Official Report: Minutes of Evidence

The Chairperson (Ms Kimmins): I welcome from the Department of Health Michael O'Neill, interim director of the quality, safety and improvement directorate; Robbie Davis, director of the general healthcare policy directorate; Anne-Marie Bovill, healthcare inquiries oversight directorate; and Patricia Donnelly, independent member of the inquiries implementation programme management board (IIPMB) and chair of the assurance subgroup. We really appreciate your coming here today. We have an hour in total for the session, and it will be reported by Hansard. I ask you to make your opening remarks, and then I will open up the meeting for questions.

Mr Robbie Davis (Department of Health): Good afternoon. Thank you for giving me the opportunity to speak with you today. I am director of the newly formed healthcare inquiries oversight directorate. Anne-Marie, Patricia and I will try our best to answer any questions that you may have relating to the independent neurology inquiry (INI) implementation programme. Michael O'Neill will provide opening remarks and cover any questions that you have on the inquiry into hyponatraemia-related deaths (IHRD) implementation programme.

I acknowledge the significant healthcare failings identified by the independent neurology inquiry and how those matters have affected the patients and families involved. I assure you that the Department continues to listen to patients, families, support groups, charity groups and political representatives, and we are committed to the overarching principle of enhancing patient safety, which the INI report sets out. A written briefing paper was provided in advance of today's meeting that provided an overview of the Department's independent inquiries programme management board and updates on the IHRD and INI implementation programmes. An update on the urology services inquiry (USI) has also been provided. I hope that members have had the opportunity to consider the written update and found it helpful. To avoid the risk of repeating the content of the briefing, if you are in agreement, Chair, I will highlight a few key points.

In April 2023, a decision was made to amalgamate the programme boards of the inquiry into hyponatraemia-related deaths and the independent neurology inquiry into a single Department of Health programme management board. That approach was taken due to the commonality of issues across both inquiries and to support a consistent approach through the alignment, engagement and assurance requirements related to the implementation of inquiry recommendations. The common themes that appear in the IHRD and INI public inquiry reports include assurance and accountability, which are divided into three work streams: workforce, quality and safety, and governance. Information and data management is another common theme and is divided into two work streams: information systems and information sharing.

The IIPMB is chaired by the permanent secretary and its membership comprises key policy and professional leads from across the Department and external experts. You have a list of the full membership in the briefing that was provided. Members will note that six IIPMB meetings have been held to date. Stakeholder engagement and assurance are key elements in supporting the implementation of public inquiry report recommendations. The IIPMB structure includes robust independent assurance and bespoke engagement arrangements to support the implementation of public inquiry recommendations. Arrangements are being made to expand the IIPMB remit to include the implementation of recommendations from the recent infected blood inquiry report, which was published in May of this year, and the Cumberlege and Hughes reports relating to pelvic mesh and the prescribing of the medicine sodium valproate. Under the scope of the programme management board, there is also the potential to consider the implementation of other relevant public inquiry reports when published, such as the USI and the Muckamore Abbey Hospital inquiry.

I move on to a few key points regarding the INI implementation programme. The INI report was published in June 2022 and included 76 recommendations for the Department, healthcare organisations, the independent healthcare sector and the General Medical Council (GMC) to ensure patient safety and reduce the risk of similar events happening. Ensuring that the recommendations are implemented and, critically, that they deliver the improvements intended is a priority for the Department.

The Department published an overarching INI implementation plan on 27 July 2023. The INI action plan, which outlines the specific actions required against each recommendation, was published on 7 March this year. The Department considered the feedback received following the sharing of the draft implementation plan with stakeholders prior to publication and established two key independent groups to support the implementation programme: the IIPMB assurance subgroup and the independent neurology liaison group.

Independent assessment of each recommendation is provided through the IIPMB assurance subgroup, which makes recommendations to the IIPMB in respect of actions required for each INI recommendation and whether each INI recommendation has been fully implemented. Progress at each stage is reported to the programme board in order to provide oversight and approval. The independent neurology liaison group aligns with the work of the assurance subgroup to further enhance feedback and recommendations from service users, carers and families on the assurance process and implementation programme. The liaison group comprises 14 members who are patients or family members of patients. Membership of the group remains open to service users, carers and families who would like to be involved.

The current position with the INI implementation programme is that 22 of the 76 recommendations have been verified as implemented, following review by the independent neurology liaison group, scrutiny by the programme board assurance subgroup and approval by the programme board. There are 44 recommendations progressing through the INI engagement and assurance arrangements by theme and in tranches, 10 of which have agreed frameworks and action plans in place. A further 19 recommendations will be presented at the next programme board meeting in November, seeking approval of the assurance frameworks and action plans, along with evidence of partial implementation and full approval of implementation, as appropriate. One recommendation will be deferred, as primary legislation is required.

It is important to highlight that the pace of progressing the INI recommendations through the independent neurology liaison group and the assurance subgroup may vary, depending on the complexity of the recommendation. The positive and constructive engagement provided through those engagement and assurance arrangements is very much welcomed.

Delivering the changes identified by the INI requires a series of coordinated actions. The Department continues to engage across a range of organisations, including the GMC, healthcare organisations, the trusts and the independent sector. Many of the actions to be taken to implement the INI report are aligned or interdependent with other DH work programmes and work that is being undertaken in parallel by other relevant organisations. It is clear from engagement with key delivery partners that further improvements to governance systems and processes have been made, and there is an acceptance that more work is required to ensure that there is full implementation of the INI report. Notwithstanding the progress already made on implementing recommendations, the IIPMB will confirm recommendations as having been implemented only once they have passed through the assurance and engagement processes.

Before I pass over to my colleague Michael, I will briefly touch on the ongoing urology services inquiry. The written paper provided on 18 October included an updated position on the USI, which was established under the Inquiries Act 2005 and is chaired by Christine Smith KC. The USI was set up on 6 September 2021. Members will be aware that the inquiry is wholly independent and is not accountable to the Department of Health. As the inquiry is ongoing and independent from the Department of Health, it is not possible for the Department to provide a timescale for its completion. We can provide the assurance that the Department will consider the USI report, including its findings and recommendations, when it is published.

