretary of State, made an announcement which is to be
  21     found at document -- here we go to a different file --
  22     277/93. May we focus, please, on the centre of the
  23     page, under the heading "Neonatal and Infant Cardiac
  24     Surgery"? We see again the list of hospitals. Can we
  25     go down to paragraph 31? We can read there, some of it
0029
   1     is missing at the edge:
   2        "In its recommendations last year, the advisory
   3     group pointed out that there were effectively 10
   4     designated centres and that some activity was taking
   5     place in other units. This meant that the service must
   6     be considered for dedesignation. The government would,
   7     however, prefer in the interests of patients, that the
   8     service be rationalised into fewer designated units.
   9     Discussions are taking place with professional bodies,
  10     but unless these confer the prospect of early
  11     rationalisation, designation will have to be withdrawn."
  12        So what paragraph 31 suggests is that although
  13     patients benefit by having fewer rather than more
  14     specialist centres for cardiac surgery, because in fact
  15     more rather than fewer centres were actually performing
  16     the service, designation might have to be withdrawn.
  17     You may ask, why should this be, and there is an echo
  18     perhaps here of a letter which was written back in
  19     October 1986 -- may we look, please, at 278/432?
  20     Enlarge that. It is the second paragraph. Just reading
  21     from the bottom of that:
  22        "Supra-regional arrangements apply only to England
  23     and the exclusion of Wales was made clear. Secondly
  24     funding arrangements: we have no powers to determine
  25     referral practices which remain a clinical
0030
   1     responsibility. HN(83)36 discourages health authorities
   2     from providing supra-regional services in units which
   3     are not designated as supra-regional centres", and this
   4     is the sting: "but this is not binding on clinicians."
   5        Referral practices therefore remain and remained
   6     a clinical responsibility. Did private professional
   7     decisions purportedly made in the best interests of
   8     patients, in fact harm patient care overall? No
   9     conclusions can be drawn at this stage. I must
  10     emphasise that, particularly on the basis of two
  11     documents which I have selected largely to impress you
  12     with the technology, but the issue is one for the
  13     Inquiry to consider.
  14        A moment or two ago, I showed you a document which
  15     contained a summary of numbers reported for
  16     Supra-regional Services Advisory Group. You remember
  17     the 50/55 operations. You may have thought that those
  18     numbers were definitive. Sadly, this may not be the
  19     case. Again, as a result of the work which we have
  20     already done, I can tell you that there is some
  21     uncertainty about the accuracy of those figures. For
  22     instance, if one goes back to the Bristol Royal
  23     Infirmary and open heart surgery in 1984, some records
  24     suggest that four open heart operations were conducted
  25     that year; others have it as three. It seems no
0031
   1     definitive data was kept by the Bristol hospitals of the
   2     number of operations conducted. I hope I summarise our
   3     current information accurately and say a number of
   4     different systems, some on card index, some on computer,
   5     were kept for different periods by different
   6     individuals. At least one of those systems was
   7     unreliable, in part because no-one had sole
   8     responsibility for inputting information into it, and
   9     often medical staff did not enter information into the
  10     system which it was supposed to hold.
  11        The information on one system, which was
  12     maintained in recent years by cardiac perfusionists was
  13     maintained for three years or so, and then the computer
  14     and the information stored within it was stolen from the
  15     Trust. I do not want to bore you with the further
  16     details, save to say that they are contained in a letter
  17     of 9th March 1999, only last week, from John Grey on
  18     behalf of the Trust to the Inquiry, which we shall put
  19     before you as part of the documentation. Indeed, if
  20     I can just add, it has taken the Trust some three months
  21     to identify all these relevant clinical records.
  22        What, however, this indicates, is that there is
  23     a very great need for care in drawing conclusions too
  24     readily from data. Everybody here may already know that
  25     concerns were expressed by different people over
0032
   1     a number of years about paediatric heart surgery at
   2     Bristol. The suggestion is that other centres may be
   3     better, or better at least for some if not many
   4     operations to which congenital heart defects give rise.
   5     That is easy to say, but it is actually very difficult
   6     to discover whether there is any truth in it. In 1987
   7     a TV programme was screened in Wales as a result of the
   8     Children's Heart Circle for Wales criticising the
   9     Bristol Royal Infirmary paediatric cardiac surgical
  10     unit. That alleged, and I quote, that a "degree of
  11     concern has been expressed by independent well-informed
  12     sources about the standard of operations carried out at
  13     the receiving centre in Bristol. It has been suggested
  14     that this concern is widely held."
