Official Report: Minutes of Evidence

The Chairperson (Mr McGuigan): I welcome Professor Lourda Geoghegan — hopefully, I pronounced that correctly — deputy chief medical officer, and Paul Cavanagh, director of hospital commissioning, strategic planning and performance group (SPPG), Department of Health; Dr Joanne McClean, director of public health, Public Health Agency (PHA); Stephen Austin, medical director, Southern Health and Social Care Trust; and Moira Kearney, interim director of cancer and specialist services, Belfast Health and Social Care Trust. I should point out that there are representatives and individuals from Ladies with Letters in the public gallery, and we also welcome them to the Committee. I will hand over to you to make some brief opening remarks and then we will take questions.

Professor Lourda Geoghegan (Department of Health): Thank you, Chair, and thank you for inviting us. There are quite a few of us, but we appreciate that the matters are pretty complex. Hopefully, we have the right people to cover the right areas that you will have questions on. I will say a couple of words in opening. If you need me to move on because of time constraints, I am happy to do that along the way.

In advance of today's meeting, we provided the Committee with some written information. I am happy to answer questions on that, and my colleagues will answer any questions that arise.

Before we go any further, we begin by saying that we are all very conscious of the patients — the ladies — and families who are at the centre of all the matters that we have been discussing. They are very complex matters, and we and the Minister are conscious, as we have been right through, of the impact on individuals and their family members, supporters and carers. The Minister, the Department and I certainly acknowledge that the past number of years have been very challenging for the group of women impacted and for their wider families. As the Minister has said before and I say again today, it is deeply regrettable. I also acknowledge that, as I have said, the matters are complex, so we will endeavour to answer questions on them in as straightforward a way as we can. We reassure members that, at all times, we are trying to keep the discussions as straightforward as we can. Please do ask questions and interrupt if the answers that you seek from us are not clear.

There are eight population-level screening programmes in Northern Ireland. Three of them are cancer-related programmes, one of which is the cervical screening programme. The Department is guided on policy by the UK National Screening Committee, which sits in London. That is an independent expert committee that advises the Ministers and all the Health Departments on policy matters and evidence-based research and so forth on all population-screening programmes, not just the cancer ones. We also have the Northern Ireland screening committee, which is chaired by the Chief Medical Officer, Professor McBride. That looks at matters that arise from the national committee in the context of Northern Ireland and advises the Minister and the Department accordingly. It is then for the Minister to consider and decide on the screening policy for Northern Ireland.

A range of organisations are involved in the provision of the screening programmes and in their oversight and assurance. For the cervical screening programme, the providers include practically all general practices, all the trusts and the business services organisation (BSO). The BSO is involved because there are complicated infrastructural pieces behind the screening programmes: IT, call and recall mechanisms and so forth.

At a regional level, the SPPG and my colleagues in the PHA have important roles in the delivery, oversight and assurance of the programme. A combination of systems run for overall governance and oversight. Systems will run in individual practices, which may do smear tests for ladies; in trusts, which do a small number of smear tests but provide a lot of the laboratory services; at a regional level, for the Public Health Agency to partially commission and provide quality assurance (QA) across the programmes; and for my colleagues in the SPPG, who do a range of work on quality, service provision and funding. The Department will, obviously, look at policy. A range of complicated pieces go on across any screening programme.

I will directly speak to the matters at hand. Following the provision of the Royal College of Pathologists (RCPath) report to the Southern Trust, the Department established an additional oversight committee called the cervical screening oversight and assurance group so that we can receive assurance about the improvements and the work that needs to be done to address some of the problems that have arisen during cervical screenings. The group is co-chaired by Peter Toogood, deputy secretary, social care policy — a grade 3 — who has overall policy responsibility, and me. A range of organisations are represented on that group. When it started its work, the group met weekly. It now meets monthly.

The overall aim of the Minister, which we, as the Department, are charged with serving, is to clearly understand what occurred with the screening programme, particularly with the delivery of the service in the Southern Trust. He wants to understand why it happened and what the responsibilities are for it, and he wants to see that lessons have been learned and that such matters will not happen again. We are all charged with ensuring that we have a high-quality, well-functioning screening programme, the aim of which is to reduce and, as far as we can, eradicate cases of cervical cancer in Northern Ireland.

A number of things have been ongoing in order for the Minister to reach a conclusion on those questions. Committee members will probably have questions about some of that work. The Royal College of Pathologists did its work. Its report, with a number of recommendations, was then published. All those recommendations have been implemented. There were recommendations for the trust and the region. One of the very important recommendations was that we should move away from using cytology, which is laboratory-based and involves making slides that are looked at under a microscope, as the first-line test. That recommendation has been fully implemented, so HPV testing is the first-line test.

Committee members will be aware that, following the Royal College of Pathologists report, the Southern Trust and the PHA jointly undertook and oversaw the review of the slides of about 17,500 women. The majority of that work was a look back, but some were called forward to be looked at. The report of that work and the report on all the cancer data from the Cancer Registry were published in December of last year. A number of other pieces of work are coming to a conclusion, and the Minister intends to publish the reports. Three to four pieces of work are coming to a conclusion, and the Minister's preference is to publish them together. They include an expert opinion from experts from outside Northern Ireland on the two reports that have already been published. The report of the peer review visit that NHS England undertook to look at quality assurance, which sits with the PHA, has literally just been received by it. That will go into the mix for the reports to be published together. A number of learning reviews are ongoing that involve patients, predominantly but not only those who receive care in the Southern Trust. Those learning reviews are reaching a conclusion, and the Minister's preference is that the recommendations of their reports also be published at the same time.

We will shortly be able to look at timescales for publishing the rest of the reports. I flag that up because it is difficult to have an understanding across the piece until all the reports are available and people can look across the piece. That is where we are. We will be happy to answer any questions on individual pieces along the way of that journey. We are probably two thirds to three quarters of the way through getting all the pieces looked at and the reports published.

Before I conclude, I want to say a couple of brief things about screening programmes, particularly cervical screening programmes. As I mentioned, the matters are complex. All the services that are involved in the screening programme are delivered through our trusts and GPs. They are delivered in the same way as services for somebody who is symptomatic are delivered. People who are participating in the screening programme should not see a difference between a screening service and a diagnostic service, but, when we look at them with regard to oversight, management and functionality, we will see that they are quite different. That is why the conversations can be quite complex sometimes. Forgive me if we give a bit of context around some of the answers to your questions: we sometimes have to explain the context for a screening programme, which might be different to a diagnostic programme.

The other thing that I really want to highlight is the focus of all of us on ensuring that we continue to have good participation in the screening programme. It is possible to almost eliminate cases of invasive cervical cancer as we go forward. We have a vaccination programme that is delivered in our schools and through some of our sexual health clinics. Again, we will be happy to answer any queries that you might have on that. That has been running since 2008 for girls and 2019 for boys. That is reducing the prevalence of HPV infection. HPV infection is associated with cervical cancer and a range of other cancers. A combination of the vaccination programme and a good screening programme with good coverage is what will enable us to reduce our cases of cervical cancer to a minimum. I will not use the word "eliminate", but it is possible to reduce the incidence of that cancer significantly. We are all focused on getting there and supporting people to get there, while understanding, if and when things went wrong on the programme, what happened and how it is remedied.

I will pause there, Chair. We are very happy to take your questions. Because the matters are complex, I am happy to direct members' questions to the appropriate colleague, if that works for you.

The Chairperson (Mr McGuigan): Absolutely. I have one question. You said that you were two thirds of the way through producing the three reports for publication. Can we have a time frame for when they are likely to be published?

Professor Geoghegan: Obviously, we do not want to publish in July, when people will be going on holiday, but I would say that, once we get into August, we will be looking at dates in August or September. It is imminent. In some cases, the reports are just being checked finally for factual accuracy and concluded. In other cases, the peer review report has been received by PHA, is being considered by the board and the Minister has literally just had sight of it and has not had a chance to consider it. Most important is that the learning reviews involving the patients are just coming to a conclusion. It was really important to the Minister and us that the people who were involved in those reviews had a chance to meet the review teams, ask their questions and receive copies of their reports. We do not want to impact on that timeline, so, once that is done, we will plan to publish the others. I would say that it will be in the short term: it will not be extended well into the autumn time.

