My Lords, it is a great honour to speak on the Health Service Safety Investigations Bill, which represents a landmark moment for safety and transparency in the NHS and is a major victory for those campaigners who have called for change. Every day, the vast majority of patients treated in the NHS receive safe, effective, world-class care. However, healthcare is complex and sadly sometimes errors occur that lead to harm. It has been estimated that more than 20,000 serious incidents and 8,000 deaths are due to problems in NHS services every year. These incidents have a devastating impact on patients, their families and staff, and cost the taxpayer up to £2.5 billion a year.
The Mid Staffordshire public inquiry and the report of the Morecambe Bay investigation highlighted the variable quality of NHS investigations into patient safety incidents. They also emphasised the many pressures that deter healthcare professionals being frank about failings in patient care and the factors that might contribute to them. In response to these findings, the Government have committed to make the NHS lead the world in providing safe, high-quality care.
In 2015, the Government accepted the central recommendation of the Public Administration Select Committee to establish an independent national body called the Healthcare Safety Investigation Branch. Such a body would conduct a small number of automatic safety investigations and identify areas of learning from healthcare incidents. Lessons have been drawn from the Air Accidents Investigations Branch—an investigative body that has been fundamental to the improvement of safety in the aviation industry.
Our Healthcare Safety Investigation Branch was established in 2016 and started operating in 2017. It currently conducts up to 30 thematic national investigations and up to 1,000 local maternity safety investigations a year. The purpose of the national investigations is not to apportion blame or liability but to share recommendations to prevent similar incidents happening again. The current investigations branch has firmly established itself within our globally renowned healthcare landscape, and is a vital component of a comprehensive plan for safety improvement in healthcare.
Let me give an example of a case that this investigation branch has taken to illustrate the recommendations and the improvement that it can give. The investigation looked into the undetected ingestion of a button or coin-cell battery in children, following an event in which, tragically, a child died after the ingestion of a coin-cell battery. Following this incident, NHS Pathways took action to ensure that NHS 111 staff were prompted to mention coin-cell batteries when asking about the ingestion of anything harmful or poisonous. In addition, the investigation branch also made a series of actionable recommendations to PHE, the Department for Business, Energy and Industrial Strategy and the Royal College of Paediatrics and Child Health. The recommendations addressed issues around the design of button batteries and public awareness about the health and safety of this product. They also focused on the recognition of the ingestion of button batteries in emergency medicine, and the role of ambulance staff concerning the urgent care of young children.
My Lords, it is a great pleasure to follow the Minister, and I thank her for her introduction to this important Bill. I declare an interest as a member of the board of the GMC, a trustee of the Royal College of Ophthalmologists and president of GS1, which has overseen the Scan4Safety programme in the NHS.
I warmly welcome the Bill. As the Minister said in her introduction, the scale of adverse incidents in the health service makes it imperative that we try to develop a systematic approach to safety. In looking for inspiration, I came across something James Titcombe wrote recently. He conducted a remarkable campaign, following the tragic death of his baby under the auspices of the Morecambe Bay NHS Foundation Trust, and he fought and fought to get answers. He wrote:
“Where healthcare professionals perceive a blame-seeking response to incidents and error, the conditions for learning can never exist. It is paramount that the NHS is able to strike the right balance between ensuring there is accountability where appropriate, and fostering a culture where staff can report and openly discuss error with the confidence that they won’t be blamed unfairly”.
For me, that sets the foundation for the whole concept of the HSSIB. The safe space provisions are so important for the confidence of staff, in ensuring that information they provide will be treated fairly, without them feeling that their employing organisation will come after them because they have disclosed it.
I first became convinced of the need for a systematic approach when the former Chief Medical Officer Liam Donaldson chaired an expert group which produced, in 2000, the report An Organisation with a Memory. This then led to the establishment of the National Patient Safety Agency, and I can tell the Minister that that was actually the first organisation in the world to tread this course. The noble Lord, Lord Patel, was its first chair, and I had the pleasure of following him as chair from 2005 to 2007. Very disappointingly, when the coalition Government came to office—it is good to see the noble Earl, Lord Howe, in his place—we had the predictable bonfire of the quangos, which all Governments seem to go through before they set up their own, and the NPSA was abolished. Disappointingly, and remarkably, the decision was made to place the national reporting and learning system, which is the key mechanism by which people reported incidents, within NHS England, with the NHS Commissioning Board. Clearly, putting it within the compass of the organisation responsible for managing the NHS was the wrong thing to do. We should acknowledge that that has now been seen; hence the Bill today and why I welcome it so much.
My Lords, I too thank the Minister for introducing this Bill.
I have always believed that, if you want to know what is wrong in an organisation, the best thing you can do is ask the people who work there. They will also very often know what to do about it. If you want to manage change effectively, your first principle has to be to involve in its design those who are going to implement it. I am also, as a keen gardener, a fan of the old saying that the best fertiliser is the farmer’s boot. In other words, there is no substitute for getting round the farm to see what is growing well and what is being eaten by caterpillars. The same goes for organisations. If managers do not get out of their offices to see how things are working on the ground, they will miss what is going wrong and lose out on valuable opportunities to hear from staff informally. Nowhere is that more important than in an organisation where people’s lives depend on getting things right the first time.
We therefore welcome the Government’s objective of moving towards a learning culture, but in many good NHS organisations this is nothing new. There have been many successes when the principles I have just outlined have been put into operation and staff have embraced change, especially when it was their idea in the first place—or at least they believed it was. Sometimes small management and systems changes can make a big difference to patient safety: for example, the introduction of checklists in surgery has reduced mistakes considerably. These things are not the responsibility of any one member of staff but involve people working together. The Bill deals with thematic or systemic issues rather than individual cases so it has a rather different role from the existing systems for improvement and safety management, but I would like to know how its operation will link with and impact on those existing systems.
Getting to the bottom of problems in the past has often been hindered by staff hesitating to report concerns because of worry about being victimised as a whistleblower —there have been some very bad cases of that—but also because of a lack of confidence that anything will be done. The safe space idea should help with this. However, I agree with the noble Lord, Lord Hunt of Kings Heath, that it has to be seen that the recommendations are put into place for that confidence to arrive.
