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Hearing summary19th October 1999
The Inquiry oral hearings will focus this week on the concerns raised about paediatric cardiac surgery at the Bristol Royal Infirmary (BRI) between 1984 and 1995 and actions taken during the period to resolve those concerns. The Inquiry will also hear evidence which will illustrate the national scene and address the subject of post mortems and tissue retention.
Today the Inquiry heard evidence from Sir Alan Langlands, Chief Executive, National Health Service Management Executive (NHSME) 1994 to 1996 and then National Health Service Executive (NHSE) to date. He described the relationship between the NHS, the NHSE and the NHS Regional Outposts during the 1980s and 1990s and discussed in detail the issue of accountability and responsibility. He commented on the role of NHS Trust Boards after 1991, the guidance issued to them by, and their accountability to, the Secretary of State. Sir Alan commented on the establishment of the Supra Regional Services Advisory Group and its role in commissioning specialist healthcare services. He went on to discuss guidelines circulated in 1990 regarding disciplinary procedures and their application following the introduction of NHS Trusts from 1991. He commented on requirements to include quality in service contracts between purchasers and providers and added that the focus of quality standards in the early 1990s was on national priorities such as Health of the Nation targets. He concluded by confirming that confusion existed between professional bodies such as the Royal College of Surgeons, the DOH, regions, districts and trusts regarding responsibilities for monitoring the quality of supra regional services and acting upon concerns.
Hearings concluded today with evidence from HM Coroner for Avon, Paul Forrest. He clarified the position regarding consent for the retention of tissue following a coroners post mortem and confirmed that tissue should not de retained for teaching or research purposes without the consent of next of kin. He concluded by saying that the current coroners system was unable to guarantee consistency and that reform was required.
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FULL TRANSCRIPT
1 Day 65, 19th October 1999 2 (9.30 am) 3 THE CHAIRMAN: Good morning, everyone. Good morning, 4 Mr Langstaff. 5 MR LANGSTAFF: Good morning, sir. Sir, today, as 6 I indicated yesterday, we have both Sir Alan Langlands, 7 who will be questioned by Miss Grey, and then Paul 8 Forrest, Her Majesty's Coroner for Avon, whom I will 9 question. 10 Before this morning begins, may I take the 11 opportunity of reminding you of the application made 12 last week by Mr Lissack on behalf of the Bristol Heart 13 Children's Action Group, and wonder if you have had the 14 opportunity to consider what response the Inquiry should 15 make to it? 16 THE CHAIRMAN: Mr Langstaff, thank you, yes. 17 CHAIRMAN'S STATEMENT 18 RE MR LISSACK'S APPLICATION OF 12.10.99 19 TO RECALL WITNESSES 20 THE CHAIRMAN: Last Tuesday, which was October 12th, as you 21 say, Mr Lissack made an application on behalf of his 22 clients, the Bristol Heart Children's Action Group, for 23 the recall of several employees of the UBHT in 24 connection with matters arising subsequent to the 25 evidence of Professor Berry, given here on 23rd 0001 1 September. 2 In response, we heard from Mr Chambers on behalf 3 of the Trust, and we have had the opportunity of reading 4 the relevant correspondence, including the letter of 5 18th October, from the Action Group's solicitors to the 6 Trust's solicitors. 7 We, the Panel, are of the opinion that some 8 further enquiries should be made into this matter before 9 a decision can be taken to grant or refuse the 10 application. Consequently, I have asked the solicitor 11 to the Inquiry to write, today, to the Trust requesting 12 certain information from the Trust and the witnesses 13 mentioned in Mr Lissack's application. 14 Once a response is received, which we trust will 15 be prompt, the Panel will consider it and rule on the 16 application. 17 Subsequently, the Inquiry will publish the 18 exchange of correspondence and its decision. 19 Mr Langstaff? 20 MR LANGSTAFF: Thank you, sir. 21 MISS GREY: Sir, as you are already aware, the first witness 22 this morning is Sir Alan Langlands. Sir Alan, we have 23 asked witnesses to stand whilst affirming and taking the 24 oath, please. 25 SIR ALAN LANGLANDS (SWORN): 0002 1 Examined by MISS GREY: 2 Q. Sir Alan, you are the Chief Executive of the NHS 3 Executive and you have held that post from 1st April 4 1994; is that right? 5 A. That is correct. 6 Q. Could we have a look, please, at WIT 335/1? Is that the 7 first page of a statement which you have provided to the 8 Inquiry? 9 A. It is. 10 Q. If we turn, please, to page 22, is that your signature 11 which appears at the bottom? 12 A. It is. 13 Q. Are the contents of that statement true to the best of 14 your knowledge and belief? 15 A. They are true. 16 Q. Sir Alan, this is the first time you have spoken in 17 public about these matters. Is there something which 18 you would like to add or raise to your statement before 19 we take that evidence as read and start this morning's 20 questions? 21 A. Thank you very much. It is the first time, and I expect 22 today that we will spend time thinking about the 23 structure and the functioning of the Department of 24 Health and the National Health Service, but I would not 25 like any of this to eclipse the human side of this 0003 1 Inquiry. I therefore wanted from the outset to extend 2 my deepest sympathy to the children, the parents and the 3 families who have suffered so much as a result of the 4 events at Bristol Royal Infirmary. 5 Q. If we can go back, then, to your statement, please, 6 page 1, you set out in the first paragraph the wide 7 variety of posts that you have held within the National 8 Health Service over the last 25 years and you say that 9 during 1993/94, you were appointed Deputy Chief 10 Executive of the NHS Management Executive, the NHS ME. 11 Can you tell us when you took up that post? 12 A. I took up that post on 1st January 1993. 13 Q. So that was the point at which you moved from the 14 regional or district structure, you had been working in 15 both, to the central Department of Health? 16 A. I moved from the North West Thames Regional Health 17 Authority. 18 Q. If we could go on to page 2 of your statement, you say 19 at paragraph 4 that the relationship between the NHS and 20 the NHS Executives reflects some of the tensions 21 inherent in this form of accountability. You described 22 that in the preceding paragraph. 23 On the one hand, you say, it is impossible and 24 certainly undesirable for the NHS Executive to monitor 25 the treatment of individual patients or patient groups. 0004 1 Can you help us a little further on what you mean 2 by "certainly undesirable"? 3 A. I mean by that that there are probably 400,000 people in 4 the National Health Service providing clinical services 5 on a day-to-day basis to 50 million people in the 6 population of England, sometimes dealing with the most 7 sensitive and difficult of personal issues. It would be 8 impossible in terms of pure scale for the NHS Executive 9 to be involved in that process and it would be, I think, 10 a breach of the relationship between these clinicians 11 and patients if they were to be so involved in these 12 individual relationships between patients and clinical 13 staff. That is what I mean. 14 Q. So by "undesirable" you are referring to the 15 doctor/patient relationship, its confidentiality, and 16 would this be a further strand: the clinical freedom 17 exercised by doctors within that relationship? 18 A. Yes. "Clinical freedom" is not a phrase I have heard 19 for a very long time in the National Health Service but 20 I think there is a relationship of trust and of 21 confidentiality between patient and doctor that should 22 not be breached. 23 Q. Help us a little further on why the phrase "clinical 24 freedom" is disappearing from the vocabulary. First of 25 all what is the chronology in the change in its use? 0005 1 A. I would think the chronology is to do with the review 2 and sometimes the audit of medical practice from the 3 late 1980s and through the 1990s. It is to do with the 4 increasing tendency, both in the hospital services and 5 general practice, for doctors to combine their 6 management responsibilities with clinical 7 responsibilities. It is to do with a tendency certainly 8 very current in the last two or three years of setting 9 clinical standards at a national level from the 10 Department of Health in conjunction with professional 11 associations and Royal Colleges, and the like, and 12 holding people accountable for putting in place systems 13 to ensure that these standards are met. 14 So I think we are seeing a change and I think we 15 have seen, through the work of the GMC and others, 16 a change in the professional accountability of doctors 17 over a period of, say, 10, 15 years. 18 Q. So there is a shifting agenda and it is one that is 19 fashioned of a number of strands, some of which you have 20 just outlined to us. Do you think that the change in 21 the vocabulary is something which is happening primarily 22 at a policy-setting level involving as it were the 23 leaders of professions, or do you think that that is 24 something which is fully reflected on the ground, as it 25 were, as well? 0006 1 A. I think it is increasingly reflected on the ground. 2 I think professional bodies have shown, certainly over 3 the last few years, a determination to reform. I think 4 there had been some very significant policy changes in 5 that direction, but all of these things, I believe, are 6 driven by the public will and both the Department of 7 Health and I think the regulatory bodies have 8 a responsibility to protect the interests of the public 9 in all that they do, and I think the public mood is 10 towards greater accountability in all things, especially 11 services provided in the public sector. 12 Q. If we could look first at one strand of accountability, 13 and that is the accountability of Trusts from 1991 14 onwards through the Department of Health and the 15 Secretary of State. If we could turn to page 5 of your 16 witness statement and to the first paragraph there where 17 you are coming to the end of the description of the 18 changes made in Working for Patients in the 1989 White 19 Paper, you come to a description of the establishment of 20 NHS Trusts. You say at the end that the Secretary of 21 State had no power to direct NHS Trusts in respect of 22 the services they provided. 23 Firstly, the members of the Trust Board and in 24 particular the Chairman, were appointed, were they not, 25 by the Secretary of State? 0007 1 A. That is correct, and the Secretary of State, while 2 having no powers to direct Trusts in the way at that 3 time that he would direct health authorities, and that 4 would be the contrast I would make, did, however, have 5 powers to remove the Trust Chairman or the Trust 6 Chairperson and members of the Trust Board. 7 Q. On specified grounds? 8 A. On specified grounds. 9 Q. Were those grounds linked to the financial performance 10 of the Trust or were they more widely framed? 11 A. I could not remember offhand what the legislation says, 12 but certainly the interpretation on the rare occasions 13 when this in my experience happened was drawn more 14 widely than just financial failure. 15 Q. More widely so as to encompass what factors? 16 A. In my experience of this, to encompass factors like the 17 breakdown of the relationship between the non-executive 18 group, the managers and sometimes the clinical staff in 19 the hospital. In other words, where relationships 20 became dysfunctional to the point at which they impeded 21 the proper work of the Board. 22 Q. You mentioned that that happened on rare occasions? 23 A. Yes. 24 Q. Are you able to help us as to the number of occasions 25 that the Secretary of State invoked that power from 1991 0008 1 onwards? 2 A. I can remember it happening once in relation to 3 a Regional Health Authority; I can remember it happening 4 once in relation to an NHS Trust. I cannot remember if 5 it is the 1970s, I suspect it is late 1970s rather than 6 early 1980s, but there was of course a case where the 7 then Secretary of State removed the whole board of 8 a health authority -- the NHS Trusts did not exist at 9 that time. So the power to intervene by removing Board 10 members is something that has been used rarely over the 11 years. 12 Q. In relation to Trusts specifically, you can remember one 13 instance of it? 14 A. I can recall one, at the very edges of my memory maybe 15 two, but I will say one to be safe. 16 Q. Are you able to help about the guidance given to Trust 17 Board members at the time they took up appointment? 18 A. I cannot give you a reference, but there was a blue 19 booklet which set out the roles and responsibilities of 20 NHS Trusts and set out the basis upon which they would 21 be monitored by the Department of Health and I can 22 certainly reference that for you and send you a note on 23 that subject. 24 Q. That would be of assistance, because I think we have 25 seen guidance that was issued in 1993 to Trust Board 0009 1 directors specifically. 2 A. Yes. 3 Q. But if you are able to provide us with the booklet that 4 was issued in 1991, that would be helpful. 5 A. I could not say that the date would be 1991, but it may 6 be. The main source of guidance in 1991, as Trusts 7 moved to the first wave, would be a series of working 8 papers developed in the wake of the 1989 White Paper 9 "Working for Patients". 10 Q. How would you describe the time? Was it a time when 11 there were clear guidelines on how Trusts were to 12 develop, or was it rather a time of experimentation and 13 innovation, if one is to put those at two ends of an 14 opposite spectrum? 15 A. It was in the middle of the spectrum. It was a time of 16 change and turbulence. As I remember it, only 59 Trusts 17 existed in the first wave, i.e. from 1991 to 1992 18 onwards, so we were running at that time a sort of mixed 19 economy where some hospitals were Trusts and some were 20 directly managed by the health authorities. In other 21 words, they were part of the pre-1991 arrangements 22 before taking on Trust status. 23 It was certainly a time where there was a very 24 good Trust development team in the Department of Health 25 at that time and there were quite precise notions about 0010 1 the roles and responsibilities of Trusts and how they 2 would function in the arrangements set out in the 1990 3 Act. 4 Q. You have spoken about the use of the power to remove 5 directors -- 6 A. Yes. 7 Q. -- in case of dysfunctional Trusts, and told us that the 8 understanding of the Secretary of State's powers went 9 wider than purely financial mismanagement? 10 A. Yes. 11 Q. What would have been the Secretary of State's 12 understanding of his or her power to direct or guide 13 a delinquent Trust, as it were, which was in trouble not 14 because of financial mismanagement but because of the 15 quality of the services which it was providing? 16 A. The Secretary of State, in legislation, had no power to 17 direct such Trusts, but would seek to influence these 18 Trusts and would use the team that supported him or her, 19 the management team, to exert that influence. So whilst 20 there was no direct power, there was very strong central 21 influence where things were going wrong and, indeed, in 22 some cases -- I cannot tie them to cases where there was 23 a breakdown in the quality of care provided but in some 24 cases there was quite a direct intervention. In other 25 words, the various Secretaries of State through that 0011 1 period would err on the side of intervention. 2 Q. What sort of factors did then trigger that intervention? 3 A. I think factors -- first of all I should probably say 4 I think these interventions were few and far between, 5 not least because if we are talking about the sort of 6 1991 to 1993 period, a relatively small number of 7 hospitals or other units had been Trusts, and they had 8 been carefully chosen because they had expertise and 9 systems that had developed in advance of others that 10 were not chosen. 11 So by definition, they were more competent perhaps 12 than some others, but where intervention did take place, 13 it was often in relation to service change where there 14 had been public concern, for example, about the closure 15 of an outpatient clinic or the closure of wards. It 16 might have come if we were suspecting persistent failure 17 against some of the numerical targets that existed at 18 that time, for example in relation to finance or waiting 19 lists. 20 Q. So what levers would the Secretary of State use by way 21 of influence to intervene? 22 A. The Secretary of State at that time -- again, if we are 23 talking of that period, in the early 1990s, perhaps it 24 is important at this point to confirm that at that time 25 I was in a Regional Health Authority -- would often ask 0012 1 the Chair of a Regional Health Authority or indeed the 2 Regional General Manager to intervene. There was, 3 I must say, sometimes some confusion about that in that 4 mixed messages emerged from the Department of Health. 5 On the one hand there was a clear signal that we should, 6 from a regional perspective, have a definite hands-off 7 approach in relation to Trusts. On the other hand, we 8 would be expected from a regional level to pick up the 9 pieces if something was going wrong. So that was a time 10 of rather confused accountabilities in that regard. 11 Q. Because the Region, surely, had no more formal powers 12 than the Department of Health possessed? 13 A. That is correct. 14 Q. If the lines of accountability were financial from Trust 15 to Department of Health? 16 A. Yes. 17 Q. And from purchasers to Trust? 18 A. Yes. 19 Q. The region had no greater powers than the Department? 20 A. There was no line management relationship, or any 21 relationship of accountability between NHS Trusts and 22 Regional Health Authorities. 23 Q. So what was the source, then, of the authority for any 24 regional intervention? 25 A. The source of authority was one of influence. The 0013 1 regions did have some levers: for example, as it says 2 later in my statement, they were responsible for 3 resource allocation. They were responsible for deciding 4 at that time on the priorities of certain aspects of 5 capital investment. They very often had long-standing 6 relationships with the people who were in the chair or 7 who had been appointed as Chief Executives of these 8 early Trusts, and one can look at this positively and 9 say it was certainly the case at that time that whilst 10 there was no line of responsibility, Trusts would very 11 often look to regional health authorities for advice, or 12 not so much to the body itself, but to individuals 13 working in the regional health authority for advice and 14 guidance on difficult issues. 15 Q. So their authority might come not so much from the 16 formal powers that they had at their disposal, but from 17 a long-standing relationship and also their 18 understanding of the regional position? 19 A. The powers came from their expertise, in the sense that 20 on occasions they were talking on behalf of the 21 Secretary of State, and from their ability to influence 22 certain crucial processes. 23 THE CHAIRMAN: Miss Grey, may I intervene for a moment? You 24 mentioned there that one of the levers was related to 25 capital investment. 0014 1 A. Yes. 2 Q. Could it be a possibility that the Region would, for 3 example, hold back or not encourage a capital investment 4 if it thought a particular Trust was not performing as 5 it should be? 6 A. I can think of no example where a Regional Health 7 Authority deliberately held back capital monies to 8 somehow penalise an errant Trust, but where a Regional 9 Health Authority might have been trying to influence -- 10 if you remember, this is a period of transition -- the 11 pattern of services in a particular part of the country, 12 it may have been taking advice from health authorities, 13 from general practitioners, from others on the regional 14 medical networks that ran counter to the views of the 15 Trust about capital investment or expenditure of that 16 nature. 17 MISS GREY: If we could go on, please, to the top of page 5, 18 we were looking at that particular sentence, no power to 19 direct NHS Trusts in respect of the services they 20 provided. You mentioned that during the earlier period, 21 1991 to 1993, this was perhaps a confused period in 22 terms of accountability? 23 A. Yes. 24 Q. By the time you took over responsibility, say in early 25 1994, had lines of accountability clarified in any way? 0015 1 A. Let me just double back. When I say it was a confused 2 period, I think it would be confused to the people who 3 were not working in the system, as it were. People who 4 were running health authorities and who retained direct 5 responsibilities for hospitals and community services, 6 people who were working in family health services, 7 authorities, people who were working in the new Trusts, 8 would not be confused about their accountability, but my 9 simple point was that the system was in transition. 10 When I took up post on 1st April 1994, we were 11 going through another cycle of change and I had been 12 party to that. I mention in my evidence that a Working 13 Group under the title of the Functions and Manpower 14 Review led by Kate Jenkins had been thinking about the 15 structure and functioning of the Health Service during 16 1993, and I was in fact part of that group. In other 17 words, the prelude to my taking up post as Chief 18 Executive was to be involved in that -- I think at the 19 time really quite significant study of the top 20 management arrangements in the NHS, which ultimately led 21 to the 1996 Act, the abolition of regional health 22 authorities, the integration of district health 23 authorities and family health services authorities. 