Thank you, again, for the opportunity to present. I pass over to my colleague Michael.

Mr Michael O'Neill (Department of Health): Thanks, Robbie. Thanks, Chair and members, for the opportunity to provide an update on the implementation of recommendations from the inquiry into hyponatraemia-related deaths. I will provide a short briefing on the background to the ongoing work and the progress across the work streams.

In January 2018, Sir John O'Hara published his inquiry report, which examined the deaths of five children in hospitals in Northern Ireland. The report made 96 recommendations, which were wide-ranging. A number of the recommendations include multiple parts, and, as a consequence, 120 separate actions arose from the inquiry. While we will discuss progress against recommendations and actions today, it is important to reflect on why we are undertaking this important work. It is because of the failings that led to the tragic deaths of those young children, who, along with their families, were badly let down.

Following the publication of the report, the Department established a hyponatraemia implementation programme to address the 120 actions. That work was paused in March 2020 so that issues arising from the pandemic could be addressed, and the programme restarted in April 2021. A scoping exercise was completed on each of the 96 recommendations, with recommendations that were closer to completion being identified and outstanding actions being progressed. Of the 120 recommendations, 69 were fully implemented in phase 1 of the implementation programme. The remaining 51 actions are being dealt with in phase 2 of the implementation programme. Of those remaining actions, 15 relate to duty of candour and the "Being Open" work stream; 21 relate to serious adverse incidents (SAIs); four relate to Regulation and Quality Improvement Authority (RQIA) functions around the duty of candour and serious adverse incidents work streams; one relates to the establishment of an independent medical examiner (IME); seven relate to workforce actions; and three relate to issues of clinical negligence and litigation.

The implementation of the four recommendations related to the RQIA are dependent on the implementation of a statutory duty of candour in Northern Ireland and the new SAI process. The implementation of those actions will, therefore, follow those work streams. Regarding the serious adverse incidents work stream, members may recall the written and verbal briefing provided by my colleagues at the end of June on the work being undertaken on the development of a new framework for learning and improvement from patient safety incidents. The programme of work to redesign the existing serious adverse incidents procedures is ongoing and is on track for the Department to launch a three-month public consultation towards the end of the year. At that briefing, the Committee indicated that it wanted to continue to be updated on progress on the new framework and has requested an update on the consultation plans. A further written update will be provided in the coming weeks in advance of the consultation period beginning. The Committee has also scheduled officials to provide an oral briefing in March, following the consultation, on outcomes, progress and planned next steps as we move towards implementation.

A number of public inquiries and reports have recommended the introduction of an independent medical examiner service. The purpose of that recommendation is for the Department to institute that office to scrutinise hospital deaths that are not referred to the coroner. Whilst the IHRD recommendation specifically referenced hospital deaths, it is the intention that any IME service in Northern Ireland will also review deaths in the community, which has been the approach in the rest of the UK. An IME has three primary functions: ensuring that deaths are appropriately and completely reported to the coroner, when required; reviewing the quality and accuracy of medical certificates of cause of death; and identifying at an early stage any safety or governance issues relating to deaths.

Work to conduct prototypes for a statutory IME service for Northern Ireland has been ongoing since 2020. Initial work to consider the feasibility of using electronic care records to determine the accurate cause of death was undertaken in late 2020, which is when the first prototype began. In February 2022, all hospital deaths certified between 8.00 am and 4.00 pm, Monday to Friday, were subject to review by a team of 10 IMEs working on a rota.

To date, three prototypes have been completed to determine how the service might operate in Northern Ireland and what its implications might be.

Prototype 3 was paused in October 2023 to allow for a full evaluation of the service and for plans for prototypes to be developed to include a review of deaths by GPs in the community. The next stage of the process is to conduct a further prototype to identify the implications for reviewing deaths that are certified in hospitals out of hours and at weekends. Those will commence in the next few months, together with more detailed plans for reviews of deaths in the community. Once the full implications of those reviews have been examined, proposals for a statutory system can be developed in partnership with DOF, which is responsible for death registrations; DOJ, which is responsible for the Coroners Service; and DFC, which is responsible for burial and cremation policy. This is a cross-departmental issue, and it will require primary legislation and full public consultation.

A detailed briefing on the "Being Open" framework and duty of candour has been provided separately to the Committee for its consideration. Following this session, colleagues and I will provide a more detailed briefing on that work stream, during which we can pick up any issues on duty of candour that members have.

I started in post as interim director at the end of September, and already I have seen how much work has been undertaken by a few small but dedicated teams in recent times, many of which have been impacted by significant demands to support the COVID inquiry. There is, however, much still to do across the IHRD work streams. Over the next three or four months, we will see significant milestones reached in all three of the SAI, IME and "Being Open"/duty of candour work streams. Whilst that work is challenging and complex, there is momentum across the system. That is welcome, and the Department is keen to translate it into practical improvements in the provision of healthcare.

I am happy to take any questions that members may have.

The Chairperson (Ms Kimmins): Thank you for that introduction, Robbie and Michael. I will start with a couple of questions. If you cannot answer them, just say, because we have a lot of information and we have another briefing after this, so there may be some overlap.

With regard to the hyponatraemia inquiry, today is the 28th anniversary of Claire Roberts's death, and it is important to acknowledge that. That also gives us a sense of the length of time that families have been waiting to get a conclusion to lots of these issues. I appreciate that a lot of work has been done and that a lot work is ongoing, but at the forefront of all our minds has to be the fact that the lives of real people are being impacted.

There are common themes across all the inquiries, and the Committee has talked about that with regard to recommendations and how to avoid such situations in the future. That is what all of us would like to see, but we are not seeing it. Even in the time since this Committee has been in place, there have been numerous inquiries, and the vast majority of them are saying the same things. Yes, there will be nuances between them, given their specifics, but there are a lot of common themes, and those are what we need to tackle.

Is it possible for the board to commit to providing a table that gives detail across each set of recommendations on when they will be implemented, the progress on them and, if they are not accepted, the reasons for that? That would be useful for the members of the Committee and for the public to keep track of what is happening and where things are. If you were able to do that, it would be useful.

