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Hearing summary13th 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 Inquirys 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 Michaels 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.
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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 300,000 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 it to the best of our ability, given our terms of 24 reference and the limitations that were on us as far as 25 budget and so on -- we did not have a budget, nor did we 0082 1 have any staff with which to pursue anything. The best 2 we could do at the time was to approach the Directorate 3 of Ear, Nose and Throat Surgery and ask them if they 4 would be prepared to undertake a commission from the 5 Audit Committee in liaison with the relevant general 6 practitioners. I cannot remember the topic that was 7 proposed at the time, but I think it was glue ear, but 8 I am not absolutely sure about that. I do not know for 9 sure. That approach, to my memory, bore no particular 10 fruition. It came to no fruition. I think it fell away 11 for lack of interest, but possibly from general 12 practitioners and from the ENT surgeons themselves. 13 Q. You just referred there to the fact that you did not 14 have a budget. Can you describe to us, in your words, 15 the role of the District Audit Committee that then 16 became the Medical Audit Committee and its remit? 17 A. You will have seen, in the annual reports, the 18 responsibilities that the committee took to itself but 19 if you wish to look beyond them or behind them, then 20 I would say to you that the committee felt that its 21 principal objective was to set up and embed within the 22 culture of the UBHT the audit function. 23 We were aware that that audit function might well 24 change, but that until we could persuade people that 25 audit was indeed a valuable process and that they should 0083 1 not fear it, we would get nowhere. Given the fact that 2 we had no budget specific to the committee nor any 3 staff, that was what we thought we might be able to do. 4 There were a number of functions that we believed we 5 could undertake to assist that process of embedding the 6 culture. Dr Walshe referred to them, I thought slightly 7 scathingly earlier on, when he said that large sums of 8 money were spent on hardware, computer systems and the 9 like. However, I think that to be honest with you, we 10 pursued a policy whereby we set up the hardware and the 11 staff and then did the training. That seemed a logical 12 progress, to us. You may say you are surprised we did 13 not actually achieve that within a very short time-span, 14 but it is quite a difficult thing to achieve. I think 15 that certainly by the end of my chairmanship we had done 16 that and we did have staff in post, equipment they could 17 use, in some instances information systems which they 18 could use, and we had done our best to ensure that staff 19 were trained. 20 You may like me to develop that a little bit in 21 two different forms of staff because of Dr Walshe's 22 comments earlier on. 23 Q. If we can, we will come back to the issue of staff and 24 training. Can I come back to your words when you used 25 words such as "persuade" staff to start audit, to 0084 1 encourage them "not to fear", you said, audit. 2 Can you help us further on the climate in which 3 the requirement of the introduction of medical audit 4 came in 1989/91? 5 A. I think I would go back to my earlier comments, and 6 indeed, those of Dr Walshe earlier this morning, that it 7 was a common finding across the country that the 8 profession were wary of the White Paper in general, and 9 I suppose, therefore, any components of it. That was 10 the sort of ambience within which we were working. 11 There was no power within the Medical Committee to force 12 people to do audit, and indeed it would have been very 13 counter-productive had we tried to do so, because audit 14 can only be pursued if people are prepared to be honest 15 about what happened, accurate in producing figures to 16 support the discussions that they were having, and so on 17 and so forth. And in 1989/90, to do other than try to 18 persuade people that this was a good initiative that 19 would in fact result in better patient care, we only had 20 one way forward. 21 Q. So your way forward was persuasion? 22 A. Yes. 23 Q. You did not have a budget? 24 A. No. 25 Q. But nevertheless, you have described the introduction of 0085 1 hardware, staff and training? 2 A. Yes. 3 Q. How are those two statements reconciled? 4 A. Miss Grey, you may not actually have the money, but if 5 your committee members have the influence, then they can 6 persuade people which equipment to buy, what sort of 7 personnel they should have in post and how they should 8 be trained. 9 I believe that the membership of the Audit 10 Committee was such as to achieve that, and the 11 directorates themselves had little experience in 12 securing hardware, personnel or training, so we were 13 able to advise them and to divide them. 14 Q. Because the directorates themselves had been allotted 15 the audit money; is that correct? 16 A. Yes, they had. 17 Q. How was that allotted? On the basis of consultant 18 numbers? 19 A. Yes. 20 Q. Looking back on it, is that a creative way, do you 21 think, of allocating audit funding? 22 A. I am not sure what you mean by "creative". 23 Q. How does it compare with the model of funding audit on 24 the basis of bids or schemes for audit? 25 A. I think you could only allocate money in response to 0086 1 bids or plans or schemes if, in the first instance, you 2 own the money. That was never the case. The money came 3 from the Regional Health Authority into the Treasurer's 4 Department and was allocated on that basis, of 5 consultant numbers. The underlying premise was one 6 which I think you will find appears in Working Paper 6, 7 which says that each individual consultant should be in 8 a position to audit. I paraphrase that, I am not sure 9 of the exact words, but I believe that that phrase is in 10 Working Paper 6. If I misquote it, it may be in 11 a Regional Health Authority document, but that was the 12 underlying principle: that whatever or wherever, each 13 individual consultant would be given the financial 14 wherewithal to pursue audit. That was not the whole 15 story, of course, but that was the resource allocation, 16 and that is why it was done. 17 Q. I can see that that was the policy decision that drove 18 that particular form of resource allocation, but how 19 effective a policy do you think it was in encouraging 20 audit to start? 21 A. I suppose quite effective, actually. No individual, no 22 specialty, no directorate, could claim that they had not 23 been provided with the appropriate resource. They 24 therefore would be expected to carry out audit unless 25 they protested that they were unable within the 0087 1 resource, so the expectation was present, the 2 expectation that they would carry out audit in whatever 3 form they thought was appropriate for their specialty, 4 and they knew that they would then be asked to give some 5 evidence of having done so. 6 So I think from the point of view of actually 7 persuading people to carry out audit, I do not think it 8 was a problem. I do not think that that was an 9 inappropriate way of disseminating resource. 10 Q. If we go back again to UBHT 25/170 -- I will see if the 11 reference is correct this time -- no. Back to 169, 12 please. 13 At the top of the page, it says: 14 "The main hindrance to prosecuting audit is felt 15 to be a lack of time for consultants to carry out 16 individual audit, either as members of the District 17 Audit Committee, or, more importantly, as audit 18 co-ordinators. That is exacerbated by an apparent lack 19 of audit assistants in many specialties." 20 Firstly, is that an accurate statement on the main 21 hindrance to prosecuting audit at that time? 22 A. May I look at page 168, please? 23 Q. Please do. Can we scroll down the page, please. 24 A. Yes, okay. Can we go on now to 169, please? The 25 segment is to be read as it appears on the page, that 0088 1 this was a feeling that people expressed. The pressure 2 of clinical demand was such that they were reluctant or 3 unable in some instances to allocate sufficient time to 4 the creation of an audit process, and that is why, in 5 the second part of that sentence, I said more 6 importantly as audit co-ordinators, because I thought 7 then, and I still think that given the system of 8 specialty audit, the co-ordinator is very important. He 9 or she is the person who will guide the whole process. 10 They need time to do that. They need time to create the 11 project, to do the appropriate background reading and 12 produce the necessary bibliography or whatever, and the 13 lack of time -- I am still quite sure in my memory that 14 the lack of time was something which bothered people 15 a lot at that stage, and I think that that problem did 16 not go away entirely for the whole of my time as 17 Chairman of the Audit Committee. We only persuaded the 18 Trust right at the end of my tenure that they should 19 officially state that time should be given specifically 20 to audit and that that time should match the 21 recommendations that had been made by the Regional 22 Hospital Medical Advisory Committee some three years 23 before. 24 Q. Which was a commitment of how much time? 25 A. The regional recommendations, in my memory, were that it 0089 1 should be one notional half day per month. 2 Q. If we look at UBHT 24/72, we should have the first 3 page of the 1993 report. This was the report produced 4 for the last year in which you were the Chair of the 5 committee; is that correct? 6 A. Yes, that is right. 7 Q. If we go to page 80, please, first of all if we look at 8 it there is the modifications that are forthcoming to 9 produce a committee responsible for clinical audit. 10 Then, if we scroll down, please -- 11 A. Are you looking at the last three lines of that 12 paragraph, or the penultimate line? 13 Q. I am looking at the last five lines of the second 14 paragraph: 15 "While there has been general agreement from 16 purchasers and providers across the South West Region 17 that half a day per month is an appropriate expenditure 18 of time on audit, it has taken the UBHT three years to 19 accept this recommendation of its Medical Audit 20 Committee." 21 So does that record, firstly, an agreement by the 22 end of the year 1993 or thereabouts, the time this 23 report was produced, that that amount of time should 24 formally be set aside for audit? 25 A. An agreement on the part of the UBHT? 0090 1 Q. Yes. 2 A. Yes. 3 Q. What level of support do you think that management have 4 given to you in taking three years to accept that 5 recommendation? 6 A. There is a complex answer to that. In the beginning, 7 management was perceived as not being part of the 8 medical audit processes. Managers attended meetings 9 because we felt that it was important, in particular the 10 Director of Operations, and there was a standing 11 invitation to the Chief Executive, to Dr Roylance to 12 come whenever he wished. 13 So to some extent you could say that they felt it 14 was none of their business, I suppose. That is a crude 15 phrase and it is unfortunate. However, I think it would 16 be fair to say that for the whole of the three years 17 there were divergences of opinion between difficult 18 specialties as to exactly how much time was needed for 19 audit and exactly how that time might be best set 20 aside. I think that those differences of opinion were 21 appreciated by managers who might have preferred not to 22 take part in that debate. They may have preferred to 23 wait until the profession worked it out for itself. 24 Q. But it was appreciated from the very start -- I am 25 looking back now by that phrase to the Working Paper in 0091 1 1989 -- that it was the responsibility of management to 2 ensure that resources were available for audit to take 3 place. 4 Did that not include a responsibility to ensure 5 that adequate time was set aside for audit? 6 A. In my mind, yes: resource, I mean, of money at that 7 time, it was useless. 8 Q. Did the extent of the clinical disagreement as to how 9 much time was needed for audit explain a failure to 10 commit half a day per month? 11 A. Commit UBHT to a policy? Well, I come back again to 12 this history, the Performance Assessment Committee, and 13 the sensitivity of individuals concerned with the 14 District Health Authority and later the Trust to 15 protestations that absence of personnel from clinical 16 areas might jeopardise the fulfilment of contracts and 17 the pursuance of clinical activities to the detriment of 18 another specialty. 19 My perception is that that is ridiculous and that 20 there is sufficient flexibility in most organisations to 21 allow the sort of time period we are talking about to be 22 set aside quite easily. If we were to pursue the 23 philosophy, however, of allowing audit to take place in 24 such a way that bridges could be created between 25 specialties so as to allow them to share an audit time, 0092 1 an audit meeting, whatever, then that might be 2 a different argument. That might be more difficult to 3 do. 4 Q. Because the dispute amongst clinicians, one might have 5 thought, would have been more to do with the latter 6 point, the timing of sessions and the difficulty of 7 co-ordinating it, rather than an argument as to whether 8 half a day was required or not? 9 A. Yes. 10 Q. Is that a fair summary of the position, or not? 11 A. Yes, I think it is. 12 Q. I am having difficulty, Dr Thomas, if you could help us, 13 on the logical link between a dispute or difference, an 14 opinion, a disagreement amongst clinicians as to when 15 audit could take place and how to bridge gaps between 16 specialties, and using that as a reason not to make 17 a formal commitment to have a half a day a month, say, 18 set aside for audit? 