Home Page Search Final Report Interim Report Evidence - Transcripts - Witness Statements - Submissions - CCNR Report and associated documents - Statistical Reports and associated documents - Background Papers - Expert Papers Inquiry Seminars About the Inquiry Help		Daily transcripts Hearing summary 21 July 1999   Today the Inquiry heard evidence from retired Medical Director and Cardiothoracic Consultant Surgeon at United Bristol Healthcare NHS Trust (UBHT), Mr James Wisheart. Mr Wisheart answered questions from the Inquiry Panel relating to his workload as Medical Director, resources and the role of the Medical Royal Colleges in maintaining standards. He was then re-examined by his own legal representative in order to clarify several issues covered heard during previous evidence. Mr Wisheart’s legal representative then made a brief statement outlining the history of the Cardiac Surgery Department at UBHT from 1975 onwards and Mr Wisheart’s involvement in audit.   Professor Michael Green, Royal College of Pathologists, gave oral evidence to the Inquiry. He described the importance of the autopsy in medical practice, focussing on its use in the recognition of new diseases and in the assessment of new surgical techniques, the dissemination of information, the teaching of medical students, identifying trends in the community and providing tissue for transplantation. He went on to discuss the issue of retention of tissue and the information which should be given to relatives prior to a post-mortem taking place and consent for retention being given. He explained that tissue often needed to be retained for some time in order for a full pathological examination to take place. He concluded by commenting on the disposal of tissue.   Mr Robert Clifford, of the Home Office, Coroners Unit, concluded the day’s evidence. He told the Inquiry about the Home Office’s powers and duties in relation to coroners. These responsibilities include their appointment, regulation and training. He went on to discuss the Home Office’s advocacy of consistency in the approach of coroners. He commented on whether it was the role of the coroner to identify trends amongst the deaths reported to them and concluded by describing the complexity of the disposal of tissue at a later date than the original burial or cremation.

FULL TRANSCRIPT

   1                      Day 42, 21st July 1999
   2   (9.30 am)
   3            MR JAMES WISHEART (RECALLED):
   4   THE CHAIRMAN: Good morning, everyone. Good morning,
   5     Mr Wisheart. Mr Langstaff?
   6   MR LANGSTAFF: Good morning, sir. Mr Wisheart, this morning
   7     there are some questions from the Panel, and then
   8     Mr Moon wishes to ask you some questions in
   9     re-examination.
  10   A. Thank you.
  11             EXAMINED BY THE PANEL:
  12   MRS HOWARD: Good morning Mr Wisheart. Just one question.
  13     You have made mention of the advantage of having
  14     a doctor as a Chief Executive. I wonder whether we
  15     could just talk for a few minutes about that: do you
  16     feel that the fact that Dr Roylance was a doctor, he may
  17     have taken on much of the clinical and management types
  18     of issues that may have come your way as a Medical
  19     Director if he had not been a doctor? That would be the
  20     first part of the question I would like to ask you.
  21   A. Thank you. I think that that undoubtedly happened.
  22     I think not as much as part of any deliberate policy,
  23     but because of his knowledge and relationships within
  24     the hospital group. It just happened automatically.
  25     I think we both recognised that and it was not

   1     a problem. But of course its significance for me was
   2     when he retired, then of course I had to expect that
   3     rather more work of that sort might land up with myself.
   4   Q. Would it be a reasonable comment, therefore, to say that
   5     you may have moved from a rather ambassadorial role to
   6     a more direct management role with your fellow doctors?
   7   A. That is interesting. I had never thought of it quite
   8     that way. I think that, in the conversations we have
   9     had about my role as Medical Director, I hope it has
  10     been clear that the role expanded really quite
  11     dramatically over a few years. I think that was not
  12     chiefly due to the fact that Dr Roylance retired;
  13     I think it was due to all the new issues that came on to
  14     the agenda, the junior doctors' hours, Calman and so
  15     forth, that we went over on Monday, I think. Looking
  16     back, I would say that it was the work I had to do in
  17     relation to those and other similar issues that
  18     developed my role as a manager in relation to my
  19     colleagues, whereas before I would have exhorted them on
  20     this and that, but there was so much to do that was
  21     really management, but it grew and it grew very
  22     definitely in that way.
  23   MRS HOWARD: Thank you very much.
  24   THE CHAIRMAN: Professor Jarman?
  25   PROFESSOR JARMAN: I do not want to discuss any of the

   1     details of concerns but more general points. Two or
   2     three questions. In your evidence on page 57, you have
   3     previously talked about financial problems all the way
   4     through, and you mentioned, I am quoting to you,
   5     a shortage of equipment, nurses, et cetera, which you
   6     described as "potentially dangerous".
   7        I do not know if you would like to see that, on
   8     page 57? I can read it out to you. You said:
   9        "... problems that might relate to shortage of
  10     equipment, shortage of nurses, blocked beds and other
  11     potentially dangerous circumstances."
  12        We have heard earlier in the Inquiry about
  13     problems with equipment and so on. Were there any
  14     particular problems that you met, for instance with
  15     shortages due to financial problems and so on?
  16   A. Please correct me if I am wrong, but I think the context
  17     of the extract that you have referred to is in relation
  18     to whether or not an operation was carried out, and
  19     I think it goes on to say that where there was such
  20     a potentially dangerous situation, then in fact an
  21     operation might from time to time have to be cancelled.
  22     Please correct me if I am wrong.
  23   MR LANGSTAFF: Sir, I wonder if perhaps both Mr Wisheart
  24     and those who watch would be assisted by having
  25     WIT 120/57 on the screen?

   1   PROFESSOR JARMAN: It is talking about avoidance of --
   2     unsafe or dangerous circumstances.
   3   A. Yes.
   4   Q. You had earlier in your evidence talked about continuing
   5     financial problems, and then in particular, you say:
   6        "Under this heading one has to consider the
   7     possibility of short-term problems that might relate to
   8     shortage of equipment, shortage of nurses, blocked beds
   9     and other potentially dangerous circumstances."
  10        Did you have any instances or examples of, for
  11     instance, problems with equipment?
  12   A. I think what I am referring to here is not so much the
  13     larger overriding question of resources but the fact
  14     that at any given time we had a finite resource: beds,
  15     ventilators, equipment, numbers of nurses, numbers of
  16     doctors and so forth. Within that finite resource,
  17     there is always the possibility that nurses might be
  18     sick, that a ventilator might be out of order,
  19     circumstantial things of that nature. If something like
  20     that did happen -- and if of course we were aware of
  21     it -- then it might be necessary to postpone an
  22     operation because otherwise the safety of the patient
  23     would be at risk.
  24        That is what I am referring to in this section.
  25   Q. But you did not have any particular examples that

   1     you can think of that would cause problems?
   2   A. Do you mean an example of malfunctioning of equipment
   3     that would cause a problem with a patient?
   4   Q. That type of thing, because it has been referred to
   5     previously in this Inquiry.
   6   A. The incident that comes to mind is indeed the one
   7     that has been referred to, and maybe that is why it has
   8     come to mind. There was the question of the infusion
   9     pumps which were found to malfunction, and I think Fiona
  10     Thomas has discussed that. I can certainly recall that
  11     because there was a lot of discussion and thought about
  12     that at the time.
  13        I honestly feel I need notice to give you a proper
  14     answer to that one, because I cannot say that there were
  15     no incidents. I think I would need to think about it to
  16     give you a precise answer.
  17   Q. It is more the general impression that I want to get
  18     from you.
  19   A. I do not believe the situation was generally one in
  20     which there were recurring problems. I believe the
  21     situation was one in which the equipment was well
  22     maintained, functioned satisfactorily, but inevitably
  23     occasionally there is the possibility of something
  24     having happened.
  25   Q. Just to go on to the next question, on page 34 you

   1     say that the Colleges had statutory responsibility for
   2     the maintenance of standards. Did you feel that that
   3     was the case?
   4   A. I think throughout my time as a consultant, I was
   5     always conscious that those responsibilities were
   6     exercised in at least two ways, maybe three ways: first
   7     of all, their role in any consultant appointment, be it
   8     a new or replacement appointment; secondly, their role
   9     in the supervision of training of people for hospital
  10     specialties, which of course grew in its detail and its
  11     sort of interventionist interest over the period of my
  12     consultant life. And I think that the third role which,
  13     again, I think became more important in the latter part
  14     of the period, was their role in making recommendations
  15     about practice. The one that comes to mind is the issue
  16     of the book about guidelines on day case surgery. They
  17     also issued 1989 guidelines about clinical audit. So
  18     they were adopting a more active role in relation to
  19     various aspects of clinical practice in the latter part
  20     of the period.
  21        Those would be the headings under which I would
  22     respond to that.
  23   Q. You do say that their advice would always be taken
  24     with the utmost seriousness?
  25   A. Yes.

   1   Q. There was a visit which has been reported to us by the
   2     Royal College of Physicians in 1992, when I think you
   3     were Medical Director. I think it was November 1992.
   4   A. Is that the visit in relation to the potential creation
   5     of a Senior Registrar in paediatric cardiology?
   6   Q. It was an inspection by the Royal College of
   7     Physicians. They said:
   8        "There are major problems due to great increase
   9     in workload. It seems probable that at times the
  10     quality of patient care may fall below safe levels."
  11        Would you tell me what sort of action in general
  12     might be taken in relation to something like that? It
  13     is quite a serious concern.
  14   A. That was a problem which was present then and which
  15     in fact grew as I think it grew in many hospitals
  16     through those years of the 1990s. I am sorry, I should
  17     say by way of preamble that I believe that this report
  18     concerned the training of Senior Registrars in general
  19     medicine.
  20   Q. But it was a general report actually about the
  21     situation in the hospital?
  22   A. I believe it was a report about the situation in general
  23     medicine.
  24   Q. Yes, it was about general medicine.
  25   A. I think the only information that they were receiving,

   1     reporting on and commenting on, was in the context of
   2     general medicine.
   3   Q. General medicine, that is correct.
   4   A. It is in general medicine where the increase in
   5     emergency admissions has posed such a big problem
   6     nation-wide. We certainly experienced that also. So it
   7     was a problem that we were conscious of and which was
   8     repeatedly being addressed at that time and over
   9     subsequent years, and in fact -- I am not sure of the
  10     exact year, but there were a number of quite major steps
  11     to reorganise the way we dealt with emergency medical
  12     admissions. The most dramatic of those was to create
  13     a ward -- I forget the number of beds, it might have
  14     been 16 or 20 -- which was specifically to receive
  15     emergency medical admissions. Previously they had gone
  16     to all the regular medical wards, so this was a specific
  17     admission ward with consultancy provision and staff
  18     allocated to it, medical nursing and so forth.
  19        So a series of steps were taken to try to meet
  20     with this growing problem.
  21   Q. So you were sympathetic to their view that there were
  22     possibilities, for the reasons that they stated, that
  23     there might be a problem and patient care could fall
  24     below a safe level?
  25   A. I think we were very concerned, not only because of

   1     their report but because of the situation that we
   2     recognised to be the case. We did seek to address it.
   3     But of course it continued to grow year by year, so in
   4     a sense the goalposts were constantly changing, but
   5     I think the step that I have mentioned was a most
   6     effective one.
   7   Q. The last question is that you mention on page 43 that
   8     you had these guidelines and then later on, page 61,
   9     that the guidelines were not used so much after the
  10     mid-1980s -- the guidelines you drew up with regard to
  11     patient care in cardiac surgery.
  12   A. Not so much after the late '80s.
  13   Q. The late 1980s, yes. Do you think there is any
  14     possibility that the non-use or less use of these
  15     guidelines could have affected patient care in any way?
  16   A. Maybe I should clarify just a little bit what happened,
  17     and that may answer your question. Beginning in 1975,
  18     when I began, there was of course just Mr Keen and
  19     myself, and then later on there was Mr Dhasmana who
  20     joined us, and then there was Mr Hutter. In the earlier
  21     days we were quite a small, cohesive group, and the
  22     guidelines that I drew up and revised from time to time
  23     were fairly consistently used at that time. But by the
  24     time the early and mid-90s had come, we were a larger
  25     group. There were at least five of us as surgeons, and

