Official Report: Minutes of Evidence

The Chairperson (Ms Kimmins): I welcome Colm McCafferty, acting chief executive, and Stephen Austin, medical director, Southern Health and Social Care Trust (SHSCT); Joanne McClean, director of public health, and Tracy Owen, deputy director of public health, Public Health Agency (PHA); and Siobhan Broderick, director of population health, Department of Health. Thank you for waiting. I pay tribute to the women who have been impacted on by the review who are also in attendance. Thank you for your attendance today; we really welcome that.

Members, we have about an hour for the session. I know that there will be lots of questions. I remind you all to try to keep questions and responses brief so that we can get through as much as possible and so that everyone has a fair opportunity. The session will be covered by Hansard. I invite the officials to make their opening remarks, and I will then open it up to members.

Mr Colm McCafferty (Southern Health and Social Care Trust): First, I thank the Committee for agreeing to conduct its business here in Newry. The topic of conversation this morning ranged across different site visits, but your presence is important to the community adjacent to Daisy Hill Hospital in particular. I also thank members for taking the time to visit key sites at Daisy Hill Hospital this morning and for engaging with staff in order to hear about the very real pressures being experienced in Health and Social Care (HSC) and to facilitate conversations about ideas for service developments, how we are doing things differently and, more importantly, how we can upscale and do many more things differently as we move forward. Those conversations are helpful and really important in enabling ideas for service development and so forth to get traction for the betterment of the services.

I thank the Committee for inviting members of the Southern Trust and other key agencies to provide an update on the cervical cytology review (CCR), particularly on information that has been updated following the publication of the review report last month. It is important to note that there is considerable focus on the review, on where there have been deficits and on how the callback, involving 17,425 women, has progressed. That focus is entirely correct and, I suggest, essential for building trust and confidence in the process and ensuring total transparency throughout the process, to which the trust is completely committed.

From the outset, I want, again, to sincerely apologise on behalf of the trust to every single woman who has been impacted on by this. Having been involved in a callback exercise — even one in which, thankfully, the vast majority of reviews were normal — I need, again, to apologise on behalf of the trust for the anxiety, distress and uncertainty that it created. I am aware that a small number of reviews identified abnormalities and that a small number of women have since been in receipt of treatment and intervention. I reiterate that the trust is totally committed to ensuring that those women receive the best possible support, intervention and care.

The trust fully acknowledges that there were failings and difficulties in the screening process, as was clearly identified and about which there has been much commentary. We in the trust are entirely committed to learning from those failings. We are entirely committed to implementing the recommendations from the reports that we will discuss today and, indeed, from any reports that may come after them, with a view to improving services. That does not apply just to cervical screening; should there be any relevance to any other elements of trust services, we are wholly committed to ensuring implementation there.

I will introduce my colleagues, who will provide updated information: Siobhan Broderick, director of population health, will speak briefly on the roles and responsibilities in the cervical screening programme; Dr Stephen Austin, the trust's medical director, will provide background information on and the findings of the cervical cytology review; and Dr Tracy Owen, deputy director of the Public Health Agency, will give an overview of the Northern Ireland cervical screening programme, details of the confirmed cancers reported within the trust during the period covered by the review and the next steps. If the Committee is in agreement, I will hand over to Siobhan.

The Chairperson (Ms Kimmins): Thank you, Colm.

Ms Siobhan Broderick (Department of Health): Thank you for the invitation to the Committee today. As Colm said, I will set out the roles and responsibilities across the cervical screening programme.

The Department is guided on policy decisions by the UK National Screening Committee (UK NSC), which is an independent committee that advises Ministers and health services across the four UK countries on all aspects of screening. It makes evidence-based recommendations on whether to introduce, continue, change or withdraw screening programmes for a variety of conditions. In addition, we have the Northern Ireland screening committee (NISC), which considers the recommendations of the UK National Screening Committee and is chaired by our Chief Medical Officer (CMO). The Northern Ireland screening committee provides policy advice to the Minister of Health, with a specific focus on implementation in Northern Ireland. It is the Health Minister who considers and decides on screening policy in Northern Ireland on the basis of the advice of the two committees that I mentioned.

The Northern Ireland cervical screening programme encompasses a range of services provided by trusts, GPs and the Business Services Organisation (BSO). When it comes to roles and responsibilities pertaining to the delivery of the cervical screening programme, the main stakeholders are the strategic planning and performance group (SPPG), which is in the Department and with which the Committee is familiar; the trusts; and the Public Health Agency. The SPPG is responsible for planning, commissioning, improving and overseeing the delivery of effective, high-quality and safe health and social care services. The SPPG commissions services provided by trusts and GPs across Northern Ireland. As you know, the SPPG is part of the Department and is therefore directly responsible to the Minister. Each trust is responsible for the delivery of services, including the lab services and diagnostic services that sit within gynae services. Trusts have a statutory duty of quality for the services that they provide and are accountable to the Department. The Public Health Agency provides oversight and external quality assurance (QA) of the Northern Ireland cervical screening programme, including the provision of lab testing. As an arm's-length body (ALB), the PHA, is accountable to the Department.

Finally, on governance and oversight, at trust level, internal quality controls occur in line with the NHS cervical screening programme recommendations. The performance of all screeners is actively monitored and managed by the trust. At regional level, the PHA reviews all key performance data associated with the screening labs and discusses any deviation from a standard in detail and in the context of all the data and mitigating factors with each trust at annual data review meetings.

Within the Department, screening policy branch has regular contact with the PHA and receives updates on all screening programmes. In response to the Royal College of Pathologists (RCPath) report on cervical screening in the Southern Trust, which we will discuss, the Department established the cervical screening oversight and assurance group in November 2023, the terms of reference of which we shared with you — they should be in your pack. It did so in order to receive assurances about the Northern Ireland cervical screening programme, particularly the full implementation of the primary HPV screening pathway, and about the implementation of the RCPath recommendations relating to the Southern Trust. The group was also set up to maintain and build on public confidence in the cervical screening programme in Northern Ireland. The cervical screening oversight and assurance group is co-chaired by a deputy chief medical officer, Lourda Geoghegan, and Peter Toogood, who is a grade 3 in the Department. Initially, after the group was established in November, it met weekly. It now meets monthly. Its membership includes the PHA, the SPPG, Digital Health and Care NI (DHCNI), the Chief Medical Officer and senior colleagues from across the Department.

I will pass to colleagues from the trust and the PHA.

The Chairperson (Ms Kimmins): Go ahead, Stephen.

Dr Stephen Austin (Southern Health and Social Care Trust): Thank you very much for the invitation to meet the Committee today and to share information on the update of the cervical screening review. The Southern Trust provided a cervical cytology laboratory service until October 2023 as part of the Northern Ireland cervical screening programme, which was commissioned by the Public Health Agency.

From the outset, it is important that we apologise again to the women and their families who were impacted on by the failures of the cervical cytology service in the period 2008 to 2021. We are sincerely sorry for all the hurt and distress that people have suffered. It is, of course, vital to reassure women that the Northern Ireland cervical screening programme is highly effective, and people should still come forward for that.

Cervical screening — cytology, in particular — is a qualitative test that is undertaken in a laboratory setting by biomedical scientists who examine the cervical smear tests or slides under a microscope for eight minutes. It is not a diagnostic test. It does not and cannot identify all women who are at risk of cervical cancer. The screening programme looks for precancerous changes in the cervix that could, without treatment, develop into cervical cancer. Whilst the programme is highly successful, it has limitations and is able to detect only approximately two out of every four abnormalities. The new HPV tests were introduced in December 2023, which was a welcome development, as it is a much better test.

What went wrong in the trust? The performance of any screener can dip from time to time, for a number of reasons. Systems are in place to pick up on that, and screeners are given annual skills training to keep their skills up to date. During the period 2008 to 2021, some screeners' performance in the Southern Trust's cervical laboratory fell below the recognised standard. That underperformance was identified by the trust at the time, and action was taken to deliver improvement, but, for a number of consecutive years, the performance of some of those screeners did not reach the required standard, and that was not recognised. We fully accept that the actions of the trust at that time were not sufficiently robust.

In July 2022, senior laboratory staff notified the trust's senior management team that they had concerns about the performance at some steps in the laboratory screening system. In order to fully investigate those concerns, the trust commissioned Royal College of Pathologists Consulting — RCPath Consulting — to undertake an independent assessment of the cervical screening services during the period 1 January 2008 to October 2021.

