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Daily transcripts
Hearing summary
13th October 1999
The Bristol Royal Infirmary Inquiry oral hearings focus for the
remainder of this week on the subject of medical and clinical audit.
Today the Inquiry heard from Kieran Walshe, Senior Research
Fellow, Health Services Management Centre, University of Birmingham, and
one of the Inquiry’s Expert Group of witnesses. He began by defining
what audit is. He then concentrated on discussing the contents of a briefing
paper which has been prepared for the Inquiry entitled "Medical
and Clinical Audit in the NHS". He explained the development
of medical audit into multi-disciplinary clinical audit during the 1980s
and 1990s. Mr Walshe said that in 1989 audit practice was variable around
the country with some national initiatives taking place e.g. the National
Inquiry into Maternal Deaths, highlighting good practice. He commented
on the reaction amongst the medical profession to 1989 recommendations
that all doctors should engage in medical audit and explained the reservations
regarding confidentiality of data. He described the role of regional and
district health authorities and hospital managers in promoting and managing
audit and explained the allocation of funding and monitoring of how those
funds were used. He concluded by identifying the elements of a successful
audit programme.
Dr Trevor Thomas, Consultant Anaesthetist, St Michael’s Hospital, Bristol and
first Chairman of the Medical Audit Committee also gave evidence today. He described the
development of audit within the Bristol Hospitals and the role of the Medical, and later,
Clinical Audit Committee in promoting, assisting and monitoring audit within the United
Bristol Healthcare NHS Trust (UBHT). He discussed the series of annual audit reports
prepared for the Regional Health Authority (RHA) and subsequent reports sent from RHA to
the Department of Health. Dr Thomas told the Inquiry about the inclusion of audit
requirements into service contracts with purchasing health authorities after 1991. He
commented on the amount of time clinicians spent on audit activities and changes in the
reporting structure from the Audit Committee to the Trust Board.
|
FULL TRANSCRIPT
1 Day 62, 13th October 1999
2 THE CHAIRMAN: Good morning, everyone. Good morning,
3 Miss Grey.
4 MISS GREY: Good morning, sir. Before starting on today's
5 evidence, may I deal with one matter arising out of the
6 evidence given yesterday by Professor Angelini?
7 Professor Angelini has written a letter to the Inquiry
8 following his evidence, which will of course be
9 published as part of that evidence, but it is right
10 I should perhaps read it into the transcript as well at
11 this stage.
12 THE CHAIRMAN: It was written with the knowledge that it
13 would be published?
14 MISS GREY: Indeed. Well, it was written as a letter to
15 you, sir, and therefore is in the public domain.
16 LETTER TO CHAIRMAN FROM PROFESSOR ANGELINI
17 MISS GREY: Professor Angelini writes:
18 "Dear Mr Chairman,
19 "I would like to clarify an aspect of my evidence
20 given today, 12th October 1999.
21 "I refer to the comment by Mr James Wisheart to
22 Dr Roylance that the results of the paediatric surgery,
23 with the exception of one surgical procedure, were
24 comparable or above average.
25 "I believe it is incorrect that these results were
0001
1 incomparable or above average especially in relation to
2 the AV canal results. I do apologise for saying that
3 Mr Wisheart's comments was a lie", that is as the letter
4 was written, "and I do not make that accusation against
5 Mr Wisheart.
6 I would be grateful if this letter was placed on
7 record, together with my oral evidence."
8 THE CHAIRMAN: Miss Grey, thank you very much indeed.
9 MISS GREY: Sir, can we now pass, please, to the evidence of
10 Dr Walshe, if he would like to come up and take the
11 stand, please?
12 Dr Walshe, we have been taken evidence on oath or
13 affirmation. Could I invite you to stand to affirm?
14 DR KIERAN WALSHE (AFFIRMED):
15 Examined by MISS GREY:
16 Q. Dr Walshe, could you give your full name to the Inquiry,
17 please?
18 A. Yes, my name is Kieran Michael Joseph Walshe.
19 Q. You are a Senior Research Fellow in the Health Services
20 Management Centre at the University of Birmingham?
21 A. That is correct.
22 Q. We do not have available to the Inquiry, scanned in as
23 yet, a curriculum vitae for you. Could I therefore
24 invite you to tell the Inquiry of your record and the
25 work that you have been involved in, and please do not
0002
1 be modest?
2 A. I am happy to provide a CV if that would be helpful for
3 the record.
4 Q. It would, thank you very much.
5 A. As you said, I work at the University of Birmingham as
6 a research fellow in the Health Services Management
7 Centre there. Before working there I was at the King's
8 Fund in London, again as a senior researcher. I have
9 been a researcher for 11 years. Before starting
10 a research career, I was a manager in the Health Service
11 for three or four years.
12 In my research career, my main interests have been
13 approaches to assessing and improving the quality of
14 health care and approaches to measuring clinical
15 performance. I was involved in the late 1980s in early
16 work done in Brighton Health Authority, funded by the
17 Department of Health, to pilot a number of quality
18 assurance measures in an acute health care
19 organisation.
20 In the late 1980s and early 1990s I was involved,
21 whilst working at the King's Fund in some other projects
22 for the Department of Health, one that particularly
23 looked at adverse events in health care and the way that
24 detecting and monitoring adverse events could be used as
25 a way of assessing and improving quality.
0003
1 Perhaps particularly germane to today's issues for
2 the Inquiry, in the early 1990s I led a quite large
3 project over two and a half or three years for the
4 Department of Health, evaluating the development of
5 medical and clinical audit in the NHS in England, which
6 resulted in a series of reports for the Department, and
7 the data from which was used also in the National Audit
8 Offices' "Value for Money" study on clinical audit in
9 England.
10 Q. Is that the research that is known as the CASPE
11 research?
12 A. That is right, yes. Subsequent to that I worked in 1995
13 and 1996 in the NHS Executive on developing a framework
14 for managing and monitoring clinical audit in provider
15 organisations, aimed at improving effectiveness in
16 clinical audit programmes in health care organisations.
17 Q. You had not been asked to provide a statement for the
18 Inquiry, but I think it is right to say that you are
19 familiar with a paper which has been published by the
20 Inquiry Secretariat on medical and clinical audit in the
21 NHS if we could just have that on the screen, please, it
22 is INQ 11/1, please. That is simply the title page, but
23 I think it is right you have seen that paper; is that
24 correct?
25 A. Yes, I have, yes.
0004
1 Q. Perhaps we ought to start any discussion of audit by
2 asking you to define what audit means? It may perhaps
3 help to look at page 9 of this paper, where a definition
4 is offered, but would you like to comment on what you
5 understand audit to entail? Can we just scroll up
6 through the page a little, please?
7 A. I think the definition offered in the Inquiry's paper is
8 a helpful one. The Department of Health, in its early
9 policy papers issued in 1989 when it first required the
10 introduction of medical audit in health care providers,
11 defined it as the "systematic critical analysis of the
12 quality of medical care."
13 I think the definition you have offered in this
14 paper is in some ways more helpful because it makes it
15 clear the process involves both gathering information
16 about the quality of practice and performance,
17 identifying problems and opportunities for improvement
18 and then taking action to remedy those problems or
19 difficulties, to bring about change.
20 There are ways in which you can make
21 differentiations -- and the paper referred to
22 distinguishes between medical audit, clinical audit and
23 organisational audit and quality assurance and TQM and
24 CQI. There are lots of definitional discussions you can
25 have. What brings all those definitions altogether is
0005
1 that they are all about systematically attempting to
2 identify problems with the quality of care, and then
3 taking action to understand their causes and bring about
4 changes that make improvement in the quality of care
5 take place.
6 Q. Perhaps we should go back to that early paper that you
7 referred to. If we look, please, at WIT 323, please,
8 page 15, this is a section from the Working Paper on
9 medical audit. If we scroll down towards the bottom of
10 the page, a 1989 paper, as you mentioned. That is the
11 definition that you produced from memory.
12 Does the contrast between that fairly short
13 definition and the more extensive discussion in the
14 Inquiry's paper help us to understand anything about the
15 development of the understanding of audit over the years
16 since it was introduced?
17 A. Yes, I think it does. I think the paper you have, which
18 came out, I think I am right, in late 1989, a little
19 while after the publication of the White Paper itself,
20 represents the Department of Health's thinking about
21 medical audit and quality assurance in health care at
22 that time, but it reflects the level of understanding at
23 that time.
24 I think it would be true to say that the
25 Department's proposals for medical audit in the NHS at
0006
1 that point in time could be criticised with hindsight as
2 not being particularly directive, not if you like
3 mandating a particular process, not requiring the
4 organisations to undertake audit in a particular way and
5 for also perhaps not putting in place particularly
6 strong incentives or requirements for people to engage
7 in this process.
8 However, I think you need to read the paper and
9 that definition understanding that at the time this was
10 part of a set of policy reforms, some of which were
11 being opposed very strongly by the medical profession,
12 the nursing profession and by others. But the
13 department was very nervous about imposing this process
14 on the professions because in the past, in the early and
15 mid-1980s, there had been considerable professional
16 resistance at the highest level, I think, to the idea of
17 systematic quality assurance or quality improvements in
18 health care.
19 And I think there was real uncertainty in the
20 Department of Health about the best way to do this so
21 mandating a particular process was difficult if you did
22 not know what the best kind of process would be.
23 So I think the definition was as good as it could
24 be at the time, and subsequent policy guidance changed
25 and modified that definition considerably.
0007
1 Q. So to have themes or threads you have identified there:
2 firstly a nervousness of professional reaction to the
3 idea of having audit imposed upon them, and secondly,
4 central nervousness of requiring a particular approach
5 in the absence of knowledge as to what the best approach
6 would be.
7 Can you tell us what the state of knowledge was at
8 the time of different forms or approaches to audit?
9 A. I think there was probably a much better developed
10 understanding of how the process might work elsewhere in
11 the world, in other countries, particularly perhaps in
12 the US where there was a much longer history of
13 systematic efforts to improve quality in health care
14 than there has been here.
15 I think in the UK we had a very limited
16 understanding of how, given the organisational context,
17 given the way our health service was structured and the
18 way different professions interrelated and so on, how we
19 would put into place a programme of quality improvement,
20 and our ability to look outside of the health service
21 at, for example, developments in the US or indeed at
22 developments in industry, because there was a great deal
23 of activity in the 1980s in non-health care sectors in
24 the UK in quality assurance, was in part limited by some
25 of the differences in the way we run the Health Service
0008
1 and the way other non-health care organisations run, and
2 indeed the way that health care organisations in
3 countries like the US are organised. There are
4 difficulties that make transferring some of the
5 structures and processes others have developed
6 difficult, although much of the learning about how these
7 things work is certainly transferable.
8 Q. If we were to look across to the United States at the
9 time of this paper in 1989, what would we have found,
10 broadly, in terms of the development of audit or quality
11 assurance in that country?
12 A. In brief, the United States has had systems for the
13 external accreditation or inspection of hospitals in
14 some form or other since the 1980s, in a fairly rigorous
15 form certainly since the 1960s and it first mandated
16 quality assurance, introduced federal legislation that
17 required it effectively in I think 1973. So we would
18 have found a very long history of this kind of work, and
19 lots of efforts with different approaches to attempting
20 to measure quality, different kinds of measures and
21 different ways of structuring and doing this, so a great
22 deal of experience.