4:11 pm
Lord Judge (CB)
My Lords, I support the Bill for reasons that have already been given. Nevertheless, I will raise two concerns which I invite the Minister to consider during the long period that we will all have to consider everything.
My concerns arise from a very simple point, which is whether the legislation as drafted offers patients the level of protection to which they are entitled. After all, the new body is being invested with very wide powers indeed, as and when it decides to conduct an investigation. Investigators can enter premises—not people’s homes but hospitals, surgeries and so on—and from those premises conduct an inspection and take away documents. They can take away any document, relating to any patient, as the Bill stands. Having looked at such documents and obtained information from them, an investigator may require any person, including anyone who was a patient at the hospital or medical surgery that is the subject of the investigation, to answer questions or provide information or documents, with liability for non-compliance being a criminal offence.
Various exceptions are allowed to the obligation to answer. They include risk to the safety of any other patient, the privilege against self-incrimination—obviously —legal professional privilege and a rather complex contravention of data protected by legislation. But let us be realistic about this. HSSIB will be examining systems. It will have to examine them carefully: there is no point trying to examine a system in a superficial way. It will no doubt check for evidence in the documents which will certainly be—and, no less importantly, will certainly have been believed by the patients to have been—confidential. The documents may reveal, for example, that 27 patients in a surgery or hospital may have been failed by the system. So HSSIB may decide to question all 27 patients about what are essentially private matters.
As drafted, the Bill allows HSSIB to investigate and exercise all its powers over any such patient, whether the patient wishes to answer questions or not. I do not believe that any patient identified by the study of confidential documents relating to him or her should be obliged or forced to discuss his or her case or be at risk of criminal prosecution for choosing not to do so. Indeed, I do not think that any such patient identified through these processes should be obliged to take part in any investigation without his or her personal consent.
Without such consent, the Bill hands a remarkable set of powers to the investigating team. We must remember that there will be patients who do not wish to co-operate, who do not wish to discuss their condition or the circumstances in which they find themselves, having acquired a particular illness or disease, and who believed when they told their doctor or nurse about their condition that it was and would be private and confidential. Many of them will be deeply shocked by the idea that some stranger knew about it and, more importantly, was in a position to demand answers from him or her. I regard this as a totally unacceptable intrusion into what are essentially private matters, and I urge that consideration should be given to some patient consent provision. I regard such a provision as an imperative.
My Lords, first, I declare my interests as set out in the register and I thank my noble friend for introducing this important Bill. I sympathise with the predicament my noble friend finds herself in. Having been in her shoes, I know the amount of work that goes into preparing for a Bill, so it must be somewhat frustrating to think that we might not get to Committee before Parliament dissolves. However, as my noble friend pointed out, the matters under consideration in the Bill could not be more important and so it is vital that we relish this opportunity to talk about how we can make the NHS the safest it can be.
I also congratulate my noble friend on getting the Bill to Parliament with such strong cross-sectoral support. According to the briefings that I have seen, the GMC, NHS Providers, the NHS Confederation, the Royal College of Surgeons, the BMA, the Nursing and Midwifery Council and the Parliamentary and Health Service Ombudsman have all given their support, although of course with caveats. But I think that in these fractious political times, that is a cause for hope and, whoever is in charge after the election, I hope that they will bring the Bill back soon and that that consensus continues. I thank those organisations for their excellent briefings, along with the Library and the officials for their work, and of course Keith Conradi and his team at HSIB for the work they are already doing to keep us safer.
We are all reliant on the NHS to help us when we or our loved ones are sick, and much more often than not, we receive outstanding care, but accidents do happen. According to the figures in the Library note sourced from NHS Improvement, in 2017-18, there were 52,716 reported incidents of moderate harm and 5,526 incidents of severe harm, and 4,717 deaths were reported from safety-related incidents. I think we all accept that medicine, which is so intimately tied to trying to keep sick people alive, is a risky business and that accidents and harm will happen, whatever the intentions of clinical staff, but surely we would also agree that these figures are unacceptable. By comparison, in 2018, 500 people died in aeroplane accidents across the entire world.
My Lords, I am grateful for the opportunity to speak at this Second Reading. I declare my interests as set out in the register. I too am grateful for briefings from the Library, the Royal College of Nursing, the Royal College of Surgeons and the Parliamentary and Health Service Ombudsman.
Like most noble Lords, I welcome the Bill’s proposal to create an independent body which will investigate serious patient safety incidents. The NHS is to be congratulated on the way in which it has sought over the years to develop as a learning organisation. Florence Nightingale said:
“Let us never consider ourselves finished nurses ... We must be learning all of our lives”.
The Bill comes as part of the wider changes which we have seen undertaken over many years. I recognise those who work day by day in the NHS seeking to do their best and to provide safe, effective and compassionate care.
At the heart of my clinical practice when I was a nurse, a manager or even the Government’s Chief Nursing Officer, and latterly a non-executive director, was my desire to improve the quality of care that people receive. I believe that that is the intention of the majority of the people who work in our NHS, but things go wrong, and when they go wrong, it is often the result of a systems failure, at the root of which is culture. The 2013 Francis report into the Mid Staffordshire NHS Foundation Trust was mentioned by the Minister. It found that misaligned goals and behaviours in a plethora of agencies led to the tragic failure in patient safety. A system failed. It failed people and their families, and the report declared that regrettably it was a preventable tragedy.
The Francis report pointed to the need to develop a culture which was more open and transparent across the healthcare system. Professor Don Berwick, an international safety expert, called on us to embrace a culture of learning, particularly of learning from mistakes, but we have to recognise that when things go wrong, there is often a place deep within us where there is a tension between seeking to learn and wanting to apportion blame. So developing a culture in which we truly seek to learn must be a steel thread which runs through everything, including this legislation.
My Lords, my interest in this Bill was drawn by my concern to stop more avoidable deaths of sufferers of eating disorders—sufferers such as Averil Hart, who died aged 19 and whose death, and that of two other women sufferers, was investigated by the Parliamentary and Health Service Ombudsman. The title of the ombudsman’s 2017 report says it all: Ignoring the Alarms:How NHS Eating Disorder Services are Failing Patients. It concluded:
“Our investigation found that Averil’s tragic death would have been avoided if the NHS had cared for her appropriately”,
and it went on to make five recommendations for improvements in NHS eating disorder services.