I will move on to my first slide. The Royal College of Pathologists made a number of recommendations for the trust and the PHA to improve their governance, and I will mention those briefly. The first is to:

which is to say that they are doing enough work, as required.

The second is to have a safe, sustainable approach to staffing in the laboratory. The approach should match the workload and avoid the need for people to do too much work or overtime.

Recommendation 3, which is crucial, is to ensure:

Recommendation 4 is that the management of potential screener underperformance policy be appropriately updated and that any deviation from that be fully documented to the required standards.

Recommendation 5 is that, if the standards used performance for monitoring deviate from that in any way, appropriate derogations should be documented in trust policy.

Number 6 is that there should be:

all the procedures of the cervical cancer audit programme in the review and that there should be:

Recommendation 7 calls for the:

You will hear more about that in a few minutes.

Recommendation 8 was about undertaking a more detailed cervical cytology review than the one that we had undertaken.

In October 2023, the Southern Trust, in partnership with the Public Health Agency, introduced a precautionary review of the cervical screening results of 17,425 women who were screened between 2008 and 2021. That was a precautionary measure to check those women's slides and reduce the risk of women who may have had an incorrect result developing cervical cancer. The review was completed, and two key reports were published in December 2024 by the trust and the PHA. The first report dealt with the factual details and findings of the cervical cytology review, and the second report focused on cervical cancers in the Southern Trust area and across Northern Ireland. You can hear a bit more about the second report from my colleagues in the PHA.

The review identified that the results of the vast majority of women — 96% — who had previously had normal smear results, were reconfirmed as normal. In total, in the review of all the women, there were 11 whose slides were found to have precancerous or incidental changes when they were reviewed, and they had to receive treatment. The treatment of those women has either completed or is still in progression.

The second report found that 12 women were diagnosed with invasive cervical cancer in the trust during the period from 2008 to 2021. They would have been included in the review if they had not had cervical cancer, but they underwent a review in the audit of invasive cervical cancer. In eight of those 12 cases, there were concerns about the accuracy of the original screening result. All the findings were and are subject to an independent external panel review, which you will hear a bit more about in due course.

Those are the findings of the cervical cytology review.

As I mentioned previously, in December 2023, Northern Ireland introduced primary HPV screening, which tests for the presence of human papillomavirus, which is responsible for almost all cases of cervical cancer. Since November 2024, the Belfast Trust has taken over the screening for cervical cytology, and no screening is now done in the Southern Trust and has not been since 2023.

The failings in the lab extended beyond individual staff members. They reflected wider system failings in the policies dealing with poor performance. Without doubt, those were below the required standard. Whilst the screening performance was recorded during those years, it was not assessed from year to year to look for patterns. It was only when new staff came into the lab that issues were identified and concerns raised. We recognise that that was a completely unacceptable breach of governance procedures and that it represented a system failure. The Royal College of Pathologists report produced governance recommendations for the PHA and the trust, aiming to ensure that those governance failures would not happen again, and all those recommendations have been implemented in full.

Why the wider system did not pick those failures at an earlier stage will be examined by the independent review expert opinion of the cervical cytology review, and there is a wider review that you will hear about from PHA colleagues in a few minutes. The screeners identified by those failings are no longer working as cervical cytology screeners and have not been doing that work since 2021.

We appreciate and share the frustration that many have experienced in trying to understand how those historical failings in the trust lab could have happened and could have spanned a 13-year period extending as far back as 2008. It has been challenging that the majority of staff who worked at that time are no longer there, and very few of the management team from that period are still in post, but it is important to note that we have not provided cervical cytology for well over a year and that the service has been centralised.

Whilst the whole situation has been totally unacceptable, I want to conclude on a positive note, in that the introduction of the new HPV screening programme, with a much superior test, is a very positive benefit for women. Again, it is important to remind women that they need to attend for smear tests as normal, because it is extremely important to do so. I will hand over to my colleagues in the PHA to give you a further, final update.

Dr Tracy Owen (Public Health Agency): Thank you for the opportunity to meet you today to provide an update on cervical screening. First, I acknowledge the impact that this issue and the review have had on all the women involved and their families. We recognise the distress and the anxiety that have been caused. We understand that, and we apologise for it.

Screening programmes are aimed at populations, and I will talk about data and statistics. However, each of us who has lost a loved one to cancer knows that behind every statistic is an individual person, a family and those with personal stories to tell. We are very mindful of that, and we fully understand it. It is important, however, that we consider that wider context of cervical screening and how it relates to the population so that we have the full picture.

The second part of the review comprises the activity and outcomes report and a companion report that looked at cervical cancers in the Southern Trust area over the period involved. There were two main sources of the data that we looked at. The first was the Northern Ireland Cancer Registry (NICR) data. The registry is a widely recognised, trusted and reliable source of all cancer data in Northern Ireland. It provides us with comparative data that allows us to compare trusts and to compare Northern Ireland with the rest of the UK and with countries across Europe and globally. The registry can adjust its data so that we are comparing like populations.

The Northern Ireland Cancer Registry reports that an average of 81 cervical cancers are diagnosed in Northern Ireland each year and that an average of 14 of those are in the Southern Trust area. When the registry looked at the incidence of cervical cancer, it found that the incidence in Northern Ireland is very similar to that in the rest of the UK. In fact, the incidence of cervical cancer in Northern Ireland is probably a bit lower than that in England, Scotland and Wales.

The registry was able to do some comparative data analysis for us, and it found that, in the Southern Trust, the number of cervical cancers, the stage at which cervical cancers are diagnosed, the mortality, or the death, rate from cervical cancer and the rate of precancerous cervical changes that are diagnosed are not significantly different from the average in Northern Ireland. The Southern Trust is very much in line with what we see across the rest of Northern Ireland.

We also looked at the data that we have from the audit of invasive cancers. That audit is where we look at all women who are diagnosed with cervical cancer. It is an audit of a woman's screening history. That is for the purposes of learning and education, and it involves a review of all the contacts that a woman had with the screening programme in the 10 years prior to her diagnosis. It looks back at the invites that she received — did she get invited for screening in the first place, as she should have? Any screening samples that she had are reviewed, as are any colposcopy or further investigations or treatments that the lady may have had in that 10 years. It is a complete review of her whole screening history. The Southern Trust looked at the cancers that were diagnosed in the trust area between 2009 and 2023, during which 207 women had been diagnosed with cervical cancer. Those women were not included in the CCR because, under the audit process, there was a much more in-depth review of their individual cases than what the CCR was doing by way of a look-back and a review of their most recent screening test.

The graph on the next slide shows the cervical cancers diagnosed by year. As I said at the beginning, we have an average of 14 diagnosed each year in the Southern Trust area, but the rate fluctuates year-by-year, and that is a normal pattern when we have small numbers. However, it gives you an idea of what we see.

We also tried to see whether we could compare any data from the audit that we had from the Southern Trust with published data elsewhere. England publishes quite significant reports on its audit. We were able to look at some comparative data to see whether there were any real or obvious differences in the women in Northern Ireland or in the Southern Trust who were developing cancer. The table on this slide shows a breakdown of types of cervical cancer. The most common type is squamous cell carcinoma, which occurs in the cells that line the cervix. It makes up the vast majority of cases. You can see that it makes up 65% of diagnosed cervical cancers in England and 69% of those diagnosed in the Southern Trust. The numbers are very similar. Adenocarcinoma is the second most common type. It is rarer. It is a glandular type of cancer that occurs at the top of the cervix where the cervix enters the womb. It is a much rarer cancer, but a lot of evidence shows that adenocarcinomas are much more difficult to pick up at screening. Often, they are the difficult ones that turn up later.

We also looked at the screening history of the ladies who were diagnosed with cancer. Women aged 25 to 49 are invited every three years for screening. Those aged 50 to 64 are invited every five years. England has reported on that in the past. About 20% — one in five — of women aged 25 to 49 diagnosed with cervical cancer had had a negative screening result recorded in the three and half years prior to their diagnosis. For women aged 50 to 64, 27% — more than one in four — had had a negative screening result in the previous five and a half years. We looked at the Southern Trust figures. I urge caution: our numbers are much smaller; England's data covers thousands of women. We are talking about smaller numbers of women, but you can see that the comparative data is very similar to that reported in England.

