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Hearing summary

8th June 1999

 

Today the Inquiry heard further evidence from Dr John Roylance, former District General Manager of Bristol and Weston Health Authority and Chief Executive of United Bristol Healthcare NHS Trust (UBHT). Dr Roylance today answered questions about the evolution from medical to clinical audit which took place during the late 1980’s to the mid 1990’s. He said that the role of the UBHT Audit Committee was to monitor audit activity rather than to be involved in the actual auditing of services. Responsibility for carrying out audit, and action resulting from audit, was devolved to Directorate and Divisional level, with funding from the Regional Health Authority. He went on to describe the ways in which staff could raise concerns about the activity of colleagues and outlined the process known as ‘the three wise men’ by which staff could confidentially discuss anxieties with senior members of the medical staff. Dr Roylance then went on to discuss the establishment of the Chair of Cardiac Surgery at Bristol University in 1992 and commented on the unsuccessful quest to appoint a paediatric cardiac surgeon to the position. He confirmed that the ‘split site’ which existed, with open heart surgery taking place at the BRI and other procedures being undertaken at the Bristol Children’s Hospital, had been an issue for one potential applicant for the post. He then went on to discuss the role and workload of the Medical Director and concluded by describing his personal management style.

Dr Roylance will return for re-examination tomorrow morning at 9.30 a.m. to be followed by Margaret Maisey, former Director of Operations and Nurse Advisor at UBHT and Director of Nursing to 1997.

 

FULL TRANSCRIPT

   1                       Day 25, 8th June 1999
   2   (9.30 am)
   3           DR JOHN ROYLANCE (RECALLED):
   4          EXAMINED BY MR LANGSTAFF (CONTINUED):
   5   MR LANGSTAFF: Good morning, sir. Today we begin, as you
   6     know, at 9.30. Can I say now, for the interests of
   7     those in the hearing chamber, that we will sit until
   8     10.45 or thereabouts; we will begin again at 11.00. At
   9     12.15 there will be a break of 45 minutes for lunch, and
  10     then an afternoon session which will go from 1 o'clock
  11     until 2.15, and if necessary, if Dr Roylance has not
  12     finished his evidence by then, from 2.30 until somewhere
  13     round about 3.30.
  14        Dr Roylance, you have heard that; you know what is
  15     in store for you?
  16   A. I am obliged, yes, thank you.
  17   Q. Dr Roylance, suppose that you were aware, or became
  18     aware, that part of the service provided by the Bristol
  19     Royal Infirmary, or for that matter, the Children's
  20     Hospital, was or had severe shortcomings in the sense
  21     that it was performing, so far as one could tell, much
  22     less adequately than other similar institutions
  23     elsewhere in the United Kingdom.
  24        Dividing my question up into the time when you
  25     were District General Manager and Chief Executive, as
0001
   1     District General Manager would you have conceived it as
   2     any part of your role to do anything about it?
   3   A. Yes. If it had been brought to my attention that any
   4     part of the service, anywhere, was substandard, and
   5     particularly -- it would usually be I expect in the
   6     terms that it is unacceptably substandard, then I would
   7     take the appropriate steps.
   8   Q. Does the same answer apply when you were Chief
   9     Executive?
  10   A. Yes.
  11   Q. If it appears that the shortcomings were institutional
  12     in the sense that there were insufficient facilities or
  13     a lack of equipment which could not be funded, something
  14     which did not rely upon human beings as such but upon,
  15     as it were, bricks, mortar, money, so that they could
  16     not easily be remedied, would you, as part of your
  17     appropriate action, consider stopping the service?
  18   A. I am sorry, I am pausing because I am trying to put some
  19     flesh on that hypothesis. If, for any reason, the
  20     service provided was unacceptable, it would stop. I am
  21     not sure I would even need to stop it; I am quite sure
  22     the clinicians, having discussed the situation, would
  23     stop it themselves, but certainly, I would not tolerate
  24     and I would not expect anybody else to tolerate an
  25     unacceptable service.
0002
   1   Q. Suppose that the clinicians immediately responsible for
   2     the service wished to continue it, even though it was to
   3     the objective view, the outsider's view, unacceptable,
   4     would you take action or would you say that was a matter
   5     for the clinicians themselves?
   6   A. I find that hypothesis difficult to grasp, because
   7     I cannot imagine this happening, so I am sorry, but if
   8     somebody had so little insight into a situation, then
   9     I think I would ensure that the "three wise men" would
  10     advise me. It is the wrong way round for the three wise
  11     men, they are supposed to have matters referred to them
  12     by colleagues and not for Chief Executives or District
  13     General Managers to know, but I really think that if
  14     anybody took that posture, I would be concerned about
  15     their health.
  16   Q. Suppose that the issue was not one of bricks and mortar
  17     or money, or equipment, but suppose that the issue were
  18     one of individuals, individual performance. Leave aside
  19     whether one would classify it as competence or not, but
  20     suppose the performance of an individual surgeon or
  21     clinician was unacceptably low in standard. Again
  22     splitting it between the Health Authority and the Trust,
  23     would you conceive it as part of the role of the
  24     District General Manager to do anything about it?
  25   A. We are tending to jump the hurdle of establishing
0003
   1     whether this complaint is well-founded, whether it is
   2     real, but as I understand your hypothesis, you are
   3     saying that it is brought to my attention that there is
   4     a genuine substandard service from somebody's
   5     incompetence, I would act.
   6        Could I make it less hypothetical and actually
   7     describe a situation that occurred, not in paediatric
   8     cardiac surgery at all?
   9        It was brought to my attention that a consultant
  10     was not meeting his obligations, it was not a question
  11     of life or death. If I describe what the situation was,
  12     then I am afraid it is a public meeting and the person
  13     would be identifiable, so I am not going to do that, but
  14     it was brought to my attention that the contribution of
  15     a consultant to the service at Bristol was inadequate.
  16     I met him, discussed it with him, and he agreed the
  17     shortcoming and agreed to put it right. He did not, so
  18     I saw him again. I discussed it and said, this would
  19     not do, but I would give him two days to decide his
  20     future. At the end of that time, I would initiate the
  21     processes resulting in his dismissal. He took early
  22     retirement and the situation was solved.
  23   Q. So the answer is, not only you would take action, but
  24     you did in an appropriate case?
  25   A. Yes.
0004
   1   Q. You rightly say that whether you were in a position to
   2     take action or not would of course depend upon the
   3     information that came to you, and whether or not there
   4     were a proper case for action?
   5   A. The one thing I could not do is make the judgment as to
   6     whether the criticism was genuine and was well-founded.
   7     I could not, myself, make a judgment as to whether the
   8     quality of care or the competence was inadequate. But
   9     if it was made clear to me that it was, I would act. If
  10     it was made unambiguously to me as an accusation, as an
  11     anxiety, then I would institute the necessary
  12     investigation. Again, I cannot tell you what it would
  13     be unless we actually spend a long time specifying the
  14     example, but one would normally seek the advice of
  15     experts in the field who could make the judgment, and if
  16     there was some real concern, then it would be my
  17     responsibility -- and this happens about the country --
  18     to suspend the individual concerned until the facts of
  19     the matter were established and agreed upon.
  20   Q. Just completing this particular part of your evidence,
  21     you mentioned the possibility of referring the clinician
  22     who failed to recognise that his service was substandard
  23     to the "three wise men" procedure, and you indicated you
  24     would do so on the basis that it would show that there
  25     may be something, as it were, medically wrong with that
0005
   1     individual in failing to have that perception?
   2   A. I do not want to use exaggerated terms, but I would not
   3     think that somebody was in possession of their faculties
   4     if they were producing a substandard service and did not
   5     know, or did know and wished to continue to do so.
   6     I mean, I do not find that compatible with an
   7     intelligent, fit, consultant.
   8   Q. You mentioned yesterday a Health Circular (82)13
   9     which I understand to have laid down the "three wise
  10     men" procedure. May we have a look at it? It is
  11      UBHT 61/266. Can we, having identified it, scroll down,
  12     please?
  13        The recommended procedure. Can we scroll down
  14     further? We see first of all the recommended procedure:
  15        "There should be a special professional panel set
  16     up by the District Hospital Medical Committee or Medical
  17     Executive Committee consisting of members of the senior
  18     medical or dental staff for which in each case a small
  19     sub-committee should be appointed. The sub-committee
  20     should receive and take appropriate action on any
  21     reported incapacity due to physical or mental
  22     disability, including addiction ...", and so on.
  23        This is what became known as the "three wise men"
  24     procedure, is it?
  25   A. Yes. I think that is often the process and in Bristol,
0006
   1     if I can tell you, the three wise men consisted,
   2     comprised, the Chairman elect, the Chairman and the past
   3     Chairman of the Medical Committee, ex officio, so there
   4     was permanently three wise men and everybody knew about
   5     it. The staff were regularly reminded, not just medical
   6     staff, all staff, and at some time in my experience,
   7     I cannot remember quite when, a fourth was seconded to
   8     them as a psychiatrist, normally the Chairman of the
   9     Division of Psychiatry.
  10   Q. This procedure, if we scroll back to the top of the
  11     page, it is intended to deal with physical or mental
  12     disability of staff?
  13   A. Yes.
  14   Q. It is incapability rather than incompetence?
  15   A. Well, I think in practice it is a moot point where one
  16     starts and the other ends. If somebody is showing signs
  17     of not being able to do their job, then this is the
  18     mechanism that is adopted, because you cannot prejudge
  19     in a situation like that why they are not doing their
  20     job.
  21        So suspected incompetence, for whatever unknown
  22     reason, would have been referred to them. I mean,
  23     I was, for six years, having been a Chairman, therefore
  24     a Chairman elect and a past Chairman, one of the "three
  25     wise men", and I know the system well.
0007
   1   Q. Can we have a look at paragraph 15 of the circular, on
   2     the next page, please. "The recommended procedure", it
   3     says there, "is intended to deal with cases where
   4     disability, including addiction, is suspected in
   5     a member of medical or dental staff which might be to
   6     harm or danger to patients. It is not intended to
   7     replace or detract from the procedure set out at
   8     HM(61)112 and section 34 of the Whitley Council
   9     conditions of service. It may be appropriate to use the
  10     procedure recommended above where it is possible that
  11     disciplinary action could arise but where there is
  12     reason to suspect disability."
  13        That appears to draw a distinction between the
  14     incompetence case and the incapability case. You are
  15     saying you creatively would have used the procedures to
  16     deal with a case of incompetence by labelling it because
  17     of your suspicions as to the faculties of the individual
  18     concerned as a capability case.
  19   A. Well, can I just try and make that clear? You are
  20     rather presuming that from the outset it is obvious that
  21     somebody's incompetence is due to mental ill-health or
  22     disability, or due to incompetence or some other
  23     reason. That actually in practice is not the case.
  24     What is needed is a system like this where there is the
  25     possibility for anybody on the staff who has any anxiety
0008
   1     about the quality of care of the consultant, to share
   2     that anxiety anonymously with three wise men, one of any
   3     of the three wise men, and be satisfied that the
   4     appropriate steps would be taken.
   5        Clearly, the person making the complaint will not
   6     be in a position to judge the cause of the incompetence,
   7     I mean, even the psychiatrists working with them may not
   8     be able to determine that until after considerable
   9     discussion, and so on, so you cannot prejudge the case.
  10        Should a matter of clear-cut discipline arise,
  11     then the other procedures would be set out, but it is
  12     more difficult to get the information we are discussing
  13     on that basis.
  14        So I would think in practice, not because we
  15     thought it was kind, but because it worked, in practice
  16     matters of incompetence would firstly be reported to the
  17     three wise men. They certainly were to me when I was
  18     one of the three wise men, and if, as a result of the
  19     deliberations of the three wise men, and anybody else
  20     they chose to invite to help them, it made it clear that
  21     this was a disciplinary matter to be dealt with by the
  22     authorities, then that would happen.