The Chairperson (Mr McGuigan): That is helpful.

Mrs Dillon: Thank you for your presentation. The first point that I will make is that a number of members have been contacted about a specific case. I do not want to breach any confidentiality. The Department has received that; well, I forwarded it, and I am sure that other members have as well. We definitely want to have a conversation about it, because that case shows that problems still exist, even with regard to how people are dealt with on a human level, how those things are managed and confusion between trusts about who is gives certain information and who deals with meetings. That is just not acceptable, so we want to follow up on that. That is as much as I will say about that to respect confidentiality.

A lot of detail is provided on the decision-making process for moving to single-site HPV testing, including the need to complete a minimum of 1,500 screens per annum and for checkers to complete 1,000 screens to maintain competency. The words "sustainable" and "resilient" are used. Those things are extremely important, but can I get some detail on what that means for accuracy and, therefore, for the outcomes for women? That is my first question. Do you want me to give you all my questions?

Professor Geoghegan: I am happy to be guided by you, Chair. Because they are complex matters, it might be easier to take each question on its own, if we can, if that would help.

I will hand over to Dr McClean, who will answer your question on service configuration.

I am very mindful of confidentiality, but I will comment on the individual matter that you spoke about. We have received that feedback, and so has the Minister. I have shared it confidentially with senior staff in both trusts and asked for it to be addressed urgently in an integrated way so that the re-engagement with and feedback to the family in question is integrated and supportive. I give you that reassurance.

Mrs Dillon: I appreciate that.

Joanne, what does that competency piece mean specifically for accuracy and outcomes for women? We have all the detail, and I am very conscious that other members will have detailed questions. My question is specifically on accuracy and outcomes.

Dr Joanne McClean (Public Health Agency): The recommendation to move from four laboratories, as there were at the time, to one was first made in 2014 by the Northern Ireland Pathology Network. That is exactly what it sounds like: a network of all the laboratories that work in pathology across all our trusts. It comes together to provide advice and guidance to commissioners and services. It recommended back in 2014 that we should move to a single-site model. We took the decision to move to a single-site model for the reasons that you outlined. It was really about resilience, sustainability and outcomes.

I will give you a flavour of the numbers that we are talking about. We have gone from doing between 110,000 and 120,000 cytology reviews down to about 14,000 to 15,000 really quickly. We expect that number to reduce further for a couple of reasons. The first driver of the reduction will be the introduction and success of the HPV vaccination programme. As young people who are vaccinated become adults of screening age, the prevalence or amount of HPV in the population will go down. The number of slides that we receive that are HPV-positive and need cytology is predicted to fall further. It may fall by about half over the next 10 years or so. That is one of the reasons. When we looked at models across the UK, we saw that, in England, there are eight laboratories —.

Mrs Dillon: Joanne, I appreciate all that, but that information is in the papers.

Dr McClean: You have got that.

Mrs Dillon: For me, I want to understand what it means for accuracy. Will we get greater accuracy if the need for screeners to do 1,500 screens is fulfilled and the 1,000 —.

Dr McClean: That is the aim. The aim is to create a team that sees enough volume, gets enough practice and does enough continual learning with one another, as well as professional learning and training. It is about having the size of team that can deliver that. That will give you better outcomes. It also allows an assessment of how well the lab and individual screeners are doing. It makes it more streamlined, and it should be more accurate, therefore leading to better outcomes in the laboratory.

Mrs Dillon: I appreciate that. On the back of that, were the trusts meeting the level of screening that was needed to ensure competency? I know that you cannot give any guarantees, but, had that recommendation, which was made in 2014, been implemented at that point, would it have given us a greater chance of screeners having the competency to ensure that what happened did not happen?

Dr McClean: The reduction in laboratories would, I think, have been of some help. However, it would have been difficult to reduce the total volume of screenings that we were doing. Doing 120,000 in one lab would have meant a very big laboratory. The recommendation was made in 2014 in the knowledge that the HPV vaccine would reduce prevalence and that the introduction of primary HPV testing would further reduce cytology. That recommendation was not carried out in 2014. Any sort of reconfiguration of any service is difficult, but it was really important that it be done as part of the introduction of primary HPV testing, so we got a lab that was big enough to deliver a good outcome for women.

Mrs Dillon: I appreciate that, but we could not rule out the idea that, had it been done sooner, we may have had a different set of circumstances today. I do not think we could rule it out, though I am not ruling it in.

Dr McClean: I do not think that we can say. I was not involved in 2014, but it would have been difficult to squeeze all that activity into one lab, because that is a lot of cytology. It would have been a challenge. It was even a challenge to do what we did, and it continues to be a challenge as the service gets up and running. The reason for and aim of having one laboratory is to get a better outcome for women.

Mrs Dillon: I have two other questions. The first is about the reduction in screening from every three years to every five years. That is based on HPV testing. I want some understanding, because I did not really get it from the papers other than their saying, "It is because of HPV testing". Can we be confident that the increase in the period between screenings from three years to five years will not pose a risk? Do we have strong evidence that it will not, given that HPV testing has not been in place for that long anywhere?

Professor Geoghegan: We have not changed the screening intervals in Northern Ireland as yet. Other countries have at this point —.

Mrs Dillon: There is a plan, or it is at least under strong consideration.

Professor Geoghegan: It is under strong consideration, but there is no timeline associated with the plan for a couple of technical reasons that I will explain. The national evidence and advice was provided by the UK National Screening Committee before 2020; it might even have been before 2019. Wales and Scotland moved that interval in the years before 2020; I do not know the exact years. England moved it pretty recently. The nations that have moved it will generate evidence that we will be able to use. We have not changed any of the screening intervals yet, because, in the first instance, we have just moved to primary HPV and, secondly, the change needs IT and technical development behind it. The digital teams are looking at when it would be feasible to do that digital development. As you know, we have Encompass and a new laboratory information system, all of which is tied up in what can be achieved digitally.

In summary, we will have evidence from the other countries. The other thing that we will need to take account of is that, as the prevalence of something falls, screening too frequently is also a risk to the population, so we need to balance that. We do not have definitive dates yet.

Mrs Dillon: I understand that. Perhaps we could get some feedback when that becomes more apparent.

Professor Geoghegan: Yes.

Mrs Dillon: On page 224 of our papers, there is a paragraph about HPV testing — we are still talking about individual trusts making a referral to the Health and Care Professions Council (HCPC) if there is a concern about the performance of screeners. Does that mean that that will be entirely the responsibility of the Belfast Trust? What oversight is there of that? I have consistently raised this: how will that be overseen by the PHA or whatever the oversight body is? We cannot allow the same thing to happen again. The Ladies with Letters have raised the issue in a slightly different context: they are looking at the past, whereas I am looking at where the oversight is now. However, it is the same issue. I do not really understand why the oversight did not kick in in the Southern Trust. I want to make sure that it will kick in for any future issue.

Professor Geoghegan: You are talking about laboratory services and the overall screening programme. You are talking about both.

Mrs Dillon: Yes.

Dr McClean: At the outset, all of us thought, "Gosh, this was a long time. How did that happen?". As Lourda said, the review was done by NHS England. We received it the week before last, I think, and we have had a look at it. One of its recommendations is about how we strengthen things. It makes a number of recommendations about how the PHA interacts with trusts, and how we specify what we expect from them. There has been a lot of uncertainty around the data. We have had discussions in the past about how it was calculated and how we should be clearer about standards and about the specification of things that must happen in the lab, so that it is clear that those things are not optional and that you cannot do a different thing.

Really importantly, NHS England made recommendations on how we in PHA should get some external — I mean outside of Northern Ireland — assistance with QA. If we move to one laboratory, we will not have that independence from a QA lead. We are looking at the recommendations. NHS England made some specific recommendations about how we secure external expertise to do that very specialist laboratory QA in future. We have those recommendations from the NHS England peer review. They are helpful, and we will put in place a plan to implement them. One of them is specifically about how we quality assure around the laboratory.

Mrs Dillon: We definitely need a better understanding of that, including what it is going to look like. I would like to think that, when all the reports are published, you will be back in front of us and we can have those conversations with you.