We looked at those cancers and asked this question: would those ladies, had they not been diagnosed at that time, have been included in the cervical cytology review that was undertaken by the trust? We found that 12 of the 207 ladies who were diagnosed with cancer within that time frame would have met the inclusion criteria for the CCR. On review of their slides, eight of them had had concerns identified about the accuracy of their screening result in the past. Five of those eight are now subject to further investigation under the serious adverse incident (SAI) process, which Dr Austin from the Southern Trust will talk about and explain in a moment. In addition, a small number of women — under five — were diagnosed at another trust but would have met the inclusion criteria for the CCR as well. Their cases are being further assessed to see whether anything additional needs to be done for them.

I just want to explain that reviewing a slide under audit conditions is extremely different from reporting a slide in a screening programme, because the person who is looking at the slide in the audit knows that that woman now has cancer. The review is not blind. Those reviewing the slide have as much time as they want to review the slide. When you know that the lady has cancer and have longer to look at a slide, the more chance there is that you will find an abnormality. That time may not have been afforded to the person who did the primary screening. Usually, a more senior member of staff does the audit. Generally, it tends to be a consultant who looks at those cases. That is mostly not the case when we are screening. Certainly, the primary screeners are not consultants. It is a very different process, and we expect that reviews and audits will identify abnormalities in some slides that were initially reported as negative at the time of screening. Finding such cases happens in all cervical cancer screening programmes across the UK.

What happens next?

Three pieces of work are ongoing, the first of which is the review. The cases of a number of women are being reviewed under a serious adverse incident process that relates to the Southern Trust laboratory. The Southern Trust can speak a bit more about that.

Secondly, we have asked for an independent external opinion on the two published reports: the outcomes and activity report and the cancer report. They are factual reports, giving just the facts and figures — the numbers — and we have asked two external people to look at them and then give us their opinion on what they mean and what the statistics tell us. One expert is from Scotland, while the other is from Wales. One is a laboratory expert, while the other is a public health person. We anticipate that that work will be completed in February, and we will receive a report on it.

The third piece of work that we are doing is a peer review of our quality-assurance arrangements and of activities relating to our cervical screening laboratories over the period. We have approached NHS England — you have been given the terms of reference for that and the other piece of work — and we are negotiating a time frame for completion of that work. We are hopeful that it will start shortly. It is for NHS England to confirm the timescale.

The additional pieces of work that we have asked for and are taking forward are really important for ensuring that we have covered all elements in the review so that if there are any further gaps in how we have overseen services and in our data, we can identify them and make further improvements.

The changes in the programme have been alluded to, so I will touch on them. We have talked about primary HPV testing. In March 2020, as part of the Northern Ireland cancer strategy, the Minister took a policy decision to implement primary HPV testing. The project that we set up to do that was implemented from 11 December 2023. There were a lot of challenges involved in doing that, as it is not something that can happen overnight. There were IT interface challenges, and there was a significant impact on laboratory services, which I will come to. The increase in referrals for a colposcopy also had an impact, with the need to build capacity in that part of the service for the women who were going through the process.

HPV is human papillomavirus. It is transmitted by close skin-to-skin contact. It cannot be treated. It usually clears up on its own. It is a transient infection that probably about eight in 10 of us will be infected with at some point in our lifetime. It clears up in most people, but it persists in about 20% to 30% of women. They or their partner may have it for many years without knowing about it. There are over 100 types of HPV, but only a small number of them are directly linked to cervical cancer. We know that younger women have a higher prevalence rate of the infection. Some 99·7% of cervical cancers are associated with a persistent infection with high-risk types of HPV. It is about that persistent infection, not an infection that most people get that their body clears. It can take many years between becoming infected and cervical cancer developing.

We have been using HPV testing in the cervical screening programme in Northern Ireland since 2013 to help us manage decisions on which women should be sent for a colposcopy and further investigation when they have more minor changes in their cells. I will describe the pathway. We do an HPV test first. If the test is negative, the woman goes back to routine recall.

If it is positive, the biomedical scientist will create a slide, look at that slide under the microscope and, depending on the outcome, consider whether the lady is referred to colposcopy for further investigation.

What are the benefits of the HPV screening programme? As I said, HPV is related and linked to over 99% of cervical cancers. The test is a much more sensitive one than cytology for determining those women who are most likely to have abnormalities that could go on to develop into cancer, although it is a bit less specific. That is why we still need to do cytology testing. Otherwise, we would be referring a lot of women who are HPV-positive through to colposcopy who do not need to be there.

How do the two types of test compare? An HPV screening test will identify 18 out of 20 abnormalities. That compares with only 15 out of 20 abnormalities that a cytology-based screening programme will identify, so the former is a much better test. It is also a more automated test, and, because of that, we have a marked reduction in the amount of cytology testing that is now required. Less than 12% of all samples coming into the laboratory are HPV-positive and need cytology, so our workload for cytology has dropped from something like 120,000 samples a year to fewer than 20,000. That represents a massive reduction in that workload.

The decision was made to move to one laboratory for Northern Ireland to consolidate the service. We undertook a commissioning process, through an expression of interest from the trusts' laboratories, to see who would be interested in delivering that service, and the outcome was that the service moved to the Belfast Trust from 1 November 2024. A lot of work went into that transition process. There was a transition work stream and a people work stream so that all the staff involved were supported throughout the process.

What can screening deliver? It is important, and the National Screening Committee makes the point that screening is about risk reduction, not about eliminating all risk. No cervical screening programme will provide a 100% guarantee that someone does not have cancer or will not develop it. Over 99% of cervical cancers are linked to primary HPV, but a small number of women who develop cancer do not have HPV. Cases are rare, and, based on the best current evidence globally, screening using HPV testing will prevent more cancers than screening by cytology.

Having changes in your cervical cells does not mean that you have cancer or will definitely develop it. Many of the cell changes that we saw in the past disappeared by themselves. That is why HPV testing is a much better determinant of those that are more likely to go on to develop into cancer.

It is also important to recognise that screening is not suitable for people with symptoms. Anyone who presents with their GP who has symptoms, or is concerned about them, really needs to seek medical advice and onward referral for assessment, if that is needed. A screening test is not appropriate.

Finally, I will touch on participation. There has been a lot of concern about women's confidence in the screening programme and that what has been going on in the Southern Trust may put women off attending. We have some data that covers the period of the review that compares women's attendance at screening over the past couple of years across each of our trusts. What we have seen is that, in 2023-24, our coverage — our attendance, essentially — increased across all trusts in that period and particularly in the Southern Trust. We actually found that more women were coming forward for screening during that period.

We have also undertaken an omnibus survey to try to get some direct feedback from women on their experience of and attitudes to screening and on what their confidence levels are in the screening programme. In November, we included questions in an omnibus survey, which is an online panel on which a sample size of over 500 women, from whom we have now gathered feedback, provide data. These are just two of the high-level findings to date. We are still working through the analysis. Women were asked whether they had attended a cervical screening test in the past when they were invited to do so. Nearly 13% of women said that they had never attended a test. When asked whether they intended to attend a test in the future, nearly 12% said that they did not. There is still a large number of women who have never attended and who do not want to attend. Our challenge is how we encourage women to come forward for a test that is really important for their health.

Finally, I will say that there was a WHO statement on eliminating cervical cancer by the end of the century. There is a real move to do that and a recognition that there are three pillars required in order to do so, which are as follows: to encourage the uptake of cervical screening; to maximise the uptake of HPV vaccination among young people, which is a really important element of preventing that cancer; and to ensure that anyone who has cancer or abnormalities gets the appropriate treatment and support. Thank you.

The Chairperson (Ms Kimmins): Thank you, all. We will move straight to questions. I pored over the reports ahead of today's briefing in order to get my head around the issue. It is very complex. I understand that it can be quite technical at times, so I did that reading in order to try to be clear on what has happened and where we are at now.

It would be remiss of me not to mention that this week is Cervical Cancer Prevention Week. It is important to mention that, particularly given some of the figures that we have seen, which show that some women still do not go for their cervical smear. If any message can come out of today's Committee meeting, it should be one of encouraging women to come forward for their test when they receive their letter. I also pay tribute to all the women impacted on by the issues raised in the review, particularly those who have gone on to develop cervical cancer, and especially Lynsey Courtney and Erin Harbinson, who, sadly, passed away. I acknowledge the hurt and the huge amount of grief and loss that their families have experienced and continue to experience. It is so important to acknowledge that.

