UNCORRECTED TRANSCRIPT OF ORAL EVIDENCE To be published as HC 151-v

House of COMMONS

MINUTES OF EVIDENCE

TAKEN BEFORE

health Committee

 

 

patient safety

 

 

THURSDAY 19 march 2009

PROFESSOR SIR MICHAEL RAWLINS, LORD PATEL and MR MARTIN FLETCHER

 

PROFESSOR LORD DARZI OF DENHAM KBE, ANN KEEN MP

and SIR LIAM DONALDSON KB

Evidence heard in Public Questions 812 - 956

 

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Oral Evidence

Taken before the Health Committee

on Thursday 19 March 2009

Members present

Mr Kevin Barron, in the Chair

Charlotte Atkins

Mr Peter Bone

Sandra Gidley

Stephen Hesford

Dr Doug Naysmith

Mr Lee Scott

Dr Howard Stoate

Dr Richard Taylor

________________

Witnesses: Professor Sir Michael Rawlins, Chairman, National Institute for Health and Clinical Excellence (NICE), Lord Patel, a Member of the House of Lords, Chairman and Mr Martin Fletcher, Chief Executive, National Patient Safety Agency, gave evidence.

Q812 Chairman: Good morning. Could I welcome you to our seventh evidence session in relation to our inquiry into patient safety? I wonder if I could ask you for the record if you would give us your name and the current position you hold.

Mr Fletcher: I am Martin Fletcher, the Chief Executive of the National Patient Safety Agency.

Lord Patel: Naren Patel, I am Chairman of the National Patient Safety Agency.

Professor Sir Michael Rawlins: Michael Rawlins, Chairman of NICE.

Q813 Chairman: I have a question to start this session which relates to the NPSA. Do you think that your remit has allowed the NPSA to have the maximum possible impact on patient safety or could the government have given you a better job description, perhaps with a broader remit, than your present one?

Lord Patel: Let us first of all address the issue of what is our remit. Our remit is written in words which are not always very clear. If I summarise it, NPSA's role was to coordinate systems wide patient safety by key things: by promoting a culture of reporting and learning from adverse events in the health service; to devise, implement and monitor a reporting system based on relevant national standards to be issued by the Department of Health regarding adverse events and near misses, again to promote a culture of reporting and learning; thirdly, to collect and appraise the information on reporting adverse events, near misses and other material useful for any purpose connected with the promotion of patient safety. The remit itself was fairly wide. What it did not have in it was any role to work in terms of implementation of the learning outcomes or any role of monitoring that that implementation was being done or, to that matter - although we independently do that - to have a role to test the methodology and, more importantly, it did not have any specified role in that to work with other NHS organisations such as maybe NICE but also with the regulators. However, we interpreted that job description fairly widely and actually do work closely with the Healthcare Commission and will now do so with the Care Quality Commission and some work with NICE also. If you ask me the question, could a wider role have been given, organisations always say yes. On the other hand, we were able to interpret the roles that we were given in a way that would allow us to more widely interpret that. Implementation was the key. The view we have taken is that it is not our role to be an enforcer or an inspector or a regulator; we are not that. Our role mainly was to promote a culture of patient safety, particularly in providing tools and whatever was needed for people to establish local systems to collect this information and be a national repository and produce the learning from that national repository.

Q814 Chairman: Do you have anything to add, Mr Fletcher?

Mr Fletcher: I think Lord Patel has covered everything.

Q815 Chairman: There is something I want to take up with you and this is about the issue of an independent investigation process for all deaths and serious injuries caused by healthcare. When we look round at air and rail accidents these investigations are actually run by independent bodies. If it were the case that independent bodies looked into deaths and serious injuries, would that not ensure that we get to the bottom of serious incidents without a vested interest getting in the way? What is your view on that?

Lord Patel: That is a good question. You are quite right, in other fields and in other industries they do have a system of independently looking at any serious injuries. Let us just rehearse what happens now. The local organisation where the healthcare is delivered does the investigation in the first place. At times they might feel that they want an independent group, they might invite some experts from outside, for example another trust, to carry out that investigation. The strategic health authorities might decide that they want to conduct an inquiry and that might be independent of the trust where the serious incident occurred. It may be that other agencies such as Parliament or government may get involved sometimes and set up an independent inquiry. The coroners of course do their own inquiries in cases referred to them. The principle of having an independent inquiry for serious untoward incidents, particularly that might lead to serious harm or death, is important. However, the principle also should be important that you would do this inquiry with the primary purpose of learning from it and to get that learning across the NHS rather than doing an inquiry about that particular incident to find blame or where blame lies (although that may come out). The next thing we need to look at, if you are going to do this, is what is the scale compared to other industries? On the basis of the information we have if you take serious harm and death we are probably talking in terms of numbers of possibly 10,000 or more. If there are going to be large numbers there are quite considerable cost and resource implications. One way to handle that might be to set clear criteria of what incidents you would investigate, in particular they would have to be ones where there is a patient safety issue and there is likely to be learning from it. Secondly, there might be, for instance, a never event - things that should not happen - that could be investigated. That way you are setting clear criteria. That does not mean that these criteria cannot be violated; there may be others which fall outside that you still wish to investigate. The concept of local ownership of this investigation is correct; whether the independence should come from the SHAs and not individual trusts might also be right. What is important though is that you have the right people with the right skills carrying out these investigations. That is where we need to have some training and some tools so that the trusts and others understand clearly the clear criteria of what needs investigation. Before that, to make the care safer, there are other issues that we need to address. For instance, if a hospital has a higher number of serious untoward incidents than the average then we need to go round and look at our systems in this hospital. Is there something fundamentally wrong with those systems? Let us not start discussing the report of two days ago. I do not know whether that helps.

Q816 Chairman: In part it does but at the very beginning there were a lot of "mights": it might be an inquiry; it might be by a neighbouring trust that would come in and do the inquiry. Really the issue is that there are no mights in terms of rail of air; there are independent inquiries into what happened and lessons learned. We are obviously doing a comparator between risk assessments in different parts of the economy, as it were, in relation to what is happening in health. Would you like to see the "mights" being replaced by "will" or "should"?

Lord Patel: "Should".

Q817 Mr Bone: Lord Patel, I think you said in your opening remarks that there were 10,000 possible deaths a year that are untoward or needing investigation.

Lord Patel: Serious incidents and deaths.

Q818 Mr Bone: Let us take that as being a hundred additional air crashes in this country. If there were a hundred additional air crashes in this country the government would be absolutely criticised if they were not independently investigated. Is the problem that we are letting the NHS cover up these things by not having an independent investigation; independent investigation, not NHS investigation?

Lord Patel: Let us address the concept of 10,000 serious incidents including deaths where we are going to do in-depth, independent investigation. As a concept of independent investigation I sign up to it. What we need to look at is the feasibility of doing this and whether it is necessary to do it in all 10,000 because the learning that may come from two may apply across the board of the healthcare and you do not need to do more than two, depending on what the investigation is about. It is a systems failure that we normally try to pick up, not individual deaths. I think that has to be clearly understood.

Mr Bone: I am afraid you would investigate air crash; you would not just say, "It's like the other one".

Q819 Chairman: They all fell out of the sky.

Lord Patel: That is if the analogy of air crashes is always going to apply to healthcare which we can have another debate about.

Mr Fletcher: Just to add to Lord Patel's comments, I think that the key point around investigation is firstly the point about why we are doing it and we are really doing it for learning. What we are interested in is that the investigation is robust and credible and gets to the issues that have led to the harm in a way that we can then take action on those in terms of national learning across the NHS. One of the things we have done is to work very closely with each of the ten strategic health authorities in England to set up patient safety action teams. We have transferred the patient safety management resource from our agency to those SHA hosted action teams and a major focus of those action teams is on improving the quality and robustness of likely investigation of patient safety incidents. We have also done a lot of work to develop standardised tools for trusts so we have a whole series of templates that are now available on our website that are aiming to standardise to a level of quality the types of investigations that are done and training associated with that. One of the other issues that we have considered and one of the areas where we may do more is actually to think about whether we convene some sort of national panel of experts that may be available for trusts to call upon if there was an investigation that potentially had national significance in terms of learning.

Q820 Dr Naysmith: What about a body like the Independent Police Complaints Authority which must deal with almost as many incidents as you are talking about and yet is independent of any police force? Would that not be a model that might be useful in this situation for investigating incidents?

Mr Fletcher: If we went down the road of a national panel of experts it would be very much about people who had expertise in clinical areas and safety who could provide the independent perspective on any investigation. The second point I would make is that from our end in terms of national learning we do individually review every incident report that we receive where there is a report of a patient death or serious harm. We would often go back to the trust and seek their own investigation report of that; we would look at the literature and we would talk to experts. So I think there is a process that we have in place to make sure that from the point of view of national learning that where these events are reported we are really getting to the heart of what the risks are that might need action across the NHS.

Q821 Dr Naysmith: So we really need something totally independent.

Mr Fletcher: I think it is more a question of how we build on those rather than setting up something different.

Q822 Stephen Hesford: Lord Patel and Mr Fletcher, it has taken a lot of time and effort to set up the National Reporting and Learning System. What would you say have been its successes and its failures?

Mr Fletcher: Let me start with the successes of which there have been a number. The first thing to say is that the National Reporting and Learning System makes it possible for every NHS staff member to report to the system in every care sector across England and Wales, so every organisation has a connection to the system. Not only that, when they prepare a report for local purposes it also is the report that we use for national purposes because the data are transferred electronically so we have been able to have both local systems and national systems where there is not a requirement to report separately. Our trend in terms of reporting is upwards so more staff than ever are reporting, more organisations are regularly sending us data and we believe that high reporting is more likely to indicate organisations that have a strong culture of safety and openness. We think that is a good thing. We have regular systems of feedback now in place to organisations so, for example, every six months we provide feedback reports to organisations on their profile and rate of reporting and we have been doing that now for three years. Two weeks ago we published for the majority of NHS organisations in England and Wales organisational level data about the profile and nature of their incident reporting. We have just produced our eleventh quarterly data summary which we produce separately for England and Wales. So I think we have regular mechanisms of feedback well-established. We are using the data to learn for patient safety improvement and there are a number of ways we do that. We do that through identification of new risks so there may be an event that looks like a one off event at a trust level but when we look at the national data we can see a pattern in that and an example would be work we did looking at a series of patient deaths where there was a theme around patients who were deteriorating; it was not being identified or, if it was being identified, it was not being well-managed so we were able to identify that as a theme and actually work quite closely with NICE on taking action forward on that. We have done a lot of work on looking at overall patterns and trends in data and feeding that back to the service so, for example, we produced a big report on patient falls which is one of our major topic areas of reporting.

Q823 Stephen Hesford: You said about reporting back to the service but who, in that circumstance, would you actually report back to? Who would you send this stuff to?

Mr Fletcher: The organisational feedback that I talked about before - for example the confidential feedback report - would go to the people responsible for clinical governance and risk management within the organisation. We would then also separately write to the chief executives of the organisation to alert them to the fact that these data are available in their organisation.

Q824 Stephen Hesford: Not at the level of the Department of Health.

Mr Fletcher: Not directly to the Department of Health. The data we published two weeks ago - which was a summary for every organisation in the NHS in England and Wales who had reported to us - names the organisation and is searchable on the website. You can go on, put the name of the organisation and you will get a summary of their data.

Q825 Stephen Hesford: In another life you are a politician because you have not answered the failures part of the question.

Mr Fletcher: I will get to those. There are a couple more successes, if you will allow me. We have done a lot of work around speciality based learning as well. We have worked very closely, for example, with the College of Anaesthetists, the College of Surgeons, looking at the data that relates to their speciality and what we can use from that for improvement. We have done a lot of work around common contributing factors so, for example, we looked at nearly 25,000 incidents where there were problems associated with correct identification of a patient or some element of their care (they got the wrong drug or the wrong procedure because of weaknesses in the identification of the patient) and that has resulted in a whole programme around standardising use of wrist bands, use of the NHS number technologies that improve accuracy. As I said earlier, the other two areas I have mentioned in terms of successes are that we now have a very robust system of reviewing individually all reports of deaths and serious injuries. That is around 1500 to 2000 reports a month where we would individually review those reports and, as needed, go back to the trust for information, look at the international literature, talk to relevant experts to identify where national learning is needed. I have to say I think the other indicator of success is that we have had huge international interest in our work and we get a lot of people wanting to come and see what we are doing and looking at what the lessons are that could be learned from reporting systems in other countries. For us they are the successes. In terms of what you call failures, I think the sense, as you said in your question, is that the system has perhaps taken longer and has been slower to reap some of these benefits. With hindsight there would be a recognition that an undertaking of this scale was a lot more complex than anybody had perhaps at first realised. You have to remember that when this system was set up five years ago it was the first of its type in the world. There was not a recipe book to pull of the shelf and there was no international experience to look at. There has been a lot of learning as we have gone on but I believe we are now at a point where the system is delivering a lot of benefit to the NHS. I am not for a moment saying it is perfect and I am not saying that there are not areas that can be improved; however I think we have a very strong platform in place to support national learning.