  15        However, the author of those remarks was at pains
  16     to stress that such information -- and again I quote,
  17     "in no way represents hard evidence."
  18        On that occasion, there was a response from two
  19     cardiac surgeons: Mr Wisheart and Mr Dhasmana, and two
  20     cardiologists, Drs Joffe and Jordan, which asserted that
  21     the available figures showed that the allegations were
  22     totally false. They stated that the actual status of
  23     the facilities was better than most, and that the
  24     surgical results were at least equal to those achieved
  25     by other paediatric units elsewhere. Their figures were
0033
   1     used to defend surgical practice at Bristol. I quote
   2     that incident to show how in the past a non-specific
   3     allegation backed up by no figures was met by figures
   4     which in themselves were controversial. Neither
   5     approach is good enough for this Inquiry. We shall not
   6     be using figures as a weapon, rather seeking to
   7     understand what the best available figures may show us.
   8        With that introduction, let me spend a little time
   9     dealing with the whole question of statistics: figures
  10     may help to clarify the picture, but here I come to what
  11     is my fourth main theme: they cannot, in themselves,
  12     provide an answer. Figures must be approached with
  13     care. For a start, they are necessarily general. There
  14     may be much force in a complaint of a parent who
  15     observes that her child is not just a number, but an
  16     individual. We must not lose sight of the fact that
  17     each case is truly individual.
  18        On 7th August 1990, Dr Bolsin, a consultant
  19     anaesthetist, drew attention in a letter to Dr Roylance,
  20     who was then the District General Manager and
  21     prospective Chief Executive of the UBHT, to what he
  22     considered to be excessive mortality in paediatric
  23     cardiac surgery. There followed several years of
  24     professional disagreement about the outcome and quality
  25     of surgery at the Bristol Royal Infirmary. The
0034
   1     disagreement related at least in part to different
   2     interpretations of what the figures showed, and since
   3     then, various sets of figures have been looked at and
   4     interpreted by several others, both within the Bristol
   5     service and external to it.
   6        The panel will have to look at those figures and
   7     look at those interpretations, and ask, amongst other
   8     things, what those particular figures should have
   9     suggested to those who looked at them at the time. But
  10     how are we going to deal with the best figures
  11     available? What is the star by which we must steer?
  12     First, the Inquiry is not bound by the figures bandied
  13     around in the 1980s and 1990s in the Trust and outside
  14     it. Even though the GMC struck off one of the two
  15     cardiac surgeons who conducted open heart operations on
  16     children at Bristol, and censured the other, this
  17     Inquiry would lack integrity if it were not prepared to
  18     think the unthinkable: to contemplate that it may be
  19     possible, when all is said and done, that no valid
  20     conclusions can be drawn about Bristol. Of course, by
  21     contrast, the evidence which we uncover may indeed
  22     validly show that Bristol was the same as or different
  23     from other centres.
  24        This Inquiry has available to it much greater
  25     resources than anybody else who has attempted to examine
0035
   1     the figures thus far, and we intend to use those
   2     resources to ensure that the figures are thoroughly
   3     analysed. This week, we will publish our framework for
   4     handling data. Let me outline the main elements of the
   5     strategy here and now.
   6        There is a range of data sources which is
   7     available at both national and local level, which may be
   8     relevant, first to show whether there is an apparent
   9     difference between the performance of Bristol and that
  10     of other centres in the UK, and secondly, whether the
  11     difference is consistent or sporadic, and if so, to what
  12     aspects of children's heart surgery it relates.
  13        The first of the national sets is the Hospital
  14     In-patient Enquiry (HIPE) which reported on a 10 per
  15     cent sample of deaths and discharges of patients from
  16     hospitals in England and Wales on a national basis until
  17     1985. Regional health authorities established systems
  18     of hospital activity analysis (HAA) similar to each
  19     other, which reported administrative and clinical data
  20     on all in-patients treated in NHS hospitals.
