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UNCORRECTED TRANSCRIPT OF ORAL EVIDENCE To be published as HC 151-iv House of COMMONS MINUTES OF EVIDENCE TAKEN BEFORE HEALTH COMMITTEE
PROFESSOR
SIR IAN KENNEDY, BARONESS YOUNG OF OLD and DR BILL MOYES
MR FINLAY SCOTT and MR STEVE WALKER MR GEOFFREY PODGER and PROFESSOR KENT WOODS Evidence heard in Public Questions 690 - 811
USE OF THE TRANSCRIPT
Oral Evidence Taken before the Health Committee on Members present Mr Kevin Barron, in the Chair Charlotte Atkins Jim Dowd Sandra Gidley Stephen Hesford Dr Doug Naysmith Mr Lee Scott Dr Howard Stoate Mr Robert Syms Dr Richard Taylor ________________ Witnesses: Professor Sir Ian Kennedy, Chairman of the Healthcare Commission, Baroness Young of Old Scone, a Member of the House of Lords, Chairman of the Care Quality Commission, and Dr Bill Moyes, Executive Chairman of Monitor, gave evidence. Q690 Chairman: Good morning. We are just a few minutes early, which is quite exceptional in my experience, sitting in this chair, so I think I am going to seize the opportunity and start a few minutes early as well. I wonder if I could ask you to give us your name and the current position that you hold? Baroness Young of Old Professor Sir Ian Kennedy: My name is Ian Kennedy. We cease working in 26 days. Dr Moyes: I am Bill Moyes; I am the Executive Chairman of Monitor, which is the regulator for foundation trusts. Q691 Chairman: Welcome to what is our sixth evidence session in relation to our inquiry into patient safety. I have got a question really for Ian and Bill to start with. How does patient safety now compare with ten years ago? Dr Moyes: Monitor has only existed for five years and foundation trusts have only existed for five years, so my perspective, I think, is more about today and the future rather than historical, which Ian will have a very firm grasp on, I am sure. Looking today, I am very cheered by Lord Darzi's report and by the focus on quality that he has put in his report. I am very optimistic about the ability of foundation trusts to translate that into reality with good, strong boards and a very, very strong focus on governance. So sitting in my seat and looking forward, I think I am quite optimistic about the future. Ian. Professor Sir Ian Kennedy: Thank you for inviting me. With your indulgence, I put in a supplementary paper and two other papers which are to be published next week and I was grateful to you for allowing me to do that. Certainly safety is now up the agenda in the NHS and also in the independent sector. The Healthcare Commission, I think, has played some role, but so have others. If I could draw a distinction between what I would call structural responses, which have been quite significant, the creation of the NPSA, the National Patient Safety Forum and other such exercises, Darzi's review, and so on, contrast that with cultural changes and behavioural changes and I think they lag behind in translating ideas into reality. At the same time I think it is proper to recognise that these are problems throughout the developed world in terms of the safety of patients, and this country, in my view, is leading both in thinking about it and beginning to do something about it. You heard a lot of evidence on November 20, I think, about how we lack information properly to be able to answer your question. If I were to pick two reasons for that, I would say that we still search for agreement, consensus, on what constitutes safe care, what is good care, how do you identify it, and then we have still limited data, information, about deviation from what might be described as good care. Without going on too long, I would say that limited data, in a way, is a function of concentrating perhaps too much on the acute sector and also on things which are called 'incidents'. I am interested in how we get a grip on primary care, which, after all, is where 90% plus of care is delivered, and how we concentrate on omissions as well. Failure to diagnose, late diagnosis, are as important in the safety and quality of patients, and many of the things that end up in acute care are a function of what happened earlier along the pattern of care. Q692 Chairman: In your supplementary, Ian, you mentioned a number of problems, in particular the issue of excessive focus on analysis of incidents, which you have just mentioned, the need to define good services and the need for a system of early alerts. How should they be addressed? Professor Sir Ian Kennedy: Taking early alerts, the Healthcare Commission has moved from a position (and it may crop up in your questions later) where we were engaged in investigations, and we have done some very important investigations, but my memory of what I saw in Bristol and what we have recently seen in the case of Baby P, for example, tells me that we ought to be able to get in earlier, and that to me involves the creation of a system whereby, with the Strategic Health Authorities and with the executives in the trusts, you begin to identify the important data which should be sucked in - it is only data which organisations should themselves be collecting - and then working with what patients tell you, working with what complaints tell you, working from other sources - from visits, from local intelligence - you begin to find a way whereby you can spot what might be described as the beginning of spikes. We have done this recently. We have put this system into operation in the Healthcare Commission. It has taken a while, but we recently identified outliers in mortality rates and that caused us to inquire. Data does not tell you anything, you have to go find out, and when we did, we found that almost all of them were explicable but one was not without further attention and that had led to a full-scale investigation in Mid Staffs which we shall be reporting on later. So that is as regards surveillance. How we track omissions, failures to do things, is enormously challenging. There are people, like Charlie Vincent over there, who know more than I do. Over the last three days I have been chairing a group concerned with awarding Academic Health Science Centre status, and I was a cheered by some of the innovative thinking, particularly on the sharing of records across primary and secondary care, beginning to track why people are showing up here, and it may be because of here, and sharing that with proper security. So incidents, surveillance, in my view, and primary care are areas where we need to put our energy. Q693 Chairman: Thank you. Bill, you suggested that a new horizon, as it were, quality, is going to be a way of improving patient safety. What is the cause and effect? How does quality improve patient safety? What are the mechanisms that you see coming out from the Darzi review that are going to do that? Dr Moyes: The thing I welcomed, first of all, was that Lord Darzi talked quite explicitly about safety as being the driving force in the NHS, in the planning of services, in the delivery of services and in the assessment of performance. He is talking about safety there, quality in the round being safety, patient experience and clinical outcome. First of all, I welcome that. If services are planned around the best evidence of what the good outcomes are, what safe services are, things like stroke services, for example, then I think that will have a real impact. The second thing I really welcome is the real drive to develop descriptions of what a safe and high quality service looks like and the ways of measuring it. Ian made that point a few minutes ago, and I very much agree with that. So there is great drive in the department, in NICE and in CQC and the Healthcare Commission to be quite specific, which I think is very important. We have come in behind that with developing a framework for reporting quality. We set the reporting framework for foundation trusts, so we have been working with the department and the Healthcare Commission to try and describe a framework within which each foundation trust every year in its annual report can describe quite explicitly what they have achieved in relation to polity and safety and what they plan to achieve in the future. The other thing I think is quite important is the emphasis that we have placed on the role of the board, because the other thing that I think has been lacking in the past has been absolute clarity about who is accountable for the delivery of services in the round, and we are quite clear in foundation trusts that that is the board. It is not the medical director, it is the board. Therefore, saying to the board, "You are accountable and you have to give an account of yourself and, therefore, you have to know what is going on in your hospital and you have to have ways of spotting the areas of problem and intervening", I think also would be very powerful. All of that seems to me to add up to quite a useful way forward for the NHS. Q694 Mr Syms: This is for you all. The arrangements for the regulation of NHS care providers seem unclear. How could they be made clearer and would that make them more effective? Baroness Young of Old
Scone: There is no doubt
that regulation of quality and the whole quality field at the moment is very
complicated and there are a lot of players on the pitch, but I think there is
an opportunity for us to make sure that all of that effort is aligned because
there are distinctive contributions that each of the players are making. Clearly, the bodies that particularly are
important in the safety area are ourselves, the National Patient Safety Agency,
Q695 Mr Syms: So you see making them fit together in a more coherent way. Baroness Young of Old Professor Sir Ian Kennedy: I think clarity is in two halves. First of all, there are people out there and we might try to join up, but there are many audiences watching what we do: there are the patients, the public, managers, yourselves and others, the media, and I think for them it is a pretty difficult task, but Barbara is quite right, we are where we are, and this state of affairs was created, dare I say it, in large part by yourselves through the variety of statutory provisions. Then the other clarity which Barbara has talked about is, whatever the audiences can work out what we do, how we can ourselves do it, and there I think Barbara is right, that we can try through MOUs, through other things, to align ourselves. One of the critical features, in my view, which the Healthcare Commission did not have, which you have, I think, in CQC, to a greater extent, is the capacity of one agency to, as it were, corral, co-ordinate, organise the activities of others who would otherwise presume to trawl through hospitals, request information and generally muddy the waters sometimes, and that does create the possibility of alignment. The NPSA is going to, as I understand it, at the end of this week or early next week, come out with a risk profile based upon the data it has, and that is the sort of thing that you will then seek to align your activity. It is possible to align. Indeed, just one example: in three years the Healthcare Commission cut by over 50% the number of requests for special data that was being asked for by government and by the Department of Health by saying, "Hang on, it already exists. Can it be used for other purposes?", and so on. So you can do that, but it is a bit of a struggle and it is not your primary task. Q696 Mr Syms: So you feel positive about the Care Quality Commission because they have more levers to do what they need to do? Professor Sir Ian Kennedy: I feel positive because it is led by the people who are leading it. They do have those levers, and you have seen the vision already set out that they intend to do that. I think, following on from the Healthcare Commission, safety is the highest priority, continues to be the highest priority, and working with others to try to align how we can inform our audiences. This is what is the case, and come to us and find out and we will try to do something about it. Q697 Mr Syms: Dr Moyes. Dr Moyes: I think Monitor's role underpins the work of a lot of other bodies. Our compliance system gives Monitor an overview of all aspects of the performance of foundation trusts, drawing on material from other bodies, including the Healthcare Commission and, in future, the Care Quality Commission, and we do provide a focus for other people like commissioners, and so on, where there are problems. So a foundation trust in its authorisation has lots of obligations: an obligation to deliver targets and standards, to deliver its contracts, an obligation to monitor the quality of services that it delivers, an obligation to be economic and efficient, and so on. Our job is to intervene if a foundation trust is not being compliant with that obligation of its authorisations; so if it is not delivering targets and standards, if it is not delivering its contracts, if there is some major failure, including a clinical failure, then, ultimately, if the board of the hospital cannot put it right, our job is to intervene and put it right, and we are the only body that can actually change the board; we are the only body that can actually force change in the hospital. The other thing is what I mentioned earlier, to make sure that foundation trusts report honestly and transparently; so we set the reporting framework, the content of the annual report. Our assessment process of applicants, I think, has proved to be a transformational process from those trusts - they really do start to think about the organisation - and we are increasingly taking a role in helping foundation trusts develop, think about how they should function - non-executive directors and executive directors - but I think the key point I would make about Monitor is that we underpin the work of others and, when failure seems possible or likely, our job is to intervene and try and make sure it does not happen. Baroness Young of Old Professor Sir Ian Kennedy: I am sorry to be coming in like this, but the emphasis on the board that Bill laid earlier is critical, it is a view we share, but you already see, even in that set of responses, that if I were the Chairman of a board I would not be entirely sure who I am obliged to please, as it were, and that requirement for clarity will now depend upon the working together of these two agencies. The structures, because they have grown, they have grown a bit like topsy, and they do need very powerful and insightful leadership, otherwise, as I say, if I was the Chairman of a local trust I would not know quite what the tune is we are playing, or I might not. Chairman: We are going to sort out the overlaps. Sandra. Q698 Sandra Gidley: A question to start off with to Sir Ian and Dr Moyes. Regulation is quite expensive. How much does it cost NHS organisations to meet all the requirements that your respective organisations put upon them? Have you made an estimate of that? Professor Sir Ian Kennedy: How much does it cost? Q699 Sandra Gidley: Yes. Professor Sir Ian Kennedy: Nought point one of the total cost of public funding allocated to the sector, or, if you want to put it another way, 94p for every thousand pounds spent, but I would ask a slightly different question. Furthermore, in the Healthcare Commission, it is a relatively small organisation compared with other regulators in the public sector, regulating a huge sector of £110 billion and 1.3 million employees. We have to do it smarter. I would ask the following question. It is not how much it costs, with respect, it is how it can be made maximally efficient. That is the challenge we have set ourselves. The second question is, what is the cost to safety if you did not have regulation? I think we have just recently lived through, and we are living through, other sectors of our public and private life in which regulation has, as it were, eased back, and we know what the cost of that is because we are living with it. I think the costs, therefore, have to be set quite clearly against the benefits. Costs are easier to calculate, both in financial terms and in terms of, "I have to fill in this form, morale is low", and so