  23   Q. In any event -- perhaps I should ask you, if you had
  24     a complaint from a patient or for that matter a general
  25     practitioner which related purely to competence, would
0009
   1     that go to the three wise men?
   2   A. No. If it came from a patient, it would be dealt with
   3     as a complaint for a clinical matter and if they were
   4     not satisfied by the original investigation and
   5     response, then that patient or relative would be told
   6     they have the option of referring it for formal clinical
   7     review, and there was a mechanism in which appropriate
   8     experts would be set up to investigate the matter,
   9     interview the complaint and interview the subject of the
  10     complaint.
  11        But that is the clinical complaints procedure. It
  12     is quite different from this.
  13   Q. If it came from the GP, the same would apply, would it?
  14   A. Well, I think the GP would likely communicate. I do not
  15     know what the GP would do. It would depend who he
  16     told. But I imagine -- I do not think a GP is excluded
  17     from asking for a clinical review. I do not remember
  18     anything in a document that precludes that. If it did
  19     and he wanted it, he would ask the patient to ask for
  20     it. I do not see that there is a difficulty there.
  21   Q. In any event, before any action could be taken, you
  22     would have to be satisfied as to the circumstances in
  23     which action might or might not be called for?
  24   A. Oh yes, I mean, no Chief Executive or District General
  25     Manager could behave in an irresponsible individual
0010
   1     way. You could only respond in matters of expertise of
   2     this nature on the basis of very clear-cut unambiguous
   3     advice.
   4   Q. You say at page 30 of your statement, the very last
   5     sentence, that you consider that the structure and
   6     attitudes within UBHT were probably comparable with most
   7     organisations involved in risky activities?
   8   A. Yes.
   9   Q. So you took the view that UBHT was involved in a risky
  10     activity, did you?
  11   A. Well, I do, but I would want to make sure that you and
  12     I understood what I meant by that.
  13   Q. Tell me.
  14   A. Well, if, for instance, you are providing a, shall we
  15     say, an operative service in a serious condition with
  16     a high mortality rate, I think that would conform to
  17     what I mean by a "risky procedure", a risky activity.
  18   Q. I had thought that is what you would have meant, but
  19     I am grateful for your confirmation. In essence, if
  20     things are not done right, then there is a risk --
  21   A. No, there is more than that. There is a risk if they
  22     are done right. I mean, virtually everything that is
  23     done has a risk. I mean, I was a radiologist in my day
  24     and performed investigation of kidneys in people with an
  25     excretion urogram and we were not able to establish for
0011
   1     certain whether the death rate from this purely
   2     investigational exercise was one in 8,000 or one in
   3     3 million.
   4   Q. I accept that --
   5   A. So what I am trying to say is, I do not know of anything
   6     of significance that is done to patients that does not
   7     carry a risk. It does not have to be done badly to
   8     carry a risk.
   9   Q. That is entirely accepted. The issue, I think, is when
  10     an organisation is involved in a risky activity of
  11     patient care, which may, for reasons completely
  12     unconnected with the organisation, but for reasons
  13     connected with the condition of the patient, involve
  14     a risk to their survival or continuing good health.
  15        It is also the case, is it not, that that risk can
  16     be amplified or reduced by measures taken by the
  17     hospital institution?
  18   A. No, I do not think that is true. Not the hospital
  19     institution. I do not think anything I did raised or
  20     lowered mortality rates in treatments.
  21   Q. So you saw your work as Chief Executive as having no
  22     effect upon hospital treatments and their success?
  23   A. I am not sure I understand your question. I did not
  24     treat people and I did not increase or reduce the
  25     capacity of the consultant staff to be successful or
0012
   1     not. I created an environment in which they exercised
   2     their skills.
   3   Q. An environment in which there was inevitably risk to
   4     patients?
   5   A. Well, we have already established, have we not, that
   6     there is, for virtually every procedure, a hazard, even
   7     giving drugs, there is a hazard. Everything carries
   8     a hazard. They are not always as accurately quantified
   9     as we would like, but they are recognised.
  10   Q. "Other organisations involved in risky activities"
  11     is the comparison you draw at page 30, in that last
  12     sentence.
  13        Other organisations involved in risky activities
  14     have mechanisms and measures for quantifying the risk?
  15   A. Just hold on. No, I must be very careful about this,
  16     because you are talking about, if you are, management
  17     cultures. There were two sorts of management cultures
  18     on which we have been peripheral at the moment. There
  19     is the role model management culture, the administrative
  20     one which is full of job descriptions, policies and
  21     protocols, which is designed to maintain a stability and
  22     a status quo. It works very well if you are canning
  23     baked beans or making Ford Fiestas.
  24        There is another sort of organisation where what
  25     happens is a series of individual interactions between
0013
   1     the skilled person and the recipient of that skill.
   2     Each interaction is totally unique. In order for the
   3     experts to make sense of them, they group them into
   4     heterogeneous groups and try and make some deductions
   5     about it, but each individual interaction consists of
   6     a unique situation in which the expert exercises
   7     personal professional decision-making within a situation
   8     of professional freedom.
   9        The thought that you can standardise that into
  10     some sort of protest is mistaken. The only time it is
  11     done satisfactorily to my knowledge is in a teaching
  12     situation when the person making the decision is not yet
  13     fully competent, so there are guidance and guidelines.
  14        But I could just finish, perhaps, by saying that
  15     should I become ill, I would not want to be treated by
  16     somebody keeping to guidelines; I would like to be
  17     treated by the person who drew up the guidelines. In
  18     a teaching hospital, that is what happens.
  19   Q. Is the object to reduce whatever risk there may be to
  20     the lowest level reasonably practicable?
  21   A. Yes, that is the responsibility of the expert treating
  22     the patient.
  23   Q. Is it also the responsibility of the structures and
  24     systems within which that expert operates to contribute
  25     to the expert's potential success in so reducing the
0014
   1     risk?
   2   A. You would have to specify what sort of policy you meant
   3     for me to be able to answer that. The sort of policies
   4     I am thinking of is a security policy and a fire policy
   5     and so on, to make sure that the accommodation is
   6     appropriate, but if you are saying that I should ensure
   7     there is a protocol or a policy which that person must
   8     follow, then I would say that is not true.
   9   Q. Let me give you an example. It may be a silly or
  10     extreme example, but I would welcome your comment on
  11     it. Suppose one had a doctor who, having gone through
  12     the teaching process, became a consultant, so he is [let
  13     us assume he is a "he"] a proper professional man
  14     entitled to exercise professional judgment and skilled
  15     at doing so.
  16   A. Yes.
  17   Q. Suppose that he then exercises his clinical skills
  18     without ever picking up another medical journal, going
  19     to any medical conference, and doing what he does
  20     entirely in isolation from the wider medical community,
  21     albeit that he operates within the hospital.
  22        That individual would not, would he, be keeping
  23     abreast of the latest developments in medical thinking
  24     and medical approach?
  25   A. Well, I cannot talk about where it might happen
0015
   1     elsewhere. I would tell you that such a person would
   2     not survive a year in a teaching hospital. Perhaps they
   3     would not survive three months in a teaching hospital,
   4     but they would not survive a year in a teaching hospital
   5     if they took no part in the development of care and in
   6     keeping up to date. The whole culture of a teaching
   7     hospital could not countenance that.
   8   Q. So it would be part of his job, would it not, to keep
   9     himself up to date, and part of management's role,
  10     I suggest, to give him the opportunities to do so?
  11   A. Yes. I mean, when you say "management's role", it was
  12     usually done because there were things like that within
  13     the consultant's process, but there was, for example,
  14     a study in budget which was delegated usually to the
  15     Medical Committee, the internal Medical Committee, who
  16     would make judgments on the best way of allocating that
  17     resource. I did my best within the directorate system
  18     to try and enhance that limited budget.
  19        So, yes, there were ways in which medical staff
  20     facilitated members of the medical staff pursuing it,
  21     and if I could say, more recently, it has been
  22     formalised into a documented continuing medical
  23     educational system, again supervised by the Colleges.
  24   Q. And the process of clinical audit is essentially an
  25     educative tool and informative tool, is it not, which
0016
   1     will assist any medical professional in doing their
   2     best?
   3   A. The formal audit system, if that is what you are talking
   4     about, was intended to become such. It certainly was
   5     not by the time I left, and I cannot tell you, but
   6     I suspect it is not yet. It is a developing audit
   7     process and the time I was there, there were more
   8     problems about how to engineer circumstances so that the
   9     time could be found how to make sure that we had
  10     competent audit assistance and how we could develop and
  11     streamline and make more appropriate the information
  12     technology to support audit. I think it would be quite
  13     wrong to say that audit was taking place, in the sense
  14     that I would mean audit, in 1995 in the Health Service.
  15   Q. Does audit not consist of monitoring performance against
  16     agreed standards?
  17   A. Yes, but you have to first of all agree the standards,
  18     and then find a way of monitoring against it. I do not
  19     think there were any agreed standards by 1995.
  20   Q. And again --
  21   A. I cannot say for certain there was not one somewhere,
  22     but as a generality, there were not.
  23   Q. Again a hypothetical question: do you conceive that it
  24     was part of management's responsibility to take any
  25     steps in respect of any clinician or department which
0017
   1     was found, on monitoring their performance against any
   2     agreed standard, to be dropping some distance below that
   3     standard?
   4   A. Well, as I say, it would have been by the time we
   5     reached that situation. It is a hypothetical question
   6     because we had not reached the situation where that sort
   7     of information was available when I was there, not from
   8     the formal audit process. I have to be careful in
   9     words, because in teaching hospitals, we all, when I was
  10     a radiologist and everybody else, reviewed the care of
  11     patients as topics often resulting in a publication in
  12     a literature, recommending from that review what might
  13     be the best way to diagnose a condition, what might be
  14     the best way to treat a condition, so that sort of
  15     study, retrospective and prospective study, was
  16     continued; it was called in those days "research", not
  17     "audit".
  18        When audit was introduced, there was a fundamental
  19     difference and that is that audit was aimed,
  20     eventually -- and I was an enthusiastic supporter of
  21     this -- to have credible realistic standards of outcome
  22     right across the board and the continuing monitoring
  23     against those standards. That is what audit will be,
  24     I hope, one day. But it was not in 1995.
  25   Q. I appreciate the change of approach from time to time
0018
   1     throughout the period with which we are concerned. Can
   2     we look, please, at UBHT 234/177?
   3        It is a letter to you from Mr Reynolds. Can we
   4     scroll down, please, leaving the heading as it is?
   5        "The development of quality assurance - general
   6     management aspects."
   7        It talks about the development of quality
   8     assurance.
   9   A. Yes.
  10   Q. Quality assurance, obviously, looks for standards of
  11     quality in patient care?
  12   A. Yes.
  13   Q. This being 1986, are we looking here at a forerunner of
  14     what became known as medical audit?
  15   A. No, it is quite different. I find difficulty in
  16     producing a simple word. There is therapy applied to
  17     patients, not just clinical, not just medical, the
  18     nurses and all the rest of it, applying care to
  19     patients. This is the quality of the environment in
  20     which that care was taken. It is an early start;
  21     eventually it became Charter standards, I think
  22     Patients' Charter standards and we got the Charter
  23     Mark. It was in a sense whether the patient enjoyed the
  24     experience, whether telephones worked, whether the
  25     television was available, the whole environment, but it
0019
   1     was non-clinical and had nothing to do with therapy.
   2     Well, please, everybody would say the environment
   3     assisted therapy, so this is why -- what I am talking
   4     about is, it had nothing to do with the exercise of
   5     professional judgments on the part of carers.
   6   Q. Right. Can we move then to UBHT 271/19? This is
   7     a clinical audit review meeting of the UBHT on
   8     11th November 1992. We see that you were there, as were
   9     others from the Health Authority. This is after the
  10     purchaser/provider split.
  11        Can we go overleaf, please? "Bristol and District
  12     discussion paper on clinical quality."