I have lots of questions. I will try to get through as quickly as possible what I would like to ask. I read the Royal College of Pathologists' report, and the one thing that I cannot get my head around is that the underperformance was allowed to continue for 13 years. The review and its reports were published in December of last year. They go into the detail of the people who were involved and the process since the period under review, but nowhere in the review and reports have I seen why that situation was allowed to continue, why it was not picked up on and why it took so long for us to get to even where we are today.

In the briefing that we received from the Department earlier in the session, it was stated:

and that external monitoring occurs via the Public Health Agency. To what extent was that happening as far back as 2008, when significant issues were clearly identified? I think that the report stated that there were four screeners in the Southern Trust and that, for a significant period, none of those screeners was meeting the standards. I do not know whether any of the witnesses here today can speak to that, but I really want to try to get an understanding of it. We have talked about confidence in the screening process for many of the women affected and their families, as well as the general public. It is good to see that the percentage of women coming forward is increasing, but I want to make sure that people have confidence in the screening process, particularly in HPV screening. If possible, can we get an understanding of how that happened for so long without ever being picked up on or actioned?

Dr Austin: What you have described is striking, Chair, and it is striking to see, from the data and the Royal College of Pathologists' report, that individual screeners' underperformance was noticed in particular years, such as 2009. The screeners underwent the usual process to improve their performance, but, the next year, they still underperformed. Nobody looked back and said, "You underperformed last year also". Each year's performance seemed to be taken as an isolated event. If a person's performance was at 85% in one year, they would go on a training programme, but it appears that there was no follow-up to check whether people were underperforming for two or three years in a row.

One of the learnings to be taken from the report is that it is essential not only to look at a person's performance in isolation but to avoid taking a silo approach and instead look at the pattern over their entire employment history in order to see how they are doing, to see whether they are responding to the measures that have been put in place to improve performance and, if not, to take action. That is what happened when the new staff came into the lab in 2022, as I mentioned. They looked at the situation and said, "Hold on". They raised concerns and sounded the alarm with the trust management, and that led to the review. It is therefore about looking at the entire pattern of performance rather than at isolated performance in individual years. Rather than saying, "This year, the figure is this, so will we do this", it should have been a case of, "It is this year plus that year plus the year before that".

It is really important to look at the entire pattern. That is the significant learning that came out of the report, because that does not seem to have happened in that period. It certainly happens now, and it will do in the Belfast Trust. That was the issue. The problems were recognised, but the pattern of, "You did that, but you did not improve, so we are here again" was not. It was missed, and that is what was difficult.

The Chairperson (Ms Kimmins): That will not give any comfort to anyone who was impacted on. Who was responsible for monitoring the appraisal system? There is appraisal and review of people's performance in any job, and there should especially be for something so critical. Such a diagnosis is life-changing for many people. In fact, it was life-shattering for the people who were affected. The royal college's report states that, where underperformance was identified, there was no evidence of any increased quality control or targeted training for underperformers, no evidence of formal rescreening, no evidence of workload reduction and no evidence of out-of-hours services or overtime being discontinued.

It was picked up on that those were the key issues, but, whether the screeners were voluntarily sharing the information that they felt that they were doing too much work or too much overtime or whether the same person was doing the performance review every year or it was happening in silos, at no point did somebody think, "Hang on. This is ringing a bell".

I am trying to understand the process. Was it the proper process to look at performance in a silo? I appreciate that you said that there has been learning from it and that this is where we are at now, but, at that point, would anyone have said, "We're doing this wrong. We should be doing reviews year-on-year and comparing screeners' performance"?

Dr Austin: One of the difficulties is that we are looking back at the Royal College of Pathologists' report. With the benefit of hindsight, the problem is obvious. You and I have picked up on it. Those of us here today were not there in, say, 2008. It appears that, at the time, the annual appraisal for staff looked at the data for that year but did not look at the broader pattern, as I mentioned. That is one of issues that led to the review that we have done. It is reassuring to find that the vast majority — 96% — of the negative results were still negative and that only a small, albeit important, number of women had to undergo further preventative management and treatment.

We have picked up on the fact that the whole picture across the cycle needs to be thought about. That is the key learning from the report. I was not there to understand the thinking at the time. One can only presume that performance was looked at each year in isolation and not look across the piece: at 2008, 2009 and 2010. That is the strong learning that comes out of the report. It seems obvious now to do that, but I suppose that the systems were different 15 years ago. We are much more attuned to the governance issues now than we were 17 years ago.

The Chairperson (Ms Kimmins): That is what I am asking. Was it the normal process to look at performance year-on-year instead of comparatively from year to year? If you are having an annual review, for example, does someone go back and look at your review from last year and say, "Where were you at last year? This is where you are at now"? I appreciate that a lot of the people around this table who are trying to answer questions were probably not in their current role at the time. I acknowledge that, but I am trying to get an understanding. Was there a failure of governance that led to the trust not following a proper procedure, or was it the case that it was following procedure but that that was not working, if that makes sense? In the field in which I worked, you had a review done of your work and of where you were you were at, and then areas of learning were perhaps suggested to enable you to improve. That was fairly standard. The person doing the appraisal would look back and ask, "How was last year?". Stephen, you may not have the answer today — I appreciate it if you do not — but, at this critical time, three or four years on from when concerns were first flagged, I am still not clear as to whether that was the procedure at the time or whether there was a failure of governance procedures.

Dr Austin: You are quite right. It is hard to give a definitive answer, because none of us at the table was there at the time. The facts speak for what the facts say, however, and the facts are that it appears, as you have described, Chair, that it was done in an individual year — that is the only way in which it can be explained — and that there was no read-through done into the following years. It is hard to provide a definitive answer. That was an obvious failing in the system that had to be fixed.

The Chairperson (Ms Kimmins): I am not sure who would have the overall responsibility. Would it be the Department or the Public Health Agency, Siobhan? I know that the Public Health Agency plays an external monitoring role. I would like to get that clarified. I am sure that there is a policy document somewhere that states what should be happening, but I have not seen it. I would like to get that information, if it is available.

Dr Joanne McClean (Public Health Agency): I will come in there, and Tracy can fill in the detail. I also have those questions. We have all looked at what happened and said, "How did that go on for so long?". If you look at what we have asked NHS England to do, you will see that it is more or less what you have said, Chair. We asked it, "What was the process that was supposed to have been followed during that time? Was it followed? What was the PHA supposed to do? Did it do what it said it was going to do, and when it was supposed to do it? Was that the right thing to do?". There would have been a series of data reviews of and visits to the lab, on which Tracy can provide a bit more detail. The situation went on for a long time. We need someone from outside to come in, look objectively at it, ask questions and say, "Show me what was supposed to have been happening under the QA process. I will check and assess. Can you provide me with the evidence that you did what you said you were going to do?" and also comment on whether what we said we were going to do had any gaps in it. Tracy will provide more detail on the exact QA process at that time.

Dr Owen: At the time, the Public Health Agency reviewed and had meetings with every lab, every year, and looked at its data. That included its individual screener activity, workload and performance data. At those meetings, there was a full discussion had if anyone was not meeting the standards or if there were concerns about what the trust was doing to address that in order to reassure us that it was approaching the situation appropriately. As Stephen said, the data that we get in the Public Health Agency is, in many ways, anonymised data, and we were not looking at it on a long-term basis or for individual members of staff. Individual members of staff are the responsibility of the trust. We were being told that issues were being addressed, and we were satisfied with the answers that we were given, but it is that long-term trend that was the difficulty. The process has since changed. We now look at the trends, and we do so over a period of years to make sure that they are being mapped.

The Chairperson (Ms Kimmins): When I look at the levels of underperformance, I see that some people were falling to around 50%, or perhaps lower, yet, at that point, it was not flagged that there was a serious issue. It took someone new to come in and say, "We really need to look at this". To discover that it went as far back as 2008, which is only as far back as we know about, is something that I am struggling to get my head around. We have seen the impact. Thankfully, the vast majority of women have not had a negative outcome from the review, but we must not underestimate — I am not suggesting that anyone has — the impact that there has been on the women who have not had the same outcome.

That leads me on to my next question. Stephen, of the 11 women whom you mentioned who had precancerous cells and required further treatment, which, I think you said, is still going on for some, did any of them go on to develop cancer or have it diagnosed?

Dr Austin: Some of those 11 women have had investigations and various forms of treatment, which, in some cases, is still in progress. That is just the nature of the treatment: it takes a bit of time for various reasons. There are no cervical cancers in that particular group. Those are the facts. However, some of the women required some form of treatment and management, be that a colposcopy or whatever. The numbers are small, so I do not want to say the treatments that each individual received.