24 So that work had been done in 1993; it was under 25 discussion during 1994 and led to legislation in 1996, 0016 1 so yet again, we were in a period of transition. 2 The other point I would make about the period from 3 1st April 1994 -- I do not have the number to hand but 4 of course a great many more groupings of health 5 services, hospitals and community services, had become 6 Trusts at that point, so it was much more the normal way 7 of operating, so that the focus from that period onwards 8 was in sorting out the top management of the Health 9 Service, the NHS Executive and the Regional Health 10 Authorities, which later became the regional offices, on 11 integrating the district health authorities and the 12 family health services authorities. That was the focus 13 of management attention at that time. 14 Q. I am not quite sure whether you have answered the 15 question, in that I am seeking to press you on whether 16 lines of accountability would have been clearly 17 understood, say at the Trust level. Do you think they 18 would have been at that stage? 19 A. I think they were very clearly understood at the Trust 20 level. People understood the statutory basis of 21 a Trust. They understood the management relationship 22 with the Department of Health. They understood the 23 parameters on which Trusts would be monitored. So my 24 direct answer to your question is, yes, people working 25 in the system would be very clear about the lines of 0017 1 accountability. My explanation, I think, was intended 2 to show you that yet another wave of change was 3 unfolding and as it unfolded a number of new initiatives 4 were taken which influenced the way in which Trusts 5 operated. 6 Q. If we can just look briefly at one of the documents that 7 was produced during that period of examination and 8 change, this is "Managing the New NHS", which I think 9 would have been produced in October 1993. If we could 10 look, please, at the first page, HOME 2/174, that, 11 I think, must be something you are well familiar with? 12 A. Yes. Less so than I was at that time. 13 Q. If we could go to page 202, there is a statement there 14 or a summary of the requirements, the accountability 15 arrangements for NHS Trusts? 16 A. Yes. 17 Q. That is couched in financial terms, in the primarily 18 financial accountability arrangements which have been 19 described there? 20 A. Yes. 21 Q. Is that the limit of the information the Trusts were 22 required to report back to the Department of Health by 23 the Regions? 24 A. That was the technical position, the position in law, if 25 you like. Just in passing, the document that is 0018 1 mentioned on the first line there, "NHS Trusts - 2 a Working Guide" is the blue booklet I referred to 3 earlier, which would have set out these terms, the 4 financial parameters and the rest of the sentence, in 5 some more detail. 6 Q. If that is the letter of the law, in practice was it 7 given a wider interpretation and understanding, or not? 8 A. In practice it was given a wider interpretation because 9 the Health Service, as ever, was having to cope with 10 change; it was having to cope with structural change, 11 for example, and just to give you one very significant 12 example from that period, there was ongoing a very 13 detailed study of the pattern of health services in 14 London and that was a study that was driven by the 15 Department of Health, by the NHS Executive at that time, 16 and by the Secretary of State. It required the Trusts 17 who were part of that study right across London to be 18 providing information to be expected to have been 19 studied in much more detail than just these few 20 financial parameters set out in paragraph 50 on this 21 page. 22 Q. What would you understand to be the primary 23 responsibility of members of a Trust Board? Was it to 24 meet the criteria set out in this paragraph, or did 25 their duties go wider? 0019 1 A. It was to meet the criteria set out in this paragraph, 2 but I think in reality they had wider responsibilities. 3 They were expected to behave as part of a single 4 National Health Service. If I can give you some 5 examples, they were expected to pursue national 6 priorities and planning guidance produced by the 7 Department of Health; they were expected to work to 8 comply with patient charter standards and during the 9 period, I guess, 1992 to 1995, they were expected to 10 operate to a series of codes. This was a time when the 11 question of corporate governance was a controversial 12 issue in the country as a whole and based on the work of 13 the Cadbury Committee, there was work carried out -- 14 very important work, I think -- on the Health Service 15 which resulted in the production of codes of openness 16 and accountability. So each Trust was expected to 17 establish a system of corporate governance, which of 18 course now has echos in the way in which we define 19 clinical governance, which included audit committees and 20 required them to have standing financial instructions to 21 a certain format, required them to produce annual 22 reports, required them to engage in quite a detailed 23 system of internal and external audit. 24 Q. Suppose we narrow it down to a specific example of 25 a Trust Board which is receiving reports or hearing 0020 1 rumours of difficulties with a particular service or the 2 quality of that particular service, but this is an 3 example in which the Health Authority in question has 4 not laid down any contractual standards for the quality 5 of that particular service, which may be realistic. 6 What would be the source of the obligation, if 7 any, on the Trust Board to investigate that particular 8 matter, given that it does not engage a contractual 9 issue with the purchaser? 10 A. There is absolutely no doubt in my mind -- whether 11 I could tie it to a specific part of legislation or 12 whether I could find a phrase in the establishment 13 orders of Trusts that allow me to say this, I am not 14 very sure, but there is absolutely no doubt in my mind 15 that they would have to deal with that issue properly 16 and effectively. I would go as far as saying that in my 17 experience, at that time, it would be a matter of public 18 duty to ensure that the services that were being 19 provided were safe and effective. I have no doubt about 20 that and I think that has been essentially the position 21 in the Health Service since 1948. 22 Q. So there would not necessarily be any need to rush 23 around finding a particular guidance letter or terms of 24 an establishment order to create a common understanding 25 on the members of the Trust Board that part and parcel 0021 1 of their responsibility would be to ensure that health 2 care provided in hospital was safe and adequate? 3 A. That is my view. Can I just add one point, because that 4 is a view based on specifics. I think it is very 5 important in thinking about the regime at that time to 6 recognise that another of the things that happened in 7 the 1990 Act was the development of a relationship 8 between the Audit Commission and the National Health 9 Service and, indeed, something called the Clinical 10 Standards Advisory Group and the National Health 11 Service. So the Audit Commission were carrying out 12 value-for-money studies, but studies that often strayed 13 into quite complex clinical areas at that time. The 14 Clinical Standards Advisory Group, perhaps a precursor 15 to some of the changes we see now in the health service, 16 were beginning to carry out studies which began to raise 17 generic problems in the way care was provided in the 18 Health Service. I have absolutely no doubt that a Trust 19 Board functioning properly at that time would be taking 20 that good practice on board as part of their normal way 21 of working. 22 Q. If we look back at the paragraph, paragraph 50 of the 23 document on display here, would it be right to think 24 that Trusts were required to report to regional outposts 25 in the terms of the information contained within that 0022 1 paragraph? 2 A. That is right. 3 Q. And would their reporting obligations to those outposts 4 have trespassed or been any wider than that? 5 A. The people who were running the outposts were 6 responsible to or accountable to the Financial Director 7 in the NHS executive, as it then was, from 1st April 8 1994 onwards, the Management Executive before that. 9 Q. So were they solely then, as it were, a financial arm of 10 the Department of Health, or were their interests and 11 obligations wider than that? 12 A. They were essentially a financial arm. They were very, 13 very small groups of people. Just to put this in 14 context, there were seven outposts and each outpost 15 probably employed something like 8 to 10 people and the 16 contrast there would be, for example, with the prior 17 relationship with the Regional Health Authority, which 18 may, you know, at their peak have employed 500 or 700 19 people. So there was a very small group of people 20 monitoring some very specific measures in Trusts, and 21 given that there were seven outposts and probably 22 upwards of 300 Trusts at that time, each having 23 responsibility over a wide geographical area for about 24 50 Trusts, so this was not a detailed process of 25 inspection, review or scrutiny; this was a rather 0023 1 mechanistic measure against the parameters set out in 2 paragraph 50. 3 The only additions I would make to that is that 4 I think they were probably tracking some of the higher 5 profile national objectives. They would be looking 6 perhaps at performance on waiting lists; they would 7 certainly be advising and sometimes supporting the 8 Trusts in handling the process of capital investment and 9 capital development that I was talking with you and to 10 the Chairman about earlier. 11 Q. If we go back to your statement, WIT 335/9, please, and 12 paragraph 26, you describe there a change from 1995 13 onwards, in that all Chief Executives of NHS Trusts and 14 health authorities had been designated as accountable 15 officers and they are answerable to Parliament through 16 you for the efficient and proper use of the resources in 17 their charge, and in cases of serious management 18 failure, they would be expected to accompany you to 19 answer personally before the Public Accounts Committees. 20 That continues the focus of responsibility of 21 Trusts to the Department of Health and then upwards to 22 Parliament, being primarily a matter of reporting for 23 the efficient use of resources and financial matters. 24 Is that an emphasis that you intended to give, or is 25 that merely a reflection of a particular issue being 0024 1 addressed in that part of your statement? 2 A. I think that is the impression I intended to give and 3 the phrase "the efficient and proper use of resources" 4 is intended to mimic, if you like, at that local level, 5 my responsibilities at a national level as the 6 accounting officer for the NHS, so that we were trying 7 to localise that process. Bluntly, we were trying to 8 give ourselves an additional management lever. The 9 punch-line, perhaps not included in this paragraph, is 10 that if a Trust Chief Executive or indeed a health 11 authority Chief Executive, or soon the Chief Executive 12 of a primary care Trust when they exist, fails to 13 discharge their duty in a way that is not giving rise to 14 efficient and proper use of resources, I can effectively 15 remove the accounting officer responsibility from them, 16 which, in my book, means they will be unable to function 17 effectively in that job. 18 So this was a means of tightening up accounting 19 responsibility, and, if you like, overcoming the 20 difficulties of operating in a big, distributed system 21 where there is no clear line management responsibility. 22 Q. If we stay with the matter of what your understanding 23 would be throughout this period of the responsibilities 24 of Trust Board members to deal with allegations or 25 issues of the quality of clinical care or safe practice, 0025 1 we have heard the view expressed to the Inquiry that 2 a Trust, as the employer of a consultant, had the 3 primary or direct responsibility to act if allegations 4 of poor performance or poor clinical judgment were 5 made. On the other hand, others have responded that the 6 responsibility on the management of the Trust -- one can 7 perhaps trespass rather broader than Trust Board and 8 include a CEO, for instance, or other senior management 9 figures -- for dealing with such problems lay rather 10 with various professional bodies, whether one is talking 11 about the Royal College of Surgeons in the case of 12 surgical performance, or the General Medical Council, to 13 identify, to act on such problems of professional 14 judgment and that if there were so, the duty of senior 15 management or Trust Board would be limited rather to 16 drawing it to their attention, but that the freedom of 17 clinicians prevented any more effective or direct action 18 from being taken. 19 What would your view be on that circle of 20 responsibility which is there being described? 21 A. I do not think I accept that interpretation. It is 22 certainly very clear, and I am sorry I cannot reference 23 it for you. I probably could, if I search through my 24 notes, but there is guidance -- 25 Q. Can I just interrupt you for a moment, in that you say 0026 1 you do not accept "that interpretation". I think I was 2 putting two hypotheses to you, or two views. Which one 3 were you responding to, or perhaps both? 4 A. Perhaps you could just summarise the question again, if 5 I got it wrong. 6 THE CHAIRMAN: It was about the response to poor 7 performance: was it for the Trust Board and its Chief 8 Executive, or was it as some would say a matter for the 9 professional bodies with which the Trust Board entered 10 with trepidation? 11 A. I did get the question clear in my head. There is no 12 doubt in my mind that the Trust Board had responsibility 13 in both areas, and I think the words that are used in 14 the guidance are "personal conduct" and "professional 15 conduct". Sometimes the boundary between the two is 16 very difficult to establish. It was sometimes the case 17 that the Trusts had in place locally agreed policies, 18 disciplinary policies, essentially, or policies for 19 dealing with poor performance that had these two 20 elements to it. Personal conduct and professional 21 conduct. And I can remember these cases during this 22 period of change. 23 In other cases where a Trust Chief Executive felt 24 unable to handle a very difficult or sensitive area of 25 professional conduct, he would often, as I said in my 0027 1 evidence earlier, not draw on the Regional Health 2 Authority or the regional office because of the 3 statutory position of that body, but draw on the 4 expertise there. There were people who, by that time 5 I think they were probably called Regional Directors of 6 Public Health who had been Regional Medical Officers who 7 would have handled these very difficult employment 8 issues in the past, but I have absolutely no doubt 9 whatsoever that Trust Chief Executives should not have 10 limited their intervention solely to matters of personal 11 conduct that they were quite at liberty to tackle issues 12 of professional conduct; they might do with advice. 13 They would certainly have to take on board the possible 14 requirement to refer a particular issue or a particular 15 case to the General Medical Council, so there was 16 a professional dimension to this. 17 I think it is also fair to say that some people 18 found that process a very difficult thing to deal with, 19 the process was often long drawn out and legalistic, and 20 still is, and indeed, it is something that we are 21 looking very carefully at, at this moment. I have known 22 these cases, which perhaps have resulted in suspension 23 and disciplinary action and appeal, to go on for a very 24 long time, certainly many months and sometimes years, 25 and I do not think that is an acceptable position, and 0028 1 it is something that we are looking at very carefully at 2 the moment. 3 Q. Because if we look, please, at HOME 1/221, this is the 4 circular HC(90)9. 5 A. You could have told me and I would have remembered. 6 That is exactly the one I was referring to. 7 Q. I rather assumed it was, because you spoke in terms that 8 reflected its content. 9 A. Yes, but I could not remember the number! 10 Q. This is dated, of course, March 1990, so it is 11 a pre-Trust piece of guidance. 12 A. Yes. 13 Q. If we go, please, to page 226 we can see there, if we 14 scroll down a little, that there were broadly three 15 types of cases which may involve medical or dental staff 16 and those include both professional conduct and 17 professional competence cases? 18 A. Yes. 19 Q. If we go down a little, please, we can see that they are 20 cases involving professional conduct and professional 21 competence, how they are dealt with. The circular at 22 that stage envisaged that the Chairman of the Health 23 Authority would need to decide whether there was a prima 24 facie case? 25 A. Yes. 0029 1 Q. Presumably, post 1991, the role of the Chairman of the 2 Health Authority would be replaced by action by whom? 3 A. By the Chairman of the NHS Trust. 4 Q. He has to -- 5 A. In cases where NHS Trusts existed. Of course some 6 health authorities would still have these residual 7 management responsibilities. 8 Q. I am positing the example of the Trust in all these 9 cases. He may need to have an investigation conducted 10 in order to decide whether there is a prima facie case 11 and the mechanism envisaged here is that the 12 investigation would be placed in the hands of either the 13 Regional or the District Director of Public Health on 14 behalf of either the Regional or District Health 15 Authority? 16 A. Yes. 17 Q. Whichever would be the appointing authority? 18 A. Yes. 19 Q. That mechanism enabled an investigation to be carried 20 out by persons who were not directly attached to the 21 hospital in question? 22 A. That is right. 23 Q. Do you think that the mechanisms which were set up after 24 1991, again looking at the Trust example, were 25 satisfactory replacements for that procedure? 0030 1 A. There is one area that I am slightly struggling with 2 here and that is the sentence which says the decision 3 which is reached should be in the hands of the Regional 4 or District Director of Public Health on behalf of the 5 Regional or District Health Authority. The 6 interpretation of the 1990 guidance on these issues 7 would vary quite considerably, depending on what point 8 of time we were between 1990 and 1996, and it was, as 9 I remember it, sometimes the case the Regional Health 10 Authority is mentioned because they were the primary 11 employers of consultant staff, and it was sometimes the 12 case during that period that consultants who were 13 working on Trusts, as I remember it, retained their 14 employment authority as the Regional Health Authority 15 and only lost that at the point at which the regional 16 health authorities were abolished from 1st April 1996. 17 The reference to the District Director of Public 18 Health is something of a red herring here, I think, 19 because that really only applied to people who were 20 employed either in the public health specialty or as 21 community-based doctors, child health doctors and things 22 like that, at a community level, a very low number of 23 people. 24 The real point here would have been to determine 25 whether the consultant concerned was an employee of the 0031 1 NHS Trust or, as part of a transitional arrangement, 2 still the employee of a Regional Health Authority. 3 In the second case, the example I referred to, the 4 Trust Chief Executive would have been working in 5 conjunction with the Regional Director of Public Health 6 to deal with the matter. In the former case, where 7 a consultant was maybe a Trust appointment, as some new 8 consultants were, and indeed some who had changed their 9 terms of employment, the matter would have been dealt 10 with by the Trust Board. For "Health Authority" in that 11 sentence you would read "NHS Trust". 12 Q. Perhaps we could just carry on over the page, to give 13 the full context of the sorts of investigation that are 14 considered may take place, because we see that there is 15 an initial investigation envisaged by the Regional or 16 District Director of Public Health, but then if we 17 scroll down, if there is a prima facie case established 18 or considered to have been established, the practitioner 19 is notified and then there is provision made for 20 proceeding to an Inquiry. There is further detail given 21 in the remainder of the circular, but what one can see 22 from paragraph 7 is that nobody involved in the hospital 23 in question would be made part of that Inquiry team? 24 A. That is right. I am not sure I am absorbing this as 25 quickly as I should from the text. We can come back to 0032 1 the text if necessary, but my memory is that the inquiry 2 team was made up of specialist sources of advice, if you 3 like, they were nominated by the Joint Consultants 4 Committee and the appropriate Royal Colleges. 5 Q. The fault is mine, because I should have referred you to 6 paragraph 8 in any event. What I was paraphrasing 7 rather than quoting, if we scroll down a little, please, 8 is the phrase "no member of the Panel should be 9 associated with the hospital in which he works, or in 10 the case of a doctor, in public health medicine or the 11 community health service in the authority in which the 12 practitioner concerned works". Then one sees further 13 detail. 