  21     Eventually, the 10 per cent samples, or HIPE, were drawn
  22     from those bases. Data was collected regionally but not
  23     reported nationally between 1986 and 1988. Then, in
  24     1989, following the recommendations of the Korner
  25     committee, a national reporting system based on all
0036
   1     reported episodes of care, not just 10 per cent of them,
   2     was instituted.
   3        Over the period affected by the Bristol Inquiry,
   4     the data derived from patient administration systems
   5     (PAS) were aggregated regionally and transmitted
   6     nationally to an agency which analysed and reported the
   7     data for the Department of Health as Hospital Episode
   8     Statistics (HES). The coding of diagnostic information
   9     used in these systems over the period we are concerned
  10     with is based sequentially on the International
  11     Classification of Diseases, 9th Revision 1975, and 10th
  12     Revision 1992, the latter from 1995. The surgical
  13     operation data was coded according to the Office of
  14     Population Censuses and Surveys' Classification of
  15     Surgical Observations, 3rd Revision (until 1985), and
  16     4th revision from 1989. It became impossible to analyse
  17     and record clinical data in progressively greater detail
  18     and depth.
  19        In respect of paediatric cardiac surgery, data was
  20     sought independently of government from each hospital
  21     performing such surgery throughout such period with
  22     which the Inquiry is concerned, by the Society of
  23     Cardiothoracic Surgeons. They prepared a register of
  24     cardiothoracic surgery. Data from this source were used
  25     extensively at the GMC hearings. The data which were
0037
   1     supplied voluntarily were not always complete, and there
   2     is a need to examine carefully the reliability of these
   3     returns.
   4        There are key questions to be asked about data
   5     coverage, data quality, how the data were collected, how
   6     the data were validated, and indeed, the potential
   7     comparability of data sources. This task, to appraise
   8     the quality of the data, is the first task for the
   9     Inquiry to undertake if it is to have any proper
  10     assistance from the available data sources. It will be
  11     published before any new computations or new tables are
  12     produced, to help to ensure that any conclusions
  13     reached, if indeed they can be reached from the data,
  14     are sound and capable of standing up to scientific and
  15     public scrutiny.
  16        May I please have slide SLD/1/1? Can it be turned
  17     around please? One of the great advantages of the
  18     system is that it allows us, as you see, to deal with
  19     things in landscape as in portrait style, but it may
  20     mean there is a moment or two of glitch.
  21        I can summarise the process of statistical
  22     investigation in this way -- the first stage, which
  23     I have dealt with, is "Preliminary (but vital) critical
  24     overview" of the sources of data. Let me identify each
  25     of the next three stages before dealing with them in
0038
   1     detail. "Exploration", the second stage;
   2     "Confirmation", the third stage; "Explanation", the
   3     fourth stage. "Exploration" is to see whether the data
   4     suggests a difference in any and what respects between
   5     performance at Bristol and elsewhere. "Confirmation"
   6     examines whether the accuracy of the national
   7     performance figures and those from other centres can be
   8     confirmed; to see whether the Bristol performance can be
   9     calibrated against the results obtained on exploration
  10     of the data; and to make a judgment as to the degree of
  11     bias in the results -- "bias" here, of course, I am
  12     using in the technical sense.
  13        The third, "Explanation", looks to see to what
  14     extent explanation offered as to any apparent and
  15     confirmed difference between Bristol and other centres
  16     may be consistent or inconsistent with the data.
  17         Going back to the second of those, exploration is
  18     going to be a very considerable undertaking, and it
  19     involves two aspects: first of all, there is an exercise
  20     to look at the clinical record of every single child who
  21     had surgery at Bristol; to capture information about
  22     each child's diagnosis, the surgical procedure performed
  23     and the outcome. Secondly, it involves independent
  24     analysis of the national data to see what they can tell
  25     us about comparative performance. Although the Inquiry
0039
   1     will be conducting its own analysis from the records
   2     themselves, the results will, where necessary, be
   3     cross-checked against existing local records.