  13        So we are now looking at clinical issues.
  14        "John Roylance commented that in his view the way
  15     that care is carried out is the responsibility of the
  16     Trust, but the outcome is Bristol and District's domain,
  17     both in terms of patient acceptability and health gain."
  18        Pausing there, was that your view?
  19   A. Well, it says so. I do not know whether I signed it and
  20     agreed it, but I think, looking back, what I was trying
  21     to say is that it was for Bristol and District, who were
  22     responsible for the community, to satisfy themselves
  23     that the health care that they were purchasing was
  24     producing a maximum benefit for their community.
  25     I think I was trying to encourage Bristol and District
0020
   1     to accept the totality of their responsibility as
   2     a purchaser.
   3   Q. The distinction, as expressed, and I appreciate that
   4     they are not your words, but the distinction appears to
   5     be between methods, clinical methods, which you are
   6     recorded as saying -- or "you" for the Trust -- and
   7     results, which was for somebody else to be concerned
   8     about?
   9   A. Yes. What I think I was trying to say, and please,
  10     I have not seen this document since it was written,
  11     I suspect. What I wanted to say is that Bristol and
  12     District, in placing contracts either with us or with
  13     other Trusts, could not disassociate themselves from the
  14     benefit that those contracts were achieving for
  15     patients.
  16        I actually was encouraging -- I mean, I think at
  17     that time, if not shortly afterwards, I was urging us to
  18     start very gently moving forward to the time where
  19     clinical outcome was put in the contract. If I could be
  20     simple: that if they bought 100 operations for
  21     reconstructing the arteries of the lower limb, the
  22     contract could ultimately, one day, include how many
  23     patients would still have the leg on after a year.
  24        If they were not interested in that, then they
  25     started going back to concentrating on the process
0021
   1     rather than the value of the process. I was trying to
   2     encourage everybody to look at audit. I think this
   3     antedated the national initiative on clinical audit --
   4     it may not have done -- but we were discussing together,
   5     as we often did, how we could assist in the improvement
   6     in contracts to make them more, what shall I say,
   7     patient benefit sensitive.
   8   Q. Is it then the case that the Trust were concerned and
   9     interested in the outcomes of the methods of treatment
  10     which they applied?
  11   A. Well, of course we were interested in it. I was trying
  12     to make sure that the purchasers of the health care were
  13     interested in it. I mean, if I can use a simple
  14     analogy, because I am not experienced in commerce I may
  15     be wrong, but if a major store places a contract with
  16     a manufacturer to produce goods, I believe that the
  17     major store should be concerned about the quality of the
  18     goods.
  19        Now of course the provider has to be concerned
  20     about the quality of the goods or they do not sell any
  21     more. What I was trying to say, it would not be enough
  22     for the purchasers employed by the store to satisfy
  23     themselves that they just bought the stuff and stuck it
  24     on the shelves.
  25        Does that explain my meaning?
0022
   1   Q. I follow your statement that it was in essence a dual
   2     responsibility, that both purchaser and provider had
   3     responsibilities?
   4   A. There was no way the Trust, the staff in the Trust, can
   5     absolve themselves of an interest in the outcome. There
   6     was no question about that at the time. Clinicians then
   7     and clinicians now were very concerned in the outcome.
   8     I wanted to make sure that Bristol and District
   9     addressed their interest in the outcome.
  10   Q. So what you needed then was the systems within the Trust
  11     to identify the outcome, so that you could be concerned
  12     with them?
  13   A. Yes, and the purchaser to pay for them so that we could
  14     have them.
  15   Q. Can we have the witness statement of Mr Stone,
  16     WIT 112/27.
  17        Can we go over the page? Can we go back to
  18     page 11, paragraph 27? It is my fault. Can we
  19     highlight paragraph 27, please?
  20        What Mr Stone is saying here is that the
  21     prevailing view within first the District and then the
  22     Trust was that the medical staff were professionals and
  23     thereby self-correcting, "their clinical work as against
  24     workload contracts and issues did not need to be
  25     controlled through the management process."
0023
   1        That was the prevailing view, was it?
   2   A. I think it was an observation. I am not sure about the
   3     "did not need to be". I think that relieves management
   4     of the process. It is not the prevailing view, it is an
   5     actual situation, part of the contractual employment of
   6     consultants was that they could exercise free clinical
   7     judgment.
   8   Q. And the last sentence of the preceding paragraph:
   9        "The medical audit was part of an initiative led
  10     by the Regional Medical Officer and was very much the
  11     preserve of the medical profession", so that this was
  12     controlled professionally rather than managerially?
  13   A. Yes, I think that reflects the introduction of it,
  14     because the medical audit, it became clinical audit
  15     after that, but medical audit was introduced on the
  16     professional network from the Regional Medical Officer
  17     and his Regional Hospital Medical Advisory Committee to
  18     the consultants within the staff through the Medical
  19     Committee and their divisions; it was not through the
  20     management process; it did not come from the Regional
  21     General Managers.
  22   Q. Can we please have WIT 89/34? This is Rachel Ferris's
  23     witness statement. She says in the third bullet point
  24     down -- she is looking at the 1994/95 period -- systems
  25     of audit did exist but they were crude in 1994/95. It
0024
   1     must, I think, follow that they were no less crude
   2     before that. "These are now multidisciplinary and the
   3     systems themselves provide more accurate and complete
   4     information. I would say that our audit systems are now
   5     amongst the best in the country."
   6        Is she right in saying that such systems of audit
   7     as existed were, at least in 1999 eyes, crude in
   8     1994/95?
   9   A. Well, we would all use different descriptions. I would
  10     say non-existent, because I was unaware, I do not think
  11     anybody had agreed standards, certainly not across the
  12     board. As far as I was concerned, we were desperately
  13     trying to encourage the introduction of this and we got
  14     as far as 1993, I think it was, and we had something
  15     from high, something I should have been the start of,
  16     saying effectively we should not have medical audit, we
  17     should have clinical audit, and the philosophy of that
  18     is that we should audit patient care against the outcome
  19     and not just one element of it. It represented
  20     a recognition that it was not just care by a doctor by
  21     which patients had good outcome. I do not need to
  22     emphasise that nursing had a major part in patient
  23     benefit and so did the professions allied to medicine.
  24        So we started again in 1993, all over again, to
  25     create a medical audit system and if you can imagine it,
0025
   1     the information technology that had been developed was
   2     now inappropriate; it had to be changed. The structure
   3     was inappropriate; it had to be changed. As I recall,
   4     in 1993 we were very much urged by the Department of
   5     Health to do everything we could to get it up and
   6     running by 1998, not by 1995, 1996; the actual message
   7     from the centre, the great enthusiastic encouragement,
   8     helped us all to work very hard so that we could at
   9     least try to achieve it within five years. I think that
  10     was a realistic estimate. So, I am really not --
  11     I mean, I think that second half is no more accurate
  12     than complete. It is optimistic, shall we say.
  13   Q. Do I understand that the way in which the audit systems
  14     operated whilst you were Chief Executive was for the
  15     responsibility for the audit to be devolved to the
  16     directorates?
  17   A. From where? It started -- I mean, audit was at
  18     directorate level, it was not devolved there. Can
  19     I remind you that audit introduced by the Regional
  20     Medical Officer was introduced directly to caring,
  21     consultant members of staff and they were in
  22     directorates.
  23        That is where audit was introduced. It was not
  24     introduced at Trust level and delegated; it was
  25     introduced at operational level and Trusts, with some
0026
   1     initial difficulty, tried to pick up the pieces and
   2     introduce a little bit of management competence to make
   3     sure it was introduced effectively and more speedily
   4     than was the case. So the Finance Director said, "You
   5     cannot have money going straight from Region into
   6     divisions. You put it in my bank and I will allocate
   7     it", and that sort of thing.
   8   Q. So each directorate had the responsibility for auditing
   9     its own work?
  10   A. No, not the directorate. Please, the director and the
  11     directorate is a management structure. We still had, in
  12     effect, a divisional advisory system, and it was
  13     introduced as a professional system at divisional and
  14     not directorate level.
  15   Q. Thank you. Can we have a look at UBHT 98/13?
  16        These are minutes of the Steering Committee with
  17     chairmen of divisions for 5th January 1994. Can we go
  18     to page 17, please?
  19   A. Can you just remind me, this is now two years later?
  20   Q. This is now January 1994.
  21   A. Yes.
  22   Q. "Clinical audit". We see Dr Thomas reporting that it
  23     was "the government's intention that Trusts should move
  24     towards multidisciplinary clinical audit and although
  25     there are several problem areas, a number of
0027
   1     departments, specialties, were in fact already carrying
   2     this out. However, there was concern that medical audit
   3     will be marginalised under the pressure from clinical
   4     audit."
   5        It goes on.
   6        The second paragraph is what I want to ask you
   7     about. Can we scroll down, please?
   8   A. Could I just emphasise, you will notice this is all
   9     being discussed not in a management forum but in
  10     a medical advisory forum. The Steering Committee is the
  11     Steering Committee of the Medical Committee, not of the
  12     Management Board.
  13   Q. Thank you.
  14        "Dr Thomas said we have been criticised for the
  15     way in which audit money has been distributed in the
  16     past via the clinical directorates as it could be
  17     construed that there is no clear evidence that these
  18     funds were spent on audit."
  19        Just stopping there, was the money for audit
  20     distributed in the past, up to 1994, via the clinical
  21     directorates?
  22   A. I think you really ought to ask Graham Nix about this,
  23     as the precise mechanism. It started off as something
  24     that was a bit of a shambles, and Graham Nix talked to
  25     his colleagues at Region and said "You must formally
0028
   1     give this to the Finance Department", which they did,
   2     and he ringfenced it and authorised its use for the
   3     payment of clinical assistants and for the purchase of
   4     equipment.
   5        The clinical directorates, although they employed
   6     their staff, they did not write their cheques, they did
   7     not pay them; the Finance Department did. So I think,
   8     in all honesty, it does not mean anything other than
   9     that the money was held and monitored by the Finance
  10     Director, and he would have incorporated it so that the
  11     Trust and everybody understood what was going on within
  12     the budget of the appropriate directorates.
  13        The medical advisory structure did not have
  14     a budget; it was the medical advisory structure. So it
  15     could not have been delegated to them; there was no
  16     mechanism to do so.
  17        This is what I said. When it started off it was
  18     a professional-to-professional introduction and we had
  19     to rationalise it and make sure that we knew and could
  20     tell Region where every penny of audit money was spent
  21     and to satisfy Region that it was spent on audit.
  22   Q. What is suggested in the first sentence here is that
  23     money for audit was not being spent on audit?
  24   A. Well, I can guarantee that not a ha'penny of audit money
  25     was spent on anything but audit. It was a ringfenced
0029
   1     sum of money in addition to the Trust's allocation and
   2     there was no way the Trust could quietly filch it, or
   3     anybody else.
   4   Q. So whatever the source of Dr Thomas's view that there
   5     was no clear evidence that the funds were in fact spent
   6     on audit, he must be wrong?
   7   A. He is wrong.
   8   Q. Can we look at UBHT 30/24, please. This is now April
   9     1994 and the Chairman inviting committee members to give
  10     their views on clinical audit, and the role of the
  11     Clinical Audit Committee?
  12   A. I am sorry, this is a Steering Committee, is it?
  13   Q. Can we go back a couple of pages and we will see what it
  14     is?
  15   A. I am sorry to be awkward, but it does make
  16     a difference.
  17   Q. It is the UBHT Clinical Audit Committee.
  18   A. No, this is the reforming Clinical Audit Committee. You
  19     will see that I was invited by special invitation to try
  20     and give some lead and clarity to what we were trying to
  21     do.