19 A. You are asking me to argue a case for managers, and 20 I have difficulty doing that. I believe that it was 21 their perception -- you understand, this is what 22 I believe, I do not know that it is so. I believe it is 23 their perception that audit could be pursued as it were 24 "out of hours" and if it were not pursued out of hours, 25 then it would jeopardise the performance or the 0093 1 efficiency, if you will, of the Trust. I think that 2 that management view was produced by those clinicians 3 who we have already mentioned in the last few moments. 4 I think it is an erroneous view. 5 Q. Can I just say, Dr Thomas, I am not seeking to make you 6 argue any case, I am seeking to explore and understand 7 the evidence you were giving on that perception. 8 A. I am sorry if I am being opaque or difficult. 9 MISS GREY: Sir, I am conscious of the time. I wonder 10 whether in fact this ought to be the moment where we 11 break, perhaps, for half an hour, or a little longer, 12 for lunch? 13 THE CHAIRMAN: Yes. Thank you, Miss Grey. I think we 14 should take a break. Why do we not say 35 minutes? It 15 is now a feature of the transcript, my inability to add 16 up, but I think that is about 25 past 1 or thereabouts. 17 MISS GREY: All I can say is that I can now put on 18 transcript the fact that your watch does not accord with 19 mine! 20 THE CHAIRMAN: How diplomatically you put it! I think it is 21 a quarter past 1, my fault. 22 (12.40 pm) 23 (Adjourned until 1.15 pm) 24 (1.15 pm) 25 MISS GREY: Perhaps we could start by going back to the 0094 1 document which I was having trouble locating earlier, 2 UBHT 98/195. It is now on the screen. It is the 3 meeting of the audit review group, the Hospital Medical 4 Committee Steering Committee, which in fact effectively 5 set up, or planned to set up, the District Audit 6 Committee. 7 If we could just scroll down the page, please, to 8 paragraph 5, can you assist us on what was meant by the 9 phrase "District Audit Committee" at that time, because 10 the title implies that it is a Health Authority-wide 11 organisation, but its evolution into the Hospital 12 Medical Audit Committee suggests otherwise? 13 A. My apologies, I had forgotten about this small group. 14 Paragraph 5 refers to the fact that the district, 15 as it then was, comprised the United Bristol Hospitals, 16 plus Weston-super-mare, and the certainty in our minds, 17 I think, was that Weston would not wish to use the same 18 audit committee as the United Bristol Hospitals. That, 19 I think, was very reasonable. They were separated from 20 us geographically by 25 miles and they had a very 21 different practice and set of activities going on in 22 Weston General Hospital. So it made much sense to 23 separate the two. 24 Q. So the hospitals that were comprised within the District 25 Audit Committee were the same, were they, as those which 0095 1 subsequently became the UBHT? 2 A. I think the absolutely correct answer is "No". But to 3 all intents and purposes, the answer is "Yes". I am 4 sorry to be difficult about that, but when the Trust was 5 formed, there were some changes made in the hospitals 6 that made up the Trust. For instance, there was 7 a Bristol Homeopathic Hospital which was sold. I just 8 use it as the easy example. You are going to ask me 9 what other hospitals fell out of the Trust envelope. 10 I am trying to remember the name of it. 11 Q. I think we do not need the precise detail. I think what 12 I would ask, however, is that the name "District Audit 13 Committee" might imply there was some interest or 14 involvement in primary health care or extra-hospital 15 health care for which the district would have 16 responsibility. 17 Was this any part of the remit of this District 18 Audit Committee at any time? 19 A. Yes. It may not have formed explicitly part of the 20 remit when we wrote it down, but it was always in our 21 minds that we needed to have an interface of some sort 22 with general practitioners, for instance, and obviously 23 it depended on the specialty that was carrying out the 24 audit. Some specialisms had no interface with the 25 community at all in the shape of general practitioners, 0096 1 but others had quite a substantial interface. 2 Q. If we turn over the page, please, we should see there 3 the proposed constitution. We can see that it includes, 4 for instance, the district nominee to the Regional Audit 5 Committee, the RHMAC, who would have been who at that 6 stage? 7 A. That was me. 8 Q. What difference did the creation of the UBHT make to the 9 structure of this committee, because you talked about 10 liaison or interface between GPs and the hospital. What 11 I am asking is whether there was any responsibility at 12 any earlier stage for primary health care, or whether 13 this was solely a group concerned with the auditing and 14 practices of the hospital, despite its name "District 15 Audit Committee"? 16 A. My memory is that it was concerned almost entirely with 17 within-hospital activities and that the interface that 18 we sought with general practitioners was limited to an 19 interface where the two practices were actually dealing 20 with a similar condition or the same patient, or where 21 they had a shared interest and we had no intention of 22 casting the audit net more widely into primary care. 23 Q. Which is why, presumably, you talk about this body 24 evolving or transforming itself into the Hospital 25 Medical Audit Committee after the creation of the UBHT. 0097 1 It did not have to shed any Health Authority functions 2 in order to make that transformation, did it? 3 A. No. I think not. 4 Q. We have spoken about the development of that audit 5 structure. At the end of the period of your term as 6 Chairman of the Medical Audit Committee, the evolution 7 into a Clinical Audit Committee began and took place 8 eventually in mid-1994. I think that is right? 9 A. Yes. 10 Q. If we look, please, at UBHT 98/13, this gives us the 11 context, a meeting of the Steering Committee with 12 Chairmen of Divisions held on 5th January 1994. You are 13 in attendance. If we go on, please, to page 17, there 14 is a discussion there of clinical audit and you are 15 reporting back on the government's intention that Trusts 16 should move towards multidisciplinary clinical audit. 17 Then there is a second sentence: 18 "However, there was concern that medical audit 19 will be marginalised under the pressure from clinical 20 audit. The Chairman pointed out that we must be 21 perceived to be carrying out the national guidance lest 22 we lose audit monies. We must also maintain medical 23 audit as a valuable educational and peer review 24 activity." 25 How was the interface between medical and clinical 0098 1 audit seen within the Trust at that time, that is, early 2 1994? 3 A. I am not sure I can answer your question 4 satisfactorily. I can give you a view that I held at 5 the time, that might have been informed by meetings that 6 I attended, but if you say what is an average Trust 7 view, I cannot actually give you that. 8 Q. My question was loosely phrased. I am asking for your 9 evidence as to how the interface should operate. 10 A. In that case, the answer to your question is that the 11 short history of medical audit set up a system which was 12 being used as an educational system, and that the new 13 form of audit, clinical audit, was going to be a much 14 more widely-based type of audit; it was not going to be 15 limited to educational purposes, and it was going to 16 address problems of resource allocation, throughput and 17 so on and so forth in a much wider sense and with 18 a different emphasis. 19 Q. Did that mean that medical audit should continue 20 alongside clinical audit, that there was a continued 21 role for it? 22 A. I believed that there was and there were indications -- 23 again, I am afraid I cannot quote the document 24 precisely, but there were indications in I think both 25 the government documents of the time that medical audit 0099 1 should indeed continue. I think that there were 2 substantial reservations about the progress that had 3 been made because -- and I speculate here, you 4 understand -- I believe that in government circles they 5 had anticipated that progress would be much more rapid 6 than it was. 7 Q. Progress in medical audit? 8 A. Yes, and they also anticipated that medical audit would 9 embrace the wider sphere of information-gathering, which 10 I suspect was sought in the first place. 11 I think that those anticipations of rapid progress 12 were ill-founded and had the government chosen to listen 13 to advice, it would have realised that setting up such 14 a system as they had proposed in the White Paper was 15 actually going to take a substantial amount of time, and 16 not just a couple of years. It was not just a simple 17 thing to put in place. 18 May I say one other thing which I omitted when 19 I was responding? There was, among most of the 20 documents at the time, an emphasis on bringing 21 non-medical, paramedical, whatever you wish to call 22 them, members of the hospital staff, the teams and so 23 on, into the audit process. It is my memory that we had 24 already done that to a limited extent in the 25 directorates, not in the audit committee, but in the 0100 1 directorates. But that was another aspect of clinical 2 audit. 3 Q. You mean that at a directorate level, some overlap had 4 been taking place? 5 A. Yes. 6 Q. Some participation amongst non-medical staff in the 7 audit process? 8 A. Yes. 9 Q. Are you able to help us on how widespread that was? 10 A. I cannot tell you how widespread it was, but the 11 directorates that spring to my mind, as directorates 12 where I was aware that that was happening, were medicine 13 in general, although that was made out of separate 14 subgroups, but general medicine, rheumatology and so on, 15 ophthalmology and the dental services. 16 Q. You implied by your answer as to the length of time it 17 took to develop and set up a medical audit programme 18 that the reason for continuing with medical audit, 19 notwithstanding the introduction of clinical audit, was 20 that it needed more time to develop a proper and 21 effective programme? 22 A. No, I am sorry, I did not mean that. If I gave that 23 impression, I apologise. 24 What I meant was that in my mind, at any rate, the 25 function of education was a very important function. 0101 1 That particular function was served by medical audit and 2 I believed at the time that it might not be so well 3 served by clinical audit. 4 Q. Why would it be jeopardised by allowing other 5 professional groups into the process? 6 A. It is not a question of letting other professional 7 groups into the process, it is a question of how people 8 perceive the time and the opportunity. So, for 9 instance, I might, as I said this morning, wish to 10 explore the complications of epidurals in pain relief. 11 On the other hand, if you enlarge the group beyond me as 12 a medical person and bring in somebody who may, perhaps, 13 manage the resource of the Trust, they might be more 14 interested in how I was going to use the money that they 15 were prepared to let me have to buy kits or whatever. 16 So the emphasis within the meetings was going to 17 change and that might well have damaged educational 18 processes, I thought. 19 Q. Is that purely a management versus clinicians, broadly 20 defined, debate, or were there concerns also that if, 21 say, doctors were joined by nurses or perfusionists or 22 other such disciplines, the process, the potential 23 agenda, would be too wide? 24 A. I suspect it is the former. Yes. I suspect it is 25 doctor versus manager rather than anything else. There 0102 1 is very little problem with having nurses at these 2 meetings. That does not interfere with the educational 3 process at all. That is fine. So I think you are 4 right, it is management that I worry about. 5 Q. We had this morning the view of Dr Walshe that many of 6 the issues that might be raised by audit would very 7 rapidly trespass or come to involve other non-medical 8 groups, such as nurses, for instance? 9 A. Yes. Well, he is absolutely right. For many -- 10 although I suppose not all groups, specialty groups, 11 their activities are overlapped with the nurses most of 12 the time. The two groups work in the same area at the 13 same time within the same patient care episode or 14 whatever, so that is not ... 15 Q. In the event, in 1994 and 1995, did clinical audit and 16 medical audit both proceed in tandem, as it were, or did 17 one devolve into the other? 18 A. I think the one devolved into the other and medical 19 audit became clinical audit. 20 Q. Dr Roylance again was asked questions about the 21 introduction of clinical audit. He gave a long passage 22 of evidence which I will, if I may, read out to you 23 section by section. He said: 24 "A number of things changed with the introduction 25 of clinical audit. It was no longer, as somebody said, 0103 1 a pursuit by consenting adults in private. In other 2 words, it was no longer a matter for the medical staff 3 to pursue in private. It had now become 4 a multidisciplinary process ..." 5 So far, would you agree with that description? 6 A. Yes. I think I would not have chosen those words, but 7 the sentiment is there, roughly, yes. 8 Q. "... and therefore could not reside, if I may say so, in 9 the professional advisory structure of the Medical 10 Committee, the Steering Committee and through the 11 Chairman of the Medical Committee to the Trust Board. 12 It now had to be on a management basis because it was 13 multidisciplinary and we had to get it up and running." 14 Again, would you agree with that description of 15 the change in the line of reporting? 