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Patient Safety

Thank you, Mr. Russell, and may I say how pleasant it is to serve under your chairmanship for the first time? Just before close of play in terms of the parliamentary timetable, I am pleased that we have the opportunity to discuss our patient safety report and the Government's response. I intend to give a broad-brush speech explaining why we took up the report, some of the evidence that we took and some of the recommendations in the Government's response. "Do no harm" is a fundamental principle of medical practice that goes back many thousands of years, but there has always been scope for patients to be harmed accidentally. That is an issue in all areas of clinical practice and all types of health care systems around the world, however they are funded or organised. Reviews of patients' case notes indicate that in health care systems across the developed world, about 10 per cent. of people admitted to hospital suffer some form of harm, much of it avoidable. Indeed, the report states that 50 per cent. of harm created in our health care system is avoidable. The national health service in England treats huge numbers of people—1 million every 36 hours—and the vast majority receive safe and effective care. Over the years, however, notorious cases have illustrated how badly things can go wrong. In the 1990s, patient safety became an important issue in the NHS following the inquiry into the Bristol Royal Infirmary, where unsafe heart surgery on young babies had had fatal consequences. In 2000, an expert group convened by the chief medical officer published "An organisation with a memory". That document acknowledged that in most cases when patients are unintentionally harmed, the harm is not down to negligence or serious incompetence on the part of individuals, but to unsafe systems and ways of working. The expert group recommended that patient safety in the NHS be improved by the creation of a national patient safety incident reporting system, so that lessons could be learned and repeat incidents avoided. The group recognised that the system needed to be underpinned by a culture of openness and "fair blame", allowing people to report incidents without fear of being unfairly made to shoulder all the responsibilities when systems were at fault. The Government accepted the expert group's recommendations and created the national reporting and learning system and the National Patient Safety Agency. That made the Government one of the first in the world to attempt to address patient safety systematically across an entire health care system. Despite nearly a decade of emphasis on patient safety as a policy priority, major lapses in safety have continued to come to light in recent years. At Stoke Mandeville hospital, and at Maidstone and Tunbridge Wells NHS Trust, there were stark failures in preventing and controlling health care associated infections, with, sadly, some disastrous consequences. At Mid Staffordshire Foundation Trust, wholly inadequate accident and emergency care led to unnecessary deaths and suffering, while at Basildon and Thurrock University Hospitals NHS Foundation Trust, poor hygiene and unacceptably high death rates also came to light. Against that background, we must ask how far the Government's policy has succeeded in reducing harm to patients and what more needs to be done, and we decided to conduct our inquiry on that basis. We found that although reporting is useful for learning from incidents, it is not a reliable way of measuring the extent of harm. Judging the overall effectiveness of patient safety policy is made difficult because of the failure by the Department of Health to collect adequate data. Despite all the policy innovations of the last decade, it is apparent that there has been insufficient progress in making services safer. Indeed, underlying Lord Darzi's emphasis on quality and safety in the next stage review of 2008 was a tacit admission by the Government that not all services are safe enough yet. Patient safety is a multifaceted issue that touches on many aspects of the NHS, and we examined in some detail those we regarded as the most important. We concluded that there were significant deficiencies in current policy, and we recommended several changes that were needed to bring about further progress in tackling unsafe care. To monitor whether services are being made safer, data on the incidence of harm must be systematically collected. The best available means of doing that is to review samples of patients' case notes at periodic intervals in order to calculate a rate of harm. We concluded that such a review should be undertaken by all hospitals, and that data produced in that way should be gathered together by the NPSA. In their response, the Government told us that the high cost of large-scale record reviews, and the need for extensive involvement in them of people with clinical expertise, meant that they could not be conducted frequently. However, they did agree that small-scale, local case note reviews were vital in helping NHS organisations to measure their performance. When patient safety incidents occur, harmed patients and their families or carers are entitled to receive information, an explanation, an apology and an undertaking that the harm will not be repeated. We found that too often that does not happen and we felt that recent changes to the NHS complaints system were unlikely to improve how the service treats complainants. Patient advice and liaison services should be provided independently of the NHS organisations to which they relate, and not by in-house staff, as happens at present. The independent review stage of the complaints process, which the Government abolished nearly a year ago, should be reinstated—the Committee has said that before. However, once again, the Government failed to agree with those recommendations. Harmed patients are currently forced to endure often lengthy and distressing litigation to obtain justice and compensation. There will not be many hon. Members of the House whose case work does not suggest that; I have a case in my constituency that has lasted for more than a decade, and it has still not been resolved. At the same time, NHS organisations are obliged to spend considerable sums on legal costs, and are encouraged to be defensive when harm occurs. Four years ago, Parliament passed legislation to enable the Department of Health to introduce the NHS redress scheme, removing the need for litigation in many cases. However, the Department has not implemented the scheme, and seems not to have a timetable for doing so. In responding to our