Mr Davis: Yes, I am certain that we will be able to provide something along those lines.

The Chairperson (Ms Kimmins): That would be great. Thank you.

Michael, you spoke of the SAI process redesign. We have meetings coming up with families who have been involved with and impacted by that. I would like to understand a wee bit more about that co-production and what it looks like. Is it meaningful and working well? The panel was set up only last December, is that right?

Mr O'Neill: Yes. There was a lot of co-production in the initial SAI work stream that started in 2020. Now that that work has restarted, we have an engagement panel through the Patient and Client Council (PCC). We also have three family members, two of whom have experience of the SAI process as it is now and one with an interest in patient safety on our project structure. We are taking two different approaches. We have met members of the PCC engagement panel in person twice and taken written evidence from them, and they have significant issues with some of the proposals. That group in particular have had the traumatic experience of an incident and then the SAI process. We are listening carefully to what they say and to the other engagement that members are having. We will then move to public consultation, because we are keen to hear from other people who have had other experience of SAI processes, so that we can take all views into account.

The Chairperson (Ms Kimmins): OK. The Committee will meet the engagement panel and the PCC in the coming weeks, so we may have more questions after that meeting. We want to make sure that the co-design and co-production is really strong, because it is the only way that we will achieve proper learning and change things for the better.

It may be too early to say, but, as I mentioned, the time that a lot of these things take is soul-destroying for the families. I am dealing with the case of a wee boy called Charlie, and the family will not mind me mentioning it. That case has been going on since he was born 11 years ago, yet they are no further on. Is the time that it takes for cases to be considered part of the redesign? In Charlie's case, there were a number of failings, which have been outlined already, so I am not saying anything that is not already known. His family do not want to see the families who are coming behind them, who may be in a similar situation, having to wait for that length of time.

Mr O'Neill: That is one of the key things: families are waiting too long for reviews to take place. Many SAI reviews should be undertaken quickly. The feeling in the sector at the minute is that the system does not provide for that to happen. We hope to establish a more proportionate system for the SAI reviews that can be delivered quickly, which will free up resource for more complex cases that take more time and involve more investigatory work. Timeliness is at the top of the agenda of what we need to deliver on.

The Chairperson (Ms Kimmins): Absolutely. The proposals for implementation that come out of that need to happen quickly, as does anything that is offered to families so that they can get their lives back on track. That is a key part of it.

Mr O'Neill: A key part of that is taking a compassionate approach to families during the process as well.

The Chairperson (Ms Kimmins): My other question is about collaboration across Departments. The Cawdery case is a prime example of that, and I know that some of the family are involved with the engagement panel. What has come out of that case is the need for proper collaboration between Health, the PSNI, Justice and all Departments. Are we looking at improving in that area as part of the redesign?

Mr O'Neill: There has been engagement with those organisations in the past 12 to 18 months. I have not been involved with them yet, but they have been engaged with, and, as part of the public consultation, we expect to engage with them again on those issues.

The Chairperson (Ms Kimmins): Yes. In many of those cases, a number of agencies and Departments are involved. Things fall through the cracks, and that is how we end up with the horrendous situations that we deal with through the SAI process and the inquiries. Those issues are really important, particularly when we are dealing with mental health patients, as was the case with the last example that I mentioned.

My final question is about the duty of candour. I appreciate that you may not be able to answer this, but the duty of candour is really important to the Committee. We hope to take forward some work on that. An individual and a statutory duty of candour is a common theme across all the inquiries. Can the board give any view on how that should be pursued?

Mr O'Neill: If you do not mind, we will give a briefing on that in the next session. Peter McBride and Ian Plunkett, who are sitting behind me, can brief you on those specific issues. We will try to be as transparent as possible on those issues.

The Chairperson (Ms Kimmins): That is no problem.

Sorry, members, I have one last question, which just came into my head. Robbie mentioned that the urology review is an independent review and that there are things that you cannot comment on, like timelines and things like that. Does that mean that you do not really know when you will receive the action plan from the trust? Do you have to wait to see what the review brings back?

Mr Davis: Well, the urology services inquiry has finished its hearings and is now in its final stages. How long that takes is a matter for the inquiry. I know that they will be keen to publish the report at the earliest possible juncture. When the Department receives the report, we will assess and analyse it, as you would expect, and we will work with our partners in the trusts, the GMC and other relevant organisations and with stakeholders to develop any necessary action plan to progress the recommendations from that. As you say, Chair, it is difficult, at this point in time, to know what the outcomes and recommendations from that inquiry will be, although, as has been noted, there are certain common themes that we have seen across prior inquiries.

The Chairperson (Ms Kimmins): OK. No problem. Thank you, Robbie.

Mr D Donnelly: Thank you for coming today. As the Chair alluded to, there are quite a lot of common themes throughout the inquiries, and failure of clinical governance is one that crops up again and again. That impacts on the public's confidence in the health service. How will you restore the public's confidence in the health service? How does that apply to the work of the board, particularly with regard to accountability and transparency?

Mr Davis: I will make a few remarks on that and then pass over to my colleague Patricia. Ultimately, it is important to acknowledge that the circumstances that led to the public inquiries have dented public confidence in the healthcare system. We acknowledge and recognise that. The inquiry reports are extremely helpful to us, as a Department, in pinpointing the precise areas in which we need to drive improvements across the wider system, and, through delivery on those recommendations, we can help rebuild public confidence in healthcare systems. I will pass over to Patricia.

Dr Patricia Donnelly (Department of Health): Thank you very much. You have touched on one of the most important issues: all the inquiries have raised issues around governance, who knew, what was done about what they knew and what control systems were in place. When the hyponatraemia inquiry reported, one of the first things that happened — I think that I was involved in providing assurance at that stage — was to look at how we could introduce a system whereby you put in place not only the things that were to improve but a mechanism for how you will know that they have improved. There is a moment in time when everyone's faces turn towards the outcomes of an inquiry and making sure that the right things happen. Indeed, some things have to happen immediately for the safety of patients and clients, but some of the governance work takes a little longer. There are recommendations in the hyponatraemia report and recommendations in the independent neurology report that cover that.