My final point is about the distribution of the reports before they are published. The Ladies with Letters and every person who is affected by this should be entitled to have sight of the reports if they wish. Not everybody will want that, but is there a way of working that out? It has been done before, Lourda. I have dealt with the Historical Institutional Abuse (HIA) inquiry, and the mother-and-baby homes and Magdalene laundries inquiry. A process is put in place whereby victims and survivors are given the information. It may be shortly before publication, but those people are given their place and that information. I go back to what I talked about at the very start: it is about that humanity and making sure that the people who are most impacted are given their place.

We should go back to the Minister. I ask you, as part of his advisory team, to go back to him and ask him to look at how that can be done. It does not mean that everybody will have access to the reports, but people should be offered that and whoever takes that up should receive the information. The offer should be made, at least. There has to be some way to put that in place.

Professor Geoghegan: I am happy to take that back to the Minister and discuss it with him. I think —.

Mrs Dillon: It could be done on a confidential basis. If we are entirely honest, reports have been leaked by people who were not victims and did not suffer because of certain issues; they have been leaked by people in this Building, so, for me —.

Professor Geoghegan: I am happy to take that back and talk to the Minister about it. We hear a range of views on this, including strong views about wanting prior knowledge and information. We also hear the opposite, and I have heard that said myself: people have said that they would not want it. We are trying to balance a range of things, but I am content to take that away from today's discussion and talk to the Minister about it again.

Mrs Dillon: It could be done within a time frame. That is how it is managed in the mother-and-baby homes inquiry. I acknowledge that it can be constrictive for the victims and survivors. It is not ideal or perfect, because we are trying to meet the needs of many people, but we have to find some way of managing it. Such a way has been found in other circumstances, so we know that it can be done. Nothing that will be done in this circumstance will be perfect. We should just acknowledge that now: because of the harm that has already been caused, we are not in a perfect situation.

Mrs Dodds: I thank you for the presentation and for coming back to the Committee. At the outset, I must say that there are people in this room who are deeply involved in this. We owe them our thanks for their persistence in trying to get answers for their loved ones. Some in this room have lost loved ones.

Every time I return to this, more questions are raised than are answered. That is why, at the end of the day, we will need an inquiry that establishes the truth, notwithstanding the reports of the reports that are due this summer.

I go back, first of all, to the issue of screener data, which is massively important. The Committee has been asking for the individualised screener data across all trusts for a very considerable period. I note that, at paragraph 45 on page 187 of our papers, you say that you are still analysing that data in order to present it to us. I will say more about that in a minute.

This morning, I was given a determination from the Information Commissioner's Office. UTV had asked for the same data, or maybe for similar data from a limited number of trusts. The same excuse was given to UTV as was given to this Committee, indicating, "No, sorry, we cannot give you the data because it might identify individual screeners." I now have the decision of the Information Commissioner, who says that that is not true, that the data should be provided, that it should be provided in the way in which it was requested and that it has to be provided within 30 calendar days of the commissioner's notice. That was issued this morning, 3 July.

Why are the trust and the PHA so hesitant to provide us with the data, given that, having reviewed your submission and the request, the Information Commissioner said that there was no reason why the data could not be provided without identifying individuals and screeners? The data that was provided to the Committee is generalised, which is of very little use to us in assessing screener performance. Screener performance is key to the whole issue.

Can I have some thoughts on that?

Dr McClean: I will answer from a PHA perspective. We received a freedom of information (FOI) request some months ago. Initially, I think, the determination was that the data would not be released for two reasons. It was partly to do with a worry about identifying individuals, but the other reason was that the work that was required exceeded the FOI limits. The person who put in the FOI request appealed that decision. That was considered through the PHA appeals process, and we responded to say that we would provide the information to the individual but that we could not do it within the FOI window. That is because it genuinely took a lot of work.

We now have the data. We pulled the data, and we had to go through a process of checking it with the trusts. One of the issues is that the data around this has been really hard to understand. As a public health person, I found it hard to understand why that has been so difficult. One of the problems that we came up against is that, unless you calculate it in a specific and particular way, you will get a different answer every time. The data was calculated and was reviewed by the trusts, which have all said that they are happy that the PHA has produced an accurate reflection of their data and that it was calculated as the PHA set it out.

The data is being finalised, and we hope to be in a position to release it to the FOI requester and to the Committee in the next few weeks. We have worked on it. It was not as simple as just typing it into a computer and it all coming out; there was a lot of work behind it. As I said, in the PHA, we made a determination that it was in the public interest to get the data, but we needed a bit longer to do so.

Mrs Dodds: Why did you use the excuse that the could identify individual screeners? I will, for the Committee record, read paragraph 24 of the decision. The commissioner:

That is what you told us for months and months, and the Information Commissioner has now decided that that is not a relevant consideration.

Dr McClean: I will come back on the identification. I cannot answer for the trusts, and I have not seen the determination; it is one for them. From the PHA's perspective, the concern was that, if you were to look at, say, "Screeners A to Z", and you had the same data for the following year, you would be able to say, "Screener A worked between x and y, so that must be person X". There was a bit of concern about that. As I said, in the PHA, we determined that that information was in the public interest. We are going to provide it and have worked to do so. Unfortunately, I have not seen that determination.

Mrs Dodds: You can understand why this raises a lot of concern for us when you see the the lengths that we are going to. We are a scrutiny Committee — a Statutory Committee — and we do not have the information. The Information Commissioner says that there is no reason why the information cannot be released, yet we are still weeks away from getting it. Part of the problem with this whole episode is the failure to supply information in a timely manner.

The data and information are important. I am reliably informed that the PHA sent data to each trust and that, on screening data, there is something called an annual data visit by the PHA to each trust. I am just a simple politician — who am I to ask this? — but why can we not have data that is supplied every year?

Dr McClean: I would need to check that, but I think that that data has been supplied on previous occasions. What was asked for in the information requests was individual screener sensitivities over a very long period of time for all the screeners. It was not just about looking at the 10 screeners who worked in 2025 but about going right back, so there had to be a bit of a historical look at it, but —.

Mrs Dodds: If we had that data on an ongoing basis, we would be able to assess screener performance. I assume that that data indicates screener performance, and we would be able to assess that. You are bound to have been able to assess that.

Dr McClean: That is one of the things that the trusts and the PHA assess. As part of what the trusts do in the programme, they constantly look at the data and take actions where there is deviation. The data meetings and quality assurance meetings that the PHA have with the trusts are partly about reviewing that data annually. Where there are deviations or people do not meet the sensitivities, the reasons are explored and remedial actions are put in place.

We have said this before at Committee: one of the issues in the Southern Trust in the past was that the data was not viewed over a number of years. If screener A underperformed one year and you said, "We will fix this by doing x, y and z", there was not a robust enough process of going back and asking, "Did they underperform in the next year and the year after that?". We have accepted before that that needs to be improved and to run over a number of years, but it feels overly complicated. I assure you that I want to be as transparent as possible and to provide as much accurate information as possible. One of the difficulties has been that, depending on exactly how you run the data, you get different figures. That has been a challenge throughout the process.

Mrs Dodds: I will move on. The way in which that data has been withheld is really unsatisfactory. The way in which data was scrutinised and quality assured in the Southern Trust is clearly an issue. I am told that that may be an issue in other trusts. There is a real issue around the data. The fact that people have to go to the Information Commissioner to get a resolution on the release of that data is really appalling. In Health, we should be much more transparent than that.

Linda alluded to the serious adverse incident (SAI) process. I am conscious that that is a live issue and that there are people who are deeply affected by it. However, 12 cases were to be reviewed under the SAI process. I do not want any individual or private information, but can we have a round-up of where those 12 cases are at? Lourda, you now know of the horrendous circumstances in which one of those cases was dealt with. Do you know of any others that have been dealt with in that way?

Professor Geoghegan: First, I will hand over to Stephen on your question about where the trust is with the overall process involving the 12 cases.

Mr Stephen Austin (Southern Health and Social Care Trust): Thank you for the question. First, we are very conscious of the hurt that people suffered with the disclosure. We have learned from the SAI process so far that disclosure is a difficult thing. For a woman to hear the results of the audits that relate to invasive cervical cancer is in itself very challenging. It is ultimately becoming clear that the process does not help us to share that information with women.

How the disclosure process is done, particularly across the UK, has not really been looked at. There are broad guidelines, but they have not been reviewed. Disclosure was one thing that we specifically asked about in looking at the more recent SAIs. We had a large number of cases at once, so we wanted to get some learning on that.