Q826 Stephen Hesford: It is suggested to us that basically what you do is busy yourselves with minor incidents from acute hospitals. Is that fair?

Mr Fletcher: No. Let me tell you why I think it is not fair. I presume this is perhaps a comment about the fact that around two-thirds of our data relate to incident reports where there is either no harm or low harm to patients. We believe that those incident reports are very important for two reasons. One reason is because what it is telling us is that staff across the NHS are much more aware of safety and are not waiting until a patient is harmed before they are raising a concern. We think that is a good thing in terms of being able to take preventative action. Secondly, from the point of view of the way that we work, it is often the patterns in those data that are actually very important in terms of being able to contextualise a serious event. If I can give you the example of amphotericin, there has been a lot of publicity recently about a coronal inquiry where there were two deaths relating to amphotericin in one trust. When we went back into our data when this first came up 12 months ago we had around 50 near misses so we were able to show that this was not just a one-off event in one trust but actually there was a generalised pattern of risk to do with confusing two types of this medicine. On that basis we were able to issue an alert to the NHS for other trusts to take preventative actions. For us those data are very important in terms of knowing whether we are looking at a one-off risk or a generalised pattern of risk. The thing that is frustrating for us in terms of the data would be concerns about the accuracy and completeness of the data. One of the areas we are putting a lot of focus and part of the reasons why I think that is so important to trusts is that if we are going to do our job as a national reporting system then we need the data we get from trusts to be as accurate and complete as possible. Let me give you two examples. We get a lot of medicine safety reports but we often get reports on medicine safety issues where we are not told the name of the medicine, so it is very difficult for us to take action on it if we do not know the name of the medicine. Another example would be that we often do not get the age of the patient in the data. We are aware that there are some emerging themes in our data around the treatment of children in non-paediatric areas but we obviously need the age to be able to focus our understanding of the incident reports. Where we need to do more around the data is actually about working with trusts to make sure that the data we are getting through incident reports both for local review purposes as well as national purposes is as accurate and complete as it can possibly be.

Q827 Stephen Hesford: Given that part of your function is an educative function to inform the service and trusts, underreporting is still very substantial. Would you accept that?

Mr Fletcher: What we know is that if it is hard for people to report, if it is not relevant to the patient care they are providing and if we do not provide feedback, there is little benefit in reporting. We know that if we can address the issues of making it simple, relevant and giving feedback then we can improve reporting. We know from our data, as has already been mentioned, that we get a lot more reports from the acute care sector than the primary care sector so we think that is an area where more needs to be done in terms of reporting. We have had some recent success. I will give you one example where we worked very closely with the College of Anaesthetists to design with them a speciality reporting system for anaesthesia. The electronic form was designed in a way that was very relevant to their speciality. The College was very involved with us in analysing the data and providing feedback. In the pilot of that which involved 13 trusts across England, in the first 150 reports more than 100 of those were from senior consultants. We believe that if we can get these things right that means we can make reporting very much more worthwhile.

Q828 Stephen Hesford: You have touched on a few areas there. Doctors underreport in relation to other healthcare workers, so there is an issue. There is almost no reporting from primary care - it is a sort of reporting desert - so after five years there is an issue there. Adverse drug events are still underreported. What can we do and what are you doing about those three particular areas?

Mr Fletcher: To take those one by one I will start with primary care. The picture in primary care is mixed. What we know is that there is underreporting from general practice. When we look, for example, at our mental health data we get quite good reporting from community based mental health services. It is absolutely clear that general practice is underreporting and that is why we are currently working with general practice along the lines of what I have talked about with anaesthesia, of designing specialist electronic form, working closely with the college on the analysis and feedback of that data. We have a number of pilot sites about to get under way in the NHS South West who actually test this and look at how we can improve general practice reporting. In general practice we have also done quite a lot of work with the college around significant event audit which is a well-established methodology in general practice for learning from things that go wrong as well as things that work well. What we have done is to develop a tool kit for the college around using significant event audit as a more meaningful tool for learning. I think that is very much in our focus.

Q829 Stephen Hesford: Is that for GPs?

Mr Fletcher: Yes. The other quick point I would make is that as a result of Lord Darzi's High Quality Care for All report we have support to establish something that we are calling Patient Safety Direct and that will build on the National Reporting and Learning System and create a single portal nationally for reporting and learning. We are very much targeting that effort on the bigger issue of doctors reporting as much as we see nurses reporting.

Q830 Stephen Hesford: What about drugs?

Mr Fletcher: We get around 8000 or 9000 medicine safety incident reports a month. It is one of our top three areas of reporting (falls is the other one I mentioned) so I think we get a lot of data and are very actively using that.

Q831 Dr Taylor: Still sticking with Lord Patel and Mr Fletcher, you have told us that you have pretty good systems for collecting reports and for promoting safety messages but there seems to be an absolutely stark divorce between these messages and the people who should take note of them. The Committee of Public Accounts in 2006 we are told found that "Patient safety alerts and other solutions are not always complied with though trusts self-certify that they have implemented them". Would you agree that there is this huge gap? You have said that staff are becoming more aware of safety; are they really? We cannot avoid talking about what has been happening in Staffordshire; the Department of Health have said it is down to the Healthcare Commission and strategic health authorities to check compliance. The strategic health authority involved in this case certainly did not check compliance. How can you bridge this gap between your immense amount of knowledge about the risks to patient safety and actually getting it across to the people who are doing the work?

Lord Patel: I will make an initial comment and then I will let Martin come in. You are absolutely right; this is the crux of the whole issue, that we can have a mechanism from which we get a lot of learning but unless there is are clear processes to make sure that that learning gets implemented, monitored, tested and it makes a difference to patient care we are not going to get very far. The crucial issue is: how do we get this learning implemented?

Mr Fletcher: Perhaps I could set some context in terms of how the mechanism works. Basically, as I said in my earlier comments, having analysed the data if we had identified some risks that we thought were important for the NHS to know about and some actions that we felt needed to be taken at a local level, we would issue an alert or a random response report. That is done through a system called the central alerting system which is managed by the Department of Health in England and that goes electronically to every trust. We can specify who it goes to in the trust - it might be the medical director or the pharmacy director or the chief executive - depending on what the nature of the alert is. When we issue an alert we set a date for compliance to be reported. By that date trusts are required to report their compliance with the alert fully, partially or not as the case may be. We obviously look at those data from the point of view of whether there is more that we can do to help support implementation. Obviously the Healthcare Commission looks at those data as part of its annual health check and in fact we have gone further in our partnership with the Healthcare Commission where we have actually identified particular alert areas that we think are important for them to look at. The alert we issued around high risk medicines was a particular topic focus for the Healthcare Commission's last health check and they were able to look much more closely at compliance around that.

Q832 Dr Taylor: You have said we can look on the web for alerts from each trust. Did you actually have alerts about Mid-Staffordshire?

Mr Fletcher: Sorry?

Q833 Dr Taylor: One of you said that we can look up our own trusts for a summary on the web for alerts that you have had. What I want to get at is had you had alerts about Mid-Staffordshire?

Lord Patel: I think we need to clarify the distinction between alerts. I think what you are referring to is what Martin spoke about earlier on about the comparative data from different trusts that we published two weeks ago in several areas. Was Mid-Staffordshire one of them? Yes, it was.

Q834 Dr Taylor: So you did have a number of alerts about that particular trust.

Mr Fletcher: Not so much alerts. What we published in these organisational data reports was essentially a profile of the incidents that that trust had reported to the National Reporting and Learning System. So we profiled the incident type - patient accidents, medication, et cetera - the degree of harm that was associated with those incident reports; we gave feedback on the rate of reporting and consistency of reporting and we also gave comparative feedback on the number of reports as compared to other trusts like them in order for a trust to look at whether they felt their reporting rate was as it should it.

Lord Patel: Dr Taylor, if I answer specifically, what it indicated was that Mid-Staffordshire was a relatively low reporting trust and it had a higher incidence of severe harm and death.

Q835 Dr Taylor: Did you convey that to the Healthcare Commission? What did you do with that?

Lord Patel: The Healthcare Commission would be aware of it because everybody was made aware of it.

Mr Fletcher: On an annual basis we provide data on reporting rates of trusts to the Healthcare Commission and they use that as part of their screening process in the annual health check.

Q836 Dr Taylor: The fact that there were more serious incidents there than other places did not mean you really felt you had to alert somebody specifically to that?

Lord Patel: This is the first time we have published this data transparently. Before the arrangement - an arrangement that I did not approve of ever since the day I became the Chairman of the NPSA - was that this data was kept confidential and should be available to the trust itself. We have broken that rule this time.

Q837 Dr Taylor: So it is now, for the first time, available widely.

Lord Patel: Correct. That is the intention from now onwards, not to have this data confidential. That is why we broke the rule.

Q838 Dr Taylor: In future, if one particular trust was standing out, would you jump up and down about it more than you did before?

Lord Patel: We need to develop a relationship of working with the new CQC - Care Quality Commission - as to how the new agenda in quality can be inclusive of all this information that we might have. I was going to refer to this later on because I know you might ask me a question about the priorities in NHS.

Q839 Dr Naysmith: You just said that everybody had this information.

Lord Patel: When we published it, yes.

Q840 Dr Naysmith: Did Monitor know about it when they gave the trust foundation status?

Lord Patel: Probably not.

Q841 Dr Naysmith: Why did Monitor not know about it?

Mr Fletcher: I think we have to be a little bit cautious because one of the things we know is that there is wide variation in how trusts report because they use different definitions. Part of the whole point of us publishing the data trust by trust is to actually look at how we can get greater consistency in comparing the data because it may be that a higher number of events is because this is a trust that has a better culture of reporting. It may also indicate that it is a trust where there are problems. The key audience for these sorts of publications is really the board of that organisation. In the organisational data summary what we have done is made a number of recommendations to boards about looking at this data, understanding them and making sure that they think this is right for their organisation. Whether over time these data could become some sort of early warning sign of an organisation where there were concerns, I think it is too early to say.

Lord Patel: What we should be doing - and we are trying to address this - is to have a reporting system which has some kind of uniformity in what is reporting and consistency so you can use comparative data, not only when you publish the data but develop indicators or early markers of a problem developing long before it actually becomes something like what happened in Mid-Staffordshire. That is the challenge.

Q842 Dr Naysmith: What do you do about a board that is in denial, it is being given the information but is refusing to act on it?

Lord Patel: What I told Dr Taylor was an observation based on information we have. We have to accept that that is crude information. The observation on that crude information is that this trust comes in the bracket of a lower reporting trust and when you look at serious harm and death incidents it is higher. We can make a hypothesis about it but we cannot be accurate. However we can make this kind of data more robust but to do that we will have to do some work on it. What do you do when the data is robust and a board ignores it? Clearly there needs to be some kind of sanctions available; without sanctions it cannot work. That is a personal view; that is not a board view or an NPSA view.

Q843 Dr Taylor: When did you put the Patient Safety Action Team into the West Midlands SHA?

Mr Fletcher: The first of April of last year, 2008. That is when the teams were officially established.

Q844 Chairman: Is one of the major issues in this, what was highlighted by the Committee of Public Accounts Report in 2006, that "Patient safety alerts and other solutions are not always complied with though trusts self-certify that they have implemented them"? How do you overcome this self-certification in these areas when we look at the outcome of the report that was published yesterday? Is it safe?

Lord Patel: Is it safe to do what?

Q845 Chairman: Is it safe to allow self-certification when alerts have been issued in terms of an institution?

Lord Patel: It is a good question; the problem is that if I am providing care to the patient as an obstetrician and I am sent an alert of some system failure that harms patients and I do not implement that or my management does not implement that, what is the sanction?

Q846 Chairman: Garden leave.

Lord Patel: I have never had any experience.

Q847 Chairman: Let us hope you never do.

Lord Patel: If you are going to make a recommendation we should explore what are the mechanisms in place that makes an institution implement them. Whether that is a guidance or an alert from us or whether it is guidance from NICE or any other organisation, what happens and who monitors it? We do not have that monitoring role, neither do we have a role of forcing implementation.

Q848 Mr Bone: I have it in my mind that when you publish an alert that is now in the public domain. If there was an air crash they would say, "You have to fix this widget because a hundred people died", is that happening or is that something new? I am not quite clear on that point. Is it in the public domain?

Mr Fletcher: Yes.

Q849 Mr Bone: So the newspapers and media can get it.

Mr Fletcher: Yes.