The Chairperson (Ms Kimmins): Absolutely. I just wanted to be clear on that.

Dr Austin: They have all either completed their management or are in the process of completing it. That process is ongoing, and we track that in the trust to make sure that it continues.

The Chairperson (Ms Kimmins): We have heard, particularly in the past few days, how intensive some of the treatments for cervical cancer are. That, in itself, is something very traumatic that many women would not have had to go through had their cases been picked up sooner. That is a really important point that we have to acknowledge.

Dr Austin: To clarify, for some of the women, the results were from recent smears. It is not entirely clear whether those represented changes from previous smears. They had all had recent smears, and, due to the nature of the process, there is always a bit of uncertainty on exactly where —.

The Chairperson (Ms Kimmins): For those women who are under the SAI process in particular, where there is evidence that their misread smears led to their not being diagnosed, the impact and trauma has been huge.

I am led to believe that, as with any profession, there is a regulatory body. I am not sure of the name of the governance body to which screeners report. Once issues were identified, were referrals made to that body? What was the process when issues were raised?

Dr Austin: The Health and Care Professions Council (HCPC) is the governance agency. We are certainly in communication with the HCPC, and it is aware of the matter. It received some referrals from members of the public. We have provided it with information in the usual manner, including all the reports, such as the RC Path report and the more recent reports. Specific screener histories and data have also been provided in the usual way. The HCPC is considering that matter.

The Chairperson (Ms Kimmins): So members of the public sent the referrals to the HCPC. That was not done as part of this process or when the issue was first flagged?

Dr Austin: We identified concerns and then undertook to do the review to find out whether there was a concern or not. We have done the factual review and are at the stage of getting independent opinion to understand what it all means. We have got the data, but we do not feel that we should make the decision on what it means. That is why we have asked the two external experts to look at the data. Then, of course, we will make appropriate decisions on that. It is complex and, as you have mentioned, it is not entirely clear-cut because of the screeners. As you would expect, some screeners do not always pick up everything, so there is a bit of a grey area. Hopefully, the review will be helpful and the external expert opinion will help us as part of that. We are providing the information to the HCPC, and it is still considering the matter.

The Chairperson (Ms Kimmins): It was said in the presentations that there is a margin of error because of the nature of the screening. However, it is concerning that there was such significant underperformance and no one referred the screeners to the regulatory body. I assume that, if members of the public made a referral that was acted upon by the HCPC, there was obviously a case to be looked at.

Dr Austin: There are various thresholds, and it is for the HCPC to decide. My understanding is that it is in the early stages of its consideration of the matter. We are just providing information to assist the HCPC personnel in their deliberations. They have not made any final decisions: they are working their way through it and appreciate that it is a complex and difficult area.

Miss McAllister: Chair, may I ask a question?

The Chairperson (Ms Kimmins): I was going to finish, but go on ahead very quickly.

Miss McAllister: I was just going to ask why that was the case. What happens if a different specialty needs to be referred to a regulatory body? When does the trust do that as opposed to members of the public?

Dr Austin: As with any profession, you do a risk assessment to identify the issues. Sometimes, you need more information or the internal consideration of the trust to figure out whether there is an issue. When a concern is raised, you do not automatically refer somebody to the regulator: you carry out an internal process. That is standard practice. Most of the regulators expect you to have done a local process within an organisation first, and part of that might be your own internal investigation or analysis. The trust has to undertake its own processes to see whether there is an issue that it needs to deal with. In this case, the screeners were removed from screening in 2021. So, action was taken at that stage, and safety was provided at that point. It was then a question of figuring out what that meant. The staff concerned were not screening once the concerns had been raised, so the trust had the time to figure out what it all meant. That led to our review.

The Chairperson (Ms Kimmins): OK, thank you. In conclusion, I have two points. First, if ever there was an example of why we need a duty of candour, this is it. There have been lengthy discussions on that in the Committee and in the Assembly regarding governance but also the responsibility that all staff have to raise concerns if they feel that they are having issues. I do not know the different circumstances that led to this, but if there were issues impacting on the screeners that were affecting their ability to perform to the standard to which they should have been performing, that should have been flagged up, even if it was by the individual concerned.

Secondly, it is key that we ensure that we are doing everything possible to restore confidence because this is critical. I said that at the start of the meeting, and I want to finish on that point. We probably need to do more, and that is why we want to scrutinise this as closely as possible because it is far too important. As was said at the end of Tracy's presentation, we have an opportunity to eliminate cervical cancer — we really do — and setbacks like this will only impact on that. I implore everyone to put their shoulders to the wheel in that respect because we cannot allow this to happen to any other woman.

Mrs Dillon: Thank you to all of you. Some of your answers have probably raised more questions. The Chair just mentioned the duty of candour and that responsibility. Performance was only being looked at from year to year, but I still do not understand why nobody else was looking at that or why there was not some other policy.

We only got the draft terms of reference today, and I was at a Policing Board meeting all morning, so, unfortunately. I have not even got to read them. I will outline the kinds of things that I think should be included. The screeners would have been able to say, "I underperformed last year, I underperformed the year before that, and I have underperformed this year. Here is why I think I have underperformed. I'm not doing it intentionally". I am not suggesting that they were for one minute, but they could have said, "Here are the issues that I think that I have". Was it that they were overworked? Did they think that they had not received the right training? Did any of them raise those concerns? Were they raising those concerns with anybody, be it the trust, the PHA, the Regulation and Quality Improvement Authority (RQIA) or anybody else? Did they raise those concerns anywhere? If they did, where did those concerns go? That has to be part of the peer review. What they did or said or did not do or say must be part of it, because if they did not raise any concerns, it goes back to the Chair's point about a duty of candour. Why did they not ? Were they afraid? I do not know. Those are questions that need to be asked and answered. I do not expect you to answer those questions today, because I understand that trying to do so could prejudice other processes. However, something on that issue needs to be in the terms of reference.

The Chair focused on what has gone wrong. We might come back to you on the terms of reference. It is important that somebody somewhere has a conversation about the terms of reference with the people who have been impacted on by this and asks them whether they are satisfied by those terms of reference. What is the point of having another review or oversight procedure if it is not going to meet the needs of the people who are impacted on by the problem? Have a conversation with them. They might look at it and say, "They are not meeting my needs". However, if there is a two-way conversation about what is included and why — perhaps other things cannot be included — that allows the people who are impacted on to understand why things may not be included. If they just see terms of reference and have no understanding of why things are or are not included, the review is not going to satisfy them. If it does not satisfy them, it will not satisfy all the other women and the public. We need to be honest about that.

Like the Chair, I am delighted that there has been an increase in the number of women who are going for smear tests. As much as people were concerned that some of this stuff might put women off going for their smear, highlighting it has probably had the opposite effect and made more women aware of its importance. We know that, whatever percentage of abnormalities are not picked up, 100% of those who are not tested will not be picked up. It is important to make that point again. I do not think that we can make it enough.

HPV testing is now in place. In your presentation, you said that that is now under the direction of the Belfast Trust. Is all HPV testing for all of the North being carried out in Belfast by the Belfast Trust?

Dr Owen: Yes.

Mrs Dillon: Are you confident that a good mechanism is in place to provide oversight of that testing? I know that the process is entirely different to that for cytology — there are no similarities between them — but we still need to be confident that that test is right.

Dr Owen: Yes. The Belfast Trust has a lot of experience in doing a wide range of different tests. HPV testing has been added to its remit and it is putting in place all the staffing and the structure that it needs to deliver that. The United Kingdom Accreditation Service (UKAS), which is the external accreditation body, is overseeing that. The Belfast Trust has shared a lot of its documentation with UKAS, which will visit the Belfast Trust next week to walk through that process to see it in operation. Then, it will feed back if there are any areas for improvement. The Belfast Trust has been working very closely with UKAS as the service has moved from elsewhere into Belfast.

Mrs Dillon: OK, that was my first question. I want to ask about the time frame between somebody having their smear test carried out and getting the result. What are the two time frames from the smear to the screening and from the screening to the result? Do we know them? They are probably similar. It is OK if you want to give me one figure for the whole process; my question might have been confusing.