report, the Government insisted that their reforms of the NHS complaints system had made the NHS redress scheme unnecessary. However, I say to my hon. Friend the Minister that that prompts the question as to why the Government bothered to take up Parliament's time putting through legislation that now seems to be unnecessary. The NRLS is collecting significant amounts of data that are being used to help make services safer, but significant underreporting remains, particularly for incidents in primary care, medication incidents, serious incidents and reporting by doctors. We found that a major reason for underreporting is the persistent failure to eliminate the blame culture. Another important factor is fear of litigation or prosecution, which underlines the need for the Government to address the medico-legal aspects of patient safety. We particularly recommended the decriminalisation of dispensing errors on the part of pharmacists. The apparently now redundant NHS redress scheme also seems relevant to that issue. The one-size-fits-all nature of reporting systems seems to be a significant cause of underreporting, for example by GPs. We thought that as much as possible of the data collected by the NRLS should be published, and we welcome the decision to start publishing reported data broken down by individual NHS organisations. We had some criticisms of the policy on data collection; we thought there had been too much emphasis on gathering summary data on common or less serious incidents. The NRLS should be gathering more in-depth information on serious and sentinel events—those needing an immediate investigation and response, as they involve death or serious injury, or the risk thereof. We thought that that particularly applied to the less common types. Also, there must be much wider and better use of root-cause analysis, which is an investigative method designed to identify the underlying causes of an incident, with a view to preventing its repetition. Although the patient safety observatory, which is a part of the NPSA, was already collating data from a variety of sources other than incident reports, we thought that doing so should become a key priority for the NPSA. We found that, too often, although patient safety solutions were well known, there was a failure to adopt them where they were needed—on the front line of the NHS. Solutions are handed down from on high as diktats—if they are passed on at all—without clinicians being convinced of their effectiveness. We had a number of clear examples of that. Moreover, a culture persists in which various types of easily avoidable harm are seen as inevitable risks of treatment. However, safety improvements can be fully integrated into front-line services by engaging and involving clinicians and other health care workers. That has been shown in schemes such as the safer patients initiative and the productive ward programme, which have been successfully adopted at a number of hospitals. We made visits to a number of hospitals to look at that issue. We were particularly impressed when we visited Luton and Dunstable hospital, which is an exemplar of good practice on patient safety in the NHS. We heard that central venous line infections, which clinical staff had previously regarded as a normal risk of that type of treatment, were now very rare and seen as exceptional occurrences. We were particularly struck by the fact that the NHS lags unacceptably behind other safety-critical industries in recognising the importance of effective teamworking and other non-technical skills. Health care clearly has much to learn from other industries such as aviation in that regard. We took evidence from a person who has worked as an adviser to the aviation industry. When things go wrong in that industry, they are reported and lessons are learned immediately. Although we cannot do a complete read-over on that, the NHS and its health professionals could do far worse than accepting that when things go wrong, we should learn the lessons, and we do not learn the lessons if they are not brought to the fore. We found that inadequate staffing on the front line had been a major factor in undermining patient safety in a number of notorious cases. Given the recent huge increases in funding and staffing overall in the NHS, it seems inexcusable that some services have ended up being run with too few doctors or nurses, to the extent that safety has been compromised and patients harmed. A number of years ago, the Committee produced a report on NHS work force planning, and found that when there were overshoots, in terms of taking people on, or when there were major increases in the NHS work force, that was not necessarily related to service improvement. Targets for more doctors and nurses were set centrally, and I am very pleased that the Government provided exactly that, but we need to look at where that takes place. We heard that several technologies could make significant improvements to care, but were being implemented far too slowly. Examples include automated decision support systems, including electronic prescribing support systems—that seems a pretty obvious one to us—and automatic identification and data capture technology, such as barcoding. We have heard in different parts of not just this country but the world about exactly how barcoding can ensure that people do not suffer any harm. The most classic example that we saw was at Charing Cross hospital. It had a system whereby patients were barcoded, so that when people went to the patient's bed and scanned the barcode, information immediately came up on what medication the patient needed at that time of the day, and on the right quantity as well. It is extraordinary that medication error causes a lot of harm in the acute sector of the NHS. When people take a prescription home from the pharmacist, they might misuse the medication, but medication being misused in the acute hospital sector is not acceptable. In the case of Charing Cross, two individuals watch each other as they put the medication in the right quantity into the—I was going to say "contraption", but that is not the word. They put the medication into a dispenser, which they take on to the ward. It was shown that that system, which was an attempt to avoid medication error in that hospital, had reduced and further reduced human error. Another example is the electronic patient record. You will know, Mr. Russell, that we have commented on that before in our reports. We were alarmed at the lengthy delay in developing spinal needles that cannot be connected to a Luer syringe, which is a simple technical solution to a known and potentially lethal