You asked about the current situation. The multi-patient SAI investigation for 12 patients is nearing conclusion. There is a bit of listening to take place with a number of families and women, which we expect to conclude shortly, and the final report will then be produced.

Early learnings give us an idea that one of the issues is how the disclosure process is done and how it can be improved. There is really good learning from that. The trust, having had a bit of insight into that over the past number of months, has been looking at how it can improve that. We have been talking to patients who have been impacted on by it and have taken that learning and their suggestions to try to improve the process.

We have a new procedure in the Southern Trust that we are, more or less, seeking to finalise. It is about better communication with women to understand why they are coming for disclosure and to give them support before and after disclosure, because it is very harrowing to receive that information. It is also about who is present in the room: you do not really want to be met by a panel of about 10 people; you want people whom you have met before. Usually, according to best practice guidance, the gynaecologist should be there. There is learning from that that we can take forward.

You are right to say that the disclosures, to date, have not been as good as they could have been — absolutely — and we accept that, clearly. However, there is real, good learning that we can put in place to improve that, involving ladies who have been impacted on by that. Being seen would have worked better for them: that is really important to them, and that is what we have been doing.

We will share the disclosure process that we have come up with with the other trusts. Our preliminary feedback is that there is interest across the UK in the work that we are doing to review the disclosure process, because there is a recognition that it is a very challenging conversation to have with women, and the UK is interested to see what learning we have. As I said, it has not been looked at in detail before. I hope that that answers the question. We recognise that there is a problem, but we are developing really good learning for that. Disclosure will always be difficult but, hopefully, it will be done in a better manner, with better communication with women, and they will be given clear information along with appropriate support.

Mrs Dodds: That does not help the people who have been through the current process. Those people have had a very harrowing time. What additional supports have you put in place for those women and their families?

Mr Austin: What we do is — . What is supposed to happen is that ladies will be given a dedicated liaison officer, who will support them through that process. That is somebody who is not part of the disclosure process but is there simply to support women. They are specifically trained to provide that support and listen to requests for any clarity that is needed and then to go back to trust colleagues to get that clarity on various matters. They are also there to provide women with support and direct them to different pathways, whether that is for psychological support or support from general practitioners, and to make sure that women are not left on their own and that they have people with them when they hear news. It is really important that that be carried forward and to have liaison staff who are dedicated to a particular case. Not all trusts do that, but, in the Southern Trust, we certainly do.

Mrs Dodds: I see a lot of heads shaking behind you, which would indicate that that has not happened. The distress that that has caused is really — almost unforgivable. That really — .

May I ask a final question, Chair? Many of us will have listened to the interviews that were given recently about the process whereby this came to light. I have just two questions to clarify the process that the trust followed. When the consultant pathologist said, "Stop. There is a problem here", what happened, and what was the timeline before action was taken by the Southern Trust?

Mr Austin: In reviewing the data, the consultant noticed issues with it, so he looked at the data from a bit further back and took the precautionary step of taking various screeners off screening duties. He did that himself, liaising with the laboratory staff, and those staff ceased screening from that time. At that stage, the staff member tried to raise those concerns upwards in the trust. That was around 2021-22. He raised the issues with senior members of staff in the laboratory service. As I understand it, they tried to investigate the situation, which was escalated to the trust's senior management. That process took too long, however: it seems to have taken approximately six months for it to be escalated to the senior team in order to get further action and for the trust to get that information.

There are a number of factors in that, and we are speaking to the people you mentioned to understand it in much more detail. Those discussions are ongoing. We are investigating in detail so that we can understand how and why that happened and how it can be rectified. It appears, however, that the time that it took for those concerns to be escalated was longer than I would have liked it to be. If that were to happen today, I would like to hear things much quicker than that. For those reasons, it seems that that was delayed.

When the information was seen by the trust directors at the trust's senior table, it was acted on very quickly. Thereafter, they instituted the Royal College of Pathologists review and so forth; that is well known. You are quite right, however, that there seems to have been too long a delay in that. That is one of the things that the trust apologises for, because that should have been done much more quickly, but there is learning to be had from that about how we do things in the future. Part of that is about trust staff raising concerns — knowing who to refer their concerns to — and those concerns being listened to as quickly as possible. We are certainly making it very clear to trust staff that they should raise concerns directly with their line management, and that, if they cannot do that, they should speak to me or other directors in the trust. We are happy to hear those concerns. The whistle-blowing process is also available. Again, we are happy to hear from any members of staff through that process. We support staff in that, and there are ongoing discussions with staff about this matter in order to make sure that we get the full learning from their experience. It is important that we do that.

It absolutely took too long.

Mrs Dodds: It is 2025. It happened in 2021, and you are still in discussions with staff to take the learnings out of it. That seems like an incredibly long time to discuss learning about something that should have been pretty automatic: "There's a problem here; we need to deal with it. Women's lives could be lost; we need to deal with it". I am incredulous about its taking that length of time to get action, on something that is very important, that means that we are moving towards doing something.

This is my final question. My understanding is that, when a woman is given a diagnosis of cervical cancer, which is a devastating diagnosis, they are not offered their cytology history but have to ask for it. Is that correct? If so, why is that case?

Dr McClean: This is what should happen. For every woman diagnosed with cervical cancer, it is, as you say, a devastating diagnosis, and there is a lot of information to take in. Every case of invasive cancer becomes part of the invasive cancer audit. Before that starts, however, there should be a discussion with the woman at an appropriate time at the point of diagnosis so that she understands that we will look at her screening history in due course: if she has previously attended screenings, her slides will be reviewed. At the point of diagnosis, they should be given a leaflet with some information. The purpose of the leaflet is to give the information and to give it to them to take away, because a lot of information comes at them at that time. They should be told at the point of diagnosis or as close to that as is appropriate. The guidance says that the audit should then be completed and shared with the woman within, I think, 12 months. Whether the woman wants that disclosure and to find out what has been found is up to her. She would discuss that with the people who are looking after her.

Mrs Dodds: How is that person asked whether they want disclosure?

Dr McClean: As someone from the PHA, I should say that that takes place in the trusts. The guidance says that there should be a discussion with the person who is treating the lady. Often, that is the gynaecologist, who will say, "The audit will take place. Do you wish to find out the results of the audit?", and, "How would you like to find out the results of the audit?". Some of the work that the trust has done on the disclosure meetings has identified a lot of areas for learning, including on how the audit is discussed with women and how the information is disclosed. The discussion should take place with the treating team.

Mrs Dodds: OK. I will not pursue that too much further at the moment, other than to say that I have had conversations with women who had that diagnosis. They were given a leaflet and asked to tick a box to indicate whether they wanted to know their cytology history. It was only when they ticked the box that representatives from the trust arrived, en masse, to tell them what had happened.

Unfortunately, one of those women is no longer with us. I would like to think that the trusts, the PHA et al. will take this on board and understand how utterly devastating it is to hear that your slide has been lost. You have had misread slides, some over three periods — nine years — and only when the cancer is diagnosed are you asked to tick a box to indicate whether you want to know.

Miss McAllister: Thank you very much for coming today. We had an earlier session at the trust premises, so a lot of my questions are ones that I asked then to which we may not have had the answers back then. I also want to recognise that the people who were involved when the issue first came to light — not the issues with the screening but the issue that came to light with the service — and who need to answer the questions are not here. That is why the inquiry is needed: to get the people who were there to answer questions. That is important to note, because one might see different faces at the table if it were an inquiry.

I will ask a question supplementary to Diane's question. What about the women who were diagnosed before 2019? What about their history?

Dr McClean: For anyone who was diagnosed before 2019 and wishes to find out about their audit, the best way to do so is to contact us in the PHA. On the nidirect website, there is an email address at the end of the cervical screening information. If any woman who was diagnosed before 2019 feels that she has not had an audit discussed with her or wants to find out more, she can email that address, and we will contact the relevant trust. We thought that providing a single point of contact in the PHA would be better than women having to chase the trust and finding out that, perhaps, the person who had treated them had gone. That is the best way to get it done. We will link them to the relevant trust.