23 We would have found a huge amount of activity.
24 Every hospital we visited then and indeed now, would
25 have had a well-developed internal quality assurance
0009
1 programme, with staff, structures, processes and things
2 like that in place. They would also have had programmes
3 for risk management and utilisation review, looking at
4 the use of resources, and then we would also have found
5 a number of external programmes, payers for health care,
6 examining the quality of health care provided by
7 hospitals and health care providers.
8 I think it would be right to say you would also
9 have found far from a consensus about how useful that
10 very substantial investment had been in bringing about
11 quality improvement and in fact in the late 1980s, the
12 US health care system began to move away from its
13 traditional approaches to quality assurance and to
14 embrace what is sometimes called "whole system"
15 approaches to continuous quality improvement and TQM,
16 and that movement in the US has continued.
17 Q. You said that it might be difficult to draw lessons or
18 transfer information across from the US to Britain at
19 that time. Does your answer suggest that there may be
20 two main reasons for that: firstly that the system of
21 quality assurance or audit within the US was in large
22 measure imposed from the outside, or required from the
23 outside by externally imposed or required regulatory
24 systems, and secondly, that there was a lack of
25 consensus as to the benefits that had been produced by
0010
1 those approaches?
2 A. I think I would agree with both those reasons. Yes, it
3 had been required and mandated by federal legislation
4 and by payers of health care who required providers to
5 do this. That was not necessarily the way this was
6 working here. Also there would be a second point.
7 I think I would add perhaps that there are big cultural
8 differences between the way that US health care
9 organisations had traditionally been run and British NHS
10 Trusts or health care organisations had been run, big
11 differences in the employment status of doctors in the
12 degree of medical involvement in the management of those
13 organisations, and big cultural differences that affect
14 the transference of an organisational approach to
15 quality improvement from their context to ours.
16 THE CHAIRMAN: Forgive me if I interrupt just a moment. It
17 is only to remind Dr Walshe that the person sitting
18 immediately to your right is perhaps the most important
19 person in this room because she is taking a note --
20 DR WALSHE: I am speaking too fast.
21 THE CHAIRMAN: Not too fast, but it may help sometimes,
22 because we use technical terms, to keep an eye on how
23 things are proceeding on your right, and slow down
24 sometimes. I apologise for interrupting.
25 MISS GREY: Not at all. It is actually my responsibility,
0011
1 Dr Walshe, to keep an eye on that, I had not been doing
2 so and I will try and do so.
3 You talk there about "large cultural
4 differences". Can you explain a little bit more what
5 you mean by those?
6 A. I think the sorts of differences I would point to would
7 be that in the US it has been much more accepted for
8 much longer that the quality of clinical practice is
9 a consideration for the organisation and not just for
10 individual clinical teams and that would be one thing
11 I would point to. So every US hospital you would visit
12 would have quality assurance mechanisms, would have
13 surgical review and medical review committees, would
14 have corporate structures designed to identify and deal
15 with quality problems. Those systems have been there
16 for in some cases decades, so the acceptance, if you
17 like, that the organisation has not just a legitimate
18 role but a central role in understanding and dealing
19 with quality problems is much greater than it
20 traditionally has been here in the UK.
21 I think there is also a difference in our approach
22 to measurement and the US approach to quality
23 improvement has been highly adversarial, kind of quasi
24 judicial in the way it has worked, and I know that in
25 1989 and before that, people from the Department of
0012
1 Health and from organisations in the UK have been over
2 to the US to look at the way that quality in health care
3 was managed and improved, and have taken from that some
4 important lessons about how it can be done, but also
5 real concerns about not emulating a system which has, in
6 the US, become very bureaucratic, quite expensive and
7 about which to this day there is still much debate about
8 whether it really produces improvements in quality
9 concomitant with its costs.
10 Q. So if we went back to 1989 in the UK, what audit would
11 we have found in clinical practice at that time? What
12 was the background to the introduction of this paper?
13 A. Before the White Paper, I think you would have found
14 a very varied and patchy pattern of clinical audit.
15 I was involved in working with one Health Authority
16 quite closely, and less closely with a number of others
17 at that time, and in most hospitals you would have found
18 a small number of clinical professionals, particularly
19 doctors, who were gathering data about their own
20 practice, who were, if you like, audit enthusiasts and
21 who were engaging in a process of clinical audit for
22 themselves.
23 You would have found, I think, in most parts of
24 most organisations, relatively little activity. There
25 would have been some traditional mortality and morbidity
0013
1 meetings or death and complication meetings going on, at
2 which problems to do with the quality of care perhaps
3 got reviewed, but you could not have said that in
4 I think almost any health care organisation at that time
5 in the NHS there was a systematic programme of quality
6 assurance or quality improvement in place.
7 You would also have found some important national
8 initiatives which were focused on particular areas of
9 care and were important in those areas but were somewhat
10 isolated in that they did not have a wider remit or
11 impact. Examples would be the Confidential Enquiry into
12 Maternal Deaths and the National Confidential Enquiry
13 into Peri-operative Deaths, work done by the Royal
14 College of General Practitioners on standards for
15 general practice, and things like that.
16 So there were important initiatives, but there was
17 no system that covered even a large minority of the care
18 being provided.
19 Q. So against that background, can you describe the driving
20 force or reasons why this paper and the government's
21 reforms, not to mention, of course, the initiatives from
22 the various professional organisations, the Royal
23 College of Physicians, the Royal College of Surgeons and
24 so forth, were developed?
25 A. Yes. I think it is hard to point to a single driving
0014
1 force. I guess your enquiry about why the policy
2 documents included this focus on medical audit could
3 also be directed to some of the policy makers at that
4 time.
5 I think there are three things that had happened.
6 One was the rise of general management during the 1980s
7 and the arrival of individuals, some clinically
8 qualified, some not clinically qualified, but
9 individuals who had general management responsibility
10 and authority for health care services, and had more of
11 a remit and a legitimate right to ask questions about
12 the quality of care.
13 Second was the rise of concerns about quality of
14 performance across public services, and indeed private
15 services. It was a theme in government in the 1980s and
16 a focus on the role of managers and managerialism and
17 a concern about the power of the professions running
18 across education and health and social services, and
19 other sectors. I guess I would also point to the fairly
20 positive experience of those initiatives I have
21 described going on in the 1980s, seen as examples of
22 good practice that perhaps we should be trying to
23 emulate and roll out on a wider scale.
24 I do not think I could point to one particular
25 event or set of circumstances which led the government
0015
1 then to say "We have to have systems of medical audit".
2 It was a combination of things.
3 Q. I think if we looked at the Inquiry paper again, we
4 would see a whole string of factors mentioned, all of
5 which culminate perhaps in the initiative in 1989.
6 If a bystander had come along and said, "Well, is
7 this initiative going to guarantee safe clinical
8 practice across the United Kingdom?" would those behind
9 the reforms have said, "Well, yes", or would they have
10 said, "That is not quite what we are hoping to achieve",
11 or "It is too early to hope to achieve that"?
12 A. We were asked to evaluate the development of medical and
13 clinical audit in, I think, 1992, three years after the
14 process had been put in place. I remember engaging in
15 some sort of post hoc attempts to work out what the
16 objectives had been at the time. It was difficult to
17 discern those objectives. I think the purpose in 1989
18 was much more about putting a process and systems in
19 place than necessarily about delivering either huge
20 improvements in the quality of care or necessarily
21 ensuring that significant problems could not happen or
22 would be less likely to happen in the future. The
23 objective was, I think, more modest. It was to engage
24 the professions, particularly the medical profession in
25 a system or a process for quality improvement that would
0016
1 lead in the future to those sorts of objectives and
2 ends, but I do not believe the policy makers at that
3 time thought that the introduction of medical audit was
4 going to be something that would bring short-term gains
5 and would deliver those sorts of improvements
6 straightaway. I think they recognised that it was
7 a long-term issue involving cultural change in the
8 service that would take time to work through.
9 Q. If we can look briefly at the reaction of the medical
10 profession to the introduction of audit, it is touched
11 on in the Inquiry's paper if we go back to INQ 11/13,
12 please.
13 We see, towards the bottom of that paper,
14 paragraph (ii) on the reaction from the medical
15 profession, which suggests that against a background of
16 general concerns or hostility to the proposed reforms in
17 1989, the reaction to audit on behalf of the medical
18 profession was strikingly positive, but that there were,
19 nevertheless, if we turn over the page, please, a series
20 of concerns about how it would actually work in
21 practice, even if the broad thrust was surprisingly
22 welcomed.
23 Can I ask you, what main threads did you see in
24 the reaction to the introduction of audit?
25 A. I think it is important to note that the positive
0017
1 responses from organisations such as the Royal Colleges
2 and the BMA and others were distinctly different from
3 the sort of evidence they had given ten years earlier to
4 the Royal Commission on the NHS when they had seen no
5 case for systems of medical audit in the NHS. So it was
6 a real step forward. I cannot think of one of the
7 professional bodies which did not respond in positive
8 terms to the White Paper's proposal for medical audit.
9 In that sense, the Department of Health strategy
10 of, if you like, a softly-softly approach, which was not
11 directive and did not mandate and did not require but
12 built gradually on things that were already there, was
13 perhaps justified.
14 I would distinguish though, between the reaction
15 of the professional bodies, the Royal Colleges and
16 others and the great and the good, and the profession on
17 the ground. I think your paper cites a study that
18 suggested that on the ground the profession was perhaps
19 less enamoured, less convinced, than professional bodies
20 and organisations. That is reflected in some of the
21 papers recruited from individual clinicians, saying
22 "Whilst we sign up to the aims of this, we are not sure
23 it is really going to work and deliver improvement" or
24 whatever.
25 Q. The paper mentioned a number of reasons for concern from
0018
1 clinicians, such as bureaucratic committee structures,
2 adequate time for audit, and concerns about the use of
3 resources. But what in particular I would like you to
4 address, if you would, is whether confidentiality could
5 really be maintained. That was a concern. Can you tell
6 us a little more as to the elements of that concern?
7 A. Yes. At the time I think many clinicians --
8 I encountered this in work I was doing at that time in
9 the South-east Thames region and I was involved in
10 drafting with others in that region a policy on the
11 confidentiality of medical audit, clinical audit data.
12 I think the concern of clinicians was primarily
13 about the confidentiality of data that referred to
14 individual clinicians, or indeed, to clinical teams and
15 they had two concerns: (1) that information would be
16 disclosed outside the clinical team to others, perhaps
17 particularly to non-professionals or to managers, who
18 would misunderstand it, who might misuse it for whatever
19 purpose and who would therefore draw conclusions that
20 should not be drawn from that data, or take actions
21 which should not be taken. That was one concern. The
22 other concern that clinicians had was that data that
23 they collected for clinical audit would be discloseable
24 to patients, or to patients' representatives in actions
25 for clinical negligence, and at the time, in those two
0019
1 areas in the first area many hospitals developed
2 guidelines that were designed to reassure clinicians
3 that data, particularly data about individual
4 clinicians, would not be passed willy-nilly around the
5 organisation, but would only go to those who needed to
6 know and had a legitimate right to know.