  22   Q. Then back to the next page, please. Can we scroll down
  23     to what it had to say. You pointed out the function of
  24     the group, I think that must be the Clinical Audit
  25     Committee, "would be a supportive one to directorates
0030
   1     because in future, clinical audit will form an important
   2     part of contracts. There will therefore be
   3     a requirement for the development and nurturing of
   4     acceptable outcome measures. The committee would
   5     obviously have a role in advising the Trust Board,
   6     probably via the Medical Director. It was clear that
   7     members had some concerns that the committee had no
   8     specific resources and that its influence on the conduct
   9     of audit would necessarily be an indirect one."
  10        Was it right that the committee set up to deal
  11     with audit had no specific resources?
  12   A. Yes. This is at a time when it was developing and
  13     I remember some of the turmoil, and in fact some of this
  14     did not materialise, so this was an early discussion.
  15     A number of things changed with the introduction of
  16     clinical audit. It was no longer, as somebody said,
  17     a "pursuit by consenting adults in private", in other
  18     words, it was no longer a matter for the medical staff
  19     to pursue in private. It had now become
  20     a multidisciplinary process and therefore could not
  21     reside, if I may say so, in the professional advisory
  22     structure of the Medical Committee, the Steering
  23     Committee, and through the Chairman of the Medical
  24     Committee to the Trust Board.
  25        It had now to be on a management basis, because it
0031
   1     was multidisciplinary and we had to get it up and
   2     running.
   3        I think Dr Thomas had a number of concepts of how
   4     this should go. He was worried about immediate medical
   5     audit disappearing, he wanted it to continue and so on,
   6     and he had anxieties about this new initiative. As
   7     I remember, he resigned as Chairman of this committee
   8     after a while because it did not seem to be doing what
   9     he wanted to do. We eventually, after much discussion,
  10     of which this is a small part, made the Clinical Audit
  11     Committee report through the Patient Care Advisory
  12     Committee, and through that committee to the Board. The
  13     Chairman of the Clinical Audit Committee was invited to
  14     attend that committee, to shorten the lines of
  15     communication.
  16        I think Trevor Thomas -- I do not want to malign
  17     him and you may be able to ask him, but I think he,
  18     having chaired the Medical Audit Committee, wanted to
  19     control medical audit outside management as
  20     a professional thing, and himself being in charge. That
  21     could no longer be appropriate. What the Clinical Audit
  22     Committee had to do was to monitor the activities now of
  23     management and of audit activity, and report in the
  24     manner I have said to the Trust Board, and to me, to
  25     assure us that it was continuing.
0032
   1        The committee in my view, was developing --
   2     probably always had -- a clear monitoring role to ensure
   3     audit was taking place; it was not itself managing
   4     audit. Therefore, it was to one side of it. I think
   5     I could best describe what I believe Trevor Thomas
   6     wanted was a separate management structure going back to
   7     a system I may have described yesterday, when I became
   8     District General Manager of having a quite separate
   9     management structure for audit, and clearly, that could
  10     not have survived.
  11   Q. So the system at this stage was for the Clinical Audit
  12     Committee to monitor audit to report to the Patient Care
  13     Advisory Committee and report through them to the Board?
  14   A. Not at this stage. We had not got that far. This is an
  15     element of the considerable discussion that took place
  16     in order to achieve what was ultimately achieved, and
  17     that was achieved, as I remember, shortly before
  18     I retired, so I would not like you to think that this is
  19     a definitive step forward; this is a discussion which
  20     I was invited to, to get the views of the expanded
  21     Clinical Audit Committee to inform them, have a thorough
  22     exchange of information, so that that was one step in
  23     the consultation process which we went through in order
  24     to achieve clinical audit. I mean, there were a lot of
  25     other people to talk to, there were nurses doing their
0033
   1     own audit, physiotherapists and so on all doing their
   2     own audit, and I had to go around with others and talk
   3     to those and say "How can we bring this all together?"
   4   Q. The Regional Health Authority had a responsibility for
   5     monitoring audit, did it not?
   6   A. The Regional Hospital Medical Advisory Committee
   7     certainly set itself up to audit the introduction of
   8     medical audit. I am not sure about your next step.
   9     I mean, the Regional Health Authority, I think it was
  10     becoming an outpost of the Department of Health by then,
  11     had an interest in everything that went on, but whether
  12     they had charged purchasing Health Authorities to pursue
  13     audit or not, I cannot tell you. I think they probably
  14     did.
  15   Q. We will come to it in a moment. We have been looking
  16     here at a 1994 document. Can I trace something of the
  17     development of audit by going back to HA(A) 34/89, which
  18     is 16th January 1990.
  19        This is a memo from Dr Baker, the Director of
  20     Public Health Medicine. In 1990 he talks indirectly
  21     about medical audit?
  22   A. Yes.
  23   Q. He mentions that one area that needs to be tackled, the
  24     second paragraph, was that of medical audit, and he
  25     would wish through meetings with you to determine what
0034
   1     changes are necessary to achieve the right level of
   2     medical audit. His initial view is that most medical
   3     staff spend time already on audit or audit related
   4     issues and that if this time was used more efficiently
   5     then little change in programmes would be required.
   6        Then he adds this at the end:
   7        "This view, although strongly pragmatic, seems to
   8     be some distance from the view given by the Regional
   9     Medical Advisory Committee."
  10        Is he right that there was a difference of view
  11     between your approach and that of the Regional Medical
  12     Advisory Committee?
  13   A. I do not know at that moment. I mean, that is but part
  14     of the very early development steps of trying to get
  15     medical audit up and running. I mean, at this stage now
  16     I think that is an entirely transient document, and
  17     I really do not know. I mean, I do not know whether
  18     I was some distance from the view given by the Regional
  19     Medical Advisory Committee or Ian Baker had a different
  20     view of what the Regional Medical Advisory Committee --
  21     I really do not know. We had a whole series of very
  22     constructive discussions, and this is so early on that
  23     I really cannot -- I mean.
  24   Q. Let me move it on a little. UBHT 63/161: the District
  25     Audit Committee, annual report for 1990/991, with
0035
   1     Dr Thomas as Chairman, and it reports in the second
   2     paragraph, it has been produced by the newly constituted
   3     District Audit Committee, successor to the disbanded
   4     District Medical Information Working Party.
   5   A. Yes.
   6   Q. Then go down to the second paragraph:
   7        "The process of audit ... in 1990 has not been
   8     well documented, largely because of the lack of guidance
   9     and monitoring associated with the changing committee
  10     structure."
  11        Just pausing there, this, one understands, was at
  12     a time when Trust status was on the horizon, so there
  13     may have been a number of management changes, but what
  14     is complained about there is that there was an absence
  15     of documentation to enable one to see what process audit
  16     had made, a lack of guidance, a lack of monitoring.
  17        Is that historically right in respect of that
  18     time, or not?
  19   A. I would not like -- I mean, I find it difficult because
  20     we are all talking as if audit is going on, and I have
  21     to say at this stage we were all struggling for the
  22     introduction of audit, so to talk about monitoring the
  23     process of audit at that stage was wholly premature. We
  24     were monitoring the introduction of clinical -- I do not
  25     know that we necessarily had all the audit support
0036
   1     people in by then. This is the early stages of the
   2     introduction of a system and you are asking me questions
   3     as if we are talking about monitoring the system. By my
   4     standards, it did not exist. What did exist was a great
   5     deal of effort right across the Trust to try and
   6     establish a sensible process of audit. But if you had
   7     walked round with me at that time, you would not have
   8     seen anything that you and I would now recognise as
   9     audit.
  10   Q. Can we have a look at UBHT 58/26, and take it a year
  11     further on? This, I think, indicates that the medical
  12     staff have had some reservations about audit which are
  13     now resolving. Am I right to draw that conclusion?
  14   A. Yes. I remember at the time the Freudian slip of the
  15     spelling of "duel".
  16   Q. Yes.  UBHT 67/81; the Medical Audit Committee. Can we
  17     go down the page and go across, please, to 83?
  18        "Purchaser's access to audit information."
  19        This is June 1992?
  20   A. Yes.
  21   Q. Dr Thomas is referring to constant pressure from
  22     purchasers to have some access to audit information. We
  23     see that the meeting to which he refers of the Steering
  24     Committee, Mr Wisheart referred to the confidentiality
  25     of audit and confirmed that purchasers were requesting
0037
   1     more detailed information but Dr Thomas had assured him
   2     that he would resist any attempt by any purchaser to
   3     breach confidentiality. Should they require
   4     information, they would be referred to the relevant
   5     Clinical Director.
   6        Do I take it that there was at that stage,
   7     mid-1992, resistance for whatever good or bad reason
   8     from the medical staff to the audit results being
   9     available to purchasers?
  10   A. I think the resistance was led by Dr Thomas properly as
  11     the Chairman of that committee, again in the medical
  12     advisory structure, and he consistently reassured people
  13     this was a confidential audit process, and I think he
  14     was trying to make sure that he could deliver that
  15     promise, that it would be confidential. I mean, he may
  16     not have the letter, but there was clear instruction
  17     written, agreed at the Regional Medical Advisory
  18     Committee, Hospital Advisory Committee, or it was the
  19     sub-committee, the Regional Audit Committee, on which
  20     Trevor Thomas I believe also sat, that every care should
  21     be taken to ensure that the actual results of audit, the
  22     audit figures, should not come into the hands of
  23     management.
  24        The reason for that was that it was felt it would
  25     set back the introduction of clinical audit, or medical
0038
   1     audit, as it was then, very substantially; it would not
   2     profit. For that reason, because I was Chief Executive,
   3     and known as a doctor, and known to know his way round,
   4     I was extremely careful to be seen to be outside the
   5     audit process.
   6   Q. There are two stages in the answer you have given.
   7     I was asking about the position in so far as purchasers
   8     were concerned, and do I take it from your answer that
   9     you sympathised with the view expressed through
  10     Dr Thomas in that entry, that purchasers should not, at
  11     that time, have access to information because it was
  12     confidential to the clinicians?
  13   A. Yes. I was aware that for the effective introduction of
  14     audit, we needed to sustain the active support of the
  15     very people who could achieve audit or torpedo audit,
  16     and I was aware myself, and this was not a unique view,
  17     the Regional Hospital Advisory Committee and the
  18     Regional Audit Committee, I think there was one, were
  19     both instructing that audit and the outcome of audit,
  20     the actual figures, must remain confidential to those
  21     people who had done work which was audited.
  22        I was extremely keen that we should move very
  23     quickly to set up and introduce a viable audit system.
  24     I was extremely keen that the outcome of those audits
  25     should eventually form part of future contracts. I was
0039
   1     aware, and I think Trevor Thomas was more aware even,
   2     that we would run into a brick wall if we allowed the
   3     information to emerge from the actual audit level.
   4   Q. I am not clear from your answer whether you are saying,
   5     yes, you sympathised with the view at the time which was
   6     a necessary and pragmatic view --
   7   A. Yes.
   8   Q. -- to achieve the introduction of audit?
   9   A. Yes.
  10   Q. Or whether you are saying that whatever may have
  11     happened since, you think that this view nonetheless
  12     ought to hold good today as it did in 1992?
  13   A. What, the confidentiality bit, do you mean?
  14   Q. Do you maintain that is the case now?
  15   A. I do not know whether the clinicians have been
  16     reassured. I do not know whether that problem of
  17     anxiety has been overcome. Normally, when you change,
  18     when you do something new that appears threatening, and
  19     a lot of people find anything new threatening, you have
  20     to wait until reality has been experienced for some time
  21     for that anxiety to ameliorate.
  22        I would guess, and I can only guess, that we are
  23     nowhere near the position yet of making clinical audit
  24     a management tool.
  25   Q. That was the second part I was going to explore with
0040
   1     you. Is it your view that it should be a management
   2     tool?
   3   A. Eventually, but whether it ever will be, I cannot tell
   4     you.
   5   Q. But it plainly was not used as a management tool in
   6     Bristol Trust; it may be elsewhere, in 1992?
   7   A. I do not think it was used anywhere else. I do not
   8     think anywhere else had got audit as far as we had got
   9     it. I do not think the situation when I was there had
  10     arisen anywhere else, but I do not know. I can only
  11     talk about the South West.