Professor Geoghegan: As part of the discussion that we had at the oversight and assurance group, we asked that ethics discussions be taken forward by the PHA with the regional ethics committee to inform what the approach would be. The approach that has been agreed was fully discussed with the regional ethics committee, and it is about that balance of harm. There is a piece about transparency and providing a route for people if they want information, and we balance that with going back to people potentially from some time ago, which might be re-traumatising. Therefore, we specifically asked the PHA to have discussions with the regional ethics committee, and they have done that to inform what the pathway looks like if people from pre-2019 come forward.

Miss McAllister: What did the ethics committee say?

Dr McClean: It advised that we make the information available to women who wished to come forward, which is what we have done.

Miss McAllister: It is important, because one of the screeners was flagged with the trust in 2019 over performance issues, but no action was taken on that screener. That was brought to my attention. Is that a true reflection of 2019 and performance then?

Professor Geoghegan: We would have to see that from the trust's perspective.

Mr Austin: I do not know the specific case that you are talking about, but, as I understand it, each screener's performance was looked at, and remedial action was then taken for that year. As I said last time to the Committee, the failing seems to have been that they did not look back to previous years to spot patterns of activity. Within the year, remedial measures were put in place for performance, but, the following year, that was not checked to see whether it had made a difference. They just looked at each year in isolation. I described that to members — I know that the Committee membership has changed — last time. That is part of the learning that we have got: making sure that we look across trends in more detail. It is obvious now, but, for whatever reason, it was not obvious when those policies were designed.

Miss McAllister: That is important, because it could flag women who were diagnosed before 2019 who need to have their other audit done.

Data is important, but so is conduct. That issue has also been brought to my attention. The issue was flagged in 2019; we then move forward to October 2021, when the whistle-blower, who has already been on the news and appeared in a UTV report, immediately took steps to take two screeners off duty. That was the right decision.

I have also heard discrepancies in when things were raised. At the previous Committee session on this issue, I asked questions about the six-month delay. There have been claims and counterclaims — a lot has been said in public — about an internal meeting with the PHA in February 2022 to deal with whistle-blowing and grievances and to make sure that it was aware of the issue. I do not know who was at that meeting, but it was raised then. It is also possible that, between February 2022 and July 2022, an associate medical director brought the issue to the trust's senior leadership. I assume that there are paper trails of everything, given the number of internal processes and grievances that happen. The information that the Committee has received publicly is being contradicted by information that we are being given in good faith in private. I am not sure how we can square the circle of who knew what and when.

That brings me to a question about the paper trail: will there be a disclosure of when meetings were held, who raised what and with whom and the point at which the leadership team became involved?

Mr Austin: Thanks very much for that. My understanding is that various issues were raised, as I mentioned earlier, by the consultant and that those were then raised in the lab management. I understand that the data was looked at at that level, that it escalated and bubbled up through various levels in the trust, as you described, but that it did not get to the senior director level of the trust until around June or July of that year. Prior to that, there was escalation in the trust, but part of that was about internal scrutiny that colleagues were doing to look at the data, understand it better and see what the issues were from their perspective. To my mind, that took far too long; it should have been escalated much more quickly, as I have said. I would have preferred, as one of the first steps, to learn about the issue at the same time as everybody else. That would have made a difference. That process seems to have taken far too long. Perhaps people were over-checking the data. That seems to be part of the situation that you are describing. I recognise what you are saying: a bit of time was spent looking at stuff, but the problem is that the issue was not escalated fully to the senior leadership of the trust quickly.

Miss McAllister: I raised that only because the cervical screening scandal is not the only issue that has arisen in trusts across Northern Ireland with regard to being open and transparent and in ensuring candour about what is going on. It is important that all the i's are dotted and t's are crossed and that there is a paper trail back to 2019. At that time, when there was a yearly look at the individual rather than at trends, was the issue with that screener escalated in the trust? Do we have all the paperwork for that? That is important, because it highlights when you should get involved and who should be involved. Hopefully, that will be reflected in the report and any learning from it.

Has there been any examination of the Kent and Canterbury inquiry or of the issues that arose from it? My understanding is that, between 1990 and 1995, 30 women required a hysterectomy, 333 had a misread slide — they were told that it was clear when it was not and there was, in fact, a high risk — and eight died. It took six years for the equivalent body there to be open and transparent. I recognise that the situation is better here — you have come to the Committee to answer questions — but those stats, relative to the population and the number of women affected, are lower than those here in Northern Ireland. That was described at the time as one of the worst medical scandals that had arisen, but we have not had an equivalent inquiry here. I am not saying that individuals do this, but it is as if the figures are dismissed because they are quite low. When you look at that inquiry and compare the figures by population or with the 17,000, the percentage of issues that have arisen here is higher.

Professor Geoghegan: I will say a couple of things from an overall perspective. Joanne may want to come in on the issue of comparability. From a policy perspective, we have not looked in detail at any reports from the Kent and Canterbury inquiry, but information on some of the data was shared with us recently. We will certainly be happy to look at that and any recommendations or learning from it.

To the best of my knowledge, while there have been various assessments, look backs and partial examinations of parts of screening programmes, a full and transparent report, which was published by the review here, has not been done by any other group or nation. I will certainly look at the detail of that inquiry, but it is hard to know whether we are comparing apples with apples. That is part of the challenge here. We will be very happy to look at any learning that anybody provides to us.

Joanne has had conversations with expert colleagues from other nations. Generally, their sense is that there have not been papers or reports, either peer-reviewed or published, that describe a similar type of review cohort to that in Northern Ireland. I have not had a detailed discussion with those colleagues.

Dr McClean: I have not gone through the Kent and Canterbury inquiry in enough detail to be able to provide numbers today for a comparison. The inquiry's recommendations included the introduction of quality assurance for screening so that there would be external assurance. That is being taken forward. One of the reports that we commissioned was the review by two external experts to look at what we found in the Southern Trust review. As Lourda hinted, one of the big challenges was that there was no comparator. Nowhere else has done a look back of this size in cervical screening. That report will be published in full. I guess that you are asking what we asked them.

Miss McAllister: Was it a look back at years or numbers?

Dr McClean: It was a look back at the numbers of slides that were physically reviewed. A bit like you, we said, "OK, we have done this review: how does it compare with similar reviews and exercises that have been done elsewhere?" The detail will be in the report when it is published, but the authors of the report could not find a piece of work anywhere — they looked beyond the UK — that was done on that scale and in the detail that we provided. I look forward to the publication of the report so that we can be transparent.

Miss McAllister: Yes, I am sure that it will come up in the Committee again in September.

I will ask my final two questions together. Did the two screeners who were removed in October 2021 screen cervical cancers only? Do they or did they screen other conditions? When did the Belfast Trust seek accreditation for the current regional screening, and when did it start screening? Was the trust already doing that in 2023? Was accreditation not sought until 2025, and, if that is the case, what was the reasoning behind that?

Mr Austin: I will take the first one, Nuala. Cervical cytology screening is a specific skill because of the nature of the slides and the material that is used to examine them. It is not comparable with other types of screening that are done in other types of diseases. In the Southern Trust, those screeners were doing cervical screening work only. They would not have been able to transfer to other work. When they stopped cervical screening, they did not transfer to other screening programmes looking at other slides. That was not the case. They were doing other, unrelated lab duties.

Miss McAllister: If one of the issues was conduct, has that been looked into? Has there been an examination of whether the issue was —.

Mr Austin: The duties of those technicians might involve preparing slides or technical preparation, such as taking slices of material and putting chemicals on to fix them and so forth — the technical work that lab technicians do. That is technical work that is done as part of a broader team, whereas the screening work is much more subjective work that people do on their own. The other stuff is done with colleagues, and there are always colleagues who are doing that work. Those individuals will have been doing more general work that is not comparable and will not have been impacted.

You are right about the cytology. That is subjective: you look at slides yourself in a darkened room. Other stuff is done in a general lab where people are doing the same work, so the stuff is much more interchangeable. It is a different type of work.

Professor Geoghegan: The other question was about the accreditation.