The system that we now have in place is much more robust than has ever been the case. We look at what you need to put in place as an ordinary, business-as-usual, good, robust governance model that the public, patients, staff and boards can have confidence in. First of all, we take the recommendation and define what it actually means, because, when recommendations are written, they may be interpreted in many ways. We get an agreement on that definition. We then say, "Who should do what, and how many individuals should be involved?", because the recommendations are often not just for one person to action. We also ask, "What is the scope of this? What are the limitations? How does it link?". As you have heard, there were 76 recommendations in the case of the INI and 96 in the case of the IHRD. No single one of those will improve governance, but, as a system acting together, it will say, "The RQIA should do this. Trusts should do that. GMC should do this". It tells different parts of the system how they need to act together. We look at who needs to do what.

We then ask whether a new policy or new procedures need to be introduced or whether there are existing ones that you need to fix. Having done that, how do you know that it has happened? What is the level-1 evidence? What is happening on a daily or weekly basis on the delivery front? What does a team do? How does it report? What records does it keep? At level 2, what does the trust do? How does it assess? How does it audit? What is its governance statement? What control systems does it have in place? At level 3, there is a very important but less frequently asked question, which is for the regulators, whether it is RQIA, GMC, the Medicines and Healthcare products Regulatory Agency (MHRA) or some other external regulating body: what do they see when they look at the evidence, and how is it demonstrated to them that that is in place?

In the assurance group, we work with the key stakeholders who have been affected by the inquiry. For example, in neurology, we have a liaison group, and Robbie set out the number of individuals on the group. It is also engaged with a wider group of people who do not want to be directly involved but are definitely interested in the outcome. They sit on our assurance group, so there are independent people, such as me, who come in and say, "We have now looked at each individual recommendation". There is an elaborate assurance framework drafted that says all those things, including, "Where is the evidence? Where is the action plan?". We then agree whether it is the right scope. To be honest, many times, we change it on the basis of the commentary from the neurology liaison group. That has been most useful, and we have then gone back to the owners who are accountable for the actions and set out some changes that need to be made.

Only yesterday, our group met, and the GMC and the liaison group chairs were in the room with us, and we went through the remaining recommendations that were for action by them. We have agreed changes to that framework to increase its robustness and the confidence that people have in it. I am not breaking any confidence by saying that the co-chair of that, who is one of those affected by the neurology inquiry directly, has said how much it is appreciated and that they have greater confidence in this as a process.

Because it is interactive, it also has validity and credibility for the individuals. I think that the Chair said that, when you do co-production and this kind of engagement, it slows it down but you get a much better outcome. Only through that do you rebuild trust, but you need that credible scrutiny, and you need people in the room who are prepared to say, "This is not going to work" or, "This is not the right thing" or, "You need to do more". Indeed, I believe that we have had that kind of constructive commentary.

Mr D Donnelly: I absolutely agree that co-production is vital, and I am glad to hear that that conversation is part of it and is built in. Obviously, there are a lot of levels to this, and you mentioned that it takes a long time. Can you point to anything in particular? Can you give us an example of lessons that have been learned that show that patients are safer?

Dr P Donnelly: I will go back to the governance issue. Recommendation 20 is that there will be the introduction of a safety and quality committee. The liaison group said, "That needs to be patient safety. Let's not lose the focus on that". Indeed, that has been accepted by the Department. It is to describe terms of reference that show what standing reports it needs to know, what the trend information is that it needs to look at and how it knows, given that it is chaired by non-executive, that it is calling the executive directors to account for their reports on that. Those are the kinds of improved controls that you can put in place.

Another example is recommendation 15, which is relevant to a number of inquiries in that it deals with the practice of lone working. Recommendation 42 is on what the trusts need to do about lone working. Sometimes, in a small specialty, there might only be one expert, and therefore a person might work alone. There are potential risks to patients when that happens. Again, when we have worked through the framework, what we say is that trusts need to understand that that risk exists, so they need to be sure that they have scanned, for example, an individual working in a wider team or in a geographically separate place. They need to put in place mitigation measures to employ more staff if necessary; build a clinical team around the individual; connect them to a wider expert group, which may be outside their own trust or, indeed, outside Northern Ireland for a particular sub-specialty; and put in place all of the support measures that would reduce any risks. They need to be aware of the situation and then monitor it, so that it is not just that you do it once and then it is over but you make sure it is continuous and that the individuals are supported right through that process. Some very direct actions can be taken, but it is about making sure that the process is in place and that you identify and control what those risks are. The risks may not be absolutely avoidable, but they need to be mitigated.

Mr D Donnelly: Thank you. As you are on the board as an independent member —

Dr P Donnelly: Yes.

Mr D Donnelly: — are you able to give us your opinion on duty of candour? [Laughter.]

Dr P Donnelly: I would prefer not to. Do you mind if I do not? I have been involved in duty of candour. The most important thing is the culture of being open, and that creates protections for everyone concerned. I am aware of all the challenges around individual duty of candour and the penalties around that. It creates a resistance from the system that does not need to be there. I see the bigger prize as the culture of being open and change being made so that, in everyday life, people are used to being transparent about what they do.

Mr D Donnelly: Thank you.

Miss McAllister: I have a few questions that carry on from some things that you said, and I have some questions of my own. I will be flicking back and forth through a paper copy. Thank you for coming in today. I want to go back to recommendation 2.

Sorry, before I begin, I should have said this. I echo the Chair's words about the anniversary of the death of Claire Roberts, and I pay tribute to the parents of all the children — Claire, Raychel, Conor, Adam and Lucy — because the hyponatraemia inquiry was about them, and, unfortunately, they lost their lives.

The hyponatraemia inquiry was launched — correct me if I am wrong — in 2004, and, with regard to the timelines between then and now, we have also had the neurology inquiry and the Muckamore inquiry, which is ongoing. We have had the inquiry into mesh implants, the urology inquiry and, most recently, an inquiry on cervical screening. Between hyponatraemia and the cervical screening, which, I believe, is the latest scandal, there have been at least 120 actions and recommendations to be implemented to ensure that such things do not happen, but, unfortunately, the latest scandal — cervical screening — broke just last year, so lessons have clearly not been learned. If some of the recommendations from the earlier hyponatraemia and neurology inquiries had been implemented, we could have prevented further scandals. However, I appreciate all the work that is ongoing and that it is not easy.