Eighteen months later, in June this year, the Public Administration and Constitutional Affairs Committee in the House of Commons followed up on that PHSO report and concluded that insufficient progress had been made on delivering its recommendations. I echo the comments of the chairman of the PACAC, Sir Bernard Jenkin MP, who said that,
“if the tragic circumstances which lead to avoidable in-care deaths and other serious incidents are to be avoided in the future, lessons must be learned”.
Moreover, the PHSO acknowledges many examples in its casework where poor investigations or fear of blame have hampered efforts to understand what went wrong in a patient safety incident and what can be done to prevent similar failings happening again. Therefore, like others, I welcome this Bill, given that investigations by this new independent body that do not attribute blame but ensure a statutory “safe space” for NHS clinicians, patients and their families to speak freely will be a key part of enabling such learning.
My Lords, I too thank Jeremy Hunt for his contribution as Health Secretary and his interest in patient safety, and for driving the Bill to the position it is in now. In the Queen’s Speech debate on Tuesday 22 October, I drew attention to the title of the Bill:
“The humble Address refers to new laws to establish an independent body to investigate serious healthcare incidents”.—[Official Report, 22/10/19; col. 539.]
I pointed out that this was at odds with the title of the Bill, which deals solely with health service safety incidents and those carried out in the private sector on NHS patients. It does not apply to those receiving private treatment in the private sector, a point that has already been made by others.
The Joint Committee of MPs and Peers on the draft Bill made it clear that it should be amended to extend the HSSIB’s remit to the provision of all healthcare in England, however funded. It is therefore disappointing that this Bill fails to address the issue with the private sector. I gave the example of the Sellu case, where the evidence of a root-cause analysis of the surgeon’s work was not disclosed at the trial. Today I make reference to another case, that of Ian Paterson, a surgeon who was sentenced to 15 years in prison for undertaking needless breast surgery in the private sector. After his conviction, the Royal College of Surgeons called for a review of safety standards in the private sector. Both cases indicate why the scope of the Bill needs to be widened to include the private sector. The apparent exclusion of private healthcare providers and organisations, save for those that are treating NHS patients and providing service and equipment to the NHS, would appear to limit the potential scope and effectiveness of the HSSIB.
In the Queen’s Speech I declared my interest as chairman of the Confidential Reporting System in Surgery, CORESS, which serves to support surgeons in providing confidential reports of near misses and adverse incidents in surgical practice, with the aim of disseminating the learning from these incidents to inform the surgical community and prevent further occurrences. One of the committee members, Peter Tait, previously director of flight operations for British Aerospace’s commercial section and latterly the CEO of CHIRP, the confidential human factors incident reporting programme, worked closely with the chief inspectors of the Air Accidents Investigation Branch for 20 years. He described the aviation equivalent of the current scope of the HSSIB Bill as restricting the AAIB to investigating air transport operations and their service provision but excluding aircraft, engine and equipment manufacturers, air traffic services and airport providers directly or indirectly involved in the survey safety of the air transport system. It is a whole-system effect that needs to be looked at, not just one area.
4:54 pm
20 of 51 shown
Other examples of investigations at the investigations branch have followed reference events to establish the safety risks associated with patients with special needs and to reduce the risk of prisoners with long-term, chronic conditions being moved without crucial medication. All these investigations have found system-wide solutions to system-wide problems, making this unique in the patient safety investigation system. An investigation into these cases by a local NHS trust would have been unlikely to have had the investigative ability or reach to determine what happened outside of the trust. Therefore, it is easy to see how similar incidents could happen again to other patients elsewhere in England if only local investigations had been carried out.
However, the current investigation branch is an organisational arm of the NHS Trust Development Authority, which is part of NHS Improvement. It was an important first step, but the story must not end there. It lacks independence and the necessary powers to make its investigations fully effective. The Health Service Safety Investigations Bill addresses these issues in four ways.
First, it establishes a new independent arm’s-length body, otherwise known as the health service safety investigations body—a snappy name. This body will continue the national thematic investigations work of the current investigations branch, focusing on a small number of significant patient safety issues where there is the greatest opportunity for learning across the NHS. This will be the first independent healthcare body of its kind in the world, leading the way in investigating for the purpose of learning, not blaming. The independence of the new body’s investigations from the NHS and government will give the public full confidence in its investigation processes and its ability to deliver impartial conclusions and recommendations.
Secondly, the Bill will establish safe space protections, prohibiting the disclosure of information held in connection with an investigation, apart from in tightly limited circumstances, as set out in the legislation. The safe space information includes documents, equipment or other items, and is referred to as “protected material” in the Bill. The safe space provisions encourage all participants, such as NHS staff, to be completely candid in the information that they share. This will enable more thorough investigations and the development of meaningful recommendations.
Thirdly, the Bill provides for appropriate powers, so that the new body can discharge its investigative function. These include powers of entry and inspection, powers to inspect, copy or seize documents and equipment, and powers to require information from individuals or organisations, including national public bodies.
Finally, the Bill makes an amendment to the Coroners and Justice Act 2009, to provide a statutory footing for the medical examiners system in the NHS in England. This will underpin the system that is already being rolled out successfully across the country. Medical examiners will ensure that every death in England and Wales is scrutinised, either by a coroner or a medical examiner, to strengthen safeguards for the public. It will provide support to doctors by being able to provide expert advice, in turn improving the quality of the death certification process. It will also be able to provide a service for anyone who has just lost a loved one, by increasing transparency, by offering an opportunity to raise concerns, and ultimately, by avoiding unnecessary distress for the bereaved.
Overall, the medical examiner system is a key element of the NHS safety system and will ensure that any clinical issues and learning are quickly identified to improve patient safety. I take this opportunity to thank the noble Lord, Lord Hunt of Kings Heath, for his continued support over the years in implementing the medical examiner system, and of course the noble Lord, Lord Patel, for his ongoing work on patient safety and leadership in this area.