  12   Q. You took yourself out of the loop so far as audit was
  13     concerned, because it was not management's business, is
  14     the way I understand you --
  15   A. No, I got myself out of the audit loop because I was
  16     absolutely certain that if I was seen in the audit loop,
  17     the audit would stop.
  18   Q. I see.
  19   A. Not that it was not my business, but that I had the
  20     ability seriously to delay the introduction of audit and
  21     I was not going to exercise that.
  22   Q. So the position I ask for your comment on is, if audit
  23     had revealed in any department or in respect of any
  24     particular surgeon an unsatisfactory result when
  25     monitoring performance against standard, management
0041
   1     would, for practical and pragmatic reasons in 1992, not
   2     have wanted to know?
   3   A. In 1992 the information you are hypothesising would not
   4     materialise. What I am trying to say is that audit
   5     requires a whole series of things and that is the
   6     establishment of standards and so on. What was being
   7     gone through here was audit of specific events.
   8     Perhaps, I do not know, but I would give you an example,
   9     they might audit the incidence of deep vein thrombosis
  10     in long operations, and audit the value of elastic
  11     stockings no doubt because that was something we audited
  12     years ago in my youth as a consultant, but they audited
  13     those sorts of specific features. We saw yesterday, did
  14     we not, somebody auditing the success of putting in
  15     a particular occlusive device in patent ductus
  16     arteriosus. That is -- I have used the expression
  17     elsewhere -- light years away from sorts of audit you
  18     are postulating could produce the sort of information
  19     you are postulating.
  20        Being told that this new device was not bad,
  21     perhaps ought to be used, is so far away from the sort
  22     of information you are postulating that I find it very
  23     difficult to give a sensible answer in terms of 1992.
  24   MR LANGSTAFF: Dr Roylance, we will take a break now,
  25     Chairman, until 11 o'clock?
0042
   1   THE CHAIRMAN: Yes. We meet again at 11, thank you.
   2   (10.50 am)
   3               (A short break)
   4   (11.00 am)
   5   MR LANGSTAFF: Dr Roylance, I take the point that you made
   6     just before the break, that the content of audit in
   7     1992/93 consisted in items such as the acceptability of
   8     the Rashkind device for occlusion of a patent ductus,
   9     and may not therefore have extended to what one might
  10     call the broader picture, the monitoring, for instance,
  11     of mortality rates from particular types of surgery.
  12        Did management, as you see it, have any role in
  13     saying to those who were conducting audit, "Well, ought
  14     you not to look at this? Ought you not to look at
  15     that?" To select the topics upon which audits could and
  16     should be carried out?
  17   A. No, early on I believe that would have been
  18     devastating. We did gently do it later, as I think you
  19     have seen, through the purchaser/provider link with the
  20     purchaser saying "We are going to buy a contract and we
  21     are going to include, audit money, and we would like you
  22     to include these things", but it does not say "We want
  23     you to do across-the-board audit of mortality". That at
  24     that time was not feasible.
  25   Q. Does it follow when assertions were made as to the
0043
   1     quality of the service which was provided, at least up
   2     to this stage, that there was no empirical statistical
   3     basis for making such a claim?
   4   A. What assertions are you addressing?
   5   Q. I am talking in terms of general assertions as to
   6     quality service.
   7   A. I am sorry, I do not understand. I really would like
   8     to answer your question, but I do not understand it.
   9   Q. In the first contract between the Health Authority and
  10     the purchasers, which we have copies of, for the
  11     provision of cardiac services in 1991, there is
  12     a commitment to providing a quality service by the
  13     Health Authority.
  14   A. Yes.
  15   Q. If necessary, we can look at the document. I was
  16     asking --
  17   A. If that is what it says, that would be entirely
  18     unexceptional. You would hardly put in the contract to
  19     provide poor service.
  20   Q. I was asking how management could assure itself of the
  21     quality of the service without --
  22   A. Management could not. I do not know why you suddenly
  23     introduced management. Management could not. In fact
  24     I tried to explain repeatedly that the involvement of
  25     management in medical audit at that time was recognised
0044
   1     throughout the South West region, not just Bristol,
   2     would have been an enormous hindrance.
   3   Q. Can I go back to an answer you made a moment ago? You
   4     suggested it would not have been feasible for management
   5     to direct the topic of audit in 1992/93, although that
   6     is what you did later.
   7        Why would it not then have been feasible?
   8   A. I hope I did not say that. I said it would not be
   9     appropriate for management to attempt to direct audit,
  10     and in fact the response to the sort of audit I think
  11     you are talking about would not have been feasible; the
  12     information technology, the time, the organisation,
  13     simply was not there.
  14        I am really trying -- we are dodging about.
  15     I perhaps have not made it absolutely clear, but
  16     clinical audit was an enterprise recognised as
  17     developing over a considerable period of time and as
  18     I say, before medical audit was up and running and in
  19     any sense robust, it was changed to clinical audit, and
  20     even with clinical audit, it was not expected to produce
  21     anything effective, anything that you could rely on as
  22     an audit thing, for another five years.
  23        So, really, when you keep asking me about the
  24     outcome of audit, I have to say that misrepresents the
  25     situation. What we were talking about is reporting the
0045
   1     developing process of audit and even the Audit Committee
   2     was charged with monitoring the development of the
   3     process of audit: Did people go? Were there meetings?
   4     How often were they? Was anything discussed? Was
   5     anything improved as a result of it? That was the
   6     purpose and the function of the Audit Committee -- the
   7     Medical Audit Committee.
   8        For you and I to be discussing that as what we
   9     were doing with the results of this audit process,
  10     I have to say, we had not got near that. I was spending
  11     my time encouraging people that this different form of
  12     audit was in their best interests and the patient's best
  13     interests, and so forth. I was not going around saying,
  14     "Have you got mortality figures for your hip
  15     replacements?"
  16        I mean, that is nowhere near the situation we were
  17     in at the time.
  18   Q. Can we have a look, please, at UBHT 29/78?
  19        What was the function of the Regional Audit Team?
  20   A. They were set up as a resource to try and encourage the
  21     development of audit. You see, it was not just local
  22     initiative, it was a regional initiative, it was
  23     a Department of Health-driven initiative and what the
  24     Region does on this scale is to try and develop a source
  25     of information, a source of expertise at regional level,
0046
   1     which was available to District, so we were not all
   2     inventing the wheel simultaneously.
   3   Q. Can we scroll down, please? It records the UBHT Audit
   4     Committee -- this is in 1994 -- is currently being
   5     restructured in line with requirements to move towards
   6     clinical audit. You have dealt with that already.
   7   A. Yes.
   8   Q. It says how the committee has opened its doors to two
   9     nominated therapy/paramedical staff, and so on.
  10   A. Yes.
  11   Q. The last paragraph on that page:
  12        "The organisation and direction/development of
  13     audit within UBHT has been significantly different to
  14     that of all other Trusts within the region. There has
  15     been a devolvement of the budget and all audit staff to
  16     a directorate level. This is in line with the
  17     decentralised philosophy of the Trust as a whole and
  18     operates successfully in the main by virtue of the
  19     immense size of the Trust."
  20        Just pausing there, are you in a position to say
  21     how similar the pattern and organisation of audit was in
  22     UBHT to other Trusts the Regional Audit Team might have
  23     looked at?
  24   A. I mean, I have only vague ideas now. I may have had
  25     some idea what was happening, we often did, we talked
0047
   1     a lot across-region, but I cannot tell you now what was
   2     happening. If the question is what was happening in
   3     other Trusts, I have to say today --
   4   Q. That is not the question. The question is, are you in
   5     a position to comment? You say you are not, really?
   6   A. On other Trusts?
   7   Q. Yes.
   8   A. Today I could not possibly speculate how far they had
   9     got at that time.
  10   Q. And it describes, does it, accurately, the way in which
  11     audit was organised in the UBHT at this time. Let us go
  12     back to the bottom of page 78, so we can look at it
  13     again.
  14   A. It was the way audit was developing at this time.
  15     I keep trying to be specific.
  16   Q. No, forgive me. It says in the second last sentence:
  17        "There has been a devolvement of the budget and
  18     all audit staff to directorate level".
  19   A. If I can explain that --
  20   Q. Dr Roylance, forgive me. The question is simple:
  21     was there or was not there not a devolvement of the
  22     budget and all audit staff to a directorate level? The
  23     answer must be "Yes" or "No".
  24   A. I am anxious you allow me to explain why that was right
  25     and why it was different to other Trusts.
0048
   1   Q. Let me please give you that opportunity. If you follow
   2     my questions, we will get it.
   3   A. Yes, but I was trying to expedite the thing. Forgive
   4     me.
   5   Q. So, I hope, was I, but let us not argue about who is
   6     going faster. Is the answer "Yes" to that sentence?
   7   A. It says there, I mean, it is an accurate description.
   8   Q. This is a document and I am asking whether that
   9     corresponds with your --
  10   A. If it had been wrong, I would have had it amended, so
  11     I am quite happy that that was what was said. I am
  12     sorry, I did not understand, you were asking me whether
  13     people wrote the truth and they usually do.
  14   Q. That may not always be the case. Can we look at the top
  15     of the page? "This is in line with the decentralised
  16     philosophy of the Trust as whole and operates
  17     successfully in the main by virtue of the immense size
  18     of the Trust."
  19        The question is, was the decentralisation, the
  20     devolvement referred to, which you agree happened, was
  21     that a consequence of the decentralised philosophy of
  22     the Trust?
  23   A. In part, yes, but in part, can I say, there was
  24     something they did not understand. The Audit Committee
  25     was a monitoring committee and there is an implication
0049
   1     here that the people responsible for making it work
   2     should also be the monitoring committee, and as
   3     a radiologist, I understand monitoring radiation
   4     protection and if you make the people actually
   5     irradiating people the same people monitoring whether
   6     they are doing it properly, you get a substandard
   7     monitoring. The Audit Committee was to monitor that the
   8     thing happened properly. To say, "Well, we will make
   9     the Audit Committee make it happen properly" would then
  10     mean I would have to have another audit of the audit
  11     committee to make sure it was happening properly. Do
  12     you understand my meaning?
  13   Q. I understand the point. May I persist with this
  14     paragraph and then invite you to comment further,
  15     because I am sure you may wish to.
  16        "The control of audit", it is said, "lies
  17     ultimately with the Clinical Directors"?
  18   A. It could lie nowhere else.
  19   Q. "The Audit Committee is not, however, constituted of
  20     Clinical Directors, which means its role has been
  21     relatively powerless."
  22        What do you say about that?
  23   A. I do not want to be unkind to the person who was
  24     directing that sort of thinking, and I think I have
  25     mentioned that he resigned. The Audit Committee, by
0050
   1     definition, was set up to monitor the implementation of
   2     audit; not to audit, but to monitor it. When it became
   3     multidisciplinary, it had to come out from the medical
   4     professional machinery and the Chairman of the Audit
   5     Committee was rather sad about that.
   6        It had to come into management. The management
   7     structure existed. I mean, if you want me to criticise
   8     what is written there, I find the words "in the main" in
   9     the top and second line absurd, but the
  10     multidisciplinary audit could only take place, the
  11     machinery for it, the process, could only take place now
  12     at directorate level; it could not take place at
  13     divisional level. And the Audit Committee was there to
  14     reassure me, to reassure the Trust Board, through the
  15     Patient Care Advisory Committee, that audit was
  16     developing; that things were happening and if there was
  17     any inhibiting factor, to tell us what it was so we
  18     could help resolve it.
  19        This was a development of a process, you will
  20     remember, that was expected to take five years. In fact
  21     it was expected to take longer than five years, so we
  22     were urged to reduce the timespan to five years.
  23        There clearly is a misunderstanding and
  24     a difference of opinion, but the idea that the Audit
  25     Committee could be set up as a separate management
0051
   1     structure of audit, I believe, then, and I think now,
   2     was a misunderstanding of this new concept we were
   3     introducing.