7 Q. What would that unit be?
8 A. That varied according to the level of concern and the
9 local context. In the work I was involved in
10 developing, the model we worked out was that data about
11 individual clinicians should primarily stay with those
12 clinicians in the clinical team and the Clinical
13 Director for that service. Data about clinical teams
14 would be shared more widely with the Management Board of
15 the health care provider. That was the compromise we
16 evolved to try and reassure individual clinicians that
17 they would not see information about them in Trust Board
18 minutes or whatever.
19 Q. I am sorry, you were talking of concerns about civil
20 litigation and I interrupted you.
21 A. Yes. That was the second concern. That concern
22 remained unresolved. There was some discussion with the
23 Department of Health at the time about whether that data
24 could have some kind of privilege, some kind of immunity
25 from disclosure, as indeed information collected for the
0020
1 Confidential Enquiry on Peri-operative Deaths and the
2 Confidential Enquiry on Maternal Deaths, which both had
3 PII certificates and the Department of Health was not
4 enthusiastic about attempting to pursue that, and it was
5 not pursued and it seemed to go away as an issue.
6 Q. It went away when, or why?
7 A. I think gradually, as people -- this was part of the
8 initial abreaction, if you like, the initial concern
9 about the whole idea. Gradually, as people engaged in
10 medical and clinical audit into the 1990s, their worries
11 about the confidentiality of the process tended to
12 decline. I cannot think of a single example that I have
13 come across of data from clinical or medical audit
14 having been misused in the way that it might have been
15 suggested, and although I have had a number of
16 discussions with defence lawyers involved in medical
17 litigation for health care organisations, I am not aware
18 of any real examples of that data being then picked up
19 and used by the plaintiffs in litigation. So I think it
20 was a set of concerns that were not particularly real,
21 although they felt very real to the individuals who
22 raised them.
23 Q. Does the position --
24 THE CHAIRMAN: I just wanted to explore a little bit more --
25 I may be asking something you were going to ask,
0021
1 Miss Grey, if so, forgive me, but the notion of
2 confidentiality as used here is not the traditional
3 notion of confidentiality we are used to hearing about,
4 namely as between patient and doctor, which is
5 established; it is, as it were, a claim to privacy or
6 secrecy, or, if you like, confidentiality as regards
7 a new lot of data which is going to be generated. Would
8 that be accurate?
9 A. Yes. I do not think most people saw a big issue about
10 the confidentiality in patient terms, because if you had
11 a set of data about, for example, a series of cases, it
12 was easy to anonymise without removing the key issues to
13 do with what the quality problems were or whatever.
14 I think the debate about confidentiality
15 reflected, if you like, an underlying theme to do with
16 who owned the audit process: was it owned by individual
17 clinicians in the clinical team, or did it belong to the
18 organisation? Whose data was it? That changed between
19 1989 and 1995 quite significantly.
20 MISS GREY: Two questions: did the attitude of the
21 Department of Health or the legal position in the UK
22 about such data not attracting public interest immunity
23 or any other form of confidentiality within civil
24 litigation differ from the stance taken in other
25 countries?
0022
1 A. Yes, it did. In the United States, something like 47 or
2 48 of the States have legislation which gives some kind
3 of qualified immunity or privilege to information that
4 health care providers collect for quality assurance
5 purposes. Not all States have that, but the great
6 majority do. Some people pointed to that as an example
7 and said clearly that is needed to allow audit or
8 quality improvement to be established.
9 That has to be seen in the light of levels of
10 litigation for medical negligence which are an order of
11 magnitude higher at least in the US, so a very different
12 situation.
13 Interestingly, more recently, I think I am right
14 Australia has introduced some legislation which gives
15 some qualified privilege to information that providers
16 there collect for the purposes of quality improvement.
17 Q. How can one evaluate whether that immunity makes any
18 difference to the effectiveness of the audit process?
19 A. I do not think we can really answer that question. You
20 could argue in practical terms. It clearly has not been
21 necessary in Canada, it has not been necessary in other
22 European countries and it does not seem to have been
23 necessary here, but we cannot prove the counterfactual,
24 had we had that legislation, things would be different
25 today.
0023
1 Q. Because there are too many other confounding factors to
2 be able to evaluate it. Going back to your discussion
3 of the model of who obtains information about the
4 performance of an individual clinician and the
5 suggestion that at least in one team that you were
6 working, the organisation that you were working with,
7 the solution was found that that sort of information
8 should stay at the level of the team and the Clinical
9 Director, what was the justification for saying that it
10 was in effect the responsibility of the team and/or the
11 Clinical Director to address concerns about an
12 individual clinician's performance or record or whatever
13 aspect of the data gave rise to concern?
14 A. I think, in thinking about how we developed those
15 guidelines in the South-east Thames region, it was
16 essentially a pragmatic justification. We were trading
17 off overcoming clinicians' concerns and worries about
18 confidentiality, and hindering or even hampering the
19 process of clinical or medical audit and its results.
20 The concern we had was that if you drew too tight
21 a set of confidentiality guidelines, then information
22 about quality problems would not be able to flow to the
23 people who needed to know about them, or who had perhaps
24 had the capacity to do something to then change
25 practice. So confidentiality, we were concerned, could
0024
1 be a bar to actually producing effective medical or
2 clinical audit.
3 On the other hand, we were responding to the very
4 real concerns of clinicians, and this compromise we
5 worked out, we distinguished between data about
6 individual clinicians and the clinical team. We said
7 that information about teams should be much more widely
8 shareable. Data about individual clinicians would stay
9 within the team and the Clinical Director, so that the
10 Clinical Director had a key role there. That did not
11 mean that if that Clinical Director had concerns about
12 a particular individual, they would not then be able to
13 raise those concerns, and indeed, they would have a duty
14 to raise those concerns with those higher up in the
15 organisation. But it was our kind of pragmatic response
16 to try and find a middle way between the concerns of
17 clinicians and the effectiveness of having an effective
18 audit process.
19 Q. The answer you are giving there implies there was some
20 formal discussion and agreement on how data should be
21 shared within the organisation; is that correct?
22 A. We developed these guidelines for Brighton Health
23 Authority, and Brighton Health Authority and the
24 clinicians involved in audit there endorsed them and
25 used them. They then got picked up by the South-west
0025
1 Thames region which used them themselves, the Regional
2 Health Authority endorsed them, and in fact several
3 other regions picked those up and a number of other
4 Trusts around the country took copies of our guidelines
5 and then used them or modified them. I think there is
6 in the papers a set of similar guidelines or a set of
7 guidelines on confidentiality for UBHT, and most Trusts
8 around the country at that time wrote some sort of
9 a paper describing how they would try to manage
10 confidentiality in the audit process and tread this
11 middle way between keeping clinicians reassured and
12 making sure that problems with quality could be raised
13 and dealt with effectively.
14 THE CHAIRMAN: May I ask another question? Again, perhaps
15 just proceeding the way Miss Grey is going to go.
16 Would this compromise you talked about work as
17 well if you included in the audit process what Professor
18 de Leval mentioned when he was here, namely near-miss
19 examinations, not merely mortality and morbidity but
20 near-miss, where you might need to have more specific
21 information than just the unit, that you may identify
22 one particular individual. Could that compromise work?
23 How would one manage that, if it were desirable?
24 A. I think the compromise we came up with places a lot of
25 responsibility on the clinical team to deal with the
0026
1 sorts of problems that arise, not just near misses but
2 significant adverse events of one sort or another.
3 I do not think I would feel comfortable with
4 a Trust following that compromise today. It was very
5 much a compromise of its time. It dealt back in the
6 early 1990s with the worries that clinicians had.
7 MISS GREY: Can I just go back to an answer you gave
8 earlier, when you mentioned that the Department of
9 Health was reluctant or would not grant PII
10 certificates, or immunity for data produced in the audit
11 process.
12 Can I just ask you for further details of how that
13 information came to light, or you know of it?
14 A. I would have to look back to papers at the time, but
15 I know I had discussions with people who were in the
16 Medical Audit Unit at the Department of Health about the
17 issue, having been involved in producing some guidelines
18 on this, and other organisations produced sets of
19 guidelines on this. I think the BMA issued some
20 guidance and I think the Royal College of Physicians did
21 too, and it was raised by a number of individuals with
22 the Department. I think I am right that I have
23 somewhere on file a letter from the Department's
24 solicitors, I might struggle to find it now, because
25 I know they did get legal advice on the confidentiality
0027
1 of that data.
2 THE CHAIRMAN: I think it is being urged that if you do have
3 any such material, we would be very grateful to see it,
4 if you could let us have it in due course?
5 A. I will endeavour to find it, yes.
6 MISS GREY: If I could leave the topic of confidentiality,
7 unless there are any further questions arising out of
8 it, and pass back to the structure that was set up in
9 1989 to develop audit: firstly, can you tell us a little
10 bit about the role of Regional Health Authorities in the
11 system, as it was developed from 1989 onwards, to 1995?
12 A. The situation in 1989 -- it was actually I think 1990
13 and early 1991 when the policy began to roll out into
14 practice -- was that the Department of Health allocated
15 sums of money that were ringfenced for the purposes of
16 medical audit and it allocated those sums to regional
17 health authorities and regional health authorities went
18 on to allocate them to district health authorities, and
19 a variety of formulas were used to do that, mostly based
20 on the numbers of consultants in those organisations or
21 areas.
22 Every Regional Health Authority established some
23 kind of a function, a regional audit committee or
24 a regional audit co-ordinator to manage this process, to
25 allocate the resource and also to follow up how that
0028
1 resource was used to make future decisions about
2 movement of that resource and so on.
3 So every region established some kind of
4 a function.
5 Q. Is it right to say that the regions devolved that money
6 down to the districts, or did they at least in some
7 cases distribute it directly to hospital Trusts
8 themselves?
9 A. That changed over time. Initially, they distributed
10 that money to districts, and I think the circular that
11 came out in 1990 described a process of having
12 a District Audit Committee. This was a time when NHS
13 Trusts were being created and so gradually, between 1990
14 and 1992, regions began to allocate that resource more
15 to individual provider units or Trusts rather than to
16 districts.
17 But in that process of allocating the resource,
18 district health authorities tended to play a very
19 limited role. The resource went largely from Regional
20 Health Authorities and their Audit Committee to
21 a District Audit Committee at district level to
22 a hospital or to a provider unit audit committee at
23 provider level, with the Health Authority often seeming
24 to act as not much more than a sort of post-box for the
25 funding as it went down and for the report that would
0029
1 then come back up on an annual basis.
2 Q. I think if we look at the documents from the UBHT, by
3 1992, at any rate, the line of reporting went from the
4 Trust directly to the Region, rather than via the
5 District Health Authority. That would be in no way
6 atypical, would it?
7 A. No, some regions were more interventionist than others.
8 Some regions for example, their regional audit function
9 undertook visits to Trusts to assess what they were
10 doing with their audit resource, to advise them, try to
11 encourage them to take particular directions and so on.
12 Others were much more hands-off and simply allocated
13 a resource and then waited for an annual report. But
14 the position of the Health Authority here, in not
15 playing an important role in the process, is far from
16 atypical. We did some research about that time that
17 looked at the role of health authorities and suggested
18 that most health authorities had a fairly limited role.