Ms Moira Kearney (Belfast Health and Social Care Trust): It might be easier if I start with the present and work back. We took on the regional lab in November 2024. We already had our United Kingdom Accreditation Service (UKAS) cytology accreditation. We then applied for an extension to the scope. We have all our standards and quality indicators in the lab. For UKAS to visit, a lab has to be live and up and running so that UKAS can see that what we are seeing is correct. UKAS came for the visit, looked at the lab, spent a period of time with us and asked for further information. On the basis of the visit, seeing the lab at that time and the additional information that it requested, it accredited us with the extension of scope in May or June this year.

Does that answer your question? I will go back to the other one, but is there anything that you want to ask about that period?

Miss McAllister: No, I guess not. There may be some confusion as to the accreditation. When you said that UKAS expanded the "scope", were you referring to the screening work that was being done for the Belfast area before that, for example? Is it just geographical scope? What does that mean?

Ms Kearney: There was the cytology lab as it stood. We then took on primary HPV in November. We had not been doing that, so we asked for the extension of scope to commence that. That means that, if UKAS comes back, it will accredit us as a whole lab rather than a

lab. We had to bring in UKAS to ensure that the quality assurance that we already had in the lab was as we said and that it was OK to sign us off at that stage. On the back of that, we brought in UKAS to look at all our accreditation in all our labs — we have it in a number of labs — and how we could work better together and learn from each other. We had a workshop in spring of this year with UKAS and all our lab managers to see how we could work better. That is from November onwards.

You spoke about 2023, when we did not have the extension of scope. At that stage — Joanne will keep me right, because I was not in post at that stage; hopefully I will keep myself right — there was a backlog. Whilst we had all the quality indicators in-house but not the extension of scope, we looked to see whether we could help by using the equipment that we had from pre-COVID, because a lot of analysers were sitting there not doing any work. We had the equipment, the staff and our internal quality assessment to do that. We worked through that with our team and then with the PHA to see whether we should go ahead and ensure that that work was done and the validation took place.

That is my understanding. Joanne, you were there.

Dr McClean: In 2023, in the Belfast Trust, for the reasons that Moira gave, people were enthusiastic. They had the equipment and wanted to do the HPV testing. At that time, however, the HPV testing part of the programme was being commissioned from the labs at the Western Trust and the Northern Trust. We did not want Belfast to do it, because it had been commissioned elsewhere. That is primarily why Belfast was stopped from doing it then: we were already buying the testing from somewhere else.

Mr Donnelly: We keep coming back to this issue, and every time that we come back to it, I feel that there are more and more questions. More and more gets uncovered, and more questions are then based on that. It has been said many times that this is an absolute scandal and that the women and families affected deserve full truth and transparency. We should be striving towards those, especially for those who are no longer here. That absolutely needs to be said. We also need to build back confidence in the screening programme, which has been badly damaged. Women are seeing this on the news all the time, and I can only imagine what it must be like for them.

We will have seen the interview with the whistle-blower whom Diane referenced in her questions. His name is now in the public domain: Dr Michael McKenna. He was interviewed on UTV a couple of weeks ago. As a whistle-blower, how was he treated?

Mr Austin: We have been engaging with Dr McKenna in detail about those matters. Those discussions are ongoing, and I am still meeting Dr McKenna. He is raising a lot of issues, and I want to understand the depth and detail of those and to understand his experience. We are taking learning from that and working cooperatively with Dr McKenna. We welcome his coming forward. I will meet him alongside another colleague in order to understand those matters in great detail. It is important that we hear about the experience that he has had. Part of the learning from that will be to see whether we can put measures in place that will make his concerns easier to raise as part of a normal process. We are actively discussing those matters with him, as you would expect. I will not go into the detail, because the discussions are ongoing. Suffice to say that we welcome his contribution and the information that he has made available to help us to work through the learning from that. That is really important.

On a more general point, we are really keen that, if anybody has concerns, they can feel free to raise them. The door is open. I am happy to take personal calls about these matters, and we will do that. In fact, any member of the trust staff will do that. We are making it clear to staff that they can do that and will be supported. We want to make it safe.

Mr Donnelly: You said the same in one of your previous submissions. I am glad to hear that, and I encourage any staff member, as I am sure anybody would, to come forward. Do you feel that he was well supported at the time?

Mr Austin: To my mind, he had support. Could we have done better and offered more support? Yes, we could. The feedback that I am getting is that support could have been better. Part of the learning from this is about how to make that better for people who raise concerns. It is about making sure that people can raise concerns and that those concerns are welcomed. Rather than question people, we need to look at those concerns with curiosity and say, "What is that? How can I understand that better?", and work with colleagues to do that. At the end of the day, people come forward because they have noticed something. They want to raise it to make things safer. That will be my ethos, and that is the way that I will approach it. The learning that we are getting will allow us to see how we can do that. Danny. I hope that that will be helpful.

Mr Donnelly: Absolutely. That is why he raised it. He had noticed long-existing patterns of underperformance that he was very concerned about.

One thing that I am unclear about is the lab inspection reports. Labs have to be inspected regularly by the PHA and the quality assurance team. Were all the labs inspected regularly, and were those inspections up to date?

Professor Geoghegan: Let me clarify things so that we are answering the right question. Is your question about annual quality assurance or about inspections? The likes of UKAS and other accreditors inspect laboratory systems and processes. What is your question about?

Mr Donnelly: It is about whether quality assurance is based on an annual inspection.

Professor Geoghegan: An annual visit.

Dr McClean: It is not really an inspection, as such. What UKAS does could probably be described as an inspection. The quality assurance process involves an annual data review alongside a visit, when the team goes to the trust. That is not done as frequently as annually: I cannot remember the exact frequency of that. There is certainly an annual data review. As far as I understand it, those were happening. I do not want to get this wrong, but I think that the visits were happening every five years. The most recent visit to the Southern Trust lab was in 2019, just before COVID. We had some disruption during COVID. The annual data assessment visits are virtual visits or, sometimes, paper reviews. The PHA team does not inspect the laboratory as such.

Mr Donnelly: Were those all up to date?

Dr McClean: To the best of my knowledge, they were.

Mr Donnelly: OK. Can we see them?

Dr McClean: I will check with the team to see what records of visits we have available.

Mr Donnelly: There are four labs, are there not?

Dr McClean: There were four labs at that time.

Mr Donnelly: There were four, but there is one now.

Dr McClean: Yes.

Mr Donnelly: OK.

Professor Geoghegan: Much of what we are talking about is what was previously the case, as opposed to what will be the case.

Mr Donnelly: I get that.

Professor Geoghegan: There were four, and when the Southern Trust stopped, there were three. Now there will be one.

Mr Donnelly: Will be or is?

Professor Geoghegan: There is one. The PHA will use the NHS England report to help it design the quality assurance framework for that. It has to be different, obviously, with just one laboratory provider.

Mr Donnelly: I have a couple of questions about the Belfast Trust lab. Did the Belfast lab review any slides during the review?

Dr McClean: The Belfast Trust lab started to participate in the review of the Southern Trust labs in, I think — I get lost in the years — late February 2023. It began to assist in the assessment of the slides.

Mr Donnelly: Was it fully accredited at the time?

Dr McClean: UKAS had suspended its accreditation in October 2023.

Mr Donnelly: It was not accredited.

Dr McClean: UKAS had identified issues with the lab. The trust did not participate in the slide review until late February 2023 — I am totally mixed up with the slides — or maybe it was 2024.

Mrs Dillon: It was 2024.

Dr McClean: Late February 2024. That followed a decision by the steering group for the overall cervical screening review, which Stephen and I co-chaired, its having taken into account all the UKAS recommendations and made sure that the trust had addressed any that were pertinent to cervical cytology. A risk assessment was done, and we made an assessment, which we shared with the oversight group at the Department of Health that Lourda referenced, that stated that the Belfast Trust had addressed the main things from UKAS and that the outstanding things were mainly recommendations — they were not mandatory — and not pertinent to the review. Our advice at that stage was that the Belfast Trust should start to contribute to the review.

That was a carefully balanced decision. You will remember how long it took to get through the 15,500 slides. We were very conscious that women, having received a letter, had been waiting for months and months. We wanted to make sure that we got through the review but only when we were sure that we could have confidence in the labs.

Maybe Stephen will vaguely remember that decision. It followed a careful risk assessment.