14 The point I was seeking to put to you was that 15 there is a mechanism which gives to the person 16 conducting the inquiry the ability to draw on a number 17 of sources of expertise and provides that they should 18 not be located within the hospital in question. 19 If we take the example of a Trust where the 20 contracts are held by the Trust in question, and so the 21 Region or the District has no formal involvement as an 22 employing authority, do you think that the systems that 23 were set up in such Trusts were adequate substitutes for 24 the mechanism set out in this guidance? 25 A. I do not think I could say with any certainty what the 0033 1 systems were. I can see clearly the strengths of this 2 system in that it has a strong element of expertise and 3 independence. I think there is another side to this 4 coin, whoever. Normally when this issue is discussed 5 with me, I am being criticised because this is thought 6 to be terribly medically dominated; it is thought to be 7 a very legalistic process, one that requires 8 determination from the employing authority to see it 9 through, and indeed we have had in the past gross 10 examples of delay in setting up these panels and 11 providing the right group of experts and all the rest of 12 it which has slowed the whole process down. 13 I think it is worth saying in that context, and 14 indeed in relation to this whole issue, that I am sure 15 somewhere else in this guidance it makes clear that if 16 there is at stake a clear question of public safety, 17 there is a route by which the doctor concerned, the 18 consultant concerned, be suspended. 19 Q. I think what I am seeking to explore with you is what 20 your understanding is of the relevance of this guidance 21 to Trusts after 1991. What applicability did it still 22 have, and was it adequate guidance? 23 A. I think that is complicated in the way I have 24 suggested. I am not trying to make this more difficult 25 than it is, but I think a lot depends on the point at 0034 1 which employment responsibility transferred essentially 2 from the Regional Health Authorities to the Trusts. 3 I think this in many ways is a sound piece of 4 guidance, and I think I could mount an argument that 5 says that any Trust worth their salt would want to 6 include these sort of elements in their approach. They 7 would want it to be fair, they would want it to be firm, 8 they would want the power of suspension, they would 9 certainly not want to tackle issues directly that were 10 outside their own area of expertise. Equally, I think 11 this guidance as it currently stands, this 1990 guidance 12 as it currently stands in 1999, is not really fit enough 13 for the purpose, and it is being thought through at the 14 moment in terms of trying to ensure some streamlining 15 and improvement. 16 THE CHAIRMAN: I have one question, Sir Alan, just going 17 back to the first page of this. When you were talking 18 a while back, you contrasted what you described as 19 "personal conduct" with "professional conduct". 20 A. Yes. 21 Q. This document has three categories: personal conduct, 22 professional conduct and professional competence? 23 A. Yes. 24 Q. Were you including in "professional conduct" both the 25 notion of whatever conduct may be and competence? 0035 1 A. I think I was. I was drawing from memory and I am sure 2 somewhere later, maybe in an appendix, these three 3 things are accounted for, but the distinction I always 4 make in my mind is, you know, personal conduct may be 5 absenteeism or pinching petty cash. Professional 6 conduct or professional competence is about the 7 treatment of patients, about communications with 8 patients, about keeping good medical records; it is 9 about acting in the patient's interests at all times. 10 Q. When you talked about how you would regard it as part of 11 the Trust's responsibility to take account of 12 professional conduct, you were not intending to exclude 13 professional competence? 14 A. No, I was not. 15 MISS GREY: Would it be right to take from your previous 16 answer, the fact that this guidance has not been updated 17 since 1990, firstly? 18 A. I am sorry? 19 Q. It is right that this guidance has not been updated 20 since 1990? 21 A. It is correct that it has not been updated. I think 22 there have been some adjustments to the system which 23 have been designed to speed up the process. For 24 example, I see every six months, personally, a list of 25 current suspensions and I ask questions if I think there 0036 1 is an undue delay in these, because I think that can be 2 to the detriment of the individual involved and to the 3 detriment of the service. I think throughout all of 4 this, one wants to balance the responsibilities of the 5 individual and the responsibilities of the requirements 6 placed on employing authorities. 7 The other thing that it is terribly important to 8 balance, and I do not want my answer on professional 9 conduct and competence to be interpreted as a sort of 10 hard-nosed question of employment practice: of course it 11 is important in all of these things to balance the 12 relationship between the employing authority and the 13 appropriate regulatory authority, so I do not intend my 14 comments in any way to diminish the role, for example, 15 of the GMC or the UKCC in relation to nursing in dealing 16 with these issues of professional conduct. 17 My simple point is that actual cases very often 18 contain all of these elements, intermingled in the most 19 complex way, and I think everyone has a distinctive role 20 to play in sorting that out and that includes the 21 employer. 22 Q. Do you think that employers were given adequate guidance 23 in the years from 1991 to 1995 in how to handle cases 24 involving professional conduct and professional 25 competence, in particular, after the transition to Trust 0037 1 status and a shift in holding of contracts at least for 2 some Trusts? 3 A. I think the transition, as I have tried to explain, 4 mainly took place in 1996 on the abolition of the 5 regional health authorities, where the employment 6 relationship between consultant staff and regional 7 health authorities broke down. So if your question was 8 rephrased to say "Did people receive adequate guidance 9 at that point?" I would say in retrospect, no. I do not 10 think this guidance is good enough, nor has it proved to 11 be good enough over the last couple of years, which of 12 course is why we are currently looking at it. 13 Q. If we could look, please, at WIT 351/1, this is the 14 statement of Sir Duncan Nichol to the Inquiry. If we go 15 down a little, we should see a description of the NHS 16 Trusts and NHS outposts. There is a sentence beginning: 17 "NHS Trusts were introduced from April 1991 ..." 18 Do you have that? 19 A. Yes. 20 Q. Then it continues: 21 "NHS ME outposts monitored Trusts to ensure they 22 were meeting their financial obligations." 23 A. Yes. 24 Q. I would ask you perhaps to read through to the end of 25 that paragraph. We have touched on this already in your 0038 1 evidence, but would you agree with that as an accurate 2 summary of the role of the outposts, their activities? 3 A. Yes, I would, and I think the important element that 4 I missed out when I was talking about this was the 5 review of Trust business plans, although they were at 6 the very early stage of development through that period, 7 but I think that is pretty accurate, yes. 8 Q. The regional outposts, the NHS ME outposts, were 9 abolished as part and parcel of the changes that 10 culminated in legislation in 1996, so I think that their 11 abolition was foreshadowed by the Jenkins report, or 12 suggested by that. 13 A. To say they were abolished suggests they were statutory 14 bodies. They were not. They were not abolished; their 15 work was integrated into that of the new offices. In 16 some ways they were the precursors to the model of the 17 new offices. They had no basis in legislation. They 18 were as the word says, outposts of the NHS Management 19 Executive. They were part of the NHS Management 20 Executive based in several different parts of the 21 country. 22 Q. So what was the verdict on their effectiveness and 23 performance? 24 A. The verdict on their performance was in the areas for 25 which they had responsibility, set out in the 0039 1 paragraph from Duncan Nichol's statement and what I have 2 been saying, they were really quite effective. Trusts 3 liked them a great deal and contrasted the hands-off 4 approach with the rather bureaucratic approach of the 5 regional health authorities. The whole point about 6 regional offices was perhaps to work towards a more 7 rounded approach to the management and performance of 8 the Health Service, but to retain some of the really 9 quite shrewd lessons that were learned from the outposts 10 during that period, and the people in these jobs at that 11 time built up some very specific expertise which is now 12 part and parcel of the regional office roles. 13 Q. If we go back, please, to HOME 2/174 -- 14 A. Can I make one other point, perhaps? It is just 15 a contextual point, to make the point that by having the 16 outpost on the one hand and the Regional Health 17 Authority's fledgling regional offices on the other 18 hand, the attempt was being made to mimic the separation 19 of purchaser and provider responsibilities in the NHS. 20 The crucial point about this document which is now on 21 the screen is that that brought them together again in 22 one place. 23 Q. What was it envisaged, then, to take that a bit further, 24 would be the benefit of bringing that expertise back 25 under one roof rather than maintaining the 0040 1 purchaser/provider split? 2 A. I think the benefits or the perceived benefits were 3 two-fold: one that we would adopt a much more coherent 4 approach to the planning development and control of the 5 NHS -- these in the document you are showing there would 6 be the key words in that document, the key 7 responsibilities of the regional offices were to plan, 8 develop and control the Health Service. 9 I can remember a period in 1993, before this 10 integration took place, where to solve a problem that 11 crossed institutional boundaries, maybe boundaries of 12 different health authorities, different Trusts, and 13 maybe at that time some GP fundholders, you had to have 14 a great army of people in the room to set about what was 15 a rather simple problem. I thought that was not a very 16 good way of doing things and I was very supportive of 17 the notion of streamlining the top management of the 18 Health Service, which reduced in that period in scale. 19 If you take the outposts of the regional health 20 authorities and the NHS Management Executive together, 21 in the early 1990s a group of about 9,000 people to 22 a group that is now substantially less than 2,000 23 people. 24 So there was a real attempt to get smarter in the 25 top management of the Health Service. 0041 1 Q. If we could go to 183, please, of this document. We can 2 see there that the present changes are designed to 3 ensure or assist in achieving a number of objectives. 4 If we scroll down, please, we can see that the last 5 bullet point is that "The continued development of the 6 purchasing function and greater use of Trust management 7 freedoms will create further incentives to improve 8 quality and ensure efficient use of resources." 9 The reference there to "use of Trust management 10 freedoms": what had been the experience by the date of 11 this document -- October 1993 -- in the use that Trusts 12 had made of their management freedoms, particularly in 13 their freedom to develop and to promote capital 14 projects? 15 A. I think, if you do not mind, I go wider than capital 16 projects, because I think the balance sheet here is 17 pretty interesting, because my sense is that there were 18 merits in local Trust freedoms, but there was also 19 a downside. My balance sheet would be that there was 20 certainly improved management at a Trust level, and 21 I think one of the very significant parts of that was 22 the development of management expertise amongst doctors 23 and nurses, the so-called medical directors and nursing 24 directors at Trust level, and indeed rather more 25 prosaically, the develop of the finance function. 0042 1 I think there was real innovation in systems 2 development in some places and a real attempt to begin 3 to tackle, to move beyond, if you like, the rather 4 sterile business of financial control and to tackle 5 issues of quality improvement and some really quite 6 imaginative capital developments which, if you like, 7 broke with some of the earlier traditions of the Health 8 Service. 9 So there was an upside, but the difficulty was and 10 the difficulty still is, that that upside is the result 11 of strong leadership and executive management at a local 12 level, and our experience is that even now, after lots 13 of efforts to improve across the board, the management 14 expertise and the clinical leadership in the NHS is 15 still pretty patchy. So the downside was, there was no 16 consistent means in many places of spreading good 17 practice; there were gaps that were exposed in our 18 planning of services, with no apparent means other than 19 intervention to deal with them -- I am thinking about 20 things like mental health services and paediatric 21 intensive care, and there were some quite deep-seated 22 structural problems. If you have even a quasi market, 23 you have to be interested in the structure of that 24 market and that structure was no more than the past 25 history carried forward. So, as in my earlier example 0043 1 when it came to sorting out the pattern of health 2 services in London, there was no market mechanism for 3 rationalising hospital services and investing in primary 4 and community based services in London. That required 5 a succession of interventions. 6 So these arrangements were doing a job in 7 stimulating innovation in some places, but they were 8 failing in the sense that there was no adequate planning 9 of services across boundaries. 10 Q. And to come back to capital freedoms, what use did 11 Trusts make of their powers to build, to extend, to 12 spend money by way of capital projects? 13 A. I think to the extent that they could, they made good 14 use of that, but one of the financial parameters that we 15 talked about, one of the things that the outposts 16 measured very consistently, was that each Trust had to 17 make a 6 per cent return on capital invested, had to be 18 very aware for the first time of the issue of capital 19 charges, of handling depreciation. These things were 20 all trying to mimic life in the public sector, trying to 21 mimic life in the private sector, so there was quite an 22 exacting regime, but those who learned how to play the 23 system, those who had good mechanisms for generating 24 capital internally, perhaps by land sales or some sort 25 of rationalisation of their estate, were making good 0044 1 progress and doing good things. 2 Q. The idea was that only those schemes which had purchaser 3 support would go forward? 4 A. Yes. 5 Q. Was that a significant factor in hampering Trust freedom 6 in that area if purchasers themselves had financial 7 constraints upon them? 8 A. I think that I can only think of one example, one rather 9 spectacular example, of a Trust who, presumably with 10 support up the line, barged on to make a very 11 significant capital investment that led to a rather 12 silly over-provision of services in a particular area 13 and one that could not be funded by the local health 14 authority. 15 That sort of thing, when dealing with -- remember 16 the words from earlier on -- accountability, the proper 17 and efficient use of public money, could not really be 18 encouraged, so again, it led to an intervention. 19 Increasingly this was part of the responsibilities 20 of regional offices as they developed, increasingly the 21 attempt was being made if you like at an intermediate 22 level to reconcile the views of health authorities and 23 GP fundholders and Trusts about the wisdom of particular 24 capital developments in particular areas. 25 So once again, in the cold light of dawn, the 0045 1 Trust freedoms were being sort of squeezed a little, 2 because the market dynamic was being played out in 3 a very public setting. 4 MISS GREY: Sir Alan, it is probably time now to take 5 a break, for perhaps a quarter of an hour? 6 THE CHAIRMAN: Yes, thank you. Let us adjourn now and 7 reconvene at about 11.05. 8 (10.50 am) 9 (A short break) 10 (11.05 am) 11 MISS GREY: Sir Alan, we have spoken about the 12 responsibilities of Trust Boards vis-a-vis the 13 Department of Health. Clearly they also had 14 responsibilities, contractual responsibilities, to 15 purchasers in the sense that the word "contract" was 16 used within the NHS. 17 So purchasers were meant -- is this right -- to 18 hold Trusts accountable against the standards that had 19 been set in those service agreements? 20 A. Trusts were meant to establish a contractual 21 relationship with either health authorities or GP 22 fundholders to provide services to a certain 23 specification. 24 Q. And presumably those purchasing bodies were meant to 25 scrutinise and detect whether or not Trusts had been 0046 1 able to fulfil those contractual requirements or 2 obligations? 3 A. That is correct. 4 Q. Did the purchasing bodies have enough information 5 available to them, looking across the period from 1991 6 to 1995, to allow that to happen effectively? 7 A. Everything would hinge on the definition of the word 8 "effectively". Let me reply by saying that I think it 9 is fair to say that the contracting system throughout 10 that period, throughout the existence of the so-called 11 market arrangements in the health service were pretty 12 rudimentary. That is not to say that information did 13 not improve with time and that information really was 14 about three or four things: it was about costs, the 15 volume of work, it was often about the case mix and 16 sometimes it was about the quality of the work or the 17 outcomes that were being sought from the provider of 18 health services. 19 Q. But to what extent was information available, you say 20 "sometimes", about quality or outcomes? 21 A. I think it varied enormously. It is important to put 22 that in some sort of perspective. The definition of 23 "health outcomes" is something that every health system 24 in the developed world has been struggling away with for 25 the last 10 or 20 years. This is not an easy area and 0047 1 I would not want to give the impression that the system 2 was rudimentary and therefore people did not look at 3 health outcomes. The whole question of measuring health 4 outcomes is a sort of developing science, really, or 5 developing work, right across all health systems, not 6 just the NHS. 7 Q. Do you think that the need for that, or its importance, 8 was appreciated back in 1989 to 1991, when this policy 9 was developed and the managed market created with only 10 very rudimentary information about such matters? 11 A. Oh yes. I think there was a sort of parallel track of 12 work that would lead me to the view that that was 13 appreciated. The development of clinical audit, the 14 focus on clinical effectiveness, the important work that 15 was prompted by the NHS R&D programme which had its 16 origins in a 1988 House of Lords Select Committee report 17 and then resulted in a huge initiative to develop the 18 notions of evidence-based practice in the UK. 19 So all of these things, if you like, were 20 happening in parallel with the development of the 21 internal market, and indeed, for some of us, these 22 things were much more interesting than playing around 23 with the market mechanism. 24 Q. If we go back to Sir Duncan Nichol's witness statement, 25 WIT 351/3, please, and we look at paragraph 5, he talks 0048 1 about the centrally funded quality programme which was 2 established to take forward initiatives which emphasised 3 the centrality of the patients' experience. He listed 4 four areas of quality improvements: "appointment 5 systems; information to patients; hospital waiting and 6 other public areas; and consumer satisfaction surveys." 7 The impression that one might get from that 8 statement, and from various pieces of evidence before 9 the Inquiry, was that national priorities such as, for 10 instance, waiting lists or Health of the Nation targets 11 or Patient's Charter standards, were matters upon which 12 district health authorities tended to concentrate in 13 setting contractual standards with providers. Would 14 that appear to be a fair summary of the effort or the 15 energy levels expended on types of quality indicators? 16 A. I think that is fair. I think you had to be very 17 special indeed and there were some very special people 18 who could do it, who would handle all of the national 19 initiatives which would rain down in the Department of 20 Health and still unfortunately do, to a certain extent, 21 sort of take these in their stride, if you like, and 22 focus on coherent approaches at a local level to 23 improving the patient's experience, so that, yes, 24 I mean, it would be the case that most people would put 25 most onus on following the national priorities, as it 0049 1 were. 2 Q. What is missing from that list, although it is headed 3 "Quality of service initiatives", would be any 4 indicators that go directly towards the quality of care 5 in terms of the safety of treatment and its competence? 6 A. Yes. 7 Q. What were the barriers for purchasers in trying to put 8 those criteria in the framework when negotiating 9 contracts? 10 A. I do not think there were barriers. But just to take 11 your very specific point still on the screen here, 12 Duncan Nichol was referring there, if you like, to the 13 non-clinical aspects of quality improvement, and for 14 anyone who has had any contact with the Health Service 15 in the country, the things he lists there are very 16 important, and indeed are still very important, and 17 still require a great deal of improvement and 18 attention. 