19 There is a report on that that I can provide, if that
20 would be helpful.
21 Q. If we look back at WIT 323/18, we are back in the
22 Working Paper of 1989 on medical audit. At this stage,
23 at items (c), (d) and (e) we can see the role envisaged
24 for management in the audit process.
25 I think firstly it is a fair comment perhaps that
0030
1 at this stage the detail of the level of scrutiny or
2 involvement from management that was envisaged is not
3 particularly clear?
4 A. Yes, I think that is true. You should remember that at
5 this time managers in the Health Service had a fairly
6 substantial change agenda, the creation of NHS Trusts,
7 the development of contracting, one or two other things
8 to deal with, and most managers sat at best as
9 a spectator rather than a player in local clinical
10 audit. I note that I think the Audit Committee for the
11 UBHT had a manager in attendance rather than a manager
12 as even a member of the Audit Committee. That was far
13 from being atypical; that was a common model: the
14 committee was entirely clinical or almost entirely
15 clinical.
16 One of the things we examined in our research was
17 the reporting relationships of those committees, so if
18 you have a local Audit Committee, to whom or how does it
19 report? What became clear was that many did not see
20 a particular reporting relationship to their
21 organisation; if anything, it was to the Region.
22 The process was kind of semi-detached. It was
23 certainly not corporately owned. Ringfencing of the
24 resource had an effect here because --
25 Q. Can I just slow you down? You were saying that
0031
1 ringfencing ...
2 A. Ringfencing had an important effect here too. Because
3 the money was dedicated to clinical audit, many managers
4 seemed to simply say, "This is not our concern, we will
5 leave it to the Audit Committee". It was actually when
6 ringfencing of the resource ended in 1994 and it became
7 a local funding issue for health authorities and Trusts,
8 that managers began to get much more involved because
9 they were then accountable for and could influence the
10 spending of that resource.
11 Q. So do you see, then, a development in the involvement of
12 management and its agenda throughout the period of the
13 Inquiry?
14 A. Yes. Managers moved from being spectators to being
15 players. As policy on audit evolved, as the process
16 began to mature and people began to understand it better
17 in provider units or Trusts, and as the funding process
18 for it changed and it became locally a process that
19 health authorities funded through a contract with their
20 provider units, you saw much greater management
21 involvement in the process.
22 Q. What shape or form did that management involvement tend
23 to take? I know I am asking for generalisations, but
24 you can perhaps help us at least?
25 A. I think it worked at several levels. It meant there
0032
1 started to be more management input into audit
2 committees with a manager or a number of managers taking
3 a role. We started to see an executive lead for audit
4 quite often, so quite commonly the Medical Director or
5 Nurse Director of the Trust being clearly identified as
6 the Executive Director who had responsibility for
7 clinical audit and in the process of auditing
8 directorates, you began to see more managerial
9 involvement. This was at a time when Clinical
10 Directorate structures were developing, and it was
11 becoming more common to have Clinical Directors with
12 a busy manager working with them to manage a clinical
13 area, and increasingly, those business managers were
14 involved in audit processes within their directorates.
15 Q. What does that mean in concrete terms? For instance,
16 does it have an effect on whether or not managers feel
17 able to specify topics for audit, or guide that process?
18 A. That became commoner. In fact, the guidance from the
19 Department of Health on the evolution of clinical audit
20 issued in about 1993 or 1994 began to suggest that
21 a proportion of audit topics should be determined by the
22 local health authority; a proportion should be
23 determined by the Trust; and a proportion should be
24 determined by clinicians. That I think is an explicit
25 recognition of the fact that there are other people who
0033
1 have an interest in the process.
2 In some ways, that was not necessarily that
3 productive, because it was often the people in the
4 service who were best placed to see what the quality
5 problems were and to identify an agenda. What it did do
6 was at least make health authorities and Trusts engage
7 more in identifying what topics for audit should be
8 addressed; much more than they had done in the past when
9 it was entirely an issue in most places for the local
10 clinicians.
11 THE CHAIRMAN: May I ask another question? You talked about
12 the parallel development of clinical directorates. Do
13 you have any insight as to whether, if audit was
14 developed along with clinical directorates and was
15 particular to that area of activity, there might be
16 a price to be paid in terms of being able to audit
17 across directorates to see, for example, whether there
18 were a number of directorates involved in stages in the
19 care of a particular patient?
20 A. Yes. I think it might be helpful to refer to some of
21 the research in the evaluation that we did here. One of
22 the things that we looked at in our survey of all Trusts
23 in 1993 was whether Trusts had devolved the process to
24 directorates and devolved the resource as well to
25 directorates, or whether they had a central function.
0034
1 I think we found from memory about 10 per cent of
2 Trusts had chosen to devolve the process wholly or
3 largely to directorates. The great majority had
4 established some kind of central audit function, quite
5 often with a link then to directorates, so individual
6 audit staff would serve particular directorates, for
7 example. In that report -- I can provide it for the
8 record -- we argued that the devolved model was not
9 a good way to go, for a number of reasons: because it
10 fragmented the resource across areas, it made it much
11 more difficult to do anything across directorates; it
12 was hard to monitor and there was some evidence from our
13 survey that directorates did not necessarily use the
14 resource for clinical audit as it was intended to be
15 used, and it led to some very isolated audit and quality
16 improvement staff. So we felt that a centrally led
17 model, particularly in the early days of clinical audit,
18 was much more appropriate.
19 THE CHAIRMAN: Could I ask where that research was
20 published, where and when?
21 A. It was published in a research report from CASPE
22 Research for the Department of Health in 1993, I think,
23 but I will provide the report. That was widely
24 circulated. That report was sent to all the Trusts that
25 had taken part in the survey, for example.
0035
1 MISS GREY: Can you just tell us a little more about the
2 methodology of that work, because I think you visited
3 a number of Trusts in order to do your research?
4 A. Yes. There were two parts to it. We did a very
5 detailed survey of all health authorities and all
6 Trusts, and we used data from that survey to identify
7 29 Trusts, chosen to be broadly representative of the
8 different sorts of Trusts, broadly representative
9 geographically of England, and also broadly
10 representative, from the data we had in our survey, of
11 progress in clinical audit. So we were not just looking
12 at the leading edge or the trailing edge but looking
13 across the spectrum of clinical audit.
14 We chose 29 Trusts whom we then visited -- I am
15 working from memory here -- across 1994. I think it was
16 the first few months of 1994 that we did most of that
17 work. Each Trust we visited for about two days. We did
18 confidential interviews with a range of staff at each
19 Trust, including leads for audit, chief executives,
20 medical directors and others. We held an open meeting
21 at which people came and talked about what they were
22 doing for clinical audit. We reviewed their documents,
23 their audit reports, minutes of meetings and we also
24 collected data on a sample of audit projects at each
25 Trust.
0036
1 MRS HOWARD: Dr Walshe, may I interrupt again. You talked
2 about 29 Trusts and gave a wide spread. Out of memory,
3 can you remember whether Bristol was actually one of the
4 Trusts?
5 A. No, it was not. I think I am right there were two in
6 the South West region. I am 99 per cent -- can you
7 confirm, Eleanor?
8 MISS GREY: That is my understanding from the
9 documentation. Were there any Trusts of a size
10 comparable to the UBHT that were included in the study?
11 A. Yes, we looked at some very large acute Trusts and also
12 some smaller acute Trusts. We looked at community
13 Trusts and combined Trusts that combined medical health
14 and acute services.
15 Q. I think the argument that might be advanced for
16 a devolution model in a Trust the size of the UBHT would
17 be that really its size drove that particular policy and
18 to impose centralised control would have been
19 counter-productive and stifle local initiative, as it
20 were?
21 A. Yes. I am quite cautious about imposing a particular
22 shape to the process on a Trust, because one of the
23 things the research suggested was that it was very
24 dependent on the local context; it was hard to prescribe
25 that "this is the best way" of organising and auditing
0037
1 an organisation. We published four reports on Trusts we
2 thought were very good at doing clinical audit. One of
3 those was North Staffordshire Royal Infirmary, a very
4 large acute Trust which we thought developed a very
5 effective clinical audit programme. I am happy to
6 provide that report for the record. There they had
7 a central audit function, a clinician and physician who
8 led the process and an audit team of about 9 or 10 audit
9 staff working across the Trust. It was an example of
10 a model that we thought had worked well.
11 Q. You in fact identified, through your research, the
12 elements of a successful audit programme?
13 A. Yes.
14 Q. If we look at INQ 11/17, please, towards the bottom of
15 the page we can see -- perhaps we should scroll up
16 a little for the full information. Firstly, there is
17 a paragraph there which says at (i) that a successful
18 audit programme is defined firstly as one directed to
19 quality improvement, valued and respected by
20 stakeholders, it covers the full range of provider
21 services, departments and professions, and produces
22 documented demonstrable improvement in the quality of
23 care.
24 Then this summary reports you as having found that
25 there were really only a very few providers whose audit
0038
1 programmes would genuinely be said to be achieving most
2 or all of those benchmarks. So one had, as it were, to
3 lower one's ambitions in order to find successful signs
4 of improvement or development in audit.
5 If we go on, then, and scroll down the page to
6 (iii), please, they set out there seven critical success
7 factors for clinical audit programmes. Can you just
8 talk us through the summary of the seven that we find
9 there: firstly, clinical leadership?
10 A. Yes. We found that these were the seven key
11 determinants of whether audit had worked, or would work
12 in an organisation. Whilst the presence or absence of
13 any one was not necessarily a determinant in the sites
14 we visited, being able to say that these things were
15 present seemed clearly associated with greater progress
16 in clinical audit.
17 Clinical leadership emerged from the qualitative
18 research that we did as the most important single
19 determinant of whether audit worked, having the right
20 clinical leader for the audit programme, the chair of
21 the audit committee or whatever. In some places we
22 visited, the person put into that role was the most
23 junior consultant, or one of the most junior consultants
24 in the organisation. In some places they had no time to
25 fulfil this role. In some places they were not
0039
1 interested, or had been given the role because nobody
2 else would take it; they had no real enthusiasm for it.
3 In others, the clinical leader was someone who had
4 authority, who had perhaps played other roles within the
5 organisation, was respected clinically by doctors and by
6 others, who was genuinely interested in quality
7 improvement and demonstrated that by their own practice
8 of clinical audit, and who had the management skills and
9 the interpersonal skills to make the programme of change
10 involved in implementing clinical audit work.
11 That seemed the most important single determinant,
12 having the right person as the clinical leader.
13 Q. Just to clarify, presumably these benchmarks, as it
14 were, would be being assessed either at the level of
15 a centralised audit committee in a centralised
16 structure, or perhaps at a devolved level if audit was
17 taking place, say, at the Clinical Directorate level?
18 A. Yes. I think you could use the framework of the seven
19 areas that we suggested, both to think about a Trust and
20 to think about performance in a Clinical Directorate.
21 Q. If we go on, you talk about vision, strategy, objectives
22 and planning, and perhaps not surprisingly, it helps if
23 one is clear about all of those things.