Mr Austin: I recall that discussion and that there was a careful risk assessment. The group that we led was cross-trust, so we took views from lab staff at all the trusts. It was about achieving a balance. We were trying to increase capacity — Belfast Trust has a large large lab, which allowed us to significantly improve the speed of the cervical cytology review — but, against that, as I recall, we were informed that the measures that UKAS had queried in Belfast had been addressed but that it had not done its formal inspection to re-accredit the lab.

Mr Donnelly: It was not accredited at the time.

Mr Austin: It was waiting for that accreditation to come through. The inspectors look through the records retrospectively. That was a risk-balanced decision, and it seemed appropriate to do that.

Mr Donnelly: Belfast was made the one lab, effectively, after that. I want to ask about the Belfast Trust lab being designated as the one lab. Joanne said that there was a recommendation in 2014 to move to one lab. Was there ever a recommendation to move to two labs?

Dr McClean: There were four labs in the programme at one time. As part of the process to implement primary HPV testing, a lot of work streams and options were considered. A laboratory work stream had a big workshop at some point — I have totally lost track of dates — during the process. I think that that was in February 2024-ish, about a year and a half ago. The workshop was made up of staff from all the labs, trade unions — a big group. They scored, I think, 11 or 14 options and identified four viable options. The preferred option on that day, with all the staff from the labs, was a two-laboratory solution.

That workshop made recommendations to the overall primary HPV implementation programme board, which I chaired and which included among its members Paul, as director of commissioning; an expert pathologist representing the Pathology Network; and an external person from a big cervical screening laboratory service in London. The decision was a commissioning decision: we did not have the volume of work to support two laboratories, as I said. Our volumes at the minute are, even one lab, lower than in any other lab in the UK, and we know that the numbers will go down. As a project board, we took a commissioning decision to make sure that that laboratory was sustainable, that enough work was being done, and that it was comparable in size with its peers. We could not sustain two laboratories in Northern Ireland.

Mr Donnelly: Has there been a review of that decision?

Dr McClean: There was an expression-of-interest process. Three trusts put forward expressions of interest. Belfast Trust was identified as the successful bidder. One of the unsuccessful bidder trusts lodged an appeal, and the appeal panel that sat upheld the decision to appoint Belfast Trust as the preferred, single laboratory.

Mr Donnelly: It was good to hear about the possibility of eliminating cervical cancer; that was fantastic to hear. We have heard a couple of times that that is due to the programme and good screening. Confidence has been rocked entirely, but it is good to hear that we have the new lab. Is it functioning at the minute? Is it running?

Ms Kearney: Yes, it is.

Mr Donnelly: It is running. I heard in May that it was not running, and slides were going to Gateshead. Is that correct?

Ms Kearney: No, that was not so in May. The lab has been up and running since November.

Mr Donnelly: OK.

Ms Kearney: At that stage, there was a backlog in the other two trusts — we downturned services in the Western and Northern Trusts as they came in to start up the new lab with the new equipment, etc — and the programme board decided that, rather than have women waiting longer than expected for slides as we set up the lab, we would send some of our slides to Gateshead. That is our contingency: if something were to happen to any labs in Northern Ireland, we have somewhere else to send slides to. We have not sent any slides off since we sent that initial group at that time.

Mr Donnelly: It is up and running at the minute.

Ms Kearney: Yes, absolutely.

Mr Donnelly: Who is doing the quality assurance inspections? Those cannot be done by another lab in Northern Ireland, because there is no other lab.

Ms Kearney: There are standards in the labs and the lab management systems, so there is external quality assurance (EQA); those are just the tools that are used. There are inter-lab comparisons, and we have the UKAS accreditations that I talked about. We then bring that up to trust assurance. We have also presented at the regional cervical screening oversight assurance group, and as Joanne alluded to earlier, the next stage is to move to independent assessment by someone from outside Northern Ireland. That is the final stage, and we are just waiting for —.

Mr Donnelly: How often does that happen?

Ms Kearney: It has not happened —.

Dr McClean: That has not yet happened because we are waiting for advice from NHS England on how to put in place the most robust quality assurance mechanism. Remember that quality assurance —.

Mr Donnelly: The new lab has not been quality assured.

Dr McClean: The lab has been assessed and certified by UKAS, plus there are lots of other programmes, which Moira referenced: the EQA, the inter-lab stuff and the stuff in the trust. The PHA quality assurance — its look at the data — which, as you know, happens annually, has not yet happened because the lab has not actually been running for a full year, but that will happen by the time that it has been up and running for that period. We have recommendations from NHS England on how to put something robust in place. It has made a number of observations and comments on some of our past arrangements. We want to make sure that what we put in place for the lab going forward is robust. We will implement NHS England's recommendations on that.

Ms Kearney: We really look forward to being involved in that. It is really important to us, as a lab service, and to our women who get those services.

Mr Donnelly: It is about rebuilding confidence. We have one lab now: the future is a lot safer, and that will be more effective for those women. Dr McKenna, the whistle-blower whom I mentioned, said in his interview that he has concerns that oversight and quality assurance of the programme at the minute have not significantly changed. How do you respond to that?

Dr McClean: The NHS England review definitely identifies areas for us to improve. It notes that our processes have significantly improved in the past few years, which is welcome. We accept that there are things that we want to improve further, such as, as I have referenced, how specific we are in some of our definitions. There is also how we work with trusts to make sure that there is an understanding that certain things are not optional: they must be done and they must be done in a certain way. The report recognises that there have been improvements. There will be further improvements, and, as Moira said, there is a range of other external processes, including but not limited to those of UKAS, in the lab.

Mr Donnelly: The whistle-blower who started this whole thing does not have confidence in the system or that there has been enough change in it. That is pretty damning, but I hope that —.

Professor Geoghegan: I might comment on the confidence issue. It would not be appropriate for me to pick up specifically on the whistle-blowing piece. It is really important that confidence in the programme is maintained; that is hugely important. All of our focus, in addressing what has happened already and, going forward, in serving our sisters, daughters and friends, is on doing all the work that we can to eliminate, as far as we can, cervical cancer.

As I said in my opening remarks, and the Minister has also said this, we are deeply sorry about and really regret what has happened. We acknowledge the huge impact that it has had on individuals. We keep a close eye through the PHA on participation in the programme. To reference your words about potentially eliminating cervical cancer, the World Health Organization (WHO) would say, "You need to keep your vaccination rates high, at 80% or 90%, and you need to keep participation in the cervical screening programme high, at 70% at least". When we look at the data for 2023-24 and the previous year, we do not see a drop-off in participation in the programme overall at the regional level, which is good. That participation level is in and around 70% for eligible people, with some minor variation across the regions. The participation level appears to be holding, which is really important. It is also important to note that participation in the Southern Trust area has gone up slightly by a couple of percentage points in the most recent year. That is encouraging. We will keep a close eye on it. That is not to say that what has happened has not had an impact on people; we recognise that it has. However, when I look at it from a population level, I do not see a worrying drop-off, which is really important.

Mr Donnelly: Good. That is to be welcomed; absolutely.

Professor Geoghegan: Yes, and we will continue to focus on that.

It has also been important — members here have given us support on this — to have discussions with lots of industry groups and others about highlighting the importance of getting children vaccinated in school and of participating in the programme. We know from the omnibus survey that, when asked, about 20% of people say either that they have never participated in screening or that they are unlikely to. We have asked the PHA to begin some work to try to reach people who have never participated. It is really important to bring on board that 20% of people who have never participated.

Mr Donnelly: I understand that the results from Scotland are very encouraging for young women who have come through the HPV —.

Professor Geoghegan: Yes.

Dr McClean: I have last year's figures for our HPV uptake rates. The vaccinations are done in schools. The figures show that 77% of girls had their HPV vaccine by the time that they got to the end of year 10. The figure for boys was 72%. Obviously, we would like to get that higher. It is a really important vaccine. Through the combined efforts of keeping our screening coverage as high as possible, getting young girls and boys vaccinated and really reaching people who maybe do not participate in screening or vaccination, we hope to really reduce our rates.

Mr Donnelly: We always encourage people to get vaccinated.

Professor Geoghegan: Thank you. That is really helpful.

Mr Chambers: I will be brief. I have just one question. The failings happened over a considerable period of time. We have heard this afternoon about the active steps that have been taken to avoid the identity of the individual screeners becoming known. I appreciate and respect the fact that the panel that is sitting in front of us today dealing with the hard questions perhaps had no direct involvement in the scandal. Where does the buck stop in the Southern Trust on this life-and-death scandal?