Q850 Mr Bone: Moving on then, I have certainly had this experience from constituents where a loved one has been harmed or maybe killed by a failure in the hospital to do with patient safety. Instead of having an open, warm and sympathetic reception to these people you go into spin doctor mode where the whole thing is to protect the hospital from any damaging comment and to protect the hospital from being sued. There are whole departments of bureaucrats to this. I am not saying that happens in every hospital because I have no evidence of that, but we have had evidence of this happening in some. Do you accept that that does happen in some places?

Mr Fletcher: There is no doubt that organisations often react in a very defensive way when things have gone wrong. This concept of being open or having greater openness is something the agency health services championed for a number of years. Essentially what we have argued is that what patients want is an apology, an explanation, a commitment that some sort of investigation will occur to look at what has happened and why it has happened, and they want feedback on what changes are being made to prevent it happening to other patients. We have done a lot of work to develop guidance, training and resources to help trusts do it because I think it is easier said than done in practice. As you are probably aware, the Department of Health commissioned a review of the implementation of the guidance by Albert Wu, an expert from the United States. We welcome that review because I think he has made some very helpful recommendations about how we can further strengthen implementation of this for example through more targeted training of senior clinicians to really make sure that this is happening much more in practice than it is at the moment.

Q851 Mr Bone: That is all to be welcomed and what you are doing is greatly appreciated. However, do you think that the actual practical pressures on my foundation hospital are more to be defensive and to protect their interests of the hospital's PR and to save it being sued? Do you think that pressure is greater? It should be more open so how, in practical terms, can we get them to be more open?

Mr Fletcher: To give you one example in terms of the point you make about litigation, we have worked very recently with the NHS Litigation Authority on the circular that they sent out explaining what you should do when something has gone wrong to make sure that that has very strong and clear messages about the importance of openness and links to the guidance and tools that are available through the work that we have done. That has been a very strong partnership not only with the Litigation Authority but also the number of protection societies as well. This message that openness is probably a better approach - even where there is threat of litigation than defensiveness - because we know when we talk to people about why they litigate it is often because they had a sense that people were not telling them and were not being honest and open with them.

Q852 Mr Bone: Do those guidelines apply to foundation hospitals?

Mr Fletcher: Yes.

Q853 Mr Bone: If you found someone who was really not being open what would the sanction be in that case? Would it be name and shame?

Lord Patel: We do not have any sanctions. All we do is issue a guidance about being open and transparent.

Q854 Mr Scott: Lord Patel, what do you think the top priorities should be for improving patient safety?

Lord Patel: The Chairman and Dr Taylor referred to it and I emphasise it again: the key issue here is about implementation of learning. It is the implementation of the learning that identifies where there is system failure that leads to harm to patients or something that happens in one trust - a system they operate - that leads to harm. If the learning that comes if not implemented then we are never going to see the improvements in patient care that we are after. That would be one of my priorities, a systematic approach to patient safety that the local organisation must address. Secondly, I think there needs to be a greater engagement of the board - whether it is a foundation trust or whether it is a non-foundation trust - in the quality of patient care and the safety of patient care rather than a focus on the agendas of targets and finances. Targets and finances are important, but the issue about patient safety and quality needs to be on the board agenda on a regular basis. I personally believe there ought to be a non-executive director who gets appropriate training on what quality and safety means in healthcare and that would be the person who takes the role of governance in every trust, focussing on safety and quality. Senior clinical involvement is extremely important. The question was asked earlier on about involvement with doctors and I think what we require is a senior clinical involvement, whether that is in acute trusts or in primary care. Reporting of patient safety incidents is important and implementation of learning outcomes is important, and a demonstration that that is being implemented and not just a tick chart approach to it. If there was a monitoring system they could demonstrate that that had implemented it. That is important for us too because we need to have this learning tested to find out that it works. Not every alert we produce might be appropriate and demonstrate that the good outcome that you might think it might do. There is another issue at trust level about an in-depth understanding of serious incidents and deaths to ensure we get to the root causes and appropriate lessons are learned. The trust we were discussing earlier, on from the report that I have read it is quite clear they did probably have higher incidents of untoward deaths. They should themselves have been going round asking the question why and looking at their systems. The independent inquiry and Healthcare Commission has done that, but we are moving onto the new agenda Quality Accounts. I think Quality Accounts might be one way to embed patient safety; patient safety becomes part of the Quality Accounts. a demonstration by the trust and primary care to make sure that safety is part of the Quality Accounts that could be monitored. So there are several things that could bring patient safety more to the action level rather than the level where we are sitting just now which is more information, possibly doing good, but not knowing whether it is doing good.

Q855 Dr Stoate: Professor Rawlins, I want to pick up on a point from your recommendations in Safety First published in 2006. One of the recommendations was that, "A pilot should be established to examine the option of NICE developing technical patient safety solutions". Can you tell me where you have got with that and where you see it going?

Professor Sir Michael Rawlins: We did this jointly with the NPSA; it was very much a joint venture looking at costs of interventions to prevent serious safety problems. We used two examples, one was ventilator-associated pneumonia and the prevention of and the second one was medicines reconciliation (which is a funny way of putting, making sure when you go into hospital everyone knows what medicines you were on before you came in and you are continued on the ones that are appropriate). We did these; they were very satisfactory. We produced reports and advice to the service. We know that our ventilator-associated proposals have been taken up to 90% of patients in intensive care units; it was 50% before and it has gone up to 90%. On medicines reconciliation it is a bit slower because it needs the input of pharmacists and there are not enough of them necessarily - there is a financial implication - but 40% of hospitals have actually got it sorted out and another 40% are apparently making good progress. It was a very successful venture. We have not continued it. To be honest with you I do not think the NICE necessarily needs to be involved; I think the NPSA are perfectly capable of doing that sort of thing themselves. We did it jointly so we have not set up any special programme at NICE. Indeed it was a wise decision not to take any more on at NICE in view what has happened within the last few months when we have been given a whole host of other things to do. The arrangement for the NPSA to do this sort of thing is that they come to us if they want to, we get on very well. Lord Patel and I often meet and Martin often meets with Andrew Dillon so it is an easy relationship.

Lord Patel: I would just add that every trust will implement this ventilator-associated pneumonia package and we will soon introduce central venous line infection reduction. As far as reconciliation of medicine is concerned, the good trusts have come down from 40% failure on reconciliation of medicine to as low as 8% or 9%.

Q856 Dr Stoate: Professor Rawlins, you will know from our previous conversations that I am quite keen on technical solutions in patient safety cases. Last week some of us went to Charing Cross Hospital Pharmacy Department and we were very impressed with their automated dispensing arrangements and the fact that they showed clear reductions in patient safety incidents and medication errors but - and it is a bit "but" -in their clinical systems they have turned off their drug interaction programmes because they say that they are confusing, they are unhelpful and in fact they increase the risk of errors being made because of different doctors interacting with them differently. I am very concerned about this. Is this something that NICE has looked into?

Professor Sir Michael Rawlins: Not really, no; not into the prescribing systems. Those are really being looked after by the Connecting for Health programme.

Q857 Dr Stoate: The next question - as you probably anticipated - is that I am extremely keen for interactive expert programmes with NICE guidelines because I believe NICE guidelines are a huge bonus to patient safety. The big problem I have is that they are not available in a form that GPs can use.

Professor Sir Michael Rawlins: I plead guilty as I have done in the past, but on 30 April NHS Evidence will appear on your screen in your surgery. You click on it, you type in in a Google-like way Bell's Palsy - which is the example I give - and you probably just want to know whether to give steroids or not and whether to give antivirals. That sort of information will come straight up. I would like to make an offer to you, Dr Stoate. We are actually testing the system out and if you would like to be a guinea pig I made special arrangements yesterday with the person running this that you can easily be included.

Q858 Dr Stoate: I would love to be. Actually, I want you to go further and I want to put this on the record. I want your system, your NICE guidelines, to interact directly with the clinical records so that when I type in, for example, asthma, into a patient's read code in a corner of my screen I want a box to say that this person should be on this, this and this and have you done the following tests?

Professor Sir Michael Rawlins: I am afraid that will take us a little bit longer but we are getting there.

Dr Stoate: Okay, I shall continue to press you on that.

Q859 Dr Naysmith: Lord Patel, you said a few moments ago that you thought there should be at board level a responsibility and it should be a priority for boards. Is there currently any guidance telling boards, whether they are ordinary trusts or foundation trusts, that this should be the case or could that be one of our recommendations?

Lord Patel: We have worked with both Monitor and the Appointments Commission to help produce guidance about boards and we also work with the Appointments Commission to see non-executive directors and did seminars for them.

Q860 Dr Naysmith: All I am asking you is whether it is documented at the moment, that this is something that should be a responsibility of a board?

Lord Patel: No.

Q861 Dr Naysmith: So we need to strengthen your arm in this.

Lord Patel: That would be helpful.

Chairman: Could I thank all three of our witnesses very much indeed for coming along and helping us with our inquiry this morning. Thank you.


Witnesses: Professor Lord Darzi of Denham KBE, a Member of the House of Lords, Parliamentary Under Secretary of State, Ann Keen MP, Parliamentary Under Secretary of State for Health Services and Sir Liam Donaldson KB, Chief Medical Officer, Department of Health, gave evidence.

Q862 Chairman: Good morning. Could I welcome you to what is our seventh evidence session in relation to our inquiry into patient safety? I wonder if I could ask you for the sake of the record if you could introduce yourselves and the current position that you hold.

Professor Lord Darzi of Denham: Ara Darzi. I am the Parliamentary Under Secretary for Health.

Ann Keen: Ann Keen, Parliamentary Under Secretary of State for Health.

Sir Liam Donaldson: Liam Donaldson, Chief Medical Officer in the Department of Health.

Q863 Chairman: I am going to start with a question for you, Sir Liam. What effect has An Organisation with a Memory had on safety in the NHS? How much better is patient safety now compared with a decade ago?

Sir Liam Donaldson: I think An Organisation with a Memory started the journey that the NHS has been on to make patient safety central to how healthcare is delivered as it is now with Lord Darzi's report, but I think it is a journey that every health system needs to go on if it is to get patient safety in that central position. Just touching briefly on the areas where I think major progress has been made, we have seen much greater awareness of safety as an issue when An Organisation with a Memory was published. It was not something that people talked about; the terminology was not even used. I think there is also a much better understanding of some of the sources and causes of risk in healthcare. At the time An Organisation with a Memory was published I think most people would say that when harm occurred to patients it was as a result of incompetent doctors. There were a small number of incompetent doctors and we need to ensure that we keep the number of people who are in that category down to a minimum. However, the vast majority of things that go wrong in healthcare are errors made by good people in weak systems, as you will have heard from other witnesses. The point there I think is the Swiss cheese - which is the metaphor for all of this - is well understood by a large proportion of staff in the NHS. One of the things that we initiated very early on was the setting up of a reporting system. That has been successful; it is certainly bigger than anywhere else in the world. There are things that need to be done to make it more useful and effective. To a certain extent we have been slightly victims of our success in setting that so early; we now have a huge number of incidents and the key to it is how to successfully analyse that huge database. I think also we have commitment at the top of the NHS. Going back to my time in the regions as well, I have worked with many chief executives of the NHS and unless the chief executive of the NHS is espousing and promoting a priority then it tends not to be taken seriously. That level of commitment is there now. We have not seen all this commitment at board level. I said many years ago that boards are more concerned with money and activity than they are about quality and safety, but again with changes through the Next Stage Review that is changing and is a major necessity. If you look at the other tests which An Organisation with a Memory set out - I will be brief with some of these - greater openness about errors, getting rid of the blame culture where the solution to anything that goes wrong is to chop somebody's head off and believe you have solved the problem. That is not to say that people should not be help to account in serious circumstances, but in many circumstances the emphasis should be on learning and not judgment and if you continue to punish people who make errors - nurses, others - then people will be too frightened to report errors and you will kill many more patients. We have also seen research. One of the areas I think has gone less well - this is not a feature only of our system, it is a feature also of many healthcare systems around the world - is that we do not yet have enough examples of solutions where we have seen something go wrong, we have learned from it and we have put in a solution that has effectively eliminated or reduced that risk. Around the world there have been many alerts issued about wrong-site surgery but wrong-site surgery continues to occur. We need to find ways of developing more effective solutions.

Q864 Chairman: How do we compare with the rest of the world?

Sir Liam Donaldson: As far as having a programme in place, being committed, having a large amount of information that we can learn from, we are probably the only whole healthcare system that is in that position. We can see around the world individual institutions - large hospitals, groups of hospitals - who are further ahead in some ways than we are, but nobody that has tried to do it on this scale across a whole healthcare system. I think we are very much in the forefront in that respect. I think more needs to be done on education and training. Finally I would say that involving patients and family members, which has been done very successfully in the initiative I have run through the World Health Organisation, listening to somebody who has risen above their own personal tragedy to speak powerfully about the need for safer care is a way of moving hearts and minds in a way that somebody like me could not hope to do. Getting those patients into the medical schools, the nursing schools, the management schools, to tell their stories is probably something that is as powerful as anything and we need to do more of that.