24 A. Yes, researchers often come up with the blindingly
25 obvious. The point was that in some places we visited,
0040
1 there was no clear idea of what audit was meant to be
2 doing, so it became taken over by individual agendas of
3 individual clinicians, or indeed other individuals who
4 wanted to do something in particular, and you ended up
5 with a very uncoordinated and rather incoherent
6 programme of quality improvement, if at all.
7 In others, they had a clearer shared view that the
8 Chair of the Audit Committee had communicated to
9 clinical colleagues that this is what audit is about,
10 and there was then much more coherence and where that
11 was linked to having someone perhaps as the audit
12 co-ordinator or manager who was good at delivering the
13 objectives, translating that into an action plan and
14 making sure that those actions happened, then it worked
15 much better.
16 Q. And those set of objectives, they had tended to emerge
17 how? Through discussion? Through debate?
18 A. Every Trust was obliged to have a forward plan for
19 clinical audit, and also to produce an annual clinical
20 audit report, particularly in the time of ringfenced
21 funding to receive their ringfenced funding, but those
22 plans varied very much. Some of them were not much more
23 than a statement of the guidance, with some information
24 about local activity, and others were much more a real
25 plan, setting out what the objectives were and how they
0041
1 were going to be achieved.
2 Usually, those objectives and the planning process
3 emerged from chairs of audit committees and chairs of
4 audit co-ordinators as the driving force behind them.
5 Q. Going on to audit staff and support, if we just turn
6 over the page?
7 A. Yes. Especially at the start of clinical audit, the
8 perception amongst many clinicians was that they needed
9 people to help them collect data, so quite often Trusts
10 appointed a raft of audit assistants to help gather
11 data, to put it into computers and so on.
12 I think what soon emerged was that data collection
13 was not necessarily the problem. They needed more help
14 with the quality improvement process, with helping them
15 to identify opportunities for improvement or policy
16 problems, and manage a clinical audit project that would
17 result in recommendations that would then bring about
18 a change in practice, and Trusts gradually moved to have
19 more senior people involved. For example, people who
20 had a clinical background, working as an audit
21 facilitator, who are much more able, if you like, to
22 punch their weight with the clinicians they were talking
23 to, who understood the clinical issues much better and
24 were more able to provide real advice and support, not
25 just collect data.
0042
1 Q. Do you mean that at the beginning there was too much
2 attention paid to collecting data, without adequate
3 thought given to how it would be used, or be useful?
4 A. Absolutely. One of the findings from our survey was
5 that at the time of this survey I think about 25 per
6 cent of the ringfenced funding for clinical audit was
7 being spent on IT. In some Trusts, some of the ones we
8 visited, it was much more than that. We raised concerns
9 about the value of much of that investment because it
10 produced lots of information systems and the gathering
11 of a huge amount of data, much of which was never really
12 used in clinical audit.
13 Q. If we go on, then, please, to structures and systems --
14 A. In a sense, it is like the point about vision and
15 strategy and objectives in planning. The people who
16 were running audit, chairs of audit committees, were
17 almost all consultants, and some of them had never
18 managed staff, for example, before apart from their
19 junior medical staff. Suddenly in a place like UBHT,
20 you would have responsibility for a budget of œ300,000
21 for perhaps five, six or seven audit staff, and some
22 were much more able to get to grips with the process of,
23 you know, setting up structures for a department,
24 managing staff appraisal, dealing with all the issues
25 concerned with managing this new function. And some
0043
1 audit departments were just much better managed than
2 others. They had systems, for example, for deciding
3 which audit projects they would do, which audit projects
4 they could support for prioritising, for timetabling,
5 for monitoring what was going on. Others were much less
6 well developed.
7 Q. The entirety of that answer is, I think, largely
8 premised upon the 9 per cent of the larger departments
9 with large budgets, deployment of staff and so on.
10 Presumably you might say that had an application
11 nonetheless again at Clinical Directorate level, albeit
12 that smaller programmes would be run at that level?
13 A. Yes, indeed. If you talk to Clinical Directorates, or
14 to directors and consultants about how audit was managed
15 in their directorate, some would have a system for, for
16 example, identifying what topics they would address.
17 They would say, "Once a year we sit down together and we
18 discuss what topics we want to do over the coming year
19 and we plan out a programme". Others would say, "We
20 each take it in turn to run an audit meeting and it is
21 up to whoever runs the audit meeting to choose a topic
22 to present".
23 Q. It would follow if that model were adopted, it is likely
24 that the whole process of audit would be collapsed into
25 one single meeting?
0044
1 A. Yes, absolutely, and one of the perverse effects of the
2 Department of Health's policy on audit and the way it
3 monitored the process of audit was that there was
4 a focus on having audit meetings as being a major part
5 of the audit activity. So consultants were very much
6 encouraged to establish meetings where they had
7 regularly talked about audit. Some Trusts established
8 an audit half day where all consultants would spend time
9 talking about audit, but that encouraged a wrong-headed
10 view that audit was all about sitting down and having
11 audit meetings and once you had been to the audit
12 meeting, you had done audit. Much of what was important
13 about audit -- identifying problems, collecting
14 information, putting into practice change -- had to take
15 place outside those meetings.
16 Q. Training and education: I think that if we look through
17 the regional reports to the Department of Health from
18 the South West Regional Health Authority during the
19 period of our Inquiry, we would find comments that
20 little money was spent on training clinicians in audit.
21 That was a theme, then, that you found repeated in your
22 research?
23 A. Yes. Very much. Very few of the providers we visited
24 had done more than run a few ad hoc workshops to equip
25 clinicians with skills in quality improvement. The
0045
1 assumption was that they had those skills because they
2 were already doctors or nurses or whatever.
3 If you look at other sectors, if you look outside
4 of health care, effective quality improvement programmes
5 invest a lot of money in equipping people with the
6 skills in teamwork, in problem identification, in change
7 management, that they need to make quality improvements
8 happen and we thought this was an important failing
9 here.
10 I would also say that those Trusts who did invest
11 a lot in training, and Brighton Healthcare was one
12 I worked with a lot in the 1993/94 period on training
13 clinicians in clinical audit, struggled sometimes to get
14 clinicians to see that they had a need for training,
15 struggled to persuade particularly doctors that they
16 should take a day away from clinical practice and spend
17 that in a seminar on clinical audit or quality
18 improvement.
19 Q. How much guidance or help was coming on that issue, on
20 the need for training, because presumably your study and
21 its publication might have identified that as a failing;
22 but before such work was coming out of the evaluation of
23 audit, how much recognition of the problem would there
24 have been?
25 A. I think quite limited. It was not really a strong theme
0046
1 in the policy documents, earlier or later. Because
2 although they talked about audit as being fundamentally
3 educational, it was more about educating people about
4 clinical practice than about educating them about how to
5 do effective clinical audit.
6 THE CHAIRMAN: May I ask a further question? In your
7 reference to the preparation of clinicians and training,
8 what provision was made, and presumably it would be
9 financial, for the engagement of locums or others to
10 take over those duties that the clinicians would
11 otherwise be doing?
12 A. That was a local issue for Trusts. They had their audit
13 resource and they spent it how they chose. And not just
14 for Trusts but also in primary care, where I think it
15 was even more of a problem for the primary care audit
16 groups, in getting GPs and others to take time away from
17 the workplace to engage in training.
18 MISS GREY: Did they make use of locums, that you saw?
19 A. Not very much. I think where training was organised,
20 often it was orientated around those audit meetings that
21 I described, so if a Trust had a regular audit half
22 a day once a month, they would try and organise training
23 workshops and things like that. The Audit Department
24 would focus its training activity on times when it knew
25 clinicians were able to make it.
0047
1 Q. Presumably it might say that it is not easy to find
2 a replacement for a senior consultant surgeon, for
3 instance, you cannot find a locum to substitute for such
4 a person?
5 A. Indeed, but I think it was treated within Trusts very
6 much as absences for other purposes from the clinical
7 workplace would be treated, absences for other
8 directorate meetings, for other meetings within the
9 organisation, for continuing professional development,
10 where the workload would get reorganised but it would be
11 unusual, I think, often to hire a locum to cover a day's
12 session.
13 Q. If we move on, then, to understanding and involvement,
14 you say that "successful participation in audit
15 programmes also depended on resources, time and
16 appropriate incentives and sanctions."
17 What use was made of incentives?
18 A. Many Trusts used the ringfenced audit money itself as an
19 incentive. They used the distribution of that resource
20 as a way of encouraging participation in clinical
21 audit. It was used to kind of oil or grease the wheels
22 and encourage people to take part.
23 Very few Trusts had other incentives that they
24 could rely upon, other than the sort of encouragement
25 and support of, you know, the audit chair and others,
0048
1 and I cannot think of any Trusts who had real
2 sanctions. I mean in our research we interviewed what,
3 29 chairs of audit committees, and I remember one
4 telling me that in his year or so as the Chair of the
5 Audit Committee, he had made himself more unpopular than
6 he had in 20 years of clinical practice. It was
7 a difficult role to fulfil in raising with colleagues
8 issues such as "Why is your directorate not doing any
9 clinical audit?"
10 The result of that was that clinicians or chairs
11 of Audit Committee tended to raise the issue once or
12 twice, but they did not bang their head against a brick
13 wall, because they had few other sanctions they could
14 take. Quite often, what chairs of audit committees
15 would do is include in their annual audit report the
16 fact that orthopaedics was not doing any audit because
17 there would be a blank page for orthopaedics, but they
18 would not do more than that. It was hard to see what
19 more than that they could do, quite often.
20 Q. If we go on to the organisational environment, the
21 summary again comments that the those organisations
22 likely to be most in need of audit and quality
23 improvement were probably the least able to be able to
24 make it happen.
25 A. Yes, good organisations are good at implementing change
0049
1 and the introduction of clinical audit was another
2 change, so it was clearly the places where managerial
3 and clinical relationships were good, and not just at
4 a Trust level but at a directorate level, where, for
5 example, the clinicians got on, met regularly, there
6 were good relationships between doctors and nurses, who
7 were more able to engage in setting up a clinical audit
8 process.
9 I can think of places I visited where groups of
10 clinical staff did not talk to each other, individual
11 clinicians just did not get on, and establishing an
12 audit programme in that rather hostile environment is
13 clearly much more of a challenge.
14 Q. Are you saying then that audit functions as a sensitive
15 indicator for other more deep-seated problems, or that
16 it may do so?
17 A. Yes, we argued in the conclusions from our research,
18 that audit was a useful kind of proxy for deeper seated
19 organisational problems and that by pointing to Trusts
20 who had struggled to establish any kind of audit
21 programme, or to directorates within a Trust who had
22 struggled to establish any clinical audit, you could
23 often point to places where there were deep-seated
24 clinical problems that had implications for the quality
25 of clinical care widely.
0050
1 THE CHAIRMAN: When you say audit was a useful proxy, you
2 mean, do I take it, the existence or effective use of
3 audit, rather than the results of the audit?
4 A. No, the process. I think having done the research,
5 I would be much reassured as a patient to be treated in
6 a directorate or department where I knew they had
7 established an effective set of arrangements for
8 clinical audit, and I would worry if I knew they had
9 struggled to do so and failed to do so.