I will go back to recommendation 2 of the neurology inquiry. It says that the Department of Health should remind healthcare organisations that they ultimately:

I assume that that still stands today, that it was implemented and actioned and that management is ultimately accountable for managing employees.

Recommendation 33 of the hyponatraemia inquiry says:

It is similar to the previous recommendations on where responsibility and accountability lie within trusts, and it is part of being open and honest and ensuring that we have the proper processes. Are you aware of any serious adverse incidents that took place after the hyponatraemia inquiry — after 2018 but before the neurology report — where correct procedure was not followed?

Mr Davis: I will start by saying that patient safety is at the heart of everything that we do. All the inquiry reports that are published have a patient safety focus and are designed to drive forward the agenda to make our healthcare system safer for patients and to minimise and do everything that we can to drive down the risk of adverse incidents in the system.

Recommendations across the inquiries have varying levels of complexity. Some are easier to deliver. Some, such as those that have cultural dimensions — trying to drive changes in healthcare culture — can take longer to deliver and can be more complex. Our priority is to deliver at pace, and I am reasonably confident that we are delivering at pace. Obviously, there is more to be done. There is a programme of work ahead of us, but all the efforts that we are taking forward are designed to minimise and mitigate the risk of adverse incidents in the future. One of my colleagues might want to add something.

Ms Anne-Marie Bovill (Department of Health): I want to add to what Robbie said about recommendation 2. That is one of the recommendations where there is an assurance framework that details the intention and understanding behind the recommendation, which has also come from engagement with the INI panel to get a clear understanding of the intention behind each recommendation. That framework has gone through review, through the engagement structures that we have in place in the independent neurology liaison group, and feedback and comments have been provided in relation to that. It has then gone through the assurance subgroup that Patricia chairs in relation to scrutiny. It has also been brought through to the programme board, and the programme board has approved the current position on that one, which is what I am trying to get to, which is that, for that specific recommendation, the framework has been approved at programme board level, so the required actions have been agreed through the engagement assurance process and approved by the programme board, but there is still work to be done to verify that that is fully compliant with the actions that are required on that.

Miss McAllister: You just said "the intentions", but you did not say what the intentions were or whether you went back to the inquiry panel to find out what the intentions of that recommendation were. Is it correct to read that the intention is around accountability and responsibility in the trusts?

Ms Bovill: A lot of the accountability and governance recommendations fit within that framework, as Patricia has outlined. Not one recommendation will be taken forward on its own. It will need the collective required actions across all the recommendations. I am not sure whether Patricia wants to comment in detail on recommendation 2.

Dr P Donnelly: Yes, please. We have — I have personally — continued to engage with the authors of the inquiry report to make sure that, if there are any issues where we are not clear about their intentions, we can clarify them. That has been helpful, and they have been supportive to us in that.

There is an issue about patient safety, absolutely, but it is about all the things that you need to put in place. As part of the process, for example, we have been having meetings with trusts, so that trusts will have had to say how they fulfil that function. They have had to audit and report to us periodically. We have also met them, and we continue to do so. I will meet one of the trusts and the team in the coming weeks to go through specific recommendations, to look at what the trust has implemented and for the trust to demonstrate the evidence 1 level, evidence 2 level and what external bodies have said about their improvement processes.

These are part of continuous improvement. One of the things that we have been doing as part of this is identifying the need. It was identified during the hyponatraemia inquiry and the work that was done then. It will only come to fulfilment now because of the hiatus that there was around COVID and that post-COVID period, when people were distracted and doing other important things. That is to produce an updated governance guidance for trusts that says clearly what the expectations are. That strengthens that and makes normal accountability arrangements much clearer to trusts. It would still be open to other improvements.

One of the last things I will say is that, following the hyponatraemia inquiry and the work that was done then, I and others produced a handbook for directors on guidance on their legal and governance responsibilities. We included a lot of case examples of where there had been failures. It looked at what they needed to do: how they needed to be curious about situations; how they needed to seek assurance; and what they should look for in the absence of information that they are given, so that they can see through otherwise quite optimistic, positive and reassuring data and information from trusts so that they are looking for assurance, not reassurance. A lot of that is ongoing work around improvement.

Miss McAllister: I asked specifically about serious adverse incidents after the publication of the hyponatraemia report, the neurology report and then the cervical smear inquiry. I think the answer is that you are not aware. I do not expect you to have awareness of all the individual cases. Perhaps, you might be able to answer this: regarding the serious adverse incidents recommendations from the hyponatraemia inquiry, how many of those recommendations and which ones specifically are included in the review of the SAI process?

Mr O'Neill: In the SAI policy area, some have already been implemented, such as the training of executive directors with specific responsibility for learning from SAI-related patient deaths. Some have already been implemented. I will need to double-check this because there is a range of SAI recommendations, but my understanding is that the rest of them depend on the SAI work that we are doing at the moment. There is a significant number of them, and they make up a significant chunk of the remaining actions that need to be implemented.

Miss McAllister: May I get feedback on whether all the recommendations in the hyponatraemia report have been implemented? It was clearly outlined that those needed to be and should be actioned. I recognise that Departments do not always agree with recommendations. May we get written feedback on which recommendations have been implemented? I am talking about not just the ones that have already been implemented but all of them, because they are included as part of the ongoing SAI review. My worry is that they are in yet another system and another process and that, despite trying to get change, the can is being kicked down the road. You can understand the frustration of many families who, despite getting an inquiry and a report, are still fighting, are still meeting political representatives and still want to see the recommendations implemented overall.

I have another question regarding accountability. However, before I go there, the Chair asked for a table showing which recommendations were implemented and which were not. It is really disappointing that that information has not already been given to us, given that, at every Committee session with officials from the Department of Health, we ask that question, no matter what the inquiry is and no matter what the issue is. If there are recommendations, we ask every time which ones have and have not been implemented. I honestly do not know why it was not provided. It is so disappointing that, yet again, the Department of Health has stonewalled questions about exactly which recommendations have been implemented, because the public who fought for those inquiries deserve to know what happened with their fight. Did they get the change that is needed?