   4        There are several local records, and sadly, none
   5     were complete. They were the surgeons logs, the
   6     operating theatre registers, the patient administration
   7     system (PAS), a cardiologist's card index system which
   8     was maintained from 1984 to 1988; the South Western
   9     Congenital Heart Register maintained by Dr Jordan until
  10     1993; and the Patient Analysis and Tracing System
  11     installed in 1992. Those will be cross-checked against
  12     other incomplete national sources, for instance, there
  13     may be some information to be gained from the National
  14     Confidential Enquiry into Peri-operative Deaths. You
  15     understand why I call that "NCE". In 1989 it conducted
  16     a particular survey of paediatric cardiac surgery, and
  17     you also have the Working Party report, of which
  18     I showed you a brief extract on the screen earlier.
  19        We intend to deal orally with the conclusions
  20     which expert statisticians reach in relation to the
  21     data. Since this is an Inquiry not a trial, we are able
  22     to deal with the issue by having two or three experts
  23     engage in public discussions with the limitations of the
  24     various data sources. Rather than the process of one
  25     expert at a time giving evidence independently
0040
   1     cross-examined by a barrister on the basis of a lawyer's
   2     possibly limited understanding of expert issues, we
   3     anticipate a panel or group discussion, moderated as it
   4     were by me, and the experts should be able to determine
   5     whether the evidence suggests that Bristol has
   6     consistently or sporadically outlying performance, and
   7     hence whether the data raises further questions, and if
   8     so, what those questions are.
   9        Because of the comprehensive nature of this
  10     Inquiry, its determination to draw conclusions justified
  11     by the best available evidence, we cannot begin with any
  12     assumptions as to what those answers are going to be.
  13     Although, for our part, the legal team has looked at the
  14     various analyses produced by others throughout the
  15     history of this matter, it would be wrong to begin with
  16     any one of them. We are, in reality, in a better
  17     position to establish the facts if they can be
  18     established, than those who produced those studies.
  19        In summary, I repeat the fourth theme of my
  20     opening: the data, when it is analysed, may establish
  21     a difference between Bristol and other surgical centres,
  22     either comprehensively or in particular respects. If it
  23     shows this, it will lead us to ask what might be the
  24     reasons for the difference, but it cannot, on its own,
  25     establish what are those reasons. The most the data can
0041
   1     demonstrate is an association between factors. They do
   2     not permit a conclusion about causation.
   3        Terms of reference as wide as they are, the fact
   4     that the Inquiry is looking at a process rather than
   5     a series of events, rather than an individual tragedy,
   6     the inadvisability of drawing conclusions from available
   7     data without private, detailed and public discussion,
   8     the sheer mass of documentary and statement material and
   9     the comprehensive nature of the Inquiry, may lead anyone
  10     to wonder how sense can be made of it all. If
  11     unreliable statistics are the currents which may pull in
  12     the wrong direction, what is the star by which to
  13     steer?
  14        This is where the Issues List comes in -- an
  15     issues list which I am pleased to say appears to have
  16     been well-received. The Issues List is of course
  17     inclusive. It provides a focus, but it must be
  18     remembered that not all of the issues which are listed
  19     in that list are of necessarily equal weight, nor will
  20     they necessarily receive equal treatment.
  21        The Issues List is not of purely intellectual and
  22     analytical significance. To demonstrate how it works,
  23     let me take a human example. First, let me, I think,
  24     remove the slide from the screen and have it blank,
  25     thank you.
0042
   1        Let me take a human example. Suppose a baby is
   2     born some time between 1984 and 1995, so it is some time
   3     ago, and, say, somewhere in North Devon. Suppose that
   4     the baby, unknown to her parents, has a congenital heart
   5     defect. I will follow her through from birth to the
   6     outcome of treatment at Bristol hospitals, and comment
   7     on the issues as I go.
   8        At first the baby may not thrive. She may be off
   9     her food. She may show tinges of blueness, a peripheral
  10     pulse may be absent. The parents take the baby to their
  11     GP or a clinic, a doctor, perhaps, or paediatrician,
  12     notices the problems at the maternity hospital. Since
  13     the quality of outcome depends in many cases on the
  14     speed and quality of referral, the Inquiry has to
  15     examine that. It is issue E1.
  16        "The arrangements and services available to manage
  17     the transfer of sick children from referring hospitals
  18     to the Bristol Royal Infirmary."
  19        The local hospital perhaps it is, after referral
  20     from the GP, refers the child to a cardiologist from
  21     Bristol. This will be the first occasion when the
  22     parents come into contact with Bristol. The
  23     paediatrician chooses Bristol, but he might, arguably,
  24     have chosen Southampton, Birmingham, or even London.