   4   Q. What the author appears to be looking for is power in
   5     the Audit Committee; what you were looking for, as
   6     I understand your answer, was information coming from
   7     the Audit Committee to say, "Well, this is happening" or
   8     "That is happening"?
   9   A. Yes. Well, I mean, not everybody understood the
  10     introduction of general management, but if there is
  11     a general manager personally responsible for everything
  12     that happened in his directorate then that precludes
  13     somebody else having personal authority for things that
  14     happened in his directorate. I hope that is clear. The
  15     concept that seems to be being suggested in this paper
  16     is contrary to the introduction of general management.
  17        In other districts, in other Trusts, general
  18     management, by definition, was not introduced.
  19   Q. The concept which appears to be suggested is that the
  20     Audit Committee should have a role in to an extent
  21     controlling, organising, running audit and for that it
  22     needs the Clinical Directors because they are the people
  23     who have the power in the directorates. That is the
  24     suggestion, is it not?
  25   A. That is a misunderstanding, as I hope I have explained,
0052
   1     at that time, that the role of the Audit Committee would
   2     be to audit. That kept coming up from time to time.
   3     There was also the wish that the audit process should
   4     remain outside the management structure and in the
   5     professional advisory structure. There were a lot of
   6     sensitivities about that, and I understood and had
   7     sympathy for how they arose, and it was our job and my
   8     job, to resolve these misgivings so that audit could
   9     take place.
  10        The role of the Audit Committee -- quite clearly,
  11     all the documentation that was produced was to
  12     facilitate and monitor the development of an audit
  13     process; it was not to control it and be powerful; it
  14     was to monitor it. That was a very important function
  15     which I, as a Chief Executive, and the Board, required.
  16        If the Chairman of that committee did not want to
  17     do that, then we had to take steps to adjust the
  18     situation.
  19   Q. If we read on, "the tight directorate structure and
  20     approach operated at all levels and for most issues and
  21     has therefore led to a confusion for the Audit Committee
  22     over its role ..."
  23   A. Yes, I was explaining the confusion.
  24   Q. So the question is, was there in fact any confusion in
  25     the Audit Committee over its role?
0053
   1   A. There was in the mind of the Chairman of it.
   2   Q. The second paragraph of the page:
   3        "There was direct admission from a representative
   4     of the management team that issues of audit which they
   5     (the managers) feel need to be addressed or are asked to
   6     address by purchasers tend to be implemented via the
   7     Clinical Directors rather than by any central overview
   8     from the Audit Committee."
   9        That would be consistent with your explanation, as
  10     I understand it, that it was for the Clinical Directors
  11     to run the directorate and the Audit Committee's role
  12     was not to control audit but to monitor it?
  13   A. Absolutely. I mean, people who, like, spin on it
  14     a direct admission, that always implies that they did
  15     not want to let it be known but eventually released it.
  16   Q. Leave aside the spin. What it indicates is that the
  17     author of this document from the region, the Regional
  18     Audit Team, envisaged audit in a very different way from
  19     the way in which it was in fact being delivered?
  20   A. No, that is quite wrong. That is quite wrong. He
  21     actually attended the Audit Committee, and he was
  22     reflecting the view of some of the Audit Committee.
  23     I talked to him directly. I talked to the audit group
  24     directly, from Region. I spent a lot of time ensuring
  25     that audit was set up.
0054
   1        The implication is that somehow these people are
   2     right and I was wrong. I have to say that that would be
   3     an incorrect conclusion.
   4   Q. I am exploring the issue, not putting a conclusion to
   5     you.
   6   A. Can I say, the issue is self-explanatory. What you are
   7     exploring, as I see it, is in some way that the view
   8     expressed there has relevance and stands up. It does
   9     not, and it did not. We actually pressed forward with
  10     the development of a proper clinical audit machinery.
  11     If I say, there is a contract that the purchasers have
  12     with the provider; that contract is agreed between the
  13     Clinical Director and others, and a contract manager and
  14     others, and the purchaser, they sign the contract.
  15        If the purchaser wishes to include in that
  16     contract audit, then it is clearly for the signatory of
  17     the agreement on the part of the Clinical Director to
  18     implement the requirements of the contract. That is
  19     what the contracting process was. I have difficulty
  20     understanding your difficulty in understanding that.
  21   Q. Can we scroll down the page, please? The paragraph
  22     second from the top of the screen as it now stands
  23     refers to something which has been a theme of some of
  24     your evidence, as to the sensitivity and fragility of
  25     audit.
0055
   1   A. Yes.
   2   Q. It goes on, in the next paragraph:
   3        "There appeared to be an urgent need for detailed
   4     debate between the Audit Committee representatives and
   5     the senior management team to establish firstly a common
   6     language on audit and its role and purpose within the
   7     organisation and secondly to establish clear groundrules
   8     on the role and approach of the management team and
   9     Audit Committee for moving audit forwards".
  10   A. Yes.
  11   Q. You have already told us there was a confusion in the
  12     mind of the Chairman of the Audit Committee as to his
  13     role and purpose?
  14   A. Yes.
  15   Q. Do I take it that this detailed debate then happened?
  16   A. Yes.
  17   Q. The next paragraph:
  18        "A strong philosophy on quality as everyone's
  19     business is held within UBHT. Thus unlike many other
  20     Trusts, no single person holds responsibility for the
  21     overview of quality issues."
  22        Is that an accurate statement?
  23   A. Yes.
  24   Q. Is it a danger that if quality is everybody's business,
  25     it becomes ultimately no-one's particular business?
0056
   1   A. There is a danger, but if you have a problem when you
   2     adopt management style, you have a problem, so you
   3     appoint somebody whose title is the problem, and then it
   4     immediately becomes nobody's business. I have no
   5     sympathy with the view that if punctuality at meetings
   6     in a Trust -- I give a facetious example so I am not
   7     criticising any particular event in the Trust, but if
   8     punctuality were considered to be a problem, I would not
   9     admire the management approach which says "We will
  10     appoint a punctuality officer", because it does not
  11     work. It costs money and it does not work. I would
  12     want to improve punctuality. I cannot understand
  13     anybody who believes that anybody in the health care
  14     business is not intimately concerned with policy.
  15     I would not wish to be a Chief Executive of an
  16     organisation where sections of the staff had no
  17     responsibility for quality: I was accountable for the
  18     delivery of that quality and I would not have an
  19     unworkable system.
  20        This, you have to remember, is being recommended
  21     by somebody with no management experience at all.
  22   Q. If we go down to the bottom of the page:
  23        "It is recommended that some mechanism for
  24     bringing issues which cover all such areas", and that is
  25     a reflection back to the paragraph immediately above,
0057
   1     "and audit together is established. Again, this is
   2     currently seen as via the management team direct to
   3     Clinical Directors and yet in practice it may be worth
   4     exploring the role the Audit Committee might take in
   5     this."
   6        Did you make anything of that recommendation or
   7     not?
   8   A. I have to say, looking at it in retrospect, I do not
   9     even understand it. I may have done at the time, but
  10     I do not understand what that says.
  11   Q. Can we go over the page --
  12   A. Yes, I can speculate, but I do not think it would be
  13     helpful.
  14   Q. The first paragraph, the top of the page, I invite you
  15     to read. I do not at the moment invite your comment on
  16     it. Can we go to the next page, please, UBHT 29/81?
  17        Dealing with the resources that were devoted to
  18     audit, first of all, time, half a day per month for all
  19     medical staff, but at this stage, no time allowance for
  20     nursing and therapy staff.
  21        Is that an accurate historical reflection of the
  22     position at that date?
  23   A. I expect so, but I do not think it means anything. This
  24     is at a time of development and you must remember that
  25     the introduction of other professionals into the audit
0058
   1     process had just started; it was not established.
   2     I suspect at that time -- I mean, the half day a month
   3     is the takeover of medical audit. We are now faced at
   4     this time with the development of clinical audit. You
   5     will see the first step, and you may think they are
   6     rather niggardly, is to invite two nurses and somebody
   7     else to a Medical Audit Committee and think it is
   8     multidisciplinary. We made a lot more progress after
   9     that.
  10        So this is a very transient situation for
  11     reflecting the very early introduction of clinical audit
  12     and the change from medical audit. We had had enough
  13     trouble creating medical audit, and we were having
  14     trouble, as you see, converting that to
  15     multidisciplinary audit. We succeeded, but these are
  16     the early birth pains.
  17   Q. What is plainly called for there is time and audit
  18     support staff?
  19   A. Yes.
  20   Q. Was such time, were such support staff, subsequently
  21     made available?
  22   A. Some were already available and we did a lot of work to
  23     try and create them as a cohesive whole. So, yes, I do
  24     not know how many at that time were actually in post,
  25     but I suspect -- yes, they were in post, for medical
0059
   1     audit. This is now saying, if these audit assistants
   2     are going to have to cope with multidisciplinary audit,
   3     then that is a much bigger task and we will have to
   4     address by how much we need to expand the resource.
   5   Q. When Dr Bullimore subsequently became head of the
   6     Clinical Audit Committee and produced her first report,
   7     she commented that there was a problem in getting
   8     information for the report because there was no central
   9     co-ordination of audit.
  10   A. She was actually talking about a bureaucratic process to
  11     collect all the things. I mean, I think that that had,
  12     at that time, yet to be set up. We were having
  13     difficulty setting it up in the directorates. What was
  14     needed was to resource the Audit Committee so it could
  15     fulfil its new function, and when she was appointed the
  16     first thing that happened, and one expects that to
  17     happen, is for her to make recommendations or criticisms
  18     in order to establish that.
  19   Q. Mr Ross told us when he gave evidence [Day 19, page 89,
  20     lines 19 to 23] that he found there was no central
  21     co-ordination in terms of managing and gripping audit in
  22     the way that he felt was necessary.
  23        That is his view. Was there a difference of
  24     approach as you define it between him so far as audit
  25     was concerned and you?
0060
   1   A. There had to be. He had no medical qualification. He
   2     was somebody with an administrative background, and
   3     I would expect him to wish to implement an
   4     administrative solution.
   5        So I think it is highly unlikely that he and
   6     I could or would resolve any solution in the same way.
   7   Q. The difference being your medical background?
   8   A. Absolutely.
   9   Q. Why should it be that your medical background would make
  10     the difference between whether there was a central
  11     co-ordination of the audit process or not?
  12   A. I should have thought that was self-evident. I would be
  13     more interested in showing that audit was taking place
  14     and putting my effort at the operational end of the
  15     spectrum and persuading consultants to actually produce
  16     it. This was something that, with the greatest respect,
  17     Hugh Ross could not do, and he would have to set up an
  18     administrative process which he then would hope would
  19     reassure them their audit, but I have to say it was
  20     difficult enough for me to talk to people about audit.
  21        I mean, I do not want, please, to comment on how
  22     Hugh Ross would do something, but when we created Chief
  23     Executives across the country they came from a wide
  24     variety of backgrounds and all used their particular
  25     experience and talents to achieve the same end result in
0061
   1     different ways. That is inevitable.
   2   Q. Can we see what followed after this report by going to
   3      UBHT 30/29, and scrolling down, please? 11/9? The
   4     second paragraph:
   5        "The clinical audit committee agreed", it is not
   6     the context, it is the inference which matters, "that it
   7     is entirely appropriate that PAMs audit activities could
   8     and should be part of the directorate based on clinical
   9     audit, but that some unidisciplinary PAMs audit would
  10     also be appropriate."
  11        This is a minute I selected since it comes from
  12     June 1994, after the Regional Audit Team's report would
  13     have been received. Am I right in thinking that
  14     whatever the reception of that report may have been,
  15     there was no change as a result to the patterns in which
  16     audit was monitored by the Clinical Audit Committee
  17     within the UBHT in consequence?