19 I think it is fair to say that the whole question 20 of measuring the quality of clinical services, measuring 21 health outcomes, properly interpreting audit results, 22 was a developing feature of the Health Service. It is 23 one that had been allowed to develop, if you like, in 24 the professional arena, although around this time there 25 were some important changes. For example, the 1989 0050 1 White Paper referred I think for the first time to 2 managers having access to anonymised audit information. 3 So there were a whole number of things going on, 4 if you like building blocks being put in place, that 5 leads to, I hope, what are now a current set of policies 6 that take the early work done on clinical audit and 7 clinical effectiveness and apply it in the Health 8 Service today. 9 Q. Perhaps to summarise, firstly, would I be right in 10 understanding from your earlier answer that you agreed 11 with the proposition that I was putting to you, that in 12 effect non-clinical standards or quality standards 13 tended to be the focus of purchasers' activity, rather 14 than clinical standards? 15 A. Tended to be, but were not exclusively so. I think that 16 would be, if you like, the territory that most people 17 felt comfortable with, but what I think I have tried to 18 emphasise throughout this last phase of questioning is 19 that there was an important parlour of work going on, 20 which later, and certainly now, is to be integrated with 21 the process of commissioning health services so that the 22 old approach of focus on cost and volume and 23 non-clinical aspects of quality is now supplemented by 24 important work on health outcomes and clinical 25 effectiveness. 0051 1 My point is that people were not ignoring that 2 simply to concentrate on financial issues. They were 3 just beginning to absorb it as part of the way that 4 things would not done in the Health Service, and I think 5 I have seen evidence to this committee, for example, 6 from Dr Winyard on the evolution of clinical audit, that 7 is consistent with what I am saying: that people were 8 very, very interested in these ideas, but they were not 9 current enough to be applied to the contractual process 10 in all cases. 11 I think the other simple but important point 12 I would make is that some people purchasing health 13 services on a contractual basis were highly skilled and 14 qualified GPs, who would know about the latest on health 15 outcomes or the very detailed measures that they might 16 track in relation to the success, for example, of 17 a diabetic service, right down to very detailed 18 metabolic measures. So I do not want to give the 19 impression that this was barren land, but it was 20 a developing science. 21 Q. I used the word "barriers" to assessment of clinical 22 outcomes at an earlier stage, and you I think quarreled 23 with that, but how would you assess the proposition that 24 one barrier to the assessment of these measures would 25 have been an imbalance of information or knowledge 0052 1 between purchaser or provider, particularly when dealing 2 with specialised services? 3 A. I think there was an imbalance of knowledge between 4 purchaser and provider and an imbalance of knowledge 5 between clinician and manager, but that, I think, was 6 not a sort of systemic weakness; it was a consequence of 7 the fact that this work was being developed I think 8 quite rightly initially in the clinical community. 9 Clinicians themselves had to build confidence in these 10 processes of audit and review, and some were able to do 11 so more quickly than others. Radiologists, for example, 12 for years, have had very precise measures of quality 13 assurance in what they do, because it is relatively 14 simple to do that, compared with some other aspects of 15 medicine. So this was a developing science. 16 Q. So on the purchasing front one can summarise by saying 17 that the primary focus may well have been upon 18 non-clinical quality measures, but that there was 19 developing interest and knowledge, and expertise, on the 20 clinical outcome measures? 21 A. May well have been, but not exclusively so, and 22 developing interest that was being handled, I think, in 23 quite an enlightened and structured way, and indeed, 24 I go further and say, had these developments not taken 25 place, the present government who now have a very strong 0053 1 focus on the quality of clinical services, setting 2 national standards and processes of review and clinical 3 governance, would not have been able to do what they are 4 doing because the building blocks would not have been 5 placed. So these were important building blocks. 6 The NHS programme and their work on clinical 7 effectiveness and the assimilation and analysis of 8 evidence was leading the world in this field, so we 9 should not get ourselves into the position of thinking 10 we were somehow off the pace on this. There was a lot 11 of hard work going on, but it had not developed to the 12 point at which it would automatically become part of 13 this new contracting process. 14 THE CHAIRMAN: Sir Alan, I think part of the thrust of the 15 questioning -- Miss Grey will tell me if I am wrong -- 16 is that to a degree the purchasers were, at the start of 17 the process, making purchasing decisions somewhat in the 18 dark as to the quality they were entitled to insist upon 19 or expect, and though these developments are as it were 20 catching up, to a degree there was a need for catching 21 up, and some could argue that the process should have 22 been the other way round: have the information systems 23 in place before you introduce the other process? 24 A. I think I am jibbing a little bit at the term "catching 25 up". My simple point here is that there were areas of 0054 1 this work where we were leading the world. There were 2 other areas where we had a lot to learn from other 3 developed countries. 4 Q. Your words were "parallel development"? 5 A. Parallel development, yes. It is certainly true that in 6 a perfect world, having more information about the 7 quality of clinical care, more information about health 8 outcomes, would have been an advantage in the 9 development of this contracting process, but things had 10 not moved to that degree. That is my simple point. 11 Q. Does it not to a degree mean that the purchaser, who is 12 after all supposed to be representing the interests of 13 those on whose behalf the purchasing decisions are made, 14 is to a degree unable to appraise himself, personifying 15 the purchaser, of some of the most important matters 16 which would go to purchasing a particular service? 17 A. I think that is true without doubt and there is no doubt 18 that key constraints in the development of these 19 relationships were the lack of good clinical information 20 systems and the lack of properly defined and agreed 21 measures of health outcome. 22 I accept that. What I think I am trying to avoid 23 is some implicit suggestion that somehow the purchasers 24 were neglectful in not being able to handle these sort 25 of issues. I do not think they were. I think they were 0055 1 just working with the tools that they had available at 2 the time. That is my point. That is the emphasis I put 3 when I think of these things as parallel developments. 4 If we were to draw a timetable from 1989 to 1999, 5 I could track the parallel development of all these 6 things. The real skill at any level in the service is 7 to interleave these things so you begin to build 8 a coherent system. 9 MISS GREY: If the tools that the purchasers had at their 10 disposal were evolving during this period and being 11 refined and no doubt being improved, and they were using 12 them to the best of their ability but they were 13 necessarily imperfect during this period, where do the 14 guarantees of good clinical performance derive from, if 15 the purchasers did not have at their disposal a complete 16 and adequate lever to achieve that result? 17 A. Whether the techniques were developed or not, they 18 should principally derive from the practice of 19 individual clinicians and clinicians working in teams. 20 The commitment of these individuals and teams to agree 21 the standards of practice that they are trying to 22 achieve, to audit and compare progress against these, to 23 be willing to learn from experience, to take remedial 24 action and if necessary re-audit, the so-called audit 25 cycle I have seen mentioned in previous transcripts from 0056 1 this hearing. 2 I think that was deeply embedded in the psyche by 3 probably 1995, and I think that is the first point at 4 which the GMC guidance on good medical practice, 5 including the fact that individual clinicians should be 6 taking part in that sort of audit process, but there was 7 a long process of getting there that started with the 8 confidential inquiries in the 1980s and, you know, 9 worked through a whole series of professionally-based 10 initiatives. 11 There is a study, which I cannot reference but 12 I think it is a 1995 study from the National Audit 13 Office, that shows very high participation rates amongst 14 clinicians in the audit process and which shows, 15 I think, across the Health Service, something like 16 20,000 schemes. There was a period from 1990 to 1994 17 where we invested more than 200 million in this 18 process. 19 Q. If we take the example of a clinician -- we will assume 20 it is one clinician just for the sake of the example -- 21 who does not have insight into his or her own 22 difficulties of performance and we take a team that is 23 dysfunctional and is unable to assess the strengths and 24 weaknesses of that team, or to perceive its own 25 weaknesses in doing so, where does the line of 0057 1 responsibility for that situation go next, after the 2 team has failed? 3 A. I think there are two issues here. One is clearly 4 individuals have a responsibility to ensure that their 5 practice is up to date, but there is also, I think, 6 a system responsibility, a systemic responsibility, if 7 you like. In 25 years, I do not think I have met anyone 8 in the health service who turns up wanting to do a bad 9 job, but I think there are circumstances in which people 10 do not do their best and sometimes that is because of 11 their own weaknesses, the weaknesses in their own 12 professional practice. Sometimes it is because the 13 system fails them. 14 Q. That is to describe the problem at the level of the 15 individual clinician. What I am asking is: how does it 16 get resolved, because we have described, for instance, 17 that contractors, purchasers, may be responsible for 18 quality? 19 A. Yes. 20 Q. But may have inadequate tools at their disposal to 21 monitor that quality? 22 A. Yes. 23 Q. So that line of accountability, as you described it, is 24 capable of failing even if it may or may not in an 25 individual instance? 0058 1 A. If you want me to accept the notion that systems allow 2 failure to occur, I accept that notion. In the period 3 that we are talking about, because you use the word 4 "purchaser" in your question, we were relying on four 5 things to ensure competence in clinical practice. We 6 were relying on the process of professional 7 self-regulation. We were relying on the developing 8 processes of audit. We were relying on the rather 9 rudimentary internal market that we have discussed, and 10 we were relying on hierarchical relationships, which, as 11 we explored before the break, still existed between the 12 Department of Health and health authorities, and in 13 a very narrow way to some aspects of the work of Trusts. 14 All of these things would have to be perfectly 15 aligned to ensure that failure did not occur. Indeed, 16 you could go even deeper in thinking about the incentive 17 structures that surround that sort of process. We are 18 dealing here with a very complex dynamic. Faced with 19 that, I do not think one should just walk away and say 20 that no-one is responsible. I think individuals are 21 responsible; I think the system is responsible. 22 In that complex situation which exists, not just 23 in the NHS but in every health system, it seems to me 24 that the key thing is to ensure that the roles and 25 responsibilities of individuals, the roles and 0059 1 responsibilities of statutory bodies, the roles and 2 responsibilities of the Department of Health and the NHS 3 Executive, are adequately defined, so that everyone can 4 see the distinctive contribution that each of these 5 players should make to ensuring that we have a system 6 that is as risk-free as possible. 7 Q. Can you define, in that case, the role or responsibility 8 of the Department of Health in ensuring the adequacy of 9 paediatric cardiac services in a Trust such as Bristol 10 during the period of our Inquiry, looking at 1991 to 11 1995? 12 A. The role as you know focuses around the existence of the 13 Supra Regional Services Advisory Group and then 14 subsequently the national specialist commissioning 15 group. Both of these things operated under the auspices 16 of the Secretary of State, who has a responsibility to 17 promote comprehensive health services in this country 18 and asks the NHS Executive to ensure these services are 19 effectively managed. 20 The nature of that group changed. The nature of 21 that national commissioning activity changed during the 22 period that we are talking about. In the first 23 instance, the group which essentially was a collection 24 of professional experts and administrative support staff 25 was chaired by someone who was the Chairman of the 0060 1 Regional Health Authority, and that person reported to 2 the Secretary of State. That changed I think in 1995/96 3 as the regional health authorities disappeared. 4 The group is now chaired by a regional director, 5 who reports to the Secretary of State, not through 6 a grouping of regional Chairmen, but through a group of 7 officials who make up the NHS Executive Board. 8 So that territory is described in quite some 9 detail in my statement. 10 Q. To put it in focus, the Inquiry has heard two opinions 11 about the responsibility or otherwise of the Department 12 of Health, and by that I mean the Supra Regional 13 Services Advisory Group and the Ministers to which it 14 reported, for the quality of the paediatric cardiac 15 services. 16 One is that because it was the Department of 17 Health which as it were provided the money, and which 18 also had direct contractual relationships between the 19 unit and itself, so that this service stood outside the 20 normal purchaser/provider territory, it was the 21 Department that was responsible for ensuring or 22 monitoring and assessing the quality of the service that 23 was being provided. 24 The alternative view that has been expressed by 25 officials within the Department of Health is that it was 0061 1 the health authorities -- this is "health authorities" 2 unspecified -- that retained that role as part and 3 parcel of their public health functions and that the 4 funding mechanism that was represented by the Supra 5 Regional Services Advisory Group did not alter that 6 basic public health responsibility. 7 Can you comment on that conflict of views? 8 A. I do not think I am willing to choose either/or. 9 I think I fall back on my point. What I want to avoid 10 at all costs is any notion that somehow no-one is 11 responsible, because I do not believe that to be the 12 case, but I believe that the clinicians directly 13 involved in provision of that service have some 14 responsibility. Health authorities and the Trust which 15 was the home to that service have some responsibilities, 16 as we discussed earlier this morning, and the Department 17 of Health clearly had some responsibilities, not just in 18 relation to resource allocation in my view, back to this 19 point about systemic failure, but to ensure that there 20 was a system in place that ensured that these services 21 were being properly provided. 22 I think that the crucial thing would be to be 23 absolutely sure in each of these cases that the roles 24 and responsibilities, the distinctive roles and 25 responsibilities of each of these players, was 0062 1 adequately defined. 2 Q. Can I press you on two parts of that? Firstly, you say 3 that health authorities had a role, a continuing role. 4 We have discussed, I think, where the responsibility of 5 the Trust would derive from. Can you help us further as 6 to firstly whether by "Health Authority" you mean 7 district or region, or both? 8 A. I think I mean district in the sense that the people who 9 were referred, the children in this case, who were 10 referred to that service, were referred to that service 11 because of a clinical need and health authorities had 12 a responsibility for ensuring that the health and 13 clinical needs of their population were being met. So 14 I think I am accepting perhaps more of a theoretical 15 responsibility, compared with the responsibilities of 16 others. 17 Q. If we remain with the district, the actual people doing 18 the referring would have been individual clinicians, 19 possibly paediatricians, possibly cardiologists, within 20 a district? 21 A. They would not be within a district. This is the 22 point. They would be operating within another Trust and 23 they would be making what is referred to as a "tertiary 24 referral", and essentially, you have a new version of 25 purchaser/provider here where the purchaser is a Trust 0063 1 perhaps providing secondary care and the provider is 2 a Trust providing tertiary care. So this is a new 3 complication which we have not yet explored this 4 morning. 5 Q. When I say "within a district" I mean within the 6 geographical boundaries of a particular district, but it 7 is a clinician who makes the referring decision and 8 because of the funding arrangements for supra-regional 9 services, neither the referring Trust in which the 10 clinician is sited, nor the district within which the 11 Trust is sited, would have to pay? 12 A. That is correct. 13 Q. So is there any real locus for the responsibility of 14 the district to satisfy itself that those referring 15 decisions are being made properly? 16 A. I think I go back to what I said before: I think it is 17 more of a theoretical responsibility. There is, or was 18 at that time a clear responsibility on district health 19 authorities to ensure that the health and health service 20 needs of their population were being adequately met and 21 that means the whole range of services from primary to 22 tertiary services. But beyond that, I can see that 23 there is no real responsibility here and that the 24 responsibility is much easier to define in relation to 25 individual clinicians, the Trust where that service was 0064 1 located and the NHS Executive who, through these 2 advisory groups, were running the national commissioning 3 arrangements and allocating money. 4 Q. Could we take also the alternative health authority: the 5 region? Does that have any responsibility? 6 A. Now you are testing my memory here, but I think the 7 money was being allocated directly from the national 8 group to the Trust concerned and to the service 9 concerned, so that the regions were not, as they were in 10 some other cases, in the resource allocation chain. And 11 remember, through this period regional health 12 authorities were fading out, but as part of the 13 management oversight responsibilities of regional health 14 authorities, it was quite common for senior people in 15 a regional health authority to become involved in issues 16 relating to the designation or the funding of 17 a supra-regional service. 18 I think I gave the example in my paper of a liver 19 service being de-designated at the Royal Free Hospital. 20 If I did not, that is an example that I remember. I am 21 speaking from my perspective at that time in a Regional 22 Health Authority. The region were quite actively 23 involved in that, in discussing the problems of funding 24 and the nature of the service with the people who were 25 providing it, and there was at that time quite a lively 0065 1 system of regional medical advisory committees and all 2 the rest of it. 3 So whilst in your very tightly drawn example 4 regions do not have a clear locus and are not part of 5 the funding chain, I think in reality they would quite 6 often adopt an influential position by virtue of their 7 historical interest in the development of services and 8 some expertise. 9 Q. And does that again relate back to the wider 10 responsibility of any Health Authority to ensure the 11 health, to be concerned for the health of the 12 inhabitants within its territory? 13 A. I think it is more than that, actually. I think that 14 Regional Health Authorities whilst separate statutory 15 bodies during their existence until 1996, did have, if 16 you like, a sense of responsibility in relation to the 17 work of the Department of Health and a sense of 18 responsibility in relation to the services that were 19 provided on their patch. So I can remember very 20 clearly, as a Regional General Manager, being in 21 a region where there are a lot of big teaching 22 hospitals, being quite closely involved in discussions 23 about the development and the funding for supra-regional 24 services in places like the Hammersmith Hospital and 25 St Mary's and Charing Cross. It was quite normal for 0066 1 the regions to be involved, almost as agents of the 2 Department of Health. 3 Q. You mentioned then, when turning to the role of the 4 Department of Health, its responsibility for putting 5 a system in place to monitor or assess proper quality of 6 care. 7 Can I just take you to your witness statement 8 again, page 18, please, where at paragraph 46 you start 9 the description of this service, or service 10 arrangements. 