  25     Why? On what basis? It is issues D2 to D5. I need not
0043
   1     perhaps set them out: D2 is the judgment or impression
   2     formed by referring paediatricians or other clinicians
   3     of the paediatric cardiac surgical services provided by
   4     the BRI. D4 is the factors influencing clinicians, in
   5     deciding to refer children to the BRI rather than to
   6     other centres performing paediatric cardiac surgery.
   7        So our baby is referred for investigation and
   8     opinion. That may be by outreach at a clinic organised
   9     by Bristol but not at Bristol; for example, it is in the
  10     West Country. The process of assessment has to be
  11     looked at. The scope of the services provided is
  12     examined under issue B: was such a service readily
  13     available or not? Issue B looks at the BRI and its
  14     Paediatric Cardiac Surgery Unit, the management,
  15     structure, organisation and staffing of the Paediatric
  16     Cardiac Surgical Unit. Much may bear on the speed of
  17     the referral: whether the baby is referred as quickly as
  18     it might be elsewhere is issue C8, the adequacy of the
  19     assessment comes generally under issue E, the
  20     pre-operative management of cases.
  21        Suppose that the little girl in my example is
  22     seriously unwell and has to be admitted urgently to
  23     a Bristol hospital. What arrangements are there
  24     available to transfer her from the referring hospital to
  25     Bristol? If, for instance, she has difficulty in
0044
   1     breathing and may be in heart failure, does a paediatric
   2     team transfer her, or is she in an ordinary ambulance?
   3     If so, are there adverse consequences for her.
   4        One of the questions is whether it is better for
   5     cardiac surgery to be available at a larger number of
   6     district hospitals to ensure immediacy of treatment and
   7     to avoid the adverse consequences of transfer and the
   8     time it takes; or, conversely, whether it is better to
   9     concentrate it in fewer centres of regional, or fewer
  10     still of national excellence, to ensure that surgeons,
  11     cardiologists, intensivists, anaesthetists, are familiar
  12     through repetition with almost any unusual variant of
  13     congenital heart disease. That is where issue A comes
  14     in: the regional and national context.
  15        Our baby arrives in Bristol: is it at the Bristol
  16     Children's Hospital, or is it the Bristol Royal
  17     Infirmary? At the former, it is set up solely for
  18     children, but children undergoing different surgery,
  19     perhaps wards with cancer and heart patients mixed, some
  20     babies, some near adolescents. The latter is an adult
  21     hospital: is it suitable for children? So we find
  22     ourselves looking at issue H, the split site, as well as
  23     issue E, pre-operative care.
  24        Soon after admission, the little girl is likely to
  25     have an echocardiogram, or possibly an angiogram. In
0045
   1     1988, as a matter of fact history, facilities for both
   2     were much improved at the Bristol Children's Hospital,
   3     as they were for catheterisation. The possible impact
   4     of this is to be borne in mind when looking at review
   5     cases of medical audit, issue M, and when drawing
   6     lessons from the data considered as part of issue C,
   7     the nature and outcome of the services provided.
   8        The results of the baby's investigations have to
   9     be considered before any surgery is undertaken. The
  10     decision has to be made as to whether to treat the child
  11     by closed or by open heart surgery; it may be, for
  12     instance, that palliative procedure can be carried out
  13     now, to be followed at a later stage by corrective
  14     surgery. The Inquiry will seek to establish how those
  15     discussions were taken, by whom and what the process
  16     was. Who was it who took ultimate responsibility? What
  17     were the parents told?
  18        Moreover, unless surgery is so urgent that it
  19     cannot wait, it has to be fitted in at some time. As to
  20     timing, delays may have occurred in the surgery of
  21     babies. Did this harm them? Were other delays caused
  22     by what is euphemistically called "shortage of beds"?
  23     That is a phrase suggestive of the inability to afford
  24     a metal bedstead and mattress, but in reality is often
  25     a question of the availability of sufficient trained and
0046
   1     paid staff. Does this mean that although everyone knows
   2     the little girl should ideally be operated on between 9
   3     months and 12 months of age, she may in fact have to
   4     wait until 14 to 15 months to fit in? On the other
   5     hand, did the availability of finance play a part? Did
   6     the fact that surgery for the under ones was paid for
   7     directly out of the national pot mean that surgery may
   8     have been brought forward when it might better have been
   9     delayed? These are all part of issue E, specifically,
  10     E6 to 9, and again, I shall not bore you with reciting
  11     the actual issues.