   1     there were of course diverse views and there were
   2     changing practices. So different people did have
   3     somewhat differing approaches to problems.
   4        So my remark about it not being used so
   5     consistently means that not all the surgeons used it in
   6     the way that pretty well all the surgeons had used it
   7     earlier. I myself continued to practice -- well, not in
   8     a rigid way according to the guidelines as practice
   9     evolved, but broadly according to those guidelines.
  10   PROFESSOR JARMAN: Thank you.
  11   THE CHAIRMAN: Mr Wisheart, I have no questions, but
  12     Mr Moon, re-examination?
  13           RE-EXAMINED BY MR MOON:
  14   Q. Mr Wisheart, the day before yesterday it was put to
  15     you that unlike Dr Thomas, you did not welcome outside
  16     input.
  17        In that context, can I ask you: did you have any
  18     part to play in the establishment of the chair in
  19     cardiac surgery?
  20   A. Yes. I had a considerable part to play.
  21   Q. Can you briefly summarise what part you had to play in
  22     that?
  23   A. In the first instance, it was my idea and it became
  24     a view and a conviction that it was right that an
  25     academic department of cardiac surgery, a University

   1     department, should be developed. I then discussed that
   2     with my immediate colleagues and following discussion
   3     over some period of time, we all agreed that that was
   4     correct.
   5        The next step was to prepare an outline proposal,
   6     and armed with that, if you like, we were able to gain
   7     the support of the hospitals on the one hand and the
   8     University on the other.
   9        We then proceeded to approach the British Heart
  10     Foundation, and again, after a long period of discussion
  11     and debate and negotiation, they agreed in principle to
  12     fund a personal chair in cardiac surgery.
  13   Q. What, if anything, do you say that says about your
  14     reactions to outside influences and outside input?
  15   A. There was not going to be an inside appointment to the
  16     chair, so clearly, whatever sort of a person it was who
  17     occupied the chair, he was going to be someone from
  18     outside and as a Professor, he would always have
  19     considerable influence, both within the department and
  20     within the hospital.
  21   Q. I would like now to turn to the question of workload.
  22     Yesterday and the day before you gave us some indication
  23     about certain reductions in workload which had occurred
  24     during the course of your career in Bristol.
  25        Can I ask you whether or not there was any

   1     reduction in about 1990 or 1991, in your workload at the
   2     Children's Hospital?
   3   A. Yes. I think I referred to that. This was a time
   4     following Mr Dhasmana's appointment -- it was a few
   5     years later -- and I had operated for two sessions there
   6     and he was operating for one session, so around 1990 or
   7     1991 we swapped that, so I gave him one session of mine
   8     and reduced my operating, therefore, from two sessions
   9     to one session.
  10   Q. So summarising, the effect of that is that you reduced
  11     your work at the Children's Hospital by one session in
  12     alternate weeks?
  13   A. Yes, thank you, it was alternate weeks. Thank you.
  14   Q. Was there a reduction in 1992 when you became Chairman
  15     of the Hospital Medical Committee?
  16   A. Yes. When I became Chairman of the Hospital Medical
  17     Committee I reduced my open-heart operating in the
  18     Infirmary from three whole days, that is six sessions,
  19     to four sessions each week.
  20   Q. And that was in what year?
  21   A. That was in 1992.
  22   Q. Can we turn now to 1995? In 1995 was there an occasion
  23     when you reduced your workload at the Children's
  24     Hospital yet further?
  25   A. When Mr Pawade came to Bristol in May 1995, I withdrew

   1     from paediatric work so that one session on alternate
   2     weeks that we mentioned just now I no longer carried
   3     out. So I stopped doing that.
   4   Q. Lastly, was there a yet further reduction when you
   5     became Medical Director?
   6   A. There was a further reduction when I acquired a new
   7     job description and contract for being Medical Director
   8     in early 1996. At that point, I reduced my open-heart
   9     operating further from four sessions to two sessions
  10     each week, that is to say, one whole day.
  11   Q. You were asked on the first day whether anyone had ever
  12     suggested to you that your managerial commitments might
  13     be having a negative impact on your clinical work. You
  14     told the Panel that you were asked that by a Professor
  15     Stirrat.
  16        What you were not asked was what your answer to
  17     that question was. I wonder if I could ask you, what
  18     was your answer to Professor Stirrat's question?
  19   A. It was a serious question and it had a serious answer
  20     and my answer was that I believed it did not have
  21     a negative impact upon my clinical work.
  22   Q. You were also asked generally about workload. Can I ask
  23     you this: were there others who you felt had a similar
  24     workload to you, or were you unique in that respect?
  25   A. I always felt that there were a large number of my

   1     colleagues who carried a very similar load of
   2     professional work. There are a number of possible
   3     areas: it could be academic work; it could be work with
   4     the Royal Colleges, specialist societies; it could be
   5     work in private practice. All legitimate and proper
   6     activity, but I know many colleagues who worked
   7     certainly as hard and in some instances harder, that is
   8     to say, longer hours than myself.
   9   Q. Can I ask you this: would you find it invidious to
  10     name names on this topic?
  11   A. I would hesitate to, but if anyone felt that it would
  12     make what I am saying more acceptable, then I could
  13     certainly do so. But there is not a shortage of names.
  14   Q. I do not think I will pursue that. Did you or did you
  15     not take your full holiday entitlement?
  16   A. I did take my full holiday entitlement.
  17   Q. Can we now turn to the question of audit. You were
  18     asked a number of questions yesterday about regular
  19     audit and the effect of your answers was that regular
  20     audit began from about late 1989.
  21        Can I ask you whether it was your practice to
  22     carry out audit, in the broadest sense of the word,
  23     before 1989?
  24   A. Yes, we did. Whether the correct adjective is "broad"
  25     or "primitive" or what, but we carried out an activity

   1     which we will describe as "audit" in the sense that it
   2     was a monitoring of the results of our work.
   3   Q. I wonder if we could have turned up document JDW 7 at
   4     page 4?(JDW 7/4) This is a document dated 6th June 1986. It is
   5     a memorandum from you to a number of doctors,
   6     cardiologists, surgeons and -- are there any
   7     anaesthetists there?
   8   A. Yes, Dr Masey is an anaesthetist and at that time
   9     Mr Hutter and Mr Chatterjee were our junior surgical
  10     colleagues. Dr Wilde is a cardiac radiologist.
  11   Q. Dr Joffe and Dr Jordan are both cardiologists?
  12   A. Correct -- paediatric.
  13   Q. The heading is the "Fontan operation" and there is
  14     a reference in the first paragraph to the sad death of
  15     a patient. At the bottom of the page, having identified
  16     a number of other difficulties in relation to the Fontan
  17     operation, the last paragraph says:
  18        "When faced with a problem of this type, there
  19     seem to be two attitudes which can arise in response.
  20     The first one can say is that if the correct things are
  21     being done then one should persevere and things will
  22     come right in due course. Secondly, one can say because
  23     of the disappointing results things are not being done
  24     right and therefore must be altered."
  25        You go on to say, over the page to page 5(JDW 7/5) of this

   1     document, that you believe that probably a combination
   2     of views is appropriate and as a basis for further
   3     discussion you say you would like to concentrate on the
   4     selection criteria and make the following suggestions.
   5        You make a number of suggestions including the
   6     setting up of a formal written protocol to be checked
   7     out in every case.
   8        You are suggesting in this memorandum some
   9     discussion with the recipients of this document. Did
  10     that discussion take place?
  11   A. Yes, it did.
  12   Q. And put shortly, what was the result of that
  13     discussion?
  14   A. The result of the discussion was that we should be
  15     much more rigorous in the application of the selection
  16     criteria for this particular operation.
  17   Q. In general, how does this document reflect your attitude
  18     to "primitive" audit, if I can put it in that way?
  19   A. This document essentially is something I wrote because
  20     I considered that the results of this operation, at that
  21     particular time, were disappointing. So I wanted to
  22     draw the attention of my colleagues to that so that we
  23     could discuss it together. I then go on to suggest, as
  24     I have pointed out, some possible reasons for the
  25     disappointment, that we should consider, and some

   1     possible changes or adjustments in our approach that we
   2     perhaps should consider implementing.
   3        But because the work is teamwork, it was important
   4     that we should look at it together. That was what
   5     happened.
   6   Q. Could I ask the document UBHT 61/218 to be turned up?
   7        This is a letter to you, we can see, dated
   8     16th March 1990. If we scroll to the bottom of the
   9     page, we can see that it is from Mr Sethia, a consultant
  10     cardiac surgeon at the Children's Hospital in
  11     Birmingham.
  12        Going back up to the top of the page, the heading
  13     of the letter is "Second annual meeting of the UK
  14     paediatric cardiac surgical group."
  15        Mr Sethia refers to a letter from you in the first
  16     paragraph, and then in the second paragraph he says:
  17        "I write to you because I took the opportunity to
  18     publicise the comments enclosed in your letter to me of
  19     4th January 1990 and you will be pleased to know that
  20     your comments received general support and in
  21     particular, this seems to be a measure of agreement that
  22     we should move towards some more generalised system of
  23     audit."
  24        Do you recall the gist of your letter to
  25     Mr Sethia of 4th January 1990? We do not have that in

   1     the documents that I am aware of, but do you remember
   2     what the gist of that letter was?
   3   A. Unfortunately, I do not have the letter either but the
   4     gist of the letter was to suggest that all the
   5     paediatric cardiac surgeons in the UK should work
   6     together to develop a common database, a common source
   7     of information, that would be similar to the UK cardiac
   8     surgical register, but much more detailed, so that we
   9     would be helped by that in auditing our work and in
  10     sharing information, because as we said yesterday, there
  11     is a terrific problem in paediatric cardiac surgery
  12     stemming from the small number of operations in each
  13     individual category.
  14   Q. Could I ask now for you to look at document DOH 4 at
  15     page 45? We looked at this document yesterday; it is
  16     a document dated either 6th or 8th February 1992. If we
  17     identify those present, it relates to a meeting with
  18     people at the Department of Health, including Mr Owen.
  19     You are the third person mentioned under "Bristol",
  20     although your name, I think, is misspelt.
  21        If we scroll down the page, you were referred to
  22     the second substantial paragraph beginning with
  23     "Mr Wisheart presented the surgical results to date."
  24        You gave certain statistics comparing the Bristol
  25     results with the UK average results.

   1        What, if anything, do you feel this document has
   2     to say about your attitude in relation to sharing
   3     information with the Department of Health?
   4   A. Mr Owen was a civil servant and my understanding is
   5     that his interest was limited to knowledge of the number
   6     of operations we carried out, but at the meeting, he was
   7     provided with information by category with the results
   8     and with the UK comparator in terms of what was
   9     available at the time.
  10        Indeed, there is some evidence that he also had
  11     a paper record of these results which he took away,
  12     because one of the documents is in the file from the
  13     DOH .
  14        So I was anxious that our results should be on
  15     the table, should be openly known and that hopefully one
  16     would benefit from feedback and so forth.
  17   Q. Can I now ask you to turn to the document UBHT 308/170?
  18     This is a letter from you to Professor Berry, which you
  19     were taken to and cross-examined on in some detail
  20     yesterday, a letter dated 9th September 1992.
  21        Parts of the letter were quoted to you by
  22     Mr Langstaff in the course of that cross-examination.
  23   THE CHAIRMAN: Mr Moon, I prefer "examination".
  24   MR MOON: I beg your pardon, sir. I am sure that is not
  25     a Freudian slip, but I apologise.