Another issue that is raised with us every time that we meet families is accountability. With regard to the cervical smear scandal, I recognise and respect the fact that stage 1 had to be about ensuring the safety of every patient, whether that meant reviewing their slides or providing any additional treatment that they needed. I absolutely agree that that was the right process. When we recently met the trust, it said that the next stage will be about finding out what happened. My understanding is that it took place over 10 years. Will you use the recommendations in the reports to find out whether people are willing to be open about what went on and what happened? I am not saying that there should be finger-pointing or anything. However, I am saying that it took place over 10 years, when all those other reports and inquiries were going on, yet it seems to have been missed by the Public Health Agency (PHA) and who knows how many clinicians. How can we use the recommendations from those inquiries in the cervical smear review? How will you work with that trust to ensure that the proper process is followed?

Mr Davis: I will take your first point about the table. My understanding is that the Chair asked that we provide a list of, essentially, the state of play with each recommendation, what needs to be done and what is outstanding. What we provided in our briefing to the Committee, at paragraph 55, is a summary of the position with all 76 recommendations. It sets out the recommendations that have been approved by the programme board as implemented; the recommendations with actions agreed by the programme board where further action is required before implementation is complete; and the recommendations that remain subject to consideration through the engagement and assurance structures and approval by the programme board. Hopefully, that provides some of what you were hoping to see. We are, of course, happy to provide the additional information, as requested.

Miss McAllister: No. What we need is information. We can read what the recommendations are. Sometimes, the excuse given to us is that the recommendations take funding or require work streams to be set up. What will it take to just do it? With respect, I know that this is not the individual fault of any of you who are sitting at the table. However, recommendations that have been sitting here since 2018 have not been implemented. There is now an SAI review. I hear that many of the recommendations around SAIs are not part of the SAI review process. We get information, but we do not get enough. The RQIA, on the other hand, has provided, in its briefing to MLAs, a detailed account of recommendations and what should and should not happen with regard to hyponatraemia and neurology. We cannot speak to it too much with regard to urology, but there is a bit of a difference here. In order to carry out its function, the Committee needs to be able to hold the Department to account.

The final question, I am not sure who was —.

Ms Bovill: I will just come in on what Robbie said in response to the member's question on details and the position against recommendations. I appreciate that the written update provided numbers, and maybe the specific number of a recommendation does not mean so much when you want to see the detail behind it. In July 2024, the Department published a detailed action plan that outlined the current position, the intended recommendations and the current status against each recommendation, which, I hope, members will find helpful. Obviously, it would be our intention to provide further updates on that as we progress through it.

I will just caveat that with one additional point: although the action plan outlined intended recommendations, you will appreciate that those recommendations are still going though scrutiny through the assurance subgroup and the engagement process and could be subject to further refinement as we go through that to ensure that patient and family voices are heard, as well as independent scrutiny of what the intention is.

I think that your other question relates to —

Miss McAllister: I have another question, just before that. We had a look at the action plan. I recognise that there was detail in it, but, within that, there was also action. There were recommendations, and, out of recommendations, there were actions. If you add all the actions and recommendations together, you get over 200. It is not quite as straightforward when all the information is provided. I do not say this to be deliberately difficult, but people just want to know whether that has been done. I appreciate that things are hard, but, after six years, from 2018 to 2024, you should be able to say yes or no and not just say bureaucratically why it has stalled or anything. That is just not acceptable.

The other question was about the cervical screening review. Will the lessons that have been learnt from those inquiries and the recommendations be used in that review? I appreciate that it might not be your role, but what conversations have been had?

Ms Bovill: We understand that the cervical screening look-back review is ongoing. I do not think that anyone here is involved in that, so we would not be able to provide you with a briefing or update on that other than to say that we understand that the look-back review and oversight arrangements for that look-back review to take place are being taken forward in the Department with similar structures to, for example, the urology look-back review and the neurology patient recall process.

Miss McAllister: I respect that it is not your responsibility, but, going back to recommendation 2, which said that the Department of Health must remind trusts about who has ultimate responsibility, there should be conversations between the Department and trusts about what is happening with that cervical screening review. We are getting representations at a political level about what went on there. We must ensure that there is transparency from the very beginning of the second stage of that review. Again, I appreciate that it is not your role, but it ties in because of recommendation 2.

My final question relates to accountability and those who sit on the programme board. You will recognise that I asked the Minister a question for urgent oral answer some time ago, but this is not coming from individual parties; it is coming from people who were affected by Dr Watt and the families of deceased patients. Has there been a review of who sits on the implementation programme board or any of the oversight boards, so that we can ensure that families have confidence? Last week, during the Muckamore inquiry, the Chief Medical Officer (CMO) apologised for the role. Again, recommendation 2 clearly states that ultimate accountability and responsibility lies with the chief executive of a trust, which, at the time, the Chief Medical Officer was. Has there been a review since we asked the questions in the Chamber?

Mr Davis: It is important to note that the Department recognises that it is important to have an appropriate level of independence in its structures for accountability and for ensuring that recommendations are delivered as was intended. The Department keeps its membership of programme boards and other structures under review as appropriate. I believe that, at present, our membership of the programme board is appropriate for fulfilling its terms of reference.

On the substructures that we have, Patricia kindly referred to the liaison group and the assurance group that she chairs. It may be useful to go into a bit more detail on the independence that that provides and, indeed, to emphasise that the liaison group provides helpful input from families and patients. That is absolutely invaluable to the process and should, hopefully, give confidence, given the wider networks that members of that group have. It should give confidence that we are genuinely listening and taking on board their perspectives in the shaping and sign-off of recommendations.

I will pass over to Patricia.

Dr P Donnelly: All the members of the assurance group are independent from the Department of Health and are present because of their expertise in particular areas. I believe that you will meet one of the members shortly. They are experts on transparency and being open, experts in governance and experts in regulation. We are independent, and we make our recommendations to the programme board. That board is not independent; it deals with independent inquiries. It comprises those with authority in the Department of Health who can sign off the recommendations. Of course, the board can also look at the processes and be critical. It can look at the outcome of the processes and challenge whether they fulfil their function. They are two separate and independent aspects.