In preparation for this Bill, a Joint Committee of both Houses was appointed to conduct pre-legislative scrutiny of the Government’s draft Bill. I am grateful to the Members of this House who participated in that committee and gave the Bill such careful and thoughtful consideration. They were the noble Baroness, Lady Billingham, my noble friends Lady Chisholm and Lady Eaton, the noble Lords, Lord Elder and Lord Kirkwood of Kirkhope, and the noble Baroness, Lady Watkins. Their expertise was greatly valued by the Government. The committee made a number of recommendations and I am pleased that they were able to accept the majority. It was clear that the new body should not be able to accredit safe space investigations at a local trust level, as it was felt that this would confuse the new body’s role and make it part of a system that it is investigating. The Government have listened to this concern and removed this provision from the Bill. We consider that there are other ways to improve local investigating capability, including the provisions in the Bill for the new body to provide training and guidance.
The Government have also listened to the committee’s recommendation that the maternity investigation programme for local investigations, undertaken by the investigation branch, should not be part of the new body’s remit. We want to ensure that HSSIB focuses only on a small number of thorough, national and thematic investigations, conducted using a safe space approach to ensure the greatest opportunity for learning in the NHS. It is important to note that it will be possible under the Bill for the new body still to carry out national and thematic investigations into maternity; in fact, the current branch has conducted two national investigations relating to maternity care, which are separate from the local maternity investigations programme. I reassure the House that we will also allow the current investigations branch to continue to run the local maternity investigations programme for a period, so that it gets the maximum learning for the NHS.
A lot of recommendations were taken on board to strengthen safe space and we have defined more carefully when exemptions would apply. One recommendation which was not implemented was that the Government should make it clear that the prohibition on disclosure of safe space material applies to coroners and to the Parliamentary and Health Service Ombudsman. In response to this, the Government had extensive discussions with the Ministry of Justice, while also speaking with the Lord Chancellor and the Chief Coroner. After careful consideration, we concluded that the safe space should not interfere with the coroners’ ability to carry out their statutory functions. The Bill now provides that a coroner may request disclosure of safe space material from HSSIB, but only if it relates to a matter that is relevant to an inquest or an investigation. However, crucially, the Bill also provides that a coroner may not disclose such information in an inquest or otherwise to another person unless the coroner has obtained an order of the High Court. This ensures that participants in an HSSIB investigation still see it as a safe space. We consider that this is the most appropriate way for safe space provisions under the Bill to work alongside the powers of coroners, as set out in the Coroners and Justice Act 2009.
The Government have also decided not to accept the committee’s recommendation to extend HSSIB investigations to independently funded healthcare. We are sympathetic to this recommendation but do not want to pre-empt the findings of the Paterson inquiry, which is expected to report shortly. The Government have committed to review this recommendation once the report is published. I am sure that we will have some debate as this goes through the House.
Finally, the Joint Committee considered whether the new body’s remit should be extended to the devolved territories in Wales, Scotland and Northern Ireland and how it would be devolved across cross-border healthcare pathways. After extensive discussion with the devolved Administrations, the Government concluded that the remit of the new body will not be extended to cover the devolved nations. We want to enable co-operation between the new body and the devolved Administrations where investigations involve cross-border care pathways. We believe that the best way to achieve this is through memoranda of understanding rather than through legislation. I am sure that that point will also be ably tested as the Bill goes through the House.
Overall, the Joint Committee, the CQC, the BMA, NHS Providers and patient representatives have all welcomed the draft Bill. They have looked forward to the introduction of this legislation as soon as possible, stating that they believe HSSIB in its new form will play a vital role in improving patient safety and learning across the NHS.
Having set out the general purpose of this Bill and its broad terms, my priority today is to hear the expertise of the House, so that we can begin the robust process, as ever, of scrutinising and strengthening the Bill. I want to listen as carefully as possible and will seek to engage as fully as possible with all groups across the House, whether by party or by individual, to ensure that we deliver the HSSIB on the best possible statutory footing, so that it can deliver for patients and the NHS in a world-leading way. On that basis, I beg to move.
There are a number of issues. We have the benefit of the organisation having been in shadow form for some time, so we can see the quality of the reports it has already produced. We have also had pre-legislative scrutiny, which has been very helpful in identifying some of the key issues. As the Minister said, the first issue is: what areas should the Bill cover? At the moment, it covers NHS patients, who can be treated in the private sector, but there is a restriction on private health services where patients are not NHS patients. The noble Baroness says that the Government want to await the Ian Paterson report, and I can see why, but I think it would be perfectly possible to provide in the Bill for the right of the Secretary of State, by order, to extend the provisions to the private sector in the light of the Paterson report. This may well be the only stage of the Bill we will take, and we may have another Bill fairly soon, so there might be time to reflect on that. I think it is very odd that the Bill as it is being brought at the moment does not encompass private healthcare. I think it should.
I am very supportive of the safe space concept, particularly as Clause 2(2) makes it clear that the purpose of the HSSIB is to focus on system issues and not to determine individual blame. It is clear though, from the briefs we have received the last few days, that many organisations do not agree with that. I have had briefs from the ombudsman, from the Association of Personal Injury Lawyers, from the Campaign for Freedom of Information and from the News Media Association on behalf of media outlets. All have sent submissions arguing that the restrictions on access to information held by the board are too strong and ought to be modified. Obviously, we will test this in Committee, but I think there is a clear tension between an approach that looks at systems safety, which tries to learn from errors and mistakes to say how we can put this right by a redesign of equipment or practice, and the absolute right of individuals to pursue cases against the health service and the right of regulators to regulate professionals appropriately.
Clearly, the Bill seeks to get the balance right. Clause 15 enables the Chief Investigator to disclose protected information,
“to address a serious and continuing risk”,
to safety. Clause 17 allows for a person to go to the High Court for an order of disclosure. In my view, that is the right balance: the safe space concept is set out in legislation, but there are circumstances where information can be disclosed. Where I question it, I must say, is in relation to Clause 19, which makes specific provision for a senior coroner to require disclosure. The noble Baroness has given some explanation of that. My understanding is that there are 95 coroners’ areas in England and Wales, employing 87 senior coroners. That seems rather a lot of people to be given special provision. Again, I think that in Committee we need to test whether coroners should be given this special provision. I remain dubious at this stage.