   1   Q. One sentence which Mr Langstaff did not identify to you
   2     is the penultimate sentence. I wonder if we could read
   3     that together:
   4        "I would be grateful therefore if you would simply
   5     confirm your advice and of course we can discuss it the
   6     next time we meet. Thanks for your letter."
   7        So there you are asking for confirmation of the
   8     advice that Professor Berry had apparently given you,
   9     given your confusion about the apparent easing in
  10     relation to the new Coroner.
  11        Do you recall receiving such confirmation at any
  12     time from Professor Berry?
  13   A. I do not recall any further conversation or letters on
  14     this subject following this.
  15   Q. Can we turn, please, to UBHT 60 at page 1: the
  16     application for Trust status.
  17        If we turn to page 41(UBHT 60/41), please, and scroll down
  18     the page, under the heading "Quality of service" you
  19     were referred in examination by Mr Langstaff to the
  20     sentences:
  21        "Within the Trust, each contract will be the
  22     personal responsibility of a Clinical Director supported
  23     by a manager" and the next sentence and that following
  24     were referred by Mr Langstaff to you.
  25        Did you write this document?

   1   A. No. I had no part in the writing of this document.
   2   Q. Lastly, Mr Wisheart, we have discussed this morning the
   3     guidelines which you wrote for the care of cardiac
   4     surgical unit patients. I think the guidelines appear
   5     at UBHT 152/8. That is the font page of the guidelines
   6     which you wrote.
   7        In fact this document is a 69-page document with
   8     five appendices. I think we looked at one or two
   9     sentences in the introduction yesterday.
  10        Can you just summarise for me: what was this
  11     document and what was its purpose?
  12   A. The document is basically a handbook setting out how
  13     I, after consultation with many of my colleagues, felt
  14     the patients should be treated. So it contained
  15     a framework for the treatment of the patients both
  16     pre-operatively and post-operatively.
  17        It sought to provide for the needs of a patient
  18     who went through in a fairly uncomplicated way, and it
  19     also sought to give advice for the various problems that
  20     might arise and how they should be approached.
  21        It was important to do this because the care of
  22     cardiac surgical patient involves doctors and nurses and
  23     other people from many disciplines who have to work
  24     together, so it was intended as a document which would
  25     help to co-ordinate the contributions of the different

   1     team members.
   2        Of course, in intensive care, which is a 24-hour
   3     enterprise, people obviously work for a time and then
   4     hand over their responsibility to others, and so forth,
   5     so it is quite important to achieve consistency of care
   6     with those changes taking place.
   7        Of course, finally, working with members of the
   8     team of varying experience and competence, it is
   9     important that they should each have some understanding
  10     of what are the limits to which they should go.
  11        So there is very positive advice here as to when
  12     people should be seeking advice.
  13   Q. Did I understand your evidence yesterday correctly:
  14     you effectively wrote this document?
  15   A. Well, I wrote it in collaboration with colleagues
  16     because, in as much as it was intended to integrate the
  17     work of a team, then I had to have the views and
  18     contributions of the team members, which made it much
  19     more difficult to write, but that was done.
  20   MR MOON: I am grateful. Sir, I have no further questions.
  21   THE CHAIRMAN: Thank you, Mr Moon, I am very grateful.
  22     That was most helpful.
  23   MR MOON: Sir, I have a brief application -- it is a brief
  24     application -- to make a short speech on behalf of
  25     Mr Wisheart. I wonder if it would be appropriate for me

   1     to do that now, or whether it might perhaps be more
   2     appropriate for Mr Wisheart to leave the witness-box?
   3     I am entirely in your hands, sir.
   4   THE CHAIRMAN: Why do we not ask Mr Wisheart to step
   5     down, but before we do so, merely say, you gave evidence
   6     for two long days, and we are grateful. We have been
   7     helped by what you have had to say. We will hear from
   8     you again in due course, but for the moment, thank you.
   9            (The witness withdrew)
  10   THE CHAIRMAN: Mr Moon?
  11   MR MOON: Sir, I shall not take longer than 15 minutes.
  12     I think I took exactly 20 minutes to re-examine, and
  13     I do not intend to take more than 15 minutes in making
  14     this short speech.
  15        MR MOON: SPEECH ON BEHALF OF MR WISHEART
  16   MR MOON: The speech deals with two main subjects. The
  17     first is an overview of the history of the cardiac
  18     surgical unit at Bristol, which I thought might be
  19     helpful to the Panel, and secondly, a focus on
  20     Mr Wisheart's part in the development of audit
  21     generally.
  22        Dealing first of all with the question of the
  23     history, in 1975 Mr Wisheart arrived at Bristol and at
  24     that time the cardiac surgical unit was undertaking
  25     about 110 open-heart adult and paediatric operations per

   1     year. There was one full-time and one half-time surgeon
   2     and the future was clearly quite uncertain.
   3        By 1995 the number of open-heart operations in
   4     Bristol had increased to approaching 1,000. There were
   5     five surgeons. The paediatric work was established in
   6     the Children's Hospital and the adult work in the
   7     Infirmary. It is fair to say, and you have heard
   8     a great deal of evidence about this already, that that
   9     development was incremental and each step came after
  10     what might be described as quite a hard struggle. The
  11     unit was always under immense pressure and the number of
  12     patients needing operations really exceeded the
  13     resources available to cater for those patients.
  14        Through nearly all of this time, the closed
  15     operations, the closed-heart surgery was performed at
  16     the Children's Hospital and the open-heart surgery in
  17     the Infirmary and this undoubtedly increased the
  18     pressure and demands placed on the surgeons because they
  19     had to see acutely ill patients in two different
  20     hospitals.
  21        The need to change this state of affairs was
  22     recognised in the early and mid-1980s, accepted as
  23     a practical proposition towards the end of the 1980s,
  24     and eventually achieved in 1995.
  25        It was suggested on the first day of his evidence

   1     to Mr Wisheart that whilst others welcomed outside
   2     input, Mr Wisheart did not. In my submission, that
   3     view, that suggestion, patently does not accord with the
   4     facts. It was Mr Wisheart who was the driving force
   5     behind the creation of the Chair in cardiac surgery and,
   6     sir, you will be well aware that academic approaches
   7     bring fresh and outside views to the practice of
   8     medicine in a practising department.
   9        That is just an example of Mr Wisheart's openness
  10     to outside influences. We saw this morning that
  11     Mr Wisheart was very careful to share information with
  12     the Department of Health in February 1992, at the
  13     meeting with Mr Owen.
  14        That is the history, a short overview of the
  15     history in Bristol.
  16        Turning now to the question of audit, Mr Wisheart
  17     was deeply involved in audit in the hospital and the
  18     Trust generally, as well as within paediatric cardiac
  19     surgery generally. He was a member of the Audit
  20     Committee from the beginning when the leadership was
  21     provided by Dr Thomas and Dr Stansbie, and when
  22     Dr Thomas resigned, you will recall, no-one could be
  23     found to step into his shoes so Mr Wisheart became
  24     Chairman of the Audit Committee thereafter.
  25        Mr Wisheart assisted the process of change from

   1     unidisciplinary to multidisciplinary clinical audit and
   2     strengthened audit at directorate level. He was
   3     involved with discussions with the purchasers about the
   4     role of audit within the service agreements, and he was
   5     involved in the evolution of audit to enable the
   6     purchaser and the provider to work together. There are
   7     numerous examples of his advocacy in relation to audit
   8     of outcomes in the minutes of the meetings, through the
   9     latter part of 1994 and in 1995 and indeed, Mr Wisheart
  10     organised a national conference about outcomes in
  11     January 1995.
  12        It is also clear from the documents and from his
  13     evidence that Mr Wisheart advocated openness about
  14     outcomes. Even before formal audit was introduced,
  15     Mr Wisheart maintained his personal log of all the
  16     open-heart operations he carried out, and from 1977
  17     until 1992 he completed a return to the United Kingdom
  18     Cardiac Surgical Register on behalf of the unit.
  19        From the early 1980s until 1992, Mr Wisheart
  20     produced an annual statistical summary of the cardiac
  21     surgical work, including the paediatric cardiac surgical
  22     work of the unit. The 30-day mortality was given,
  23     together with the mortality for all the relevant
  24     categories from the most recently published UK Cardiac
  25     Surgical Register. These facts may be seen simply by

   1     looking at the statistics, the successive annual
   2     statistical summaries.
   3        These facts do not appear to be consistent with
   4     the assertions by some that the figures were not
   5     available. These facts do not appear to be consistent
   6     with the assertions by some that the figures were not
   7     available in a form that could be compared with the
   8     United Kingdom Cardiac Surgical Register and these facts
   9     are not consistent with the assertions by some that
  10     mortality figures were just not available.
  11        From the mid-1980s the multidisciplinary meetings
  12     and the clinico-pathological conferences, together with
  13     the statistical summaries I have just mentioned, were
  14     effective, although primitive, forms of audit. The
  15     ethos of the audit meetings was an ethos of openness,
  16     self criticism and a desire to achieve constant
  17     improvement with an ethos of dialogue leading to
  18     improvement.
  19        Once audit became established and generally
  20     practised, paediatric cardiac surgery undertook audit in
  21     the following formats: firstly, paediatric cardiological
  22     audit completed by Dr Martin; secondly, cardiac surgical
  23     audit; thirdly, the clinico-pathological conferences
  24     following the death of a patient; and fourthly, the
  25     continued preparation of annual statistical summaries

   1     and the return of data to the United Kingdom Cardiac
   2     Surgical Registrar and to the Department of Health Supra
   3     Regional Services Advisory Group, or its ad hoc working
   4     parties.
   5        So, really summarising Mr Wisheart's part in
   6     relation to audit, there was openness in the use of the
   7     figures. They were generally circulated to members of
   8     the team. The figures including mortality and
   9     comparators were used at meetings with representatives
  10     of the Supra Regional Services Advisory Group and when
  11     they visited Bristol and by way of an example,
  12     Mr Wisheart made presentations to the Public Health
  13     doctors of the South West Region in March 1993.
  14        If I could just conclude by reference to one of
  15     the documents which has come up twice this morning, that
  16     is to say, the guidelines for the care of patients in
  17     the cardiac surgical unit, in my submission that
  18     document really reflects three aspects of Mr Wisheart's
  19     approach. The first is, his energy. Mr Wisheart, you
  20     can see, was an energetic person. The second aspect
  21     that that document reflects is his commitment to his
  22     patients. The third, which is connected in a sense with
  23     the second, is his attitude towards his patients.
  24        The prime object of those guidelines was to
  25     improve the standards of patient care in a situation

   1     where many different disciplines are working together
   2     and where, because of the 24-hour nature of the
   3     commitment, inevitably the care of the patient is handed
   4     over from one person to another from time to time, such
   5     a document was of immeasurable value. Within such
   6     a framework, it was particularly important to maintain
   7     co-ordination and continuity of the management of
   8     a patient, and that is what the book is directed towards
   9     and that is why it was revised three times and continued
  10     to be used. It was an important instrument in forging
  11     teamwork within the cardiac surgical unit.
  12        Of course, if one takes the time simply to
  13     skim-read this document, one can see immediately what
  14     the focus of the document is and what it was that was
  15     always at the forefront of Mr Wisheart's mind, and that
  16     is the well-being of his patients.
  17        Sir, thank you very much for giving me this
  18     opportunity to make a short speech on behalf of
  19     Mr Wisheart.
  20   THE CHAIRMAN: Thank you, Mr Moon. Mr Langstaff?
  21   MR LANGSTAFF: Sir, before I deal with the rest of
  22     today's programme, which I will in a moment, I wonder if
  23     I may just make two comments.
  24        It may have seemed to those who listened to
  25     Mr Moon that his application and the accession to it by

   1     the Panel may have come as a surprise, and I want to
   2     take this opportunity to remind both the general public
   3     and indeed the representatives of participants in the
   4     Inquiry that before this Inquiry ever started last
   5     October, it was said by you that those witnesses who
   6     chose to do so, by themselves or through their legal
   7     representatives, might make a short final presentation
   8     in writing or, at the panel's discretion, orally. That
   9     is, you will remember, an opportunity which Mr Lissack
  10     availed himself of I think at the end of the first day
  11     or the second day of the Inquiry, on behalf of parents,
  12     and Mr Moon has only, I think, been the second person to
  13     take advantage of it, which is why I simply remind
  14     people of it in the spirit that we engendered this week
  15     of reminding those of some of the ground rules that you,
  16     sir, have adopted for this Inquiry.
  17        May I also take this opportunity to reiterate one
  18     of those guiding principles that whatever the views of
  19     others may be and however expressed, it is the
  20     determination, I know, of this panel to make its own
  21     decision on the facts as seems right on the evidence
  22     that you hear.
  23        Reference was made quite rightly by Mr Moon to
  24     the fact that there were published records of statistics
  25     and audit during the time that Mr Wisheart had