16 A. That is an accurate description of the change that took 17 place, yes, if that is what you mean. 18 Q. Is it also an accurate description of the reasons why 19 the change took place, that once -- 20 A. Yes, because the changes were not within, for instance, 21 my gift. I might have thought otherwise, but they 22 certainly were within Dr Roylance's gift. His decision 23 was that that was the changing culture and because of 24 that and because of the changing culture of Trust 25 status, it was more appropriate for the audit function 0104 1 to report through a different channel, a different 2 route. 3 Q. Can you explain to us what you mean by the change in the 4 culture of Trust status? 5 A. I suppose I should start before 1989, almost. You 6 understand that in what I am going to say I will be 7 representing some ideas that I have as a person and that 8 do not necessarily reflect the ideas of an Audit 9 Committee, of which I was a member. But having worked 10 in the Health Service since 1972, as a consultant and 11 prior to that as a trainee, I perceived it as a service 12 that the individuals within it felt was theirs. 13 Everybody knew that was not true but they had a sense of 14 ownership and that is why they were prepared to knock 15 themselves out to get the job done to work late or 16 whatever. 17 The culture at the end of the 1980s and the 18 beginning of the 1990s changed and became, if you like, 19 more business-like, and so a commercial flavour entered 20 into what was being done and it was being done for 21 money, contracts, whatever. 22 So it is that sort of flavour and that change in 23 flavour that I think underpinned or overlay, whichever 24 way you put it, the decisions that were made. 25 Q. And in particular, the decision to make the reporting 0105 1 structure upwards to the Trust Board and the management? 2 A. No, we had always reported to the Trust Board anyway. 3 We had always sent them the annual reports and we had 4 anticipated that since we had non-executive directors 5 attending the meeting, that there were no secrets and 6 the information flowed freely from us to them just as it 7 did to the Medical Committee. 8 Q. I am sorry, I should have repeated more accurately 9 Dr Roylance's comments on shifting the line of reporting 10 from the professional advisory structure to the 11 management structure. 12 A. Right. 13 Q. It is that change you would see as a culmination or link 14 to the change in culture that you were describing? 15 A. Yes. 16 Q. Dr Roylance continued: 17 "I think Dr Thomas had a number of concepts of how 18 this should go. He was worried about immediate medical 19 audit disappearing. He wanted it to continue and so on 20 and he had anxieties about this new initiative. As 21 I remember, he resigned as Chairman of this committee 22 [the Medical Audit Committee] after a while, because it 23 did not seem to be doing what he wanted it to do." 24 Is that an accurate description of the reasons for 25 your resignation? 0106 1 A. No. I had, from the very beginning, said I would chair 2 the committee for three years, at the end of which time 3 I would cease to be Chairman and that is what I did. 4 Q. Did you have concerns about the way in which the 5 committee was going at the time you left it? 6 A. Yes. We have just explored them. 7 Q. He then continued: 8 "We eventually, after much discussion of which 9 this is a small part, made the Clinical Audit Committee 10 report through the Patient Care Advisory Committee and 11 through that committee to the Board. The Chairman of 12 the Clinical Audit Committee was invited to attend that 13 committee to shorten the lines of communication." 14 That is the change in reporting structure we have 15 just been discussing, is it not? 16 A. I believe so, yes. 17 Q. He then continued: 18 "I think Trevor Thomas -- I do not want to malign 19 him and you may be able to ask him, but I think he, 20 having chaired the Medical Audit Committee, wanted to 21 control medical audit outside management as 22 a professional thing and himself being in charge. That 23 could no longer be appropriate. What the Clinical Audit 24 Committee had to do was to monitor the activities now of 25 management and of audit activity and report in the 0107 1 manner I have said to the Trust Board and to me to 2 assure us that that was continuing." 3 Again, if we leave aside the comment about 4 yourself being in charge and confine ourselves for the 5 moment to Dr Roylance's comments, as he said that he 6 thought that you, having chaired the Medical Audit 7 Committee, wanted to control medical audit outside 8 management as a professional thing: is that an accurate 9 comment on your attitude to -- 10 A. No. The word "control" is inappropriate. The whole 11 point about audit is that it is not controlled in that 12 central way. At least, that is my perception. 13 Dr Walshe may have a different view as to what is the 14 right way forward, but I was still of the view that 15 clinical specialty groups should have the responsibility 16 to educate themselves by carrying out audit projects. 17 I did not think that that should disappear. 18 So that is the difference of view, not that Trevor 19 Thomas wanted to control anything, which would not have 20 been possible. 21 Q. I think it must follow from that that you would equally 22 well, and for the same reasons, disagree with the 23 comment that Dr Roylance made when he said that you 24 wanted to retain the existing Medical Audit Committee as 25 it was, with yourself being in charge? 0108 1 A. No, not at all. My term of office had come to an end. 2 I had said I would do three years as the Chairman and 3 that was the end of it. 4 Q. If we could look, please, at UBHT 24/76, this is 5 a report of a visit of the Regional Audit Team which 6 took place after you had come to the end of your formal 7 term of office but whilst you were still the "caretaker 8 chairman", if I may call it so, which is a role you took 9 until mid-1994; is that right? 10 A. I cannot give you the exact data, but approximately, 11 yes. The Trust had some difficulty, I believe, in 12 finding a replacement Chairman. 13 Q. You say the Trust had some difficulty in finding 14 a replacement Chairman. Do you know why? 15 A. No. I think you would have to ask the person who 16 replaced me, because they may have given an answer more 17 accurately. 18 Q. Why did the Regional Audit Team come to visit the UBHT? 19 A. The Regional Audit Team visited all the units. It was 20 UBHT's turn. 21 Q. If we scroll down, please, through the report, we can 22 see that it took place at a time when there was debate 23 on the future role and constitution of the Audit 24 Committee as the shift towards clinical audit was being 25 discussed. 0109 1 Then, at the bottom in the last paragraph, there 2 is a description of the organisation and the direction 3 and development of audit within the UBHT, and it is said 4 to have been significantly different from that of all 5 other Trusts within the Region. 6 Is that accurate? 7 A. Yes. 8 Q. We heard this morning from Dr Walshe the difference 9 between a centralised structure and a devolutionary 10 model. Did the other Trusts in the region therefore 11 follow the centralised model? 12 A. As I remember, yes. 13 Q. Set out in that paragraph are the beginnings of a series 14 of conclusions on how the structure has worked. It 15 comments firstly that the control of audit therefore 16 lies ultimately with the Clinical Directors. Do you 17 agree with that? 18 A. Yes, I think I do. Effectively they had the 19 responsibility, they had the resource, and therefore it 20 was their control that dictated what could or could not 21 be done. 22 Q. The report then says: 23 "The Audit Committee is not however constituted of 24 Clinical Directors, which means its role has been 25 relatively powerless." 0110 1 Can you comment on that? 2 A. Well, I agree with it. 3 Q. "The tight directorate structure and approach operates 4 at all levels and for most issues and has therefore led 5 to a confusion for the Audit Committee over its role." 6 A. I do not think there was any confusion in our minds 7 about what we might be able to achieve. We had, as we 8 said this morning, no budget, no staff and therefore the 9 only way in which we could influence people was by 10 persuasion, by cajoling them into doing things which we 11 thought were valuable. Sometimes they agreed with us, 12 sometimes they did not. We knew that we would be able 13 to influence people over such things as hardware, 14 staffing and training, because the members of the Audit 15 Committee had information which was not available easily 16 to the Clinical Directors. So we could pass that 17 information on to them and persuade them to take the 18 steps that we thought were wise. 19 There was, I suppose, the other element to the 20 equation, and that was that they knew at the end of the 21 year they would have to account for how they had 22 expended their money. Certainly when things started the 23 Audit Committee was required to put its seal on those 24 items of accounting and say, "Yes, that is what 25 happened". 0111 1 Q. Would putting Clinical Directors on the Audit Committee 2 have assisted matters? 3 A. I am not sure I can answer that question. I suspect it 4 would have made little difference. I do not know, but 5 I suspect it would have made little difference. 6 Q. Why so? 7 A. Because I think that the directorates viewed the 8 resource as theirs and at any meeting to discuss what 9 audit was to be done, that would have coloured people's 10 judgment. 11 The success of Dr Walshe's alternative, the 12 centralised audit committee that responded to requests 13 or projects, would have ignored directorate interests 14 and parameters. 15 So given the devolved structure and the fact that 16 the money was going to devolve anyway, I think having 17 the Clinical Directors there would have made little 18 difference to what was done. 19 Q. Is it your view, then, that the devolutionary model that 20 was adopted within the Trust was a sensible response to 21 its structure? 22 A. In a general sense it was a very logical way to 23 proceed. It maintained the contact between like 24 clinicians who had similar problems and could therefore 25 explore them. One of the problems of audit was always 0112 1 how does the single-handed practitioner audit, and that 2 was always difficult to do and had to be done on 3 a cross-district or cross-region or whatever basis. 4 So if you bring people together with a common area 5 of interest, then that is perceived as concentrating 6 your skills into a group that can improve its practice, 7 can identify problems and so on and so forth. 8 Q. What about the problem of cross-speciality audit? How 9 do you tackle the need for, for instance, surgeons and 10 anaesthetists to tackle topics of common interest? 11 A. It is quite difficult and was, I think, done not very 12 successfully over that three-year period of 1991 to 13 1993. No, I take that back. That is not fair because 14 there were some groups who did it very successfully, 15 particularly among the medical specialties. I think 16 where it was not done particularly successfully was 17 between anaesthesia and surgery. That is why I gave you 18 the first answer, because you must remember my 19 background is as an anaesthetist, and it does colour my 20 comments sometimes. 21 Q. What were the particular difficulties with anaesthesia 22 and surgery that led to that failure? 23 A. I think two main difficulties. One is that if you look 24 at the generality of anaesthesia and the generality of 25 surgery, there are subgroups who have their own 0113 1 particular interests. Because of that, there will be 2 difficulty in agreeing a project, a report, an 3 investigation or whatever, that will be of interest to 4 the whole group. When you think about it, we are 5 talking about -- I cannot remember, if you add all the 6 anaesthetists and all the surgeons together, I think it 7 is 50 or 60 people. 8 Q. But many people have specialties of their own, cardiac 9 surgery, cardiac anaesthesia, for instance? 10 A. They do and there is no reason why they should not do 11 their own particular audit within the limit of an audit 12 session, if you wish. There could be a bit of it on 13 obstetrics, a bit of it on cardiac surgery. That could 14 be done. It was not done and one of the bones of 15 contention was time. 16 Q. The Regional Audit Team's report set out a series of 17 criticisms based on the proposition that the Audit 18 Committee was relatively powerless, and therefore had 19 not had a strong central influence. 20 Do you think that the committee was effective, 21 notwithstanding that? 22 A. It was effective in doing what it set out to do. You 23 may say we should have had higher expectations, but 24 I think that we recognised that what we could do -- 25 I think I said this this morning -- is that we could 0114 1 encourage a system of audit, an audit philosophy, if you 2 will, among all the clinicians in the district and in 3 the Trust, and that was something which could be done by 4 persuasion rather than requiring power. 5 Q. Could we go back, please, to UBHT 67/81? This is 6 a meeting of the Medical Audit Committee, 10th June 7 1992. If we go, please, to page 83, we can see there 8 a reference to a discussion about purchasers' access to 9 audit information. 10 A. Yes. 11 Q. You are minuted as referring to the constant pressure 12 from the purchasers to have some access to audit 13 information, but you were reluctant to accede to their 14 request, particularly their suggestion that they should 15 receive copies of the committee's annual report. 16 Why was that a request that you were reluctant to 17 accede to? 18 A. I cannot answer your question. I do not know because 19 the annual report had a very wide circulation and went 20 across the Region. I suppose that I was responding to 21 their wish as purchasers to have free access to 22 information which the Audit Committee did not have and 23 had it had that information, it might not have chosen to 24 share it with the purchaser. A provider, fine, because 25 that is within the envelope of the organisation. 