Mr Austin: One thing that we have identified is that there are a large number of system issues. There are governance issues that were not properly dealt with. We talked about some of those this afternoon. There are issues about quality assurance and oversight, and we talked about how we can strengthen those. The thing that strikes me, looking at this almost fresh, as you suggest, is that the system has changed, been modified and improved over the years. The system that was in place back when this all started in 2008 was quite different from what it is now today, most strikingly because cytology is now done entirely in one lab, which has changed matters. Hopefully, that will improve quality further.

I know that it is quite easy to say that, when you look back, you can see things differently, but, when you look back at the paperwork from throughout the years and spend a bit of time learning about and working on the matter, you see how the system has improved. Various improvements have been made that have changed the system because of the learning that has been done. As Joanne mentioned, the framework in Northern Ireland has changed a number of times as learning has come through. Part of that is because of learning from the invasive cancers audit. Some external reviews have been learning from, as I understand it, the bigger systems that are in England, Wales and Scotland. Those have allowed us to improve learning as well.

It is clear, however, that the systems were quite different when they started. As you look at the healthcare that is provided in this particular matter, you can see quite clearly that there have been improvements. However, you need to make sure that you follow the processes and procedures, and you are maybe hinting at making sure that that is done. Part of that is about staff training and awareness of its importance, as well as awareness of governance. We are certainly putting efforts into making sure that staff learn about the importance of governance and about raising concerns and using that to improve the system. We are doing that work now, and some of those things would not have been as obvious a number of years back. That is the journey that we are on in healthcare across the UK. We are focused on it in Northern Ireland, particularly in the Southern Trust.

Mr Chambers: We are unlikely to see anybody, ultimately, taking responsibility for this.

Mr Austin: As you hinted at in your question, some of the staff have changed as well. They have changed roles or have retired and so forth. There is an element of that as well. A lot of it is also about the system change. It is quite hard to pin system changes to individuals and how those are done.

Professor Geoghegan: I will add to that and reference what I said in my opening remarks. The Minister has consistently said that he wants to understand what happened, why it happened, where the accountability lies and what actions are needed to remediate it in order to make sure that it will not happen again. We are two thirds of the way through getting all the various reviews and reports done. The Minister has charged us, as officials, to set out whether all the work that has been done clarifies those questions exactly for him. He will not make any determination about what else is needed until he sees that.

Mr Chambers: I accept that the most important thing is to make sure that this never happens again.

The Chairperson (Mr McGuigan): Are you finished, Alan?

Mr Chambers: Yes, thank you.

Mr Robinson: I have one very quick question. I am very conscious of the time, and we have given the issues a good airing today. The whistle-blower is a man of integrity. There has been public commentary about how he feels that he was professionally undermined. Those are not my words; they are his words. Do you accept that?

Professor Geoghegan: I will ask Stephen to comment, and Joanne may then wish to add to that.

Mr Austin: We have been engaging with Dr McKenna. I do not want to go into the detail of that, but I will say that Dr McKenna continues to practise as a consultant histopathologist in the Southern Trust, and he works in the regional laboratory as well. We have full confidence in his ability, and he continues to practise fully. There have been issues with transitioning into the new service, but we have full confidence in his abilities, and he is fully supported. In line with our discussions with him, we are making sure that that is the case.

Mr Robinson: Has anyone apologised to him?

Mr Austin: As I said, I am in discussions with him, and those are ongoing. It is clear, and we firmly recognise, that things could have been done better. I said a few moments ago that there could be better support for people who raise concerns. We are discussing that with him, and we have taken his listening on board. We are working out solutions for that together.

Mr Robinson: Do you recognise that, had it not been for that man and his integrity, we could have other empty chairs?

Mr Austin: Absolutely. As I said, we welcome what he has done. That is why I have been really keen to engage with him. I thank him personally for coming forward and engaging with us. That has been really important, and you are right to raise that point.

The Chairperson (Mr McGuigan): Very quickly, Linda.

Mrs Dillon: I just wanted to make a point rather than ask a question. I want to reiterate that we need to do more work on all screening processes, not exclusively cervical screening, to ensure that people understand the difference between screening and being symptomatic. I believe that there are people who think, "I have had a smear test, so I am OK". If you are symptomatic, you need to go to your GP. Your GP needs to know and should not think, "You have had a smear test, so you are probably OK". That is not the approach to take, and a wee bit more work needs to be done on that. I have had recent experience of individuals who have been told, "You are probably OK, because you have had a breast exam or a smear test". That is not the case. If you are symptomatic, you should be treated as though that test never happened.

Professor Geoghegan: That is a really important reflection, first of all. It is part of what I was trying to say in my opening commentary. Even though patients will experience them all as the same service, whether they are being screened or are symptomatic, it is complicated, because the ways in which we look at them, plan them and manage them are totally different. We look at them quite differently. Calling somebody forward for screening who has no symptoms or, you hope, no illness is different from somebody coming forward with a symptom — any symptom. Those are totally different things to plan and manage, and they are totally different things for the patients. Those reflections are really helpful overall for what we are trying to do, but they are equally and probably more important for people who have symptoms, who should come forward.

The PHA has done some work on written material and information on cancer and cancer symptoms. You have probably seen it in your community pharmacy. I see it every weekend when I am in getting things from my pharmacy. Work is starting and will be ongoing to have ladies involved in planning and working the screening programme to make those messages much clearer.

The Chairperson (Mr McGuigan): OK. Equally briefly, Diane.

Mrs Dodds: I want to reflect on Dr McKenna. He has been one of the most courageous doctors to come forward and put himself out there. May I ask you for some clarification, Stephen? When Dr McKenna became a whistle-blower and said, "There are things wrong here. This must stop", what happened to him professionally? What does the trust intend to do generally to make sure that whistle-blowers can come forward and are protected and not penalised?

My second question is for Joanne. In 2023, when the Belfast Trust labs lost their accreditation, did they continue to carry out cytology screening? Are you satisfied with that?

Dr McClean: When the laboratories lost their UKAS accreditation, a risk assessment was carried out on whether we should stop screening in Belfast, which, at the time, was doing 40% of cytology screening in Northern Ireland, and whether we should send cytology screening to other laboratories. We carried out a detailed risk assessment with SPPG, and we met the trust. Having completed that, we looked at the type of recommendations that UKAS had made. A decision was taken to continue Belfast's participation in the screening programme and in doing cytology in spite of that, but additional measures were put in place around some of the recommendations, including more frequent reporting on their sensitivities and actions. That risk assessment was passed to the Department of Health and the oversight group that Lourda mentioned in order to make sure that continuation was in women's better interests.

Mr Donnelly: Were you also doing the review at that time?

Dr McClean: The review had not started at that time. We did not allow the review to start until the issues that UKAS had raised were dealt with. As I said, a risk assessment was done, and some additional mitigations were put in place. We did that with SPPG colleagues and the trust, and we provided assurance through the oversight group to the Department on the steps that had been taken.

The Chairperson (Mr McGuigan): Diane made a second point.

Mr Austin: That was about the whistle-blower's experience. One of things that we have tried to explore in detail is to understand Dr McKenna's experience and the impact that it had on him. It is really important to listen to that, and I have been listening closely, just to understand what that impact was. When you are dealing with issues, it is important to remember to keep on top of all the aspects from the practitioner's point of view. We have taken his feedback directly. Part of our learning will be to make sure that we fully recognise that routinely. Some issues came up before we had our discussions; external factors may have had an impact but were not necessarily part of the whistle-blowing as such. We need to learn how to support colleagues through that. Support was given, but was it sufficient? Possibly not, because Dr McKenna has indicated that it had some impact on him. The outworkings of all that are that this has been successful for him. As I said, he is fully supported by the trust and contributes well to the system at present. The key thing is to learn from that. We are engaging with him to understand what will make a difference.

The Chairperson (Mr McGuigan): OK, folks, we will draw the meeting to a conclusion. That was such an important session, which is why I allowed it to be extended by an hour. It was important to allow members the opportunity to ask the questions that they wanted to ask.

We expect to see you back, or certainly some of you, when the other reports are published, so this is not the end of the questioning. I thank you for the time that you have given us today.