   1     responsibility as, amongst other things, Associate
   2     Director of Cardiac Surgery. We, at the moment, in the
   3     Secretariat, have difficulty in tracing any such record
   4     beyond his tenure of office and during the tenure of
   5     office of Mr Dhasmana. I mention it at this stage so if
   6     anyone who is listening to this knows of the existence
   7     of those documents, would they please get in touch with
   8     the Secretariat so we can get to the bottom of things
   9     and know whether in fact those documents were actually
  10     produced, even if they were never circulated and if they
  11     were produced, whether they were circulated.
  12        I say this not to suggest that Mr Wisheart had
  13     responsibility for them, but simply to comment that, at
  14     the moment, it appears that they are absent, beyond the
  15     beginning of 1993.
  16        Sir, the rest of the morning, we have Professor
  17     Green. Miss Grey will be asking him questions. He, as
  18     I indicated yesterday, must finish his evidence by 12.30
  19     or thereabouts so that he may catch a train at a quarter
  20     past 1. We will then hear from Mr Clifford of the Home
  21     Office Coroners' Unit. Both witnesses will be directing
  22     their evidence towards the question of tissue retention
  23     and the exercise of the coronial jurisdiction.
  24        Sir, it may be appropriate, perhaps given the time
  25     at this stage, to take a short break before Professor

   1     Green begins. I suggest perhaps no more than 10
   2     minutes.
   3   THE CHAIRMAN: That is helpful, Mr Langstaff. If we
   4     take 10 minutes, then you are contemplating that we go
   5     through Mr Green's evidence throughout; is that right?
   6   MR LANGSTAFF: Yes.
   7   THE CHAIRMAN: Very well. Let us do that. Shall we break
   8     for 10 minutes until about half past.
   9   (10.25 am)
  10               (A short break)
  11   (10.40 am)
  12   MISS GREY: Sir, we have today now the evidence of Professor
  13     Michael Alan Green, who is speaking on behalf of the
  14     Royal College of Pathologists. If I could ask firstly
  15     for witness 210/1 to be put up on the screen.
  16        Before we come to the detail of the evidence, we
  17     have, of course, been taking evidence on oath or
  18     affirmation in the Inquiry, so could I invite you to
  19     stand first, please?
  20         PROFESSOR MICHAEL ALAN GREEN (SWORN):
  21             Examined by MISS GREY:
  22   Q. Would you like to sit, Professor Green?
  23        Professor Green, we have here the first page of
  24     your witness statement to the Inquiry. If we could
  25     simply turn to the second page, is that your signature

   1     that we see at the bottom?
   2   A. It is, yes.
   3   Q. Are the contents of this statement true to the best of
   4     your knowledge and belief?
   5   A. They are.
   6   Q. If we could also turn to WIT 54/2, this is the statement
   7     of Professor MacSween on behalf of the Royal College of
   8     Pathology --
   9   A. May I interrupt for one moment, Miss Grey? It is, for
  10     the record, the Royal College of Pathologists. It is
  11     the Association of Clinical Pathology, but the College
  12     is the Royal College of Pathologists. I think we had
  13     better have it correct for the purposes of the record.
  14   Q. If we could scroll down the page, please, we see there
  15     that Professor MacSween speaks of consulting you in
  16     relation to part of his statement; is that correct?
  17   A. That is correct, yes.
  18   Q. Can you tell me what your involvement was with Professor
  19     MacSween's statement?
  20   A. My involvement was to prepare a briefing document which
  21     I can produce should the Inquiry so require. It is
  22     dated 3rd March of this year and in fact Professor
  23     MacSween has used it almost word for word with only
  24     minor modifications in preparing pages 25 to 35 of the
  25     report which he has submitted.

   1   Q. If we turn to page 25 of his statement, which you have
   2     just referred to, it should be coming up on the screen
   3     in front of you. We see there that that is the section
   4     headed "Postmortems and inquests."
   5   A. Yes.
   6   Q. So are you happy to adopt that part of his evidence as
   7     your own, and can you speak to it?
   8   A. I can speak to it. As I say, it is largely as I wrote
   9     the briefing document, some modifications were made by
  10     Professor MacSween, but he did consult me about them
  11     when he made them and I was happy to accept them.
  12   Q. Thank you. If we go back to your statement, that is
  13     210/1, we see there your qualifications at the first
  14     paragraph?
  15   A. Yes.
  16   Q. In particular, you mention that you were, until
  17     recently, the Professor of Forensic Pathology in the
  18     University of Sheffield and that you are still
  19     a consultant pathologist to the Home Office. You are
  20     now, of course, the Emeritus Professor of Forensic
  21     Pathology in the University of Sheffield.
  22        Can you tell us just briefly what your general
  23     role has been in both of those functions?
  24   A. Yes. In the eyes of the general public and I think in
  25     the eyes of a lot of the medical profession, forensic

   1     pathology and forensic medicine is associated entirely
   2     with the investigation of murder and suspicious deaths
   3     and the teaching of medical students and young doctors
   4     on those particular aspects.
   5        In fact, forensic pathology and forensic medicine
   6     incorporate a far wider brief than that. I prefer the
   7     old-fashioned name "medical toxicology and
   8     jurisprudence" because in fact at least a third of the
   9     curriculum and a third of my teaching time in the days
  10     when forensic medicine was an examinable subject was
  11     devoted to teaching medical students about the interface
  12     between medicine and the law, particularly the law
  13     relating to consent, confidentiality, the disposal of
  14     the dead and, of course, the law relating to injury.
  15     But that was a relatively small part of it. Obviously
  16     a lot of my teaching time, which has progressively
  17     diminished over the years as the medical undergraduate
  18     curriculum has changed, was devoted to teaching medical
  19     students about what to do when someone dies and how to
  20     comply with the law in those matters.
  21   Q. It may well have been, at least in part, because of your
  22     experience in these areas that you then served on the
  23     Specialist Working Party which has recently produced the
  24     document "Guidelines for the retention of tissues at
  25     postmortem examination", to which I think again you can

   1     speak today?
   2   A. I can speak to that document. The reasons I became
   3     involved in its production are three-fold. First, for
   4     a few years before I became a member of the College
   5     Council, I had been Chairman of the Forensic Pathology
   6     Sub-committee of the College.
   7        Secondly, it was known that I had wide experience
   8     in teaching and had served on various working parties,
   9     established by the government, by OPCS as it then was,
  10     now the Office of National Statistics, on death
  11     certification, cremation and so on.
  12        My Home Office involvement, of course, came into
  13     it, and also over the late 1980s, my wife and I wrote
  14     a series of articles in the first instance for the
  15     Nursing Times on death in ethnic communities and this
  16     was then brought together in a book which I have
  17     produced as an exhibit to the Inquiry called "Dealing
  18     with Death". This was published in 1991, and is divided
  19     basically into three parts: the law; the social problems
  20     of dealing with death; and then thirdly, it examines
  21     death by ethnicity and religious group and gives advice
  22     on as much what not to do as what to do if you do not
  23     wish to cause hurt and offence.
  24        This book is intended not just for doctors but for
  25     nurses, bereavement counselling officers, Coroner's

   1     officers and everybody else who might be involved in
   2     a death in a family in the broadest sense.
   3   Q. We are grateful to you, Professor Green, for supplying
   4     a copy of your book. We will be scanning into the
   5     record those parts of it which are most relevant to the
   6     Inquiry, after which it will be returned to you.
   7   A. Thank you.
   8   Q. I think perhaps the general point that emerges from
   9     the work is that you have a particular interest in what
  10     might be called the "social" aspects of death as well as
  11     the medico-legal aspects of it?
  12   A. Yes.
  13   Q. However, can I ask you this: the Inquiry has been
  14     concerned with this issue partly at least out of the
  15     events at the Bristol Royal Infirmary's pathology
  16     department, the hospital pathology department. Do you
  17     yourself have any experience as a consultant clinical
  18     pathologist who would provide a routine hospital
  19     pathology service?
  20   A. I have only worked for a relatively short time as
  21     a part-time hospital consultant and this was at
  22     St James' Hospital, Leeds in the mid-1980s. For most of
  23     my career in pathology I have been in the University
  24     Department of Forensic Pathology so my dealing with the
  25     public and dealing with families of the recently dead

   1     has been limited. But I must emphasise at the outset
   2     that most pathologists have little contact with the
   3     relatives of the dead in the hours and days immediately
   4     after death. The first contact, and most of the seeking
   5     consent and so on, is the role of the clinicians who
   6     have been treating the patients in life.
   7   Q. To the extent that I ask you questions this morning on
   8     the content of hospital consent forms or the practice of
   9     clinicians or pathologists in seeking and obtaining
  10     consent from relatives for postmortems, on what
  11     experience and knowledge would your answers be based?
  12   A. My experience and knowledge would be based first of all
  13     on personal experience as a junior and middle-rank
  14     doctor. As all doctors do, I started my career with
  15     pre-registration house jobs. At that time it was my
  16     intention to follow a career in clinical paediatrics, so
  17     I spent a total of three and a half years in clinical
  18     paediatrics, mainly in a teaching hospital, where I was
  19     dealing with the parents of dead babies on a fairly
  20     regular basis.
  21        After that, I was in general practice in the
  22     United Kingdom as a principal for six months. I was
  23     also in the Flying Doctor service in South Australia for
  24     two years and although this sounds romantic, it was
  25     basically a general practitioner with an aeroplane, so

   1     I was dealing with patients and relatives under those
   2     circumstances as well.
   3        So I have a fairly sound knowledge base, although
   4     it was established in the past. Indeed, it was
   5     established at about the time that the Human Tissue Act
   6     was passed, which I think is relevant, because I have
   7     therefore been able to follow the changes in
   8     professional and public attitudes that have evolved over
   9     those 30-odd years, even though for the last few years
  10     I have been teaching people how to do it rather than
  11     doing it myself.
  12        Incidentally, I must apologise for the voice, like
  13     you, Chairman, I am in the club, I had my sinuses washed
  14     out yesterday and I am not at my happiest and talking as
  15     though I have a clothes peg on. If I am inaudible,
  16     please tell me.
  17   Q. I think you are very clear so far, Professor Green,
  18     thank you.
  19        You have talked about the firsthand knowledge you
  20     gained about the time when the Human Tissue Act was
  21     passed.
  22   A. Yes.
  23   Q. I think thereafter what you are saying is that your
  24     knowledge would not have necessarily have been, as it
  25     were, front-line, but you have been directly concerned

   1     in teaching and therefore in examining these sorts of
   2     aspects, these sorts of issues, during the remainder of
   3     your career and to date?
   4   A. Yes. I was involved in teaching at both undergraduate
   5     and junior doctor level, and quite frequently throughout
   6     my career, I have been consulted by clinicians of all
   7     grades, particularly as to whether a death should be
   8     referred to the Coroner, how a particular issue should
   9     be dealt with in talking to relatives and so on. There
  10     was one period in my career when there was an acute
  11     shortage of paediatric pathologists in part of the North
  12     East of England which I serve, where my department was
  13     responsible for investigating the majority of cases of
  14     cot death, sudden death in infancy. At that time, when
  15     everybody seemed to be less busy than they are now, it
  16     was standard practice at the Coroner's request for me or
  17     the member of staff who carried out the autopsy to meet
  18     the relatives afterwards and explain what had been found
  19     and what its significance was.
  20        So I have had second-line involvement throughout
  21     my career with occasional forays into the front-line,
  22     although they have become less frequent.
  23   Q. If we could look, please, at the document RCP 1/73,
  24     this should be the first page of the Working Party's
  25     document which we have just referred to, the guidelines