problem. It is unacceptable that the NHS does not have a mechanism to ensure that such changes, which impact seriously on patient safety, occur in a timely fashion. It is not the first time that the Health Committee has considered that particular issue and made recommendations on it. Since we published our report, significant progress has been made on non-Luer spinal connectors. In November, the NPSA issued a patient safety alert, which I am told should mean that the new connectors are in commercial production soon and in use across the NHS by next year. We will all be very pleased that that is happening, but it makes us wonder how long we have to keep making the call before someone takes action to try to avoid the situations that we have found. We found serious deficiencies in the undergraduate medical curriculum, "Tomorrow's Doctors", which were detrimental to patient safety, in respect of training in clinical pharmacology and therapeutics, diagnostic skills, non-technical skills and root-cause analysis. We said that those issues should be addressed in the next edition of "Tomorrow's Doctors", and we understand that that is in hand and will happen. We concluded that patient safety must be fully and explicitly integrated into the education and training curriculums of all health care workers. In addition, there should be much more interdisciplinary training; those who work together should train together. That is important. I have knowledge of medical training from the time when I was a lay member of the General Medical Council, and what is rightly being said to trainee doctors and others is that we cannot avoid all aspects of harm to patients. However, because we cannot avoid all harm, I wonder whether it is being said that some of it is inevitable, and that nothing can be done about it. We believe that through the consideration of systems, something can be done about it. Each time that a major patient safety scandal has come to light, the Government have assured us that it is a unique case and that no other NHS bodies are in the same situation—and then, normally, within about three to six months, we get an example that seems to disprove that. Such cases are extremely rare, but we thought that there were too many gaps in the current arrangements for commissioning, performance management and regulation to be able to say with certainty that there are not further, as yet undiscovered, cases. That is probably a good maxim for everyone to use in the health care system. The case of Basildon and Thurrock University Hospitals NHS Foundation Trust, which I have mentioned, and which emerged after we published our report, seems to prove the point. People said, "Well, things are okay now," but clearly they were not. A key role for primary care trusts in commissioning services is to ensure the quality and safety of those services. However, we have had grave doubts about whether all PCTs are doing so. We welcomed the principle of linking payment by PCTs to the quality of care, but recommended that that be piloted first. We supported the use of never events by PCTs, but had doubts about whether they should involve a financial penalty. We recommended that that be piloted, too. We shall pass further comment on that in the next few days, with the publication of a report on an inquiry that we have undertaken in relation to commissioning. We found that the performance management role of strategic health authorities appeared to be a bit ill defined and to vary between SHAs. We recommended that the Department of Health produce a formal definition of that role. In their response, the Government said that the new SHA assurance framework would clarify the SHAs' role. We welcome that. We found that the regulation of health care has been too rule-based, looking at processes and procedures rather than outcomes and consequences or professional competence. Consequently, the annual health check did not pick up major failings in some cases. We believe that the Care Quality Commission's registration system, which is to be introduced this year, should focus on the outcomes being achieved by NHS organisations rather than on formal governance processes. There remains concern about the role of self-assessment in regulation. That was undoubtedly a weakness in the annual health check. Indeed, that was confirmed this week by the widespread lapses in hygiene standards that the Care Quality Commission uncovered when inspecting 167 trusts on that aspect of care as part of the transition to the new registration system. We felt strongly that the relationships between bodies responsible for commissioning, performance management and regulating NHS service providers were not sufficiently defined. Baroness Young, then chair of the Care Quality Commission, told us that there were""a lot of players on the pitch"." We thought that the rules of the game were none too clear. In particular, there was a lack of clarity about the role of Monitor, the foundation trust regulator. It is rather like a moving picture, and I know that the Minister will want to bring us up to date. We told the Department of Health that it should produce a succinct statement on how commissioning, performance management and regulation are defined, and how they, and the organisations responsible for them, relate to each other. The Department said in its response that that would be included in the next NHS operating framework. The report on the Mid Staffordshire NHS Foundation Trust by Robert Francis QC was published last month. It seems to vindicate our concerns. Mr. Francis recommended that the Department""should consider instigating an independent examination of the operation of commissioning, supervisory and regulatory bodies in relation to their monitoring role at Stafford with the objective of learning the lessons about how failing hospitals are identified."" I am pleased to say that the Department accepted that recommendation. Mr. Francis has agreed to chair the new inquiry. We took evidence not only about Mid Staffordshire but about management and governance in other places. We found disturbing evidence of catastrophic failure on the part of some senior managers and boards, including at Mid Staffordshire. Although other boards are not failing as comprehensively, there is substantial room for improvement. Boards too often believe that they are discharging their responsibilities in respect of patient safety by addressing governance and regulatory processes, but we believe that they should be promoting tangible improvements in services. We believe that there is a case for providing specialist training in patient safety issues, particularly to non-executive