on and so forth. The benefits, and I could enumerate them but I will not unless you press me, are huge in terms of what regulation can bring for the benefit of patients, for the encouragement of staff and for the improvement of safe care. Q700 Sandra Gidley: The question I did ask was about cost, . I was not clear whether that was the cost for each organisation that has to provide information or that was your cost of the total budget? Professor Sir Ian Kennedy: That is the cost to the public purse of what the Healthcare Commission does. As regards the cost to each individual trust, I do not have that data. It may well be that it is discoverable, but I would have thought it is quite difficult to calculate, because, of course, it depends on lots of things, namely the energy put into it. I can say, we have done objective analysis commissioned by external agencies as to evaluation of our interventions and our general monitoring, and of those who are regulated - that is the most difficult correspondent to talk to - 81% of those asked said that we did effectively focus their attention on safety, and 93% of those regulated said, by our interventions and our regulation, we had a positive impact on the care of patients, and those are the regulated. Q701 Sandra Gidley: Dr Moyes? Dr Moyes: This year we will spend about £15,250,000, and of course that is on different aspects of regulation. Like Ian, we do not ask individual foundation trusts what they think the cost is to them, and in practice I think it might be quite hard for them to identify precisely what the cost is because quite a lot of different parts of foundation trusts are involved in being regulated and a lot depends on how intensely they are regulated. We have everything from a couple of foundation trusts that are performing so satisfactorily that we get reports from them twice a year, full year accounts and half year accounts and that is all, through to trusts that we are in touch with pretty much every week, or certainly every month, because their performance is a problem. So I think the cost itself to each foundation trust may not tell you very much, and that is one of the reasons we do not ask it. Like Ian, we ask about how the sector views us - we get IPSOS MORI to do independent surveys and focus groups, and so on - and we have the same kind of figures as Ian: about 90% per cent of the people that we regulate say that we are operating a sensible system, looking at the right issues and tackling them in pretty much the right way. I feel, on balance, that is a reasonable outcome. Q702 Sandra Gidley: By the same token, neither of you know how much time this all takes up and whether the trusts think it is the best use of their time to balance all of the different regulations they have to comply with? Professor Sir Ian Kennedy: I can give you a very specific answer, because that was a question we put through our study, and even of the regulated, the public, of course, would want more regulation than we currently do and we know that, but 70% in our first year said it was (and you have this data) "a good use of their time" and, furthermore, it ought to be understood that the system that the Healthcare Commission has developed (and I am sure Barbara will pay appropriate attention to it) is one in which we only ask of trusts what they should be asking of themselves, not least as regards safety. We ask for information, we engage, through our local organisational mechanisms, with them to find out whether they are doing what they are claiming to be doing, namely looking after patients, and if they do not have that information, then we ask why they do not have it, and if they do and we look at it and we are satisfied, we get out of their hair. Q703 Sandra Gidley: Are you saying that every piece of information collected by the trusts is necessary? I will put it different way. If you had your time again, if you could have a groundhog day and you could perhaps learn from any mistakes you may or may not have made, do you think there are better ways of spending the money to improve patient safety, or is regulation the holy grail here? Professor Sir Ian Kennedy: Both. If I had my time again, I do not think I would do a great deal that was different, because the vision which we published in 2002, which was described at the time by a number of commentators as ambitious, which persuaded me that it was worth trying, has stood the test of time. Of course you could do more for safety, but the system of regulation that we have introduced and the fact that we are regulated has, I think, made a significant difference through our system of looking for information, persuading boards that this is the information that they need to collect, analysing it, sharing it, visiting when we need to, and the total result has been, in my view, the raising of safety on the agenda and some attention to the problems that need to be resolved. Barbara, I am sure, if you are inviting her to answer, will answer also, but there are some who have a view that regulation is a punitive policing, top-down, heavy (and the B word is usually introduced) burden and that if any regulation is called for it should be "light touch", although Lord Mandelson has now, this morning, changed the word "light touch" to "right touch". In my view, right touch is exactly the point. Regulation is a lever: it is neutral. It is available to government to do a job. It is neither burdensome, nor the other. It has to be efficient in so far as it has to be cost-effective, the benefits outweigh the costs - and, in my view, in the Healthcare Commission case they do - and it has to be effective in so far as delivering what you have asked us to deliver, which is to promote improvement. In my case it has done that. Q704 Sandra Gidley: I think we need to look to the future now. Baroness Young, how are you going to achieve that aim: minimum burden but greatest improvement in safety? Baroness Young of Old Q705 Sandra Gidley: Yes; I wish I knew what that meant. It is one of those phrases that is banded around endlessly and means zilch. Baroness Young of Old Scone: For me it is risk-based, it is proportionate, it is working with providers on issues that they ought to be focused on because they are important issues and also with a strong focus, and, indeed, we have introduced into our structure and our processes a strong focus on looking at the administrative burden particularly of changes in regulation that we make. So we will be doing impact assessments of all of the regulatory changes that we make to ensure that they are not putting disproportionate burdens on the folk we are regulating. But I think the point that Ian made is absolutely the case, and that is that, if the regulator is asking questions about things that the governance structure or the commissioners or the performance managers are not asking questions about, somebody is on the wrong page. So we have got to explore, if people are saying, "We do not want to look at this because we do not think it is important", why there is a difference of view as to the importance of a particular issue. So I think the alignment point that we made previously about making sure that we are all clear about what it is we are trying to achieve in terms of safety and quality outcomes means that then you look at what the best mechanisms are for getting that delivered in a way that does not become too burdensome. There is a lot of experience from other regulatory fields on this which I hope I can bring with me from this environment, and media regulation. Q706 Sandra Gidley: That was quite vague. It sounds as though you do not know what the effective mechanisms are. Baroness Young of Old Dr Moyes: Can I comment on that from my perspective? The thing I would like to persuade you is of real value is getting the boards of foundation trusts to recognise that they are responsible for the running of all aspects of their organisation, getting them to self-certify to us, which in the main we do. There is very little direct collection of data by us. We get the boards to tell us about what they are doing. Forcing them, therefore, to look at the performance of their own organisation, I think, is also very important, and I think the third thing that is also having an impact is making clear to boards that, if they really cannot change in circumstances where failure is happening or is possible, then we will force change and it will happen. I think increasingly that as boards recognise that that is a real possibility, they do look very carefully at the performance of their organisation and we do find the self-certification process is taken very seriously by boards and boards learn a lot from it. So I think telling boards that they are actually the front line of regulation and that our type of organisation are simply bodies that have to come in at points where things are not happening properly is a very important development. It may not be the holy grail, but I think it has been a real shift in the way a board works in the organisations that I deal with, and I would like to see that as a lasting legacy. Q707
Dr Stoate: Professor Kennedy, I would
like to ask you about the Annual Health Professor Sir Ian Kennedy: The fundamental point about self-assessment is what Bill has just said, and we share that analytical starting point, but the people who are responsible for delivering the care that patients are entitled to and clinicians who look after them are entitled to, not least safe care, is the board. They are responsible; they are accountable. The Annual Health Check is only part of what we do, as you know. It responds to Parliament's request that we do an annual assessment of performance. What we do is say: you have got to tell us what you are doing, but we do not leave it at that, because that would be, first of all, arguably perilous and, secondly, mechanistic in the worst sense of the word. So it is not just what the boards assess themselves as doing - that is the first step - because then there is a series of other steps. We have over 2,000 sets of data, and this is in response to the previous question. We do not go out and collect, as Bill says, lots of the other stuff. We find out where it already exists and pull it together, and we test, on the basis of an understanding of what might constitute a risk to the care of patients, and that is where agreement on what constitutes risky behaviour is required, and we have our own definitions. We test and, if we do not think that the self-assessment coincides with our understanding of risk, we will begin to ask questions. One of those mechanisms will be visits, which are a central feature of our approach, but they come after, rather than having a regulatory system which trawls the lands looking under the beds. There are a million contacts with patients every 36 hours. How you would do that through a system dependent utterly on visits and inspectorial visitations, I do not know. So visits which are targeted. Then we listen to patients. They provide us with local intelligence through their complaints, through conversations, letters and whatever else, and then we actually listen to groups representing patients and the public. MENCAP were the ones who alerted us to Cornwell Partnerships and the treatment of those with learning disabilities. Then we listen to local government through their oversight and scrutiny committees, and all of that is added to our final view of performance. It is not just self-assessment, self-assessment is the first step, and because the boards know that we are going to do the other stuff, having attempted in the first year, as it were, to try it on, they have now learned that trying it on does not work because we have these other ways of cross-checking and we get a better dialogue when they admit sometimes, "We have a problem over here", and recognition of that is the first step to doing something about it, because we would then say, "SHA", or whatever, "Monitor, can you please go in and help?", and that is in the interests of patients. Q708 Dr Stoate: You mentioned organisations such as SHAs, you have mentioned patient groups and you have mentioned OSCs (Oversight Scrutiny Committees). How can you be sure that those really have brought to light all the issues that you would wish to be brought to light? Professor Sir Ian Kennedy: You cannot be sure of anything in this life, but the point I would make is that the larger the number of sources of information you have, the greater the possibility that through that cross-checking mechanism you will identify things that are not right and then be able to do something about it. If you simply relied upon published data or self-assessment as the only thing, you would seriously be in trouble. Q709 Dr Stoate: What I am asking is: are there any gaps? As you know, I am involved in general practice, and I still do general practice to a certain extent. I have just been through my annual appraisal, in fact, this week, which is an interesting and edifying experience. However, my appraiser can only appraise the information that I have effectively provided. So when the appraiser says to me, "Can you tell me examples of patient safety incidents occurring in the practice?", all she will find out is those that I have reported. It does not make it easy to plug any gaps. Professor Sir Ian Kennedy: You are absolutely right. If that were the case and we were operating that system, I would be pretty ashamed of myself because you would say, "I have done this." I would want to go, and I have a deal with the General Medical Council and the Nursing and Midwifery Council, and I would say, "Is this the case? Has Stoate told us the truth?" Q710 Jim Dowd: Highly unlikely! Professor Sir Ian Kennedy: Then, if there were dissidence between what you say and what we discover, that provokes a conversation. It may be that there is an explanation - there may not be - and then we escalate it to the SHA, or whatever. Q711 Dr Stoate: What I am really asking is whether you think the system is sufficiently robust? It sounds to me as though you think it is. Professor Sir Ian Kennedy: I am persuaded that there is always room for manoeuvre, for improvement, and it has been improved over the three years we have run it, but it is pretty robust. I think Barbara will be operating a different system, but the mentality behind it will not be too different. Baroness Young of Old Q712 Chairman: Very briefly, because we are slipping on time here. We have got three sessions this morning, I am afraid, so I am going to have to speed things up. Baroness Young of Old Q713
Dr Naysmith: I have a couple of questions
for Sir Ian but, first of all, I would like to welcome him back to this
committee. You have helped us in the
past with a number of our investigations and, as I suspect this may be your
last appearance before the committee, given your change of circumstances, I
just wanted to say thank you for all the help you have given us. The Healthcare Commission has conducted a
number of what one might call landmark investigations into major lapses of patient
safety, such as Professor Sir Ian Kennedy: I am very conscious of time, so thank you for your very kind remarks. It has been my pleasure to appear. We published a document called Learning from Investigations in 2008. If we have not given it to you, we will. On page 39 through to page 45 there are both the general themes we have learned from all of our investigations and some specific themes. I just make two other points. First of all, things will always be going wrong somewhere in a very large organisation. Modern healthcare is risky and the job of all of us is to try and minimise or mitigate those risks. We have had about 320 requests to do investigations. We have actually only done 14, with about three pending. We have chosen the ones which we think will allow us to generalise about problems which are not specific but national: vulnerable people with learning disabilities, maternity care, hospital-acquired infections, dignity and care of the elderly, and so on. We have found leadership, priorities in management, structural changes and mergers and general governance and information about what is going on, recurring themes, and that is where Bill is quite right to say that the buck starts and stops with the board. Q714 Dr Naysmith: Can we organise the board and ensure it operates properly to make sure that it takes safety seriously? Professor Sir Ian