   1     for the retention of tissues at postmortem examination.
   2        There is an introduction there speaking about the
   3     role of the autopsy and its importance.
   4        I wonder if you could outline to us, Professor
   5     Green, what you would see as the continued importance of
   6     an autopsy in medical practice?
   7   A. I think that it says in the last line of paragraph 1.1:
   8        "The autopsy will always remain the gold standard
   9     against which new techniques are assessed."
  10        It has been important in the recognition of new
  11     diseases, Creutzfeldt-Jakob disease is mentioned, and it
  12     has certainly been important in the assessment in the
  13     success or the modification of various surgical
  14     techniques, particularly laparoscopic surgery as opposed
  15     to minimally invasive surgery for things like
  16     gallbladder operations and so on.
  17        It also remains of importance because the
  18     information gained at autopsy can be passed on to the
  19     relatives either directly by the pathologist, more
  20     commonly by the clinician after he has received the
  21     pathologist's report and in cases of deaths within the
  22     community which make up approximately a third of the
  23     autopsies which are carried out in the average city the
  24     size of Leeds or Sheffield, deaths on the district, as
  25     they are known. What tends to happen there, certainly

   1     in the area in which I practised, was the postmortem
   2     report was passed by modem to the family practitioner --
   3     he is now called the FHSA -- who in turn distributed to
   4     the deceased's general practitioner, so it is important
   5     for the dissemination of information.
   6        It is important for the teaching of medical
   7     students because, although one can use videos, one can
   8     use colour photographs et cetera, and we use these
   9     increasingly, I think it is important for doctors,
  10     whatever their specialism, to know what normal and
  11     abnormal tissue looks like, and feels like -- this is
  12     particularly important if a candidate intends to follow
  13     a career in surgery and again, particularly in the
  14     training grades whatever the specialism, the importance
  15     of the clinico-pathological conference cannot be
  16     over-emphasised when all the doctors in the team and the
  17     pathologist who carried out the autopsy are together.
  18        The human body -- this is mentioned at one of the
  19     bullet points which is at the bottom of the screen -- is
  20     an invaluable source of spare parts. I do not use this
  21     term facetiously. In the replacement of cardiac valves,
  22     for example, particularly 15 years ago, when we were
  23     treating, or the profession was treating a spate of
  24     elderly and middle-aged people who had had rheumatic
  25     fever in childhood, the best type of aortic valve to use

   1     as replacement which had the longer success rate was
   2     a human aortic valve rather than a metal prosthesis.
   3     The fasciolata, the broad tendon found along the outside
   4     of the thigh, is a useful building block for many
   5     medical and orthopaedic procedures: there is no
   6     artificial substitute which works as well and it is
   7     infrequently rejected. The value of corneas has been
   8     appreciated since the early 1950s. So again,
   9     a sensitively conducted autopsy with appropriate
  10     permission beforehand provides material not only for
  11     research and teaching purposes, but provides an ongoing
  12     source of treatment for the living.
  13        The other point I would make is that particularly
  14     during the tenure of office of Sir Kenneth Calman as
  15     Chief Medical Officer, the importance of audit became
  16     increasingly appreciated. It had been appreciated by
  17     the anaesthetists a few years earlier, Lennon and
  18     Mushin published their first report on mortality
  19     relating to anaesthesia in the late 1970s, but the
  20     autopsy forms an invaluable part of audit. I have
  21     already referred to the clinico-pathological conference
  22     which takes place in hospitals, but an aspect of the
  23     autopsy which is often overlooked is the community
  24     autopsy. It identifies trends in deaths in the
  25     community, changes in mortality, for example, from acute

   1     unexpected cardiac death in young to middle-aged males;
   2     the community autopsy led to the recognition of the
   3     association between the first high dosage contraceptive
   4     pills, deep vein thrombosis and pulmonary embolism in
   5     young women, and the community autopsy likewise was the
   6     way in which the potential dangers of monoamine oxidase
   7     inhibitors associated with consumption of red wine,
   8     Marmite sandwiches, tyramin-containing foods in general,
   9     was identified. Because, as I say, a third of the
  10     population at least die outside hospital and it is those
  11     deaths which are reported to the Coroner and autopsied
  12     under the coronial system which provide audit of death
  13     in the community as well as the contribution that we
  14     make to audit in hospital.
  15        Of course, there are now three main areas: NCEPOD,
  16     which looks at peri-operative deaths in general; CESDI,
  17     which looks at deaths in infancy and the perinatal
  18     period, and CEMD, the Confidential Enquiry into Maternal
  19     Deaths. In all these statutorily established enquiries,
  20     the autopsy plays an invaluable and major role. In
  21     fact, if no autopsy is performed or an inadequate
  22     autopsy is performed, that particular case has to be
  23     excluded from the study.
  24   Q. If I could ask you to turn to WIT 54/938, this is the
  25     first page of a document called the Autopsy and Audit of

   1     1991. If we turn to page 941, we see there, in the
   2     introduction, a discussion of the continued use of the
   3     autopsy to examine discrepancies between clinical and
   4     autopsy diagnosis, because one argument that might be
   5     used against the use of permission autopsies in
   6     particular is that with the increasing sophistication of
   7     diagnostic techniques, an autopsy might not be regarded
   8     as being so important these days. The thrust of the
   9     argument in this paper, however, is that it remains of
  10     central importance as a means of checking,
  11     cross-checking and gaining further information upon the
  12     accuracy of the clinical diagnosis.
  13        Is that something you would care to comment on?
  14   A. Yes, I would support entirely the statistics which are
  15     given and are shown on the screen at the moment.
  16     Although the clinical diagnosis is confirmed in the
  17     majority of cases, in a significant number of cases
  18     other conditions emerge or the clinical diagnosis is
  19     modified. You will notice that particularly in the
  20     investigation of cancers arising within the abdomen,
  21     particularly liver, pancreas, biliary tract, the areas
  22     that are not easy to approach through an endoscope,
  23     there was this situation described in paragraph 2 where
  24     in only 56 per cent of cases was the primary site
  25     identified correctly. That, of course, was 1991; this

   1     is 1999. What is called ERCP, where you are able to now
   2     look up the biliary tract as well as into the intestine,
   3     has reduced that gap, but there is still a significant
   4     divergence, even in the permission autopsy, where the
   5     case has been fully worked up in hospital, the
   6     pathologist will still find diseases of other organs or
   7     modify slightly the disease of the principal organ as
   8     a consequence of the autopsy.
   9        Again, this is even more important, I think, in
  10     community autopsy, because not infrequently one examines
  11     a patient who has died of a heart attack and one finds,
  12     for example, a cancer in the upper lobe of the left
  13     lung, industrial disease such as asbestosis, or
  14     pneumoconiosis in my part of the world, which was
  15     unsuspected during life. This is important for correct
  16     mortality statistics for the community as a whole and it
  17     also means that widows and other dependents are not
  18     denied benefit which they might have been denied if this
  19     associated industrial disease had not been identified.
  20        So I am a great believer in the continued value of
  21     the autopsy, and like Sir Kenneth Calman, I would like
  22     to see more sampling autopsies carried out both in
  23     deaths in hospital and deaths in the community, if we
  24     are to improve accuracy of medical statistics and
  25     therefore adequacy of medical treatment.

   1   Q. Whilst we are on that page, if we just scroll down
   2     a little bit, I would just ask you to note that in the
   3     middle paragraph that we are looking at there, the
   4     reference is given there to an audit in a paediatric
   5     cardiologist unit, showing unsuspected abnormalities in
   6     80 per cent, with undiagnosed abnormalities or surgical
   7     problems contributing to death in 38 per cent. I think,
   8     if we looked at reference 16, we would find that that is
   9     a reference to the paper written by Professor Berry?
  10   A. Rushman and Berry, 1988/89.
  11   Q. Yes. That is there cited as being consistent with the
  12     general trend of autopsies revealing abnormalities or
  13     other diagnoses that were not previously identified in
  14     the previous clinical diagnoses?
  15   A. Yes.
  16   Q. We will come back to that later, if we may, but if we
  17     turn back to RCP 1/74, back to the Working Party's
  18     report, this starts to describe the need to retain
  19     either tissues or organs following autopsy, and its
  20     purposes or medical justification.
  21        Can you help us by telling us in general terms how
  22     likely it is that either tissues or whole organs would
  23     need to be retained either for a short period of time or
  24     for longer following an autopsy?
  25   A. Yes. I will start with tissues, if I may, and then move

   1     on to organs.
   2        The view of the College is that no autopsy is
   3     complete with (sic) microscopical examination of
   4     a representative small piece of tissue, and I stress
   5     "small". We are looking at something as big as the top
   6     of my little finger.
   7   Q. Could I interrupt, you say no autopsy is complete
   8     "with", or "without"?
   9   A. "Without". An autopsy from the days of Virchow in the
  10     late 1970s, the old Virchow description of a complete
  11     autopsy was an autopsy with microscopy. It is for this
  12     reason in fact that recently the College has got rid of
  13     the old term "morbid anatomist" and now calls people
  14     like me histopathologists, emphasising the fact that
  15     good pathology should look at cells as well as the whole
  16     body. So a small piece of tissue should be taken from
  17     every major organ. This is important (a) because it
  18     teaches and trains young pathologists; but (b) because
  19     again we come back to this recognition of unsuspected
  20     disease which is important for accurate mortality
  21     statistics.
  22        If I can now move on to the retention of whole
  23     organs --
  24   Q. Can I just ask you, if those samples are taken, what
  25     would be the practice regarding their retention?

   1   A. I can speak mainly only for Coroner's cases because by
   2     the very nature of a department such as mine, all the
   3     cases that I examined, except in very unusual
   4     circumstances, were Coroner's autopsies. Tissue
   5     retained under those circumstances tended to be retained
   6     usually until the Coroner had completed his Inquiry,
   7     either with inquest or without it. Then the
   8     paraffin-fixed material from which the slides had been
   9     taken is permanently archived, and this is referred to
  10     in a report published by the College recently on the
  11     archiving and storage of pathological specimens and
  12     records. The so-called wet tissue, i.e. the tissue
  13     which had been fixed in formalin but not used for
  14     processing, is disposed of in hospitals either by
  15     incineration or by using what is called a macerator.
  16     Its disposal is controlled not just by aesthetics and
  17     standards of decency, but also, particularly in these
  18     days of awareness of hepatitis C, et cetera, we are
  19     subject to Health and Safety Executive regulations and
  20     so on.
  21   Q. You were going to go on and talk about organ retention?
  22   A. Yes. There are many circumstances in which it is either
  23     difficult, impossible or unsatisfactory to examine an
  24     organ immediately it has been removed from the body.
  25        The brain in particular, particularly if the brain

   1     is swollen because of the way the patient has died or
   2     because the patient has been nursed on an intensive care
   3     unit where brain swelling is often a complication, it is
   4     literally like trying to dissect a jelly or
   5     a blancmange. You do not get much of value out of it
   6     with the naked eye and you are liable to create more
   7     artifacts as you cut the unfixed specimen which then
   8     misleads you when you look at the microscopic specimens.
   9        So to examine a brain properly requires fixation
  10     for a minimum of weeks and preferably 12. Examination
  11     before that time is unsatisfactory because the brain is
  12     fixed on the outside but the structures at the centre of
  13     the brain, which are often the ones of most interest,
  14     are not properly fixed so you get all sorts of artifacts
  15     during the processing that leads to the preparation of
  16     the slide. Examination of the heart may require
  17     retention in two sets of circumstances: to examine an
  18     adult heart properly in some of the rarer diseases like
  19     hypertrophic obstructive cardiomyopathy, the young
  20     schoolboy who collapses at the end of a PE session, the
  21     soldier who collapses at the end of a training
  22     programme. It is important to get it because it is
  23     a genetically structured disease and it is important to
  24     counsel the other members of the family.
  25        A baby's heart, the heart of a neonate is about