Dr Owen: OK. The service that was being provided in the Western Health and Social Care Trust and the Northern Health and Social Care Trust was stood down about two weeks before it moved into Belfast, so a bit of a backlog built up. Belfast has not quite got all the staff in place; it is still recruiting to some new posts. We had to work through the transition as the staff moved. Everybody was given the option either to move to the new service in Belfast or to stay in their current trust and be redeployed to another role. Very few staff decided to move, so there are some gaps in the staffing, which are being addressed. Once they are up to full complement, the intention is that those results be turned around quickly. HPV negative results should be out within two weeks. We know that that is not happening at the moment because there is quite a manual process for authorising the results. So, although the tests have been carried out, every single result has to be authorised manually. We are working on an IT development that should be in place in February. That will automatically authorise all the negative results. As soon as the negative result is issued, it will go through the machine, be authorised and then issued to the GP. That will speed up the process significantly.

Mrs Dillon: What happens if it is a positive result?

Dr Owen: If it is a positive result, the sample is taken and a slide is made, which goes through the cytology process. It will be primary screened, rapid reviewed and sent on to a consultant, if necessary. That takes a bit longer.

At the moment, it is hard to know what that timescale will look like. I would hope that all results would be out within four weeks of a sample being taken. As I said, there are still some staffing issues. The service is very new and represents a big expansion on what was there. Staff are working through those issues. We are hoping that, come February, they will be able to clear a lot of the results that, because of the manual process, people are waiting for.

Mrs Dillon: Can we get an update, at an appropriate time, on the time frame for positive results? You will not be able to give us that within a month — I get that — but the time frame for positive results is a big concern.

Earlier, we talked about the big difference between having a screening result and being symptomatic. If somebody with a negative HPV test result goes back to their GP because they are symptomatic, and says that recently — even within the past number of weeks — they have had a negative HPV result, is there an immediate pathway for them because they are symptomatic, even though they have had a negative HPV result?

Dr Owen: Anyone who goes to their GP with symptoms will be assessed to determine the significance of those symptoms. If the GP feels that there is a clinical need and the symptoms are of clinical significance, they will refer the patient to gynae services. That is the appropriate pathway for those ladies.

Mrs Dillon: Can I get reassurance that GPs are being made fully aware that a negative HPV test result should not be taken into account in that assessment?

Dr Owen: Yes. They have been told repeatedly, over many years, that, regardless of a negative cytology or screening result, if someone presents with symptoms, they must assess, treat and manage the symptoms appropriately. It does not matter what that person's screening result was.

Mrs Dillon: The last point that I want to make on the new independent review is that one of its terms of reference should be to find a way in which to consult the 17,500 women who have been affected, including the women who are involved in the SAI process. There has to be a way of doing that. I understand why they are being separated — rightly so — with regard to how they are treated and the level at which you will have to investigate their cases. I understand that. However, not including them skews the stats on what went wrong over those years. We have to find some way to include them. I do not know what that is. You can come back to us on that; I do not expect you to answer that today. However, there needs to be some way for us to understand the overall picture.

Dr McClean: That is why we have asked external people to look at that. There are statistical problems with doing what sometimes seems to be straightforward. That is why we have asked for the independent review. The external experts have both reports — the CCR report and the invasive cancer report — and we can provide them with additional information if they want it.

Mrs Dillon: Maybe that is in the terms of reference, to be fair. As I said, we got them only today, so I do not know. I just want to ensure that the things that we have in our —.

Dr McClean: From a statistical point of view, it was not as simple as just adding them in. That is one of the things that we have asked the review to comment on — the significance of the cancers — but I do not think that we can just necessarily add in 17,500 —.

Mrs Dillon: No, and I am not suggesting that you add them in, but we have to find a way in which to include them.

Dr McClean: Yes.

Mrs Dillon: There has to be a way of

on that.

Dr McClean: Yes. The experts are looking at that as part of their work.

Mrs Dillon: OK, Chair. I am conscious that other people have questions.

Mrs Dodds: Thank you for the presentation. To reinforce and develop Linda's last point, it seems to me that we have been presented with a lot of statistics and process. I fear that we are in danger of processing this out but not actually listening to women. I would like, at some stage, for the trust, or even the Minister and the Department, to indicate to us how the voices of those 17,500 women will be heard in the process. I know that there have been meetings — the trust has held meetings — but there has been no formal mechanism, as far as I can see, for the voices of those women to be heard in the process. I attend — not frequently — the Ladies with Letters group, where I listen to the stories of women who have been terribly impacted on by the whole debacle. We need to find a process that allows those women to be heard. I would prefer to have a statutory inquiry, where people are compelled to give evidence and all is laid bare. We need to find a formal process that includes those women. Involving NHS England, NHS Wales and NHS Scotland is fine, but the women who have been affected need to have their say. That is my starter for 10.

I, like the Chair, am completely taken aback by the fact that this went on for so long and simply was not acknowledged or recognised and that nothing was done about it. In March, I wrote to the then Health Minister and asked whether the Southern Trust had advised that no screeners had been referred to the professional body. The Minister wrote back to say that the review was ongoing, which I accepted at the time, and that there was:

Was that the right decision then, and do you regret not referring them to the professional body, given the evidence that we now have?

Dr Austin: As I mentioned, there are two parts to the internal trust process. The first is about maintaining safety, and the screeners were not screening from around October 2021. The second is a due assessment of the issues. The screeners were not screening, so they undertook no further work. At that stage, there was the external review by RCPath, which provided information for us. An assessment of that was done at the time, which reported in 2023. At that stage, we undertook the review here, which provided much more detailed information on the issues. We are now doing the external assessment, which Joanne mentioned earlier, to provide some information on what it all means. The findings of our review are still not entirely clear, which is why we are getting the external review.

With hindsight, you might make a different decision. Would we have made a different decision? I suspect that we still would have had to undertake our own internal processes. That would have meant us doing the review, so the investigations that we did effectively comprised the cervical cytology review and the RCPath review, both of which provided information to us. However, they did not provide sufficient clarity. The screeners were not screening at that stage, so the public were protected. There was no risk at that stage, and we were trying to understand the issue that we were dealing with. There is much more information available now, and hopefully we will have more information in the next month to look at what happened detail. It is a complex area, as we have heard already, so —.

Mrs Dodds: I cannot agree with that. I do not think that it is that complex to know that people were not screening at the appropriate levels, year-on-year-on-year. That is not particularly complex, and it is not really appropriate to say that it is. We have heard about a lot of ifs and buts and process today. I will move on, but it was a huge mistake, and the fear among women who have been impacted on is that, ultimately, no one will be made accountable. That is the exact fear of the women with whom I have spoken and spent time. When you talk to the families of those women who have lost their lives, that is their fear as well. I am sorry but I just do not think that that was an appropriate answer.

Like everybody here, I want to see positive outcomes. I am glad to hear that as many women as before, if not more, are reporting for screening. That is a positive outcome, and I want there to be a positive outcome across Northern Ireland. I desperately want that, which is why I continue to ask questions on the issue.

In December, in the Assembly, I asked the Health Minister a question about the withdrawal of the Belfast Trust's accreditation from 31 October 2023 to 7 June 2024. I asked why it had had its accreditation withdrawn.

I will read into the record a sentence from the letter that the Minister sent me:

It does not say what target the trust did reach. Joanne, Tracy and Siobhan, do you have performance data for all the trusts from the period 2013 to 2023, and will you share that performance data with the Committee so that we can be assured that, across all the trusts in Northern Ireland, the screening programme, as a whole, was achieving what it should have done?

Ms Owen: We do have performance data. The standards that we use for monitoring performance nationally have changed in that time period, so the data that we use now is different to the data that was used at that time. However, we do have that data for every trust over those years, and I am sure that we are happy to share that.

Mrs Dodds: OK. You can, of course, give a rationale and an explanation around the changes in how the data is treated. I think that that is quite important for transparency's sake on this issue.

That leads me to another question that I asked the Minister in another letter. Sorry to the Minister; there are so many letters. I asked him why, given that the Belfast Trust had lost its accreditation because documents to manage underperformance were not in place and it had not met the target of 90% in all abnormalities, it was awarded the contract for HPV testing. Given that it had lost its accreditation — it was not accredited when the service was being commissioned — why was the Belfast Trust awarded the contract?

Ms Owen: When the panel met to review the submissions from the trusts, in the commissioning of the service, the Belfast Trust had had its accreditation reinstated. The accreditation had been reinstated. Obviously, I cannot speak for the Belfast Trust, but my understanding of the documentation was that it was not there and available to the assessors from UKAS who attended on the day. Some of that was because the trust could not put its hand on it, but that documentation was later found in the trust. There were staff who had moved on. A number of years previously, the service had moved from the City Hospital to the Royal site. The managers were not there on the day of the assessment, but, when they were back in place, the documentation was found and was shared with UKAS. UKAS assessed it and cleared the trust on the basis that it was satisfied that appropriate action had been taken at the time.