Kennedy: I would take a
completely different tack. Yes, the
board has to be stronger, and there is an initiative that Bill and I started
with Sir William Wells some time ago about how you educate modern boards, and
so on and so forth, and that, I think, is very important, but I would say that
the future is not investigations, the future is surveillance and what I
described earlier. We should be in the
business of preventing Baby P, preventing Q715 Dr Naysmith: Is it a good idea to make one member of the board responsible for safety matters, or should everyone have a role? Professor Sir Ian Kennedy: Everyone. Q716 Dr Naysmith: Everyone? Professor Sir Ian Kennedy: It is the job of everybody. It should be part of the job description of everybody, from the cleaner to the chairman of the board? Q717 Dr Naysmith: I think Dr Moyes wants to come in, but I will ask you one more question before I ask Dr Moyes. You were due to publish a study today, in fact, of patient safety in 30 trusts. We understand that it has been put back for a week. I do not know if you want to tell us why it has been put back for a week, but the question I was going to ask: does the study tell us anything about how widespread the failings are in patient safety? Professor Sir Ian Kennedy: I apologise that it is not before you today; it will be before you by the end of the week. This is because we are suffering from indigestion in the Healthcare Commission. We have to publish a lot of reports and we have three weeks to do it. Q718 Dr Naysmith: I find it surprising how often the Government publishes a document the day before they appear at this committee! You have not taken that opportunity? Professor Sir Ian Kennedy: I would hope that you would not accuse me of in any way seeking other than to be open with you, as you already indicated in your encomium earlier. You will have copies of that. It does identify - I will make two short points - that trusts are now paying greater attention, but still they seem to be giving insufficient attention, focusing more on targets and finance and mergers, and so on, than on safety, and non-executives, in particular, describe themselves as being passive recipients, not really able to get into the granularity of what is going on in their trusts. Q719 Dr Naysmith: I was not going to ask you about this, Bill, particularly, but you obviously want to come in and have a word or two. Dr Moyes: Perhaps just one quick comment, if I may. When I talk to boards about their role, there are five things I really stress to them. They have to have proper information on safety and performance - that is the work with William Wells, the intelligence board that Ian referred to - there has to be transparent reporting within the board, within the hospital. The clinical teams have to report to the board. There has to be challenge. The non-executives have a legitimate role to ask the medical director questions. There has to be clear accountability, and there has to be a proper risk assessment done in the board of the decisions that they take. Investment decisions sometimes have safety aspects, and that has to be thought about. That is the only comment I wanted to make. Q720 Charlotte Atkins: What went wrong with Mid Staffordshire Foundation Trust? Dr Moyes: I think what happened with Mid Staffordshire was that at the point where we authorised it, they did meet our criteria. We were quite clear about that. Q721 Charlotte Atkins: When did you authorise it? Dr Moyes: We authorised Mid Staffordshire in February 2008, after quite a lengthy assessment. We were aware at that stage that Dr Foster's work had identified a high SMR (standardised mortality rate), it was 127, but it was declining. There had been work commissioned by the trust itself, by CHKS, to look into that. There had been meetings with the SHA and the PCT and all of that seemed to indicate that the issue was about the very, very poor quality of coding. So at the point when we authorised the trust in February, the consensus around the system was that the trust had a serious problem with its coding and that was leading to a misleading set of SMR data. When the Healthcare Commission decided to investigate, it was on the back of that, that they had an outlier, as Ian said, in relation to SMR that caused them to investigate. Now that they are in the trust, now that they have been in the trust and we have been kept very closely informed by the Healthcare Commission as this investigation has proceeded, they have identified a number of areas where clinical staffing levels had been very poor, clinical leader strip had been very poor, nurse staffing levels had been very poor; there had been aspects of privacy and dignity that had not been given proper priority. So, to answer your question, I think that the points I have just made are probably the things that have gone wrong. I do not think the board has always had good information; I do not think the board has always had good reporting. I do not think they have challenged, I do not think they have always asked the right questions, or, when they have, they have always been behind the curve; they have been reacting. To their credit, as the Healthcare Commission started to uncover problems, I do think the board started to try very hard to rectify them; they did not simply watch and see a body of evidence building up. Clinical staffing levels in A&E, for example, have been hugely increased, nurse staffing levels have been increased, but the reason why the chair woman has stepped down is that she has recognised that leadership of the board needed to be changed, needed to be stronger. The reason that we used our formal powers of intervention to put in an interim chair, and now an interim chief executive, is that we think they need much stronger leadership to tackle the problems that the Healthcare Commission has identified, which are real problems, to get this hospital back on its feet. So that would be my answer to your question. Q722 Charlotte Atkins: But it was less than year ago that you authorised them as a foundation trust. Surely you are not suggesting that at that point they should have got that status? Dr Moyes: At that point the criteria that we had, financially viable and well governable, were the criteria they met, and at that point there were a lot of aspects of the performance of the hospital that we did not look at because, like all regulators, we are under pressure to be proportionate and not excessive. Since Mid Staffs, we have expanded our assessment process, so we do take a look at local press cuttings, for example, we do ask the Healthcare Commission, not just at local level, but at national level, "Is there anything you want to tell us?" We ask the investigation team in the Healthcare Commission, "Are you"---. Q723 Charlotte Atkins: But less than a year ago, when you authorised the fact they should have foundation status, now we are hearing we have high rates of mortality for emergency admissions and concerns of poor nursing care at the trust. That does not happen over one year, it must have been there a year ago when you authorised them to have a level of independence which would assume that you had confidence, not only in the chief executive and the chair person, but also in the board. A lot of hospitals now are rushing towards foundation status, so much so, in fact, that they are beginning to neglect things going on in the hospital, and I am talking about a hospital very close to me, North Staffordshire University Hospital Trust, and what worries me is that it appears from the evidence of Mid Staffordshire that it is relatively easy to get foundation status when there are clearly significant problems within the trust and that maybe we are scattering this independence far too widely without proper scrutiny. Dr Moyes: I do not accept that for a
second. I do not think it is at all easy
to become a foundation trust. One
applicant in three does not get authorised the first time. My memory is that Q724 Charlotte Atkins: But potentially people may have died as a result of not considering the core problem and considering it is just a coding problem. What worries me is that it puts into doubt the whole process of self-assessment, if you were convinced that actually it was just a coding problem and not a significant problem within the trust. Dr Moyes: Do not forget that, for a good part of the time when we now know that there were problems in this trust, it was not a foundation trust, it was directly managed by the SHA, ultimately, so it was part of the previous system in which, in my view, the board's responsibility was very fuzzy. The Healthcare Commission's investigation has spanned four financial years, in two of which this was not a foundation trust and in two of which it is a foundation trust; so I do not think one can draw any conclusions from this about foundation trust status. Q725 Charlotte Atkins: I think you can draw the conclusion that perhaps they should not have been given foundation status in the first place. Dr Moyes: Well, at the time we authorised them they met our published criteria, and we have to stick to those criteria, but, as I say, we have learned lessons and we have expanded the range of data we bring to bear, and I think that is important. Dr Taylor: This is to Ian, and I have been instructed to be brief. Like Doug, I have greatly appreciated your thoughtful and open contributions, and I am looking for an open contribution on this. The new NHS complaints process has removed the Healthcare Commission from the process and has not put the Care Quality Commission there, so complainants automatically lose the automatic independent review. Do you agree with me that this is a disaster; that it has implications for patient safety? Chairman: We do not ask leading questions, you know! Q726 Dr Taylor: I want a straight answer. Professor Sir Ian Kennedy: When the Healthcare Commission was being set up I asked the then Minister not to give to the regulator the responsibility of adjudicating on complaints but, rather, give the regulator the responsibility of monitoring what complaints were coming through, what they were telling us, particularly as regards safety, so that action could be taken. The Government and Parliament took other views. We then had to build a system at some point. Talking about the cost of regulation, it was commanding 14% of our annual budget building a system and for a while we were behind the curve, using Bill's language. We got ahead of the curve, we learned an enormous amount and we fed that back, so the experience was valuable. I refer you to our document which is called Spotlight on Complaints 2008 - I am not going to go through it again - in which we identify the recurring themes which come through complaints, and they are recurring and they remain more or less consistently the same. What the taking away of the responsibilities of second-tier complaints from the regulator will do, we will have to wait to see. Critically, it will mean that trusts will have to deal with them more effectively at local level, and historically they have not done so. If we get the same rate of appeals as the Healthcare Commission had to deal with, the ombudsman will be dealing with 8-9,000 a year. That cannot be the case; that cannot happen. So there has to be some way, and Barbara, through CQC, will have some mechanism whereby she will monitor - and it may be a regulation requirement that they deal adequately with them - but without sanctions against individual trusts, it is my experience that trusts still do not sufficiently take seriously complaints. Good ones do, and, indeed, good ones welcome complaints. I was talking to the Chief Executive of UCLH. They have a lot of complaints. That is an index of good performance, in my view, providing they deal with them, but if they are not dealt with, we will have a lot of unhappy patients and we will have a lot of issues of safety. After all, 23% of complaints had to do with safety in the context of GPs and 38% of all our complaints were about GPs and 0.3% of incidents collected by the NPSA came from GPs. Q727 Dr Taylor: Have you been able to form any impression about the effectiveness of PALS and ICAS? Professor Sir Ian Kennedy: PALS have been useful to patients, and we have certainly found in the context of complaints that they have helped patients. If I were to accept your invitation to be a bit open for a moment just to say one thing, I think mechanisms which are reactive for hospitals waiting to hear about PALS while you are waiting to hear about ICAS, waiting to hear other things, is the wrong way of doing it. What I would like to see is hospital trusts, PCTs and GP practices develop more active, rather than reactive, mechanisms, talking to patients in a consistent way, doing surveys, finding out mechanisms for feedback from patients in a consistent way and then showing what they have done about it so they close the curve. Reactive mode is fine, but it does not get us anywhere near where we need to be. Q728 Dr Taylor: So good communication can prevent lots of complaints? Professor Sir Ian Kennedy: And the initiative from the trust rather than expecting the patient to do it. Baroness Young of Old Q729 Chairman: That is the next question actually. Baroness Young of Old Chairman: Could we ask the question. Q730 Mr Scott: I think, Baroness, it is the other way round: you give the answer and then I will ask the question! From April the NHS service providers will have to be registered with the Care Quality Commission relating to infection prevention control. Are we on track to be fully registered, and then you can go on and give the answer you were just giving? Baroness Young of Old Q731 Mr Scott: Yes. Baroness Young of Old Scone: We are on track and we have got 25 days to go before all the NHS providers have got to be registered for healthcare acquired infection. Everyone has applied, which was the first step. We are doing the risk assessments. We will come to a view as to who will be registered without conditions, who will need to have conditions applied to them because they are not quite up to scratch, and then we will follow up that with an on-going programme of inspections for the poor performers and for areas where we have got less information. For example, ambulance trusts are coming in for the first time, and we do not really have a huge wealth of information about those. So we are on track. I anticipate that a proportion of the trusts who will not be adhering to the Hygiene Code sufficiently will have quite strenuous conditions put on them with quite short timescales for those conditions to be implemented, and we will be keeping a very close eye on those, but I do not anticipate that we will fail to register a trust, because I think we know enough about particularly the acute trusts from all of the inspections and the work that the Healthcare Commission has done in the past to know that they are all improving, that the rates of infection are going down, there is a much stronger engagement within trusts on healthcare acquired infection issues now, but there are still a few that need a bit of a push to get to the level of the rest. Mr Scott: Thank you. With your psychic powers, you have answered the supplementary as well! Chairman: We will move on then. Q732 Charlotte Atkins: Baroness Young, the Patients Association have told us that they have a great concern that the Care Quality Commission will not be as robust as the Healthcare Commission in reporting on safety. What is your view to that? Baroness Young of Old Scone: I think I am probably going to leave this room and phone the Patients Association, because we have not met them yet, so it is kind of weird that they have got this impression. I would quite like to see their