   1     the top of my index finger. One cannot examine that
   2     properly, even using a pair of loop-lenses on your
   3     spectacles and a video-camera. It is often necessary --
   4     although I am neither a cardiac nor paediatric
   5     pathologist -- to inject the blood vessels of the
   6     heart. Also it is often necessary to cut serial
   7     sections, as many as 300, through the so-called
   8     "conducting bundle", and this can only be done on fixed
   9     tissues. To fix a heart in formalin takes 10 days.
  10     There is experiment now with microwave fixation
  11     techniques but this can only be used on relatively small
  12     organs and it is not, in my view, anywhere near as
  13     satisfactory as conventional formalin fixation, which
  14     has withstood the test of time --
  15   Q. If I just stop you there for a moment and ask you to
  16     look at WIT 204/8, this is a part of Professor Berry's
  17     statement which I think you have had an opportunity to
  18     look at. If we scroll down the page a little, we will
  19     see, paragraph 26, please, down a little, there
  20     a discussion of the necessities, the requirements, for
  21     examination of hearts after surgery. Professor Berry
  22     makes the point that this is a difficult dissection,
  23     even for paediatric pathologists and that it was his
  24     practice to perfuse the heart with preservative under
  25     pressure for several hours, to restore its contours in

   1     life?
   2   A. Yes.
   3   Q. And then to carry out most of this dissection after the
   4     postmortem examination of the body itself?
   5   A. Yes.
   6   Q. Then he talks about the retention of lung tissue, if we
   7     just go over the page, please, to make that complete,
   8     page 9?
   9   A. I think this is important, because, you see, a goodly
  10     percentage of congenital heart disease is in fact not
  11     confined to the heart. There are associated
  12     abnormalities of the vessels which run between the heart
  13     and the lungs and also the aorta, the main blood
  14     vessel. So really, to do it properly -- and this
  15     applies in coronial practice as well, such as mine, for
  16     example, every so often I would do a sudden infant death
  17     case which turned out to be unsuspected congenital heart
  18     disease, so it was desperately important to take the
  19     thoracic organs en bloc, fix them, recolour them and
  20     then look at them with the aid of magnifying spectacles,
  21     television camera, dissected against a clean and
  22     bloodless background, and as I say, it takes 10 days to
  23     do it properly and you would delay the funeral for
  24     10 days if you returned the organs to the body.
  25        The point I was going to make, when you quite

   1     rightly interjected, is that increasingly we live in
   2     litigious times. I think Professor Berry has adverted
   3     to this in his statement, but it has certainly been my
   4     experience now, as far as post-operative death is
   5     concerned. For example, if you are passing an
   6     endoscope, a flexible fibre-optic examining rod, tube,
   7     call it what you will, down the intestinal tract or up
   8     the intestinal tract, there is a risk of perforation of
   9     the gut, particularly if the gut is diseased.
  10     Increasingly, I find, in the biased sample that I see,
  11     that relatives want an independent opinion. They retain
  12     a firm of solicitors. The solicitors in turn will
  13     retain another pathologist, who wants to see the actual
  14     organ. You will then find that the hospital Trust
  15     retains their lawyers, their pathologist, and so on, so
  16     there is a new reason for keeping whole organs which
  17     might have been damaged as a result of surgery, which
  18     has emerged in the last ten years of my working life,
  19     which we never even considered when I was younger.
  20        Finally, and I must mention this en passant,
  21     although it is rare, there are after all only 850
  22     homicides a year in England and Wales, it is usually
  23     said that the organ should be retained until the Coroner
  24     has completed his inquiry. Of course in a criminal
  25     case, the best advice we can get from the Crown

   1     Prosecution Service at the moment is that the organ in
   2     question, for example, a brain in a head injury, or
   3     a lung with a stab wound through it, should be retained
   4     until the conclusion of the criminal proceedings, and
   5     this has recently been extended to include due time for
   6     appeal. So we find ourselves in forensic departments
   7     particularly under duress to keep whole organs for
   8     a very long time indeed. Indeed, it was the view of the
   9     recently retired Director of Public Prosecutions that
  10     organs should be kept until the whole sentence had been
  11     served. This has not been confirmed by the new split
  12     directorate, but you can see it leaves forensic
  13     pathologists in a very difficult situation as far as
  14     retention of organs is concerned. And again, a third of
  15     homicides in England and Wales are head injury related.
  16     The brain is an organ which is sensitive as far as
  17     relatives are concerned, but by the very nature of our
  18     work, we have to retain an awful lot of them.
  19   Q. If I could take you back to the example of prospective
  20     or possible civil litigation as being a reason to retain
  21     tissue or organs, would it be your practice in the
  22     biased sample of cases you see to retain habitually
  23     because that might be in prospect, or would you only
  24     retain if there was some knowledge or indication that
  25     the relatives or other concerned individuals might be

   1     wishing to pursue that further?
   2   A. Even in a Coroner's case, where the case has been done
   3     more or less the morning after death, or the Monday
   4     after death if it has occurred at the weekend, the
   5     Coroner's officer has already interviewed the relatives
   6     and the fact that they are thinking of consulting
   7     solicitors usually emerges early rather late.
   8        In the small minority of cases where the relatives
   9     have not expressed concerns but my findings or my
  10     staff's findings at autopsy have suggested that there is
  11     something which might cause concern later, it has been
  12     policy to retain the organ in question, but only after
  13     telephoning the Coroner in question and making sure that
  14     he or she was in agreement and this fact is recorded in
  15     the autopsy note, both the rough note made at the time
  16     and the typed report which is subsequently made
  17     available.
  18   Q. That, I think, leads on to the question of how much
  19     information was habitually given to relatives of
  20     a deceased person about the need or the practice of
  21     retaining tissues or organs. If we could look, please,
  22     at RCP 1/75, again from the Working Party's report, if
  23     we can go down a little.
  24        Could you scroll back up to the top of the page?
  25     The paragraph there, perhaps to give you the full

   1     context I should take you back first to page 74(RCP 1/74), where
   2     the Working Party sets out legal and ethical principles
   3     relating to the retention of tissues, firstly that it
   4     must be legal, secondly that it must be professionally
   5     regulated to high ethical standards?
   6   A. Yes.
   7   Q. And over the page, then, the reasons must be defensible,
   8     open and justifiable in law and in clinical practice?
   9   A. Yes.
  10   Q. Can I ask you, please, about the word "open" in those
  11     guidelines. To what extent has past practice in this
  12     area been open?
  13   A. I am sorry to go into history and I will try to be as
  14     brief as possible. I qualified in 1960. The Human
  15     Tissue Act was passed in 1961. My generation were,
  16     therefore, taught by those who had always themselves
  17     been taught that there was no property in a dead body
  18     and the general lesson that was drilled into me as
  19     a medical student was, be courteous, be polite, explain
  20     that you are asking for permission for this autopsy
  21     because it will help others, both in learning and in the
  22     treatment of disease, but do not go into any more
  23     detail; it will upset the relatives and they will be
  24     distressed and they might refuse consent.
  25        This was the attitude on which my generation was

   1     brought up.
   2        The Human Tissue Act was passed the year
   3     I qualified. At first it made little difference.
   4     I think everybody, both hospital management and
   5     clinicians, said "But we are doing all this anyway. We
   6     have a consent form which we always have witnessed", and
   7     in those days there were no such things as bereavement
   8     counselling officers, it was usually the SHO or the
   9     Registrar who saw the relatives and got permission, and
  10     you simply had a bald consent form which said "I, being
  11     [the wife, husband, et cetera] of ... hereby agree to an
  12     autopsy being carried out. I understand this will help
  13     advance medical knowledge", or words to that effect.
  14     There was nothing organ specific and equally, there was
  15     no option of a limited or restricted postmortem.
  16        As I say, immediately after the passing of the
  17     HTA, it did not make very much difference. Then
  18     I suppose in the 1970s, people started talking about
  19     "informed consent", which is in my view an Americanism
  20     which has crept into English law; I was always taught to
  21     talk about "valid consent", but the realisation dawned
  22     on the profession that fully informed consent involved
  23     rather more than just using the old-fashioned bald
  24     one-paragraph consent form, and my understanding in the
  25     various hospitals that I went to, because as a forensic

   1     pathologist I am, by the nature of my job, peripatetic,
   2     although I was based then in Leeds and Sheffield, I used
   3     to carry out autopsies in every NHS hospital in the
   4     whole of the Yorkshire region, and two-thirds of the
   5     Trent region. So I had a pretty shrewd idea of what
   6     common practice was amongst the pathologists, but of
   7     course I did not meet the clinicians at firsthand, but
   8     I got the feeling that there was a gradual swing to them
   9     either verbally or in writing incorporating,
  10     "I understand that it might be necessary to retain
  11     certain tissues for further examination", but as far as
  12     I know, it is only in the last few years in this present
  13     decade that people have then carried it forward and
  14     started making what I call the organ-specific consent
  15     form, which is the thing that is now recognised.
  16        Even so, I think from the early 1980s onwards,
  17     I certainly in my teaching, was emphasising to medical
  18     students and to young doctors, "Look, distasteful though
  19     you might find it, you must get used to the idea of
  20     asking relatives specifically for retention of an organ
  21     or tissues" and by the time the book which you have
  22     before you was published in 1991, I had said and I quote
  23     from memory, "under no circumstances should this issue
  24     be fudged", and emphasised the point that to comply with
  25     the HTA, we really had to get our act together and start

   1     being more specific.
   2   Q. You should not have to do it from memory. If we look
   3     first at HOME 6/26, we should see there the first
   4     page of your book, is that right?
   5   A. That is it, yes.
   6   Q. Together with Jennifer Green?
   7   A. Yes.
   8   Q. Over the page, page 27(HOME 6/27), we are told there that this
   9     edition, the first edition, was 1992. Was it actually
  10     written in 1991 but formally published in 1992?
  11   A. It was written over the period late 1989 to the middle
  12     of 1991, but of course publication is a slow business,
  13     or certainly was then. Things are speeding up now. The
  14     book came on the market in January 1992, as I recall.
  15   Q. If we then turn to page 28(HOME 6/28) of this database, we see
  16     there -- if you could look at the last --
  17   A. It is the bottom of page 57.
  18   Q. Could we have that, please, "When may an autopsy be
  19     performed?" This is a discussion of hospital autopsies
  20     specifically, but we see that at the very bottom of the
  21     guidance that you and Miss Jennifer Green give, you see
  22     there:
  23        "If it is desirable that tissues or organs should
  24     be retained, specific consent coupled with further
  25     explanation should be sought. Under no circumstances

   1     should this issue be fudged or material illicitly
   2     retained. Such actions invite at best serious complaint
   3     or censure, and at worse litigation."
   4   A. Yes.
   5   Q. To what extent do you think that your advice reflected
   6     current practices in hospitals for hospital autopsies at
   7     that time?
   8   A. It represented best practice and certainly in the two
   9     teaching hospitals in Leeds with which I was associated
  10     when I started writing the book, this was being done,
  11     although, before when the old style form was still being
  12     used which did not specifically have a printed "I agree
  13     to the retention of ...", house officers, SHOs et al
  14     were hand-writing in the appropriate permission.
  15        When I moved to Sheffield, it was my understanding
  16     that that was the practice at the Royal Hallamshire
  17     Hospital and the Northern General. I did get the
  18     feeling that it might not be the practice in many
  19     district general hospitals, but I would make a broader
  20     point here about the permission autopsy, the academic
  21     autopsy: when I first qualified over 50 per cent of
  22     deaths in a teaching hospital would be subjected to
  23     a permission autopsy and round about 15 to 20 per cent
  24     in district general hospitals. By the time this book
  25     was written, in the teaching hospitals with which I am

   1     associated, the permission autopsy rate was less than
   2     10 per cent and I can think of some district general
   3     hospitals where a permission autopsy has not been
   4     carried out for several years. So it was a relatively
   5     rare event. So nobody, not medical staff senior nor
   6     junior, nor bereavement counselling officers, really had
   7     the opportunity to hone this particular skill. As
   8     Professor Berry says in his paper which you have already
   9     referred to, over the period from 1961 to the mid-1980s,
  10     there was what he called a lamentable decline in the
  11     incidence of permission autopsies.
  12   Q. If we go back to WIT 54/25, this is Professor MacSween's
  13     statement, the part in which you were heavily involved
  14     in writing. If we scroll down a little, you say there
  15     is a discussion there of the general issue. Then down
  16     a little further, please, the beginning of a discussion:
  17     before the Human Tissue Act there was no statute law
  18     relating to autopsies by consent.
  19        Then over the page, please: "Medical students were
  20     taught there was no property in a dead body."
  21        Then it was felt that if organs were to be
  22     retained, "relatives should not be further distressed by
  23     being presented with a list of organs that might be
  24     retained."
  25        Can I just ask you to clarify, does it follow from