  18   A. This was an evolving situation. I am sure it did not
  19     stand still, any of it. If you are asking me, ever
  20     achieve a stationary situation by June 1994, I have to
  21     say that that is quite impossible. What they are
  22     talking about is what I was saying. Within the
  23     professions allied to medicine, there was audit
  24     activities within their professional advisory structure,
  25     which would be across directorates and would address the
0062
   1     activities of their professional members. This is
   2     saying that in drawing in those professionals into
   3     multidisciplinary audit, it was entirely appropriate, it
   4     is saying there, that they should continue their own
   5     independent audit. I cannot say what the argument was
   6     at the time and what sort of audit we are talking about,
   7     but I find that unexceptional. I cannot draw the
   8     conclusion from it that you have asked me to draw.
   9   Q. Can we have a look at Mr McKinley's statement,
  10     WIT 102/11?
  11        He starts at 38 talking about clinical outcomes:
  12        "As regards clinical outcomes and adverse events,
  13     these were fundamentally a matter for the audit meetings
  14     of the particular services involved."
  15        He is describing the position historically here,
  16     I think.
  17        He was your Chairman, was he not, in the period
  18     leading up to your retirement?
  19   A. Yes, immediately before my retirement.
  20   Q. "These were not, as a matter of course, reported to the
  21     Board."
  22        Is that right?
  23   A. They were not reported anywhere; they were confidential
  24     to the source of the audit, I think. They were
  25     fundamentally a matter for the audit meetings, which is
0063
   1     why I explained, in this sensitive area of developing
   2     audit, that was an understanding throughout, so he is
   3     reflecting the situation.
   4   Q. Paragraph 39:
   5        "Control of individual situations was in the hands
   6     of the clinical teams and the Trust Executive
   7     Management. A yearly audit report covering clinical
   8     performance was produced by the Medical Audit Committee
   9     under a senior consultant. In my time, it was not
  10     practice in UBHT for this report to be seen by the Board
  11     or the Board Committee."
  12        So again, that is an accurate statement, is it?
  13   A. I did not think the final sentence was accurate, but the
  14     audit report was initially introduced along the
  15     professional line from Region down to District, it was,
  16     and then became Trust. I was anxious that what was
  17     being reported outside the Trust should be made known to
  18     the people responsible for the Trust, but I had to move
  19     very gently and delicately, because at this time the
  20     reassurance given to the staff is that it was nothing to
  21     do with management.
  22        I thought we had achieved the report by that time
  23     but, I mean, he and I overlapped for so short a time it
  24     may well be that he did not see a report before
  25     I retired, I do not know. But there certainly was
0064
   1     a difficulty initially as to whom the audit report,
   2     which was a report about the process of audit and not of
   3     audit, should be made available and I think we have seen
   4     before Dr Thomas's view that anything out of the audit
   5     committee could only go where he said.
   6   Q. So we had the position, did we, because of the
   7     sensitivities which you describe, perhaps, that Medical
   8     Audit Committee, and after that the Clinical Audit
   9     Committee, had a responsibility to monitor the progress
  10     and process of audit, but their reports did not go to
  11     the Trust Board?
  12   A. Not initially, no. I thought they had done, before
  13     I retired, which is why I --
  14   Q. Which is why you take some issue with the last sentence?
  15   A. But it is not a big issue. They started off not being
  16     available to the Trust Board and they became available,
  17     and we are just talking about which side of October 1995
  18     that happened.
  19   Q. Who actually then made any use of the work done by the
  20     Clinical Audit Committee?
  21   A. The region did. They summated them, had a look at them
  22     and they issued an encouraging document, so say, to say
  23     "Look what has been happening across the region and
  24     please, would other people like to do a similar thing",
  25     but it was a report on the introduction of the process
0065
   1     of audit with a few encouraging notes to say, "and we
   2     have found something we can improve on".
   3   Q. Did the Clinical Audit Committee have any internal
   4     purpose, apart from satisfying the region?
   5   A. I am sorry, this Clinical Audit Committee were
   6     responsible for monitoring the introduction of audit.
   7     I think I have said that.
   8   Q. Yes. You may not have followed or understood what I was
   9     asking you in the last couple of questions.
  10   A. That is entirely possible, yes.
  11   Q. It may be my fault; please do not blame yourself. I was
  12     asking, if the reports from the Clinical Audit Committee
  13     did not go to the Board, what use was made of the
  14     Clinical Audit Committee and its deliberations within
  15     the Trust?
  16   A. Are you asking me what use was made of the report or
  17     what use was made of the committee? What use was made
  18     of the report is that it went to Region and was, as
  19     I say, processed with all the others, and returned as an
  20     encouraging document, to say what everybody else is
  21     doing, and so on, and that works.
  22        If you say what function did the Audit Committee
  23     have, I think I told you: the Audit Committee was
  24     charged with encouraging and monitoring the introduction
  25     of the process of audit.
0066
   1   Q. Did it report on that to the Trust Board?
   2   A. That is what the annual report was. What it was
   3     supposed to do, to me -- these were very early days and
   4     I cannot really discuss sensibly what we did with the
   5     outcome of audit because there was very little outcome
   6     of audit at that stage, it was only the process of audit
   7     we were concentrating on, but the Chairman of the Audit
   8     Committee was clearly responsible for informing me as
   9     the Chief Executive, directly and urgently if necessary,
  10     if any management action was required for the
  11     introduction, for the Department, of audit, and in
  12     theory, to deal with any adverse result of audit,
  13     although that was necessarily some time in the future.
  14   Q. Mr McKinley goes on:
  15        "To an outsider used to an open statistical
  16     approach to performance monitoring" -- he had come from
  17     the aircraft industry?
  18   A. Yes.
  19   Q. "I was not comfortable with the activities of the
  20     medical audit committee. They seemed to carry out
  21     audits without established criteria."
  22        They did not actually carry out audits themselves,
  23     from what you have said, the Medical Audit Committee?
  24   A. No.
  25   Q. "I personally saw only one report. In that report,
0067
   1     I could not find the criteria used, the information was
   2     expressed in a generalised manner, and I could not get
   3     a clear picture of areas where there should be concern
   4     and the actions which might be taken. I, of course,
   5     recognise and respect the need to maintain patient
   6     confidentiality."
   7        Is that an accurate description of a position as
   8     it was in that stage of its evolution, or not?
   9   A. In part I think I could say what it says is, in general,
  10     true. It is written as though he -- I can understand
  11     this -- comes to an organisation and we say we have an
  12     Audit Committee and we have an auditing process, and he
  13     could not find much evidence of it. There was a reason
  14     for that: there was not much of it. He came from an
  15     organisation where audit clearly had been established
  16     for a very long time. He comes to an organisation where
  17     it is very new, it has just been changed, we have taken
  18     the whole thing to pieces and are rebuilding it with
  19     some difficulty, and there were no standards against
  20     which audit could be taken until a great deal of audit
  21     had been done to identify a standard.
  22        If you pick a standard out of the air and say "Are
  23     we meeting that?" that is ridiculous. It would carry
  24     the confidence of nobody. So the first task in the
  25     introduction of audit is to introduce the process of it
0068
   1     and we have seen some difficulties about how we provide
   2     time, information technology, audit assistants and so
   3     on. You also have to produce a cultural change that
   4     people actually want to do it.
   5        That is the first stage.
   6        The next stage is a great deal of observation,
   7     discussion, cross-district, cross-regional discussion
   8     takes place, to try and establish what standard there
   9     should be, and there was not one then. That is why he
  10     could not find one.
  11   Q. There are two steps as you describe it: one is the
  12     setting of criteria, and the second is the collation and
  13     collection of information or statistics to be measured
  14     against those criteria?
  15   A. You have to collect all the information to create the
  16     standard. That is the thing. That is where the
  17     standard comes from. Let us say, we are talking about
  18     something I understand --
  19   Q. I follow the point. What you are saying is that
  20     throughout the time of your chief executiveship, you
  21     were not in a position to set criteria because they had
  22     not yet evolved from the material which was being
  23     collected elsewhere?
  24   A. I did not set the criteria anyway. The only criteria
  25     I could have helped set was in my own specialist area.
0069
   1     What I am saying is that one of the first things the
   2     experts and the specialists had to do was to establish
   3     an agreed standard, not ask the Chief Executive to tell
   4     them what the standard was: (a) that would have been
   5     totally incompetent and (b) it would have been
   6     disastrous.
   7   Q. You see in the next paragraph Mr McKinley goes on to
   8     that. In the area of audit he says Hugh Ross moved
   9     towards setting criteria and logging statistics.
  10        Leaving aside whether it was Hugh Ross who set the
  11     criteria or whether he adopted the criteria established
  12     and suggested by others, "While maintaining patient
  13     confidentiality, he moved to set up specific people in
  14     each directorate with the responsibility of logging data
  15     into the audit system."
  16   A. Yes.
  17   Q. Taking each of those sentences separately, was there
  18     any, and if so what, any reason that could not have been
  19     done beforehand?
  20   A. Because it was an evolution. Hugh Ross had the benefit
  21     of developing and progressing clinical audit from the
  22     stage to which we had managed to move it before
  23     I retired. If he had stayed at the same position, as
  24     I had retired, you and I would think he had failed. If
  25     what he did as a further development of the service is
0070
   1     offered to me as a criticism of why we did not do it
   2     before, then I am not even prepared to discuss that.
   3        Can I say, this was a five-year programme.
   4   Q. I think we follow that.
   5   A. Thank you.
   6   Q. Can I turn from audit to another issue that you cover in
   7     your statement. Can we go to page 24, please, where you
   8     deal with mechanisms and structures available to staff
   9     members to raise and secure action on matters of concern
  10     to them, what in some situations might be called
  11     "whistle-blowing"?
  12   A. Could you define what "whistle-blowing" is, please, at
  13     the beginning, because it has a number of meanings?
  14   Q. Let me ask you specific questions, and we will see where
  15     we get to. Can we have UBHT 115/113, please?
  16        1995: there is a letter about the Allitt Inquiry
  17     report: "serious untoward incidents". It went to you,
  18     no doubt, in 1995. Let us look at the signatory,
  19     please; and looking for the "notification of serious
  20     untoward incidents".
  21        The Allitt incident involved the performance of
  22     her duties by a member of staff, did it not?
  23   A. I am sorry, I mean, you will have to remind me.
  24   Q. Beverley Allitt.
  25   A. Yes, but there were so many things.
0071
   1   Q. The Munchausen's by proxy case?
   2   A. Yes, I remember, was it the nurse or the mother?
   3   Q. It was the nurse who succeeded in killing a number of --
   4   A. Yes, I think I remember the case.
   5   Q. The Allitt situation, I think, came -- you may not
   6     remember it quite so clearly as others do, but it
   7     certainly achieved great prominence in the press.
   8   A. I am sorry, I was trying to identify which one, not
   9     that -- I did not know that one. I could not relate the
  10     name to the incident, but I am quite happy to accept
  11     that.
  12   Q. Can we look at UBHT 6/200? This is 1993. Can we scroll
  13     down, please? And go over the page. Further on down --
  14     I am sorry, I have missed the reference here. Can we go
  15     to page 6/26? I am sorry, Dr Roylance, it is my fault
  16     entirely.
  17   A. That is all right. I am lost in admiration in the
  18     linking of these.
  19   Q. These are the minutes in 1993, the same minutes but
  20     a different reference. "Matters arising: Dr Roylance,
  21     Mr Stone and Mr Wisheart would meet to discuss how
  22     members of staff could express any concerns they had
  23     about colleagues' behaviour."
  24        In the middle of 1993, at this time, was it
  25     necessary to have such a discussion, because the lines
0072
   1     of procedure were unclear?
   2   A. I cannot draw that conclusion. We were always having
   3     discussions trying to improve things and if for some
   4     reason -- and I cannot remember it now -- there was some
   5     reason where greater clarity or a change in attitude,
   6     a different policy was desired by the Trust, that would
   7     be a natural way to start it and it would be natural to
   8     inform the Trust that that is what was happening.
   9        I do not know the background, I do not know the
  10     outcome.