Q865 Chairman: We will be covering one or two of those areas in the next few minutes, but one of the things we have been told in this inquiry is that there is no reliable data on how many patients are actually harmed by the National Health Service each year. If there is no reliable data, how can we be sure that things have changed?

Sir Liam Donaldson: We cannot yet be sure that things have changed but you would be hard pressed to find any healthcare system in the world that could tell you that. We do have data on patients being harmed through the reporting system that you will have heard a lot about. We believe there is underreporting. However, the prediction when An Organisation with a Memory was published was that nobody would report. We have had a massive level of reporting but the weaknesses are that we are probably not hearing as much about the serious errors as we should and we are not hearing enough about primary care. If we can get those right then I think we will really have something to be not just encouraged about but proud of.

Q866 Dr Naysmith: Sir Liam, we have just been hearing from the National Patient Safety Agency and it is clear that the people involved and the staff generally are obviously dedicated and hardworking people. Are you confident that the NPSA's current remit allows it to have the maximum possible impact on patient safety?

Sir Liam Donaldson: I think I would say, "Yes, but...". I think it has shown over the last couple of years remarkable leadership. It has engaged local NHS services in a way that they did not perhaps do in the first phase of the NPSA. They are feeding back information which the airline industry tells us is very, very important to give to people, a sense that their information is being used and acted upon and is coming back to them. I feel that the area that needs debate - I am not sure what the right answer to it is - is that when an air crash occurs you see an accident investigation team going straight out and getting to the root causes of the problem and making a report. I do not want to prolong the Committee's time, but having been in post a long time I have seen many, many forms of inquiry and most of them grind the whole system to a halt. Worse still, lawyers get involved. Any investigative mechanism which would produce rapid results for learning and perhaps saving the lives of future patients through what was learned would have to have a cordon sanitaire put around it because if it started to get into the territory of people calling for public inquiries and for barristers to be rolled out on huge fees, then you would learn something but you would probably learn it five years later.

Q867 Dr Naysmith: There is probably quite a lot of involvement by lawyers in any case at the moment in the National Health Service. Do you think having an independent inquiry would make that much more likely?

Sir Liam Donaldson: How could you run 50 independent inquiries in the country at the same time? The whole system would grind to a halt. I say that because I do believe an in-depth investigation done rapidly is very, very important but I would say to you as parliamentarians, can you write a law for us that will prevent that from becoming turgid, bureaucratic, lengthy and legalistic? Can you do it in such a way as it is not a blame and retribution exercise because otherwise you are back to square one killing people whose lives could be saved if you had a different culture?

Q868 Dr Naysmith: If we could, would you think it would be a good thing to have something totally independent of the National Health Service? At the moment we have local inquiries and sometimes strategic health authorities get involved and then they move on up and now, like we have in Mid-Stafford, there is this question of bringing in from outside, but still from within the National Health Service, an expert to look at accident and emergency. This is a muddle. If you have a purely independent step that you take when the circumstances justify it, such as happens with the Police Complaints Commission (I know it is not on the same sort of level of importance, although sometimes it is) then you can have this independent look at things which people think does not happen at the moment.

Sir Liam Donaldson: I am broadly in agreement that something needs to change. I would see a conceptual distinction between an accident type incident which is the majority of situations that we are talking about in the field of patient safety where you need a rapid investigation that learns quickly. It would not seem logical, given that the NPSA has in-depth from all its incident reports of more minor matters not to let it be the one that initiates that sort of investigation. When you look at the sort of incidents like Mid-Staffordshire which are more to do with the failure of standards of care due to the functioning of the whole organisation then I think a body like the Care Quality Commission and the Healthcare Commission is better placed to do that provided that the public have confidence in its independence.

Q869 Sandra Gidley: Lord Darzi, in your Next Stage Review Final Report you refer to safety as an aspect of quality. It would be helpful if you could explain how you could see the two relating to each other.

Professor Lord Darzi of Denham: If I could take you back to the process of the Next Stage Review, one of the challenges for me was when I asked people what you mean by quality. That was an interesting question because you got a different response from the clinical staff, you got a different response from the patients and the public and you also got a different response from management in relation to what quality means. If you remember I said this in July, having an evidence based review I went back to look at what we mean by quality in healthcare. There are many, many academics and policy makers and probably the most famous one was Donabedian in 1990 who essentially said that quality has seven pillars ranging from efficacy, effectiveness, efficiency, optimality, acceptability, legitimacy and finally equity. That was 1990 and if you look at the debate that moves on and so contemporary healthcare's definition of quality now is effectiveness, safety and patient experience. There are more - we can talk about productivity and cost effectiveness and I agree with that - but we picked up these three because we wanted a clear framework that the NHS understands; the three domains of quality within that framework are safety, effectiveness and patient experience. These are interrelated but that is the framework that we put together. Based on that framework we are taking the bill through Parliament - I am taking it through the House of Lords at the moment, it will come to you soon - we hope to use indicators that measure safety, effectiveness and patient experience and every provider organisation through legislation will be publishing annually their Quality Accounts which would include indicators reflecting safety -----

Q870 Sandra Gidley: Would these be self-reported? How is that scrutinised?

Professor Lord Darzi of Denham: Within the Quality Accounts there are three sections. The first section is what the Healthcare Commission - CQC in the future - tends to measure in relation to, for example, safety. We have a number of safety indicators; that is a given, that has to be in the Quality Accounts because it is already reported to the Healthcare Commission. Then, as you know, the Department of Health publishes annually the operating framework and it has a number of different tiers of indicators. The compulsory ones are called the vital signs and will be in another section of the Quality Accounts. Then there is the third section. There is a huge amount of information in the NHS but that information does not necessarily have the ownership of the clinicians and staff who are working with it. We have just been through a terribly long consultation and we have what we call a short menu which is about 200 indicators. Many of these are safety indicators like hospital acquired infections, which is part of the CQC. The whole purpose of this is at different levels of the system. The first purpose of this for me is that as a clinical team if you want to improve your service, if you want to know where you are, you have to take ownership of measurement and then see where you are and constantly improve. The board has to sign this quality account off. You have to be accountable to the quality of care which includes safety, effectiveness and patient experience to the local population that you serve. At a regional level commissioners have to have that data before they start doing proper commissioning. You cannot commission a service if you do not know what the output of that service is. At a national level we want these indicators to monitor the progress of the NHS on a year by year basis. That is the driving principle behind this ownership of the data and the publication of the Quality Accounts.

Q871 Sandra Gidley: Having to pass legislation to make the board accountable, is this an acknowledgement, if you like, that boards have not been fully accountable in the past and have not paid enough attention to patient safety at the expense of balancing books and some of the other indicators?

Professor Lord Darzi of Denham: I did sit on a board many years ago where most of the discussions were on other issues rather than what matters to clinicians and patients, which is the quality of care and I am bringing the Quality Accounts at the level of the board. The board has to sign these off because ultimately the business we are in is to provide high quality care. We know that. The money is the enabler and the government has doubled the amount of money invested in the NHS to make sure that we achieve that. If you look at the NHS plan in itself - we have debated that many times - we have areas of focus which, at the time, were very bad. The major killers in this country were cardiovascular disease and cancer. Let us take cardiovascular disease. In six years we have dropped the mortality rate of cardiovascular disease by 50%; that is a great, great achievement. We set out to do something and we did it. That was based on setting an outcome as a target and we changed everything to make sure that we met that. The Next Stage Review is: how do we make that systemic? How do we make that for end of life? How do we make that in long term conditions? That is the transition that I am talking about and the only way you can achieve that is to have ownership of all of these pathways with the indicators that measure them within hospital settings. Let us not forget that Quality Accounts is not just for acute hospitals; it is about primary care, it is about community services. It is a bold statement to say that quality will be the organising principle of the NHS and that is exactly where we want to head.

Q872 Sandra Gidley: Back to patient safety, how will the Commissioning for Quality and Innovation allow patient safety issues to be addressed?

Professor Lord Darzi of Denham: CQUIN, which is the Commissioning for Quality and Innovation, was another enabler in High Quality Care for All. It is purely to give the commissioners a lever for quality improvements. Contractually the PCT will have to contract with the provider and say, "Right, we need to identify your priorities in these three domains" (let us not forget, safety, effectiveness and patient experience). So when they are contracting with the provider they will look at their safety indicators and they may decide that these are the areas we need to improve in your provision. That would be part of the contract between the PCT and the provider. At the moment we started with 0.5% of the uplift of the tariff; we hope to increase that. My ultimate aim initially, for the first year the message I want to try to get out to the PCTs is: please concentrate on improving the quality of reporting and please assure the data. After that we start concentrating on quality improvements.

Q873 Sandra Gidley: You are also going to be recording Patient-Reported Outcome Measures. How will that influence safety?

Professor Lord Darzi of Denham: Something we should be very proud of is the creation of PROMS (Patient-Reported Outcome Measures) because these are high risk indicators that measure effectiveness as the patient sees it, not the doctor, and what the patient experience is. A good example is that someone could come to me with groin pain, I would say, "You have a hernia". I repair that; he comes back and says, "I still have the same pain". As far as the patient is concerned that procedure did not meet their expectation. If I could give you an example of safety within that, I have no doubt that if there is a safety issue which will reflect on the outcome or the experience of the procedure, that will be captured through the PROMS. A good example is that you come in and have a hip a replacement and you may get deep venous thrombosis prophylaxis. You had a good operation but you ended up with a clot which delayed your discharge, it means you have to be on warfarin for six months. The patient's experience reflects very much on that; it is one way of capturing the whole experience of safety effectiveness and the patient's experience.

Q874 Dr Stoate: Bruce Keogh, the NHS Medical Director and Martin Fletcher told us last year that PCTs could withhold payments in the result of a never event. You mentioned never events earlier on; have we got anywhere with that yet?

Professor Lord Darzi of Denham: Yes, we have. If I could give you the background to the policy itself, again this was evidence based because it has been used in the United States and I think the discussions you had with Bruce were based on the evidence in the US where insurers withhold payment to the provider if there is a never event. Our approach to this is slightly different; we want to phase this. Firstly we had to decide what should the never events be. The NPSA did a great job in consulting stakeholders and they have decided for the first year there should be about eight never events. I do not know whether you want me to go through them. Wrong-site surgery is one; the injection of chemotherapy in the wrong areas is another. Those are just two examples. The whole purpose of these never events is that they need to be binary, in other words there is no doubt about the fault. If you do wrong-site surgery no-one could ever doubt that there is a fault; that is quite clear. It has to have a clear accountability too. Wrong-site surgery is a good example. The team who are involved are accountable within that organisation. We have decided these eight. At PCTs we will run this for a year and then that will be part of the contract between the PCTs and the providers. After a year I think we should have this debate about whether payments should be withheld or not. It depends who you ask really. There are those who are likely to suggest that it may suppress people reporting, in other words it will disincentivise them from reporting. There are those who think penalties are appropriate. I think we should wait and see what the year gives. If you ask me why I think it is important, my view about this is that we need to do everything possible to increase awareness about these eight never events which should never happen. So it is a big awareness issue and I think through the never events policy we will achieve that. Secondly, we want to encourage the system to be more transparent in reporting these. I know that the never events that we have are slightly lower than the never events reported across the Atlantic. The first year is to see whether we can create that culture of people feeling comfortable in reporting these and then following that.

Q875 Dr Stoate: I understand that - that is quite straightforward - but what about the should not events? What about the patient who goes into hospital with a UTI (I am quoting now from patients I know about), catches a hospital acquired, ends up staying in hospital three months and then falls out of bed or has a fall and breaks something. All that time that is happening not only is that a disaster from the patient's point of view but the meter is running and the PCT ends up with a bill for many, many tens of thousands of pounds. As I say, I have examples of actual patients where that has happened. Surely that is an example of things you should be stamping out. If that person went into hospital with a UTI we should be paying for the UTI, we should not be paying for the C.diff, the hip replacement, the month in intensive care which happens as a direct result of a patient error.

Professor Lord Darzi of Denham: There are two parts to the answer. Firstly, you are right and I think if you happen to be the commissioner on behalf of the PCT there is no reason why you cannot bring other never events locally.

Q876 Dr Stoate: These are should not events; they should not happen but they are nevertheless patient safety events and effectively the PCT ends up with the bill.

Professor Lord Darzi of Denham: Absolutely, but let us not forget that healthcare - Sir Liam was mentioning this earlier - used to be an art, medicine used to be an art but it is science now, but it is not the perfect science. We are quite clear, we all make errors and the question is how do we create a culture in which we capture these errors, we learn from them and we do something about them.