Mrs Dodds: My understanding is that, at the time that the service was commissioned, the Belfast Trust was not accredited, and its accreditation was reinstated only a short time after the service was commissioned. I would love you to write to me formally on that. That would be very useful. "Sorry, I lost the papers" is a poor excuse when we are dealing with something as important as women's cervical smear records and the management of the laboratory that is processing the tests. I am at a loss on this one.

Did the Belfast Trust carry out cytology examinations when it was suspended and had had its accreditation withdrawn?

Ms Owen: It did. There was a risk assessment. First of all, UKAS is not a regulatory body. We did a risk assessment of the performance of the Belfast Trust, which was shared with the SPPG and the Department, and there was agreement that it could continue to do its own work during that time, while it was working to reinstate its accreditation. The accreditation issue was around documentation, but it was not felt that that was a key quality in the delivery of the service.

Mrs Dodds: You are saying that the trust, the PHA and the Department gave the go-ahead for the trust, even though it was not accredited by a professional assurance body, to continue to do the cytology tests at that time?

Ms Owen: At that time, the decision was taken that the risk assessment gave sufficient assurance that the trust was safe to continue to operate and provide cytology.

Mrs Dodds: OK. As to where we are now, another correspondence from the Minister confirms that the Belfast Trust has not —.

Sorry, just before we move on from that, the Belfast Trust was not accredited, and, in fact, it had lost its professional accreditation during the time of the commissioning process, but the Northern Trust and the Western Trust were accredited for HPV testing. I struggle to understand why we would award to a body that was not accredited when we had two trusts that were accredited. Is there a rational explanation for that?

Dr McClean: An expression of interest process happened: the trusts that wanted to put themselves forward to deliver the new single service were invited to fill in an expression of interest. Three trusts did that. Expressions of interest were scored on a wide range of criteria. UKAS accreditation was one of the criteria, but there were a lot of others, including deliverability, the engagement and involvement of virology services, the ability to provide enough staff and a resilient service and the ability to be able to cope should something such as a flood in the laboratories happen. The Belfast Trust is a regional provider and it scores well on things such as that, because it is used to delivering those services. UKAS accreditation for cytology had been restored by the time that the bids were assessed. UKAS accreditation for HPV testing specifically can only be gained once the service is in place, so the Belfast Trust is going through that process at the minute. I think that you said, Tracy, that they are coming next week.

Ms Owen: Yes.

Dr McClean: One of the challenges is that UKAS, as a body, has a waiting time before it can give an appointment to do an assessment, so that is one of the reasons why there is a delay. However, a range of things were looked at when making a decision on the scoring. The scoring involved people from PHA, the SPPG, the Northern Ireland Pathology Network and an external expert.

The Chairperson (Ms Kimmins): OK. Is that you, Diane?

Mrs Dodds: I have just a couple more questions. Some of this is quite mind-blowing.

The Chairperson (Ms Kimmins): We have quite a number of people still waiting.

Mrs Dodds: I do not know the scoring, but I presume that trusts that were already accredited scored the same as a trust that was not accredited. Is that right?

Dr McClean: Not for that particular field. It is like when you are assessing anything and there are multiple criteria. It would not have scored as highly for having HPV accreditation in place, because it did not have it. However, it scored highly in other fields, such as workforce, the ability to provide a regional service and so on.

Mrs Dodds: Very quickly, because I have had more than my fair share. You said that you wanted a resilient service. Are you satisfied that we have a resilient service, given that 5,000 samples were sent to Gateshead for testing because of the backlog? You have talked about staffing and IT issues. I have talked to GPs who have said the wait time to get results back from HPV testing is impossible. Are you satisfied that we have a resilient service?

Ms Owen: Yes, we think that we will have a resilient service going forward. It is a new service. As I said, there have been some recruitment issues because staff from other trusts have not moved to the Belfast Trust. Some of the vacant posts have had to be recruited for, and some of them were new posts for the new service. That process takes time to work through. The service has only been operational since 1 November. The two trusts that were still providing the service stood that down two weeks in advance, for different reasons. Therefore, the service started with a two-week backlog of work that had built up, and that is why 5,000 samples were sent to Gateshead.

Going forward, we are working to make continuous improvements when the service has all staff in post. The IT development — it is not an IT issue; it is an IT development — for auto-authorisation of the negative results will speed up the process. That is in place in labs in England, and we want to put that in place here, and it will speed up the turnaround of results. Within the next month or two, we will start to see real improvement. It is an early, new service, and we need to give it a bit of space to get up to speed and get everything in place that it needs.

Mr Chambers: One of the slides in the presentation said "Screening saves lives", and we all agree with that. However, to inspire confidence and to give that statement credibility, the system has to work. In this case, it failed abysmally. The job of screening is not just routine work; they are carrying out life-and-death work. As others have said, this went on for a long time, and the buck stops with someone. In this case, the buck seems to have stopped with the screeners. We have not heard about disciplinary action being taken against senior management, but there must have been senior management who had the responsibility to review this performance and do something about it. Somebody did not do their job, and they may be still in the job. I do not know. There is certainly no evidence that any disciplinary action was taken against senior management.

The slides also gave a lot of figures comparing the performance of the Southern Trust with other trusts across Northern Ireland and, indeed, the United Kingdom. If you were an outsider looking in and you did not know about the particular circumstances of the situation, you would say, "Not much to see there. The Southern Trust does not seem to be out of kilter too much with other figures from across the rest of Northern Ireland and the United Kingdom". However, there is a big difference and, as Tracy said, behind every stat, there is a person and a family. The difference in the performance across Northern Ireland compared with the Southern Trust is that over 17,000 women received a very concerning and worrying communication. It must have caused a lot of concern, not only to them but to their families. I am sure there were a lot of sleepless nights caused by that. It is not really reassuring to compare the figures and say, "Yes. They were not that much out of kilter". The figures were out of kilter, without a doubt.

We were briefed by the Ladies with Letters earlier in the week, and I asked about the message that they would give to other women, despite their experiences.

They were totally passionate about their message that every woman should go for their smear test when it is time to go for it. That is the message that the Committee sends out today: do not put off going for your smear test just because of that particular situation. The figures show that this might not have had that big an impact, but it would be terrible if even one person were to put off going for their smear test because of what happened here.

The Chairperson (Ms Kimmins): Thank you, Alan. I do not think that there were any questions there.

Mr Chambers: I just wonder whether any member of senior management was held accountable. Was any disciplinary action taken above the level of the screeners? The buck seems to have stopped at the screeners.

The Chairperson (Ms Kimmins): That is the issue. I do not think that that has happened to date. That is the point that I was making in relation to all the reports that we have seen. None of that has been addressed. Hopefully, it will come out of the independent review, but that remains to be seen.

Mr McGrath: I will build a bit on what Alan said. While this is a significant health issue that has impacted on people in ways right up to and including death, one of the most galling things is that it appears to be because of an HR issue. It is because somebody did not do their annual appraisals correctly. If somebody and some service was not performing year-on-year, that is a HR issue. That has resulted in people potentially being missed, and that missing information has potentially resulted in deaths. We will never know or find out whether that was the case, no matter how much we look back.

Colm, this question is for you. You have kind of been landed in it. You are new to the job, and you are in an acting role. Was it the practice for HR appraisals in the Southern Trust to not be cross-referenced year-on-year, or was it an isolated issue in that specific role? If so, does the trust know that as a fact?

Mr McCafferty: It is impossible for me to give the Committee a definitive answer to that question, Colin. Dr Austin tried to outline what had been identified clearly. There is no question that the episodes were looked at in isolation, but it is impossible for me to give a definitive answer with regard to practices in those days. However, it is fair to say that, even before the review, infinitely more stringent attention has been afforded to staff appraisal. We have significantly promoted that in the Southern Trust across all disciplines. Over the past years, our compliance has significantly increased across all disciplines, and, particularly down the professional lines, it is of the utmost importance to us now.

Mr McGrath: I am glad to hear that. I hope that you take that message from the Committee and go back to your senior management team and say, "Can we make sure that anybody who does year-on-year appraisals makes reference to the year before to see whether somebody has improved or reduced the quality of their provision?" Like the Chair, I had a career before I came to the Assembly, and I was subject to year-on-year appraisals. You had to set targets from one year to the next for what you wanted to improve, and you had to put in your training plan for what you wanted to do. In a lot of places, I did that with volunteers in the organisations that I worked in. To think that that was not being done for people who were doing something as serious as screening whether someone potentially had cancer is really frightening, and it will be no comfort to any of the families.