10 THE CHAIRMAN: I am grateful.
11 MISS GREY: If I may leave, then, the indicators of
12 a successful audit programme and just ask you to discuss
13 briefly the shift from medical to clinical audit during
14 the latter period, if we are looking at the period 1991
15 to 1995.
16 We know from various papers before the Inquiry
17 that in around 1993, to put it broadly, the Department
18 started to encourage and then indeed to require of
19 clinical audit programmes as against purely medical
20 audit programmes.
21 Was that replacing medical audit, or was it common
22 to find the two beginning the operate in tandem?
23 A. It generally replaced and it was part of the wider shift
24 towards for example more managerial involvement, that
25 there was this move towards a more multi-professional
0051
1 approach to audit and quality improvement.
2 The department had established, back in 1990,
3 a separate nursing and therapies audit programme run by
4 a separate part of the Department of Health, part run by
5 the Chief Medical Officer's section and part by the
6 Chief Nursing Officer's section. In 1993 they
7 recognised, as did others, that that division did not
8 make sense and they brought the two together and
9 encouraged Trusts to bring the systems together.
10 What usually emerged within a Trust was a Clinical
11 Audit Committee with a more multi-professional
12 membership, although the membership of those committees
13 tended to be quite medically dominated.
14 Q. So was there no clinical role for a medically orientated
15 form of audit?
16 A. I think it depended on the specialty, the area and the
17 quality issues that you were addressing, but I think
18 most people would agree that most quality problems do
19 not belong to an individual profession. When you start
20 to examine why a particular problem or difficulty
21 exists, it quickly rolls out, given the complexity of
22 the process of care, into the territory of other
23 professional groups.
24 So clinical audit seemed much better fitted to
25 dealing with the very multi-professional nature of most
0052
1 areas.
2 Clearly there are some specialties who tend to
3 work much less multi-professionally than others, and
4 there was no purpose in having a multi-professional
5 process if the issue simply, you know, affected the
6 anaesthetists. But the default, I think, was meant to
7 be that these processes should be multi-professional,
8 because most of the time that was what was needed.
9 Q. And if we are looking at 1995, how well-developed was
10 that form of audit by that time?
11 A. Here I have to rely more on anecdote, because I do not
12 have research data to refer to, but anecdotally, it
13 changed gradually. Initially, it was a clinical audit
14 process, but still very medically led, with both at
15 Trust level and directorate level doctors dominating the
16 process and also having most of the resource for
17 clinical audit in terms of support and so on.
18 That changed gradually and quite often what you
19 found was that the Nurse Director for a Trust would
20 become the person responsible for quality, including
21 clinical audit, and the shape of the clinical audit
22 committee would be changed to make it less medically
23 dominated and to make it involve managers, therapists,
24 nurses and others much more. So gradually it did shift,
25 and I think most Trusts today would have fundamentally
0053
1 a clinical rather than a clinical and medical audit
2 programme.
3 Q. I am touching on a number of themes very briefly, but
4 just to complete that process, can I touch on something
5 that we mentioned briefly earlier but did not explore in
6 any detail, which was the issue of the lessons or
7 experience to be gathered from other industries,
8 experience in introducing quality assurance programmes.
9 Do you think that the NHS learned as much as it
10 could have done from that experience, and if it did not,
11 what were the obstacles to it?
12 A. With the benefit of hindsight, I have no doubt we could
13 have learned much more from the experience of quality
14 improvement, both in other industries and in health care
15 in other countries, than we did. You can attribute that
16 to a kind of parochialism in which we tend to think of
17 things invented in the NHS as being much more important
18 and useful than things invented elsewhere.
19 I think there were important lessons we adopted at
20 least in part. There was for example some very useful
21 research that compared the use of total quality
22 management in pilot TQM hospitals in the NHS with its
23 development in a number of non-health care
24 organisations, Post Office Counters, a water company,
25 a building society, and so on, and highlighted some of
0054
1 the differences in culture and context that made it
2 harder, they argued, in a health care organisation to
3 implement TQM than it was in those non-health care
4 environments.
5 Q. Can you summarise those factors?
6 A. Yes. I mean, I think there are three things, perhaps,
7 they pointed to. One was the professional culture,
8 which did not fit well with the fairly corporate and
9 planned approach that TQM demanded and sort of implied,
10 so the tradition of having a strong professional base
11 and professionals who were not conventionally
12 accountable in a non-health care sense to people was one
13 issue they identified.
14 The second issue was the difficulties of making it
15 work more broadly in public sector organisations, where
16 the incentives are not always as clearly aligned with
17 improving quality as they are in the private sector.
18 You can argue that in a building society, if you
19 improve quality you stand to increase market share, to
20 improve return, and there are a number of measures you
21 might look to. In the public sector, measuring
22 performance is sometimes more difficult. Deciding what
23 the goal is if it is not profit is more difficult, and
24 the incentives to improve are sometimes not really there
25 in the way that they are in a private sector
0055
1 organisation.
2 The other point they pointed to was the complexity
3 of hierarchy in health care organisations, the fact that
4 all the non-health care organisations they worked with
5 have fairly simple hierarchies, and it was much easier
6 to make decisions at the top that rolled down to the
7 bottom, to gather data from the bottom that went up to
8 the top. The hierarchies and structures in health care
9 organisations, partly because of the professional
10 culture but also because of the nature of health care,
11 were so much more complex.
12 MISS GREY: Thank you. Dr Walshe, we have covered a great
13 deal of ground in an hour and a half, and some of it, of
14 course, will be further supported by further papers and
15 research which you have very helpfully offered to
16 provide to us.
17 Is there anything else for this morning's session
18 that you would like to highlight as being an important
19 theme or development in the development of audit in the
20 NHS, across the period of our terms of reference.
21 DR WALSHE: I do not think there is anything I would like to
22 add.
23 MISS GREY: There may be some questions from the Panel.
24 THE CHAIRMAN: We want to know whether Dr Walshe is going to
25 be with us for some time, because we may have some
0056
1 thoughts, but we would like to reflect on them.
2 MISS GREY: The answer to that is that Dr Walshe is able to
3 be with us today, so he will be, I hope, available for
4 further discussion at the end of today's session.
5 THE CHAIRMAN: That is excellent, thank you.
6 MISS GREY: In that case, could I suggest a break for
7 a quarter of an hour?
8 THE CHAIRMAN: Let us break now. I thank you now, but we
9 will converse further later. We will reconvene at
10 11.20.
11 (11.00 am)
12 (A short break)
13 (11.20 am)
14 MISS GREY: Sir, we are now to hear from Dr Trevor Thomas,
15 please. Dr Thomas, could I you to stand, please to
16 swear or affirm?
17 DR TREVOR THOMAS (AFFIRMED):
18 Examined by MISS GREY:
19 Q. Dr Thomas, you have provided a statement to the
20 Inquiry. If we look, please, at WIT 323/1, is that the
21 first page of the statement?
22 A. Yes, it is.
23 Q. If we turn, please, to page 7, is that your signature
24 which appears at that page?
25 A. Yes, it is.
0057
1 Q. Are the contents of this statement true to the best of
2 your knowledge and belief?
3 A. To the best of my knowledge, memory and belief, yes.
4 Q. If we turn to page 2 of that statement, you have
5 helpfully provided to us your abbreviated curriculum
6 vitae and we see there that you are a consultant
7 anaesthetist within the UBHT and that in particular,
8 since 1991, you have been the Associate Director of
9 Obstetric Anaesthesia within the UBHT, and this would
10 be, then, in addition to your duties as Chair of the
11 Medical Audit Committee from 1991 to December 1993?
12 A. Yes, that is correct.
13 Q. It appears, if we turn down through the CV, scroll down
14 the page, please, that your principal responsibility for
15 the last 24 years has been the provision of safe and
16 effective anaesthesia and analgesia services within the
17 hospital maternity unit.
18 Did that involve developing and participating in
19 systems of audit?
20 A. Yes, I think I have been involved in audit in a number
21 of ways during my time as a consultant in the United
22 Bristol Hospitals. I suppose that I could say that the
23 system of medical records that we introduced for
24 obstetric anaesthesia in 1975 might be one of the
25 aspects of audit, because it is a starting point for any
0058
1 of our assessments of what we do.
2 I also have had a role for quite a substantial
3 period of time as the regional assessor in anaesthesia
4 to the confidential inquiry into maternal deaths.
5 Q. You mention that in your CV: since 1978, you say?
6 A. Yes.
7 Q. Can you tell us briefly what the pattern of audit would
8 have been within your division or unit before 1989/90?
9 A. When you say "my unit" you mean in the obstetric
10 anaesthesia unit?
11 Q. I mean the clinical unit with which you were most
12 directly concerned.
13 A. In obstetric anaesthesia, we developed, in 1975, and
14 continued to develop thereafter, a system of recording
15 our activities and bridging between them and midwifery
16 and obstetric records, so as to be able to use data
17 which were being accumulated by the other two
18 disciplines when producing denominator figures.
19 MISS GREY: Could I just break off for a moment, there,
20 please, because it appears to me, sir, I have been
21 guilty of an unintentional discourtesy in that I failed
22 to introduce Mr Hoyte to you. Dr Thomas is today
23 represented by Mr Hoyte, and I do apologise for having
24 failed to make that introduction at the outset.
25 THE CHAIRMAN: I am sure Mr Hoyte will forgive you. I, for
0059
1 my part, am impressed by the telepathy that sometimes
2 takes place between you and me, Miss Grey, because I had
3 just sent a note asking who was the legal
4 representative. So I am very grateful. I am sure you
5 are forgiven; you are by me.
6 MISS GREY: I am sorry, Dr Thomas, you were describing the
7 system that had been introduced?
8 A. Yes ... I am slightly dislocated.
9 I think that our intention was to accumulate
10 sufficient information for us to be able to assure
11 mothers who came into the unit that we could provide
12 safe anaesthesia and pain relief, and where we found
13 that we had a deficiency of some sort, or where we found
14 that our practice was not as good as national figures
15 might suggest it should be, then we would be able to
16 address the problem.
17 An easy example, I suppose, is the incidence of
18 something called an inadvertent dural tap, which is
19 a complication of epidural pain relief. That is quite
20 commonly used across the country to judge the quality of
21 the service, and it was one of the pieces of information
22 that we actually accessed.
23 Q. You have described a system of recording your activities
24 and bridging between them and midwifery and obstetric
25 records, so as to be able to use data accumulated across
0060
1 those units to monitor care. You have also just
2 described a particular factor which you would examine to
3 see whether there were particular problems.
4 Can you tell us a little more what the system
5 consisted of, because from your last reply, it appeared
6 it might be some form of critical instant reporting or
7 near misses or something along those lines. I may be
8 entirely wrong.
9 A. It was a composite. When we began in 1975, we began in
10 a new building. The Maternity Hospital had been built
11 at the top of the hill above the BRI, and the unit moved
12 from its old site to this new building.
13 So the opportunity presented itself for us to
14 start pretty well from scratch with most of our
15 practices, and quite a lot of our record-keeping.
16 So we introduced at that time a computerised
17 record. The first version of that was a clumsy affair
18 which, well, I use the word loosely, for the time
19 I suppose was quite advanced, but looking back now it
20 seems to have been quite a clumsy affair, which was
21 based on punch-cards and mainframe computing.