  12        As to information given to parents, for instance,
  13     whether there may be legitimate grounds for debate as to
  14     the best procedure in the interests of the child, are
  15     the parents of the little girl in my example told?
  16     Suppose that the cardiologist and surgeons know that
  17     they can perform a procedure which may give her life for
  18     some 10 or 20 years, which is of much lower risk than
  19     a procedure which, if it succeeds, will probably give
  20     life for 60 or 70 years? But which, if it fails, will
  21     lead to speedy death. Whose decision is it to perform
  22     such an operation? To what extent are the parents asked
  23     for their views?
  24        We are looking here not only at issue E, but also
  25     at issue L, L being informed consent. Moreover, when
0047
   1     the parents are told of the risk of the operation, are
   2     they told the risk the surgeon has experienced or is it
   3     the risk which the unit has experienced, or is it the
   4     last reported national record, or is it from
   5     a textbook?
   6        Returning to our baby, explanations will be given
   7     to the parents of our child about the condition, the
   8     need for surgery and the risks, but not just about
   9     surgery; also in relation to the continuing care of the
  10     child. If surgery is to be delayed, it may be of great
  11     importance to the parents to know what they should best
  12     do to watch their child and to protect her and to
  13     strengthen the baby for later operation.
  14        Again, issue E, in particular E11 and E15, and E15
  15     I just need to quote. You will understand how it fits
  16     in: liaison of staff with parents and the participation
  17     of parents in the assessment and care of their child.
  18        Eventually, let us suppose that the baby goes for
  19     open heart surgery. The conduct of this is issue F.
  20     Many factors may go to make the operation on the child
  21     successful or the reverse. The British Paediatric
  22     Cardiac Association will tell the Inquiry that to look
  23     just at the role of the surgeon, the skills of whom are
  24     an obvious factor, issue F1, is to take too simplistic
  25     an approach. Systems failure is very important and the
0048
   1     role of others deserves emphasis too. So we shall look
   2     also at the skills of those other than surgeons
   3     assisting at the operation, and we shall look at the way
   4     they work as a team.
   5        The reliability of the pre-operative assessments
   6     with which they begin are one factor, as are the less
   7     obvious ones, such as the design and performance of
   8     equipment, the hours of work, the familiarity with the
   9     work and the effect that this may have on how long the
  10     procedure takes. Timing might be critical: for
  11     instance, the amount of time spent on by-pass, or the
  12     cross-clamping times.
  13        So far as one can tell, were operations carried
  14     out at Bristol in the same manner as they were elsewhere
  15     at the same time? Issue F.
  16        Suppose the baby spends a long time in theatre.
  17     What about her parents? How have they found what is
  18     undoubtedly an anxious time? Issue I: treatment of
  19     families. Were there adequate facilities to help them
  20     and to help them to help their child? Suppose that the
  21     little girl in my example comes through the operation.
  22     What now? She goes to ward 5 in the Bristol Royal
  23     Infirmary, into intensive care where adults and babies
  24     are cared for together in a single ward. It has often
  25     been said that the hours following difficult surgery may
0049
   1     be critical to survival. Our issue G looks at this.
   2        The baby's parents will want to know how far the
   3     ICU, the Intensive Care Unit, meets or met any published
   4     standards. Bear in mind, standards have changed over
   5     the period with which we are concerned.
   6        Issues overlap here, as they do elsewhere. The
   7     split site, which is issue H, may have an impact, for
   8     the care may be provided to the baby in the Bristol
   9     Royal Infirmary, where I have for the purposes of this
  10     journey placed her. As I say, there she will be in
  11     a ward which will have adults undergoing intensive care
  12     and the Association of Paediatric Anaesthetists will
  13     tell the Inquiry that having just one site is a matter
  14     of importance because of the availability of facilities,
  15     clinicians and infrastructure and the Inquiry will have
  16     to consider to what extent its absence, the fact there
  17     was not just one site, makes a difference to our baby.
  18        Intensive care may demand very different things
  19     from those nursing adults to those who nurse children.
  20     How is the mix arranged to avoid potential disadvantage?
  21        At a later stage the baby may be taken from the
  22     BRI for intensive care at the Children's Hospital. That
  23     involves a transfer, with any attendant risks. The
  24     surgeons are no longer on hand for urgent consultation.