0115 1 So I will, if you like, take you back to what 2 I said shortly after lunch: that the philosophy within 3 the Health Service had changed quite markedly from 4 a service to a business. Part of that change of culture 5 involved a change of attitude towards many things, 6 including information. Information then became 7 commercially sensitive. This was one of the reasons why 8 I, and I think the UBHT, were resistant to sharing 9 processed information. 10 It was, if you like, "What is the recipe for 11 Marmite, because if we know what it is, we might be able 12 to make it cheaper". That is the commercial view. That 13 was the sort of attitude that was beginning to creep 14 into those discussions, and information was regarded as 15 sensitive and not to be shared in a way that would make 16 it accessible to competitors. 17 Q. Is that, then, what lies behind the next sentence: 18 "At the meeting, Mr Wisheart had referred to the 19 confidentiality of audit and was concerned that the 20 purchasers were requesting more detailed 21 information ..." 22 You reassured him you would resist any attempt by 23 a purchaser to breach any confidentiality. 24 Should we read "confidentiality" as being 25 a reference to patient confidentiality or commercial 0116 1 confidentiality, or neither? 2 A. I think you must interpret the word in its wider sense, 3 in the way it was being used at the time. It was the 4 confidentiality of our original remit which had not 5 changed. That was the confidentiality which we had 6 established and which was part of the foundation for 7 confidence being built up among clinical staff in the 8 audit process. 9 If we had been seen -- this is what I believe -- 10 to waiver in our commitment to that, then I believe that 11 we would have lost the confidence of some or possibly 12 the majority of those who were taking part in audit 13 within the Trust. 14 Q. Dr Walshe this morning referred to the fact that 15 problems of patient confidentiality within the audit 16 process were fairly readily dealt with by anonymisation 17 and that the sensitivity of confidentiality therefore 18 centred around a scrutiny of individual clinicians' 19 performance in particular. 20 Was that a sensitivity within the UBHT? 21 A. As it was within any hospital. I do not think there was 22 any particular difference at that time. I am not sure 23 I would entirely agree with Dr Walshe, because I know 24 I sat through a number of meetings, audit meetings, not 25 of the Audit Committee but as a consumer of audit, 0117 1 I suppose, as an anaesthetist, and the issue of patient 2 confidentiality did not go away in people's minds. I am 3 sure he is right that there are few, if any, instances 4 of patient confidentiality being breached and then being 5 used in a litigation action, but it was a constant worry 6 and I remember people being fairly heavily criticised 7 for using patients' initials in reports that they made. 8 So people were very sensitive about patient 9 confidentiality, as well as clinician confidentiality. 10 Q. What about clinician confidentiality, then? Was any 11 understanding reached within the Trust as to the level 12 at which complaints, concerns or issues about an 13 individual clinician's performance would be raised or 14 shared following the audit process? 15 A. Concerns about individual clinicians and their abilities 16 or performance or suitability for a particular task, 17 there were a number of routes open to any group or any 18 individual who wished to make that sort of complaint. 19 The Trust maintained the older "three wise men" 20 approach to many of the complaints and that is the 21 channel that was used, not the Audit Committee. 22 Q. But was there any explicit discussion of how issues that 23 had specifically arisen out of an audit process that 24 might cast doubt on performance or raise an issue as to 25 performance of a clinician, could or should be handled 0118 1 as part of that process? 2 A. No, I do not think so. I think that at that time any 3 observation of that nature would have gone through the 4 same channels because that channel was dedicated not 5 just to addressing problems of, for instance, the sick 6 doctor, but also to problems of levels of performance. 7 Q. But that was a relatively high level mechanism, if I may 8 describe it as such. It perhaps might have been thought 9 to be appropriate for serious concerns, serious 10 worries. Was there nothing more informal or closer to 11 a junior consultant's, say, perspective, where an issue 12 arising out of the audit process could and should have 13 been taken? 14 A. Within the Trust as it was set up, the path that would 15 have been pursued by the sort of junior consultant you 16 describe would have been in the first instance, if it 17 was appropriate, to discuss the problem with the 18 individual concerned; in the second instance, to have 19 discussed it with either the Chairman of Division, if 20 one still existed, or the Clinical Director. 21 Following that discussion, the individual would 22 have taken his or her concerns to the Medical 23 Director -- no, possibly to the Chairman of the Medical 24 Committee, still, in those days, I think. Yes, to the 25 Chairman of the Medical Committee, I am pretty sure. 0119 1 Q. You have mentioned the Clinical Director and the 2 Chairman of Division? 3 A. Yes. 4 Q. Are either of those interchangeable or is there any 5 difference in the approach of speaking to them? 6 A. Not really. Both tended to be people who were regarded 7 with respect by their colleagues, and who were felt had 8 good judgment, and so either could have been approached, 9 and the approach might have been predicated on who the 10 individual regarded as most friendly, most approachable, 11 most whatever. There are all sorts of shades of 12 reasoning why they would choose the one or the other. 13 Q. Did the Audit Committee ever get information in the form 14 of the annual reports or any other reports that it was 15 receiving on the audit process in such a form as to 16 raise doubts about clinical performance of any 17 particular practitioner? 18 A. No. 19 Q. So the issue of how the Audit Committee would in turn 20 have dealt with that situation never arose; is that 21 correct? 22 A. No. 23 Q. It never arose? 24 A. It never arose. 25 THE CHAIRMAN: May I ask one question about 0120 1 confidentiality? Was there ever any formal arrangement 2 made between consultants and the Trust, as its 3 employees, that material for audit would be kept in 4 a manner where it would not be released or revealed 5 beyond that purpose of audit? 6 A. You mean -- may I quote an example and tell me whether 7 I am going in the right direction? You mean that 8 information might be derived from an audit project, but 9 then might be used for contract negotiations with 10 a purchaser? 11 Q. No, simply if it was something that it was thought other 12 people should learn about, they should be told about. 13 A. You are asking whether there was any formal agreement. 14 Q. I am trying to get to the heart of the confidentiality, 15 whether it was, as it were, something that was assumed 16 or agreed informally, or whether there was some more 17 formal agreement between the employer and the 18 consultant? 19 A. To my knowledge and memory, I think there was no formal 20 agreement between the employer and the consultants and 21 the issue of confidentiality derived from two principal 22 sources, one of them being the Working Paper 6 from the 23 government and the other being the Regional Health 24 Authority's paper on confidentiality which had a very 25 wide circulation. 0121 1 MISS GREY: And which I think you have attached as an 2 appendix to your witness statement? 3 A. Yes, it is. 4 Q. We have looked here at a discussion of confidentiality 5 and whether or not information should be provided to the 6 purchasers. If we go back, please, to page 81, we can 7 see there that apologies for absence were received from 8 Dr Kammerling. Dr Kammerling was a representative of 9 the District; is that correct? 10 A. Yes. 11 Q. Did his absence make any difference to the form in which 12 this discussion took place at that meeting? 13 A. I would think not. The group exchanged views very 14 easily and freely. Dr Kammerling might have had 15 a different view had he been there, but my view would 16 not have stifled his view and his view would not have 17 stifled mine. It was a forum, as any reasonable 18 committee should be, for discussion. 19 Q. Was anyone articulating the case for purchasers to have 20 access to this situation? 21 A. No. 22 Q. How long did Dr Kammerling remain a member of the Audit 23 Committee? 24 A. Oh dear, I cannot remember, I am afraid. It is in the 25 documents and I know that we discussed -- Dr Kammerling 0122 1 said that he felt that his loyalties were sorely tried. 2 He did not say that, but he felt that he had divided 3 loyalties and that he should therefore resign from the 4 committee in order to pursue his activities for the 5 Health Authority. 6 We were in some difficulty to know whom we should 7 invite as our public health representative in his place. 8 I believe that it was a suggestion of Mrs Maisey 9 that we should ask the University department for 10 a nomination, which we did, and Professor Colley pointed 11 out that Dr Charles Shaw was in fact within the Region 12 and was working within Professor Colley's department and 13 would be available, so we invited him to come instead. 14 Q. So Dr Charles Shaw, as the person who had been employed 15 by the Region to assist in the development of audit 16 across the Region, effectively replaced Dr Kammerling 17 as, as it were, an outside voice on the Audit Committee; 18 is that correct? 19 A. Yes, that is right. 20 Q. If we could go to UBHT -- 21 A. Can I just go back a moment, because I just worry a wee 22 bit here. You said, I think -- correct me if I am 23 wrong -- that Dr Kammerling was a representative of the 24 District Health Authority? Am I correct? 25 Q. Yes. 0123 1 A. Can I refine the answer a little bit. The District as 2 it was to begin with -- you understand the District 3 Health Authority then became the purchaser, which was 4 when Dr Kammerling found he had difficulties. 5 Q. So he had been on the committee prior to April 1991? 6 A. He, I believe, was a member of the committee from the 7 beginning. 8 Q. It was after the purchaser/provider split that the dual 9 role he was playing became troublesome? 10 A. Yes. 11 Q. If we could go to UBHT 1/219, there is a meeting there 12 of the Hospital Medical Committee Steering Committee, 13 1st July 1992. It is not a meeting that you were 14 yourself present at. Could we, however, turn 15 nonetheless to page 221, and to a discussion there about 16 an issue relating to audit and the possible conflict 17 between fulfilling the obligation to audit and 18 fulfilling the contract with the purchaser, and there is 19 an agreement being reached that the two obligations 20 should be seen as complimentary. 21 I appreciate you were not at this discussion, but 22 does the debate raise any memories with you? 23 A. No, it does not. 24 Q. If we could move on then, please, to the issue of -- we 25 have talked about incentives or sanctions for the 0124 1 failure to conduct audit, and if we look at the UBHT 2 Audit Committee report, 66/107, the 1992 report, and 3 over the page at 108 there is an index to the report 4 which tells us where the reports are coming from. 5 The point I would make about this report, 6 Dr Thomas, is that there is no report of audit 7 activities in cardiac surgery or in paediatric 8 cardiology. 9 I can take you through the report if that needs 10 confirmation, but I think it is a fair comment, both on 11 this report and also in the following year's report in 12 1993. 13 Can you tell us, firstly, was this omission 14 something that the Audit Committee was aware of? 15 A. Yes. 16 Q. What happened, then, to comment or rectify that 17 omission? 18 A. You will understand that responses from clinical groups 19 came to the committee over periods of time. In my 20 memory, I think we probably sent out certainly one, 21 probably two reminders to audit co-ordinators that they 22 had not yet filed their report with us. 23 The route to cardiac surgery from the committee 24 would have been via the co-ordinator for surgery. That 25 was Professor Farndon. The reason that that was the 0125 1 route was because we had a specific number of members of 2 the committee and to have divided the major specialties 3 into their integral subspecialty groups would have 4 produced such a profusion of co-ordinators for the 5 committee members to liaise with that it was not 6 practicable. 7 So Professor Farndon was our contact point with 8 surgery. Certainly, he would have received the letters 9 that went out asking for reports and he would have 10 received the reminders. However, I would make two 11 comments about cardiac surgery: I, as the Chairman of 12 the committee, and Mr Wisheart as a committee member, 13 had a conversation on a couple of occasions in which 14 I pointed out that we had not yet received the report 15 from cardiac surgery. In my memory, as I recall, he 16 said, "Well, the quality of patient care is improving in 17 cardiac surgery". I said, "Well, in that case that 18 makes it even more important that a report is received 19 so that throughout the Region people will know that that 20 is the case". 21 However, we did not receive a report and 22 I regretted the fact that they had been unable to 23 produce one for us. There was some reassurance, I felt, 24 in that we knew that cardiac surgery were carrying out 25 basic audits on mortality outcomes as part of their 0126 1 contract with the purchaser and that they were returning 2 figures to the Central Cardiac Surgery Registry, the 3 national registry. 4 So although I regretted the fact that they had not 5 been able to produce a report, I was reassured that 6 audit was in fact being done, and I believe that that is 7 the case: it was being done. 8 Q. So ultimately, the only means you had of ensuring that 9 reports were made to the committee was one of persuasion 10 and exhortation? 