Baroness Blackwood of North Oxford

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That the Bill be read a second time.

The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Blackwood of North Oxford) (Con)

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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.

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 arms-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.

Baroness Blackwood of North Oxford

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My Lords, I welcome the almost unanimous support for the Bill. As ever, I am indebted to your Lordships’ House for an informed and robust debate on the measures in the Bill, and I pay tribute to everybody who has contributed today. I want to take a moment to thank my right honourable friend Jeremy Hunt for his international leadership on patient safety in recent years. I also reiterate my thanks to the Joint Committee for its thorough pre-legislative scrutiny process, which has clearly been of great benefit to the Bill and has shaped our debate today. As we can see, it has created some important changes in the Bill.

I want to take a moment to reflect on why the Bill is so important. The new Health Service Safety Investigations Body will have the powers and the independence to conduct thematic investigations into patient safety incidents that occur in the NHS, in particular not to apportion blame but to spread systematic learning and establish the trust of NHS staff, patients and the public. Until now, we have not had that on a statutory basis. The noble Baroness, Lady Finlay, and the right reverend Prelate the Bishop of London rightly said that the opposite of a learning culture is a culture of fear. With that culture of fear, we cannot make the improvements in patient safety that we need. In my view and in the view of the Government, the establishment of a safe space system—which previously has been seen only in respect of transport accident investigation bodies—is a big step forward in ensuring that the NHS can go forward and learn from its mistakes, particularly by addressing the concern that, at the moment, NHS workers do not feel that they can speak out when mistakes occur. This new body will play an important role in improving patient safety and creating that vital culture of trust and learning, which will be able to prevent serious patient incidents happening across the NHS. I believe that we have the support of the whole House in achieving that.

As ever, a wide range of issues were raised in the debate, so I will do my best to respond to them as much as I can, but I will write to noble Lords where I am not able to do so. One of the primary issues of concern was the effectiveness of the body. The best place to look for the answer to that involves looking at how well HSIB has already been performing in its pilot form within NHSI over the past year and a half. HSIB’s internal management and staff survey found that the current investigation branch was very positively received. There was an engagement rate of 91%, and 80% of staff said that they are proud to work for the organisation and want to be there in two years’ time. The responses are well above the scores of other NHS organisations, and it shows that there is more to be done and that it is progressing well.

In addition, we can measure the impact of HSIB as an organisation outside. The current investigation branch’s approach puts patients and families at the centre of its work, and I can quote from the feedback it has received. People say that they found that the “process was so supportive” in the way that it was approached and that it was,

“a great feeling that you’ve got a voice which is entirely down to the approach”,

of the current investigation branch. Another very touching response said that, “Just knowing that my mum’s death may not be in vain and may prevent similar instances from happening to other families is the best legacy that I can think of in memory of my wonderful mum. That is what she would have wanted”. That is what the HSIB has already achieved, and by putting it on a statutory footing we can ensure that it can do more and that it can do more effectively.

I want to move on to the important issue of the safe space, which was raised by a number of noble Lords, including the noble Lords, Lord Hunt of Kings Heath and Lord Turnberg, the noble Baronesses, Lady Walmsley, Lady Parminter, Lady Jolly and Lady Thornton, and my noble friends Lord O’Shaughnessy and Lady Eaton. I can do no better than to quote, as did my noble friend Lord Hunt of Wirral, from the report of the Joint Committee on the Bill:

“the primary and overriding purpose of this Bill is to put in place arrangements that will lead to learning and improvement arising from objective and comprehensive analysis of the causes of clinical mistakes and incidents, leading to better and safer outcomes for users of the healthcare system. We do not think this second principle is incompatible with obtaining justice in individual cases, which may and should be pursued by other means”.

The safe space is central to that, but it does not prevent patients and families pursuing other routes of investigation via the CQC or via the criminal courts. It is very important to understand that.