evidence, and it would be worrying if they did not have concrete evidence. We certainly have made an absolute commitment to safety as a fundamental part of our manifesto as the most important element of our model of quality. We are going to be in a better position to look after safety issues than the Healthcare Commission was or the Commission for Social Care Inspection, because we do have this ability to move across health and social care and it is often in the gaps between services that some of the big safety issues do arise. We will also be bringing GPs into registration, which will give us an opportunity to look at an area where safety as yet is not hugely examined. The information that is available on GP issues of error and omission is not as well developed as it is in, for example, acute provision, and we have also got stronger enforcement powers. So I would find it really difficult to understand how the Patients Association feel that we are going to be a kind of limp rag. The other commitment we have got right at the heart of what we do, of course, is to involve users and patients and carers and families. So we will be hot-footing it to the Patients Association to make sure that they have a full opportunity to explore with us what we are going to be doing and have an opportunity to influence that if they are feeling concerned about it. Q733 Charlotte Atkins: But your own memorandum says that the proposed registration requirements regarding patient safety, as currently worded, are in some ways not as comprehensive as the standards for better health that underpin the Annual Health Check. What did you mean that by that? Will that hinder your ability to address patient safety issues? Baroness Young of Old Q734 Charlotte Atkins: But something that has been raised with me is that there are some outcomes that the CQC might rely too heavily on data and paper-based reviews at the expense of on-site inspections by well trained and experienced inspectors. Is that a concern that you can understand? Baroness Young of Old Q735 Charlotte Atkins: I think that Haringey Children's Services probably demonstrated that on-site inspections are really important, but there is also a concern that there might be reductions in staffing associated with light-touch regulation. Again, I do not know if that is justified or not, but clearly, it is important that you have the qualified staff that are able to carry out these inspections in a way which would be robust. Baroness Young of Old Scone: Not being a saint, before I took the job as Chairman of the Care Quality Commission, I did check that we were not scheduled for mammoth reductions post setting up, and I think the reality is that were the three existing commissions to be on trajectory, and I think the Healthcare Commission is not necessarily the case but certainly with their other two commissions there are still some remaining streamlining reductions that they were due to make that will not now be completed until after we come on the scene, so there will still be some streamlining, our commitment in setting up the new organisation was to protect the front line as far as possible and to bring across as many of the inspectors that are currently in the Healthcare Commission and Social Care Inspection Commission as were willing to come to us and to make sure that that ability to be there on the ground is as rich as it was previously, but we want to go further than that because we have got the opportunity of looking at two very different field work forces, two very different recruitment and training processes, two very different inspection methodologies, and I think we can learn from the good stuff that is in each of the three commissions and produce a united cross social and health and mental health care inspection and local process that is exactly what you describe: well targeted, risk-based inspection by people who know what they are talking about. Professor Sir Ian Kennedy: May I, with your indulgence, Chairman, very quickly say as regards healthcare, I am not sure, though I am an adherent to the need for visits and inspection, that they ought to be, as it were, targeted. I am not sure going to visit any particular location would have done anything for the healthcare of Baby P, because one of the problems was, as I recall the facts, he was moved around into this A&E and into that doctor, and so, if we were able to have proper electronic recording of the relationship between children at risk and doctors being able to have access to that and then record that they have just seen a child, that would be, in my view, something to think about as to how we look after the situation of children like that: because there is a lot of what lawyers call 'forum shopping' and what parents such as this might call 'doctor shopping', where you move from one doctor to the other, so that unless you have some consistent way of capturing that information nobody knows that this is happening. Q736
Dr Taylor: This is specifically to
Baroness Young. Almost four years ago to
the day this Committee did a report on prevention of venous thromboembolism in
hospitalised patients and, to our horror, we described that between 25,000 and
32,000 deaths per year occurred from this.
The cost was estimated at 640 million, and what makes it even worse
is that these deaths are largely preventable, and we actually said that
thousands of lives could rarely be saved by the use of a tried and tested
treatment and all one needs is a risk assessment and then you know which
patients have to have the thromboprophylaxis and there you are. We understood also, which makes it rather
worse, that the Healthcare Commission and the Baroness Young of Old Q737 Dr Taylor: So really we have got to work on ministers? Baroness Young of Old Q738 Dr Taylor: In a parliamentary question in November 2008, the minister responding did say, "We will be monitoring the position closely and formally reviewing the policy in time." It does not go on to say how many more deaths might occur in that year. Are they going to be monitoring it or are you monitoring it for them? Baroness Young of Old Scone: I cannot speak for the department and the NHS itself, but certainly we, through the 2008/2009 Health Check, the one that is underway at the moment, will be using our ability to look at implementation and the NICE guidelines to raise the venous thromboembolism issue. Dr Taylor: I think you should check, because the NICE guidelines, from my memory, only apply to clinical patients, and this applies to medical patients very definitely as well. Q739
Dr Naysmith: A couple of questions for
you, Dr Moyes. We have already touched
on them when you were talking with Dr Moyes: We learnt some lessons about the volume of data, the breadth of issues that we should look at in the assessment process. Now, when we are assessing foundation trusts, as I said earlier on, we do ask the Healthcare Commission quite explicitly, national and locally, "Is there anything you want to tell us?" We do look at press cuttings, we do look at trends and serious untoward incidents and complaints and lots of other things that we bring in, where previously we did take probably a slightly too narrow focus. So in the assessment process we try to make sure that we have some understanding of the quality of governance in the hospital as well as its financial strength. Q740 Dr Naysmith: The safety figure really. Dr Moyes: We regard safety as a key indicator of governance. We do regard boards as responsible for everything in the hospital and we want to understand: is there a problem with safety? Are there untoward incidents or are there clinical failures that the board should know about and they do not know about, or, if they do know about them, are they doing the right thing about them? Medway, for example, we identified quite a high SMR, and, again, we delayed the authorisation of Medway for several months to force them to get to the point where they understood what was going on and they could explain it to us, and I think that led to quite substantial changes in the clinical governance processes in Medway which I think was to the good. So, yes, we do make sure, as best we can, that we identify potential or actual problems of safety and that we have got confidence that the board will deal with them. Q741 Dr Naysmith: I move on to a different topic now. In evidence to the Public Bill Committee on the Health and Social Care Bill when it was being considered by Parliament, Monitor stated - I do not know whether this was in evidence or whether it was a written statement - "The creation of a new regulator, the Care Quality Commission, with statutory powers over NHS foundation trusts puts the success of the financial trust regulatory regime at risk. Giving two regulators powers of intervention over the same bodies risks confusion, duplication and loss of accountability." Do you still hold that view? Dr Moyes: It is still an area I am anxious about. Monitor has been consistent throughout, quite openly saying that we believe that the strength of the system is that we have the responsibility to intervene in circumstances of failure where other mechanisms such as the Commission's pressure, and so on, has not had an effect. As Barbara said earlier on, the Care Quality Commission has a power to register and, therefore, to deregister and, therefore, to vary the registration conditions, and I think we both recognise that that is an area where, once the CQC comes into being properly, we are going to have to work quite carefully together to identify who does what in what circumstances. But it is an obvious issue that has to be sorted. We both recognise it has to be sorted. We are developing a memorandum of understanding between our two organisations which tries to make sure that we can describe to the world in language the world can understand, how our compliance system and the CQC's registration system will bolt together. It is not an insuperable problem but at the point when we made those comments it was very strongly felt by us. Q742 Dr Naysmith: There is another area of possible confusion and that is in the area of performance management, the role of strategic health authorities in respect of non foundation trusts. Are strategic health authorities doing something different? Are they going wrong in some of the things they do, that we need to have another two bodies involved? Dr Moyes: The point about strategic health authorities for us is that they are obviously responsible to the Secretary of State. The Secretary of State has no powers of direction over foundation trusts. Therefore we would like to persuade the strategic health authorities that their focus should be on commissioning and what commissioners are doing and whether commissioners are commissioning effective health care or not. In cases where foundations trusts have not responded to commissioners properly, are not co-operating, not delivering and not doing the right thing, then it is our job to come in and make sure that the foundation trust performs properly. I think that way of working is gradually being teased out and accepted as the right way to get the system operating efficiently. Baroness Young of Old Q743 Chairman: Dr Moyes, I think it was Alan Milburn when he was in office who said that all hospitals would be foundation trusts within three years or something like that. It has not quite turned out like that. If they were at some stage in the future, what would be the implications on your budget? How much extra money would you need to do your job? Dr Moyes: I very much hope and believe that all hospitals will eventually be foundation trusts, although not necessarily all hospitals in their present form. In the long run I do not see Monitor as being a large organisation with a huge budget. We have invested a lot in technology - a lot in our terms, but in national terms not very much - in order to produce a system that can collect in a lot of data and process a lot of data very efficiently, without a huge increase in staff, so we would have a period, and the Department recognises this, where our assessment teams would have to continue in existence, but as we get more foundation trusts, we have to add to our compliance function. There is a bit of double running there. In the longer run, when hospitals are all foundation trusts, our assessment effort should largely wind down and we would be primarily a compliance organisation. I expect our budget to go through a bulge and then decline again, but we are 90 people or thereabouts today, and a budget of £15/16 million. I am expecting next year a budget of around £17 million and perhaps one or two more people, but I do not see us as being an enormous organisation and I do not think it is necessary. Q744 Chairman: Thank you. Sir Ian, could I echo what Doug Naysmith said earlier and thank you personally for the co-operation that this Committee has had from you and from the Commission over many years now. I do not know where your future lies, but I hope you will be very happy there. I hope that we can, as a Committee, get the same co-operation from your successor Commission, as it were. It is vital in terms of overseeing health care in this country that we have co-operation from organisations like that in our day-to-day work and not just when we are sat in witness sessions as we are this morning. I would like to thank all three of you very much for coming along and assisting for this inquiry. Professor Sir Ian Kennedy: Thank you very much. Chairman: Thank you. Witnesses: Mr Finlay Scott, Chief Executive, General Medical Council, and Mr Steve Walker, Chief Executive, NHS Litigation Authority, gave evidence. Q745 Chairman: Good morning. Thank you for coming along to help us with this evidence session in relation to patient safety. For the record, could I ask you to give your name and the current position you hold, please. Mr Scott: I am Finlay Scott. I am the Chief Executive of the General Medical Council. Mr Walker: I am Steve Walker. I am Chief Executive of the NHS Litigation Authority. Q746 Chairman: It might be the case that I will be exiting before the end of this particular evidence session. I have another important engagement in my diary and Doug Naysmith is going to take over. Absolutely nothing personal is intended. I have no interest to declare now, Finlay, in terms of my ex membership of the General Medical Council, but perhaps I could start with you because we have heard evidence from junior doctors that patient safety was not an overt theme in their undergraduate training. How should the undergraduate medical curriculum change to ensure patient safety? Mr Scott: I understand that this has been said. As I think you are aware, at the moment we are in the middle of a consultation on a new edition of Tomorrow's Doctors, our guidelines for medical schools. Among other things, the draft guidelines identify nine domains, the first of which is patient safety. We will be reflecting in the course of the consultation on whether that yet makes it sufficiently clear that patient safety should be an important element of the early education given to all undergraduates in this country. Q747 Chairman: Professor David Webb told us that patients are being harmed by prescribing errors as a result of inadequate pharmacology education for doctors. He said that the GMC has acknowledged that there is a problem there. We saw some statistics on prescribing errors of new doctors, as it were, which were a bit alarming, although new doctors do not work in isolation. Are you going to amend Tomorrow's Doctors accordingly to make sure that we do have proper education in that part? Mr Scott: The draft on which we are
currently consulting is very clear about the importance of prescribing. In the course of the consultation we will
consider whether more has to be done to make that plain, both in the light of
what has been said to this Committee and in the light of other responses. I think it is important to try to ensure that
we understand the reasons for prescribing error, and I am not sure that those
reasons are genuinely well understood.