11 If we turn over the page, we can see that the 12 supra-regional services reported, after endorsement by 13 regional Chairs, to the Secretary of State? 14 A. Yes. 15 Q. Are you able to help us on the reasons why the structure 16 apparently fell outside and remained outside the sphere 17 of the NHS ME or the NHS Executive until 1996? 18 A. I cannot remember it offhand, but I think if you scroll 19 up, you will find -- it is at the top of the page -- 20 references to the Supra Regional Services Advisory Group 21 being set up with the support of the regional health 22 authorities and the Joint Consultants Committee in 1983, 23 it says on the previous page. 24 The Health Service was a very different place in 25 1983. The Department of Health was a very different 0067 1 place. It was not actively managing the Health Service 2 in the way that it does now. The regional health 3 authorities were statutory bodies. In some cases, they 4 were very strong fiefdoms, and the regional Chairmen -- 5 and they were Chair men during that period in the 6 main -- were pretty powerful and influential players. 7 Although they only had part-time jobs, they were pretty 8 influential advisers to the Secretary of State and it 9 was quite normal, for example, not just in these areas 10 we are discussing today, but in other areas, for 11 regional Chairmen to have a lead role. I can remember, 12 for example, a Regional Chairman having a lead role on 13 handling the policy in relation to international 14 relationships in the health service. I can remember 15 Regional Chairmen having a very strong lead role in 16 relation to NHS pay negotiations. 17 So this was the way in which the Health Service 18 was run. The Regional Chairmen were powerful players. 19 They were each running their own fiefdoms. 20 That began to change very dramatically through the 21 1990s. The abolition of regional health authorities was 22 a major issue and the notion to the people who had been 23 around during the 1980s that we had had a regional 24 director, Mr Spry and then Mr McKay running this very 25 important committee, was a real kick in the teeth, 0068 1 really. It was signalling a very different world and 2 a very different power structure. If you like, it was 3 managerialism arriving at the centre of the NHS rather 4 belatedly, in my view. 5 Q. Do you think, then, that if one is looking at 6 a committee or group that is not merely deciding whether 7 or not a particular service should be designated, but 8 also on the running of the management of that service 9 throughout the years, that the omission from the loop, 10 as it were, of the NHS Management Executive, 11 subsequently Executive, until 1996, may have had any 12 effect on the expertise available to that group, or its 13 approach? 14 A. There were two reasons for the omission. One is the 15 reason I described, and you note there the change of 16 chairmanship did not take place in 1996, it took place 17 in 1994. If you go back to our earlier discussions 18 about the document "Managing the New NHS", which was the 19 precursor to the abolition of regional health 20 authorities, the preparation for that took place between 21 1994 and 1996. We had to be very careful not to 22 pre-empt legislation, but changes in the structure were 23 clearly being made at that time and that was the switch 24 from Sir Michael Carlisle to Chris Spry in 1994. So 25 that was a significant point. 0069 1 The other significant issue, which I think came 2 out in Graham Hart's evidence, was that policy 3 responsibility for this area of work did not rest with 4 the NHS Executive until 1995. It was part of the 5 residual responsibilities of what we refer to as the 6 "wider Department of Health". So the two key changes 7 were a regional director clearly in the loop and two in 8 1991, and two in 1995, the responsibility for policy in 9 this area transferring to the NHS Executive. 10 You asked if that meant any difference in 11 approach. The crucial difference it made was that the 12 people who were responsible for policy and 13 implementation were one and the same for the first time 14 in history, so it was not a case of policy being handed 15 down by the Department of Health to be implemented by 16 the people managing the NHS. The people who were 17 managing the NHS were informing the development of the 18 policy, and I think that integration which results from 19 the Bank's Review, mentioned in my statement, was 20 a jolly good thing. 21 Q. But at an earlier stage, looking pre-1994, as 22 I understand your statement, the NHS Management 23 Executive had no role, even for management issues, 24 within the supra-regional services set up? 25 A. That is correct. 0070 1 Q. So I think my question was -- 2 A. So, I am sorry, whilst Chris Spry was an NHS manager, at 3 that time working in a Regional Health Authority and in 4 the transition period between 1994 and 1996, soon to be 5 part of the NHS Executive in its new form following the 6 abolition of Regional Health Authorities, he was 7 carrying out that chairmanship role on behalf of another 8 part of the Department of Health who retained policy 9 responsibility, I think, until probably the summer of 10 1995. 11 Q. But from 1991 onwards, in particular, until 1st April 12 1994, which was when paediatric cardiac surgery was 13 de-designated, the Supra Regional Services Advisory 14 Group was, as I understand your statement, taking 15 responsibility for managing this service in so far as 16 they placed contracts directly with the units concerned, 17 and yet appeared to be remote from the specific 18 managerial expertise of the NHS ME as it then was? 19 A. That is correct. That is not to say that -- I would not 20 want that to imply that the people doing that work did 21 not have expertise in their own right, and I would also 22 want to make the important point that ultimately these 23 people had a line of responsibility to the Secretary of 24 State who was in overall charge. 25 So it was not as if that activity was taking place 0071 1 in organisational space, but it is absolutely true to 2 say that it was not taking place in the context of the 3 developing central management arrangements for the NHS. 4 Q. Do you think that that may have had or did have an 5 effect on the competence, or the effectiveness with 6 which systems were put in place to monitor or assess 7 supra-regional services? 8 A. It may have had, but I would not want to say that for 9 certain. Again, partly because I do not even know them 10 in the sense that I have not worked with them closely, 11 I am reluctant to comment on the competence of 12 individuals who I am sure at the time were doing their 13 best, given the cards they had been dealt. 14 Q. Are you familiar with the details of the contracts or 15 the contractual mechanisms whereby services were run 16 within supra-regional services? 17 A. No. 18 Q. Are you able to help us then with assessing whether or 19 not a proper system had been put in place by the 20 Department of Health to ensure the quality of care at 21 a supra-regional service level? 22 A. I do not think I can do that today with confidence. 23 I do understand that there is a significant issue here, 24 and indeed, an issue that is made more complex by the 25 fact that although the service was de-designated in 0072 1 1994, it continued until 1st April 1996 to have 2 nationally based funding. 3 So in the period in the run-up to 1994 and in the 4 period between 1994 and 1996, I do not think I can speak 5 with absolute confidence about the systems that were in 6 place, but I understand that that is an issue of 7 potentially real concern to this Inquiry, and I would be 8 happy to provide a more detailed note, if that would be 9 helpful. 10 Q. I think that would be extremely helpful, if you would, 11 Sir Alan. Perhaps I might touch on another issue that 12 you might like to consider, if not today, in such 13 a statement. It is this: we have heard that when the 14 service was de-designated, no guidance was offered to 15 local district health authorities who had to place 16 contracts with the units in question for the first time 17 in 1994 and 1995? 18 A. Yes. 19 Q. And it may be that you would be able to help us on 20 whether or not you think that was a significant failing 21 or not a failing at all on the part of the Department of 22 Health, and whether such guidance might perhaps usefully 23 have been offered to such district health authorities. 24 A. If no guidance was issued, I think that does fall into 25 my category of systems failure, because I think taking 0073 1 on a new responsibility for which some people have 2 expertise and others do not, there should be 3 a responsibility in any managed system to ensure that 4 that expertise and knowledge is passed on to those who 5 subsequently have to do the work. 6 In accepting that, I am not accepting that no 7 guidance was issued, because I do not know, but I am 8 happy to check and to deal with that point in the 9 context of a further note. 10 Q. We have heard at least from the District Health 11 Authority that it was not aware of any such guidance, or 12 did not receive any, so perhaps that might be clarified 13 by yourself. 14 A. All right, we will check that point. 15 Q. The point that I think perhaps we would welcome your 16 assistance on is that we have talked about information 17 and balances and it might be thought that there would be 18 difficulties in local authorities in taking over such 19 a specialised service, and perhaps inevitably, that they 20 took the approach that they did adopt, which was in 21 adopting a "steady state" attitude, at least in the 22 first year, the initial year of contracting? 23 A. Again, I think we need to look at the precise 24 arrangements. It was certainly the case in some issues 25 like this that district health authorities taking on 0074 1 these sort of responsibilities for the first time pooled 2 their expertise. In other words, they developed 3 consortia arrangements; they did not seek to contract 4 with specialist centres always in their own right; they 5 often developed a little locus of expertise and then 6 arranged a consortium or some sort of co-operative to 7 work on, on their behalf so that they would pool their 8 money, their expertise and ensure that the good practice 9 required in these areas was followed through. 10 That was certainly true in a number of other 11 areas, and I cannot cite the detailed reference, but 12 there certainly was guidance to that effect, that that 13 would be a good way of doing certain things. 14 Q. I am being reminded from behind me that the evidence was 15 that the districts were told, were advised, to take 16 a "steady as you go" approach in taking over 17 responsibility for the funding of these arrangements. 18 A. Yes. 19 Q. Again, I think our evidence has been that that 20 responsibility did start from 1994 onwards, rather than 21 being delayed until 1996, as I think you just suggested? 22 A. I do not think I suggested that the responsibility did 23 not transfer until 1996. The point I made is that 24 central funding was still in place until 1996, and it 25 may be that the contracting responsibility was delegated 0075 1 and that the continuation of central funding was part of 2 the process of ensuring stability. 3 It was quite normal -- there is dreadful jargon 4 around this, but a "steady state" I remember is one 5 example of that. It was quite normal, in making 6 a change like that, that for at least a year beyond the 7 change, current arrangements, meaning current financial 8 flows, were essentially maintained to ensure the 9 stability of the service. 10 I think it is also worth saying that many of these 11 services, not necessarily this one, which I cannot talk 12 about in detail, but many of these services had links to 13 universities, sometimes to really rather important 14 clinical trials, so the aim was not just to ensure 15 a steady state in the flow of Health Service money; it 16 was to ensure the continued viability of important 17 research projects and all the rest of it. 18 When I talked about intervening in the market, it 19 was not unusual at that time to intervene to ensure 20 stability for health services and for associated 21 research and teaching programmes. 22 Q. One small matter. Can I ask you, Sir Alan, who 23 appointed the members of the Supra Regional Services 24 Advisory Group? 25 A. It must have been the Secretary of State. 0076 1 Q. Would that also apply to the National Specialist 2 Commissioning Advisory Group? 3 A. I would think so, yes. 4 Q. If we go on, please, looking again at your statement and 5 go on to paragraph 48, where you talk about the 6 development of the National Specialist Commissioning 7 Advisory Group, does that body now have at its disposal 8 any powers or levers to control where specialist 9 treatments are provided that were not available to the 10 old group? 11 A. I cannot think that it will have new powers. I think 12 the development in that area -- we are back to our 13 parallel developments again -- as in many other areas, 14 would be the development of the audit and review 15 processes, so that whereby in the past the aim would 16 have been to draw on the expertise of the group members, 17 the Royal Colleges and others in the way that the SRSAG 18 did, now the attempt has been made to install audit 19 systems and I think I refer to one of those later in the 20 text here, where, in relation to cardiac surgery, there 21 is an attempt, a very detailed attempt, being made to 22 develop outcome audit by operation that is, if you like, 23 so "risk-stratified", I think, is the terrible jargon -- 24 Q. That is paragraph 55 of your statement, if we look at 25 page 21. 0077 1 A. That would be the advance that I would point to; the 2 other of course being that by virtue of reporting back 3 into the NHS executive, that is the new route to the 4 Secretary of State. 5 Q. Because again, we have heard a certain amount about the 6 inability of the Department of Health ultimately to 7 prevent centres from offering specialist services 8 outside this structure if clinicians want to do so and 9 referrals are being made to them. 10 A. Yes. 11 Q. Is that a situation which still exists now? 12 A. I think it would be wrong to say it cannot exist, but 13 I think the barriers to that happening are much greater 14 now than they used to be. There have certainly been 15 cases recently that I can think of where a proliferation 16 of services for a particularly difficult clinical 17 procedure was frowned upon to the extent that -- 18 following some public concern and some clinical concern, 19 the pattern of that service was changed and was focused 20 on -- 21 Q. I am thinking perhaps of the decision that the Kasai 22 procedure -- 23 A. The biliary atresia, that is right. 24 Q. The Kasai procedure for biliary atresia has now been 25 restricted to three centres? 0078 1 A. That is correct, yes. 2 Q. So presumably the levers, the use of the new group, are 3 as they were for the old, that is, a combination of 4 funding plus guidelines for local commissioners of 5 services? 6 A. I think that is right, and as I have said in 7 paragraph 35, an increasing emphasis on audit, and 8 I think not to underplay it, just an example we have 9 touched on, a willingness to intervene, not to sit back 10 and see how things go, but to deal with an issue that 11 was clearly of concern to special interest groups of 12 patients and parents, that clearly raised its head in 13 the media. There was a clear willingness to intervene, 14 to draw on the professional expertise on that issue, and 15 to deal with that issue by confining the work to the 16 three centres best placed to achieve good results. 17 Q. You are saying that the Department of Health's attitude 18 in that matter has altered? 19 A. I think that is right. 20 Q. Over what period of time? 21 A. I think it has probably altered over the last few years, 22 and I would not want to under-estimate the influence of 23 this case in that respect, but I do not think that is 24 the sole reason for the change. I think there is just 25 much greater awareness of these issues. 0079 1 If I take a completely different example, even 2 ahead of the work that is currently being carried out in 3 the Department of Health on the national service 4 frameworks, the NHS Executive took a very clear lead on 5 behalf of the Secretary of State to develop a position 6 on paediatric intensive care services a couple of years 7 ago, where it set very clear national standards, where 8 it developed clinical consensus on how these services 9 should be organised, and was quite precise on what was 10 required and is now managing that new approach into the 11 system. 12 So there is much more willingness (a) to intervene 13 if things are thought to be going wrong; (b) to plan 14 these things on the basis of good clinical evidence, not 15 to be shy of setting national standards, and not to be 16 shy of holding people to account for implementing change 17 that allows us to meet these standards. That is 18 a change in attitude. 19 Q. So how was the agreement that the Kasai procedure, the 20 treatment for primary biliary atresia would be carried 21 out only in three centres, achieved? 22 A. You will know that -- this is the version as I remember 23 it, and maybe this needs to be checked, but as far as 24 I remember it, when the issue was raised, the matter was 25 taken up by Dr Peter Doyle, who will be giving evidence 0080 1 to this Inquiry before long. 2 He was concerned enough to assemble people with 3 clinical expertise in this area, the key players. I am 4 sure he discussed it given his role with the NSCAG 5 group. I certainly know the Chairman of that group, 6 Neil McKay, and one of the chief medical officers was 7 consulted along the way. He, given all that advice and 8 guidance from senior officials and advice from clinical 9 experts, recommended that the procedure be carried out 10 in only three places: I think Kings, Leeds and 11 Birmingham, if I remember. He made that recommendation 12 to the Secretary of State. The Secretary of State 13 agreed and that will be the position that operates as 14 quickly as possible. 15 Q. But is that a position which reflects medical consensus, 16 such that you do not have a problem with clinicians 17 disagreeing with it and saying that they wish to 18 continue to operate? 19 A. Well, it reflects medical consensus to the extent 20 that -- I do not know the detail. I really do not know 21 the detail; you would have to ask him direct, but there 22 is enough consensus to allow this decision to be made 23 without any medical objection being raised. I am much 24 more confident in my territory in relation to paediatric 25 intensive care where there was broad consensus but where 0081 1 some individual clinicians felt that their practice was 2 being challenged unnecessarily, and essentially they 3 were overridden by a national policy and a national 4 change process. 5 So "consensus" need not mean absolute consent from 6 every individual who has ever been involved in that 7 service; it means that the broad body of clinical 8 opinion and expertise thinks there is a correct way to 9 do things, or a better way to do things in terms of the 10 desired outcomes. 11 Q. In any event, if we want to pursue that example further, 12 the correct person to ask would be Dr Peter Doyle; 13 is that right? 14 A. I think, yes. I do not want to complicate his life, but 15 I am sure I have already done that. So, yes. 16 Q. If we could go back, then, please, to page 14 of your 17 witness statement, you talk there about adverse incident 18 reports, and you set out there the government's policy. 19 That, as I understand it, is a statement about the 20 current government's policy and current position; 21 is that right? 22 A. Yes, although a lot of these elements have been in 23 place, this is sort of drawing it together, but it is 24 certainly true that the current government has put 25 a focus on this that perhaps did not exist before. 0082 1 Q. If we scroll to the bottom where in the last bullet 2 point you talk about "critical incident reporting that 3 ensures that adverse events are identified, openly 4 investigated, lessons are learned and promptly applied", 5 can I ask, has a view been taken on whether these 6 reports, if made, should be protected from disclosure in 7 litigation? 8 A. I am honestly not sure on that point, but I can check. 9 There would clearly be an issue to be thought through in 10 relation to litigation, and indeed, in some cases where 11 it might be difficult to anonymise in relation to 12 a patient confidentiality. 13 I think later, in paragraph 7, you will see 14 a reference to an expert group -- 15 Q. Can we scroll up, please? Paragraph 37. The "learning 16 from experience" group. 17 A. Yes. This is an area where the Chief Medical Officer 18 has a long-standing interest, and these sort of issues 19 are being considered, I am sure, as part of the work of 20 that expert group. 21 Q. So would it be wrong to ask for a considered and 22 finalised Department of Health view on this matter 23 because it is still under active consideration? 24 A. It would be wrong to ask me today, because I do not know 25 the answer, but I would be very happy to try and give 0083 1 you the up-to-date position as things currently stand. 2 I think you do open up a very important point about 3 litigation and confidentiality that would have to be 4 dealt with, yes. 5 Q. Again, if you could do that, Sir Alan, we would be very 6 grateful. 7 A. I would be happy to do that. 8 Q. If we scroll down to paragraph 38, you say "at present 9 all serious untoward incidents must be reported in 10 writing to the appropriate regional director of the NHS 11 Executive". 12 When you say "at present", can you help us as to 13 when that obligation was imposed? 14 A. I think it has probably existed in that form since the 15 creation of the regional offices in 1996. 