Q877 Dr Stoate: My question is slightly narrower than that. My question is, should the PCTs not say, "Your problem, you pay because we are not going to". I know insurers in America would take that view. They would say they would not pay for that because it is nothing to do with the condition the patient went in with. I think that might focus the mind rather well at board level if the hospital did not get payment for having somebody in the hospital for three months when they should have been in hospital for three days. That might focus the mind. Why are we not going down that route?

Professor Lord Darzi of Denham: That is a reasonable point. I am starting with things that we are absolutely sure should never happen. If your policy idea captures the minds of PCTs and they wish to contract with their providers to add other things - should not events, as you call them - then I think that is a local issue that needs to be decided. Let us not forget that those who are involved in the delivery of healthcare are professionals, they have professional values in doing what they are doing and I think changing the culture and behaviour locally in preventing mishaps and errors that lead to harm is exactly what we are trying to achieve in the NHS.

Q878 Dr Stoate: What I am saying is that there are no financial incentives for hospitals to crack down on that sort of thing. If the centre were to say to hospitals, "You are going to have some very large bills unless you change your culture, I think that might get the board focussing in a way that they did not just focus on things that perhaps were not so critical for patient care.

Professor Lord Darzi of Denham: I think that is correct to a point; financial incentives are one, but it is not everything. What we have seen through the Next Stage Review and what I have seen out there and most of your hospitals and primary care providers, clinicians go to work to provide high quality care, they do not go to work to make mistakes intentionally. I do not think the financial incentives are going to change that. What we need to do is work from board to the ward in making sure that the culture is changing where there is vigilance rather than complacency; there is resilience; there is learning culture and whatever way we look at this we will always have errors in healthcare provision. Our ultimate aim is to learn from them and constantly reduce them. Financial incentives may be one, but I think there are other factors in which we will make this happen. Leadership is the one which I mentioned to you the last time I was here; I think that in itself is the one that I personally think we should focus on.

Q879 Mr Bone: Lord Darzi, I understand how incentives could work in a commercial situation; I do not see how it works in a health service because all you are doing in reducing the money going into my primary care and my hospital is reducing the service to my constituents.

Professor Lord Darzi of Denham: I agree; it is not everything.

Q880 Stephen Hesford: Lord Darzi, what role does Patient Choice have in driving up safety standards?

Professor Lord Darzi of Denham: A lot, and you know my commitment to Choice because, although the government introduced Choice about four years ago, some clinicians were a bit critical about Choice because Choice in those days was about access (where could you get the quickest waiting time and things). As I have explained it in the Next Stage Review, Choice is informed choice; the type of choice you all exercise in this room: where to go, what is the best care, what is the information you need before you have that. That is where we need to go to. Informed choice is based on safety, effectiveness and also the patient experience. If I can give you one example on a personal basis, three years ago when I was seeing patients in the clinic, you do your consultation, you finish your counselling, the patient needs an operation and the first question they will ask you is, "What is the MRSA rate here?" That is a choice based on safety. When clinicians are operating or even physicians sit down at the end of the consultation and describe to the patient risk benefits. That is the world we are living in; everything has a risk. The idea that we are going to reduce risk to zero in healthcare is not going to happen in our lifetime and patients do appreciate that discussion of risk benefits. Within those risks you talk about safety issues that may happen and most informed patients, at the end of that consultation, make the judgment call whether it is the choice of provider and choice of treatment because some treatments could be more radical and could be actually less safe. I see this in cancer surgery. Safety is very much part of the discussion you have with a patient.

Q881 Stephen Hesford: We have just heard that the NPSA have started publishing statistics on reported patient safety incidents which is a new departure. Is that to inform patient choice? If it is, is there not a tension between publishing that data and creating a risk that if it is published people will stop reporting?

Professor Lord Darzi of Denham: This is an NPSA decision, as you know. They are independent. I was delighted to see that. It is part of what we are trying to bring in, that is transparency. You have it in Parliament. Transparency of healthcare providers in this country use taxpayers money; we are talking about transparency within the system. If you look at what they have done recently, there are a number of ways in which they are reporting what these incidents are (some of them are minor errors). I think the message out of that to the public when you see an organisation reporting a high error rate it is not necessarily a problem; we should actually trust these organisations because they are reporting it, they have a culture of reporting, they are learning from it and they are doing something about that. I would be more concerned if there was one that is not reporting anything. That is the clear message there. As I said, I have not met a patient who believes that we can do everything one hundred per cent risk free, but they know what it is and that is another set of information that empowers them, what these issues might be when they discuss it with their clinician.

Q882 Chairman: In the first evidence session we had here a health provisional told us they were concerned about how things do get out of our hospitals, particularly in the local media. There was one story about one incident that can demoralise the workforce, as it were. Do you think there is any risk, with the publications of PROMS - which is not the NPSA decision but your decision - that the Patient Related Outcome Measures may in some senses bring on this type of debate in localities?

Professor Lord Darzi of Denham: I do not think so. I think we all have responsibility here. We want to bring this transparency. All clinicians in the NHS are very proud to publish what they do. The media also has a responsibility and I think they will appreciate the transparency; that is what the media wants. We are not talking about single individuals here, we are talking about the organisation itself and if that in itself could drive improvements then so be it.

Q883 Dr Taylor: It seems to be that it is largely non-technical skills that will improve the patient experience. I am thinking of leadership, delegation, team working, compassion, communication. Has the NHS been very slow to recognise this compared with the aviation industry? Why is this and how are we going to promote these sort of non-technical skills that are absolutely vital for communication?

Professor Lord Darzi of Denham: I could not agree more with you and this is something that I have declared to the Chairman. I have a research interest in this area and we have published a large amount on non-technical skills or human factors (another term being used). I think that is very important, certainly in the environment that I work in, like the operating theatre which is very complex and is getting more complex by the day. I believe it is even more complex than a cockpit now. You need non-technical skills and there is the evidence base to support that. I think there is another leader in this field who is advising you and I am delighted to see that. Ultimately it is not the Department of Health who decides what is the curriculum of a trainee working in the NHS or even a senior. It is very much a local issue and what we need is to focus more on improving the commissioning of education and training. In a high quality workforce we have said we will split the commissioner provider functional deaneries and that will happen soon. Commissioners will start using evidence based commissioning for education and training. Providers will move into so-called health, innovation, education clusters which I mentioned to you before. We need more universities involved in this and provide more leadership. Then we need to work at a national level with the leadership of the profession. The colleges have a huge role to play here in really trying to get these skills integrated into the curriculum of postgraduate trainees. We also need to work on these as part of the curriculum of the undergraduate trainees. Then you get the regulator - I am talking about a very big landscape here - which is the GMC that holds the universities into account as to whether they are doing this, or the postgraduate providers of training (which, as you know, we combine GMC and PMETB together) in seeing whether these bits of competencies are met. This is a big story.

Q884 Dr Taylor: Do you think communication skills can always be taught and always acquired?

Professor Lord Darzi of Denham: I think it will be easier acquired in some than others. There is a degree of self-selection also when we decide which speciality to go to.

Q885 Dr Taylor: We have heard in the first session that the NPSA are very good at collecting the reports and promoting the messages but there seems to be a divorce between the messages and the messages actually getting through. You have been closely involved with the WHO Surgical Safety Checklist. The NPSA is now saying this should be used throughout the NHS.

Professor Lord Darzi of Denham: Yes.

Q886 Dr Taylor: How can that be enforced?

Professor Lord Darzi of Denham: There is an alert and if there is an alert from NPSA that needs to be enforced by every NHS organisation. My understanding is that it will be February next year before the Checklist is enforced in every operating theatre.

Q887 Dr Taylor: So if a surgeon does not use it he will be in trouble.

Professor Lord Darzi of Denham: No, we will not even get that far. If he does not use it, the operation does not happen. It is very simple; the plane would not take off.

Q888 Chairman: Who stops it?

Professor Lord Darzi of Denham: The team. Surgeons are not the only people running the theatre, they are not; there is a team there.

Ann Keen: It is usually the sister. We could talk at length about behaviour in theatre but we will not.

Q889 Dr Taylor: So the team sister would completely stop the arrogant surgeon or physician doing something they should not do.

Professor Lord Darzi of Denham: The reverse is true as well. A surgeon would not start the operation if the kit is not available, the nurse does not have everything right and ready. The reverse is true and, I promise you, the reverse is as important.

Q890 Sandra Gidley: Just coming back to that, how will you know afterwards that the check was done?

Professor Lord Darzi of Denham: There will be a check list in the operating theatres.

Q891 Sandra Gidley: Yes, but I have worked for organisations where you have to do fridge checks, for example, and people used to just go and tick them off and sign them at the end of the day. How is it going to be monitored?

Ann Keen: You have to introduce yourself. You have to announce that you are now doing this checklist.

Professor Lord Darzi of Denham: Are you asking whether we could make an error doing the checklist? Yes, there are errors doing the checklist but I promise you those errors are minute if you compare the errors made without a checklist.

Q892 Dr Naysmith: I must just say that we have had some evidence to the Committee that it does not happen in every operating theatre even though it should and even though the system should be there. Lord Darzi, this is probably the last question for you for a least a while, but I would like to quote something that was said to the Committee by John Black, President of the Royal College of Surgeon. He said that the new European Working Time Directive rules are "the biggest threat to patient safety and, not only that, to delivery of service for a long, long time". Do you agree with that? If you do not, does it not worry you that the leading representative of your surgical colleagues believes that that is the case?

Professor Lord Darzi of Denham: John is not just the President of the College he is a good friend of mine, he has been a mentor of mine and I go back many, many years operating with him when the laparoscopy or keyhole surgery came in. Firstly I will talk about the safety aspect and then I will talk about the training aspect.

Q893 Dr Naysmith: He really believes it to be a real threat to safety.

Professor Lord Darzi of Denham: Let us firstly decide why we have a Working Time Directive. We have the Working Time Directive because people like me and him in our training days did 72 hours on a weekend and then back to work doing one or two on call because my boss felt that the only person who could see his patients was me every second night. We were working like zombies and there was an evidence base why the Working Time Directive was brought in.

Sir Liam Donaldson: If I could interrupt, I started life as a surgeon and on three occasions when I was training I saw people falling asleep in the operating theatre, quite literally.

Q894 Dr Naysmith: You will trigger Howard off to tell you in a minute about his experience! I do not think there are many people round the table who do not think that the Working Time Directive in principle is a good thing, but the way it is being applied now in some hospitals, according to John, is a real threat to safety.

Professor Lord Darzi of Denham: It is a health and safety act; it is purely to protect patient safety. All patients ask me the night before their complex surgery, "I hope you are getting a good night's sleep tonight". That is exactly what they ask; that is quite common to any surgeon. Where I sympathise with John is the debate: could you train a surgeon in 48 hours a week over a period of five or six years.

Q895 Dr Naysmith: That is another point.

Professor Lord Darzi of Denham: Yes, that is another point and I have sympathy for that. The question is, if we are to use the same way I was trained - which was an apprenticeship system - then we should all be concerned. What we need to challenge is not the number of hours; it is the quality of an hour training, what we put in that hour of training. We were talking about human factors earlier. We have simulations now; we need to challenge ourselves on the training tools, the training culture. The idea that training is done on the side is no longer; not everyone should be doing training. Training itself is a very important thing; we are training our future surgeons who will be operating on us. It is very important that we have the culture right, we have consultants with the right PAs in their contract to train; we have dedicated lists for surgeons to train and ultimately we need to look at the curriculum. We are working with John and the College of Surgeons looking at what we can do with the curriculum to enhance the quality of the units of training. It is not quantity, it is quality. I think we can then try and see whether at the end of the belt we are producing these competent surgeons.

Q896 Dr Naysmith: We might not know that for a few years. That is the problem, what happens in the interim.

Professor Lord Darzi of Denham: Most trainees finish their training programme, get a competence certification of their ability to do things or not to do things. That is a very important part of the trainee's assessment on a year by year basis. If there is a trainee who has not yet met the competencies that the college have put together at a local level then that person will have to do an extra year or two years. That is nothing new. I know and you know that some people take longer than others.

Q897 Dr Naysmith: Is this a possible outcome of the directive, that there will be a lengthening of training?

Professor Lord Darzi of Denham: We will know that in due course. Americans historically trained competent surgeons in five years; before the Working Time Directive we used to take 12 or 15 years before you became a consultant. How did they do it? They really concentrate on the units of training time. You have someone there supervising you during the day; you have someone supervising you at night. If you expand these hours to night hours, night hours are not the hours that you train.

Q898 Mr Scott: We have been told about the continuing lack of openness, reporting and learning culture in the National Health Service. What is the government doing about it?