We have commissioned two pieces of relevant research, the results of
which are already available in one case but not in the other. The first piece of research relates to the
preparedness of new doctors for practice.
It was led by Dr Jan Illing from Q748 Chairman: You do not have a time scale of when they are likely to be finished at all, do you? Mr Scott: I think that research is reporting later this year. Because I am aware of evidence about errors in primary care, the next stage in our research programme will go on to look at the probability that prescribing errors can be better explained in primary care, leading us to take appropriate action. Q749 Chairman: The other thing on the undergraduate curriculum is to take account of non technical skills, issues around human factors training (communication and team work skills, situation awareness, etc). You will have seen the Darzi Review on the next stage and the need for team work in particular. Can you give us any idea of how you think that might improve. Are they able to provide that kind of teaching in terms of not just the technical side but the human factors side as well? Mr Scott: As I think the Committee is aware, when we launched the first edition of Tomorrow's Doctors in 1993 it marked a shift away from the acquisition of knowledge to be recited by rote at your finals and then promptly forgotten. It tried to move the education of new doctors more on to the acquisition of non technical skills - not ignoring the technical skills but taking full account of non technical skills - with greater emphasis on communications and the ability to keep oneself up-to-date in the course of a 35 or 40 year career. By common consent, I think, today's new doctors are able to communicate more effectively than their predecessors. However, I think there remain major challenges around ensuring that today's new doctors are also able to operate effectively in teams, which is an important aspect of the non technical skills. I think it is less about what we write in Tomorrow's Doctors - the messages are plainly there - and about understanding better through research and analysis what leads to more effective team working and the avoidance of some of the tragedies that this Committee has heard about. Again we have that very firmly in our sights. The core messages about effective team working and communications and non technical skills more generally are already there. Q750
Dr Stoate: Previous witnesses, the
Medical Decision-Making Research Group at Mr Scott: If I may say, I think we were all a little surprised to read elements of that evidence, because from your own experience - and I do not believe much has changed - the ability to take a history and to communicate effectively with the patient, to diagnose differentially, is at the heart of medical practice. Dr Jan Illing's report, to which I earlier referred, does not give us any reason to believe that today's emerging doctors are poorly prepared in that sense, subject to two qualifications. It is possible that the evidence you heard was less to do with whether we are teaching students how to produce differential diagnoses and more about the theoretical aspects of decision making which they feel may be more effectively taught in the course of the curriculum. That is something we will follow up with them. The second point which Jan Illing's research has exposed is that today's new doctors appear to be well equipped in terms of knowledge and skills but they are under-prepared in terms of applying that knowledge and those skills in a clinical setting. We have tried to reflect that in the new draft of Tomorrow's Doctors, the essential argument being that much earlier in their undergraduate training and before they take up positions of responsibility within the NHS, they should be confident that they can apply their knowledge and skills in actual practice and then gain confidence and competence in order to deal with some of the issues that you have heard about. Q751 Dr Stoate: Several of our witnesses have also expressed concern about the level of missed diagnosis and delayed diagnosis in general practice. Is that not a cause for concern that the GMC might wish to take up? Mr Scott: Yes. Again I think it is really important, as the regulator, that we work with others to try to understand why that should be. Generally speaking, as you know, the GMC has been recognised as - what I call the taxi driver test - "The organisation that strikes doctors off". That is usually the response that I get from a taxi driver if I tell them what I do. In fact our most important contributions to patient safety are through education and training and standards and ethics, and of course ensuring that only good doctors are registered in the first place. To come back to your question, I think it is important that we work with others, including the postgraduate medical education and training boards, to ensure that these issues are pursued. If I may talk about the planned merger of PMetB with the GMC, probably from April of next year - a merger that this Committee, I am glad to say, endorsed - that will create for the first time an opportunity to look at how we regulate education and training across all stages of a doctor's career to ensure that we identify the point at which the risk of error begins to emerge, not necessarily always at the undergraduate stage. Dr Stoate: That is fine. I just wanted to ask the question, but you have covered that point. Thank you very much. Thank you, Chairman. Q752 Sandra Gidley: We are told frequently that the NHS aspires to a "fair blame" culture and that the point is to look at systems rather than blame individuals when something goes wrong. Clearly there will be cases when it is incompetent practice by an individual and you have to draw the line somewhere. Where does the GMC draw that line? Mr Scott: I think we all have to start from the point that doctors are human beings and they make mistakes. There is a widespread literature, both in the healthcare industry, our economy and in other industries, that demonstrates the relevance to error of systems. We tend to approach it from this point of view, that there are two key requirements of doctors. Their conduct should not step outside the guidelines that we lay down - they should not behave inappropriately with patients and so forth - and when they transgress in relation to those guidelines, it is right that their conduct should be properly examined. But we also require doctors to practise within the limits of their knowledge and skills and within their competence, and that leads to the kind of distinction to which you were pointing. Perhaps I can illustrate it by reference to the figures that we publish. We receive about 5,000 inquiries, complaints or allegations each year about individual doctors, and they fall into broadly three groups. The first is a group which could not conceivably engage our procedures. I do not want to trivialise the point, but we do get complaints about where doctors park their cars and so on, so we can pretty quickly decide that that group does not deserve our attention. There is a second group, which for internal reasons we call stream 2, where on the face of the complaint it would not be just to take action against a doctor's registration but it is possible that put in a broader context there might be a possible concern. With our stream 2 cases, therefore, we immediately engage with those who employ the doctor or contract with the doctor for medical services. In the great majority of cases the allegation or complaint does not sit in a context that requires us to take action, and we can leave, therefore, the employer or contractor to deal with it. I think that enables us to stand apart, largely, from single incident clinical events or omissions, which might be regarded in a different parlance as mistakes, where we do not unduly bear down on the doctor. The third category is where on the face of it we need to investigate further, or, having contacted the doctor's employer, there is a context that requires us to take action. So I think we are moderately effective. No doubt we could do better but we are trying to distinguish between the deep-seated fundamental problems where we need to take action and those where they reflect the fact of mistakes or systems that fail. Q753 Sandra Gidley: To be absolutely clear, if a doctor makes one mistake, that could be human error. If a pattern starts to emerge, then that is when you would intervene. Mr Scott: Yes. Not to exclude the possibility that some mistakes might require us to take action, but in the normal course of events the distinction you have drawn is extremely helpful. May I make a supplementary point? I think there is a real tension in the way in which we operate our procedures, which is this: the philosophy that we have just espoused is easy to describe here and to intellectualise, but in fact many of those who contact us, many patients or relatives or friends who contact us, would not necessarily accept the distinction that we have just drawn, and they do not distinguish so readily between the mistakes that unfortunately do happen and the more deep-seated problem. One of the challenges we face if we are to move towards a fair blame approach is to try to have a better public understanding of the function of our procedures, which is not always to bear down upon doctors who make mistakes. Q754 Sandra Gidley: Is the National Clinical Assessment Service effective? If not, how could it be improved? Mr Scott: It is probably not for me to say whether they are effective or not. Q755 Sandra Gidley: Go on. Mr Scott: What I can say is that we work very constructively with them. I think the NCAS performs an extremely useful role. Despite what I started by saying, I think it does so effectively. It enables engagement by the doctors, employer or contractor with a process that can be less threatening to the doctor than inevitably our procedures will appear to be. One of the great strengths of the NCAS approach has been to provide advice and guidance to trusts and others on how actual or emerging problems might be handled. I think there is a great opportunity in the future, with the introduction by the Government of responsible officers in every trust and also by the pilots that we are pursuing at the moment of what are rather inelegantly called GMC affiliates, to ensure that it is a joined-up approach. As part of the two pilots that we are running in North Yorkshire and in London to explore the concept of affiliates, we have set up with others within the special health authority what is called a Regional Medical Regulatory Support Team, involving the NCAS and others, in order to try to ensure a more joined-up approach to the patient safety agenda. Q756 Sandra Gidley: Revalidation is coming up. How will that fit in with what we were talking about earlier? Mr Scott: Perhaps I could start by referring to the evidence you have just heard. Dr Moyes stressed the importance of boards, trust boards but, indeed, primary care trusts, accepting their responsibility for patient safety. The second important point was made by Sir Ian Kennedy, when he stressed the importance of surveillance, as distinct from investigation after the event. We have now a good track record in relation to after-the-event investigation and dealing with doctors whose fitness to practise is impaired. The thrust of revalidation is to make our contribution to preventing things going wrong in the first place. It is very much about the quality agenda, it is not about dealing with bad apples, but, inevitably, our ability to introduce revalidation without imposing a huge bureaucratic burden upon doctors, distracting doctors from their frontline responsibilities and thereby damaging patients, inevitably depends on local systems of clinical governance and of appraisal. We have already heard this morning an example of how the appraisal system may not be as robust as it might be, and that is why, together with the Chief Medical Officer for England, Sir Liam Donaldson, and the Department of Health for England, and, indeed, all four health departments, there is a commitment, reflected in the White Paper, to make appraisal more robust. If we can introduce or develop robust clinical governance and fully effective appraisal, then I believe revalidation will add considerable value to the quality agenda but at a very low marginal cost and greatly to the benefit of patients. Q757 Dr Naysmith: You talked about your three streams: the trivial; the one incident which gives cause for concern; and then the more serious investigation. You said that with the second stream you would get in touch with the employers and let them know. You presumably then say to them, "You sort it out," and they say, "We will sort it out." Do you ever follow that up? Do you regularly follow that up, maybe a few weeks later, and say, "Have you sorted this out or not?" Mr Scott: Yes. We have tried both approaches, one of complete radio silence on the assumption that they would do something effective, and we have also followed up. The general conclusion from the second approach is that trusts and other health care organisations take their responsibilities seriously and do deal with the issue. Q758 Dr Naysmith: But you do not do it routinely? Mr Scott: If I could come back to the burden of regulation, although Sir Ian did not much like the word, the cost of regulation, we have to be sensitive to the fact that each time we interact with a doctor or with a trust there is an effect which is not necessarily beneficial. We have reflected on our experience with both approaches and the result is that we do not now always follow up, simply because it was not an effective use of resource at our end or within the trust. Q759 Stephen Hesford: Could I first of all, Chairman, apologise to the Committee for not being with you for the first session. I had other House duties. Would you accept that in times gone by the GMC did not approach its task to doctor regulation as robustly as it might have done and that led to a certain lack of confidence in that process? I see you nodding. That might engender a lapse in culture with doctors, because they understood the process and Big Brother was not watching them as carefully as it could have done. Are you confident now that the GMC is in a position not only to have reversed that culture but to lead the culture in a different direction whereby the public can now be satisfied that the GMC is in a position to undertake that role in a way that I am sure we all like to think it does? Mr Scott: We have acknowledged in other places, including before the Shipman Inquiry, that the operators of what are called our Fitness to Practise Procedures were not as robust as they should have been. It is for discussion whether that had a real practical effect, but