22 However, I had a colleague who had a lot of
23 interest in computer affairs and he introduced a number
24 of versions of those records through a period I suppose
25 of some, I do not know, 15 years, and the system
0061
1 underwent changes until finally it met the Regional
2 Health Authority initiative for medical data indexing,
3 and that MDI system was something which, at the time,
4 the United Bristol Hospitals wanted to implement.
5 So we tried to blend the two systems together.
6 I think the result -- we are living with it now -- is
7 less than happy and there are a lot of improvements that
8 could be made, given the appropriate financing.
9 Q. We will come back, I am sure, to the MDI system, but
10 what I was trying to understand was, what was it that
11 you were actually scrutinising?
12 A. We stored a very, very large amount of information and
13 we had a retrieval programme which addressed that
14 information and pulled out correlations between a number
15 of activities and results. One I have already
16 mentioned. Another was a simple scoring system of how
17 many general anaesthetics versus regional anaesthetics
18 were given for Caesarean section; what was the forceps
19 delivery rate in patients; the epidurals, and so on and
20 so forth. We looked at the data on an annual basis with
21 a view to modifying our retrieval of information to fit
22 in with current concerns, whether they were our local
23 concerns or concerns that had been voiced nationally by
24 national associations, or whatever.
25 So it was a changing spectrum of data that we were
0062
1 looking at. We were trying to provide a good service
2 and assure ourselves that is what we were doing.
3 Q. If we can turn, then, to page 3 of your statement, you
4 say there that you were a member of the Medical
5 Information Working Group which in turn, when it was
6 disbanded, became the UBHT Medical Audit Committee. You
7 were, I think, the first Chair of that committee?
8 A. Of the District Audit Committee.
9 Q. Of the District Audit Committee, subsequently the
10 UBHT Medical Audit Committee?
11 A. Yes.
12 Q. When discussing the creation of the Audit Committee,
13 Dr Roylance gave evidence as follows -- it is not
14 scanned in so I will read it to you, if I may:
15 "When medical audit was introduced, it was
16 introduced on the professional line, not the managerial
17 line. The then Regional Medical Officer, in conjunction
18 with the Regional Hospital Medical Advisory Committee,
19 made a series of proposals directly to the divisions,
20 which was the medical consultant advisory machinery, not
21 to management, to develop audit. So it started on that
22 axis. Slowly, the responsibility of management emerged
23 to facilitate that professional activity."
24 The point that Dr Roylance is clearly making there
25 is that the initiation of the process of audit began
0063
1 along a professional line of responsibility and
2 accountability, rather than a managerial one, and was
3 addressed in the first instance to the divisions rather
4 than to any managerial structure.
5 Would you agree with that as a description of the
6 history of the audit process?
7 A. Yes, I think I would.
8 Q. Can you tell us how you remember the origination of the
9 development of audit at that time, that is, prior, even,
10 and around 1989?
11 A. Medical audit as we now look at it is different from
12 medical audit in the early years between 1989 and
13 roughly 1993/94, which I think, in itself, differed from
14 what was being done before 1989.
15 The introduction of medical audit that you have
16 just described and that Dr Roylance was referring to
17 I believe was in response to Working Paper 6 of the
18 White Paper, and that Working Paper is something that we
19 used quite extensively when we were considering what we
20 should do in order to implement medical audit as
21 described in that White Paper.
22 Q. Dr Roylance went on to make the point that audit was not
23 introduced at a Trust level and then devolved, or
24 perhaps one might say at a hospital level, because this
25 was still the period prior to the inauguration of the
0064
1 UBHT. It was not introduced at a hospital level and
2 then devolved, rather it began with the medical
3 divisions in the first place.
4 Would you help us on that distinction?
5 A. I am not entirely clear what he meant by that, but my
6 perception of the introduction of audit was that in the
7 first instance there was a regional interest in
8 beginning the process of audit. That regional interest
9 was accelerated by Working Paper 6, which also, of
10 course, laid down a deadline by which hospitals, health
11 authorities and so on, had to have audit in place in
12 a recognisable form.
13 So during 1990, the Medical Committee discussed
14 the way forward and I had just completed a term of
15 office as the Chairman of the Medical Committee, and so
16 I was asked if I would produce a constitution which
17 might address the problem.
18 I did so, and the Medical Committee approved that
19 constitution, and I was invited to chair that committee
20 in the first instance, which I agreed to do for three
21 years.
22 Q. When you speak of the Medical Committee, you mean the
23 Hospital Medical Committee?
24 A. Yes, I do.
25 Q. So what was the relationship -- looking now still at the
0065
1 period in 1989/90, prior to 1991, between audit and the
2 divisions?
3 A. The basic function of audit, as we understood it at that
4 time, was that it would be for educational purposes and
5 that it would be carried out by various groupings of
6 clinicians and would be led clinically and would
7 function as a form of peer review within that clinical
8 group.
9 There was already in existence a culture of
10 devolvement within the hospital, partly because of the
11 size of the unit -- it is quite a big unit and if you
12 add all the big hospitals together, it had nearly 1,000
13 beds, and there were slightly more than 150 consultants
14 on the staff.
15 So it was a large unit and it was perceived that
16 it would function best if the specialties were allowed
17 to develop their own audit and their own audit topics,
18 because they understood their particular aspect of
19 medical care, its risks, its problems, its quality and
20 so on, far better than anybody else.
21 Q. If we look at UBHT 273/1, please, we should see there
22 the first, I think, report produced by the UBHT's
23 Medical Audit Committee.
24 If we turn, please, to page 7 of the report and
25 scroll down a little, you can see there the last
0066
1 paragraph on the page:
2 "The committee has adopted the philosophy that
3 medical audit activities should be the responsibility of
4 specialty divisions or departments and not necessarily
5 the responsibility of directorates. The committee
6 maintains a watching brief in order to determine whether
7 any changes along directorate lines are necessary."
8 That, I think, is a summary of the process or the
9 decision you have just been describing; is that correct?
10 A. Yes, that is right.
11 Q. What sort of debate took place before that decision was
12 taken? Was there a consensus that this was the right
13 approach? Was there a debate or disagreement about it?
14 A. From my memory, I think that all shades of opinion were
15 voiced. People were, I think, worried or concerned
16 about the prospect of audit being undertaken in a way
17 which did not allow them to guide it or to be the owner,
18 if you wish, of the process and the information.
19 We looked at the Regional Health Authority's
20 pronouncements and the Working Paper 6 for guidance and
21 it seemed to us that if we were to reassure colleagues
22 and actually persuade them to pursue audit and gain the
23 benefits from it, that we had to actually allow them to
24 build their own audit process within their specialty.
25 That, we felt, would assuage their concerns quite
0067
1 considerably, but there is no question in my mind that
2 concerns continued for the whole of my time as the
3 Chairman of the audit committee, and there was
4 a constant need to reassure people that confidentiality
5 would be protected in all the ways that Dr Walshe spoke
6 of earlier this morning.
7 Q. Can I just stop you there? Firstly you say that people
8 were concerned?
9 A. Yes.
10 Q. By that you mean individual clinicians, do you?
11 A. Yes, I do.
12 Q. And you say that concerns continued: that is concerns
13 over the ownership and nature of the audit process, or
14 what?
15 A. Yes. I think concerns over the ownership of audit.
16 Q. Was there any discussion of what might be dubbed the
17 "alternative model" of audit?
18 A. Could I just go back, before you ask that question, and
19 say that it might be helpful if the Inquiry remember
20 that within the United Bristol Hospitals, the District
21 Health Authority -- if you do not mind, I will say
22 United Bristol Hospitals as the catch-all phrase --
23 there had been attempts previously to audit in the
24 widest sense, not as we now know it, but audit and the
25 Medical Information Working Group was formed because the
0068
1 authority had formed, previously to that, a Performance
2 Assessment Committee which had been less than tactful in
3 its treatment of information and medical staff.
4 So there was a considerable air of suspicion about
5 any process that looked in any way like the Performance
6 Assessment Committee.
7 I am sorry, I just thought that was helpful.
8 Q. It is, thank you. I was going to ask you, in any event,
9 about something which I think is a reference to the same
10 point in your witness statement.
11 If we can perhaps go back to it now, since we have
12 raised it, WIT 323/3.
13 In the most substantial paragraph, the third
14 paragraph, you wrote in that statement that the Medical
15 Information Working Group was formed to assist the
16 Performance Assessment Committee of the Health Authority
17 by interpreting technical medical information and that
18 it was formed following misinterpretations and
19 misunderstandings between the PAC and members of the
20 medical staff of the United Bristol Hospitals.
21 Is that a reference to the same point you have
22 just been making?
23 A. Yes, it is.
24 Q. Can you help us a little further, then, about the nature
25 of those misinterpretations and misunderstandings?
0069
1 A. I suppose it would be easiest if I quoted a couple of
2 examples which, if you will allow me, I will cloak to
3 a certain extent in anonymity, because it would be
4 pejorative to do otherwise.
5 The Performance Assessment Committee were very
6 keen to ensure that the hospitals functioned as
7 efficiently as possible. In order to assure the Health
8 Authority that that was happening, they examined a lot
9 of work-related figures, and I suppose the simplest
10 example is that there was a failure to understand that
11 surgeon A, who operated on major cases, would do fewer
12 operations in an operating session than surgeon B whose
13 workload comprised mainly minor surgery. That may seem
14 surprising to you, but that difference was not readily
15 appreciated.
16 In addition, there were approaches made by the
17 Performance Assessment Committee through the Health
18 Authority demanding to know where medical staff had been
19 when they were, as far as the PAC was concerned,
20 supposed to be doing a list. That particular example
21 sticks in my memory because the person who was so
22 denigrated in fact was not at fault at all and was on
23 leave at the time.
24 I am sorry to give you simple examples, but this
25 sort of thing happened quite frequently. It did lead to
0070
1 a certain amount of difficulties.
2 Q. Was that an issue that had anything to do with the
3 composition of the Performance Assessment Committee?
4 A. Yes. I think that is what I was referring to when
5 I said that the committee was formed of lay members of
6 the Health Authority. It had no professional members in
7 the first instance and so information went directly from
8 hospital activity analysis sources to a group whose
9 insight into medical activities was limited to their
10 time on the Health Authority.
11 Q. If we go back to a different document, it may be that
12 there is a thread here we can trace. UBHT 25/170,
13 please. Can we go to 169, please?
14 MRS MACLEAN: Can we ask one small point? Could you give us
15 a date for the setting up of the PAC; an approximation,
16 if not an exact date?
17 A. No. I think --
18 Q. We are anxious to make sure we have things in their
19 proper order.
20 A. I cannot give you a date for the setting up of the
21 Performance Assessment Committee. I cannot remember
22 when it was set up.
23 Q. The mid-1980s?
24 A. I would think so, but I would wish you not to put any
25 reliance on that figure. Actually, I think it was
0071
1 earlier than that, to be honest with you. I think it
2 was at the beginning of the 1980s.
3 MISS GREY: What we appear to be looking at is a dispute or
4 a memory of a dispute that coloured the introduction of
5 medical audit in 1990 or thereabouts?
6 A. Yes.
7 Q. So it was sufficiently live in people's memory to still
8 have an influence?