Ann Keen: It is the basic question really in relation to safety because it does depend on the culture that you work with. It depends on the organisation's ability to show that sort of leadership that really will encourage people - all clinicians, all members of that health unit - to be open about their practice. To do that they have to feel very safe. Patient Safety is the title and it sounds huge and we wonder how we can deal with that because we are doing all these other things. It is really about being honest, showing leadership that has gone throughout our contribution this morning already. Really strong leadership is about openness and not about secrets, and it is not about a blame culture. Most of us would never be able to operate in that sort of environment, that is blaming someone else always for something that has gone wrong. To start with you have to get that culture right and you have to have an organisation that is willing to say, "Be open with us and we will be fair back with you". To provide that we have different steps. You can take small steps and show improvement. There is nothing worse, having done this myself when I was practising as a nurse, than to go to a conference or a study day and come back and try to change something only to have someone say, "No, we don't do it like that here; we always do it this way. You might have that idea but you can't do that because we always do it this way. So-and-so always likes something done in that particular manner." That is not an organisation that is open and which will progress and develop. With our constitution now in place that also will help very much people to see - whether that is patients or staff - that they have the right to operate in an environment that allows them to say about their practice and allows them to encourage safety as being a priority.

Q899 Mr Scott: To elaborate on that, if we could take for a second a mythical hospital where a patient has had a procedure like a kneecap replacement where the kneecap has been put in the wrong way. I am not talking about blame but is the person who actually made that error then taken to task if retraining is needed? I was told that in those instances it could become maybe a better use of the word never event.

Ann Keen: That should not happen. If you are not able to admit your mistakes you cannot learn from them and it is back to that environment. The past, all of us could acknowledge, is more of a secretive past and people were afraid to say that an error has taken place. There have been examples when junior colleagues have witnessed something taking place and did not feel that they were actually able to speak out and say, "I have to stop you there because you are about to make an error". If you feel you cannot do that, that tells you everything about the culture that you are working in and that particular environment and leadership that you are working in. I can relate to that. There is no doubt that some people feel that they cannot point out to a senior, in particular, because the team does operate in a hierarchical way. When it does that it is not operating in the best way. It should not have that hierarchical structure other than for respect of knowledge for the team rather than not to be able to say, "You might have got that wrong".

Q900 Mr Scott: So that culture is being taken away because in some ways, perhaps much like politics, some doctors and some politicians find it much harder to say sorry than others.

Ann Keen: What we are doing in the health service right now is learning the entire environment of a much more openness which is coming through with the transparency. It is not easy for health professionals to say they have something wrong. It is not because they intended to harm therefore how can we say you have something wrong. I think the good leadership and management of that organisation should almost ask the question: did you intend to harm? I am sure the answer would be no, so therefore something must be wrong with that organisation and the system of that organisation. It is back to openness but it is hard to get cultures to change because it is so different within its hierarchy.

Sir Liam Donaldson: I guess we come back to understanding what causes these things. I can imagine three situations in which that could occur: carelessness on the part of the surgeon, the manufacturer of the joint making an error so that it was labelled "right" rather than "left" or the x-ray department was chaotic so the wrong patient's x-rays were put up on the board when the operation was taking place. I think we have to understand the causation of these things and then put in the appropriate intervention. In some cases it might be retraining.

Q901 Charlotte Atkins: Targets have been criticised in the NHS. We have had some evidence from a surgical care matron who has told us that system failures can occur as a result of making targets the overriding priority. The example given was that meeting the four hour A&E maximum target can mean putting a surgical patient on a geriatric ward and that would have consequences for patient safety. What is your response to that? Are targets to blame for this?

Ann Keen: Speaking as a nurse, I think we would have to use again our knowledge and our skill as to how that surgical patient could be managed equally safely on a ward that was not a surgical ward by asking a surgical ward nurse to accompany the patient to the ward, to see that the patient was still being managed in that particular way. It would not necessarily automatically make the situation unsafe. Certainly going back to the target within four hours, many organisations do it very effectively because it is safer to be seen within four hours and to be transferred. I think the target for A&E in relation to safety is actually the correct one. There is a margin for 98% rather than 100%, but in that particular answer you gave me I think there are ways that the pathway of that patient could still be secured if we did things differently. It is not the ideal, but it can be managed differently in a way that would not necessarily incur that patient to be unsafe.

Q902 Charlotte Atkins: Are boards and managers in the NHS obsesses with access targets rather than with patient safety? Those are the allegations that have been made.

Ann Keen: I would say that that is an excuse. We have to have proper clinical care for patients and prior to targets being set we can all remember the days when it was acceptable to wait for 12, 18, 24 hours in unsafe conditions because how many tests had been carried out, completed and reported back? What expert clinicians had seen that patient in a set time that made the patient exceptionally unsafe with their care? I totally support the targets area. Clinically it has been supported and the board's primary reason for being there has to be to make sure that the unit or the hospital is safe. To do that you would have to have proper staffing levels, that is absolutely paramount for the targets. It has to be the appropriate workforce, it is the right skill mix and then patient safety within that target will be met and will be met well.

Q903 Charlotte Atkins: You worked in the NHS as a nurse before the targets were set. What was the situation in terms of, say, A&E? What sorts of statistics would have come out of A&E to demonstrate that the hospital was failing in that particular area?

Ann Keen: Many times in A&E it was like a battlefield; you do not know what is coming through the door next. In the days that I worked in it in particular, whatever came out of the ambulance came into the next cubicle and you used your triage really to say, "Who needs life saving now, this instant? I will go towards that patient and I will see that my team goes towards that patient" rather than to have a much more organised route of care now in relation to chest pain, with possible stroke, with other trauma that should go to other trauma centres. It can be so chaotic and battlefield is the best way of actually describing it. To have systems and pathways of care in the appropriate buildings with the appropriate staff, to actually say after the initial triage that this person needs to see an expert, have the tests run quickly and for them to move on because it was never, ever acceptable to me to look at a patient and their family and see them in a distressed state for hours and hours on end. I am sure my medical colleagues would agree with that.

Q904 Charlotte Atkins: What about the four hour target getting in the way of dealing with the more severely compromised patient? Because you are coming up to the four hour target you have to put in somebody who has actually maybe got a relatively minor complaint compared with somebody who has just come through the door from an ambulance in a real emergency situation? We are told that these targets are getting in the way of dealing with the clinical priorities which would normally be set by the clinicians within that A&E department.

Ann Keen: If that is how they are practising, they are practising totally unsafely and unnecessarily. They need to organise themselves differently.

Q905 Charlotte Atkins: Ara has already given us a good account of the Quality Accounts but I do not think he mentioned the clinical dashboards which I think are also within your ideas. Maybe you could also expand on that.

Professor Lord Darzi of Denham: Just dealing with this targets issue first, I think within four hours you could really sort out the majority of patients coming in through A&E. You could see them, get a history, make a provisional diagnosis and then admit them in a safer and quieter environment. If there is an issue in which there are a very small number of patients - trauma would be a good example - the patients come in, they need a very pro-active treatment. You do not wait four hours for that. They each go to CT scans, they come back and decisions need to be made. I have never felt that that is suppressing my ability to do that. You cannot have a healthcare system that spends £110 billion a year, employs 1.3 million people and say, "There's the money; get on and do your best". This is taxpayers' money. We have to have a degree of standards. Do you expect to take an airline carrier that has a four hour delay? You do not. They fly safely but they actually get you to your destination, 98% of the cases within the time that they have given you. That is what the patients and customers expect, especially if they are actually funding it. It is not for free; our health is funded by the public. I just wanted to say that about the target side of things. Back to the dashboard. I think if we want to take what I described in the Quality Accounts as quality improvements I think we are moving from targeted interventions (like A&E, cardiovascular disease and cancer) into more systemic improvements in everything. To do that you need clinicians to set their own targets themselves and measure what they are doing. The dashboard is for them to display how they are doing when it comes to patient safety, effectiveness and also the patient experience. I could give you one good example. Healthcare in my practice is a team. I could do a very good operation on Friday, I could come in on Saturday morning and, although I am very happy with the patient, the patient is in pain. The reason they are in pain is because their epidural has run out and they have been in pain for two hours. The only way I could capture that is to measure the patient experience, get back to them and have a better pain management service. I do not think we can dictate that from the centre; that is for clinical teams to do. These are professional people. We know what the standards should be and the Quality Accounts and the ability to measure and constantly improve is the purpose of the Next Stage Review.

Q906 Mr Bone: We have two very highly regarded ministers today; I know they talk quite frankly and that is most helpful. Is what happens in practice for the board of directors in some hospitals something like this: you go into a very nice room, you have your tea and coffee; the chairman is paid £45,000 a year for three days a week, the non-executives £18,000 for a day month. The first item is the budget: how are we doing on the budget? There is a report and people say, "That's very good, we're keeping within the deficit; we're not going to have a deficit, that's rather good". Then we move on to talk about targets: how are we doing with the targets: "Yes, we're meeting all these targets, that's good". Perhaps they then go on to talk about their trip to investigate something somewhere; then they talk about the internal management (some nurse is complaining about something or other). Do they ever discuss patient safety? Is that not the problem? Are these directors in general terms just not up to the job? Surgeons and doctors have very, very good training; I just do not think these directors and non-executive directors have that. Am I on to something here or am I just way off the mark?

Ann Keen: You do have a point because it varies and that is where now, with the National Patient's Safety strategy, there is good practice and we have to really develop that good practice. Again it is back to the openness because we do have exemplar organisations which are really leading the way and assisting to get this message across. The strap line of the ward to the board is a serious one. We have examples of where it has not taken place; we have a recent catastrophic example of where it has not taken place. I am saddened to say that because of that event in Mid-Staffordshire I am sure that all boards now will be much more alert but it should not have to have happened that way. The reality is that the openness and the safety is only coming through our clinical colleagues to be able to support it, therefore to bring it up to the board level is a new area but it is an area we are concentrating very heavily on and asking people to concentrate very heavily on. David Nicholson, our Chief Executive, has written to all chief executives to make sure that this is a priority as part of the response to the tragedy of Mid-Staffordshire.

Q907 Mr Bone: The chief executive tends to be well trained. Do you accept that there might be some criticism that the directors on the board - non-executive directors and, I am afraid, chairmen - really just are not up to the job and maybe they need some sort of training or better qualifications to be sitting on these very, very important boards. Many of them would not qualify to sit on boards of public companies where there is less money involved and less danger to people.

Ann Keen: Again I do think we do have to do more work in this area. People who come onto our boards do so with the best intention to support their local trusts or PCT in their community. However, because of what we are asking the board to do they have to be assisted, helped and trained and encouraged to do it, but also we need to make it clear that it is their responsibility. Safety is the responsibility of every one of us who is involved with healthcare. There is an NPSA training programme for non-executives through the Appointment's Commission which I think will have to be strengthened even more so, but there is a lot of international work being done on this as well. The Institute for Health Improvement in Boston, Massachusetts works on virtual schemes that they are doing in America. Back to the openness, chief executives in one of the Boston hospitals has put up for everyone to see how they are performing. That has been quite an opening for other hospitals in the area. The more open we become, the more the reality of this very serious training and responsibility will take place.

Q908 Dr Stoate: We have heard from the Health Foundation about their Safer Patients Initiative. Can you tell us what the Department of Health is doing in response to it?

Ann Keen: We are actively involved with encouraging organisations to take part, to learn from, to help to launch it. We are involved right in the centre of the organisation and again encouraging all parts of the health service to do the same. We work very much in partnership with the Health Foundation; it is very important for us to do that and we partner them. The work is very well renowned and again learning daily how to bring this into the culture. It is so important that we have this culture change.

Q909 Dr Stoate: Is this something the department should have been doing anyway or do you rely on organisations like the Health Foundation to come up with these initiatives?

Ann Keen: It is about partnership with Safer Patients and working with the institute in Warwick, with the institute in Boston, the National Patient's Safety Association and the Health Foundation. They have the ability to communicate with everybody with our support. It is always with the full support and encouragement of the department.

Q910 Charlotte Atkins: As a Staffordshire MP you would expect me to ask you about the Mid-Staffordshire NHS Trust. Last week we had Bill Moyse here from Monitor, the regulatory body for foundation trusts. He said that in February 2008 the hospital met their criteria, but one month later the Healthcare Commission was so concerned that they started a year long investigation into the hospital. Does this not undermine the whole credibility of the foundation trust status investigation inquiry, that that could possibly happen? There were clearly issues within the hospital which were not picked up by Monitor and were not revealed in the self assessment process.

Ann Keen: If I could just say to start, the secretary of state's statement yesterday apologised and I want to associate myself with that apology to the patients' relatives and people who suffered in Mid-Staffordshire. There was a process that we went through and in April 2007 Dr Foster published and showed high HSMR in that hospital. The SHA and the trust followed this up and were reassured at all times that this was a problem with data collection. Each time those questions were asked it was about data collection. In June 2007 the process of foundation trust was accepted. I have to acknowledge all of the work that the Health Commission has done, but in particular to praise them for not accepting this and to keep pushing to say that this, to them, was not right. They did not want to accept the consensus on the data and they then went in after and I believe that was later than the June 2007 date. It was a series of events where people believed that the data was collected and it was total mis-information. The Health Commission still battled away and to go in and to insist and then to find what we are now all too sadly aware of.