16 Q. Are you able to help us, then, on the source of that 17 obligation, whether there are letters, circulars, on the 18 matter? 19 A. I do not think there will be -- well, yes, there must be 20 circulars in the sense that the health authorities and 21 others, Trusts -- have to comply with this. I will 22 source these comments to the relevant guidance for you. 23 Q. If you would, and perhaps it might answer the question 24 of how one defines "serious". 25 A. Yes. 0084 1 Q. And also the questions of who, at Trust level, would be 2 responsible for making these reports, gathering the 3 information and so on? 4 A. Yes, okay. The definition of "serious" of course would 5 be primarily about patient safety and ensuring optimum 6 clinical outcomes, but if there is an exact wording that 7 we can give you, I am happy to do that. 8 Q. I am grateful, thank you. 9 A. And I am happy to identify the chain of responsibility. 10 Just for historical interest, but it may be an important 11 point in the context of this Inquiry, this would 12 previously have been something where the Regional 13 Medical Officer was the "locus" of attention. In 14 day-to-day reality, whilst the Regional Director is 15 responsible, it will often be the Regional Director of 16 Public Health who will be medically qualified, who 17 perceives these issues in detail and deals with them. 18 Q. From that point of view, shall we link that perhaps to 19 the role of the Regional Director of Public Health which 20 is mentioned at paragraph 41 of your statement, 21 page 17? You say it would be for the Regional Director 22 of Public Health to take responsibility for ensuring 23 that at adequate investigation and follow-up actions are 24 taken if there are informal reports of poor clinical 25 performance. 0085 1 Why choose the Regional Director of Public Health 2 in this example? 3 A. Because, alongside the regional nurse, they will be the 4 people in the top management group at the regional 5 office who have a clinical background. 6 Q. They are not, however, people who have any formal line 7 management responsibility for doctors, consultants, who 8 might be the subject of any investigation? 9 A. No, that is true. 10 Q. So what would be the source of their authority, again, 11 to investigate matters? 12 A. The source of their authority is that they are senior 13 officials in the Department of Health with clinical 14 expertise, or senior officials in the NHS Executive, 15 i.e. they are part of the central management of the NHS. 16 Q. So they can ask the right questions of the right people 17 with the appropriate standing and authority? 18 A. They can ask the right questions of the right people. 19 They also know the system. It is possible, for example, 20 that in certain cases the Regional Director of Public 21 Health, faced with some sort of informal report like 22 this, will go back to the Trust Chief Executive or the 23 Medical Director in a Trust and ask that that person 24 investigates and follows up and reports back, so that 25 there is, if you like, a responsibility for managing 0086 1 through the system to ensure that a problem is dealt 2 with at the correct level, if it can be. 3 It is also the case, because these are senior 4 officials from the Department of Health, that if there 5 are particularly difficult examples that crop up, 6 I could be informed or the Chief Medical Officer could 7 be informed, or usually both. 8 Q. We will come back to that, if we may, but could I take 9 you back for the moment to page 16, please, of your 10 statement? You refer in the second bullet point to the 11 issue of, we will call it "whistle-blowing", and you say 12 in the second sentence that it is the NHS Executive's 13 policy that there should not be confidentiality clauses 14 in contracts and that a letter to that effect was sent 15 out in September 1997. 16 Are you able to help us on the extent to which 17 those confidentiality clauses were imposed in doctors' 18 contracts, and I am thinking in particular again of 19 Trusts' consultants' contracts, before such definitive 20 guidance was issued? 21 A. We talked earlier about the transition phase, if you 22 like, the migration from a position where consultants 23 were employed by Regional Health Authorities, the point 24 at which they were employed by Trusts. During that 25 period of migration and change, when new consultants -- 0087 1 this was a period of consultant expansion and growth -- 2 were employed, they were normally employed on Trust 3 terms and conditions. 4 Sometimes of course consultants are appointed only 5 on an honorary basis and have university contracts, and 6 it is certainly the case that in some cases, as 7 I understand it, consultants were appointed by Trusts or 8 had been appointed by universities and had honorary 9 contracts in Trusts and had confidentiality clauses in 10 their contracts. 11 Q. In some cases, you say: but is there any evidence 12 available to you, or that you could find, as to how 13 widespread that practice was? 14 A. No, I do not think it was widespread at all. I think 15 the evidence would be scanty, but I just know from 16 remembering this time that there were one or two 17 examples that caused concern and alarm amongst the 18 medical profession, the Royal Colleges and the BMA and 19 others, and that was one of the reasons that we 20 reinforced this point in guidance. 21 Of course, all of that is now overtaken by the 22 Public Interest Disclosure Act, which, as I understand 23 it, renders such clauses null and void in law if 24 victimisation results from whistle-blowing. 25 Q. But still looking at the earlier period, even if 0088 1 confidentiality clauses were not in widespread use, to 2 what extent was competition between Trusts or arguments 3 about the commercial confidentiality of data a feature 4 in preventing the sharing of data between Health Service 5 providers? 6 A. I think there would be some examples of that, but 7 I think that has been overstated as an issue. I really 8 do not think, as we have discussed earlier, that the 9 market arrangements had developed in a sort of 10 tooth-and-claw way to the extent that clinicians were 11 not co-operating across institutional boundaries. There 12 may have been one or two examples of that, but I do not 13 think it was widespread. 14 It may be an important point to make in this 15 context, the reference there, the 1993 guidance that is 16 referred to in that paragraph, I also think the guidance 17 is very good and has stood the test of time. Indeed, 18 I had no difficulty at the end of July when the Public 19 Interest Disclosure Act became law, of outlining the new 20 position and restating the principles of that guidance. 21 So it is on the button in terms of dealing with the 22 whistle-blowing issue, I believe. 23 Q. Again, is the evidence on this point a matter of 24 anecdote impression, or is there hard data or research 25 that has been done on this particular issue? 0089 1 A. On the question of the effectiveness of the guidance? 2 Q. No, I am sorry, I am returning to my earlier question 3 which was the question of the extent to which issues of 4 commercial confidentiality or competition between 5 providers functioned to hamper the sharing of data 6 within the Health Service. 7 A. There is no evidence on that, and indeed, maybe I should 8 have said it earlier: there was never any detailed 9 evaluation of the workings of the internal market 10 arrangements, and no matter which issue you look at in 11 relation to that time, it is very difficult to 12 disentangle the variables. 13 So I can think of positions from the past, long 14 before the existence of the internal market, where 15 institutions were quite competitive and clinicians with 16 a particular mind set were not very keen to share data 17 with their colleagues, and indeed, there is still some 18 element of competition in relation to research. But 19 I do not think that is widespread in the Health Service, 20 and I do not think it became better or worse during this 21 period. But these are subjective views, not the results 22 of any detailed evaluation. 23 Q. Could we just then go back, please, to paragraph 41 for 24 another moment? This is page 17, again. This is 25 procedure to follow if informal reports of poor clinical 0090 1 performance are made. 2 How often do such reports reach the Department of 3 Health, as a matter of broadbrush impression? 4 A. The first point to make is that Regional Directors of 5 Public Health are part of the Department of Health: so 6 is the question how often do they reach Regional 7 Directors of Public Health, or how often do Regional 8 Directors of Public Health pass them on to someone in 9 the headquarters of the NHS Executive? 10 Q. I was thinking specifically of the headquarters in the 11 first instance. 12 A. Impressionistic: two or three times a month, maybe. 13 Maybe twice a month. Three too many, I do not know. 14 Q. If we drop that down to the regional level, the numbers 15 would presumably be magnified? 16 A. Probably, because a lot of these things actually get 17 dealt with very competently by the regional public 18 health directors, or indeed are referred back to the 19 Trusts and are very competently dealt with. 20 Again, it is an impression, but maybe two or three 21 times a month, 8 regions, 16 examples in a month, two or 22 three of which go up the line, as it were. 23 I should say that people's concerns in this 24 territory are quite considerable at the moment. The 25 existence of this Inquiry and indeed one or two other 0091 1 things that have gone on in the Health Service over the 2 year have meant that people have finely tuned their 3 antennae around this sort of territory. 4 Q. So when was the guidance referred to in paragraph 41 5 issued? 6 A. Again, I will try and tie it to guidance outside of the 7 hearing. But it is certainly in parallel with our last 8 example. It has certainly been the way of doing things 9 since the abolition of the regional health authorities 10 and the creation of the regional offices. 11 Q. When you say you have alerted staff, can you help us as 12 to how you did that? 13 A. I think, whether that has been written down, I do not 14 know. I would be very surprised if it is not, but I do 15 not remember reading in the last week or so a bit of 16 paper that would confirm that. Having said that, this 17 would certainly have been the subject of detailed 18 discussions at meetings with senior staff. It is 19 certainly something that I have discussed with the Chief 20 Medical Officers and the two Deputy Chief Medical 21 Officers, all three of whom are fairly recent 22 appointees. 23 Q. I think we would be assisted if you could help us on 24 how and when this procedure was circulated around the 25 department? 0092 1 A. There is enough nodding in the background to suggest 2 I will be able to do that. 3 Q. To take it one step further, what about before 1996? 4 You tied this particular change to that date. 5 A. Yes. 6 Q. What would have been the understanding, first, of staff 7 prior to 1996? 8 A. I think the understanding of medical staff would have 9 been that the Regional Medical Officer played a key 10 role, no matter the title that that person may have had, 11 some were called Regional Directors of Public Health at 12 that time, but they still carried Regional Medical 13 Officer type responsibilities. 14 In the case of other clinicians, nurses in 15 particular, there would be professional links with the 16 Regional Nursing Officer and sometimes both, where there 17 was an issue that was a conflict or a problem that had 18 arisen at the boundary between these two people. 19 Q. I asked you about the understanding of staff. Would 20 that have been based upon any explicit guidance or 21 written information at that time? 22 A. I think it probably was. As you ask these questions, 23 I am increasingly appalled, and I apologise for not 24 referencing these points adequately in the documents. 25 I am happy to do that. 0093 1 Q. It is the first time we have asked you this question, 2 Sir Alan, so if you could follow it up, we would be 3 grateful. 4 A. I will. I am sorry I did not think of it before. 5 Q. You have told us the understanding amongst medical staff 6 would be that the Regional Medical Officer would have 7 a role to play in that. 8 If we look forward to page 21, paragraph 56, which 9 is where you set out the actions of Dr Ashwell and 10 Dr Doyle when they were first alerted to this matter, 11 does your description of what would have been the 12 understanding of the correct ways of handling these 13 sorts of matters represent an implied criticism of the 14 way in which it was in fact handled? 15 A. No, it does not, because we were dealing here not with 16 a routine issue but with an issue that was part of the 17 work of the Supra Regional Services Advisory Group and 18 the subsequent National Specialist Commissioning 19 Advisory Group, in other words, and we did have some of 20 this discussion earlier about the informality of the 21 regional role in respect of these supra-regional 22 services. 23 The very title, "supra-regional", suggests that 24 these things were being handled at a level beyond 25 regions, although, as I said earlier, sometimes Region 0094 1 has a very great interest and a very great influence. 2 So I think in this case it would be, if you like, 3 quite appropriate for Dr Ashwell and Dr Doyle to have 4 behaved as if they were in our previous discussion 5 operating at a regional level, i.e. they both went back 6 to key people in the Trust. 7 Q. First of all, the service had been de-designated from 8 1st April 1994? 9 A. Yes. 10 Q. So that it was no longer within the remit of the Supra 11 Regional Services Advisory Group. Does that make any 12 difference to your answer? 13 A. That is true in the case of Dr Doyle, but not in the 14 case of Dr Ashwell, where the first contact was made 15 with her in December 1993 and indeed, I have seen the 16 correspondence between Dr Bolsin and Dr Ashwell, which 17 I think is dated February 1993, so that precedes the 18 first of April cut-off point, if you like. 19 Q. But is there a difference to be made in the effective or 20 correct way of handling these queries before or after 21 de-designation? 22 A. There may be, but I think, if we then take the post -- 23 I am sorry, let me take your question straight-on 24 without reference to the events at Bristol Royal 25 Infirmary. 0095 1 It is certainly the case that after 2 de-designation, I would have expected the arrangements 3 that we discussed in our previous discussion I think of, 4 was it paragraph 41, to have kicked into place, in other 5 words, that the relationship between the local people 6 and the region would be the key relationship. 7 Having said that, as I said earlier, the position 8 was a little confused here in that although the service 9 had been de-designated, there was a continuing national 10 interest because there was continuing national funding. 11 I am sure that Dr Doyle acted as he thought and in the 12 best interests of the system at that time. 13 Q. We have talked about the role of districts and 14 purchasers in supervising or attempting to begin the 15 scrutiny of quality. 16 A. Yes. 17 Q. Why is it that whether one is looking at the specifics 18 of what happened here or the more general guidance that 19 we have looked at in paragraph 41, that those purchasers 20 have no explicit place in the particular loop? 21 A. I do feel slightly hesitant in this area because I know 22 that the Inquiry will talk directly to Dr Ashwell and 23 Dr Doyle in detail about these points, but my 24 interpretation is that they behaved quite properly in 25 getting straight to the heart of the matter, going back 0096 1 to the Trust concerned, and there are references through 2 the correspondence of the discussions with Professor 3 Angelini, with the Medical Director at the Trust, and 4 with the Chief Executive. So in many ways, they behaved 5 exactly as I would expect a good regional public health 6 director to have behaved in other circumstances. 7 Q. Take it out of the specifics of Bristol and what 8 happened there. The more general question is, why, when 9 purchasers have at least an important role in attempting 10 to scrutinise, on an ongoing basis, the quality of the 11 services which they are purchasing, are they not a part 12 of this particular investigatory loop? 13 A. In the case of Dr Ashwell, we are back to this point 14 about before 1st April 1994, and after 1st April 1994. 15 Dr Ashwell essentially was the purchaser. In other 16 words, the purchasing role was a national one. At the 17 point of de-designation, you have rightly argued that 18 the purchasing responsibility was delegated, and 19 therefore in theory at least, Dr Doyle did not have the 20 same locus, i.e. he was not the purchaser. 21 But July was two or three months after 22 de-designation. We were in this sort of so-called 23 "steady state" period. The new arrangements for 24 contracting for the service would not have kicked in. 25 The funding was still central. My assumption -- and it 0097 1 is an assumption and you would need to discuss it with 2 him direct -- is that Dr Doyle behaved as if he was the 3 purchaser and, you know, my proxy for the Regional 4 Public Health Director. I think, in getting straight to 5 the point of a potential problem, in these circumstances 6 in real life, notwithstanding the sort of niceties on 7 lines of accountability, he behaved quite properly. 8 Q. The position on funding is slightly less black and white 9 than the straightforward responsibility of the 10 Department of Health in that the Department of Health 11 funded the under 1s. It did not fund, and districts 12 funded, therefore, the over 1s, so there was always 13 a mixed responsibility for funding. Does that make any 14 difference to the answer you gave? 15 A. I think it is possible to mount an argument that someone 16 in that position, as well as getting in touch with key 17 clinicians and the Chief Executive of the Trust, should 18 also have spoken to the key health authorities. But 19 I do not think I should stand on judgment on that 20 point. I think it is for Dr Doyle to explain why he 21 handled things in this way. 22 Q. Just one final point, then, on your statement. Page 22, 23 the very last line: 24 "The then Secretary of State, Stephen Dorrell, to 25 hold an Inquiry." 0098 1 Is that correct? 2 A. I think that Frank Dobson set up the Inquiry, but 3 I think a decision had pretty well been made in 4 principle to have some sort of Inquiry, if not the 5 Public Inquiry as it is currently framed. This, of 6 course, was an issue that got caught up in the period of 7 sort of purdah leading up to a general election. So 8 I think there was no doubt in my mind, had 9 a conservative government been elected in 1997 and had 10 Stephen Dorrell been the Secretary of State and had the 11 General Medical Council -- because you will remember 12 that the decision on the exact nature of the Inquiry 13 depended on the outcome of the GMC hearings -- reached 14 the conclusion that he reached, he would likely have 15 taken the same decision. He certainly was clear that an 16 inquiry had to take place; the exact nature of that was 17 determined when we knew the outcome of the GMC hearing. 18 So I stand by my reference there, just and no 19 more. 20 Q. One further matter, Sir Alan -- my final questions are 21 never final! 22 If we could look at UBHT 61/293, please, this is 23 a meeting held after events in Bristol had, as it were, 24 come to light or been the subject of public controversy 25 and various people attended from the South West Regional 0099 1 Health Authority, from the UBHT and from the NHS 2 Executive. 3 A. Yes. 4 Q. Are you able to help us on who chose those attendees, or 5 the bodies which they represented? 6 A. No. I think it would be a sort of self-selecting 7 group. The Chair of the South and West RHA as it then 8 was, Rennie Fritchie, was very active. I would imagine 9 that she, with the support of her public health 10 director, later Dr Scally, would have wanted to have 11 this discussion. Dr Doyle clearly had a stake in it 12 from the Department of Health's point of view, for all 13 the reasons we have been discussing. Miss Nisbet who is 14 mentioned there, had some specific responsibilities at 15 that time in relation to handling this sort of difficult 16 issue. I remember, for example, she handled extremely 17 well the whole Beverley Allitt affair. Mr Flynn was 18 there, I suspect, in administrative support to 19 Miss Nisbet. 20 Q. Is that an answer based on your knowledge of the persons 21 concerned rather than any direct knowledge of how this 22 group was put together? 23 A. I am making assumptions. 24 Q. And are you able to help us, then, as to why the group 25 that are not represented in that list of attendees are 0100 1 the local purchasers? 2 A. We are back to this question of the grey area between 3 1994 and 1996 and the attitude that you could argue 4 everyone on this list took to the purchasers. We are 5 talking here about more than one Health Authority. 6 I think with the benefit of hindsight, not knowing 7 precisely, having not been directly involved in the 8 dynamics at the time, with the benefit of hindsight, 9 I think you have argued me quite clearly into a position 10 where it would have been better to have some sort of 11 representative of the purchasers there in the loop, as 12 it were, even if it were only in the information loop. 13 Q. But what it appears to indicate -- 14 A. I could mount an argument that says that the Regional 15 Health Authority has direct management responsibility 16 for the purchasers, or a direct management relationship 17 with health authorities; that there were a number of 18 them and that the Regional Health Authority, by virtue 19 of their responsibility, was taking the overview on 20 behalf of the purchasers, but I do not think that stacks 21 up in anything other than theory. I think you have 22 highlighted quite well today that the purchasers, 23 perhaps, should have been in the loop. 24 Q. And that if they were not, it represents a continuing 25 attitude to this being a supra-regional service with 0101 1 direct Department of Health and Regional involvement, 2 rather than purchasing involvement; is that right? 