11 A. Oh, yes. I had no big stick with which to beat people 12 into giving me a report. 13 Q. A failure to provide a report to the committee: did it 14 produce any adverse effect for the department concerned? 15 A. Not really, no. 16 Q. When Mr Wisheart said to you that the quality of care 17 was improving, what did you understand that to mean? 18 A. I understood it to mean exactly what he said, that the 19 unit was producing a better quality of care year on 20 year, which was an entirely good outcome as far as I was 21 concerned, and knowing that his unit were returning 22 figures to a purchaser who was responsible for either 23 giving or denying money to a unit, I felt that the audit 24 was being done, the figures were being produced, they 25 were going to a suitable body to deny any further money 0127 1 if the figures were not good, and so I accepted what he 2 said. 3 Q. But it might be thought that if someone says, "Well, it 4 is improving", that that implies that it has problems. 5 Did you take it in such a sense? 6 A. The unit had not got a good reputation in general terms 7 across the Region. I think you have spoken with 8 Miss Hawkins, because I saw her appear on the television 9 not long ago, and she will have told you that there were 10 concerns about the quality of care in the Cardiac Unit, 11 and her concerns related, I think -- please, I do not 12 know what she told you because I have not looked to see, 13 but her concerns almost certainly will have been that 14 patients were being referred out of the Region for 15 treatment and that would have been a drain on regional 16 resources; and that she would have preferred them to be 17 treated within the Region. 18 Q. When you say that the unit did not have a good 19 reputation across the Region, what factors had led to it 20 having such a poor reputation? 21 A. I do not know. I genuinely do not know, but it did not 22 have a good reputation. I know that was true because 23 I was a member of the Regional Hospital Medical Advisory 24 Committee and my colleagues on that committee, from time 25 to time, would say that they did not feel that the 0128 1 cardiac surgery was all that good in Bristol. Mind you, 2 I suppose some of them had a reason for saying it 3 because they wanted to have a second cardiac unit in 4 Plymouth, but -- 5 Q. You can say something is not all that good because there 6 are problems of managing waiting lists, for instance, 7 and meeting demand, or you may say it because you have 8 a concern that the outcomes are less than good. Do you 9 know which lay behind that comment? 10 A. I cannot differentiate between the two for you. I know 11 that the unit was unable to accommodate the number of 12 patients that the Region would have liked it to 13 accommodate. 14 I am dredging my memory here a little bit, but 15 that limitation on size of the unit was one of the 16 factors that encouraged the Region to increase the 17 resource allocation for the unit in the BRI. That is my 18 memory. You may find that people at Region would 19 disagree with that, I do not know. 20 Q. Again, in describing the reputation that was enjoyed by 21 Bristol, was there any difference made between adult 22 cardiac surgery and paediatric cardiac surgery? 23 A. No: that was not a factor that they mentioned 24 specifically. 25 Q. Can I just go back to the discussion you were having 0129 1 about Dr Kammerling, please, because we should put up 2 UBHT 271/312. That is a letter to you? 3 A. Yes. 4 Q. Which I think is a letter which reflects the evidence 5 that you were giving -- can we scroll up the page, 6 please -- about the concern that he was expressing in, 7 as it were, having a double role on the Medical 8 Committee? 9 A. Yes. 10 Q. Disciplines reported to you as the Chair of the Medical 11 Audit Committee, they reported to the committee about 12 the content of audit. Was there any attempt made by the 13 committee to assess and then to offer guidance on the 14 content of the audit that was being performed in the 15 hospital? 16 A. I think the committee assessed the content because we 17 received reports which gave us an indication of content, 18 of what topics were being discussed. Beyond assessing 19 what was being returned to us, we did not go. For 20 instance, we did not suggest that group A should pursue 21 an audit into, I do not know, glue ear, except on the 22 one occasion when we attempted to set up a joint GP/ENT 23 initiative. 24 Within the two months or so following the meeting 25 between the UBHT and the purchaser where audit was 0130 1 discussed -- you will know the reference much better 2 than I, it is in the paperwork, in the documents -- 3 Q. We will come back to that in a minute. For the moment, 4 if I may, you were required, I think, to report to the 5 Regional Health Authority on the audit work as part and 6 parcel of accounting for the funds received; is that 7 right? 8 A. Yes. 9 Q. If we look at UBHT 66/316, please, this is just the 10 title page, to give us the context. It is the report 11 "Progress in Medical Audit" from the South West 12 Regional Health Authority, which would have been sent, 13 I believe, to the Department of Health. 14 If we go over the page to page 322, we can see, if 15 we scroll down, please, on the discussion of 16 expenditure, that for the purposes of the discussion, 17 units which had not provided a report have not been 18 included, neither has the UBHT because of the way 19 funding is distributed and then accounted for in the 20 year end report, and it is not possible to identify the 21 specifics of where funding has been spent as the total 22 allocation is divided amongst directorates. 23 If we go through the remainder of the report, we 24 would see that there is no financial data included for 25 the UBHT in the analysis of how Trusts and other 0131 1 organisations had spent their money. 2 How did this situation arise? 3 A. Please will you be specific? Because you are aware that 4 those two exclamation marks you see on the page and the 5 correction of spelling are mine. You know that this 6 report I found very irritating indeed, because we had 7 provided substantial amounts of information to the 8 Region to show them what was being done. We had 9 provided them with specific instances where audit had 10 resulted in changes being made to practice. Radiology 11 had achieved a huge amount with their audits and they 12 had qualified for, I cannot remember the name of it, but 13 a national award. Contributions had been made to 14 identify hazards in patient care and so on and so forth. 15 The fact that Miss Cowie decided not to accept the 16 assurances that we gave her and that were contained in 17 all the annual reports from the UBHT or the committee on 18 how money had been spent, I found difficult to accept. 19 Q. Had you been asked to provide financial data in 20 a particular form? 21 A. I believe that they provided us with a format. We were 22 unable to adhere to that format because of the 23 devolvement of money to directorates, and so we could 24 not match their particular format that they wanted 25 matched. I mean, it was not possible for us to do 0132 1 that. Nevertheless, I found it difficult to accept 2 this, and as you know, in the paperwork there are 3 letters from me to Miss Cowie and to Dr Roylance, 4 remonstrating with the format, and asking the latter if 5 he would not mind speaking up on our behalf. 6 Q. If you were unable to provide the financial data in the 7 format it was requested in that year, 1992/93, were you 8 able to provide it in the format that was required by 9 the Region in any future year? 10 A. Nothing changed in -- let me think. I cannot remember 11 the date of this particular document. Could you refresh 12 my memory? 13 Q. It is 1992/93. 14 A. When did it appear? 15 Q. We do not get a date, I think, from the document. 16 A. I believe that this document appeared at the end of 1993 17 and might even have appeared in the early part of 1994. 18 I may be wrong about that, but that is what is in my 19 memory because I remember the letters that I wrote were 20 written towards the end of my tenure of office, as 21 Chairman of the Audit Committee. 22 Q. Is the point you are making that any change in the 23 breakdown of funds came after your period as Chair? 24 A. Yes. 25 Q. Or are you able to seek to any changes or not? 0133 1 A. I cannot give you an assurance one way or the other 2 about how returns were made after I left the Audit 3 Committee. 4 Q. But did you perceive any need to change the system of 5 financial reporting in order to satisfy the Region's 6 requirements? 7 A. No. 8 Q. Why not? 9 A. It was my view that Region were being petty and they 10 were asking for information to be produced in 11 a stereotyped form, which they knew perfectly well we 12 were almost unable to do because of the very way in 13 which audit was devolved within the UBHT. It would have 14 cost them nothing to have put in a separate statement. 15 THE CHAIRMAN: Would another way of describing the concern 16 of the Region be that they simply wanted to know where 17 the money was going? 18 A. Well, sir, that was a concern that I had for the whole 19 of the three years that I was actually sitting in that 20 committee. I think Dr Walshe may agree with me, I do 21 not know, I hope he will, that that is a concern of 22 audit committees around the country. Certainly that was 23 a point made in the Royal College of Physicians' survey 24 of audit committees that appeared in 1992 -- 1993? 25 1992/93, that many audit committees had some difficulty 0134 1 in maintaining the ring, the fence, around audit money. 2 So it was a matter of great concern to us and it 3 was the source of discussions that we had with the 4 Treasurer's Department on a number of occasions, and 5 indeed, even invited the Treasurer to come to a meeting 6 to explain exactly what was going on, in 1992, I think. 7 Q. Your concerns may have existed, but they may reflect the 8 concerns of the Region. To tell the Region when they 9 ask where the money is going, "We are worried about that 10 as well" may not be entirely satisfactory to the 11 Region? I put it as an argument. 12 A. Well, I understand that, sir. You are right, of course, 13 to say that. However, the Regional Audit Committee and 14 those who assist in it were very well aware of how audit 15 was pursued within the UBHT. They knew that the Audit 16 Committee at the UBHT was assiduous in its attempts to 17 verify the use of the money and indeed, we oversaw some 18 of the uses of the money almost directly. 19 My indignation shows, does it not? I should be 20 more dispassionate, I am sorry. 21 Q. I do not want to pursue the point too far, but if I was 22 sitting before the Public Accounts Committee having had 23 money given to me, I would not feel comfortable being 24 only able to say, "As far as I know, they are all good 25 people doing the best they can". I would have thought, 0135 1 just for the sake of argument, I would have wanted to 2 get some information. 3 A. You would be right to say so. I believe that we had 4 done that, but not in the format that they wished us 5 to. 6 MISS GREY: If we go back to your statement at WIT 323/3, we 7 can see, if we scroll up the page, please, and further 8 down, please, you say in the last sentence that 9 paediatric cardiac surgery did not form a subject for 10 report to or discussion to any of the committees 11 concerned with audit in the Trust at the time with which 12 you were concerned with them. 13 Is that correct? 14 A. I cannot remember it doing so. 15 Q. Did the articles in Private Eye on paediatric cardiac 16 surgery come to your attention? 17 A. I was aware of them. I think everybody in the hospital 18 was aware of them. 19 Q. Was there not a case for discussing those in the Audit 20 Committee? 21 A. No. I do not think there was. The articles in Private 22 Eye were almost invariably scurrilous, and they had no 23 currency in proper information for much of the time. In 24 fact, all of the time they appeared, and set that sort 25 of reporting against the fact that we were assured that 0136 1 properly derived figures were being sent. I refer now 2 to the period between 1989 and 1993, were being sent to 3 other bodies who one might have expected if there had 4 been something astray with the figures, would have 5 actually said "Excuse me, there seems to be something 6 astray". 7 Q. You mean the UK Cardiac Surgical Register? 8 A. No, the purchaser I was talking about. I think the 9 Registry might not have been actually in a position to 10 say that. I do not know enough about the Registry to 11 know. 12 Q. So your impression at the time was that purchasers were 13 receiving mortality statistics for paediatric cardiac 14 surgery; is that correct? 15 A. For the whole of cardiac surgery. 16 Q. Are you able to say in truth whether they received them 17 or not? 18 A. No, I am not. 19 Q. Because in fact I think it is the evidence of Dr Baker 20 that they were never received? 21 A. Right. 22 Q. But you are not, I am sure, able to comment on that? 23 A. No. 24 Q. We have learned or heard that certainly during the 25 course of 1993, if not earlier, there were disputes 0137 1 within the department of paediatric cardiac surgery on 2 figures, on outcomes and on the results of audit and 3 that by January 1995, at any rate, some members of the 4 Department of Anaesthesia, when reporting to Dr Hunter 5 and Professor de Leval when they came to the UBHT, felt 6 that they had not been given proper access to figures to 7 enable them to decide about outcomes. 8 Firstly, to your recollection, was this subject 9 matter never brought to the Audit Committee's attention? 10 A. To my memory, we had no approaches from anybody along 11 the lines of, "Excuse me, this is not right". 12 Q. Why do you think the committee did not function as 13 a channel for concerns if there was a concern at the 14 directorate level that audit was not being properly 15 carried out, or there was not proper access to figures? 