Miss McAllister: They are separate and independent, but we have just heard that the board can challenge processes and not accept their outcome. That is not your responsibility. I know that we move in small circles when it comes to chief executives and management, but that just outlines the issue around confidence in it too. Thank you for answering my questions.

Mr McGrath: I will keep my questions brief, which might be refreshing. Are all serious adverse incidents and adverse incidents collated? Are they all reported to RQIA and others, or are there selection criteria that determine what gets passed on?

Mr O'Neill: My understanding is that they are not all collated and passed to RQIA. The strategic planning and performance group (SPPG) and PHA certainly have an oversight function for serious adverse incidents, and sampling goes on. Part of the purpose of the new framework is to have a strengthened regional oversight function so that there is more focus on surveillance, data trends and that type of thing, meaning that issues that happen in one trust can be extrapolated so that benefits can be had and learnings can be made in other trusts. Not all of them are reported, but it is a requirement that there is an executive director at board level with responsibility for serious adverse incidents.

Mr McGrath: What about adverse incidents? Is it just serious adverse incidents?

Mr O'Neill: I need to double-check. The purpose of the framework is specifically focused on serious adverse incidents. I can come back to you separately on that, Colin.

Mr McGrath: Roughly how many adverse incidents and how many serious adverse incidents are there in a year?

Mr O'Neill: I do not have that information to hand, but I can come back to you.

Mr McGrath: Will the adverse incidents form part of the review?

Mr O'Neill: The serious adverse incidents are the focus.

Mr McGrath: Is it not a concern that adverse incidents might become serious, if they are not noted or observed but are left unnoted and not collated?

Mr O'Neill: I am not sure whether Patricia is aware of the situation on the adverse incidents side of things, but the recommendations in the reports certainly focus on serious adverse incidents, hence the focus on that side of things.

Dr P Donnelly: On a wider point around governance, one of the good practices that we recommend and that is now in guidance is that people should look for trends and look for things beyond serious adverse incidents, which have their own prescribed processes, so that they learn from near misses, when something was not as serious as it could have been. We want to make sure that those who provide that scrutiny at the non-executive level understand the significance of it and get feeder reports that focus not just on large failures but on opportunities for learning and improvement.

That is the tenor of a lot of the improvements that are needed. It is not just about firefighting what has gone wrong; it is about how you improve, sustain and protect and do all those things to learn from the experience. An important part of that is how you react to feedback from users of the service. Something may be a complaint rather than an adverse incident, but it may not look that different from an adverse incident. It is usually based on something that someone has expressed dissatisfaction about. It is about trying to tie those things together and look at whether there are trends or specific things that need to be rectified.

Mr McGrath: I get the importance of looking at the trends, but, if we do not collate that data, are we not missing a trick?

Mr O'Neill: I am not sure, Colin. I would need to come back to you on reporting on the adverse incident side of things.

Mr McGrath: That is fine. If you could come back to us, that would be great. Thank you.

Ms Flynn: I will follow on on the issue that Colin raised. Interestingly, part of the feedback that we received when we met a family member was that we do not give the same focus or attention to adverse incidents. If we did, ideally, that would prevent serious adverse incidents. A family member who was directly impacted made that same point. That brings me on to the importance of having people with experience involved at every level, including at the highest level of your decision-making and outcomes structures.

Thanks very much for all your feedback so far. Patricia sits on the liaison group. On the SAI work stream, the briefing paper states that the Patient and Client Council has its engagement platform, which is five individuals. The Department did an open recruitment exercise to identify other family members to join the programme that resulted in an additional three individuals being taken on. How many family members who have been directly impacted and have lived experience are involved in helping with the important work that you are carrying out? I am conscious that you said that the SAI procedures consultation might go out at the end of this year. There have only been two virtual meetings with the SAI family panel and written feedback, is that correct?

Mr O'Neill: Yes.

Ms Flynn: I am going by the contact that has been made with the Health Committee. As you will understand, we are still contacted frequently by families who are impacted, having been through one experience or another related to the work that you are dealing with. It is important that whatever goes out for consultation is as thorough and expansive as it needs to be in terms of what families want to see in it. How have you reached out to families? What did the Department's open recruitment exercise entail? How were people contacted? How did you reach out to people? I am always conscious that we deal with families daily in our constituencies, some of whom may be out of reach for the Patient and Client Council, despite the great work that it does. Their stories and experiences are just as important to feed into this work. Could you expand a bit more on the work with families with lived experience and the outreach?

Mr O'Neill: Yes, certainly. As I said, we have five family members on the PCC platform and three on the project structures. They have been integral in developing the documents and an invaluable source of feedback. I think that I am right in saying that we are the only part of the UK that will consult more widely, publicly, on an SAI framework. A significant purpose of that is to include those who may not be able to devote hours and hours of their time to a project such as this but, at the same time, want to feed back on what we plan to do. That is a key part of the public consultation process.

Ms Flynn: The Committee is in the process of arranging its own informal meeting with families who would like to speak about their individual experiences but may not have been tied in at any level to the work that you are doing. It is an ongoing process, so, if there were a request from families to engage with your structure — the liaison group or the programme board — would there be an opportunity for that to take place?

Mr O'Neill: In the production, we are trying to balance hearing from people's lived experience with delivery on our frameworks. We have agreed how we are co-producing it, which is through those two mechanisms and the third mechanism of a formal public consultation. I am not aware of any other specific people who have not been at least provided with the opportunity to be involved in the project structure and are looking to make additional input, but, if there are, that option will be available to them as part of the public consultation. I know that there are people on the PCC platform who have issues with some of the proposals. Their views will be taken account of as part of that process as well.

It is a question of how much you continue to expand that co-production and family input, and I think that we have got the balance right to date. It may well be that people whom we have not reached raise issues in the public consultation, but at least there is another mechanism to take those views on board.