in a sense I do not want to deviate from the honest position we have taken - and of course that was one of the reasons we launched the fundamental programme of reform which has led to the introduction of a completely overhauled system of fitness to practise. We weigh the information that reaches us, we consult with doctors, employers or contractors, we have a more thorough investigation upfront before we make the preliminary decision. All of those improvements have led to a more robust approach and we can truly say that we live up to the purpose that we espouse, which is to protect, promote and maintain the health and safety of the public. It is really important that the GMC is seen as a regulator for the majority of the profession as well as a regulator of the minority. Important though it will remain to deal quickly and effectively with impairment, increasingly our contribution should be through the work we do on education and training, standards and ethics, and ensuring that only fit to practise doctors are on the register. Q760 Jim Dowd: You mentioned the Shipman Inquiry. In response to Sandra's questions about the fair blame culture, the emphasis was on inadequate or incompetent practice. What Shipman brought forward - and let us hope it does remain unique - is the notion of malice in the exercise and the practice of medicine. That had never happened before. I imagine the systems for protecting it were not in place. Are you satisfied that they are now? Without believing for one moment that there is any evidence that anything remotely comparable to Shipman's practices has gone on anywhere, are you satisfied now that your approach is critical enough? Mr Scott: I think there are two elements to answering that question. It is incumbent upon us to continue to stress the importance for all doctors of taking action when a colleague's conduct, performance or health is placing patients at risk. If you analyse not just the Shipman case but the other headline grabbing cases that led to inquiries, Ledward, Neale, Kerr/Haslam, the striking features is the length of time for which it was recognised locally that there were problems but no effective action was taken. I think we have to squarely acknowledge our own responsibility for ensuring that every registered doctor is ready to act effectively. As it happens, in the tracking surveys that we ran in 2006 and 2008 there was encouraging evidence that doctors increasingly recognised that responsibility, but I think we also have to be realistic. As Dame Janet Smith herself said in her fifth report, even if all her recommendations were implemented, she could not guarantee that the intelligent criminal - because that may be what we are dealing with: the intelligent criminal - might not defeat the regulatory system. Indeed, that was the message from the Beverly Allitt report by Sir Cecil Clothier. I think the key for all of us is to ensure that systems interlock in a way that we deter and detect quickly, so that you reduce the likelihood of these events occurring to as close to zero as you can. The key point for me that emerged from the Shipman Report was the point of strengthening death certification and coroners' procedures, as distinct from, say, revalidation. Revalidation will make a contribution, but it is not designed to detect intelligent, deliberate criminal behaviour. Chairman: Thank you for that. We are now moving on to Steve Walker. Q761 Dr Taylor: I have two questions about the Clinical Negligence Scheme for Trusts. In our extra brief we have been given details of the premium collected, going back to 2000-01, when it was £40 to £50 million. It suddenly jumped in 2008-09 to £396.3 million and the figure for 2009-10 is £713.4 million. Can you explain how you get at this figure and why it has gone up so much? Mr Walker: I had kind of anticipated someone would ask me that question this morning. The Clinical Negligence Scheme for Trusts is a risk-pooling scheme and we deal with the resolution of claims, whether they have been tested in court (very, very few of those) or by alternative dispute methods, in-year. When we pay the claim, that is when we need the money. We try to leave as much cash as possible with frontline trusts and remember it is trusts only as members at the moment. In fact at the beginning of the current period we had surplus cash and felt able to give a rebate to trusts at the beginning of this period of £70 million. In essence, the contribution for the current year should have been about £470 million. It still does not explain the big difference. The big difference came about because we found that during the year we were spending at a much faster rate than we had anticipated. We can only be reactive, obviously - we cannot go out and find people to give compensation to - and we found that for some reason we were faced with a surge of claims, settling at between about £100,000 and £0.5 million in particular. We had not anticipated that and we still have not bottomed the reason for that. They are all legitimate claims, obviously - we do not pay unless there is a liability. We also had held back, either by agreement with claimants or because the courts had stayed them, approximately 120 cases, some of which would have been settled in the previous year, because of the Thompstone case - the case which changed the basis on which indexation is applied to future care claims. We also were taken by surprise - there is no point in pretending otherwise - by the surge in the number of claims that were being funded by conditional fee agreements. They have been available to claimants for some years now but there has not been a very mature market in insurance. Insurers back the agreement, so that a solicitor can offer a "no win, no fee" arrangement, and insurance is purchased against the risk of you losing the case. That means that in cases that have been selected and do win by claimant lawyers, their costs can now be double what they previously were. The answer is that we had been hopelessly optimistic in giving the rebate we did, although on the knowledge we had at that time I genuinely think we could have been criticised had we not released that back to the service, and we were then faced with a position where we might have run out of money in-year. There were three options available. We could have allowed that to happen, but that would have impacted on patients, which would have been absolutely wrong. We could have gone back to the trusts and said, "We want a second call in-year," but we had no idea whether they could afford it and we realised that that would massively disrupt their operations in some cases. Or we could do what we actually did, which was to borrow money from the Department of Health. We did that and we have to repay that over the next two years, so £60 million of the uplift is a repayment of debt. The really important message, apart from mea culpa because we got it wrong, which we undoubtedly did, is that that is not a reflection of a deteriorating level of performance in the National Health Service. The claims that we will be paying both this year and next come from events which occurred last year, two years ago, three years ago. We have had claims going back to the 1950s, even though the authority has only been in existence since 1995. It is a function of the payments to be made in-year; it is not a reflection at any given time of levels of negligence (for want of a shorthand word) in the service. Q762 Dr Taylor: We have been given a table with two columns: total liabilities and actual clinical negligence liabilities. These have shot up from less than £1 billion ten years ago to £11.91 billion now. This has been a fairly steady increase. Mr Walker: Indeed. Q763 Dr Taylor: Is there an explanation for this? Mr Walker: Yes. The provisions figure, the almost £12 billion that you identify, is not a real number; it is an actuarially calculated number. The one thing we know about it is that it will not be right: it may be more or it might be less, but it is actuarially sound at the moment. Q764 Dr Taylor: Right. Mr Walker: And it is a reflection of the best modelling we can do. Please forgive me if I am going too far in this explanation. If the National Health Service had stopped trading in its present form on 31 March last year, and all activities that have occurred since then had been undertaken by a new corporation or body, the £12 billion is the best measure we can make of the liabilities that would still come through from previous activities, including children born in the 1980s and 1990s, et cetera, because, as you will appreciate, there is no limitation period applicable to most of those claims. Does that make sense? Q765 Dr Taylor: Help! Mr Walker: I am sorry, I am always torn between words of one syllable being patronising and ----- Dr Naysmith: Use words of one syllable here! Q766 Dr Stoate: Do not worry, we are good at bullshit. Mr Walker: I am sorry. I should know better than to invite this kind of comment. Dr Stoate: Never bullshit a bullshitter! Q767 Dr Naysmith: Mr Walker, the NHS Litigation Authority sets standards for patient safety through the Clinical Negligence Scheme for Trusts. Mr Walker: Yes. Q768 Dr Naysmith: Should the standard setting not be the job of a body that is not responsible for dealing with litigation? Mr Walker: That is a good question and it is one which we ask ourselves regularly. Q769 Dr Naysmith: What answer do you come up with? Mr Walker: Well, first of all, the background is that the Clinical Negligence Scheme is a risk-pooling scheme. It began during what used to be called the internal market, when trusts were first exploring autonomy and the idea was that risks would be pooled, claims would be settled from the pool, and the rather wise people, I think, who were putting that together recognised that if it were a mutual insurer, for example, that insurer would want to instigate some risk management activity to protect the pool. That is how standards were initially devised. Q770 Dr Naysmith: That is about risk management, is it not? Mr Walker: Yes. Q771 Dr Naysmith: Would the Care Quality Commission, for instance, not do a better job at setting standards? Mr Walker: I do not know that they would do a better job. I think we do an excellent job of setting in the context of extensive reiterations and subsequent rounds of consultations with all of the interested parties. It is entirely possible that Baroness Young, in her wisdom, might decide that is something that they would want to do. No one has volunteered to take it on historically, I should say, and what has happened is that people like the Healthcare Commission, for example, have used our assessment outcomes and fed them into their own data to produce things like the annual health check. I think that what we do, we do very well, but I am not saying that we are the only people who could do it, nor am I saying that it is not possible that someone could do it better, but lots of people take our data on the basis of what we do now and make use of it. Q772 Dr Naysmith: How does it compare with what happens in other countries, for instance? I do not want to go through them all, but is our system unique? Mr Walker: It is not unique, but there are variations. In other dispensations, as you know, there is a commercial insurance element, and commercial insurers would feel very comfortable about setting standards and they would incorporate that, as it were, into their underwriting, which is something that we do not do. We do discounting, so in a sense it comes into our underwriting of risk. A commercial underwriter, of course, can always refuse to accept a risk. That is inconceivable for us in the context of NHS trusts, so we try to create systems that we know trusts use as a template for their risk management programmes, and we know they use it and welcome it in governance terms. Indeed, we are frequently asked by the private sector if we can sell the service out to them. Q773 Dr Naysmith: That is interesting in the light of my next question. We understand that the Clinical Negligence Scheme does not cover situations where patients receive NHS care from independent sector providers. Is that true? Mr Walker: It is not true. We do. Q774 Dr Naysmith: You do cover situations like that. Mr Walker: Yes, we do. In direct response to government policy, which as you know is to widen the range of providers delivering NHS care, we have, through the ISTC programme, through the first and second wave contracts and through the extended choice network ---- Q775 Dr Naysmith: It is widespread throughout the system, then. That happens. Mr Walker: Through those programmes. Q776 Dr Naysmith: It is no wider than these programmes. Mr Walker: No wider than those programmes, that is correct. That is by agreement with the Department of Health. We deal with those claims so that the patient experience is no different vis-à-vis a claim for compensation should he or she be harmed in an acute trust as compared to in an independent sector treatment centre. We provide that cover through the Commissioner on the assumption that the Commissioner owes a duty of care to the patient. Q777 Dr Naysmith: Do you think it should be widened to widen the use? Mr Walker: With respect, the Government thinks it should be widened because of the Health and Social Care Act last year. The Act has received assent but it is only enabling legislation and requires regulation. Q778 Dr Naysmith: Will that cause problems for your organisation? Mr Walker: No. Q779 Dr Naysmith: So you are quite happy with that. Mr Walker: Well, absolutely happy to do it. We are part of the National Health Service. Our only reason for being there is to help deliver NHS policy, which in turn is presumably always government policy too. Dr Naysmith: I would not like to make presumptions like that. Thank you. Chairman: We will not have that debate this morning. (In the absence of the Chairman, Dr Naysmith was called to the Chair) Q780 Charlotte Atkins: Mr Walker, we are still waiting for the NHS redress scheme some three years after the necessary legislation was passed. When is it going to happen? When and if it does happen, will it make any difference? Mr Walker: An interesting series of questions. Let me take the first one first. When the Redress Act received assent, the Regulatory Impact Assessment that was published at the same time said that it was unlikely that the redress scheme would be up and running before 1 April 2009; in other words, at the end of this month. I believe that subsequently Parliament has been informed - and I just do not know what the mechanism is - that that date will be put back - and remember, that is not a start date; that is a likely earliest start date - to 1 April next year. When regulations are laid, then the redress scheme can kick in. The second part of your question I think is particularly