16 A. There are two questions, Miss Grey. If somebody had 17 said that audit was not being carried out, then that 18 would have been a matter properly addressed by the Audit 19 Committee, because that is what we were charged with 20 doing. 21 I do not believe that that was what was said. 22 People were not saying that audit was not being carried 23 out. The arguments were about whether or not the 24 figures were correct, or whether they were accessible to 25 Dr X or Mr Y. From what you have said to me, that seems 0138 1 to have been the bone of contention, not whether audit 2 was being carried out. We understood that audit was 3 being carried out and that that audit was continuing and 4 that it served the purpose of medical audit, in other 5 words, education, and also, we believed it served the 6 purpose of contractual obligation. 7 Q. Did you understand it to be scrutinising outcome figures 8 and in particular, mortality statistics, so as to be 9 able to determine whether or not those were acceptable? 10 A. I cannot answer the second part of the question. The 11 first part, the draft contract that the Audit Committee 12 saw stated quite specifically that mortality figures 13 were to be made available and I cannot now quite 14 remember which mortality figures they were, but I think 15 they were deaths within hospital, deaths within 30 days 16 and there was a -- 17 Q. Perhaps I can assist you by bringing it up. It is 18 HA(A) 10/94, please, and 15.2 is the relevant paragraph. 19 A. Yes, that is it. 20 Q. This is from the 1991 service agreement that we have 21 already looked at. 22 A. Yes. 23 Q. It was not, however, a contract that was repeated in the 24 same form in the following years. Are you able, 25 therefore, to help us on your extent of knowledge of the 0139 1 contractual arrangements between cardiac surgery and 2 purchasers after the date of this contract? 3 A. No. No, because contracts were perceived as following 4 a different route from audit and the sort of schism 5 between the two was quite clear. In the Trust's mind 6 and in I think the Audit Committee's mind as well, the 7 contract negotiations would proceed and would only 8 involve the Audit Committee if the Trust asked the Audit 9 Committee to be a conduit for the passage of information 10 from the directorate to the purchaser. 11 Q. So when you say that you thought that the cardiac 12 surgery department was fulfilling its contractual 13 requirements and that those included reporting on 14 measures such as 30-day mortality, that was based upon 15 having had sight of a 1991 contract? 16 A. Yes. 17 Q. But therefore, no further involvement in the contractual 18 process? 19 A. That is correct. 20 Q. Is that an adequate basis for that understanding? 21 A. We believed it to be so at the time: we knew that audit 22 meetings were occurring and we knew we were assured that 23 returns were being made to the national Registry. 24 Q. Who assured you of that? 25 A. I knew you were going to ask that. Before I said it, 0140 1 I was trying to remember who had said it. I cannot 2 remember, but I suspect it might have been Mr Wisheart. 3 Q. Equally well, when you received an account of what audit 4 was taking place within the cardiac surgery department, 5 notwithstanding the absence of annual reports for 1992 6 and 1993, would that information also have reached you 7 from Mr Wisheart? 8 A. Not necessarily, because Professor Farndon, I think, 9 would probably have been in a position to reassure me as 10 well. Certainly I spoke to him about surgical audit on 11 a substantial number of occasions. 12 Q. Dr Bolsin and Dr Black became members of the Clinical 13 Audit Committee in around June 1994. But again, they do 14 not appear to have raised any concerns with the 15 committee at that stage. 16 Are you able to help us on how the committee 17 perceived that that should be the case? 18 A. You are asking me to put myself in Dr Black's and 19 Dr Bolsin's shoes really, here, because it is their 20 perception of the committee that would govern whether or 21 not they brought data to the committee. I think -- 22 again, you will have to ask them about this, but I think 23 that they were pursuing a separate audit process. 24 That is all right. If you go back to the origins 25 of the Audit Committee, and indeed, go back to the 0141 1 Working Paper 6, it specifically makes provision for 2 independent audits to be carried out at the behest of 3 a number of authorities. There is no reason why an 4 audit should not be going on along separate lines, which 5 did not necessarily involve the Audit Committee. 6 Q. Is that an accurate parallel, if we look at HOME 3/130, 7 please, this is another reference for the same document 8 you have put as an appendix, back to the Working Paper. 9 Scroll down to (e), please. There the concept of an 10 independent audit is set out, but it is in a very 11 different context to the one we have just been 12 describing, is it not? 13 A. No. I do not think so. It says quite specifically 14 where necessary management must be able to carry out 15 a function, and although this Working Paper was written 16 before Trusts came into being, it obviously had them in 17 mind because they formed part of one of the other 18 working papers. 19 Q. I think the point I was making is that you suggested 20 that Dr Bolsin's and Dr Black's audit was of a nature 21 envisaged by this document. This document envisages 22 that it was initiated by management? 23 A. I take that point. I suppose in that point, it is 24 initiated differently. 25 Q. You said "That is okay". 0142 1 A. I think that having additional audits being conducted is 2 acceptable. There is nothing wrong with that. It comes 3 back, I suppose, to this business of control and power. 4 It is something you quoted Dr Roylance about. I do not 5 think we felt we had to control every audit function 6 within the UBHT. It was not practicable to do so, and 7 I am not sure it would have been right to do so. 8 I would not have dreamt of trying to control people who 9 wanted to go and do audit using a separate basis, 10 a separate system, a separate funding. As far as we 11 were concerned it was to be applauded. 12 Q. So concerns were never raised with you, but so far as 13 you understood it, audit was being properly pursued 14 within the department. Did you have any contemporaneous 15 knowledge of Dr Bolsin's or Dr Black's independent or 16 other audit? 17 A. No. The only contemporaneous view or contact point that 18 I have would date back to 1990. I cannot give you the 19 month, but you will undoubtedly give it to me. 20 Q. Can we look perhaps at that letter that I think you are 21 referring to, UBHT 61/19. This is a letter to 22 Dr Roylance from Dr Bolsin, if we scroll through to the 23 bottom of the page, dated 25th July. Firstly, can 24 I ask, am I right to bring this document up in this 25 context? 0143 1 A. Oh, yes. 2 Q. What involvement did you have in its production? 3 A. I saw a first draft of this letter at around this time, 4 just a short while before 25th July. It was a letter 5 which Dr Bolsin was writing principally to point out 6 deficiencies or errors in the application for Trust 7 status. 8 That was the primary purpose of the letter. 9 I know that Dr Bolsin had been disappointed in not 10 getting some equipment which he mentioned specifically 11 in the letter, so he brought me the original to look at. 12 Q. He brought you the original in the shape of, you said 13 a draft earlier? 14 A. I am sorry, a draft that he had put together prior to 15 writing the letter itself. He showed it to me and said 16 he was going to send it to the Chairman of the Health 17 Authority, and did I think that was right or an 18 appropriate destination for it. 19 I advised him on that draft. I changed the 20 English a little and I said that since he was primarily 21 concerned with the Trust status application, the letter 22 should go to Dr Roylance who was the Executive and who 23 was in the process of putting together the application 24 or who had put together the application for Trust 25 status. 0144 1 Q. If we scroll down the page, please -- 2 A. May I finish, and say that I also advised him that he 3 should send a copy to the then Chairman of the Health 4 Authority, Mr Mortimer, because he had included as his 5 final paragraph or sentence, a comment on the mortality 6 of paediatric cardiac -- could you scroll down, please? 7 Yes, the mortality for open-heart surgery on 8 patients under 1 year of age. 9 Q. "One of the highest in the country" and he says that the 10 problem should be addressed? 11 A. Yes, that is right. 12 Q. So you advised him to send it to -- 13 A. Both Dr Roylance as the -- he was then district General 14 Manager, of course, but Dr Roylance and the Chairman of 15 the Health Authority were appropriate people to send 16 a copy of that letter to. 17 I also advised him that he should discuss that 18 particular factor with colleagues within the unit, which 19 he said he had done. 20 Q. He said he had done? 21 A. Yes. I said "Well, in that case, you should copy your 22 letter to them as well so that they know you are writing 23 it". 24 I think -- I cannot be sure about this -- I also 25 said to him that he should be in a position to show 0145 1 figures to support his contention, which I think he was 2 not. I cannot remember whether I said "Have you got 3 figures to support this and can I see them". I do not 4 remember that bit of conversation very clearly. 5 Q. Is it possible that your memory of that event is 6 coloured by later discussion of when he went away and 7 gathered figures? 8 A. It is possible. 9 Q. But it says, this letter, that the mortality is one of 10 the highest in the country. Did you not yourself think 11 that you had any duty to either investigate it further 12 or to pursue the matter further to ensure that it had 13 been properly addressed? 14 A. Well, addressing it properly involved exactly the path 15 that he was pursuing in that he was discussing it with 16 colleagues. He was alerting the District General 17 Manager and the Chairman of the Health Authority, and so 18 the people who could address the problem had been 19 informed of it. 20 Q. Dr Thomas, one of the allegations that has been made 21 about events in Bristol is that the pattern of events 22 may have something to do with the issue of Freemasonry. 23 Can I ask you, therefore, are you, or have you 24 ever been, a Freemason? 25 A. No, I am not a Freemason, and I have never been 0146 1 a Freemason. I am amazed that that has been suggested. 2 Q. Those are the questions I would like to ask you. It may 3 be that Dr Walshe has further questions, or the Panel. 4 THE CHAIRMAN: Dr Walshe, please? 5 QUESTIONS FROM DR WALSHE 6 DR WALSHE: There were a couple of points I wanted to embark 7 on. Miss Grey has asked you about the devolved 8 arrangements for managing clinical audit and the 9 complete devolution of responsibility to clinical 10 directorates, and you have described how it worked. 11 Would you accept that it was an unusual structure? 12 I think you said it was the only Trust within the Region 13 with that structure and there were few others like that 14 in other regions. Is that so? 15 A. That is so, and I will accept that, yes. 16 Q. Is that still the structure within the UBHT, or is there 17 now a central function for quality today for clinical 18 governance? 19 A. There is a central function for quality. You are going 20 to ask me whether that forms part of the Audit Committee 21 function, and I am not sure I can answer your question. 22 I do not know. But there is a central quality assurance 23 function. 24 Q. So the Trust now has a central function in some form for 25 monitoring and managing all the quality -- 0147 1 A. I cannot promise you it is part of the Audit Committee. 2 I am not sure about that. 3 Q. Are you aware of any other Trust that still has 4 a structure of the kind that you describe? 5 A. No. 6 Q. You had said that cardiac surgery did not have a good 7 reputation -- your words -- and you discussed how for 8 two years in succession there was no audit report in 9 your annual audit report to the Region for paediatrics 10 or for cardiac surgery. 11 You also said that that issue had not been 12 discussed at the Audit Committee. Was that right? 13 A. I do not think I said it had not been discussed. 14 I cannot remember whether it has been or not, whether it 15 was or not. I suspect it might well have been, because 16 the committee reviewed the annual report before it was 17 finalised and they usually identified those who had not 18 responded. I cannot remember, to be honest with you, 19 whether we actually specifically addressed cardiac 20 surgery, the absence of the report and in particular, 21 paediatric cardiac surgery -- we would not have 22 addressed paediatric cardiac surgery as a separate thing 23 anyway, it would have been cardiac surgery. 24 Q. Nothing sticks in your mind? 25 A. No, save my conversations with Mr Wisheart where I urged 0148 1 him to get his audit co-ordinator in cardiac surgery to 2 produce a report. That was a separate line of 3 communication from the official one, which would have 4 been via the member of the Audit Committee responsible 5 for surgery, and Professor Farndon. That would have 6 been Dr Stansbie to Professor Farndon, on to the audit 7 co-ordinator for cardiac surgery and that was Mr Hutter. 8 Q. Given that the remit of the Audit Committee was to 9 review the reports of individual audit groups to ensure 10 that effective audit is being undertaken within the 11 limitations of suitable confidentiality of individual 12 data -- it does not have a reference, but the District 13 Audit Committee's annual report for 1991. 14 Given that was the position, do you think the 15 Audit Committee was fulfilling its remit? 16 A. Yes. You are identifying one small unit in a 1000-bed 17 hospital with innumerable subspecialties, and so by and 18 large, I would say that the Audit Committee was. 19 Q. But in this instance? 