On maternity investigations, the Joint Select Committee was concerned that the board was being given a different remit in relation to these local investigations. The noble Baroness says that the Government need more time to consider what is to be done with those investigations, but I hope that during the passage of this legislation—however long that takes—there will be some kind of conclusion. Given that we are asking the board to do a specific job in relation to system safety, I wonder whether this is the right place for local investigations into maternity services.
The fundamental question of course is: what happens as a result of the work of the board? One of the NPSA’s problems was that it produced lots of reports, but nobody in the system actually took responsibility for implementing them. Here, there is clearly a mechanism whereby the board sends its reports to relevant organisations, and the Bill also makes provision for those organisations to respond to the board. I think that is a very useful suggestion, as is the requirement for a review of the board to be undertaken after four years’ work. I welcome that. However, we have heard it said that the board might produce up to 30 reports a year. Looking at the first two or three—on piped air, oxygen and mental health in emergency departments—the responses from the organisations that received them were very positive. However, in the report on electronic prescribing, the recommendations are extensive. They would be costly in money, human resources and managerial effort. I begin to worry that if over, say, four years it really produced 30 reports a year, which would be 120 overall, the risk is that they would tend to lie on the shelf. It would be a tick-box exercise, and the impact would be far less. I wonder whether the board ought to be less ambitious in the number of reports it produces, in order to get a bigger impact.
However, the fundamental question I put to the Minister is this: whose feet will be held to the fire if the board produces a report and it is clear after two or three years, when new safety incidents have emerged, that the health service has not actually responded? It is not at all clear to me who has responsibility for making sure that these reports have bite. In the airline industry, where this has come from, the experience is that when safety reports such as these are produced, they are acted upon. The big risk here is that, knowing the health service as we do, the number and range of adverse incidents is so wide that in the end the reports will become simply good practice guidance which people can take or leave. In the end, at heart this is the most fundamental question.
I will talk briefly about governance issues. I note that there are non-execs to be appointed, and I strongly urge the Government to make sure that NHS commissioners are appointed as non-execs to the board. We know that a lot of the expertise on this board has come from other sectors, and it is vital that there are people around the top table who understand the NHS. The best way to do this might be to appoint top clinicians to the board as non-executives. Secondly, the provision in Schedule 1 is for the Secretary of State to approve the appointment of the Chief Investigator, which is made by the board itself. I do not understand why the Secretary of State has to give his or her consent. This is not normal in the way that we generally do public bodies; I fully understand that the Secretary of State appoints the non-executives, but it should then be just for the non-executives to appoint the Chief Investigator.
Finally, the Joint Select Committee suggested that, because of the importance of these roles, both the chair and the Chief Investigator ought to be subject to pre-appointment scrutiny by the Health Select Committee. That is an excellent suggestion. Have the Government given this further consideration? When they responded to the Joint Select Committee, they said that they would discuss it with the chair of the Health Select Committee. It would be very good to know the outcome of those discussions.
Overall, this Bill is enormously welcome. I wish the board very good luck in the future, but I also look forward to some of the scrutiny that needs to take place.
Currently, the duty of candour means that staff must express concerns when they believe there is an unsafe situation. However, the RCN tells us that half of those who do so are not convinced that any action has been taken. As the noble Lord, Lord Hunt, said, it will be a challenge to the new body to ensure that those who give evidence in the new safe space see that effective safety improvements are put in place as a result of their co-operation. It is also important that those who give evidence are not inadvertently put at risk by doing so. That means that the exemptions to disclosing information to other bodies must be narrow, clearly defined and well understood. I think my noble friend Lady Parminter will say something about the Parliamentary and Health Service Ombudsman, which feels that it should be treated the same as coroners. There must also be clearly understood definitions of what serious professional misconduct means.
Therefore, to fulfil the ambitions for the HSSIB, investigations must look at the whole picture, not just at the individuals involved in any incident. They must consider whether the shift at the time of the incident contained an appropriate number of staff for safe working, with the correct skill mix, training and experience for the situation they find themselves in. For example, we know that there are currently 40,000 nursing vacancies, and half of nurses in a recent RCN poll reported that their last shift was understaffed. Brexit has and will make things worse.
The investigations should also consider local and national policy and report on how they impacted the incident, and should be able to make recommendations to the Secretary of State about the need for structural changes indicated by the investigation. That is why it is so important that the organisation is independent. How do the Government plan to ensure that the recruitment of the board is really independent of government and includes lay members as well as medical professionals? Again, I agree with the noble Lord, Lord Hunt of Kings Heath, about the appointment of the chief investigator and the involvement of the Secretary of State.
It is arguable that all patients, however funded, should be able to benefit from the work of the HSSIB. Are there plans to extend its remit, after a period, to all health services, including those provided by independent providers? Indeed, the BMA has already suggested that its remit should be extended to incidents that affect the safety of healthcare workers as well as patients. In Committee there will be discussions about the potential expansion of the remit. Can the Minister clarify the relationship with other bodies with responsibility for quality and safety in health and care such as the CQC and the various regulators? Also, there are already various pathways that staff can take to express concerns, so there needs to be clear guidance as to which path to take in each situation.
Resources for up to 30 investigations per year are being provided. How has this number been arrived at? What if a serious qualifying incident happens just after the annual budget has run out? Will the HSSIB have to publish the number of incidents referred to it alongside the number conducted, to determine whether further resources are needed in the future?
How will decisions on the criteria for investigations be made? The groups consulted should be as wide as possible, including patient groups as well as healthcare professionals and managers. The Secretary of State seems to have a slightly suspiciously large role in an organisation that is supposed to be independent.
As I said, I welcome the safe space approach, but it is important that staff feel supported when they disclose what happened, especially if their view with hindsight is slightly different from what they might have said at the time. The primary objective of learning from mistakes will be achieved only through full disclosure to the investigators, and that will come only from confidence in the system.