9 A. Yes, because the process of looking at performance
10 figures, which you understand were totally different
11 from audit as it was perceived in 1989/90, nevertheless,
12 the fact that people had been reviewed, as it were, to
13 see whether they were seeing enough patients or whether
14 they were doing enough operations, it lingers in the
15 memory of clinicians, I think, and certainly did in the
16 UBH.
17 Q. Those were then throughput and workload efficiency type
18 scrutiny that was being attempted?
19 A. Yes.
20 Q. The document now on the screen is what I wanted to refer
21 you to, but to get the context we should go back to the
22 first page, the annual report of the District Audit
23 Committee, 1990/91. [UBHT 25/168].
24 Before we discuss that further, I am being
25 helpfully reminded by those behind me that according to
0072
1 Pamela Charlwood's statement, the PAC was formed in
2 August 1985. Would that accord with your memory?
3 A. I would have set it earlier, but I would not dream of
4 arguing the date.
5 Q. We have here the Audit Committee report for 1990 to
6 1991. This is the predecessor body to the Hospital
7 Medical Audit Committee; is that right?
8 A. Yes.
9 Q. Just to finish with this point, if we please go back
10 over the page to page 169, in the last paragraph there
11 is a reference to previous experience with the
12 Performance Assessment Committee, and a reference to
13 misunderstandings and recriminations, and as a result of
14 that, the committee recommends -- I am looking up the
15 paragraph -- that the audit information currently being
16 demanded by purchasers as they strike contracts with
17 providers should be provided by the Audit Committee.
18 Is that a correct link to make, that that
19 recommendation arose out of that past experience?
20 A. Yes. In my memory, that is correct. Can I say that if
21 you go to the previous page, we might as well correct an
22 error on it and say that the first paragraph says that
23 the committee first met on 5th December 1991. It is, of
24 course, 5th December 1990.
25 Q. Thank you. We were discussing the relationship between
0073
1 audit and the divisions as well as audit and any central
2 committee structure. Can I ask you, when the committee
3 started to put in place a network of audit
4 co-ordinators, to whom did those audit co-ordinators
5 respond?
6 A. They responded to the committee via one or other of its
7 members.
8 Q. And the committee responded, or reported to what? To
9 the Hospital Medical Committee?
10 A. Yes.
11 Q. Were there also lines of communication to the Steering
12 Committee of the Chair of divisions?
13 A. Yes. That basically was the route through which the
14 Medical Committee was reached, because the Steering
15 Committee was a Steering Committee of the Hospital
16 Medical Committee.
17 Q. Because the Hospital Medical Committee met only fairly
18 rarely, so the Steering Committee was the --
19 A. No, the Hospital Medical Committee met monthly. The
20 steering committee was formed in order to assess and
21 prepare information for the Hospital Medical Committee's
22 discussions. It met in two forms. A Steering Committee
23 alone and a Steering Committee with Chairmen of
24 Divisions, and those meetings alternated so they
25 occurred at two-monthly intervals. It seemed to be
0074
1 quite an effective way of not troubling people with
2 unnecessary information, and yet, at the same time,
3 allowed the specialties access to their colleagues for
4 discussion of any matters that were causing them
5 concern.
6 Q. We have heard a certain amount during the course of the
7 Inquiry about the Clinical Directorates that were
8 established in the UBHT and their evolution.
9 Can you tell us a little about what might be
10 called the medical side of that particular coin, the
11 divisions, and their continued life and existence from
12 1991 onwards?
13 A. Yes, I suppose I can give you my perception of what
14 happened. I think that it was generally felt that the
15 introduction of Trust status demanded the formation of
16 directorates, clinical directorates, and that those
17 clinical directorates would be responsible for
18 organising the services that the specialty provided;
19 that they would be the contract-making organisation
20 where contracts were made.
21 However, it was perceived that that was only part
22 of the activity and responsibility of specialty groups,
23 and that there was a continuing need for, if I may call
24 it a professional network which addressed problems of
25 education, interfacing with Royal Colleges, and the
0075
1 like.
2 So, for some time, and indeed, in some instances
3 there is still a divisional system within some
4 specialties. Some specialties, I know, felt that that
5 was inappropriate and did away with their divisional
6 structure very early on -- I cannot give you dates, but
7 very early on.
8 Q. But in others, the structure continued to have life, did
9 it?
10 A. Yes.
11 Q. Until the end of our period, 1995?
12 A. Yes.
13 Q. Are you able to help us as to what the position was
14 within the Department of Cardiac Surgery, within the
15 field of cardiac surgery?
16 A. No. I do not know.
17 Q. You describe in your statement the creation of the UBHT
18 Medical Audit Committee. If we could look back, please,
19 to first of all the District Audit Committee, its
20 predecessor, at UBHT 25/157, and go back another page to
21 156 -- I will have to come back to that, I am sorry.
22 We can see, however, from this particular
23 document, that Mr Wisheart was a member of the committee
24 from its outset; is that correct?
25 A. Yes, that is correct.
0076
1 Q. Can you help, he succeeded you ultimately as the Chair
2 of the Medical Audit Committee for a period of time as
3 a caretaker, I think it can be said. You have spoken in
4 your statement about new initiatives tending to be
5 viewed with great suspicion by staff. Can you help us
6 on Mr Wisheart's attitude to audit and its
7 introduction?
8 A. No, I do not think I can. I think you would have to ask
9 him. Guide me a little, Miss Grey.
10 Q. You were his colleague. You worked with him on this
11 committee. It is apparent, we have heard it from
12 Dr Walshe this morning, that some clinicians at least
13 were concerned, worried, by the introduction of medical
14 audit in 1989/90.
15 Was this Mr Wisheart's attitude, or was he more
16 welcoming and helpful?
17 A. His appearance, to his colleagues, would have put him in
18 a neutral position. He was not one of the enthusiasts
19 that Dr Walshe talked of earlier, but neither did he
20 seem particularly bothered about the prospect of
21 pursuing the audit process. I think he understood, and
22 probably shared, the concerns that you and I have
23 already discussed this morning, because I think those
24 concerns were common to the medical staff in the UBHT.
25 So I do not think he was any different in that respect.
0077
1 Q. But there are those who remain fixed within concerns,
2 and there are those who seek to overcome them, and to
3 answer concerns. What was Mr Wisheart's contribution to
4 the work of your committee?
5 A. He functioned as he was required to, as the
6 representative of the Medical Committee on the District
7 and then Trust Audit Committee. He functioned in that
8 role because he was, by this time, the Chairman elect of
9 the Hospital Medical Committee.
10 I cannot say that Mr Wisheart was resistant to the
11 idea of audit being pursued, but equally, as I said
12 a moment ago, he was not an enthusiast. He knew, as we
13 all knew, that medical audit was an important function
14 among the educational functions within the hospital, and
15 I am sure that he supported that educational function of
16 audit.
17 You will undoubtedly come on to something which
18 I will mention now, but audit in cardiac surgery was
19 going on from the very beginning of the life of the
20 District Audit Committee in 1990, and you will see from
21 references that I have made in my statement that the
22 District Audit Committee were aware of the contractual
23 content of some of the discussions being held between
24 the purchaser and cardiac surgery. We are now speaking
25 a little bit beyond 1990, but nevertheless, I think I am
0078
1 talking about March 1991, something round about that
2 time.
3 At that time there was a clear undertaking being
4 given by cardiac surgery to the purchaser that they
5 would provide, to the purchaser direct, figures of
6 mortality. As far as the Audit Committee were
7 concerned, those figures were passed and we were not
8 given any information that they were not passed. They
9 did not go through the Audit Committee, much to our
10 regret, because we believed that that should be
11 a function of an Audit Committee. We were defeated on
12 this matter by both the purchaser, by the directorate,
13 by the management, and so on and so forth. You will be
14 aware of the entries in the minutes of the committee to
15 indicate that.
16 Q. Had you been aware of the negotiations regarding that
17 particular contract?
18 A. No.
19 Q. At what stage were you made aware of the fact that there
20 was this contractual obligation which bypassed the
21 committee?
22 A. I cannot give you a date. I think it was March 1991.
23 But the first document that we saw or information that
24 we received that such an agreement was being undertaken
25 was in a draft service agreement. When we saw the
0079
1 draft, we commented on it. However, our recommendation
2 that the Audit Committee would have been an appropriate
3 conduit for the transmission of that information, our
4 recommendation was not accepted. That was a pity,
5 because it would have given the Audit Committee itself
6 some sight of that information and the process that was
7 going on.
8 Q. Perhaps we should pick that up whilst it is being
9 discussed with the various document references. We will
10 go back, please, to page 170 of this document first.
11 I am sorry, can you try 169, please? We have seen there
12 already that the recommendation was that, as purchasers
13 demanded audit information, information should be
14 provided by the Audit Committee. That continued as your
15 recommendation, did it?
16 A. Yes.
17 Q. If we look then, please, to HA(A) 10/1 this is the cover
18 sheet of the Bristol & Weston Health Authority service
19 agreement for 1991/92, so the first year of full
20 contracts, as it were.
21 If we look at page 9 of that contract,
22 paragraph 8.3 in particular, we can see there that
23 firstly the confidentiality of any data provided to the
24 District Health Authority is recognised and then it
25 suggests that any information concerning clinical
0080
1 activity required by the purchasing authority will be
2 released to the Director of Public Health Medicine, so
3 they are recognising the medical channel of reporting;
4 is that right?
5 A. I am not clear which Director of Public Health Medicine
6 they are talking about. I think it is the purchasing
7 authority's director, actually.
8 Q. I think it is a reference to the individual in post
9 would have been Dr Ian Baker, I understand?
10 A. You may be right about that. 1991 was the time when the
11 person in that post changed, I think. In 1992 Dr Baker
12 started, and then Dr Morgan took over. I think. I am
13 not sure.
14 Q. In any event, I think we can agree that the Director of
15 Public Health Medicine envisaged there is that person
16 occupying that position within the Health Authority, and
17 the suggestion is that this will be authorised by the
18 appropriate Clinical Director, who may wish to consult
19 with colleagues, or with the Audit Committee. So the
20 Audit Committee has been given an advisory role at the
21 discretion of the Clinical Director only.
22 Is that an agreement that you were made aware of
23 at the time?
24 A. No.
25 Q. Was there any discussion, then, of the difference in the
0081
1 recommendations, the role envisaged for itself by the
2 Audit Committee and that which appears to have been
3 agreed by the Trust with that particular Health
4 Authority?
5 A. I would imagine that the inclusion of the Audit
6 Committee in that paragraph would have followed our
7 recommendation to the then UBHT Board. I suspect that
8 that was seen as a way of accommodating our view.
9 Q. In reality, in practice, did you get, brought to you as
10 an Audit Committee, issues of information required by
11 purchasers and the propriety of those requests?
12 A. Not to my memory, no.
13 Q. And that would be true, would it, of purchasers other
14 than the local health authority?
15 A. Yes. I am casting back in my memory to see whether
16 I can recall any particular figures that came through
17 the Audit Committee and the nearest example I can come
18 to you with is that in I think early 1992, our general
19 practitioner representative, Dr Whitfield, came to
20 a meeting and said he felt that the Audit Committee
21 should have a more proactive role.
22 We discussed that suggestion. In order to pursue
23