20 A. In this instance, we knew there was no report there. We 21 were not able to do anything about it, apart from asking 22 repeatedly for it, which we did, and beyond that, there 23 was nothing for us to do except to print the report out 24 of that particular subspecialty report. 25 Q. Would it have been appropriate for you to raise this 0149 1 issue with the committee to whom your committee 2 reported, which I think was the Hospital Management 3 Committee; is that right? 4 A. No, the Hospital Medical Committee. 5 Q. The Hospital Medical Committee, I apologise. 6 A. Since Mr Wisheart was probably by this time the Chairman 7 of the Hospital Medical Committee, and since I had 8 raised it with him, I think that the answer to your 9 question is, yes, and it was done, perhaps not 10 officially in writing and discussed in open Hospital 11 Medical Committee meetings, but certainly the matter was 12 discussed with the Chairman of the Medical Committee. 13 Q. Can I ask one further question, which is: you describe 14 the arrangements for maintaining confidentiality of 15 data, and I think you have outlined that this was 16 a continuing concern for clinicians through to 1993/94. 17 Do you think that focus on confidentiality and 18 that concern in retrospect acted as a bar or a barrier 19 to identifying and dealing with quality problems -- not 20 in this case particularly in cardiac surgery, but within 21 the Trust? 22 A. It is a difficult question to answer. "A bar to quality 23 matters"? That really was not what audit was about, do 24 you see? It was about what underlay quality. It was 25 about education. If you say to me, did it impede 0150 1 education, the answer would have been no, it did not. 2 Then you will say, did it impede the transmission of 3 a message from education into the area of quality and 4 quality assurance? The answer is, yes, it might have 5 done that. Do you see what I mean? 6 Q. Let me try and clarify. I was really asking whether 7 being unable to discuss openly the fact that particular 8 problems with the quality of care or problems with the 9 way a service was delivered exists, being able to 10 discuss that openly for example with managers because 11 they fell outside the boundaries of your policy on 12 confidentiality, was that a barrier to doing something 13 about those problems? 14 A. No, I do not think it was, because it was entirely 15 within the remit of any directorate to address a problem 16 which it identified. So, for instance, if valves were 17 falling off machines, the directorate who was 18 responsible for the machine was perfectly able to 19 address that problem and had a responsibility so to do. 20 So far as the specifics that we have been 21 addressing just recently in cardiac surgery, 22 responsibility of the directorate quite clearly was if 23 it identified a problem, then it should address the 24 problem. 25 MISS GREY: Sir, I was rising to interject, that I think 0151 1 there are certain questions that I should ask arising 2 partly out of what Dr Walshe has been asking, but also 3 more generally. I do not know whether this is 4 a convenient time to do so, or how you would like to 5 handle matters, sir. 6 THE CHAIRMAN: I personally would prefer to press on. You 7 have some questions? There are some questions from the 8 Panel, both to Dr Walshe and to our witness. Why do we 9 not first take your further questions, and then we will 10 proceed from here. 11 MISS GREY: Thank you. 12 FURTHER EXAMINED BY MISS GREY 13 Q. Can I take you back firstly to a debate that we touched 14 upon, Dr Thomas, but I think we did not really follow 15 through? If I take you to a reference, please, it is 16 HA(A) 9/119. This is a meeting with the Bristol and 17 District Health Authority at which you were one of the 18 attendees from the UBHT. If we scroll down the page, 19 please, there was a discussion taking place on the 20 Trust's approach to audit and progress. 21 If we turn over the page, please, we can see that 22 there is a discussion going on here about process and 23 outcome measures with broadly speaking the district 24 arguing that process was a legitimate area of activity 25 for the Health Authority, whereas Dr Roylance was 0152 1 arguing that outcome was for the Health Authority, but 2 process was not. 3 Can you help us a little further on the matters 4 that lay behind that particular debate? 5 A. I think we touched on it earlier this afternoon, perhaps 6 it was this morning. Process and outcome are two 7 separate areas. I am sure that they overlap, but 8 nevertheless, they are separate. Process in health 9 care, as I said to you earlier, was considered as 10 commercially sensitive information. Outcome was 11 something that was a matter for the purchaser to 12 consider, so that if they perceived the outcome provided 13 by in this case the UBHT to be less good than they would 14 wish, they had a number of alternatives as to how they 15 approached that problem. 16 So outcome was definitely something the purchasers 17 needed to be aware of, and to consider when deciding 18 what contracts to strike. 19 However, the process, the way by which that 20 outcome was achieved, was considered in a separate 21 light, and it was considered to be the affair of the 22 Trust and its medical employees. 23 Q. If we turn, please, to the follow-up letter from the 24 Health Authority, this is HA(A) 9/114, from Dr Kieran 25 Morgan, Director of Public Health, if we scroll down, 0153 1 please, what we see there is that there is a report in 2 the third paragraph of this particular discussion and 3 the UBHT is reported as saying that they were adamant 4 that "they did not wish to generate and stick to 5 clinical process standards and would wish to concentrate 6 on outcome measures only. Whilst we all agreed this was 7 in fact the correct course, we did not accept that 8 process measures had no place. As usual, the UBHT will 9 not budge." 10 Can you help us there, as to the reasons why the 11 comment might be made, "as usual"? 12 A. I think you would have to ask Dr Morgan why he said "as 13 usual". 14 Q. The impression one gets from that, is it not, is that 15 the district had difficulties in dealing with the UBHT 16 because on occasion it found it stubborn or impervious 17 to argument? 18 A. Yes. 19 Q. Well, would that be a fair comment on the style of 20 negotiation adopted by the UBHT with the District during 21 that period? 22 A. I have no idea. I was not party to the sort of 23 negotiations that the UBHT had with the District on its 24 contracts, except in this one instance where it wanted 25 to talk about audit. 0154 1 Q. Arising out of that particular meeting, do you get the 2 impression that that comment might have been justified, 3 given the stance of the UBHT at the meeting? 4 A. Well, I think the stance of the UBHT at the meeting was 5 in fact correct, and Kieran Morgan in that letter says 6 that he, too, believes that it is correct and that 7 outcome was in fact the important factor to consider. 8 But, Miss Grey, I cannot comment on the negotiations 9 that the UBHT had with the District. I mean, I was not 10 party to them. 11 Q. So are you able to help us as to whether or not there 12 was any change in the dealings of the District with the 13 UBHT, or the stance of the UBHT in contractual 14 negotiations during the period of the terms of our 15 Inquiry? 16 A. I do not believe I can help you with that. 17 Q. If we could go on, please, to a letter at UBHT 65/159, 18 this is a letter to you from Dr Shaw, 10th June 1994, so 19 at this point you were retiring from the Audit 20 Committee. You are updating Dr Shaw about your 21 successor, Mr Wisheart. 22 If we look at the bottom of the second paragraph, 23 you say there that you "told James that you are happy to 24 continue coming to Audit Committee meetings. He has 25 gone away to think about that particular offer. I fear 0155 1 he has become part of the rather introspective 2 organisation of UBHT management and that he may find 3 that he will not wish to take you up on that particular 4 offer." 5 What did you mean by the "rather introspective 6 organisation of UBHT management"? 7 A. I meant that the organisation of the Trust was not an 8 outward looking organisation, and that certainly as far 9 as audit was concerned, I had felt that the rather 10 slavish pursuit of devolvement had not helped us. 11 I believe that that was what was in my mind when I wrote 12 that. 13 Q. Because if one takes that together with the minute we 14 have just been looking at from Dr Morgan, both pieces of 15 comment, one from you, one from a source outside the 16 UBHT, might suggest that the UBHT and its management as 17 a culture were resistant to suggestions of change or 18 innovation. 19 Would that be a fair characterisation of the 20 culture, or not? 21 A. Yes. Yes, I think it probably would be. 22 Q. To what extent do you think that Mr Wisheart was 23 identified with that culture, as your letter suggests 24 that he may be? 25 A. You understand, I was writing the letter about audit, 0156 1 not about cardiac surgery. As far as audit was 2 concerned, I believed that Mr Wisheart felt as 3 Dr Roylance did and that audit was going to continue as 4 a devolved process without allowing any sort of role for 5 an Audit Committee. Because you must remember that -- 6 again, this was my view -- it was my view that we had, 7 in that three-year period, done what could be done to 8 establish the necessary frameworks for medical audit to 9 occur. 10 Q. Can I just take you back to an answer which you gave at 11 an earlier stage? You were being asked by me about the 12 pressure on the Audit Committee for further 13 information. You said: 14 "At that time there was a clear undertaking being 15 given by cardiac surgery to the purchaser that they 16 would provide to the purchaser direct figures of 17 mortality. As far as the Audit Committee was concerned, 18 those figures were passed; we were not given any 19 information that they were not passed. It did not go 20 through the Audit Committee, much to our regret, because 21 we believed that that should be a function of an Audit 22 Committee. We were defeated in this matter by both the 23 purchaser, by the directorate, by the Manager, and so on 24 and so forth." 25 Can I ask you, why did you say that you were 0157 1 defeated on that matter by the purchaser as well as by 2 management and the directorate? 3 A. Because the purchaser had shown at that stage no 4 interest in having the District Audit Committee involved 5 in the passage of that information. 6 Q. It had shown no interest in it, but had it expressed 7 a view either one way or the other as to whether it was 8 received information from the directorates or from the 9 Audit Committee? 10 A. Not to my knowledge. 11 Q. So as far as you were aware, the purchaser was 12 indifferent? 13 A. I suppose so. My earlier reply may have included them 14 when it should not have. 15 Q. One final matter, and it is a final matter. Could 16 I take you back to the regional reports to the 17 Department of Health? This is HA(A) 167/1. This is 18 1993/94. Firstly, did you see this report at the time 19 it came out? 20 A. I do not think so. I do not recall seeing it. 21 Q. Did you have any involvement in the process of providing 22 information to the Region to generate the information 23 that is contained in this report? 24 A. I am sorry, I cannot help you because I am not familiar 25 with that report and I do not know, is the answer to 0158 1 your question. I do not know. 2 Q. You recollect, obviously, an exchange of letters with 3 Nicola Cowie over the previous year's report and its 4 omissions? 5 A. Oh, yes. 6 Q. No recollection of a similar exchange this year? 7 A. I do not believe so. 8 Q. If we look, please, to page 44, we can see there that we 9 have a repetition in effect of the problem experienced 10 in the previous year of a lack of information from the 11 UBHT on such matters this time as the number of meetings 12 and the percentage attendance at them. 13 That contrasts with the previous year where it was 14 financial information that was lacking? 15 A. Yes. 16 Q. Are you able to help us as to the fashion in which this 17 situation had arisen? 18 A. Yes. I still believe -- let me put it a different way. 19 I have no memory of this particular document. However, 20 I suspect that it was produced and appeared late in 21 1994 -- am I correct? 22 Q. I believe you are, yes. 23 A. That would fit with the sort of financial year that was 24 reported. 25 The annual report from the Medical Audit Committee 0159 1 for 1993 -- because we used calendar years rather than 2 financial years -- the 1993 report was much delayed. 3 The Audit Committee lost its only support and there was 4 a considerable difficulty in retrieving information. 5 One of my colleagues spent a huge amount of time in 6 actually rediscovering it and eventually the 1993 report 7 appeared, but it was much delayed. You will want to 8 know the date. I cannot tell you when it appeared, but 9 certainly it would have been in the summer of 1994. It 10 would have been in the summer of 1994, and so by that 11 time I suspect this would already have been finalised. 12 Q. So your answer is that from the best of your surmise, if 13 I may put it like that, it appears that the Region did 14 not get the information in time for its annual report? 15 A. That is correct. 16 MISS GREY: Thank you very much, Dr Thomas. I have no 17 further questions. 18 THE CHAIRMAN: We have some questions from the Panel both, 19 as I said, for Dr Walshe and for yourself. Mrs Howard? 20 Examined by THE PANEL: 21 MRS HOWARD: Dr Walshe, we have heard quite a good amount 22 this afternoon about the interface between the purchaser 23 and the provider and I think Miss Grey's last questions 24 were particularly resting on that. 25 Do you have any comment to make about whether the 0160 1 difficulties we have heard, perhaps some of the concerns 2 we have heard with regard to the Bristol interface are 3 unique, or whether there was an issue between the 4 purchasers and the providers across the country? 