Q911 Charlotte Atkins: My concern is that Monitor did not pick it up. If you take one of the conclusions of the Healthcare Commission it says, "Despite a system that looked good on paper, the trust did not have a clinical governance structure or audit process that worked. It had no effective systems and so failed to identify or understand the cause of high death rates among patients admitted as emergencies." You cannot get much more damning than that but Monitor did not pick up on this and gave foundation status. Just about 30 miles away in North Staffordshire there is the University Hospital of North Staffordshire that desperately wants foundation status. There are issues within the hospital which, to be honest with you, I do not think the hospital fully recognises. My concern is that in this great headlong rush to get foundation trust status, these things are overlooked. The other issue is that nowadays many of the boards of our hospitals are full of people with financial qualifications and inevitably therefore they look particularly at financial issues rather than patient safety issues.

Ann Keen: I should say that many foundation hospitals within the country are performing at excellent standards and providing very innovative clinical practice with a very flexible workforce where, without question, the standard is very, very high indeed and they are leading the way in best practice and encouraging others to do the same. It is very, very complex when you have the tragedy that we have had but I believe now that what the secretary of state has put in and the actions which I am sure the Committee is aware of, that the new leadership of the trust will answer any requests from relatives of patients who died at Stafford Hospital between 2005 and 2008 with a full review of the case notes to determine whether or not the care they received was appropriate. Professor Sir George Alberti will review independently the trust's procedures for emergency admissions and treatment for their progress against the recommendations in the report and he is going to report to the secretary of state within a month. The chief executive has already written to every NHS organisation in England drawing their attention to these recommendations in this report and setting out the expectations that every board will assure itself that these issues are not occurring within their organisations. Dr David Collin-Thome will review the circumstances that occurred in Mid-Staffordshire prior to the Healthcare Commission's investigation to see how nationally the commissioning system totally failed to expose and prevent the failings. Finally, the new National Quality Board will draw on all its expertise to advise the secretary of state by the end of the year on what more should be done to improve the alignment of the national system of regulation and management in the light of these very, very serious findings of Mid-Staffordshire.

Q912 Charlotte Atkins: Thank you for that. Were the strategic health authority and, to a less extent, the PCTs asleep on the job? What were they doing? PCTs are commissioning the patient care at the hospital and the SHA, who also cover North Staffordshire Hospital, clearly had not picked up on these problems. It worries me that we have these systems but I am never quite sure, when we have these awful disasters, what they are doing. Why are they not held accountable?

Ann Keen: The Healthcare Commission is very clear where the blame lies and it is the board and the trust for systems and shambolic governance. They didn't take notice of any concerns raised by patients and staff. The SHA and the PCT believe there was a problem with the data collection. The circumstances of those two situations have risen into this tragedy. Believing data was wrong, the SHA and the PCT will have to answer as to why that was the case. The Health Commission puts the blame firmly and squarely with the board of Mid-Staffordshire Trust because of their total shambolic management and total lack of concern. They met in private and there was no patient safety discussed. It is a catalogue of events but a catalogue of some of the events that the PCT and the SHA accepted.

Professor Lord Darzi of Denham: I would just like to reinforce what Ann said. I think the problem here was denial; denial of the data as Ann very eloquently explained. That is the whole purpose of what we are trying to do to move on.

Q913 Charlotte Atkins: Lastly, can you give me an assurance that there will not be a golden pay off for the sacked chief executive?

Ann Keen: The new chair and the new trust are really undertaking a rapid response to this. The suspension has taken place and then we will have to act within the confines of law and with that discussion. I understand totally and empathise totally with the sentiment that that question was asked in.

Q914 Charlotte Atkins: Will you be able to write to me if you cannot tell me now about the golden pay off if there is going to be one? I think that people need to know that the state of denial within the trust will not mean that the chief executive will get a golden pay off. Whether we are talking about banks or hospitals, there has to be responsibility at the top.

Ann Keen: I totally agree and I accept your question. As that develops I will be very happy to keep you and the Chairman informed of the progress on that. I understand totally the sentiment that that question was asked in.

Q915 Dr Taylor: Can I follow up some of those concerns? I also have a trust that is going for foundation trust status and from the complaints I get I am very unhappy that quality may not be taken into account. Following up on the SHA function, they are protected by data but from standardised mortality ratios this trust was the fourth worst for the years 2003 to 2006. We were reassured yesterday by the secretary of state that there was no other trust now in that same state, so that assumes that numbers one, two and three, who were worse than Staffordshire in 2003 to 2006, have been improved. SHAs somewhere or somebody must have been making those other ones improve. Does the West Midlands SHA have any excuse for not acting on those SMRs for so many years?

Professor Lord Darzi of Denham: You are raising the issue about the HSMR, Hospital Standardised Mortality Rate. I know something about this because it was discovered at Imperial College where I work. It is a tool and, like many tools, it has its advantages and it has its disadvantages. It looks at the mortality of the hospital, divides this over the average national mortality and then it gives it weighting against sex, age and the social deprivation, and also on the diagnostic code of that procedure. Then the come up with a figure; a figure above 100 it is slightly higher, below 100 it is where you should be. You have to remember it is comparing organisation to organisation so there will always be people above 100. What we are really talking about is an outlier, not one above 100. The ones you were referring to were above 100 but not outliers. Our reassurance for that is the regulator. It is the Healthcare Commission that picks those alerts and it has what we call an early warning system. If it picks that up it goes in to investigate or alert the SHA in relation to that. An HSMR is like a thermometer which tells you that you have a temperature but not necessarily what the cause is. I think it is a reasonable thing to look at how you are doing and how you are progressing.

Q916 Dr Taylor: Should the SHA have picked that up before?

Professor Lord Darzi of Denham: They have picked it up and I think we come back to the issue that Ann raised earlier. A debate then started between the SHA and Mid-Staffordshire NHS trust in saying that this data is incorrect because the coding was wrong. There was a period of denial in relation to that until, as Ann pointed out, the Healthcare Commission exercised its leadership and said, "Forget about HMSR, we are going to go in and find out what is going on".

Sir Liam Donaldson: Could I just add that there is quite a dispute now on the validity of these statistics. The strategic health authority commissioned the University of Birmingham to look at it. They have produced a report which is now the subject of a BMJ article tomorrow. Then the team at Imperial College who helped with the Bristol inquiry - Professor Sir Brian Jarman - have issued a rebuttal. So this is an index which itself is the subject of quite a lot of professional dispute amongst statisticians.

Q917 Chairman: Maidstone and Tunbridge Wells were also not picked up by the annual health check. Does that concern you?

Sir Liam Donaldson: I think any failure to detect these sorts of problems is a major concern. As far as the point that was made earlier about the regulators, we have to be absolutely clear in the future that one of them must have total supremacy on looking at the quality and safety of care and that will be the Care Quality Commission.

Q918 Dr Taylor: Would you all agree that the report from the Healthcare Commission is an excellent tribute to that organisation? Following on from that, the CQC has a vast amount more work to do than the Healthcare Commission; do you think it is spread too thin to be able to produce this sort of excellent report?

Ann Keen: I would like to put on record the excellent work that the Healthcare Commission has done for us. The case last week showed their courage and determination to bring those standards to everybody's attention. Building on their skills and expertise will very much be the case and we understand that the Care Quality Commission will also use surveillance and scanning, drawing on a very wide range of already available information sources, including complaints, to highlight where issues may require more in-depth investigation. So they will be building on their work, adding to their work with different skills and different knowledge.

Q919 Dr Taylor: You said yourself that hospitals must have proper staffing levels. It has come out very clearly that there were hopelessly inadequate staffing levels in Mid-Staffordshire. Whose fault was that? Was that the fault of management or was it that there just was not enough money for it?

Ann Keen: I feel it has to be management and all. If you are operating, as we have discussed, in A&E and you were asked to operate as you were in Mid-Staffordshire with so many people not in that workforce and not in that skill mix it was inevitable that there were going to be these serious problems. The clinicians as well as the managers would be aware of that. At this moment in time I do not know in depth as to how much reporting had gone on internally of the staffing levels within A&E in that particular hospital. We can all have a bad shift but you cannot have a bad year like that. I want to find out if they went through their professional organisations? Did they go to management? How many complaints were taken about the staffing levels? We ask so much of our staff in the NHS and they do, literally, perform miracles, but they have to have the right team to be able to do that appropriately for their clinical skill but also for safety and that is the responsibility of management. The resources were the same as they were for other hospitals that did not have that problem and it was how they chose to use their resources and create a problem within the workforce.

Q920 Dr Taylor: How and when are we going to get those answers?

Ann Keen: I would expect that to start unfolding now the new chairman and chief executive have the report for the first time on Wednesday. They are now starting their internal inquiry.

Q921 Dr Taylor: So there is not an external inquiry into this because Sir George Alberti will not be looking at this sort of aspect.

Ann Keen: Sir George Alberti and Colin-Thome will be doing that and they have been asked to report back to the secretary of state within a very short period of time, within a month. I know that other organisations like the Royal College of Nursing are already making those sorts of inquiries and I am sure other professional bodies will be as well.

Q922 Dr Taylor: Will we get the answer why there were inadequate nurses there?

Ann Keen: Yes, most definitely.

Q923 Dr Naysmith: Who at the Department of Health is ultimately responsible for operational issues when it comes to patient safety?

Ann Keen: We are all responsible. We really are all responsible.

Q924 Dr Naysmith: If you say everyone is responsible then no-one is individually responsible. Who is in charge? If something comes up about patient safety on whose desk does it land at the Department of Health?

Ann Keen: If it is in relation to an individual trust for example the sad example this week, the chief executive has written to all and that makes it look like I am saying the chief executive but I am not. I am trying to say that the process of responsibility really is collective, on the ground and right the way through all of the systems.

Q925 Dr Naysmith: You do not have any named person?

Ann Keen: There are named people within organisations throughout the NHS family.

Q926 Dr Naysmith: I am talking about the Department of Health. Sir Liam, do you know the answer?

Sir Liam Donaldson: Essentially the responsibility for all of this falls within the NHS management board which is led by the chief executive with a medical director.

Q927 Dr Naysmith: We have heard it said in this inquiry that we are conducting now in previous sessions and it has come up again this morning already that boards are responsible for safety, senior managers are responsible for safety, commissioners are responsible for safety, regulators can be responsible for safety and performance managers will be responsible for safety. Do you think that all of these roles are currently being performed in a co-ordinated and effective manner?

Ann Keen: Through the regulator and through the National Patient Safety Association that is improving all of the time. Being aware of safety is, as we said at the beginning, something that has only come about in the last ten years of having this responsibility. The collective responsibility has to stay because it is about the practitioner at that time or manager at that time and all of us now acting in a responsible manner with the results of this week. There cannot be a one person, but the progress and the process of the internal responsibility and the acknowledgement of that is of course taken at the senior level within the Department of Health, the senior directorate.

Q928 Dr Naysmith: My immediate reaction to all this is that if everybody is responsible then as soon as you say that then the buck passing starts as soon as something goes wrong. If somebody asked me who is responsible for quality at the moment in the National Health Service I would immediately say Lord Darzi. There is a named person at the moment whose job it is to improve quality in the NHS. Is there nothing similar in the Department of Health?

Professor Lord Darzi of Denham: The landscape was quite a big landscape: commissioners to regulators, NHS management board. That is why, if you remember, in the High Quality Care for All we created the National Equality Board. How do we align all of these people together with the ultimate aim of improving safety and quality? If I could bring you back to accountability - I think Liam said this earlier - someone needs to be out there accountable for core standards of safety and quality. That should be just one, and that will be the CQC and only the CQC. Anything above core standards, everyone who wants to be on the pitch, they should start talking about quality improvements whether it is Monitor, whether it is commissioners, whether it is the SHA and that is the culture we need to move to. The only way to do that is to go back to the teams in A&E who are providing that care to look at themselves and what they are doing. From an accountability perspective it is very important to know who is doing it exclusively. Then you come up and ask how we do it at a national level. I have tremendous expectations from the National Quality Board which was launched last week. They comprise a third of officials from the department (Sir Liam, David Nicholson and the senior permanent secretaries) and there is a group of experts, some from the US, who are advising the group on quality improvement (that is another third). Then there is another third representing lay people with an interest in quality. I think that would be an exceptionally powerful way of aligning the system and getting the message out there, but ultimately you are asking about who is accountable, then ministers are accountable. We have a health service in which we are accountable for the safety of the patients who we treat. Who is responsible for policy? I am delighted to say that Liam has done a tremendous amount in putting policies of safety together.