  11   Q. Suppose that somebody, a consultant, let us suppose, or
  12     a junior doctor, even, in one or other of the divisions,
  13     had a concern about the performance of one of his
  14     colleagues, or a nurse having a concern about an
  15     Allitt-type character who appeared to be harming
  16     patients under his or her care.
  17        How would such a person, at least before 1993 --
  18     let us divide this up into looking at it in terms of the
  19     Health Authority on the one hand and the Trusts
  20     secondly: how would they go about making any complaint
  21     in respect of that behaviour?
  22   A. They would share it with somebody who was appropriate,
  23     and did. I cannot specify it unless you actually
  24     hypothesise a much more specific situation, but can
  25     I say that there was a situation where it was thought
0073
   1     that something of an Allitt nature was happening,
   2     whether it was before the Allitt case or afterwards I do
   3     not know, and the anxiety was, I think it was changing
   4     settings on a particular automated drip injector,
   5     something like that, and they thought somebody was going
   6     around and rigging it, which was very worrying. I seem
   7     to remember the outcome was that the switching itself
   8     was defective rather than a member of staff doing it.
   9        The moment there was that suspicion, that was
  10     shared with somebody -- I cannot tell you specifically
  11     whether it was a nurse with a ward Sister, whether it
  12     was a nurse directly to Margaret Maisey, or whether it
  13     was through one of the enormous number of pathways which
  14     were open, but there was no doubt that if anybody had
  15     a concern of the nature you are specifying, there was no
  16     impediment to that being brought to the attention of
  17     somebody who could deal with it. In a ward, it normally
  18     went to the ward sister, who normally resolved it, and
  19     if she had a continuing anxiety she would normally go
  20     directly to Margaret Maisey.
  21   Q. Suppose it was in the Directorate of Surgery and one
  22     surgeon had a concern about the operative technique of
  23     another?
  24   A. Yes. That happened.
  25   Q. With whom would that surgeon raise the concern?
0074
   1   A. Me.
   2   Q. You directly?
   3   A. Yes. I cannot tell you precisely why, because is it
   4     would start identifying the source of the anxiety,
   5     but it was raised directly with me and I talked to the
   6     person concerned and took the necessary advice and
   7     established that it was a one-off failure in
   8     communication between two surgeons, and a patient who
   9     was referred across the specialty and back again, and
  10     they both were sure the other one was looking after
  11     them. It was a great pity, but I give this as an
  12     example of something that should not have happened which
  13     did happen, and it was immediately shared with me.
  14   Q. If the concern were about any other doctor, then, it
  15     could be raised directly with you. If you were not
  16     available, with whom?
  17   A. Well, with a responsible doctor. Once we had a Trust,
  18     we had two quite separate routes that overlapped at
  19     times. One was the professional advisory route, through
  20     the profession to the Chairman of the Medical Committee;
  21     the other was a management route through the directorate
  22     and to me. There was no shortage, anywhere, of people
  23     with whom to share the sort of anxieties you have
  24     expressed.
  25   Q. How would a clinician know that they should raise the
0075
   1     matter with you, rather than with their, let us say,
   2     immediate Clinical Director?
   3   A. They did not need to know. They could please
   4     themselves. They would raise it with whoever they
   5     thought was appropriate. I mean, these are highly
   6     intelligent people who see a problem, suspect a problem
   7     and quite naturally wish it to be resolved immediately.
   8     Depending upon the nature, the identity of the person,
   9     there is a whole host of people they can go to. They
  10     can go to the Chairman of the Board; they can go
  11     anywhere. They have the judgment to consult the staff
  12     to resolve an issue. That is what they spend doing
  13     every day with patients.
  14   Q. Does it follow from your answer that because of the
  15     intelligence and status of the staff who might be making
  16     complaints, there was no need for any formalised system
  17     as to whom a complaint should be raised with in the
  18     first place, or for that matter in the second place?
  19   A. If you are saying, should we have constrained and
  20     restricted the opportunities of staff to choose an
  21     appropriate route to resolve a situation, then I would
  22     say "No".
  23   Q. I am not sure that answers my question, but --
  24   A. I am sorry, I thought it did.
  25   Q. -- unless it is that you are saying that such a system
0076
   1     could have been done, but it was not done because it
   2     would have constrained and restricted?
   3   A. That is what I thought I said. Thank you for repeating
   4     it.
   5   Q. The other side of that same coin is, is it not, that if
   6     there is to be a system of going to whomsoever one
   7     chooses, people may need to be encouraged to know that
   8     that is what they should do in such an event?
   9   A. I find that insulting to the sort of staff that I had
  10     in my Trust.
  11   Q. It would inevitably be the case, would it not, that if
  12     there were a concern which one clinician held about
  13     another with whom he regularly worked, that there would
  14     also be a concern that raising the issue might prejudice
  15     relationships at the working level, the operative level?
  16   A. Please, I have to put back to you, I mean, I do not
  17     think that is true, but I have to put back to you, it
  18     depends what the nature of the complaint is. If the
  19     nature of the complaint, as an example I cited, is that
  20     patient care is unacceptable, then I would not accept,
  21     as an excuse, that some interpersonal relationship
  22     somewhere was a bar to having something done about it.
  23        Now, it is perfectly possible, and happened, that
  24     some complaints were made known to the three wise men on
  25     the understanding that the source of the complaint would
0077
   1     for ever remain entirely anonymous. That would totally
   2     resolve the problems you offer. That sort of
   3     information was regularly made available so that the
   4     medical staff and other staff, they were frequently and
   5     regularly reminded of that opportunity.
   6   Q. But the three wise men, I thought we looked at the
   7     document this morning, from 1982, was essentially
   8     a capability procedure rather than an incompetence
   9     procedure?
  10   A. I thought I explained to you that that is a prejudgment
  11     of an investigation.
  12   Q. So that anyone with a concern would appreciate that
  13     anonymously they could approach one or other of the
  14     three wise men directly or indirectly?
  15   A. Absolutely, and if I as a radiologist had suddenly
  16     started doing bizarre things, nobody would wonder
  17     whether it was because I was mentally ill or
  18     incompetent, they would have shared their anxieties
  19     immediately with the three wise men.
  20   Q. They would have this appreciation this was the route
  21     simply because they were doctors working in the
  22     hospital, not because anybody had encouraged them in any
  23     official statement to take that step?
  24   A. I thought I explained, I am sorry, the availability of
  25     that route was a matter which was recurrently the
0078
   1     subject of remindings to the staff; it was raised at
   2     Medical Committee regularly, it was minuted at the
   3     Medical Committee, it was raised in the other sorts of
   4     fora in which doctors and others meet and I am satisfied
   5     that the mechanism was known to the staff.
   6   Q. Returning to the matter which I raised a moment ago, of
   7     a clinician who you accept would have the duty to report
   8     upon a fellow clinician who was providing dangerous care
   9     for patients --
  10   A. Yes, immediately and unambiguously, yes.
  11   Q. Such a clinician, although his duty will be clear, would
  12     no doubt be concerned as to the working relationships he
  13     might have with the "guilty" clinician, if I can call
  14     him that, and also with those others with whom he
  15     worked. No-one likes a snitch, is the plain reality?
  16   A. I do not accept that is an excuse for not making the
  17     information available, and I did tell you that that
  18     information could be made available in absolute
  19     anonymity, which would remain for all time.
  20   Q. I accept that. If it became known who had -- I use the
  21     expression, "blown the whistle" -- to be the situation
  22     of informing upon a colleague providing dangerous care,
  23     if it became known that such a person had provided the
  24     information and anonymity was not conferred, what, if
  25     any, steps would be taken to ensure that such a person
0079
   1     was not victimised by his colleagues?
   2   A. Well, there was -- I mean, I currently emphasise to
   3     everybody -- it must be in documents here and there, in
   4     minutes -- that whistle-blowers would never be
   5     persecuted. You actually postulated that if one of them
   6     had reported the matter to the "three wise men", then
   7     there was a possibility that his identity would be
   8     released. I have already said that is not so. But if
   9     he chose to do something else and write a letter or
  10     raise it, if he sat in his division and said "The chap
  11     sitting next to me is incompetent", you have to do
  12     something about it, then the source of complaint would
  13     be known.
  14   Q. The question was, would any steps be taken to protect
  15     such an individual from victimisation of his colleagues?
  16   A. I do not know what sort of victimisation you might
  17     imagine. I made absolutely certain that management
  18     would prevent victimisation. If you are saying to me
  19     that as a result of the hypothetical situation I have
  20     said, the chap next to him said "I will never speak to
  21     you again", I do not know that management can say, "Yes,
  22     you will". I mean, I am trying to answer the question
  23     as I understand the question. Management would make
  24     sure there was no tangible victimisation of anybody, but
  25     I cannot ordain interpersonal relationships, if that is
0080
   1     what you mean.
   2   Q. How would the individual who might be contemplating
   3     writing such a letter have any assurance of that? Would
   4     that be from the statements, the repeated references
   5     that you mentioned a moment ago? How would an
   6     individual who was contemplating writing a letter of
   7     complaint about a colleague have any assurance that,
   8     having done so, he would, whilst within the Trust, be
   9     protected against victimisation? What would he rely on
  10     for that assurance?
  11   A. My personal word, which he would have heard many times.
  12     But please, can I re-emphasise, we have to be careful
  13     what you mean by "victimisation". If all his colleagues
  14     will not speak to him, then I would have to engineer
  15     some form of rehabilitation, some sort of
  16     reconciliation, conciliation meetings, and you may know
  17     that on one occasion I did that.
  18        But in terms of tangible retribution, that would
  19     be easy to stop. In terms of interpersonal
  20     relationships, that would present difficulties and on
  21     one occasion did, and I took advantage of the
  22     counselling expertise of some of my colleagues to
  23     attempt to address it.
  24   Q. You say, page 29 of your statement, in relation to
  25     complaints both of poor standards of care and of what
0081
   1     I have been taking as whistle-blowing, which is
   2     informing upon a colleague providing dangerous care:
   3     can I ask you two questions about what you say there
   4     in (g)?
   5        You say:
   6        "Any complaint of poor standards of care made ...
   7     was always taken very seriously and the commitment of
   8     staff to high standards was looked upon as ancillary
   9     monitoring system. A full investigation would always be
  10     made either discreetly or publicly ..."
  11        When you use the words "a full investigation", can
  12     you give us some idea of the nature and scope of that
  13     investigation which made it full?
  14   A. Anything from me talking to the people concerned to
  15     inviting a team from the appropriate Royal College to
  16     investigate the situation and advise me, anything along
  17     that spectrum. I cannot specify, it depends on the
  18     nature of the complaint, as I have said, but I would
  19     have to satisfy myself it had no foundation, in which
  20     case I would reassure the complainant, or if it had,
  21     I would have to take the appropriate action.
  22        How I would make that judgment would depend
  23     entirely upon the nature of the complaint that was made.
  24   Q. You are looking on this as a matter which would
  25     inevitably come to you, because you are talking
0082
   1     personally about your response?
   2   A. You asked me what I would do about it, so I told you
   3     what I would do about it.
   4   Q. I think I asked you what you meant by full
   5     investigation, but let me depersonalise it. Would there
   6     be occasions when the matter would not come to you and
   7     it might be investigated by somebody else?
   8   A. If it was reported to the three wise men it would not
   9     come to me unless some formal management steps were
  10     required. When I was a member of the three wise men and
  11     people shared their anxieties with me, the three wise
  12     men together, with the help when necessary of the
  13     nominated psychiatrists and with the help of anybody
  14     else, there were no constraints on how we could deal
  15     with it; we would deal with it. If we came to the
  16     conclusion that management action was required, we would
  17     furnish management with the necessary evidence and
  18     expect them to deal with it.
  19   Q. So the fullness of the investigation, when you conducted
  20     it, obviously depended upon your view of what was
  21     required?
  22   A. Yes.
  23   Q. When others investigated it, let us suppose the three
  24     wise men, you would not know what was being do