directors, in order to help them scrutinise their executive colleagues and hold them to account. Patient safety must be the top priority for boards; to show that that is the case, it should without exception be the first item on every agenda of every board. It is remarkable that that was not the case when we investigated the situation. It is difficult to comprehend why that should be so, in view of the harm that is done to patients. We recommended to NHS organisations the measures that were piloted as part of the safer patients initiative. They included implementing tried and tested changes in clinical practice in order to ensure safe care; banishing the blame culture; providing the leadership to harness the enthusiasm of staff to improve safety; and changing the way in which they identify risks and measure performance, using information about actual harm done to patients, such as data from sample case note reviews. I remember very well our visit to Luton and Dunstable hospital. I was interested to note that when something had gone wrong no one thought to consider what had happened in order to find out what lessons could be learned. They undertook systematic reviews of patient case notes to ensure that patients going through their hospital were getting the best and safest care. It is not only about investigating something when it goes wrong but about considering the system as a whole, including the management of patients, to ensure that nothing more can be done to lessen potential harm. We strongly endorsed the Department's view that NHS boards should not always meet behind closed doors. We urged the Government""to legislate as necessary to ensure that Foundation Trust Boards meet regularly in public"." The Government said in their response that they were""considering what legislative or other changes may be necessary or desirable in the light of recent events in Mid-Staffordshire"." Since then, the Francis report has concluded that the board at Mid Staffordshire discussed "far too much" business in private, giving the impression""that only good news is discussed in public while the bad is hidden behind a curtain of secrecy."" The Secretary of State responded by telling the House that there is a "strong presumption" that foundation trust board meetings""should be held in public and that governors should have access to all papers".—[Official Report, 24 February 2010; Vol. 506, c. 312.]" However, he did not mention any plans for new legislation, instead invoking the spirit of the existing law on foundation trust status. I would be interested to hear the Minister's comments on that, and if we are not to have new legislation, how that change can be implemented. We said in our report that the NHS remains largely unsupportive of whistleblowing, with many staff fearful of the consequences of going outside official channels to bring unsafe care to light. We recommended that the Department should bring forward proposals on how to improve the situation. Here too, we had Mid Staffordshire very much in mind. The previous Secretary of State told the House last year that it was a mystery why no one had blown the whistle at Mid Staffordshire, given the existence of legal protection for whistleblowers. However, our evidence led us to conclude:""Many healthcare workers remain fearful…that if they whistleblow they will be victimised."" Indeed, that conclusion was made also by the Francis report. We recommended that the Department should""bring forward proposals on how to improve this situation and that it give consideration to the model operated in New Zealand, where whistleblowers can complain to an independent statutory body."" The Government, I am pleased to say, accepted that recommendation. It is no good our passing laws in our legislative Chamber to protect whistleblowers if they are still fearful. The Francis report again vindicated our conclusions, finding that the Mid Staffordshire Trust had not offered the support and respect due to those brave enough to become whistleblowers. In response, the Secretary of State announced that a group had been established to advise him on updating NHS whistleblowing guidance. We thought that the Government should be praised for being the first in the world to adopt a policy that makes patient safety a priority. However, Government policy has too often given the impression that other priorities—notably hitting targets for waiting lists and accident and emergency waiting times, achieving financial balance and attaining foundation trust status—are more important than patient safety. Everyone will say that that is the impression being given, but it is not so. Reading such stories in the media over the past few years, that often seems to have been the case for the defence. I hope that that is not so. No case can be made for the neglect of patients, whether in the acute sector or even the primary sector. I hope that the Government are conscious of the fact that there are some basic principles when it comes to ensuring that we look after our patients as safely as we can. All Government policy in respect of the NHS must be predicated on the principle that the first priority, always and without exception, is to ensure that patients do not suffer avoidable harm. The key tasks of the Government, we said, were to ensure that the NHS""develops a culture of openness and 'fair blame'"—" we all make mistakes; indeed, incidents from this House reported in the media over the past 18 months show that many here make mistakes from time to time—""strengthens, clarifies and promulgates its whistleblowing policy"—" I am pleased that that will happen—""and provides leadership which listens to and acts upon staff suggestions for service changes to improve efficiency and quality and, by the provision of examples and incentives, encourages and enables staff to implement practical and proven improvements in patient safety."" In addition, we argued that the Government should examine the contribution that deficiencies in regulation make to failures in patient safety. I am pleased to note that the Government again seem to be acting on some of the issues raised in the Francis report. Finally, there is no health care system in the world that can be said to have completely solved the issue of patient safety. We can be proud of the fact that over the past decade, the NHS has been a pioneer in developing policies and systems to address patient safety. However, many things still need to be put right before the whole NHS—not just its best parts—is ensuring that patients are not avoidably harmed. I hope that our report can be said to have made a contribution to bringing that about.