We welcome the plan to put the new medical examiners on a statutory footing. It is important that bereaved families are helped to understand what happened and, if there is any doubt about the cause of death, that further investigations are put in place. Of course, we need the right sort of people for this with the right sort of training. It is essential that the service is properly resourced, particularly if it requires input from staff who are already stretched in their ability to provide good-quality and timely care to patients. Will the Minister say something about the staffing model for medical examiners? If they are to examine all deaths apart from those that go to coroners, there will be times of the year when they are very busy indeed, such as the winter months or in a heatwave. This is the same time when all clinicians are very busy, so if the MEs are clinicians employed elsewhere, doing shifts as medical examiners as well as their other jobs, they may need to be in two places at once at some times of year. How will the staffing model be designed to be resilient in that situation?
In summary, one could hardly be against a plan to develop more of a learning culture in the NHS and enhance patient safety, but there are questions to be answered and reassurances to be given, and I hope that the Minister will be able to do that.
My second concern touches on the same issue. The Bill provides for the protection of the privacy of those whose medical history is, or has become, known in this way during the course of an investigation. Of course, that protection would extend to every individual, including the ones I am concerned about, who had given their consent. So an offence of disclosure is created. Quite right—but the problem is that this should be not merely a criminal offence, punishable with a fine; a more serious punishment should be available.
There may be a case where the criminal offence involves one disclosure about one patient that falls within the ambit of the offence. Obviously, for such a case, a fine might well be an appropriate penalty. However, there may also be cases where the disclosure that is the subject of the now criminal investigation covered a number of patients—say, 15 of the 27 patients to whom I referred in my earlier example—and was perhaps offered in exchange for the payment of money. There could be rather more than a single moment of disclosure. In such a case, where somebody received, offered or accepted money and the disclosure affected more than one person, for the person paying the money or accepting it, I respectfully suggest that, in serious circumstances, this should be an offence triable on indictment with a penalty of, say, two years’ imprisonment on conviction and six months’ imprisonment on summary conviction.
Beyond all this—looking at how this would look to the ordinary citizen whose medical history has been disclosed in the circumstances that we are considering—the availability of such a sentence would seem much more effective as a deterrent if there were the possibility of a prison sentence. I suggest that it would enhance the chances of wider patient co-operation by the very people whose consent is being sought—assuming that my submission to the House about the necessity for consent is accepted. It would thus enable the HSSIB better to fulfil its responsibilities, it would increase confidence in the way it was required to exercise those responsibilities, and what we have called the safe space would be that much safer.
So, in brief, nothing will be done in the next few days, but I respectfully suggest that the Bill is deficient in two respects, both of which should be remedied in the interests of patients.
The Healthcare Safety Investigation Branch was set up consciously to mirror the Air Accidents Investigation Branch and to achieve the kinds of gains in safety that the airline industry has seen. Given that, we must be humble enough to admit that we have much to learn from others. At this point, I pay tribute to my right honourable friend Jeremy Hunt, the former Secretary of State, who made patient safety his guiding star and who had the humility and the courage to say, “This is not good enough”. It is because of his leadership that we are here today and because of the astonishing bravery of those patients and their families who have campaigned tirelessly for a safer NHS.
I strongly support the Bill both because I think that the HSIB is the right institution to help improve patient safety and because this is a topic which cannot get enough attention. It will seem incredible to people living in the future that as a country we were happy to let nearly 5,000 people a year die from accidents in the NHS. It is akin to smoking; we used to accept it as a normal activity—a part of life and an inevitable cause of death—until collectively we made a decision to say no, that it was not acceptable and that together we must act. The Bill should be a rallying cry for a similar level of concerted action. One patient safety incident causing harm, let alone death, is one too many. It is time to change our culture and change our expectations: enough is enough.
Those are easy words to say, but they are hard to implement. We have had and continue to have scandals too numerous to mention and learned reports on those scandals. Things change a little for a while, but the fundamental cultural change, the shift from blame and denial to learning and responsibility, has not yet happened. That is why the HSSIB and the Bill are so vital. They can bring about a different safety culture, one that has proved so successful in other industries, to the NHS.
That is not to say that the Bill is perfect. There are a number of areas of concern where I would like greater clarity, although I accept that given the likelihood of a general election, those discussions may be for another day. The first area concerns Clauses 13 to 21, which govern the circumstances under which the “safe space” can be violated, as already highlighted by the noble Lord, Lord Hunt of Kings Heath, and the noble Baroness, Lady Walmsley. Clearly, there is disagreement among stakeholders as to what is the right balance. The PHSO wants more disclosure, while the BMA wants less. I understand the need for overrides in certain circumstances and I am sure that when we reach Committee stage, we will examine the merits of each potential case, but my concern is about the overall effect on patients and clinicians. We need them to trust the system. As the noble and learned Lord, Lord Judge, has said, without that trust, the system does not work. People need to be comfortable with being honest and transparent when engaging with it. However well justified such invasions of safe space may be, there is a risk that they may undermine trust.
Has my noble friend’s department considered the collective behavioural impacts of these exemptions, and whether they might, not individually but together, undermine the core concept at the heart of the Bill? How do these exemptions compare with those in the regimes in air, maritime and so forth that have proved so effective? A table of comparisons would be helpful for us to consider whether the right balance has been struck.
Regarding the powers of HSSIB as set out in Clauses 5 to 12, again, given how important the experience of other safety investigation boards has been in the design of this one for health, it would be useful to see a comparison with those other boards to understand whether HSSIB has the tools it needs to do the job that we expect of it.
As the noble Lord, Lord Hunt of Kings Heath, has already pointed out, one obvious area where HSSIB does not have the full extent of its potential powers is in regard to the independent sector, as set out in Clause 2. My noble friend has already explained why that is the case—the pending Paterson inquiry—but I simply cannot understand why independent health services are not in scope. The trade body representing independent providers has asked for them to be covered by HSSIB, as have the RCS and the BMA. There is a big crossover of staff between the two sectors, many of whom work in both on a regular basis, and some of the most egregious medical scandals—breast implants, vaginal mesh—have been at their worst in the independent sector. Added to that, data collected in the independent sector may be crucial to an investigation into NHS services. If or when we ever get to Committee, I am sure that this will be a major area of focus for all of us to try to make sure that the Bill reaches its potential.