   1     the early evidence that you were given that this
   2     paragraph in Professor MacSween's statement relates to
   3     practice before the passage of the Human Tissue Act
   4     only? Or does it also relate to a more general attitude
   5     that persisted after its passage?
   6   A. My own experience in my own part of the world, and
   7     I admit responsibility for this paragraph, by the way,
   8     although it is over Professor MacSween's signature, was
   9     that it would be right, under the Human Tissue Act, to
  10     use this broad expression which I used earlier, of
  11     course it might be necessary to retain some tissue for
  12     further examination, but it was not more specific than
  13     that; it was, I think, into the 1970s before the
  14     thinking -- well, all doctors think, but the ethically
  15     concerned members of the profession started saying,
  16     "Just a minute, everybody is talking about informed
  17     consent, specific consent", and I suppose this really
  18     came to a head in a paper written by Bernard Knight in
  19     about 1984/85 --
  20   Q. 1985.
  21   A. -- which pointed up the fact that a lot of doctors might
  22     not be complying with the letter of the Human Tissue
  23     Act, and that more specific consent should be
  24     incorporated into dealings with relatives, be they
  25     verbal or written, particularly if whole organs as

   1     opposed to small pieces of tissue were being retained.
   2        So there was, as I said when I first started
   3     giving my evidence on this subject, the general feeling
   4     when the Act was first passed that it did not make all
   5     that much more difference, you only needed one extra
   6     sentence in the consent form. The realisation that
   7     specific agreement to the retention of organs and
   8     tissues I think crept on the profession more generally
   9     and I think the profession in general, over those early
  10     years of my involvement with it -- and I admit it freely
  11     and I think most doctors of my age do -- is that we were
  12     generally rather paternalistic. We knew what was best
  13     for the patients and the relatives and did not want to
  14     upset them and this was the attitude which was
  15     inculcated and has only gradually been replaced I hope
  16     by a more enlightened one.
  17   Q. When the College announced the publication of the
  18     consultation paper that we have looked at several times
  19     on its website, it wrote on the website, under the hand
  20     again of Professor MacSween, these words:
  21        "Stemming in part from the Bristol Royal Infirmary
  22     Inquiry, there has been heightened public interest in
  23     the issue of retention of organs or tissue following
  24     postmortem examination. Such retention of organs or
  25     tissue was previously implicit in the granting of

   1     permission for postmortem examinations by the relatives
   2     of the deceased. The College appreciates that it is now
   3     essential to be more explicit on these matters."
   4        Would you agree with the statement or its
   5     implication that in the past, or up to date,
   6     pathologists have considered that consent to postmortem
   7     to a hospital autopsy implied consent to the retention
   8     of tissues or organs without further information on that
   9     subject being passed to them?
  10   A. I must confess that I had not seen that particular
  11     website announcement. I have to, with reluctance,
  12     disagree with my President on this, in that, as I have
  13     said, I think there was a gradual groundswell change and
  14     by the 1970s, we were starting to incorporate, or many
  15     hospitals were starting to incorporate a sentence to the
  16     effect that it might be necessary to retain tissues, and
  17     certainly, by the time that I wrote the book -- and I am
  18     not getting plugs in here -- but for several years
  19     beforehand, my teaching to medical students, to junior
  20     doctors, lectures on ethics I gave for continuing
  21     education purposes, I had been saying "The way the wind
  22     is blowing it would be wise to be more specific than you
  23     have been before".
  24        So I think perhaps to make his website
  25     announcement punchy and short, perhaps Professor

   1     MacSween has contracted a bit, because again it does not
   2     make it clear in that website that we had already
   3     started preparing this, partly as a result of response
   4     to the 1991 document, the autopsy and audit, but also
   5     partly in response to correspondence generated with the
   6     College by the publication of the Green & Green book.
   7     The Council had been debating the establishment of the
   8     Working Party for some time. It had been our intention
   9     to publish it as a definitive document, as this one was,
  10     but once this Inquiry was announced it was felt that the
  11     issues were so important that it would be better,
  12     although it delayed formal publication, to put it out as
  13     a consultation paper, because we are hoping for advice
  14     and input from this Inquiry.
  15        I understand that the Inquiry will not finally
  16     report until well into next year, but if there is
  17     a mechanism by which you, sir, can give interim advice
  18     or any comment on the content of this document so that
  19     we can bring forward its publication in final form, we
  20     as a College would be grateful.
  21   Q. Going back then to the question I was asking you, would
  22     it be fair to say that if it was ever thought that
  23     consent to a postmortem implied consent to the retention
  24     of organs or tissues, that was an attitude which was
  25     dying in the 1970s and began to die in the 1970s, and

   1     perhaps died finally some time throughout the 1980s.
   2     You mention as a milestone the article by
   3     Professor Knight, but that it was a gradual change in
   4     evolution and attitudes throughout that period?
   5   A. It was a gradual change in evolution and attitude, and
   6     of course, as I explained right at the beginning, I and
   7     my fellow pathologists are in some difficulty here, in
   8     that it was not our place, usually, to act as the person
   9     seeking consent; it was the clinical team who had been
  10     giving treatment in life. So one could only get
  11     a groundswell view of what was happening by talking to
  12     mortuary attendants, by talking to young doctors who
  13     happened to come into the PM room to sign a cremation
  14     form while you happened to be there, and so on. But the
  15     water-testing which I carried out throughout my working
  16     life as first a senior lecturer and then a Professor
  17     gave me the idea that things were gradually improving
  18     along the sort of time-scale which I have indicated, but
  19     there was no day when everybody said, "Oh, it is all
  20     right, consent to one thing means consent to everything"
  21     and the next morning everybody woke up and said,
  22     "Express consent is necessary rather than implied
  23     consent".
  24   Q. If we go on to page 27 of this statement, we see
  25     a discussion of the movement and change because you

   1     discussed there the passage of the Human Tissue Act.
   2        Can I ask you about that paragraph, if we scroll
   3     down a little? It talks there of the fact, firstly, of
   4     being of the opinion that the most senior doctor who
   5     treated a patient in life should be the person who
   6     interviews the relatives and explains the need for and
   7     the implications of autopsy.
   8        Why do you make that recommendation at that
   9     point?
  10   A. Because I think that relatives are entitled to the best
  11     information and the most senior doctor, senior
  12     registrar, consultant, particularly in surgical cases,
  13     the person who carried out the procedure related or
  14     which might be related to the patient's death or the
  15     condition for which the patient had been treated.
  16     I think it is only a matter of courtesy that whenever
  17     possible, the consultant or a person at the end of his
  18     higher specialist training should be the person who does
  19     the talking, especially on a matter as serious as
  20     a death in the family. But, although it does not say so
  21     in the report in this particular paragraph, the point
  22     that I have always made in my teaching -- and I think
  23     colleagues like Bernard Knight have done the same
  24     thing -- said that right from the day somebody qualifies
  25     and becomes a pre-registration house officer, they

   1     should sit in when the boss is seeing the relatives, so
   2     they learn how it should be done, and by the time they
   3     are Registrars, Calman higher specialist trainees, they
   4     should be capable of obtaining such consent sensitively
   5     and giving a full explanation.
   6   Q. We will come back to that if we may, but could I ask you
   7     also about this paragraph? There is a sentence in the
   8     middle:
   9        "Consent had to be obtained in writing from the
  10     relatives and it was advised that if an organ was to be
  11     retained for teaching or research that specific consent
  12     should be obtained."
  13        Can you tell us, when "advised" is written there
  14     and underlined, who was advising that, and when?
  15   A. I know of no formal data publication from the College or
  16     from the Association of Clinical Pathologists that said
  17     this, but of course these were the days when every
  18     medical school in the whole of the United Kingdom still
  19     had a course in forensic medicine which was examinable,
  20     and as I say, approximately one third of that course was
  21     related to law and issues of death and dying, and
  22     certainly, my own specialist organisation, the British
  23     Association in Forensic Medicine, from the early 1970s
  24     onwards, when this was discussed at meetings of our
  25     Council and at open meetings of our membership, were

   1     suggesting that this advice should be disseminated to
   2     hospitals, but as I say, I know of no formal publication
   3     at that time, and this really is one of the first
   4     documents bearing the College authority which sets out
   5     what must be done as opposed to what is merely best
   6     practice.
   7   Q. If we look at WIT 204/41, this again is Professor
   8     Berry's statement and he attaches as an Appendix the
   9     form which he suggested should be put into use at the
  10     Children's Hospital and Maternity Hospital in 1985.
  11        If we look through that, we see the general
  12     consent to the performance of the postmortem is set out,
  13     and then it goes on to deal with the removal of tissues
  14     for diagnosis, medical education and medical research.
  15        If we scroll through to the bottom of the page,
  16     one can see that medical education and research may be
  17     deleted if thought appropriate by the relative.
  18        Would that be a form that would be consistent with
  19     those in use in other hospitals at around that time, to
  20     the best of your knowledge?
  21   A. Yes, it would. This would be what we might call
  22     Mark II. Mark I was the simple form in use when I was
  23     a medical student and for several years into the 1960s,
  24     "I hereby consent to a postmortem on the body of my
  25     relative..." so-and-so. This is now "...including the

   1     removal of such tissues as is considered necessary for
   2     the purposes of...", but there is still this groundswell
   3     underneath of, "Well, if we start talking about brains,
   4     hearts, livers, specifically, we will put people off",
   5     but this is the form which I should think was used in
   6     pretty well every teaching hospital and district general
   7     hospital at that time. I cannot recall seeing
   8     organ-specific consent forms until into the early 1990s.
   9   Q. It is the organ-specific retention form that you have
  10     attached as annex A to the consultation document, and
  11     now recommend for use?
  12   A. Yes.
  13   Q. If we go back to doing this from memory, so it may be
  14     wrong, page 39 of WIT 204 --
  15   A. That is Berry again, is it?
  16   Q. Yes -- we may see there what might be regarded as being
  17     a fairly extreme version of Mark I, is that right?
  18   A. This is bald even by the standards of the consent form
  19     that was in use in the 1950s when I was a medical
  20     student.
  21   Q. This is the form Professor Berry will say he was
  22     endeavouring to have changed into the one we have just
  23     seen at page 41.
  24   A. I do not wish to be too critical, but I would express
  25     surprise that this was still being used in a teaching

   1     hospital at that time. I would have thought that it
   2     would have been a little more sensitively worded. The
   3     form that was in use at Leeds General Infirmary, for
   4     example, at the time I was a Paediatric Registrar,
   5     contained a little paragraph of, "I understand that this
   6     will further medical knowledge and may help others", or
   7     words to that effect, to soften the blow a little bit;
   8     it was not just one sentence, it was padded out
   9     without -- it was vague, but it was not just a one-liner
  10     as this one is.
  11   Q. I think it is fair to add that Professor Berry refers to
  12     that particular form as being out of line with the usual
  13     UK form at that time?
  14   A. I would certainly confirm this from my own experience,
  15     yes.
  16   Q. He also, at points in his evidence, refers to a standard
  17     DHSS form. Are you aware of any guidance having been
  18     given by the DHSS in the format of consent forms?
  19   A. I cannot recall them. In fact it was a complaint which
  20     was made frequently in my early years as a senior
  21     lecturer in forensic pathology which was, what, 1972
  22     onwards, that every hospital -- they were not called
  23     Trusts in those days, they were either boards of
  24     governors or manager's committees -- were left to devise
  25     their own consent form, rather than there being any