  25     But paediatric expertise may be more readily available.
0050
   1        Sadly, let us suppose, that some days after the
   2     operation, our baby loses the fight for life. Issues I,
   3     the treatment of families, including the bereaved, and
   4     issue G, post-mortems and inquests, are raised, and the
   5     Inquiry will want to consider carefully, particularly in
   6     view of recent events, whether appropriate information
   7     is given to her parents first about what may have caused
   8     her death (issue J), and second, whether consent, if it
   9     is required by law, was properly and sensitively sought
  10     for the post-mortem and for the retention of tissue or
  11     organs of the body, and if it was not required, whether
  12     proper and adequate information about that matter was
  13     given to parents in an appropriate fashion.
  14        Finally, was the death of the child reviewed
  15     internally by the clinical staff to see if any lessons
  16     could be learned? Was it placed in context, such that
  17     the clinical staff had a proper appreciation of their
  18     level of success or failure, reviewed in a manner which
  19     might help to aid performance for the future?
  20        Perhaps, more particularly, if in a happier
  21     example, the child survived but had almost died, was
  22     there any attempt to learn from the near miss, so that
  23     the same risks were never taken again?
  24        The journey of the child that I have described
  25     takes place in a particular setting. To understand it
0051
   1     and the factors at play this Inquiry needs to set it
   2     into context. That obviously includes the organisation
   3     of the Bristol Royal Infirmary, physical, managerial,
   4     administrative. It involves the relations between
   5     personnel; the role of outside bodies from the Royal
   6     Colleges to the GMC, and, indeed, the Department of
   7     Health itself. If, for instance, available reports
   8     indicated that Bristol was a significantly poor
   9     performer of paediatric services to the under ones,
  10     should something have been said about it? Was there
  11     a role here for the professional bodies?
  12        In the hypothetical journey that I have described,
  13     I appreciate that I have said, really, very little about
  14     the last issues in the Issues List, issues M and N, the
  15     review of cases, medical and clinical audit and the
  16     expression of concerns. That is because these issues
  17     arise not so much out of the treatment of any individual
  18     baby, they arise out of the history of the service as
  19     a whole, and that is perhaps so well known that I need
  20     not recite it in detail.
  21        I have, I think, for completeness, to touch on it
  22     a little, and some aspects of that history may be known
  23     to many from sources such as Private Eye. Others I have
  24     already touched on when I referred to the December
  25     agreement there had been between Dr Bolsin and others,
0052
   1     and Mr Wisheart and others about the lessons to be
   2     learned from available data. It is unnecessary in this
   3     option to examine the rights and wrongs of that
   4     disagreement. Firstly, the Inquiry does not and cannot
   5     begin with conclusions. My present purpose is simply to
   6     record that it happened as a matter of history. It is
   7     also a matter of history that the concerns which
   8     Dr Bolsin had were expressed both within the local
   9     service, in particular to senior colleagues, and outside
  10     it to the Royal College of Surgeons, and that they came
  11     to the attention of the South West Regional Health
  12     Authority and to the Department of Health. Those
  13     concerns were based at least in part on the figures
  14     Dr Bolsin saw.
  15        Matters came to a head in 1995, the final year of
  16     our terms of reference. That was the year in which
  17     Mr Dhasmana performed an arterial switch operation which
  18     provoked particular controversy. The child died in the
  19     operating theatre. Following that, complex neonatal and
  20     infant cardiac surgery was suspended, pending the
  21     appointment of Mr Ash Pawade in the May of that year as
  22     a specialist paediatric cardiac surgeon. Since then,
  23     media programmes, Despatches, Panorama in particular,
  24     have raised criticisms of the paediatric cardiac
  25     surgeons in Bristol. The GMC has heard and considered
0053
   1     charges against Mr Wisheart, Mr Dhasmana and Dr Roylance
   2     and a number of legal actions have been taken by parents
   3     against the Trust.
   4        The GMC proceedings attracted considerable public
   5     interest. They were monitored closely by the parents on
   6     whose children the surgeons operated.