I would be grateful if my noble friend could give some clarity about the scope of HSSIB’s investigations. Will, for example, the systematic misuse of medicines and medical devices be included? I am thinking, in particular, of the topics under consideration by my noble friend Lady Cumberlege’s review.
Despite us knowing all about the dreadful dangers of exposure to sodium valproate in pregnancy, around 300 babies are born disabled each year because of inadequate care that contravenes all existing clinical guidelines. It seems unconscionable to me that such practice should not fall within scope for HSSIB, and I hope that my noble friend can reassure me that it does.
As my noble friend pointed out, there has been a change in the position in the Bill in regard to the 1,000 maternity investigations that are currently carried out each year. Initially, the Government resisted the Joint Committee’s proposal to remove them from HSSIB; but they have now done so, although, as my noble friend set out, at a systemic level they can fall within the scope of HSSIB if it wants to look at them.
My noble friend Lady Cumberlege is sorry that she cannot be here today, but noble Lords will know how much of her life has been devoted to improving maternity outcomes and reducing harms. Each year, more than 1,000 babies die or are left with severe brain injury because something goes wrong during labour. These devastating incidents represent the single largest litigation cost to the NHS. We need to improve and we need to learn in order to do so. We need a system for investigating such incidents rapidly, both for the sake of the families involved and so that we can identify lessons. The question should not be, “Who is to blame?”, but rather, “Was this avoidable?”. In Committee, we can consider where the right place for such investigations should be, but can my noble friend reassure the House that, wherever they take place, the right questions and principles will underpin the way that investigations are conducted?
With regard to the powers, like the noble Lord, Lord Hunt, I am worried about the real-world impact that HSSIB will have. I have no doubt that it will carry out, as it already does, superb investigations that deliver real insights and suggestions for how to change practice for the better. But what obligations is the rest of the system under to adopt the recommendations? Clause 28 talks about a duty on HSSIB to provide assistance. The noble Lord, Lord Hunt, has already set out some of the responsibilities on health providers to consider HSSIB’s recommendations. That is welcome, but it is only one side of the exchange. Surely, the rest of the NHS should have a duty to implement the recommendations, or how can we be sure that there will be any change at all?
I will end with a brief word on medical examiners. I had responsibility for this policy as a Minister and was proud to have brought about their implementation after such a long period post the Shipman scandal. I want to register my delight in seeing medical examiners put on a statutory basis and the NHS under an obligation to fully fund them. That is wonderful progress, on which I congratulate my noble friend. I hope that it is an augur of good things to come.
The stated intention of this legislation is to bring about a whole-system change to how the NHS investigates and learns from healthcare error. However, as the noble Lord, Lord Hunt, said, there is concern that the current drafting fails to do that and that there seems to be a disproportionate focus on the individual person or people involved in the incident. This could be overcome by any process of investigation, starting with reviewing the wide range of the system context, the factors and the conditions in which an incident occurred, well before any discussions with individuals involved take place.
Furthermore, to bring about a whole-system change means having a collective understanding of dangerous activity across the board, with NHS and non-NHS patients. I join the noble Lords, Lord Hunt and Lord O’Shaughnessy, in saying that we ought to consider powers to investigate non-NHS patient issues in the independent sector. We should do this for the benefit of not just NHS patients but the non-NHS patients in our care.
I also welcome that the HSSIB must review the criteria, principles and processes of the investigation procedure within three years of their publication and subsequently within each five-year period, but I wonder whether the criteria, principles and processes ought to be co-produced with clinical and non-clinical health service leaders. I also wonder whether they should be reviewed in consultation with not just healthcare professionals but families and patients.
The opposite of a learning culture is a culture of fear. Again, I refer to Florence Nightingale, who said:
“How very little can be done under the spirit of fear”.
Therefore, I welcome the proposals for the development of safe spaces. The present draft of the Bill, I believe, has resolved some of the concerns of the nursing profession, particularly around the concept of safe spaces, but they will be safe only if the new organisation is able to build trust, as already mentioned. Trust is built only in part by legislation; it will need to be built by those recruited, as part of the HSSIB, to implement legislation. Therefore, I hope that the Minister can reassure the House that everything is being done to ensure that people of the right character are recruited to this new body.
I know that some have asked that the prohibition on the HSSIB disclosing information held within safe spaces to the Parliamentary and Health Service Ombudsman be removed. I would be very unhappy with that. Removing this prohibition will do little to create a culture where people working in the NHS feel safe to speak up when things go wrong. However, I think that further work is required to clarify how the HSSIB relates to and co-operates with the Parliamentary and Health Service Ombudsman and with other national bodies, such as the Care Quality Commission, which hold power and responsibility for reporting on patient safety incidents and the causal factors that impact patient care.
Finally, I know that the relationship between staffing levels and patient outcomes is contested, but it strikes me that an independent body such as the HSSIB may be best placed to begin to shed light on this. I hope that the Minister will ask the new body to consider this as part of its focus.
I support many of the intentions set out in the Bill and I look forward to working with other noble Lords as it progresses through the House. I thank officials and the Minister for bringing this Bill forward for our scrutiny.
I have three issues to raise with the Minister, some aspects of which have been touched upon by other colleagues around the House. First, while helping the NHS to learn lessons is critical, so is supporting the patients and families involved, giving them confidence in the investigation process and thus the recommendations. That way, hopefully, they can move on with their lives or feel that something positive has come from the death of a loved one. Public confidence in the membership of the board is therefore key. As it stands—as the noble Lord, Lord Hunt of Kings Heath, has said—the Secretary of State appoints the chair and at least four other non-executive members of the body. I have the highest regard for the medical profession, and looking around this room I see many experts, but I would be concerned if all the members were from the medical profession or, indeed, were associated too closely with the party in power; let us not forget that this body has the power to make recommendations for the Secretary of State to implement. I therefore add my voice to those of the noble Lord, Lord Hunt of Kings Heath, and my noble friend Lady Walmsley, who asked what plans the Government have to achieve an appropriate level of independence for the body so that it can instil the highest public confidence.