Q929 Dr Stoate: Ann, you said earlier that we have to change the culture in the NHS to one of safety. I entirely agree with you and yet we have heard from witness after witness before this session that safety is simply not a core part of the curriculum for training, not just of doctors and nurses but of all health professionals. Worse than that, we heard from our advisors this morning that it is perfectly possible for someone to become medically qualified having never written a prescription before and never having attended a formal qualification or recognition on patient safety. So there are still massive gaps. What are we doing about that?

Ann Keen: The Department of Health is not responsible for the training of doctors or nurses but what we have to do is to bring the patient safety organisations in for modules and really get through to the colleges to say that this aspect of care is as crucial as any other part of care but to dictate the curriculum to them is not in our domain. The paper on Tomorrow's Doctors, getting into the leaderships of the professions and getting them to really lead from the front on how this could be delivered, how important this is, you certainly cannot have a tick box to say you have had half a day on safety somewhere and it was part of your induction course, it was probably about where the fire escapes are and those sorts of aspects of safety. That is where the NHS has done its training in the past. Each time you move hospital or organisation you get a half day induction on safety but it is not the sort of safety that your Committee is discussing today. So it is really getting that through to the leadership of the professions, to the leadership within the royal colleges and to make sure that we are part of that curriculum. Dr Taylor mentioned earlier communication and asked if you could teach communication skills. Well, it is a difficult area to talk about but until it is embodied right the way through everything we think of and do, then it will become the norm and we are not there yet. We are struggling, but we are going to get there.

Sir Liam Donaldson: I would like to make three brief additional points. First of all, the minister mentioned Tomorrow's Doctors; that is basically the document that determines what the medical curriculum in all our medical schools will be in the next decade. It is currently out to consultation and I am sure the Committee will have looked at that and formed a view on whether it is adequate in patient safety terms to shape the curriuculum. Secondly, we need to have more centres of the sort that Lord Darzi has in his hospital, simulation centres where people can be put in in teams, trained in a multi-disciplinary way in the sorts of skills of communication that are really necessary. At the moment we do not have enough of those centres and we need to have more of them. The third thing is that we need to ensure that the medical education leaders understand these concepts of patient safety and are committed to instilling them in their students.

Q930 Dr Stoate: I entirely agree with you, but to come back to Ann's point the rub is that you have already said that ultimately the minister is responsible for patient safety and that is the way it should be and the public will inevitably ask what the government is doing about this and yet we are still getting Mid-Staffordshire, we are still getting Maidstone and Tunbridge Wells. Is it not time that we effectively told the colleges - I know this is going to be difficult for you - that the culture at the moment is not the culture that ministers want to see. We want this culture change; the public expect it of us. As Lord Darzi has said, the money is going in which is fantastic but until we change that culture - and I believe that has to come from the top - we are just not going to change the outcomes.

Ann Keen: I totally agree with you and it is very frustrating when you are in the position of accepting responsibility and the privilege of ministerial responsibility to not always be able to steer the dictat as to how this will be delivered. It is not without passion and it is certainly not without a message. I believe the time is long overdue when we had more influence on that. Again we are back to custom and practice as to how a curriculum has always been delivered but to bring people on board with you within Ara's colleges, as Liam pointed out, we have to make it interesting. If you talk to some junior nurses and junior doctors today about patient safety, what would they think it was? They would all think it was something different. We have certainly done infection and today's figures again are showing a reduction which is excellent, so we are getting that message through. However, the message was so basic that did they see that as safety or did they see it has hand washing procedure? To be fair to the practitioners, if we are asking them to practise in a particular way we have to help them do that as well. There is much innovation out there that they are probably not even aware of; that is an exciting change of practice. It is exciting to be a health professional; it is not about putting up with old decrepit buildings like I had to work in with total unsafe practice where you transported patients from A&E on a cardiac monitor in a milk float to the cardiac unit a good mile away. We have a brand new hospital in my constituency where A&E is integrated within the hospital and it is safer to move the patients than when I had to move them. So there are buildings, there is design in safety, there has been innovation in safety and there is really getting through to the diehards of curriculum planners that actually they need to open up their books and we really need to get in there.

Q931 Dr Stoate: There are examples of safety but that is not the culture of safety and that is what we have to get across.

Ann Keen: It is, "This is what we do to you, we are doing this to you today, I am now going to do this to you". It is a really holistic approach. It is almost, "The patient is ready to see you now doctor" rather than the other way round because the patient is now safe for you to see because we have everything in place.

Q932 Chairman: When we asked the chief executive of the NHS Litigation Authority whether their standard-setting role ought to be handled by a body that is not responsible for dealing with litigation, he replied, "That is a good question and it is one which we ask ourselves regularly". Is it one that the Department of Health ever asks itself?

Ann Keen: Not that I have heard. Being honest with you, I think this is something we really do have to look at and need to look at. We would want to come back to you with those answers because it is a question that has not been addressed in the way you have asked me the question.

Q933 Chairman: I would appreciate it if you could get back to us before the end of this inquiry, before we draft anything up.

Ann Keen: Yes.

Q934 Chairman: One of the things we heard was that the Clinical Negligence Scheme for Trusts does not cover situations where patients receive NHS care from independent sector providers (apart from ISTCs). It seems to me under those circumstances that we are sending NHS patients into different independent hospitals without cover at this stage. Are you going to do something about that immediately?

Ann Keen: I will get back to you on that and you will have more evidence to show what the department will be doing on that.

Q935 Stephen Hesford: The NHS Redress Act was passed in 2006 but we are told that there is still no sign of the NHS Redress Scheme. Where is it? What is the delay? Are we going to get it?

Ann Keen: Again this ties into your previous question. Apologies to the Committee, but it is something we will have to write to you on because they interlink in actual fact very closely and work is in progress at the moment on that.

Q936 Dr Taylor: The NHS complaints process, why ever is the government abolishing the automatic, independent review in that process? At the moment it is internal, then you go to the Healthcare Commission when you do get the automatic independent review and only then onto the ombudsman. That middle stage is being cut out, why?

Ann Keen: The NHS complaints procedure has been criticised for being complex and taking too long. The previous requirements were often very inflexible and bureaucratic and more concerned about the process rather than outcome for the complaint. We published Listening, Responding, Improving for NHS organisations to put this into practice based on the NHS constitution and the ombudsman's principle of good complaint handling. On the first of April of this year these new arrangements for improving the handling will commence. The aim is to improve the quality of people's experience of services through a much more flexible approach. It has been criticised so badly that we were forced to re-look.

Q937 Dr Taylor: Will there be a compulsion on trusts as part of their internal inquiry to involve independent experts? Because that is what patients need.

Ann Keen: There will be a one stage independent review process conducted by the parliamentary and health service ombudsman for the NHS and local government.

Q938 Dr Taylor: The ombudsman cannot possibly cope. The Healthcare Commission tell us that almost half of their 8949 complaints were upheld or sent back to the trust for further work. How is the ombudsman going to cope with this number of complaints?

Ann Keen: If I could take you back to your previous point, that is a very strong argument. The trusts could also of course conduct an independent review themselves.

Q939 Dr Taylor: What I am getting at is, who is going to tell the trust they have to do that? At the moment the only way a patient or a family will get an independent review is when it goes to the ombudsman. They have to have the right to an independent review before it gets to the ombudsman because the ombudsman will not be able to cope.

Professor Lord Darzi of Denham: You will probably remember this because it came through the Health and Social Care Act last year as it passed through Parliament; that is when the legislation came through. The problem is that you have had a three tier system when it came to complaints. If you look at the data - this is amazing data - nearing 35% to 40% of the complaints that go to the Healthcare Commission go back to the trust to be dealt with. So you had a huge amount of bureaucracy in the system. The trust, because it is going to be moved up, does not deal with it properly; the Healthcare Commission sends it back to them; you have delays of up to six months to a year and what we try to do is get the trust and the board to be accountable for that, to get this right. As you know and I know, in most complaints patients are purely looking for an apology and have we learned from it. How do we strengthen the dealing of complaint at a local level? The CQC, in their registration purposes, could actually look at the complaint of an organisation and remove their registration if they are not dealing with the complaint. That is much more powerful than it used to be before but we are shifting the responsibility and accountability of dealing with complaints to the NHS provider. That is what went through Parliament last year.

Q940 Dr Taylor: How are they going to know that the individual trust is not dealing with complaints? Because of the number that are going to the ombudsman?

Professor Lord Darzi of Denham: Yes.

Q941 Dr Taylor: So the CQC then can step in.

Professor Lord Darzi of Denham: Yes, but they will not be dealing with individual complaints.

Q942 Dr Taylor: Is it not the independent aspect of the Healthcare Commission's part at the moment that tells when the thing has to go back to the trust? What I am getting at is that we are losing the independent review which is so absolutely vital.

Professor Lord Darzi of Denham: Most of these complaints go back to the trust.

Q943 Dr Taylor: Yes, because of the independent review by the Healthcare Commission, not because.

Professor Lord Darzi of Denham: No, because they have not been dealt with properly and the Healthcare Commission send it back and say, "You had better get on and deal with this complaint".

Q944 Dr Taylor: Do we know that that is without the independent -----

Professor Lord Darzi of Denham: Yes, that is exactly so; we have the figures from the Healthcare Commission.

Q945 Dr Taylor: You are happy then that somehow the new system with just the two stages is going to work and is going to give patients access to independent views of what they believe has gone wrong.

Professor Lord Darzi of Denham: That is correct. If the ombudsman is obviously raising concerns about it then that is something that the CQC needs to look into. It is bringing more transparency, more accountability of ownership of complaint to the actual provider in which a complaint has arisen. If the patient and the public are still unhappy they could go to their PCT with that complaint and the PCT will look into it, or they could send it to their ombudsman.

Q946 Dr Taylor: Do they have the right to claim an independent review before it gets to the ombudsman?

Professor Lord Darzi of Denham: They could request it from the trust if they wished to see that.

Ann Keen: This is to speed up the process.

Q947 Dr Taylor: Coming onto PALS and ICAS, are they up to the job?

Ann Keen: From our experience and from the feedback we get, PALS supply an excellent service to patients. The reporting on the PALS services is excellent.

Q948 Dr Taylor: I do not suppose you know off the top of your head how many actual PALS personnel there are per trust throughout the country. I can see a parliamentary question coming up. I have the absolute impression that in some places there is perhaps one PALS officer for three hospitals.

Ann Keen: That is not my experience but I feel confident that you will ask the question of me and I will soon know the answer and I will respond to you.

Q949 Dr Taylor: I have a very high opinion of ICAS. Is that generally shared? Do patients largely find ICAS helpful?

Ann Keen: Very much so and of course coming back to the constitution again, the constitution gets through to patients in a manner in which we want them to do so. They will see a totally different set of rights and how they can access, what they are entitled to do, how they are entitled to complain and where they are entitled to get support from. The constitution really will feature as people get more familiar in using it and that is not just public but it is staff ensuring that the public has the rights to the constitution. This is set out very clearly.

Q950 Dr Taylor: I should know and I regret I do not, does the constitution give an automatic right to an independent review of a complaint?

Ann Keen: Yes. It talks you through the process of how to achieve that.

Q951 Dr Taylor: I shall go back and check it, thank you.

Sir Liam Donaldson: I think we do have to weigh into the equation on complaints that the degree of rigour that the ombudsman brings to complaint investigation is much, much higher than ever was the second stage of the complaints procedure. Maybe you sacrifice fewer people getting that, but when they do get it the rigour, the openness, the public reporting of the outcome is very, very high compared to any other element of the complaints procedure.

Q952 Chairman: The last question we have for you is that in 2007 the department published Coding for Success which promoted and supported the use of auto-identification technology (barcoding, et cetera). We saw some of this in action last week in a National Health Service Hospital. The document stated, "The Department of Health will review progress by the end of 2008". Could you tell us what has happened?

Ann Keen: Every board has a goal to achieve this. Some of the systems at the moment are still quite patchy, I believe, but we continue to work with all of the agencies to achieve this. The implementation of coding requires both manufacturers and the NHS to make significant investment decisions and the progress of how this system is working again is very variable.

Q953 Chairman: Have you published anything in relation to the review?

Ann Keen: Not that I have information on at this moment.

Q954 Chairman: Could you share any information with us about the review?

Ann Keen: At this moment we cannot.

Q955 Chairman: Could I ask you to have a look at that as you are going to look at one or two other things you have been unable to supply evidence for this morning and see if you could give us a synopsis of what the review is going like in relation to this coding system.

Ann Keen: Yes.

Q956 Chairman: I think that is it. Could I thank all three of you very much indeed for coming along. Sir Liam, I do not know if you are aware of this, but we are expecting to call you on the first day when we take evidence on our alcohol inquiry when we get back after the Easter recess.

Sir Liam Donaldson: I will need a stiff drink before then!