interesting, and I have to say I do not know the answer. I think one of the reasons why perhaps there has not been a rush to implement the Redress Act is that the systems that are currently in place for dealing with claims, particularly the low value claims which are envisaged in redress, may be perceived to be fair, reasonable and equitable now. There will be dispute about that, particularly from those who are not successful in bringing claims, but of course the redress scheme, as many observers seem to have missed, is entirely tort based anyway, and so the same criteria will apply. It will still be necessary to show that there has been a breach of duty or negligence or one of the other factors that would create the liability to succeed under a redress scheme as envisaged by the Act. The word "tort" is expressly mentioned there. Q781 Charlotte Atkins: Action against Medical Accidents suggests that the process should be changed and that you should have an "avoidability test" rather than a blame culture. What is your view about that? Mr Walker: I do not think it would make a great deal of difference. I think it would make a difference to certain individuals who were bringing claims, but of course I am trying to answer the question in the round. To the population of people who might want to bring claims, I think that to introduce one test as opposed to another would simply lead to the lawyers focusing on proving the new test, as it were, bringing in their experts to establish that the new test had been met, and I really do not think it would make a dramatic difference. Q782 Charlotte Atkins: If you have a no blame culture would you not get more co-operation from the medical professions involved? We would go towards a system which happens in aviation - where people are willing to give information on near misses, about things that could have happened, or, indeed, when things have happened, to own up to them - rather than go down the blame culture route, where everybody puts their hands up to say they are innocent. Mr Walker: I do not think, first of all, that AvMA's image of everyone denying that they have done anything wrong exists in real life anyway. It certainly is not our experience. There will be examples, of course, because it is human nature to hide from the fact that you have made a mistake, and I do not think any kind of regulation or change in the rules is going to change that. People are very reluctant in any walk of life, whether it is driving a car or whatever else it might be, to own up to their mistakes. In terms of changes in the law, we are currently working within a system that, with all due respect, ladies and gentlemen, is created by Parliament and the courts, and I am not convinced, despite recurrent debates, about moving towards no fault - and I realise you are not talking about going quite that far in terms of compensation. The "no fault" debate always comes down to two issues: the first, in practical terms, is that there is no "no fault" scheme anywhere in the world, because they are all constrained to some extent by the wordings. Q783
Charlotte Atkins:
What
about the scheme in Mr Walker: The scheme in Q784 Charlotte Atkins: In your view, is there a true "no fault" compensation scheme operating anywhere in the world? Mr Walker: No, I do not think there is. Charlotte Atkins: Thank you very much. Dr Naysmith: Thank you both very much indeed for coming along this morning and giving us your evidence. Witnesses: Mr Geoffrey Podger, Chief Executive, health and Safety Executive, and Professor Kent Woods, Chief Executive, Medicines and Healthcare Products Regulatory Agency, gave evidence. Q785 Dr Naysmith: Good afternoon. Welcome to this our sixth evidence session in our patient safety inquiry. I would be grateful if you could identify yourselves and say who you represent for the record. Professor Woods: I am Kent Woods. I am Chief Executive of the Medicines and Healthcare Products Regulatory Agency. Mr Podger: I am Geoffrey Podger. I am Chief Executive of the Health and Safety Executive. Q786 Dr Naysmith: Thank you both for coming. You say in your written evidence, Mr Podger, that "The current regulatory situation can lead to confusion for duty holders, inhibit the establishment of improved management practices and is not necessarily the most effective use of public resources." That suggests you would like to see something different there. How would you like to see it changed? How should it be changed? Mr Podger: I think we do take the view that there are improvements that could be made to the present system. I must say I have considerable sympathy with the view that Barbara Young expressed to you, that wholesale restructuring is often not the most sensible way of bringing about improvements. But to give what is perhaps the main issue for the Health and Safety Executive, to put that on the table, we have become concerned that in those cases where we ourselves get called in to investigate, very often we are following on from an investigation which has been done by somebody else. In our view that is not (a) an efficient basis on which to do an investigation, because the basis on which we investigate is different, and (b) clearly it puts all those who are, as it were, to be investigated through the same mill twice. It means a lot of time will be expended on the process, and inherently there is the argument that justice delayed is justice denied. Q787 Dr Naysmith: What you are saying sounds perfectly reasonable but do you suggest any particular changes? Mr Podger: Let me say that we would like to see this more generally across the whole area which we investigate, not simply in the health area, but where a case is thought of sufficient seriousness for us to investigate, under section 3 of the Health and Safety at Work Act, not the normal run of cases we would investigate, we would like to see the authority that begins the investigation relinquishing investigation to us at an early stage. That is no disrespect to them at all, but if in fact something is thought worthy of considering criminal sanctions, our view is that that decision can be reached usually pretty early on and at that point it makes sense for us to take it over. Q788 Dr Naysmith: You went on to say in your evidence that you hope the Care Quality Commission will ensure more effective regulation. Mr Podger: Yes. Q789 Dr Naysmith: What would that mean for the role of the Health and Safety Executive? Mr Podger: We also strongly support what Barbara was saying about the desirability of the Care Quality Commission co-ordinating the regulators across this patch. We are, let us be honest about it, important, in our view, but nevertheless bit players in this particular area, so we think it does rest with the Care Quality Commission to co-ordinate. I should make it clear that we have had a lot of very constructive discussions with their predecessors, particularly the Healthcare Commission. We would want to see that work brought to a conclusion and, in particular, we would want further development of protocols as to where we do interface, how these can be managed in the public interest, so that, as I say, it is clear at the start who is going to do it and how and why. It is not our view - and I do stress this - that there is any ill will between the regulators in this area - there is not, to our knowledge - but I think more could be done to have smoother interfaces than we currently have. Q790 Dr Stoate: I would like to explore the interface between you and the Care Quality Commission or the Healthcare Commission. You said in your evidence that you do not routinely seek to intervene proactively in areas of clinical risk, which is fair enough, but you do on occasion prosecute people on the grounds of patient safety. Could you explain to us where you would see your role cutting in and where you would see it is not appropriate? Mr Podger: Indeed. We first of all have a category of incidents
that occur on healthcare premises where we would routinely be the people who
investigate. That is, for example, where
premises are not properly protected in the interests of the patients who are
within them. Obviously rather sad cases
are people who fall out of windows which they were able to open and should not
have been able to; people who burn themselves on radiators because, sadly, they
do not have the mental capacity to understand what they are doing; people who
are exposed to hideously high temperatures in baths in which they are
immersed. These are very important cases
to us, but, if you like, they are the slightly the run-of-the-mill health and
safety cases which occur. They would
normally be investigated by us and we would, if necessary, bring a
prosecution. It does not necessarily
mean we would bring a prosecution; it entirely depends on the evidence. We would also want to take preventive
measures both in those premises and more generally. In addition - and this is the category of
cases I was talking about in answer to your question, Dr Naysmith - there
are areas where we get brought in where it is thought that the seriousness of
what has occurred is such that criminal sanctions should be considered. You would be aware of the Q791
Dr Stoate: What was your attitude
towards the Mr Podger: Yes, and that was where we did a joint investigation with the police in fact. I think it is important to say that we, like any other prosecutor, are not and do not wish to be other than bound by the requirements on prosecutors generally. Therefore we are required to investigate the evidence, having got the evidence we then have to consider whether it is sufficient to mount a prosecution, and we also have to consider whether it would pass the public interest test. In this particular very regrettable series of events, the conclusion that we and the police jointly reached was that there was not a basis for a prosecution and we did not mount one. Obviously a lot of information came out of that inquiry, as you would expect, as to improvements that should be made in terms of the systems that were operating there and so on. As I say, we are absolutely bound to act on the evidence and the criteria which are then applied to the evidence. Q792 Dr Stoate: Professor Brian Toft has recently said that if a clinician brings a patient safety issue to the attention of a manager and that manager does not address the issue, then the legal liability should rest with the manager rather than the clinician. Do you agree with that? Mr Podger: As I indicated, we do not normally get involved in clinical cases, but I think it is right to say - and I would be supportive personally, let me say, of Professor Toft's position: I have great respect for Professor Toft - that in the cases that the Health and Safety Executive brings across the patch (that is, beyond healthcare, but we apply the same criteria to healthcare or anything else) we do on occasion bring prosecutions against individuals, often with the organisation they belong to but sometimes without the organisation, because they themselves appear to have acted in such a strange way vis-à-vis the policies under which they were supposed to be acting. I think it is important, therefore, that we should preserve in the healthcare area as elsewhere that there is an issue of individual responsibility. I do not think people should be enabled to, in some way, get out of that if they have really acted in a way which is quite improper, given the instructions under which they were. Q793 Dr Stoate: Could you see yourself then prosecuting such a person; for example, if there were a significant patient safety issue brought by a physician and the manager effectively ignored it? Could you see that as something you might take up as a prosecution? Mr Podger: The answer is, as I say, that it cannot be ruled out. As you will well appreciate, doctors may be acting in various capacities in hospitals. They may, in fact, be acting as managers, in which case I would suggest that this possibility does become a real one. I would not see us acting against a clinician on clinical grounds, because, as you know, the system is different from that, and you are well familiar with that. In relation to management, we would not inherently rule it out. The issue in that kind of case that Brian was talking about is inevitably, first of all: was the attention of the right people drawn to it? The discussion you heard this morning about the role of boards is crucial here. Boards need to be made aware of what is going wrong. If people fail to do this, then they do put themselves in a position of individual liability, in my view. Obviously whether you prosecute depends on the circumstances, but the principle is a correct one. Yes, I think managers do have to understand that they do expose themselves potentially to criminal law if they do not in fact make sure that matters of extreme importance are properly brought to the attention of the board and then the board must take responsibility for what it then does. Dr Stoate: Thank you, that is very helpful. Q794 Dr Naysmith: Before we leave this area, Mr Podger, I realise you have said that you do not want to be involved in clinical regulation, and that is fair enough, but in the borderline cases to which you make reference, when you were saying, "We need to take action here," have you found any resistance to taking action? Without naming any particular cases, when you have said, "We want to take this further and prosecute" - and you have said you have a duty to prosecute if you felt you should - have you ever encountered resistance to do that in the National Health Service? Mr Podger: No, because, in effect, the National Health Service would not be able to mount such resistance. That is perhaps the difference between ourselves and the other regulators you have been talking to, because we are external to the National Health Service. Clearly it is incumbent upon us to investigate fairly and objectively and then to listen very carefully to what people say to us. We have no interest in manic or unreasonable prosecution of any kind. Once we are enforced, we have full powers, and it would not, in my view, be possible for people to obstruct us and they do not seek to do so in our experience. Q795 Dr Taylor: Mr Podger, you have already referred to falls out of windows and scalds. In the Healthcare Commission's evidence to us they give us a table of the top ten safety incidents reported to national organisations and patient accidents come out way top of this: 230,000 in 2007-08. What can the HSE do to address these sorts of accidents? I am particular thinking of elderly patients who fall out of bed and break their hip and extend their admission time to hospital for ages. What are you doing? What can you do? How do you plan to improve it? Mr Podger: That is a very fair question
and it reflects what I was saying earlier.