As the noble Lord, Lord Hunt of Kings Heath, said, we have to strike a balance with the safe space by including an exemption for coroners. Coroners are judicial officeholders and have an important role to play in investigating certain deaths, so we have determined that it is appropriate to allow them to access protected material where this is necessary for them to fulfil their judicial functions, but we have also determined that we should put in place tight prescriptive measures to ensure that the safe space is protected as much as possible. On that basis, if a coroner requires information under the Coroners Act 2009, they are not able to share the information without a High Court order to do so, under Clause 19, and they can disclose only if the court makes an order after deciding, in the interests of justice, that the risk of disclosure is greater than any adverse impact on current or future investigations and the Secretary of State’s ability to improve patient safety in the NHS. In addition, Clause 14 provides for a few small exemptions where HSSIB could disclose information if it was needed to help carry out an investigation, while Clause 15 provides that if it is,

“necessary to address a serious and continuing risk to the safety of any patient or to the public”.

Those are important criteria because these investigations are not supposed to pose a risk to individual patients.

The noble Baroness, Lady Parminter, raised an issue regarding the PHSO. The Government’s view is that the new body’s investigations and those of the PHSO are different types of investigation and that the prohibition would be likely to have a limited impact on the ability of the ombudsman to investigate complaints about the NHS and other health bodies. The ombudsman will still be able to obtain information from the relevant trust. In addition, HSSIB will carry out only a small number of investigations—up to 30 a year—so the view is that the impact on the work of the ombudsman will be small. However, I take on board her views and we understand the position of the ombudsman.

The noble and learned Lord, Lord Judge, asked an important question about whether HSSIB has to take into consideration patient consent in order to participate in an investigation. It is required to publish its processes for ensuring that, as far as reasonable and practicable, patients and families are involved in investigations. It would be expected to be sensitive to the circumstances of patients and their families, and we would expect it to seek consent in the vast majority of cases. The current branch has developed very good working relationships with patients and their families, and we would expect the new body to continue that. However, I shall take away the point he has raised.

The noble and learned Lord similarly raised a point regarding a fine rather than a custodial sentence for a breach of information. The sanctions regime was considered following the recommendations of the Joint Committee. We believe that criminal sanctions are appropriate, regarding the seriousness placed on non-compliance with the relevant provisions in the Bill. On his point about whether it is an appropriate sanction, I will also take that away and consider the issue he has raised.

A number of noble Lords, the noble Lords, Lord Hunt of Kings Heath and Lord Scriven, my noble friend Lord O’Shaughnessy and the noble Baroness, Lady Finlay, asked questions about the scope of HSSIB to conduct investigations. HSSIB will be an independent body. It will be able to decide its own priorities and determine what it investigates based on the referrals that it achieves on its own intelligence. It is important that it should be free to do that, but those criteria will be consulted on. There will be an opportunity for patients, the public and the NHS to contribute to that consultation. The Bill is clear, however, that HSSIB may only investigate incidents that have an effect on the safety of patients which occur in the provision of the NHS and do not involve an outcome that contributes to blame, so there are some parameters within the Bill. But the criteria of how those investigations are chosen will be set by HSSIB as an independent body.

On the question of who will be responsible for monitoring the implementation of recommendations, it is essential, if the body is to be established as effective and gain the trust of the public that it does that effectively. So the National Director for Patient Safety will chair a programme board to monitor the system response to the recommendations made by the new body. We do not believe that that needs to be set out in legislation. The Joint Committee agreed with us and agreed that HSSIB should not be responsible for enforcing its own recommendations. That is to ensure that it remains independent and does not become part of the system that is being investigated.

A number of specific questions were asked about what areas were in scope. The noble Lord, Lord Scriven, asked whether prison services were in scope. They are, providing that they are commissioned by the NHS. Indeed, HSIB has already conducted an investigation into NHS-provided prison services. The noble Baroness, Lady Hollins, asked about learning disability services, which would also remain in scope if they were funded by the NHS.

A number of noble Lords asked about staffing levels and the impact on staffing. Certainly, if the question of staffing and behavioural impact fell within the question and the terms of the investigation, that would certainly be appropriate for HSSIB to report on. The standard question is that the scope of HSSIB’s investigations and learning will extend to any patient safety incident that occurred during the provision of NHS services in England, or which occurred at a premises where such services are provided. So that would also include NHS-commissioned services in the independent sector. I will return to the independent sector in a moment.