3 A. I think that is right, but of course, by this time it 4 was not only an issue of concern to the Department of 5 Health because it had been a supra-regional service; it 6 was an issue because of the circumstances that emerged 7 in early 1995 and all that happened between Dr Doyle and 8 the Trust and the later involvement of senior officials 9 in the Department of Health early in 1995. So it had 10 become an issue not just about contracting, but a real 11 issue of concern about the quality of clinical practice 12 in one of the major hospitals in the region. 13 MISS GREY: Thank you, Sir Alan. The Panel may have some 14 questions for you. 15 THE CHAIRMAN: Sir Alan, Professor Jarman. 16 Examined by THE PANEL: 17 PROFESSOR JARMAN: Just to take out the business about why 18 the purchasers were not in the loop and responsibility, 19 we have heard on Days 10, 11 and 12 from the people 20 within the SRSAG that they really considered it was the 21 local authority that was responsible for monitoring 22 services. That was Mr Owen, Mr Gregory from Wales, CMO, 23 and then later on we heard from Mr Nix and Deborah Evans 24 locally that they felt it was the public health people. 25 Then we heard from the public health consultant 0102 1 that he really thought it was the SRSAG. So it appeared 2 to be going around in a circle, responsibility. The 3 purchasers, as we have just been discussing, were not in 4 it. 5 Do you think that the reason for that problem 6 might have been that it was, as you yourself said 7 earlier on, a tertiary referral, in that the secondary 8 referrals were actually the purchasers of the tertiary 9 referral and were not actually looking into it? 10 A. That could have been a reason, although, as I remember 11 it, there were quite clearly established protocols for 12 handling referrals from secondary care physicians to 13 tertiary services. Indeed, I remember in the early 14 stages of these changes, that whole thing being rather 15 controversial, because it involved very sophisticated 16 clinical decisions and quite a lot of money. 17 I must say, I think the reason behind this is 18 a lot simpler and that is that there was confusion and 19 that the distinctive roles and responsibilities of each 20 of the players was not adequately clarified. I think 21 that the Department of Health, the NHS Executive in 22 particular, must take some responsibility for that. It 23 falls into my category of systemic failure. You cannot 24 expect people to behave sensibly in this position unless 25 they are absolutely clear where they fit in. 0103 1 So I think the position is as described, I think 2 there was a failure there, a confusion. 3 Q. Just to take that further, that may be related to the 4 fact, as Sir Graham Hart said to us, that the NHS had no 5 proper measurement of the quality of care it was 6 providing. 7 I just wonder whether you feel that the reason for 8 confusion you mention and the lack of proper measurement 9 that he mentioned could have been related to the fact 10 that, as he said, ministers were unwilling to get 11 involved in dealing with the profession, the medical 12 profession particularly, with regard to matters of 13 clinical performance? 14 A. I think I would separate the points. I hold up my hand 15 to the fact that there was confusion here. There is no 16 denying it. The fact that I have not been able to 17 adequately explain it today or cover it effectively in 18 my statement suggests that there was confusion. I think 19 that is wrong. I think that I and the NHS Executive 20 should take responsibility for that. I could mount all 21 sorts of things in mitigation about how busy everybody 22 was at the time and what a terribly complex change it 23 was, but I do not. I think it is wrong that these roles 24 and responsibilities were not clarified. 25 On the subject of proper measurement, I am 0104 1 conscious of the fact that this is an area you know more 2 about than I do, but I think there is a separate point 3 there, which is that services like this all around the 4 globe are trying to find effective forms of 5 measurement. I think we are towards it in the data 6 sets, the audit processes that I described earlier in 7 relation to cardiac surgery. 8 So I would want to separate the two points. 9 Q. There was a third point. 10 A. On the third point about the attitude of Ministers, 11 well, again, I think it depends on timing. I can never 12 remember a situation where Ministers said "We are 13 reluctant to get involved in the clinical processes". 14 But I do remember a culture where it would have been 15 unusual for Ministers to get involved in the detail of 16 clinical activity, but equally, in this period of the 17 early 1990s, there were some very dramatic cases, for 18 example in relation to mentally ill people where 19 Ministers did intervene and did want to see very fast 20 improvements in service and did require the NHS 21 Management Executive, as it then was, to behave in 22 a managerial way. 23 I would think that position is now more pronounced 24 and that current Ministers have no hesitation about 25 intervening in areas where they feel, rightly in my 0105 1 view, responsible and where they feel they have to act, 2 so that the actions they have taken in reinstating the 3 very important quality assurance arrangements in 4 relation to the breast and cervical screening services 5 I think was an absolutely justifiable intervention, 6 which no clinician in their right mind could have 7 suggested was inappropriate. 8 So I think attitudes have been changing over time, 9 and I think that really the point I want to get across 10 here is a sort of evolutionary point: that through all 11 of this, the relationship between the government medical 12 profession and the public has been changing and I think 13 Sir Donald Irvine brought this out very well in some of 14 his evidence, which suggests that issues of public 15 accountability and self-regulation have to be in keeping 16 with the current public mood. They cannot somehow be 17 rooted in the past or in sort of romantic notions of 18 clinical freedom in a bygone age. We are living in 19 a different world. 20 Q. I was just thinking of the time of the Inquiry that we 21 are meant to be looking into, the early part of it, and 22 I was wondering if you thought that might have been 23 a factor then? 24 A. I think there were other examples around that time where 25 there were concerns about the quality of clinical 0106 1 services, where Ministers used the route of the NHS 2 Executive or Regional Health Authorities or whatever 3 levers were at their disposal to intervene. I do not 4 think they were inhibited in any way by the fact they 5 had no powers of direction over a Trust or that they 6 were "treading on eggshells" with the medical 7 profession. I think that attitudes of Ministers have 8 changed and have hardened on this issue, for very good 9 reason, but I think it is too simple to say that there 10 was a sort of hands-off approach at that time. It is 11 not how I remember it. 12 Q. Just the final point: in 1986 I think it was, we were 13 told on Day 10, Dr Gregory, the CMO of Wales, mentioned 14 that he had heard about problems at Bristol paediatric 15 cardiac surgery and he mentioned this to the CMO of 16 England. 17 A. I am sorry, Gregory is the Chief Executive. Crompton 18 was the Chief Medical Officer. 19 Q. Director of the NHS in Wales. 20 A. Not the CMO. Peter Gregory is the Chief Executive. 21 Q. I am sorry, it was Peter Gregory, I think it was, yes. 22 A. He is the Chief Executive. 23 Q. It was Crompton, I apologise, who -- you know more about 24 this than I do. It was Crompton who was the CMO of 25 Wales who mentioned to his counterpart, the CMO of 0107 1 England, that he had heard about problems at Bristol? 2 A. Yes, in 1986? 3 Q. In 1986, yes, but the Department of Health only heard 4 about it in 1992, I think he said. 5 A. It is not a matter I can shed any light on. That is at 6 least two or three CMOs ago. I was busying away in 7 Harrow Health Authority in 1986, so I am not aware of 8 that, other than what I have read in the transcript of 9 this hearing. I think we need to ask the persons 10 directly involved. 11 PROFESSOR JARMAN: Thank you. 12 THE CHAIRMAN: Sir Alan, there are a couple of questions 13 I would like to put, very briefly. You were talking 14 with Miss Grey about the responsibility as between the 15 employer and professional bodies in terms of seeking to 16 maintain appropriate performance and service. You 17 mentioned that the GMC, the UKCC was having 18 responsibility. You said, as a kind of sweep-up point 19 at the end, that, yes, you could see there was room for 20 both. 21 I want to know what that means in the sense of, 22 are you saying that while the employer does have, as it 23 were, responsibility, so may also the professional body, 24 or are you saying it may be divided between them, 25 because if it is of course the latter, we then have the 0108 1 opportunity for both to point the finger at the other. 2 A. I think they have to operate in a complementary way. 3 Let me explain that by one current example. The 4 employers, health authorities and Trusts, are required 5 to introduce systems at the moment of clinical 6 governance. They have to have a commitment, they have 7 to install systems to ensure they continuously improve 8 services and safeguard the quality of services, and 9 safeguard high standards. That is a right and proper 10 thing for them to do. 11 At the same time -- and that will be 12 system-wide -- the GMC are introducing the new system of 13 revalidation that Sir Donald Irvine explained, which is 14 actually about the practice of individual clinicians. 15 I think these are complimentary contributions from the 16 system, ultimately the employers, the statutory bodies, 17 and the regulatory authority, and I think that the 18 President of the GMC and I, and in this case the Chief 19 Medical Officer, have an absolute responsibility to 20 ensure that these things work hand-in-glove. 21 So we are back to the point I was labouring: I do 22 think it is very easy in this sort of thing to try and 23 pin responsibility on one person or one event. Life is 24 rarely as simple as that. The important thing is about 25 the roles and responsibilities of individuals and 0109 1 individual organisations and the contribution they make 2 and whether they match up to their responsibilities. 3 Q. It was precisely that last point I was pursuing, that 4 clarity, because I was saying, was it exclusively with 5 the employer, with the professional bodies having some 6 other responsibility, or shared between them, because 7 you have now used the word "complementary", and Sir 8 Graham Hart used the words "shared responsibility". 9 These are terribly helpful expressions, provided 10 everybody knows what is complementary and what their 11 role is, or in Graham Hart's language, what share do 12 I have to deal with? I was not entirely sure from your 13 answer whether necessarily people would know what the 14 range of responsibility was, and if they were not aware 15 of it, it would be open to them, without in any way 16 blaming them, to say "That was not my bailiwick, that 17 was someone else's"? 18 A. Well, again, just to pursue an example, I think the GMC 19 guidance on good medical practice, the 1998 version 20 I had a look at last night, this document (indicating) 21 is excellent. I do not think any intelligent doctor 22 reading this could fail to see what his or her 23 responsibilities were. 24 Equally, I think if the Department of Health, 25 through the NHS Executive, is introducing a system of 0110 1 clinical governance, putting a new emphasis on national 2 standards, introducing new monitoring arrangements in 3 the Health Service, continuing the development of audit, 4 trying to improve record-keeping, doing all of these 5 things, that part of the responsibility of taking these 6 policies forward into implementation is to win the 7 support and the commitment of people working in the 8 service, and you will only do that if things are 9 explained to them and if everyone knows exactly where 10 they stand in relation to these policies. 11 We have seen an example today in the discussions 12 about the District Health Authority's role, about how 13 confusion can creep in if these things are not 14 adequately defined. 15 So I am all for explicitness in this. 16 Q. Can I in my final question to you, press you a little 17 bit on that: what would you say to the cynic who said 18 that clarity of responsibility, defining who does what 19 and who is responsible for what, is an interesting 20 managerial response, but is it managerially astute 21 enough because the astute manager must take account of 22 the culture in which those lines of demarcation have to 23 operate. The culture here is of very powerful beasts in 24 the jungle, historically guarding their territory, and 25 therefore, to define what are lines of responsibility 0111 1 may not be enough, unless you get those who have 2 allocated to them certain responsibility, to accept it? 3 A. I think that is right. I think it is also possible, 4 just to turn your point on its head, that these changes 5 and clarity of definition around these changes can 6 assist in changing the culture, so we are into very 7 difficult territory here, but I have absolutely no doubt 8 that the professional bodies in this country, some may 9 say belatedly, others may say as part of the natural 10 evolution, are now determined to reform and to take 11 these issues of quality improvement and quality 12 assurance head-on in a way that was unthinkable five or 13 six years ago. 14 We started this morning by using the phrase 15 "clinical freedom", not a phrase I have heard in the 16 Health Service for nearly ten years. My strong sense is 17 that the government and therefore the system, is 18 committed to change; that the professions are committed 19 to change, and the thing that is driving both of them is 20 changing public expectations, because I think the public 21 are demanding change, and protecting the public interest 22 in all of this has to be our motivation. 23 THE CHAIRMAN: Sir Alan, thank you. I hear what you say 24 about "clinical freedom". I would invite you to go back 25 and look at the early days of our transcript. The room 0112 1 echoed with the phrase. But there it is. We may of 2 course have been talking in a historical context. 3 Mr Pirani? 4 MR PIRANI: I have no questions, thank you, sir. 5 THE CHAIRMAN: I am very grateful to you. Sir Alan, we are 6 enormously grateful to you for coming and talking to us 7 today. We have learned a very great deal from you, and 8 we are deeply in your debt. A number of matters have 9 come up which we would value your further help on, and 10 a note has been taken, I am assuming, of those, and you 11 will be in touch with us in due course. 12 Equally, as Miss Grey may have said, and I would 13 say anyway, if there are other additional matters which 14 come up which you may wish to draw to our attention, 15 then, again, we would like to hear from you, but for 16 today, at least, thank you very much indeed. 17 SIR ALAN LANGLANDS: Thank you very much. 18 MISS GREY: I will hand over to Mr Langstaff. 19 THE CHAIRMAN: Mr Langstaff, I look to you, but equally 20 I look to those who support us. I think your proposal 21 is that we go on for about half an hour more, but 22 I think it would be perhaps advantageous to take 23 a 10 minute break before we do so. I understand the 24 next witness will not detain us for terribly long, but 25 advise me, please. 0113 1 MR LANGSTAFF: Sir, he will be about 30 or 40 minutes, 2 I expect. I know he is keen we should finish his 3 evidence at an early stage, if that is possible. 4 THE CHAIRMAN: I am going to propose a 10 minute break and 5 therefore to come back at 1.15. 6 (1.05 pm) 7 (A short break) 8 (1.15 pm) 9 MR LANGSTAFF: Sir, now we have Mr Paul Forrest, Her 10 Majesty's Coroner for the District of Avon. Mr Forrest, 11 if you would not mind standing for the oath? 12 MR PAUL FORREST (SWORN): 13 Examined by MR LANGSTAFF: 14 Q. Can I have WIT 308/1 on the screen, please? Mr Forrest, 15 you are Her Majesty's Coroner for the District of Avon? 16 A. Indeed, I am. 17 Q. And that means that you are an independent judicial 18 officer presiding over a court of record? 19 A. Indeed. 20 Q. You have made for us a statement, have you, which 21 begins, if you look at the screen to your right, at 22 WIT 308/1, the first page of the statement, is it? 23 A. Yes, indeed. 24 Q. If we go to page 3, that is the end of the statement? 25 A. Yes. 0114 1 Q. The contents of it I think you are happy to adopt as 2 your evidence before us? 3 A. Yes. 4 Q. There is one alteration, or one addition which I think 5 you want to make, page 2. If we could scroll so that 6 the very last paragraph is in the middle of the page, if 7 we can highlight the paragraph which reads: 8 "From my records I can say that nine deaths were 9 reported to me ...". 10 A. Yes, that is related to the switch operation solely. 11 Q. So it was nine deaths relating to the switch, and very 12 many more relating to deaths in hospital? 13 A. Indeed. 14 Q. Of which a number we have already heard were deaths in 15 respect of children who had suffered from congenital 16 heart conditions? 17 A. That is right. 18 Q. You became the Coroner in this district I think, as 19 Acting Coroner in December 1991? 20 A. That is correct. 21 Q. And became full-time in July 1992? 22 A. Yes. 23 Q. The Coroner before you was Mr Donald Hawkins? 24 A. Yes, indeed. 25 Q. You have seen I think a copy of the statement which he 0115 1 has provided to the Inquiry? 2 A. I have this morning, yes. 3 Q. What do you say about its contents? 4 A. I agree them and confirm them as far as I am able to, as 5 the procedures that were carried out. I was aware of 6 that Home Office Circular, as all deputies were at the 7 time, and I was aware of his dealing with the matter and 8 I sought to carry that on myself. 9 Q. I will ask you about the Home Office Circular in 10 a moment, if I may. Just one matter, which has inspired 11 some documentary evidence before us. I do not know if 12 you will be able to comment or not. If we can have on 13 the screen UBHT 308/50, this is 1986. It is a letter 14 from Dr Berry, whom I think you know? 15 A. Yes. 16 Q. To Dr Parker, Head of the Homograft Department. The 17 context is that he had written to Dr [as he was] Berry, 18 seeking the use of what you might call "tissue spare 19 parts" for the National Heart Hospital. 20 The reply, the second sentence, the second line: 21 "Our Coroner in Bristol [this would have been 22 Mr Hawkins] will quite properly not allow us to take 23 tissues from cases in his jurisdiction without consent 24 of the relatives, which can usually not be obtained." 25 A. Yes. 0116 1 Q. The first question: was that, as far as you know, 2 Mr Hawkins' approach? 3 A. Yes. 4 Q. Rule 9 of the Coroners' Rules -- perhaps again, for 5 clarity, we should have that on the screen. It is 6 WIT 43/48, the top of the page: 7 "A person making a postmortem examination shall 8 make provision, so far as possible, for the preservation 9 of material which in his opinion bears upon the cause of 10 death" and these words, "for such period as the Coroner 11 thinks fit." 12 A. Yes. 13 Q. That gives the Coroner a discretion, does it? 14 A. It gives the Coroner a discretion, but only in the 15 context of an inquest arising, in my judgment. 16 Q. In your judgment, yes. Why do you take that particular 17 view? 18 A. The fact that the rules were made first of all by the 19 Lord Chancellor for setting up the question of 20 postmortems; and secondly, for the conduct of an inquest 21 by the Coroner. Those rules were specifically for 22 that. When, as I think I have explained, a matter 23 becomes a natural cause, the powers of the Coroner 24 cease, become functus officio, and therefore those rules 25 also cease. 0117 1 Q. So the line, as you see it, is that a death -- for these 2 purposes, if I focus upon a death in hospital -- may be 3 reported to you and probably will be reported if it has 4 occurred within 24 hours of surgery? 5 A. Indeed, yes, that is quite right. 6 Q. Where that has happened, then you would expect to ask 7 for a postmortem, and you would -- 8 A. Provided of course I am not given a precise medical 9 cause of death. 10 Q. And a postmortem will establish a medical cause of 11 death? 12 A. Indeed. 13 Q. If it appears to you that that is natural causes, in the 14 sense of a condition requiring operative treatment which 15 has led to death rather than some rather more dubious 16 event having happened, you will then inform the 17 Registrar accordingly? 18 A. Indeed, yes. There has to be evidence to the contrary. 19 Q. Having informed the Registrar, that is it, so far as you 20 are concerned? 21 A. It is indeed, yes, and there is judicial authority for 22 that, of course, as I mentioned in my statement. 23 Q. You see this as coming into play if in fact there is 24 some evidence that it is not natural causes and then the 25 material, the tissue, whatever it is, may need to be 0118 1 kept. That is when you would expect to prescribe how 2 long or what tissue needs to be kept? 3 A. That is right, if histology is required, or 4 a histological box. 5 Q. In 1989, can we have WIT 43/153, there was a Home Office 6 newsletter, number 11. This would have gone to 7 Mr Hawkins? 