The second issue is ensuring that lasting change happens. As we know, the HSSIB has the power to make recommendations for future action after an investigation, and addressees of the report must, by the deadline given, provide a written response setting out the action they will take in relation to the recommendations. That is welcome but, given the failure to implement recommendations in the PHSO report that I mentioned on eating disorder services, I worry. My understanding is that NHSE and NHS Improvement will be charged with monitoring the follow-up; I would be grateful if the Minister could confirm that in her concluding remarks. However, it would also be helpful if the HSSIB had the power to insist on follow-up reports on the actions and outcomes, to ensure that meaningful and lasting improvements to patient safety will be made.
The final issue concerns the relationship of the new body to other bodies which not only focus on the causes of incidents but provide accountability for individual incidents and, if necessary, apportion blame. This issue has been touched on by the noble Lords, Lord Hunt and Lord O’Shaughnessy, and the right reverend Prelate the Bishop of London, although I think we will all come to different conclusions.
I have talked about the valuable work of the PHSO, which was set up by Parliament to provide an independent service to handle complaints about the NHS in England, UK government departments and other UK public organisations. It is the final stage for complaints that have not been resolved through the organisation’s own complaints procedures. In the case of Averil Hart, Averil’s father Nic Hart went to the PHSO after making complaints to six organisations: four separate NHS organisations which had provided care and treatment for Averil, as well as a local clinical commissioning group and NHS England. The PHSO is the last resort for the public, yet, as the Bill stands, it cannot have access to information held in a safe space by HSSIB to carry out its own investigations into the complaints that it receives. This could lead to the ombudsman making incomplete or incorrect recommendations for either individual or systemic remedy.
I accept the value of the HSSIB carrying out investigations in a safe space to promote a culture of speaking up and learning from mistakes, but this cannot be the only aim when looking at why incidents in the NHS went wrong. If the PHSO cannot provide assurance that it is able to investigate all the relevant evidence, this could deny patients or families closure and reduce public confidence in the findings of the organisation. The PHSO has a statutory obligation to investigate in private and is protected from disclosure under the Freedom of Information Act, so there is strong assurance that any information given would not enter the public domain. Further, given the parallels between its work and that of coroners—who have been given exemption from restrictions on receiving information from this new body—and in the absence of compelling reasons from the Minister, I would support an amendment to this Bill to provide the PHSO with access to HSSIB information. We need both bodies to be able to do their jobs properly—yes, to deliver change in the NHS but also to give confidence to patients and families that the suffering and loss that they and their loved ones went through will not keep being repeated.
I believe that by limiting the Bill to the NHS we are ignoring the lessons learned by the AAIB and others in dealing with rail and marine accidents. The Royal College of Surgeons has similarly expressed concern about the narrowness of the scope of the Bill and believes that the Bill should give the HSSIB the power to investigate non-NHS patient safety issues in the independent sector, as recommended by the Joint Committee. It is not enough to limit the remit of the HSSIB to those who provide NHS services to the private sector.
In its response to the Ian Paterson case that I mentioned earlier, the Royal College of Surgeons published recommendations for assessing standards in the independent sector, including the need for equivalent reporting requirements for independent and NHS hospitals in terms of safety and outcome data. Thus, by extending the remit of the HSSIB to the non-NHS-funded independent sector, errors or potentially dangerous activity identified in the private sector could be addressed, to the benefit of the NHS and non-NHS patients. This is all the more important as the majority of surgeons work both in the NHS and in the private sector. The Joint Committee enforced this point when it asked for the draft Bill to be amended to extend HSSIB’s remit to cover the provision of all healthcare in England, however it is funded. This is likely to require consequential amendments to other parts of the Bill, as well as to the title, and I look forward to introducing these in Committee.
The Royal College of Surgeons is also keen to widen the scope of the Bill to include the regulation of surgical care practitioners in the UK. These practitioners increasingly support routine care of surgical patients under the supervision of senior surgeons and provide continuity of care while surgeons focus on more complex and advanced patient care. The Government believe that surgical care practitioners should be regulated by the Nursing and Midwifery Council. As more surgical care practitioners enter the profession directly, rather than through roles such as nursing, it is appropriate for regulatory oversight to be introduced. Failure to do so may pose an increased risk to patient safety.
The safe space proposals have been modelled on approaches used for many years by the air accident and transport safety investigation bodies, which have contributed to safety in these industries. However, the provision in Part 2(3)(19), on disclosure to coroners, differs from the UK regulation relating to disclosure for the AAIB. The International Civil Aviation Organization sets out regulations relating to disclosure in Annex 19:
“The State conducting the investigation of an accident or incident shall not make the following records available for purposes other than accident or incident investigation, unless the appropriate authority for the administration of justice in that State determines that their disclosure outweighs the adverse domestic and international impact such action may have on that or any future investigations”.
All of this was highly pertinent to the Shoreham air display accident, which noble Lords may recall, as a full statement was given to the Air Accidents Investigation Branch and the judge refused to give the police access to this evidence. It is important that a public interest case should be made by a High Court judge in order to release information, and this approach should be applied similarly to HSSIB.
I am advised that when applications for disclosure have been made in the case of the AAIB, only one successful application for the release of cockpit voice recording data, fitted to a privately owned aircraft, has been granted to the estate of the deceased pilot. The High Court judge ruled that the disclosure would not set a precedent for the release of information related to public transport systems and their investigation. Any exceptions to the safe space protection to accommodate coroners will be problematic and the same standards should apply across the board, whether to the AAIB, the Marine Accident Investigation Branch or HSSIB. Otherwise, HSSIB will not hold the same powers or protections and coroners will be able to draw on their access to individual statements to determine how they question witnesses during inquests. Thus, information taken in confidence by HSSIB could be indirectly made public. I am reassured by what my noble friend the Minister said earlier in this respect, but we may need to tease this out in Committee, as the noble Lord, Lord Hunt of Kings Heath, observed.
Safe spaces do not prevent coroners accessing information if they have justification for it and can do so through the High Court. Healthcare staff need to be confident that HSSIB can protect their information in line with the original safe space proposals. Fear of legal, regulatory or managerial sanctions against clinicians is high and recent high-profile court cases such as Sellu and Bawa-Garba do little to reassure the profession. HSSIB must be allowed to enjoy the confidence of the profession, otherwise its work will be seriously compromised.