Dentistry is also covered, which my noble friend Lord Colwyn raised, and maternity, although HSSIB does not replace the local, independent inquiries, which would be done by NHS trusts. I shall return to that in the second. On maternity services, HSSIB will focus on only a small number of thorough national investigations conducted through the safe space for maternity going forward. But we have been clear that we will allow the current investigation branch to continue to run the local maternity investigations programme for a period—the commitment is for 1,000 maternity investigations—so that we can get maximum learning for the NHS. Those will continue but they will not be part of the statutory regime.

I note the strength of feeling in the House about the independent sector and I will take that issue away with me. I answered the question in my opening remarks so I will not go into too much depth now. At the moment, the independent sector is not covered, but I take the point on board and will take it away. In addition, I note the point raised by the noble Lord, Lord Scriven, regarding social care. However, it was the Joint Committee’s recommendation that the new body should not be tasked or expected to be an investigatory body for social care. But it should be able to investigate all aspects of the healthcare pathway relating to patient safety investigation, so people should not fall through the cracks. I hope that that reassures him.

On the question of the independence of the body, which will also be critical, and responding particularly to the questions raised by my noble friends Lord O’Shaughnessy and Lord Ribeiro and the noble Lord, Lord Hunt of Kings Heath, the new body is modelled on some features of the AAIB. It will have statutory powers and carry out impartial investigations. But the AAIB sits within a department and we wanted to make sure that the new body was more independent than that and given a statutory, stand-alone role, which is why we are setting it up as a non-departmental body. It will have the powers to conduct impartial investigations and the Secretary of State may request but cannot direct the body to conduct a particular investigation. This is similar to the CQC set-up, and we think it is appropriate.

The chair and the non-executive directors will be public appointments subject to open competition. The process follows a published governance code which is independently regulated by the Commissioner for Public Appointments. This is in line with other public bodies, as is the process for the appointment of the chief investigator, which is in line with NHS England, Monitor, NICE and ALBs. The chief investigator would be appointed by the board, but would then be subject to the consent of the Secretary of State.

We are clear that the HSSIB would need to integrate and work closely with similar regulators in the space so that there is no question of duplication, which was a point of concern raised by the noble Lords, Lord Faulks and Lord Turnberg. We are reassured that that would not be the case given that the effectiveness of the HSSIB has already been demonstrated. We will make sure that it works effectively through the mutual duty of co-operation which has been set out in the Bill, a number of MoUs and the demonstration of the effective working of the body as it stands. It does not duplicate other bodies.

The National Patient Safety Agency was in many ways a forerunner, as noted by the noble Baroness, Lady Thornton, and the noble Lord, Lord Patel. I pay tribute to it for its work in that way. As noble Lords will be aware, in 2012 the decision was made to transfer the main functions of the NPSA to NHS England. Those functions now sit with NHS Improvement under Aidan Fowler. Unlike the NPSA, the new body will focus on only a small number of thematically based investigations that offer systemic learning without any blame attached and will have a statutory footing. I hope it is recognised by those who were involved in the NPSA that this is a step in the right direction.

In answer to the noble Baroness, Lady Thornton, and the noble Lord, Lord Turnberg, I say that these investigations do not replace very important local investigations. There is no intent to replace them in any way. However, there is value in national learning, as sometimes investigations which happen at trust level do not share best practice nationally. This is not a duplication on that basis.

I shall quickly move to the end of my speech, but I want to answer the question regarding the devolved Administrations asked by the noble and learned Lord, Lord Hope, and the noble Baroness, Lady Finlay. Currently the investigative branch has had positive interactions with the devolved Administrations in Scotland and Wales and has worked closely with trusts in Wales in recent investigations involving cross-border care. We think that more formal plans will be developed with the new body which will mean that other Administrations will be able to ensure that effective working can go forward. However, I take on board the concerns that were raised by the noble and learned Lord regarding Clause 25 and will ensure that it is fully tested.

There are a number of issues that I would like to go forward and raise, but I am aware that time is ticking on, that we are at the end of the day and that tomorrow may end differently. I thank everybody who has contributed today. There are some important questions that need to be resolved. As we have a little bit of time to go through it, I am sure we will be robustly tested, but ultimately the Bill is destined to play a key role in helping to prevent the recurrence of patient safety incidents and fulfilling the Government’s commitment to ensure that the NHS provides high-quality, safe care. We expect the new body outlined in the Bill and the medical examiner system to be operational from April 2021, subject to the passage of the Bill through Parliament. I heard the support of this House very loudly today.