8 A. Yes. 9 Q. Paragraph 12: 10 "We still receive representations from MPs and 11 members of the public about the fact of postmortem 12 examinations or their extent. Invariably, our reply is 13 that postmortem examinations are required only to 14 establish the precise cause of death; they are not 15 requested or granted gratuitously", you reference a case 16 which establishes divisional authority for that, "and 17 are limited in extent to that necessary for the purpose. 18 You will wish to remind your pathologist that ministers 19 are concerned that tissue and organs should not be taken 20 for teaching or research purposes from Coroner's 21 postmortem examination cases." 22 You are nodding. I have to say that, because 23 there is a transcript being made. 24 A. Yes, of course. 25 Q. So this was Home Office guidance to Coroners? 0119 1 A. Yes, it was. 2 Q. And do you know what approach Mr Hawkins took to this? 3 A. Yes, indeed. He made sure that those departments were 4 well aware of the contents of this newsletter. 5 Q. So far as you were concerned, did you ever find it 6 necessary to mention the contents of this newsletter to 7 any of the departments with which you were concerned? 8 A. Yes, I did -- not this particular hospital, but I have, 9 even recently, had to remind a department of this, that 10 they are not to use a coroner's umbrella for the 11 retention of organs where a precise cause of death had 12 been established. The family were up in arms in that 13 particular case, and quite rightly so. 14 Q. So if anyone had asked you whether they could keep 15 tissue or organs after a post-operation Coroner's 16 postmortem, you would have said no? 17 A. That is right. 18 Q. The pathologist who would conduct the postmortem for 19 you, a Coroner's postmortem, is instructed by the 20 Coroner? 21 A. Is instructed by the Coroner and employed for that 22 purpose by the Coroner. 23 Q. So he is your agent? 24 A. He is my agent, or she is. 25 Q. And would it follow, as you see it, that he or she would 0120 1 have no better right to keep the tissue following 2 establishment of the cause of death than you have? 3 A. Exactly, the power which is vested in me, as long as it 4 exists, but if it ceases, then any power that the agent 5 has also ceases. 6 Q. You have seen I think today, at UBHT 308/18, a letter 7 which is written from Professor Berry to Mr Dhasmana. 8 We have seen it before in this Inquiry, but if I just 9 scroll down: 10 "I know we have discussed this issue before, but 11 increasing pressure from the Coroner's office and the 12 Department of Health, as well as the Royal College of 13 Pathologists, means that we must put our house in order. 14 "When we last discussed this matter, it was left 15 that you would ask your patients' permission for us to 16 retain cardiac tissue from Coroner's postmortems. You 17 will recall that a pathologist is only allowed to retain 18 tissue for the purposes of establishing the cause of 19 death, and that for the Coroner's purposes, the cause of 20 death can be general." 21 There is no difficulty in hospital postmortems 22 because of the consent form. It says: 23 "In future, we will not be able to retain the 24 hearts unless there is a signed statement in the notes 25 from one of the doctors looking after the child that 0121 1 they have satisfied themselves that the parents of the 2 child do not object to retention of tissue during the 3 course of the Coroner's postmortem examination." 4 A. Yes. 5 Q. Can you help with the increasing pressure from the 6 Coroner's office? Let us scroll back up to the top of 7 the letter and remind ourselves of the date: 6th August 8 1992. 9 A. Yes. 10 Q. This would have been one month after you took up office? 11 A. Yes, although I had been acting for six months before 12 that, of course. 13 Q. Do you recollect the context of this? 14 A. No, I have never seen this letter. I did not know it 15 existed until this morning when it was shown to me. 16 I cannot recall specific cases of seven years ago, but 17 it must have arisen on the retention of an organ which 18 had caused distress and disquiet, when I intervened. 19 It does arise from time to time and I have to 20 intervene. It is obvious at that stage it was 21 occurring. 22 Q. There was a response to a similar letter written to 23 Mr Wisheart which we can pick up at UBHT 308/170. 24 On 9th September he writes back: 25 "Thank you for your letter of August 6th ...", the 0122 1 same letter we have just seen, only addressed to 2 Mr Wisheart, "which suggests we should be a little more 3 rigorous in stating that we have received the permission 4 of parents to retain part of the heart. I was slightly 5 surprised to receive this advice, as I had been recently 6 told by Dr Sheffield that this problem had eased 7 a little under the jurisdiction of the new Coroner." 8 Can you help with that at all? 9 A. Not at all. It is totally contradictory to the previous 10 letter and the attitude that I was taking. I cannot 11 understand that at all. 12 Q. The previous Coroner, Mr Hawkins -- let me put this 13 delicately: had he enjoyed the best of relationships 14 with the Bristol Royal Infirmary? 15 A. No. 16 Q. Would you say that your own relationships were rather 17 better? 18 A. Yes. I hope so anyway. 19 Q. So it may be that you cannot comment, nor can I without 20 knowing what the content of the conversations were, but 21 one possibility, presumably, is that Dr Sheffield has 22 indicated to Mr Wisheart that the relationship between 23 the hospital and the Coroner's office has been rather 24 better since you took over, in general terms? 25 A. I suppose so, yes. 0123 1 Q. I suppose that there is an element, because one is 2 dealing with the sensitive and emotive issues of death, 3 of wanting to oil the wheels in the sense of helping 4 people to come to terms one way or another with the 5 tragedy that has happened? 6 A. Yes, indeed, that is quite right. 7 Q. You try to do that, I am sure? 8 A. Yes. 9 Q. In July of this year, the Royal College of Pathologists 10 published a consultation paper. Let us pick up the 11 first page of that to identify it: RCP 1/72. Go to 12 page 79, at the foot. Paragraph 4.3: 13 "Coroner's pathologists are expected to retain 14 tissues as follows ..." 15 Then it sets out rule 9. 16 If we go overleaf: 17 "In every case... the pathologist should seek the 18 express consent of the Coroner for the preservation of 19 tissue and for how long that should be." 20 It says the Coroner may make certain enquiries. 21 "This is not without difficulty. Each case will 22 have to be considered carefully. In certain 23 circumstances... clear in advance of the examination 24 that large tissue samples or even complete organs should 25 be retained". 0124 1 4.4 speaks for itself. 2 A. Yes. 3 Q. 4.5, it makes some recommendations: 4 "Where the pathologist is instructed to perform 5 a postmortem examination, the probable need for the 6 retention of tissue should be discussed with the 7 Coroner." 8 Pausing there, that is a recommendation. Has it 9 been, until the summer of 1999, general practice or 10 not? 11 A. Sometimes, but not really general practice. 12 Q. Occasional practice rather than general practice? 13 A. Yes. One is dealing with 4,300 cases a year, on 14 average. 15 Q. In terms of the hospital cases -- because you must get 16 a number of cases arising out of industrial or traffic 17 accidents? 18 A. Certainly. 19 Q. In terms of the hospital cases, are you generally 20 approached and spoken to, or generally not, before the 21 summer of this year? 22 A. No. 23 Q. So generally not? 24 A. Generally not. Not personally. There may have been 25 some discussion with my Coroner's Officer which I may 0125 1 well be unaware of. 2 Q. So nothing has reached you about pathologists saying, 3 "Can I keep some tissue or an organ?" 4 A. It is curious. In the case I mentioned just now, it 5 specifically had been mentioned in the report that an 6 organ had been retained for further investigation, when 7 the clear cause of death had been established. So that 8 is one example. 9 Q. The point that you would make, because a clear cause of 10 death had been established -- 11 A. -- was that there is no necessity in retaining that 12 organ, unless the specific consent of the family had 13 been obtained, for the purposes of research or teaching, 14 then I had no purpose of retention of the organ for my 15 own purposes. 16 Q. Whether the consent had been obtained or not, would not 17 be a matter for you? 18 A. No, but I ensured on this occasion that it had been 19 obtained before such retention could occur. 20 Q. Because otherwise, presumably, the purpose of having the 21 tissue retained is if, for instance, there is to be 22 a murder trial or something of that ilk? 23 A. Precisely, or death by dangerous driving, as may well 24 have occurred in this case, yes. 25 Q. "(b) Coroner's autopsy reports should state when whole 0126 1 organs have been retained and the reasons given in the 2 report." 3 A. Yes. 4 Q. Let me just pause there and interpose, on top of this 5 image, what we have as WIT 43/60. It is the schedule to 6 the Coroners Rules which you would be very familiar 7 with, and demonstrates the form of postmortem 8 examination report which is recommended by the rules. 9 A. Yes. 10 Q. If we go overleaf and scroll down a little bit: 11 "Is there any further laboratory examination to be 12 made which may affect the cause of death; Yes or No"? 13 A. Yes. 14 Q. Is that the only place that there is on the existing 15 form to indicate that tissue may have been retained? 16 A. Yes, that is right. 17 Q. So if there is a "Yes", you would know that some tissue 18 had been retained? 19 A. Yes. 20 Q. If there is a "No" it has not, obviously? 21 A. That is right. 22 Q. But nothing to indicate whether it is a whole organ or 23 whether it is a slide? 24 A. No, nothing at all. Sometimes it might be mentioned, 25 but not always. 0127 1 Q. But there is nothing which requires its mention? 2 A. No, nothing requires it at all. 3 Q. If we go back to what the Royal College of Pathologists 4 are recommending, RCP 1/79, and go overleaf, 81,down to 5 (b), that is the recommendation. It goes on about 6 disclosure arrangements needing to be discussed and the 7 Coroner's relationships with the relatives? 8 A. Yes. 9 Q. "(c) If retention of tissue or organ which is not within 10 the remit of the Coroner's postmortem examination 11 appears desirable, signed consent from relatives is 12 essential. The Coroner's authorisation must also be 13 sought. It is only where there are good grounds for 14 refusal that the Coroner's authorisation may be 15 withheld. Coroners may forbid such extra samples to be 16 taken even when the relatives consent, but cannot 17 authorise them without their consent". 18 A. You have to be clear in which context that goes in on 19 the basis of "in matters and where an inquest has 20 arisen". 21 Q. So this again is talking really about the inquest case 22 rather than the non-inquest case? 23 A. Yes, all the way through I have noticed there has been 24 a complete confusion in my mind, my judgment, as to what 25 is relevant in relation to a natural cause death and 0128 1 what is relevant in relation to an inquest. It seems to 2 be a subsumption or assumption that everything follows 3 in respect of an inquest only. 4 Q. Since these guidelines have been published, leave aside 5 the Bristol Royal Infirmary for a moment, speaking 6 generally, have you noticed any change of practice in 7 pathologists? 8 A. Not really, no. As I say, I have recently had cause to 9 act. 10 Q. So far as the BRI is concerned, have you noticed any 11 change of practice? 12 A. Yes, it has improved greatly. 13 Q. So compared to what it was, the BRI is now much better? 14 A. Yes. 15 Q. Could you, in a couple of sentences, explain how it used 16 to be; what was not as good as it is now? 17 A. No, it is not so easy. The question of retention of 18 tissue has not arisen, using the "Coroner's umbrella" 19 for an excuse. Secondly, the form used and formulated 20 under the time of my predecessor was slightly lacking in 21 information. It was the minimum, as you saw on the 22 recommended notes to the rules, and I have asked for 23 that to be expanded to come in line with the other four 24 pathology departments I have in my jurisdiction, to 25 assist the families, because quite often questions will 0129 1 arise and if you just have a minimum sentence describing 2 something, that does not help. That they have now 3 fallen in with, I am pleased to say and further 4 information is now given by the pathologists to assist 5 the families and they can go and talk to their GPs. 6 I cannot answer, not being medically qualified, but they 7 can go and talk to their GPs because we send a copy to 8 them. They can go and discuss it in greater detail. 9 Q. Again, that is something the Coroner does not have to 10 do? 11 A. No. 12 Q. It is something you do to assist -- 13 A. It is something which is my practice, yes. 14 Q. In your statement, just picking up one or two points 15 which we may not already have dealt with, you tell us -- 16 let us go back to WIT 308/1; it is right down the bottom 17 of the page -- that the Coroner has no power to retain 18 nor release organs removed at postmortem. 19 We have looked at rule 9 and you have explained 20 the very limited circumstances in which authorisation 21 might arise under that? 22 A. Yes, right. 23 Q. I suppose, although it may be said that it is not really 24 your concern legally what happens once the postmortem is 25 finished because that is the end of your official 0130 1 involvement, is it a clear area or a grey area, would 2 you say, as to who has the power to do what with -- 3 A. It is a very grey area. It gives one judicial 4 discretion, but it has never really been interpreted 5 judicially. It is a very grey area, because the 6 practice from Coroner to Coroner does vary considerably 7 in relation to that rule. 8 Q. To Rule 9? 9 A. Yes. It is very unsatisfactory. That is why I try to 10 have my clear-cut rule to try and bring some definition 11 to it. 12 Q. Is it something that you would hope that sooner rather 13 than later was clarified by those who have the ability 14 to lay down rules? 15 A. Yes, and indeed, the whole question of being functus as 16 well, which was "funked" by the Divisional Court 17 recently when I asked for a view on a certain matter! 18 It was sidelined unfortunately, so that failed. 19 Q. Did you, at any stage, get the idea that despite your 20 approach to the retention of tissue, pathologists at the 21 Bristol Royal Infirmary or the Bristol Children's 22 Hospital were in fact retaining organs after they had 23 performed a postmortem which you had authorised? 24 A. No. The first we heard was when actually a complaint 25 was lodged, which came via my Coroner's Officers 0131 1 I think. I cannot remember exactly when that was, but 2 it was certainly after 1995, I think. 3 Q. We think it may have been 1996. 4 A. Yes, that is right. 5 Q. And Miss Rickard? 6 A. That is right, yes. It was not the one that got all the 7 publicity, I recall, it was another one. 8 Q. You say that having become aware of that, steps were 9 then taken to change the processes at the BRI and you 10 think with some success? 11 A. Yes. 12 Q. Although I gather from what you are saying, you rather 13 wish that other hospitals under your jurisdiction took 14 the same approach? 15 A. Yes, one or two, who shall be nameless. 16 Q. I shall not ask you further about that. If you give me 17 one moment. (Pause). There is one further matter which 18 I should deal with. 19 Mr Wisheart took the view, he told us when he gave 20 his evidence, that you, he thought, did not require 21 consent for the retention of tissues to be recorded 22 before tissues were retained, whereas Mr Hawkins had. 23 Is he right or is he wrong about that? 24 A. No, I continued the same protocol, if you like to call 25 it, as my predecessor. There is no change. I did not 0132 1 make any specific change at all. 2 MR LANGSTAFF: I have not asked you anything in general 3 terms about the coronial system and the function which 4 you feel it not only plays but should play. If you 5 would wish to say anything more about that, or indeed 6 about any other matter that you have discussed in your 7 evidence before us, now is your chance to volunteer it 8 and say it, if you want to do so. 9 MR FORREST: Thank you very much. Matters are still 10 formulating in my own mind, but I have been long of the 11 opinion that the Coroner system really does need 12 fundamental reform. 13 It was forged in Victorian times, with Victorian 14 values, and successive Acts of Parliament have drawn our 15 teeth over the years, particularly over the last 20 to 16 30 years. The idea, I gather, was to remove controversy 17 from the Coroner's court. In my own opinion and 18 judgment, it has fuelled it, because, as I stated at the 19 beginning of my statement, those questions which are set 20 out at paragraph 1 are the only questions to be 21 answered. 22 Judicially we have been instructed that there is 23 no question of why or how a person died, but the 24 circumstances surrounding the death. We cannot deal 25 with culpability. Although we do deal with matters only 0133 1 dealt with by a High Court Judge, murder, manslaughter, 2 we can bring in a verdict or the jury can bring in 3 a verdict of unlawful killing as long as you do not name 4 anybody. That is a qualifying prohibition. No verdict 5 should be framed in such a way as to presume to attach 6 civil liability, which is an absolute prohibition. 7 Quite often families leave the Coroner's court 8 bewildered that we have not been able to answer the 9 questions that they have foremost in their minds, 10 because of the constraints by law on the system. 11 It occurs quite often that people just really do 12 not understand -- lawyers, too, Divisional Court, the 13 Court of Appeal, if you like, still do not understand 14 fully the purpose of coronial law and the constraints we 15 have on it and that the rights of families are somewhat 16 severely limited, because it is Crown's inquiry and 17 nobody else's. I am a Crown Officer holder, I act on 18 behalf of the Crown. It is the Crown's inquiry, as the 19 inquest starts, "on behalf of our Sovereign lady the 20 Queen" and it is not the family's inquiry or anybody 21 else's. 22 To my mind it should be opened so that we can deal 23 with culpability, we can have a "professional cadre", 24 as somebody in the Home Office put it, as I have been in 25 correspondence, of full-time Coroners dealing on 0134 1 a circuit or regional basis with those more important 2 cases, so we can actually go to a conclusion, we can 3 deal with pleadings or we can be a clearing house for 4 the more serious criminal offences dealing with death, 5 which can then go on to the Crown Court dealing with 6 sort of pre-trial matters. 7 But these ideas are still formulating in my mind. 8 I still have not come to them yet, but I do feel that 9 the system as it serves now is inadequate. 10 Q. So the idea that you want to develop is ensuring 11 a greater consistency amongst Coroners by having 12 a circuit system, as it were? 13 A. Yes, that is right. 14 Q. And having a power to inquire properly, so if there were 15 some disaster or incident -- 16 A. That is right. We have no government department charged 17 with us at all. The Home Office has loose 18 responsibility. We are not employed by the Lord 19 Chancellor's Department, whereas professional judges as 20 we are, although we are professional judges employed 21 full-time, but we should be employed by the Lord 22 Chancellor and trained as Circuit Judges and High Court 23 Judges are now. 24 Q. I think you have in mind from what you were saying, what 25 you described as the rights of the parents or the 0135 1 relatives, that such a system would benefit, do you 2 think, them in what are distressing circumstances? 3 A. Most certainly, indeed, because there is nothing more 4 distressing than coming into the court and being totally 5 bewildered by the proceedings, angry, cross, wanting 6 questions answered, and not achieving it. I find this 7 wholly unacceptable. 8 MR LANGSTAFF: Sir, I have no further questions that I want 9 to ask of Mr Forrest. I do not think if the Panel have 10 any questions? 11 THE CHAIRMAN: There are no questions from the Panel, but 12 Mr Forrest, I want to make it clear that it may have 13 appeared a brief visit to us, but may I assure you, it 14 has been a most helpful contribution. We are very much 15 in your debt for what you have said, not least your 16 peroration at the end, and we shall take it away because 17 these are the things we have to think about as we move 18 towards recommendations for the future. 19 But for this morning, thank you very much indeed. 20 I am sorry we kept you waiting a while. 21 MR FORREST: Not at all. 22 THE CHAIRMAN: Mr Langstaff? 23 MR LANGSTAFF: Sir, may I mention tomorrow that we begin at 24 10 o'clock, to hear Sir Kenneth Calman. That time, we 25 hope, will be a time we shall keep to, but if I do not, 0136 1 the reason is that Sir Kenneth is flying down to 2 Bristol; his plane is scheduled to arrive at 9 o'clock, 3 so we are relying upon the accuracy of timing of the 4 airline rather than our own in-house timing. 5 THE CHAIRMAN: We wish him a safe journey. Good afternoon, 6 everyone. Good afternoon, Mr Langstaff. 7 (1.55 pm) 8 (Adjourned until 10.00 am on Wednesday, 20th October 9 1999) 10 11 12 I N D E X 13 14 15 CHAIRMAN'S STATEMENT 16 re Mr Lissack's application of 12.10.99 17 to recall witnesses ...................... 1 18 19 SIR ALAN LANGLANDS (sworn) ..................... 2 20 Examined by MISS GREY .................... 2 21 Examined by THE PANEL .................... 102 22 23 MR PAUL FORREST (sworn) 24 Examined by MR LANGSTAFF.................. 114 25 0137