I think it is important not to regard hospitals as places of total
peculiarity as opposed to the problems that arise elsewhere. In fact, many of the problems they have are
generic, and therefore we do seek to address slips, trips and falls - a major
cause of accident across the patch in the Q796 Dr Taylor: Very often the reason given for an elderly person falling out of bed, even though the cot sides are up and they are confused, is a shortage of staff. Would you ever say anything about that? Mr Podger: I think that is one of the most difficult areas for us to intervene on. Issues about levels of provision of staff are always inherently difficult. It is clearly a legitimate factor to consider if you then go on to consider whether there is fault. The question has to be asked: What was it reasonable to do in the circumstances? But, equally, that would apply to individual carers. It would not inherently apply to those who are running the organisation, where you would have to ask: Are you able to run this organisation at all on the scale you are with the staff you have? That is a responsibility which, in my view, is a responsibility which is properly held at board level. Dr Taylor: Thank you for helping us to understand your case. Perhaps I could also say thank you for the calendar that you sent around with the most marvellous cartoons. It helps to dispel the image of HSE as a sort of malignant over-inspector. Q797 Sandra Gidley: I did not get one. Mr Podger: I am extremely grateful for your words. Normally I have to offer to submit supplementary memoranda for the things I have forgotten but after this session I could perhaps submit supplementary calendars! Dr Naysmith: We are going to bring Professor Woods in now. Q798 Sandra Gidley: Professor Woods, we have had evidence about risks posed by untraceable, unlicensed "named patient: medicines, internet pharmacies and counterfeit medicines. Has MHRA made an assessment of the scale of this? Professor Woods: Yes, it is an area which has
concerned us, particularly in the last five years or so, because, particularly
on the counterfeiting front there has been evidence worldwide of an increasing
interest of criminality in counterfeit medicines. Although the Q799 Sandra Gidley: Is there a bigger risk from counterfeit medicines in the legitimate supply chain or from internet pharmacies? Professor Woods: Internet sales are
particularly worrying because the scale is certainly larger. It is very difficult to regulate for the
practical reason that if you have a website offering to sell Viagra, which is
nearly always fake, the source of manufacture might be in the far end of Asia,
the website itself may be hosted in another country, and the point of sale may
be in a third country, and for one regulator working in one jurisdiction to
break that network is exceedingly difficult without the participation of other
countries. We have set up what we call
internet days of action, which happen several times a year, where we assemble
evidence we have of illegally operating websites in the Q800 Sandra Gidley: How do the public know, because there are legitimate internet pharmacies? Professor Woods: Indeed there are. Q801 Sandra Gidley: How does the public tell one from the other? Professor Woods: The Royal Pharmaceutical Society has created a scheme with a logo which is displayed on internet pharmacy sites which are doing absolutely legitimate business and communicating prescription medicines against a prescription. That is a scheme we very much welcome. We work closely with the Royal Pharmaceutical Society on this work, and we are very careful to emphasise that we are concerned about the purchase of prescription medicines without a prescription on an unverified pharmacy site. Q802 Sandra Gidley: We have also heard that bar coding technology is a significant weapon against counterfeiting. Would you agree with this? Or is there a better way? Professor Woods: It has the potential but it has substantial complications and complexities to it. It is something which is under very active scrutiny at the moment. We contributed substantially to an EU review of this area which is now out to consultation. It went out to consultation in December. The issue is that an auto-identification system, such as bar coding or auto ID or whatever, would be quite complex to run. It is more than the sort of bar coding that is necessary for, say, stock control or patient safety activities like ensuring that the right patient gets the right blood. Those essentially can be run locally. With an anti-counterfeiting system, first, because we have the global sale of medicines, manufacture can occur in almost any country. An effective auto ID system would have to be internationally agreed, working to international standards. Second, there would have to be a single, large database, so that at any point in the distribution system you could interrogate a package and confirm in that database that that indeed was the pack that had started life in a factory several countries away. The third thing which is different is that it would have to be resistant to forgery. If you have a bar coding system in a hospital to make sure that blood is properly distributed, nobody is going to try to forge that, but if you are trying to produce an anti-counterfeiting system of auto ID, you are looking at standards of non-forgeability that get close to credit cards, and that is a very demanding set of criteria. It may happen, but it will certainly need to be done on an international basis. The consultation that went out in December is also consulting on some proposals which the EU has put forward, but they are only proposals of principle, the nitty-gritty details have not yet been resolved. Sandra Gidley: Thank you. Q803 Jim Dowd: Professor Woods, the Royal Pharmaceutical Society in evidence to us stated that the Yellow Card Scheme provides only a "sparse data set and there is an urgent need for more complete information on adverse drug reactions (ADRs) soon after a medicine is licensed." Do you agree with that statement? If so, what are you doing about it? Professor Woods: The Yellow Card Scheme has certain intrinsic weaknesses about it, and yet it is an exceedingly valuable scheme which we have been running and our precursor agencies have been running and refining for 40 years now. It is an essential part of medicines safety surveillance and we have worked hard in recent years to increase the utility of that scheme. To give you the scale, we currently have a database of 600,000 adverse drug reaction reports, and if you include foreign reports which are being copied to us, we have one million reports. That is a very valuable resource based on the spontaneous reporting of what individuals consider to be potential adverse drug reactions. Originally the system was set up for doctors and coroners to report, then it was widened to pharmacists, then it was widened to nurses, and our interest in the last year or two has been widening it to the general public. There was a bit of resistance to this initially, from several quarters. The suspicion was that the general public would give us rather trivial reports of low information ---- Q804 Jim Dowd: When you say "specific quarters" do you mean professional quarters? Professor Woods: Inside the agency and outside the agency. We have an independent review of the Yellow Card System, carried out by Dr Jeremy Metters chairing it in 2004. It was floated at that point that we ought to explore whether patient reporting would add to the system. We went through a period of about three years of testing out various ways of implementing patient reporting, including, for instance, linking it into NHS Direct. That did not work - we just did not get the numbers of reports that were needed. We now have a system which we went fully operational with just over a year ago, February 2008, which has been much more successful. 10% of our reports now are coming in directly from patients and the research we have done on those reports shows that they are at least as informative in terms of telling us about things we do not know about and in telling us about important things which might alter the risk/benefit of a medicine. They have an additional element, which is, as it were, the patient experience of whatever that reaction is - something a health professional is never going to be able to give you - and so they have added to the richness of the system and they have also quantitatively made the system bigger. In the whole Yellow Card System we are getting 25% more reports per year than we were three or four years ago. We are getting about 25,000 a year. The first thing is about improving the quality and the scale of reporting; the second thing is about the analytical techniques you apply to the Yellow Card System. We had a major computer upgrade about three years ago and we invested something like £1 million in new statistical data mining software, specifically for the adverse drug reaction database. That allows us to detect patterns of association between an adverse event and a drug exposure which would not have been picked up with our previous statistical methods, so the way you search the database is important. The final and very important thing, having detected signals - they are no more than signals, they are flags waving, saying "Come and have a look at this," out of the statistical data mining or from human scientific scrutiny you get a signal of a suspected association - is that you then have to be able to deploy the full range of alternative techniques, looking at clinical trials evidence, looking at other epidemiological evidence, cohort studies. That is where you bring to bear all the other alternative methodologies. The Yellow Card system remains rather central, but we are moving, in terms of patient safety, from a reactive reporting type system to a proactive view of medicine safety. At the very beginning of a product going on to the market, it is part of the market authorisation for the manufacturer explicitly to consider the risk profile of that product, what we know about it, the safety profile, and what we will need to know about it. So the Yellow Card System is essentially reactive and now we are moving to a proactive information seeking approach to drug safety. Q805 Jim Dowd: If I understood what you were saying correctly, you were tending to agree with the Royal Pharmaceutical Society that it only presents a sparse data set at the moment. Professor Woods: It is estimated that something of the range of 5% to 10% of adverse drug reactions get reported - and that is not just our experience, it is true around the world. Q806 Jim Dowd: Has that figure changed at all with the introduction of direct references from the public to you? Professor Woods: In so far as we have got more reports, I suspect it has improved to that degree. It is helpful, but the reports we do tend to get tend to be the more serious ones. Even so, only a minority of adverse drug reactions are reported to spontaneous systems worldwide. It is an imperfect system but it is a necessary system. Q807 Jim Dowd: In the reports that you are now getting directly from the public have you noticed any duplication between references which have already been made that may tend to indicate that a professional should have made a reference but did not and the member of the public then had to do it themselves? Or it could indicate a hypochondriac. I am not sure. Professor Woods: There is a technical issue. We do have a duplication procedure inside the system, so if we get a report from the doctor and from the patient we recognise it as a single case. We have done some interesting work last year, again with the Royal Pharmaceutical Society, using community pharmacies as a way of getting across to the public, first, that they can report, and, second, that they or their pharmacist should report. We had quite a large publicity campaign running over six weeks which pharmacists were very active in. It had a dual effect. First, it reminded pharmacists that they could report, but its specific target was the patients who were using those pharmacies. All this, as I say, has pushed up reporting rates. You are trying to optimise a system which is never going to be perfect, but it can certainly be enhanced. Q808 Jim Dowd: Part of that would be making the existence of the self-referral by patients more widely known. Professor Woods: Making it widely known and making it easier. They can report on Yellow Cards, they can report over the internet. On our website we have a very easy patient reporting line. All of these things modernise and enhance a system which has been doing this very well over the years but it has scope for improvement. Jim Dowd: Thank you. Q809 Dr Naysmith: On one of our previous inquiries some years ago we recommended that the Yellow Card System should be extended to patient reporting. Professor Woods: Yes. Dr Naysmith: Even if it is only moderately successful, it is nice to achieve something. Q810 Charlotte Atkins: Professor Woods, on this Committee we received oral evidence about the appalling case of Bethany Bowen. In that case a medical device, a morcellator, was used inappropriately and it appears to have contributed to her avoidable death. I am surprised that in this situation the MHRA does not appear to have taken a particular role in terms of looking at how this device should have been appropriately used. Professor Woods: We did, indeed, have a role in that. Perhaps I can suggest that there are three aspects to it. The first and our most immediate concern, our statutory responsibility, is to establish whether the device malfunctioned. We worked with the manufacturer to confirm that that was not in fact the case. A deficiency of the device would include deficiency of the instructions for use. We consider this to be an integral part of the device. We did confirm with the manufacturer that the instructions for use made it very clear that there were certain surgical settings of particular hazard, including vascular sites where the risk of bleeding was obvious. There is the question of the device, and that is our responsibility. There is the question of the procedure in general: Is that way of removing a spleen intrinsically too risky to do, given that there are alternative ways of doing a splenectomy? That is not directly something that we work on, but there is a committee called the Interventional Procedures Advisory Committee at NICE, on which I have sat and on which my senior devices colleague Dr Ludgate still sits, which considers from the procedural point of view: Is that something which trusts should be prepared to see happen in their premises? That is the procedure. The third aspect of it is the training. We have heard from Finlay Scott the issue of the doctor's responsibility to ensure that they are working within the limits of their competence. There is a clinical governance question about the training and support of people who are carrying out rather innovative or perhaps unusual procedures, whether they have had the training they need. That is something which lies between, as it were, the professional responsibilities of the individual doctor and the corporate clinical responsibility of the institution. We follow that spectrum part of the way. Our prime concern is with the device: Has the instruction with the device made it clear what the hazards are? We are closely involved in other bodies' scrutiny of procedures, particularly innovative ones. We do not have a role in training, as such. We have adopted some areas of training in relation to devices use, because it seemed to be a rather awkward area, but the reality is that there are 80,000 or so different types of device on the market and we could not possibly provide training support for all of those. It is normally considered to be a part of the manufacture and sale that there should be training in the use for whomever the end user will be, but, nonetheless, as an agency we have put out a certain amount of training material on devices use and we would like to expand that. It tends to be fairly general issues, like using infusion pumps and so forth, but we have picked those because they crop up as a source of mishap over and over again. Although we cannot train people to use a morcellator, there are so many infusion pumps in use in the NHS and we get back our adverse incident reports which indicate that operator difficulties are very common, so that we felt that we should put out specific advice, and we will do more and more of that as the opportunity presents. Q811 Charlotte Atkins: Do you think you should be more involved with the procedural issues? I know you are on the Committee, but do you think you should be more directly involved in that, given this particular case? Professor Woods: I think the right level of
engagement is the one we have, and that is perhaps somebody with deep devices
expertise sitting on the advisory committee of Charlotte Atkins: Thank you. Dr Naysmith: Thank you both very much indeed for giving us a lot of useful information and you have done it in a succinct and yet comprehensive manner. Thank you very much. |