5 DR WALSHE: When the approach to funding clinical audit 6 changed from ringfenced funding distributed essentially 7 by regions through districts to Trusts, to an approach 8 in which that money was rolled into individual Health 9 Authorities' budgets and health authorities struck 10 contracts with Trusts for clinical audit, the emphasis 11 shifted much more towards health authority involvement, 12 understandably. Health authorities were then much more 13 explicitly responsible for those funds. Many health 14 authorities began to stretch their muscles a little and 15 to exert their influence by, for example, seeking to 16 influence the agenda of audit to determine some or all 17 topics and some health authorities were much more 18 directive than others, but all began to be more involved 19 in the process. 20 A lot depended on how good or poor the 21 relationships between a health authority and its local 22 Trusts were, but where those relationships were poor and 23 perhaps there was a history of a Trust asserting its 24 independence and being unwilling to accept that the 25 health authority should, in inverted commas, "meddle" in 0161 1 its business, then you got a clash between the health 2 authority that wanted to exert some control on clinical 3 audit and know that the investment it was making was 4 worthwhile and a Trust that was sometimes unhappy about 5 disclosing what was going on, or even providing much if 6 any information to the Health Authority. That was 7 something that happened in many places. 8 Q. You used the past tense. Is the suggestion that that 9 has changed significantly? If that is so, can you put 10 a date on that? 11 A. I did use the past tense. I think things have moved on 12 a lot in all sorts of ways since 1994/95, and in fact 13 the current reforms which do not form part of the remit 14 of this Inquiry have changed the agenda yet again. 15 I think health authorities learned a lesson. As 16 they began to exert influence, they often began by 17 saying "We want audits on these topics" and they soon 18 realised it was very hard for them to work out what were 19 the areas where audits needed to be undertaken and they 20 developed more sophisticated approaches to try and work 21 with providers to determine a combined or a joint audit 22 agenda rather than trying to dictate it from afar and 23 simply, Trusts got more used to it and began to 24 recognise that, yes, the money came from the Health 25 Authority and as I think John Roylance said in some of 0162 1 the quotes that Miss Grey used, therefore the Health 2 Authority had a legitimate interest in the process. 3 MRS HOWARD: Thank you. 4 MISS GREY: Sir, I know that we break new procedural ground 5 every day in this Inquiry, but may I suggest in fairness 6 to Dr Thomas and also Mr Hoyte, it may be appropriate to 7 remain on a slightly more conventional format and for 8 the Panel to direct their questions to Dr Thomas first, 9 allow Mr Hoyte to continue with any re-examination and 10 then to direct any further questions to Dr Walshe? 11 THE CHAIRMAN: It is my fault. You read my mind. I should 12 have intervened earlier. Mrs Howard? 13 MRS HOWARD: Dr Thomas, I have one question which is really 14 for clarity for myself. You talked in your evidence 15 about during 1993, acknowledged disputes about some of 16 the cardiac surgery audit that was taking place in terms 17 of the numbers. 18 What I would really like to know is, did that 19 audit have any status in respect of the Audit Committee, 20 particularly because you referenced forward plans, for 21 example, so at any time, had the clinicians involved in 22 collecting that data talked to the Audit Committee for 23 support or just had any sort of discussion with them 24 prior to commencing that data collection? 25 A. No. As I said, the contact that I had with Dr Bolsin 0163 1 was in 1990 over the matter of the letter that he was 2 writing principally about the application for Trust 3 status, and his throwaway line, if you like, at the 4 end. But following that, I think -- again, memory plays 5 tricks so I am unclear as to exactly when I became aware 6 of different aspects of the Bolsin/Black audit, as 7 Miss Grey pointed out to me. I became aware of it as 8 a member of the Department of Anaesthesia, but I think 9 I became aware of it at quite a late stage in its 10 progress, because by that time the audit had acquired 11 numbers to it. The numbers were in dispute, but they 12 had acquired numbers. 13 I am in some difficulty as to exactly when that 14 was. Miss Grey will probably correct me if I am wrong, 15 but I suspect that was round about 1994. I think that 16 is when they came up with a result. I am not sure. 17 MISS GREY: Dr Thomas, I cannot assist you on the dating of 18 your recollection of when you came to know of this 19 audit. 20 DR THOMAS: Touche, Miss Grey! 21 THE CHAIRMAN: Professor Jarman? 22 PROFESSOR JARMAN: Dr Thomas, Miss Grey read to you earlier 23 a quotation from Dr Roylance -- page 63, line 10 of 24 today's hearing -- in which Dr Roylance had said that 25 management's role was to facilitate professional audit 0164 1 activity. Do you remember that, earlier today? 2 A. Yes. 3 Q. Later on, you discussed the conflict between the time 4 needed for audit by clinicians and the time needed to do 5 clinical work. 6 A. Yes. 7 Q. In this facilitating role that management had, are you 8 aware that they did actually fund, say, locums to 9 provide doctors to enable clinicians to carry out audit, 10 or not? 11 A. No, I do not think so. I have no recollection of any 12 locums being secured for that purpose. And in truth, it 13 would be difficult to do, to produce a locum at 14 relatively short notice to fulfil the role of 15 a consultant, a specialist in whatever, be it diabetes 16 or cardiac surgery or anaesthesia. Locums are not that 17 easy to come by. If you want to hire a locum in order 18 to fulfil a contract for 12 months or 2 years, 3 years 19 or whatever, that is a different matter, but to cover an 20 afternoon for 50 or 60 people, that is difficult to do. 21 Q. So did management actually facilitate audit by providing 22 some means of dealing with the conflict between clinical 23 and audit demands? 24 A. No. As I said, I think they stood aside and waited for 25 the clinicians to come to a conclusion. 0165 1 Q. The second question is, you were discussing the remit of 2 the Audit Committee to review the report of individual 3 groups and your difficulty of getting a report about 4 cardiac surgery. 5 Did you actually see the annual report of the 6 paediatric cardiology and cardiac surgery unit which is 7 at UBHT 55/68? It is for the year 1989/90. 8 A. Yes, but -- 9 Q. They may put it on the screen. 10 A. I believe I remember it. 11 Q. UBHT 55/68. That is the front of the report. Then if 12 we go to UBHT 55/81 you will see on the fifth line down, 13 for open-heart surgery under 1 year, the fourth column, 14 the percentage deaths in 1989 for UBHT is given as 37.5 15 and the UK figure for the previous year is given as 16 18.8. Did you see that report? 17 A. No. The answer to your question, sir, is no, I think 18 not, and I do not believe it forms part of any of our 19 Audit Committee reports. I would have to go through 20 them again, but I do not believe it does. 21 PROFESSOR JARMAN: Thank you. 22 THE CHAIRMAN: Thank you. Mr Hoyte? 23 MR HOYTE: I have nothing to ask. Thank you very much. 24 THE CHAIRMAN: I am grateful. I do beg your pardon, 25 Professor Jarman now wants to ask a question of 0166 1 Dr Walshe. 2 MISS GREY: Unless they are interconnected, perhaps we could 3 thank Dr Thomas and allow him at least to be released? 4 THE CHAIRMAN: They may be interconnected and the decision 5 as to whether they are will rest upon the question, 6 Miss Grey. But I take your point. I am told they are 7 not. So may I, Dr Thomas, thank you very much for 8 coming to talk to us today. There are a couple of 9 things which arose during conversation as I recall where 10 there might be the possibility of your assisting us 11 further, if you were able to lay hands on pieces of 12 information. If you are, we would be very grateful. 13 DR THOMAS: Could somebody give me an indication of what 14 I am looking for? 15 THE CHAIRMAN: Someone will find out where they are, yes. 16 It was my memory that there was a reference to something 17 on which you may be able to help us further. If I am 18 wrong, then please ignore what I have just said. But in 19 any event, if there are other things that you do think 20 would help us, we would be always grateful to hear from 21 you further, but for today, thank you very much indeed. 22 (The witness withdrew) 23 THE CHAIRMAN: Professor Jarman to Dr Walshe, please. 24 PROFESSOR JARMAN: I wonder if you have seen the paper in 25 the BMJ by Berisford and Evans this year, called "Legal 0167 1 Safeguards for the Audit Process", BMJ 1999, volume 319, 2 page 654? 3 A. Yes, I have. 4 Q. They point out, and I quote: 5 "In Britain audit activities are protected neither 6 by statute nor by case law", and go on to say the 7 problems concerning confidentiality, because it is 8 multidisciplinary, and patients can discover documents 9 for litigation. They suggest the system they say is 10 used in Australia and the United States about legal 11 protection. 12 I just wondered what is your view with regard to 13 their opinion? 14 A. I wrote back actually to them and to the BMJ, and wait 15 to see whether they carry it. It is on the BMJ's 16 website. I am trying to recall what I said, but 17 essentially I disagreed. I do not really think that 18 legal protection in our legal environment with the level 19 of clinical negligence, litigation and other issues that 20 we have, is necessary. In fact, I felt that they were 21 pursuing an argument that we discussed this morning 22 about the importance of confidentiality to protect 23 individual clinicians from the misuse or abuse of data, 24 which experience during the 1990s with clinical audit 25 suggested was more an argument rooted in people's fears 0168 1 and beliefs than in the reality of their experience. 2 So I would not agree with them that there needs to 3 be some legal safeguard. 4 PROFESSOR JARMAN: Thank you. 5 THE CHAIRMAN: May I just follow that up? Professor 6 Jarman's question, if I may say so, touches on a very 7 important area. You talk of it being a perceived 8 problem rather than a real problem, but are not 9 perceptions as important as the reality in this context 10 and how do you respond to that perception, except by 11 waiting along for a long time through education, or by 12 doing something rather pointed rather quickly? 13 A. I think we have the advantage now that we can point to 14 our experience and we can say, "Well, we have had 15 systems of clinical audit for five years or so; it is 16 very hard to find anyone who can point to examples of 17 that data being misused". 18 You could argue, it has not been misused because 19 we have had such stringent arrangements for 20 confidentiality, but those arrangements have I think 21 relaxed as people have become more comfortable with the 22 use of data, as health authorities began to play much 23 more of a role in determining the audit agenda, and so 24 on, and in particular, the current reforms, the 25 development of clinical governance, imply a much greater 0169 1 corporate ownership of that information about the 2 quality of clinical care than was true in the past. 3 So I recognise that the worries are very real; 4 I just do not think that there is actually an empirical 5 problem there. 6 THE CHAIRMAN: Thank you. If I may flag something for some 7 distance from now in terms of time, I am sure we shall 8 return to this topic and if there are those not in this 9 phase of the hearing, undoubtedly when we consider wider 10 matters, and if there are those who have such experience 11 as you talk about and would wish to get in touch with us 12 we would be very grateful and no doubt we will pursue 13 such people. 14 Thank you very much, Dr Walshe. Is there anything 15 you would like to add in addition to everything you were 16 able to help us with this morning, as a final comment, 17 or are you, as it were, satisfied that you have said 18 what you wanted to say? 19 DR WALSHE: I think I have nothing more to add, but thank 20 you. 21 THE CHAIRMAN: Speaking on behalf of the Panel, we are 22 enormously grateful to you for your contribution this 23 morning, because it was very, very clear and very 24 helpful. And I am sure that is also true of what our 25 leading counsel describes as the "wider audience". On 0170 1 behalf of all of us, may I thank you very much indeed 2 for coming and helping us today. 3 MISS GREY: Sir, we adjourn today and resume again tomorrow 4 at 9.30, when we shall hear from Dr Alan Bryan of the 5 UBHT. 6 THE CHAIRMAN: Thank you. I think, Miss Grey, there was 7 a suggestion that we may begin slightly earlier than 8 that. 9 MISS GREY: It has not filtered through to me, sir. 10 THE CHAIRMAN: It is entirely my fault, since it turned upon 11 whether I would accede to the request to start at 12 9 o'clock. I am happy to do so, if that will help other 13 arrangements. So shall we say we adjourn now and begin 14 at 9 o'clock tomorrow morning? 15 (3.40 pm) 16 (Adjourned until 9.00 am on Thursday, 14th October 1999) 17 18 19 20 21 22 23 24 25 0171 1 2 3 4 I N D E X 5 6 7 8 LETTER TO CHAIRMAN FROM PROFESSOR ANGELINI ....... 1 9 10 DR KIERAN WALSHE (affirmed) ...................... 2 11 Examined by MISS GREY ...................... 2 12 13 DR TREVOR THOMAS (affirmed) ...................... 57 14 Examined by MISS GREY ...................... 57 15 Questions from DR WALSHE ................... 147 16 Further examined by MISS GREY .............. 152 17 18 DR THOMAS AND DR WALSHE 19 Examined by THE PANEL ...................... 160 20 21 22 23 24 25 0172