   7        On 1st June 1998, the BBC aired a programme on
   8     Panorama about the events in Bristol of the doctors
   9     involved and that focused on the unsuccessful switch
  10     operation I have mentioned. The allegations made in the
  11     programme were whether those operations proceeded
  12     without the opposition of Dr Bolsin of the surgical unit
  13     the night before the operation and without the knowledge
  14     of the child's parents, and very shortly, on 18th June
  15     1998, Frank Dobson, Secretary of State for Health,
  16     announced to Parliament that an Inquiry would be
  17     established to enquire into the management of children's
  18     heart surgery at the BRI and to reach conclusions and
  19     make recommendations to secure high quality care across
  20     the whole NHS.
  21        That is our task.
  22        In conclusion, then, I hope I will be forgiven for
  23     yet again repeating and emphasising my four main themes:
  24     first, this Inquiry starts with a clean slate. It has
  25     many questions to ask, but as yet no answers. It has to
0054
   1     be open. The Inquiry is just that: an inquisitorial
   2     process, not a trial. There is no case to win or lose,
   3     there are no sides and accordingly the procedures will
   4     not be those of a court of trial.
   5        Secondly, the Inquiry is comprehensive. It will
   6     and must look at a mass of evidence and do so afresh.
   7     Third, it is a Public Inquiry. It will be the most
   8     accessible Public Inquiry yet, through video links, the
   9     Internet, the publication of formal evidence as it is
  10     received for our consideration and in consequence, much
  11     of it will be in writing. (4) in so far as the figures
  12     are concerned, we must proceed with caution, remembering
  13     that if, after careful expert consideration, they do
  14     demonstrate a difference between Bristol and other
  15     centres, they still do not answer why that difference
  16     exists.
  17        If I had to select a fifth theme, to reflect the
  18     issues that will act as our star, our point of
  19     reference, it is perhaps this: to focus, to the
  20     exclusion of other concerns, on that which the surgeons
  21     did will be to select only a part, albeit a dramatic and
  22     obvious part, of the whole story. Whether an operation
  23     succeeds or not may well depend on many other less
  24     visible but nonetheless real factors. One of the
  25     purposes in sketching through the hypothetical case
0055
   1     history is to emphasise that pre-operative care,
   2     post-operative care, organisational structures,
   3     financial and human constraints and the communication of
   4     information in an effective and sensitive way, are all
   5     likely to have an outcome, an impact, on the outcome of
   6     surgery. Also, to focus solely on the surgeon's role at
   7     operation in Bristol, or anywhere else, prevents our
   8     seeing the wider context and implications.
   9        Finally, let me remind you that the first block of
  10     evidence in Phase I is that from parents. As with all
  11     other witnesses, they will be encouraged to tell their
  12     story as they see it. It is their story that the
  13     Inquiry wants to hear on its way to reaching
  14     conclusions.
  15        It is of course our duty to test recollections and
  16     the view expressed, for instance, if they are
  17     inconsistent or not borne out by documentary evidence,
  18     and equally, it is our duty to put questions which
  19     others will wish to hear the witness deal with, whenever
  20     this will further the Inquiry's interests.
  21        Counsel, in opening the case, often tell a court
  22     or a jury what they are going to hear, and they put
  23     together a picture they wish to paint before the first
  24     brushstroke of the evidence is ever applied. Here there
  25     is no case, as I have said a hundred times, and it is
0056
   1     better that the witnesses tell their own story than that
   2     I give you my version of it in advance. The evidence
   3     should come from them, not from me.
   4        Having set out the procedure which the Inquiry
   5     will adopt, may I simply say that block 1 begins
   6     fittingly, you may think, with some parents telling
   7     their individual stories. However much we may talk of
   8     systems or audit, or self-regulation of the profession,
   9     or statistics, it should never be forgotten that it is
  10     the care of individual human lives that is the centre of
  11     our concern.
  12        Today we will hear from Mrs Clarke. It will be
  13     probably at about half past 1, I suspect. Tomorrow we
  14     shall hear from Mr Wagstaff, whose child survived
  15     surgery, and Mr Parsons, whose child did not. May
  16     I hope that, however you perceive their answers to me,
  17     you accept it as their personal perspective. And please
  18     remember that it cannot be easy to give evidence so
  19     publicly about matters which are inevitably deeply
  20     personal.
  21        Ladies and gentlemen, members of the panel, thank
  22     you.
  

 


Published by the Bristol Royal Infirmary Inquiry, July 2001
Crown Copyright 2001