   1     useful advice from the centre. So if Professor Berry
   2     says there was such a form, I accept that but I do not
   3     know when it was circulated.
   4   Q. If we could go to WIT 43/42 that will give us the start
   5     page of the Coroners' Rules. I would like to ask you
   6     some questions about rule 9 specifically. The text is
   7     to be found at page 48.
   8        If we see there the text of rule 9, I will not
   9     read it out, it is there on the screen. I think that we
  10     could agree that it would require, indeed, the
  11     pathologist to make provision, as far as possible, to
  12     preserve material that bore upon or was needed to
  13     establish the cause of death, but it would not, on its
  14     face, authorise the retention of tissue for the purposes
  15     of medical education and teaching.
  16   A. That is correct.
  17   Q. Can I ask you, what was the general attitude prevalent
  18     among the profession of pathologists towards the
  19     retention of tissue for medical education, teaching,
  20     research, during the period of the early 1970s and
  21     1980s?
  22   A. The view that was generally taken was that in hospital
  23     permission cases, the consent which the relative had
  24     given for the retention of tissues or organs allowed one
  25     to take whatever one felt may be useful for medical

   1     research. You might have, for example, a rheumatology
   2     unit in your hospital who said "We would like a drop of
   3     synovial fluid and a bit of cartilage from every knee
   4     joint of everybody". We would for example, particularly
   5     in orthopaedics and some aspects of surgery, allow
   6     surgical trainees into the autopsy room to practice
   7     a technique upon a cadaver in the course of the routine
   8     autopsy which was being carried out anyway.
   9        Coroners' autopsies have always been much more
  10     difficult. In my very early years as a forensic
  11     pathologist in the 1960s, again one tended to have this
  12     view that there is "no property in a dead body" and an
  13     awful lot of research material was taken. But even by
  14     the mid-1960s to the late 1960s, it was becoming
  15     increasingly understood by pathologists who carry out
  16     Coroners' autopsies and by Coroners that the Coroners'
  17     Rules were prescriptive and restrictive and that one
  18     could only take such tissues or organs as might have
  19     a bearing upon the cause of death.
  20        The problem then -- and the problem still is
  21     now -- that the onus is left entirely on the pathologist
  22     who is carrying out the autopsy. Where does one stop as
  23     far as this sort of thing is concerned?
  24        To give you a very simple example, the General
  25     Medical Council's advice is that it is not right to test

   1     postmortem for HIV and hepatitis C, but a common defence
   2     which is used in murder and manslaughter on the gay
   3     scene, and I quote, is, "It was when he told me that he
   4     was HIV positive that I lost my rag and hit him on the
   5     head", so the pathologist in some circumstances is
   6     damned if he does and damned if he does not.
   7        The policy adopted in my own department, or what
   8     was my department until a few weeks ago, is that we take
   9     tissue -- tissue, I hasten to add, not organ -- which in
  10     my view might have a bearing on the cause of death,
  11     particularly in cases where civil or criminal litigation
  12     may result. If we feel that it is necessary to retain
  13     a whole organ, a brain in a head injury, a heart in
  14     a stabbing case, a stomach specimen where there has been
  15     perforation by an endoscope, we retain that organ but
  16     tell the Coroner or his officer by telephone immediately
  17     after the conclusion of the autopsy, and a statement to
  18     the effect that that organ has been retained is
  19     incorporated into our report.
  20        Three of the full-time Coroners in the area which
  21     I now serve over the last two years or so -- and
  22     I suspect that this Inquiry might have something to do
  23     with it -- now automatically write to the relatives of
  24     that deceased person explaining that a particular organ
  25     has been retained and the reasons for it. Certainly,

   1     two of the Coroners whom my department serves go further
   2     and explain what the possible means of disposal of that
   3     organ available to the relatives are.
   4        One Coroner incorporates a tear-off slip at the
   5     bottom of the letter which says, "If you do not wish to
   6     have any further involvement with this organ, return
   7     this slip in the prepaid envelope and I will pass it to
   8     the pathologist so it can be dealt with according to
   9     routine practice at the lab". In the few months that
  10     that practice has been in use, the vast majority of
  11     people have returned the slip and said, "Dispose of the
  12     organ as you would; we do not wish to be involved in its
  13     ultimate disposal".
  14   Q. I think that practice of informing relatives is the one
  15     that is recommended by the College in its consultative
  16     document as being good practice to be adopted across the
  17     country in the future.
  18   A. Yes, but I think when Mr Burgess gives evidence
  19     tomorrow, and possibly when Mr Clifford gives evidence
  20     this afternoon, you will find that the Coroners' Society
  21     were having parallel discussions about the time we were
  22     drawing up our Working Party document and they have sent
  23     out codes of best practice to their members.
  24   Q. You say that it is a matter for the pathologist to
  25     decide what the scope of retention may be -- what

   1     retention may be necessary to establish the cause of
   2     death -- and that there may be a wide margin of
   3     discretion involved in that judgment.
   4        What about the role of the Coroner in this
   5     matter? Is there also a variation in the attitudes
   6     taken by Coroners towards the scope of the investigation
   7     by the pathologist that is necessary for the Coroner's
   8     purposes?
   9   A. Yes, and again, Mr Burgess, I hope, will be able to deal
  10     with this. I can only speak from the experiences which
  11     I have in my own area. There was one Coroner, recently
  12     retired, who would under no circumstances permit the
  13     retention of any organ, no matter how strongly one
  14     argued that it might be wanted -- the defence might want
  15     a view of it and it might need to be fixed for three
  16     months before examination. He, I hasten to act, was an
  17     exception, but increasingly, I have advised my junior
  18     staff over the years (and it is the practice of my
  19     successors in my department) to inform the Coroner if
  20     a whole organ is being retained and the reasons for it.
  21   Q. But can there be difficulties caused to the pathologist
  22     by different attitudes on the part of different Coroners
  23     as to the scope of their jurisdiction?
  24   A. I think that there can be, certainly in the medico-legal
  25     field. I am particularly concerned -- again, I can only

   1     speak from my own personal interests here -- but most of
   2     my research and most of my specialisation over the last
   3     ten years of my working life was in physical child
   4     abuses in the first six months of life, and a lot of
   5     this involved some shaking, or shaking plus impact. One
   6     of the best ways, it is emerging from research, both in
   7     this country and in other countries, of proving that
   8     shaking has taken place is to examine the inside of the
   9     baby's eye. There is one Coroner for whom I used to
  10     work who under no circumstances would permit the removal
  11     of the eyes, no matter how strong the arguments which
  12     I put forward. This certainly, in one case I can think
  13     of, resulted in an acquittal.
  14        So whilst most of the time most pathologists and
  15     most Coroners will discuss and come to an appropriate
  16     modus operandi, the current vagueness of the Coroners'
  17     Rules and the fact that, although they are rules, they
  18     are open to wide individual interpretation, can produce
  19     difficulties.
  20        There are other difficulties within the Coroners'
  21     Rules which are of only indirect interest to this
  22     Inquiry but which should be mentioned, for example, the
  23     circumstances in which microscopical examination can be
  24     paid for and cannot be paid for. This sometimes, in
  25     a Trust which is short of money, restricts the value and

   1     the scope of an examination of, say, a peri-operative
   2     death carried out on behalf of the Coroner. As I say,
   3     this is not directly within the remit of the Inquiry,
   4     but it is something which should be considered if
   5     recommendations are going to be made about a radical
   6     revision of the Coroners' Act 1988 and the Coroners'
   7     Rules of 1984.
   8   Q. If we return to the issue of the understanding of the
   9     scope of rule 9, you were saying, I think, that there
  10     was an appreciation, gradually, that the scope of rule 9
  11     was not wide enough to permit retention for medical
  12     research and education.
  13        If we look at WIT 43/153, this is an extract from
  14     a Home Office newsletter. We get the date from the
  15     statement of Mr Clifford who speaks to it: it is from
  16     1989. The circular there is advising that Coroners
  17     should remind their pathologists that ministers are
  18     concerned that tissue and organs should not be taken for
  19     teaching or research purposes from Coroner's postmortem
  20     examination cases.
  21   A. Yes, and I think this is standard practice, certainly in
  22     the teaching hospitals in the areas that I serve.
  23     Certainly in the department -- my own department until
  24     recently -- I imposed an absolute ban on the retention
  25     of any organ tissue or body fluid for research purposes,

   1     and it was made very clear to any clinician who came to
   2     me with a request for material that if they wanted
   3     material from a Coroner's case, somebody from their unit
   4     would have to see the relatives and obtain permission,
   5     just as they would if it was a hospital permission case.
   6   Q. But there are two categories of retention, are there
   7     not, or continued retention, I should say: the first is
   8     taking a sample, taking an organ, specifically for the
   9     purposes of medical education or research. I think it
  10     is quite clear from that circular, from what you have
  11     been saying, that the realisation came by the late 1980s
  12     at least, if not earlier, that that was not permissible
  13     under the Coroners' Rules. Is that a fair summary?
  14   A. It is a fair summary, and I would certainly take it back
  15     to the "even earlier". Throughout all of my senior
  16     professional life it has been clearly understood by
  17     Coroners' pathologists that if somebody comes to them
  18     with a request for tissue, urine, blood or anything else
  19     from a routine Coroner's case, you have to say: no, not
  20     without permission.
  21   Q. The Inquiry's terms of reference start in 1984. That
  22     would have been the understanding from 1984, if not
  23     earlier, then?
  24   A. I think so, yes.
  25   Q. The more difficult case, perhaps, is the case in which

   1     organs are properly retained for examination and study
   2     of the cause of death, and so are properly taken under
   3     rule 9, but there is then an issue as to their
   4     subsequent disposal or retention after that purpose has
   5     been exhausted.
   6        Can you tell us what the understanding would have
   7     been of the legality of that practice?
   8   A. The understanding throughout my career, not just advice
   9     I have taken from Coroners but also advice I have taken
  10     on behalf of my department, and the College has taken
  11     similar advice, from counsel as opposed to Coroners, is
  12     that the material which is left over, for example, the
  13     heel of a paraffin fixed block of tissue which has been
  14     used to determine the cause of death, pneumonia in the
  15     case of a lung, or meningitis or whatever, once the
  16     Coroner has discharged his function and he is
  17     functus officio, that piece of tissue is in effect the
  18     property of the pathologist and the department which has
  19     processed it. It has had something done to it and
  20     therefore it is perfectly licit to use the heel of that
  21     block for research purposes; it is perfectly licit to
  22     use that organ for teaching purposes, museum purposes,
  23     but it has always been the tradition, in the profession,
  24     right back to the days of the Anatomy Act, back into the
  25     nineteenth century -- and I can speak from experience

   1     here because at one stage in my life I looked after
   2     a museum which went back to the 19th century -- care was
   3     always taken to anonymise such material. It was
   4     identified only by reference number and register.
   5   Q. Just on the [draft] transcript here, you were talking
   6     about a piece of tissue, the heel of a block, and saying
   7     that it has had something done to it and therefore it
   8     was perfectly "licit", I think was your word -- it has
   9     come out as something else on the [draft] transcript,
  10     but you were saying that it is perfectly licit to use
  11     that organ for teaching purposes?
  12   A. Yes. My understanding -- and I am sure the Chairman
  13     will correct me -- from Kennedy and Grubb is that once
  14     tissue or an organ has been treated, property passes
  15     into the hands of the person or department who did the
  16     treating, and I think this is mentioned in Dobson and
  17     others quite recently, but I think it goes back much
  18     further than that.
  19   Q. Professor Green, we are not looking so much for
  20     a definitive analysis of the law from you --
  21   A. Thank goodness.
  22   Q. -- we are in fact commissioning an opinion on the
  23     subject, but what I am concerned to ask for your
  24     assistance on is what the understanding of the law was
  25     amongst practitioners, pathologists, clinicians, during

   1     the period in particular of our terms of reference?
   2   A. Our understanding was, and I think still is -- and this,
   3     as I say, has been confirmed repeatedly by the different
   4     Coroners I have spoken to -- the Sheffield Department
   5     serves a total of 15 Coroners, full and part-time, and
   6     in the course of my career I consulted with all of
   7     them -- was t