Ms Bovill: I was getting the impression that your question was specifically about SAI, but you alluded to the independent neurology inquiry engagement group that we have established specifically for the INI recommendations and the implementation programme. Its door remains open to anyone, but we appreciate that families and former patients may not have the time to attend meetings or that it may be too painful for them. They may also be considering going down other routes, such as engagement with a PSNI investigation, or have a clinical negligence claim process ongoing. We appreciate the position that they may well be in, but the door is open. Patricia mentioned the positive engagement and constructive input that we have had from those members. The door is open to allow that to take place and for others who may want to contribute to the implementation work and the vision to come on board.

Ms Flynn: Thank you. I referenced the SAI work stream, but I was also thinking about the Julia Cumberlege review that you mentioned. Do any representatives of the mesh campaigns sit on your groups?

Mr Davis: The mesh report is a different type of report. Our intention is to bring it under the same governance arrangements as the other public inquiries. However, it is different in its recommendations on compensation. We are in a different place with that. Stakeholder engagement and service user participation are key to the success of any of the reports. We are open to and will progress engagement with service users, families and patients at the right point.

Ms Flynn: After the consultation, then?

Mr Davis: With Cumberlege and Hughes, as it is a UK Government-led programme, we are more dependent on what steps the UK Government take. We are waiting to see what happens at a UK Government level, and that will inform our next steps.

Ms Flynn: OK. Thank you.

Dr P Donnelly: Chair, may I just come in for a point of clarification on your opening remarks and go back to other members' commentary about adverse incidents? To be clear, trusts collect on Datix all the information on any event that reaches a threshold and on anything adverse. The trusts do the analysis of that. They retain that information and report on it, so there is a centralised system for that.

The Chairperson (Ms Kimmins): The issue that many of us have is with where that is progressed. In some cases, it is screened out. The concern is that, if it is not taken on board at the earliest possible stage, it leads to something much bigger that could have been avoided if it had been taken seriously.

Dr P Donnelly: I appreciate that concern.

The Chairperson (Ms Kimmins): I have a few small questions that came to me as we were talking. I did not think that everybody was going to come in, which is why we gave a bit of latitude for questions.

You mentioned that one INI recommendation requires legislation: what is that recommendation? When can we expect that legislation to be introduced, if it will be required?

Dr P Donnelly: It is recommendation 68, and it is specifically for the GMC. It will take national government to take that forward as part of a reform programme. The recommendation is specifically about the publication of information around rule 12 hearings. There is no discretion for the GMC in Northern Ireland to operate outside that legal framework, so it is waiting for primary legislation from the UK Government. We have deferred that, as it is outwith our control. There are no other INI recommendations that will require such legislation.

The Chairperson (Ms Kimmins): I have two other questions. In the health service, we are dealing with huge workforce pressures that are no secret. We have heard from many organisations, including the Royal College of Nursing, that they could paint the walls with SAIs at this stage. As part of any implementation of recommendations, there need to be protections for staff. That looks at safe staffing, and I know that we will consider safe staffing legislation. Is that being discussed with the Department as part of the implementation of recommendations?

It is OK to put recommendations in place — that is about protecting patients — but I am also conscious that, where incidents happen, staff are put in front of panels and all those things, when, in some cases but not all, the incident may have been the result of the environment that staff have to work in and things being missed. A very important aspect of any work that we do is a twin-track approach to ensure safe staffing levels as another means of mitigating the risk of incidents. Is the board doing that as part of the Department's engagement?

Mr O'Neill: On SAIs, among the documents that we will consult on later this year is a specific document about principles for engaging, involving and supporting staff. There is a focus on people affected and a specific focus on staff, so we are taking account of that as part of it.

The Chairperson (Ms Kimmins): Do you feel, Michael, that it is deliverable? You might not be able to answer this, but it is really important that, in this work, we are realistic in our commitment to support staff. A recommendation that comes out may say that we have to ensure that staffing is at a certain level, but is that deliverable in reality, given the funding constraints and the serious challenges across the workforce? Do you have concerns about that at this stage, or is it ongoing work?

Mr O'Neill: It is ongoing. Practising under pressure is raised with us. I am conscious that, next year, in addition to a new SAI process being opened and the duty of candour work, there will be a Northern Ireland Public Services Ombudsman (NIPSO) review of complaints. That is all happening to trusts when they are doing lots of other things. Therefore, we have to be mindful of the pressures that we put on the system from an implementation point of view. We are mindful of those things. It is something that we need to manage, and we are alert to it.

The Chairperson (Ms Kimmins): We are keen to see that as well, because it is probably the cornerstone of a lot of the issues that we see across the board.

One of the members asked a question on this final point. What outcome measures are used for implementation, and are families included as part of that? In measuring the success or lack of success, for want of a better term, what outcome measures are used, and are families having an input whereby they say that they can see the benefit of it?

Mr Davis: I will pass over to Patricia, who can give a bit more detail around the assurance frameworks that we have in place for each of the recommendations. Essentially, we have mechanisms in place to ensure that, from the Department's perspective, recommendations have been fulfilled. As Patricia mentioned, there are various levels of assurance as to how those are continually maintained when they are mainstreamed.

Dr P Donnelly: Indeed, Chair, as part of that, it would also look at what are the normal accountability processes to the Department and what is published by trusts in their governance and controls assurance statements or by the regulators — whether it is to do with training, registration or whatever — or any other external body that reviews the services.

In the new guidance on integrated governance, we ask trusts to act on the feedback that comes through to them. We want to see them being able to do that, whether the feedback comes through Care Opinion or a specific dedicated feedback mechanism that they have put in place because of an initiative that they have undertaken. The strategic planning and performance group also has an accountability process for monitoring some of that.

As I said in my opening remarks, you really want to have a "business as usual" model rather than to be saying, "We have a series of inquiries", because there are so many inquiries and so many recommendations. You need to make it work as business as usual as much as possible. I am sure that there will be a point at which you will start to look at the post-implementation of all the recommendations. At that point, it will be a matter for the implementation board to consider the look-back, what is needed and whether additional assurance is required.

The Chairperson (Ms Kimmins): OK. Thank you, all. The session went on a bit longer than we expected, but it was useful. I am sure that we will have further questions after we meet the engagement panel. We appreciate your time.