I will follow on from what Alan said. I hope that it was not the intention, but the presentation came across as quite blasé. It was as if it was saying, "Look, there is absolutely nothing to see here. Everything that happened in the Southern Trust is perfectly normal. Do not worry about a thing. Sure, look at these statistics; they are equal the whole way across". That is no comfort to the families and the ladies present who were all impacted on by it. I hope and have faith that that was not the intention, but, in case you are doing the presentation again in any other places, I want you to know that it comes across as being defensive and as saying, "Look, we did what we did, and everything is normal". We are here because we know that things were not normal, so it is a bit worrying to be told that it is.

This may be very specific, and I could be wrong about it, but we referenced 207 cases in the Southern Trust over a 10-year period and that the UK average was 14. If there were 207 cases over 10 years, that would be 20 per year, which would mean that we were about seven above the 14, which is a 50% higher incidence. Would that not have spiked some sort of analysis, assessment, input, concern or worry? Am I reading the figure wrong? I think that it was 207 over 10 years.

Ms Owen: In the Southern Trust, 207 were diagnosed between 2009 and 2023, so that was a period of 14 years. The 207 figure in the data that came from the trust through the audit is the number of people diagnosed in the trust. The data that comes from the Cancer Registry is for people who live in the trust area, so there can always be a bit of difference. You may live in one area and be diagnosed somewhere else, so those figures will never tally completely. They come from two different sources, so you cannot necessarily completely —

Mr McGrath: It cannot be directly —.

Ms Owen: — compare them.

Mr McGrath: Finally, on peer review, there is something inside my head that sounds a wee alarm bell when that goes on. I am thinking of another significant review that is being undertaken at the moment. Peer reviews are often undertaken by people who know each other and who may have trained together or worked together at some stage. Has an assessment been consciously undertaken to make sure that the independent review is being carried out by people who have no knowledge, directly or indirectly, of the people working in the sector here? The medical fraternity is quite small, and sometimes those who are carrying out a review can be the buddies of those who are being reviewed. Just to ensure that transparency, has that specific question been asked of those who will undertake the review?

Dr McClean: The reason that NHS England has been asked to do the review is that quality assurance of cervical screening programmes is a very specialist area, and there are not a lot of people across the UK who are involved in it. There is an inevitability, therefore, that people involved in our programme will have come across some of the experts in England, Scotland and Wales at different meetings. That is inevitable, and we cannot do away with that fact. The reason that we asked NHS England to do it, rather than asking a couple of people — we could have approached people — is that it has a peer review process by which it will look at its services as well. For example, NHS England has eight screening labs at the minute. It has a peer review process: it is a formal process, and it will be able to measure things. Have the people involved in our screening programme met some of the people who will be involved in the review at meetings and things? Yes. Have they had close relationships or trained with them or anything like that? No, not to the best of my knowledge. The reason that we want the organisation to do it rather than individuals is to try to make the review as robust and independent as we can.

Mr McGrath: There is not a lot that we can do about that, but I do not have a lot of faith in an independent review if those people know each other. Whilst that might be inevitable, I do not think that it is independent. If I were to review a party colleague, I would have a certain amount of bias that would be carried across there.

Dr McClean: I suppose that there are a couple of things. The first thing is that I have absolutely nothing to gain by getting someone to give me a fairy story — something that is not true. I want to know what happened and to make sure that whatever we do in quality assurance is the right thing to do going forward. I have no interest in getting something back that says, "It was all fine". I want them to identify where there are gaps. The second thing is that this is not about individuals, personalities and opinions. This is about applying standards, measurements and other objective things, rather than saying, "Well, actually, I feel whatever". I give you those two reassurances. I could not be bothered with, and do not want, a "nothing review". I want something that is honest, that explores the facts and that gets to the bottom of this. That is what we need to do. We want it to be an objective process, rather than being something woolly.

Mr McGrath: I do not doubt your motivations — I said that at the start — but I will go on the record as saying that I do not believe that an independent review that is carried out by people who may know each other is independent; by its very nature, that is not independent. Maybe there are not enough people to carry out an independent review, but that is a different point. An independent review — we have had this in reviews in other spheres — that is carried out like that, I am sorry to say, is not independent. It is impossible to be independent if you know the person.

Dr McClean: I take your point, but it is independent of the organisation. It is independent of Health and Social Care in Northern Ireland. We made sure that we did not include people from Northern Ireland in any of this, because it is a small place. We have done our best to get as much independence as we can, but there is a balance between getting independence and getting people with the right skills, experience and capability to do the review. While they may know people, they do not know them personally. It would be professional, perhaps from training, rather than there being a deep and personal relationship.

Mr McGrath: Could that be checked? It is simple to ask somebody who is carrying out the review, "Do you know people who operate in that sector?"

Dr McClean: As part of any such process, we would ask about conflict of interest.

Mr McGrath: Sure.

Dr McClean: I am sure that, when you fill out various conflict of interest forms, you say things like, "Personal friend" and "Financial". There is that sort of check. If I can assure people of something, I assure people that we want to get to the bottom of what happened. As has been mentioned, it happened a while ago, before we were in post. We want to make sure that it does not happen again. I want this to be the right thing. Tracy wants this to be the right thing. Everybody wants this to be the right thing and to get to the bottom of it. Genuinely, that is what we are trying to do.

Throughout the process, in all the different things that we have done, we have really tried to get to the bottom of it. You mentioned the 17,500 women. That is very real to us. The presentation is factual, because it gives numbers and facts. It is hard to strike a balance, but we are very conscious of the 17,500 women. We really agonised over decisions about sending out the letters, because we knew that it would cause upset to a lot of people, the vast majority of whom the Royal College of Pathologists report said had had the right result. We did not want to upset or worry a lot of people who probably had the right result, but we wanted to get to the bottom of it, and we wanted to make sure that we found any abnormalities that had been missed. We are very conscious of the annoyance that we caused those women. I am glad that we have got to the end of the process and that the vast majority of them have been reassured, but I am very sorry that some people have needed treatment. I am very sorry that people have cancer. You mentioned how awful that is for them and their families. It is not true that we just look at the numbers. We are very conscious of every woman who got a letter.

Mr Donnelly: A lot of the questions that I was going to ask have come up already. I reiterate that, like the Chair, I do not understand why the trust did not refer those people to their professional body when they were willing to suspend them. They knew that there was a problem and put restrictions on their practice. I find that confusing.

You mentioned staff moving to the Belfast Trust. One of the criteria that you mentioned in response to Diane's question was that the Belfast Trust could provide a staff cohort, and that was one reason why it won the contract. Is it correct that the Belfast Trust does not have that at the moment?

Dr McClean: All the laboratories would have needed to recruit additional staff, but the Belfast Trust had the biggest staff cohort. Maybe Tracy can talk more about the details, as she has been heavily involved in the implementation.

Ms Owen: No laboratory in Northern Ireland, as it stood, could have delivered this on its own. An expansion in staff was needed. Some of the laboratories were surviving with locum screeners; they had few permanent staff still in place. The bid from the Belfast Trust had a clear plan for how it would expand the service and the scale of that expansion. There was a people work stream, and everybody from elsewhere who was working in the field had the option of moving to the Belfast Trust. Had they done that, it would have filled any vacancies immediately, but that did not happen. Staff chose to stay where they were and to be redeployed in other areas of their local labs to address other pressures in services. That meant that the Belfast Trust was left with gaps because they were not filled by staff coming in. It takes time to work through the recruitment process.

Mr Donnelly: The Belfast Trust had a plan, it got a tick for that and it got the contract, but the plan did not work. Is it fair to say that?

Ms Owen: Everybody had a plan. As Joanne said, the panel went through a process of scoring everybody's submission against 13 criteria. Having a plan for resilient staffing was one of the criteria, but there were lots of other aspects against which all the submissions were scored.

As I say, we went through an open, transparent and clear process.

Mr Donnelly: Is it fair to say that that plan did not work?

Dr Owen: I do not think that it is fair to say that. The trust's plan showed the staffing that it would need. As I said, no trust was going to be able to deliver that at that point in time with the staffing that it had. They were all going to have to recruit staff to do that. The Belfast Trust was in a position no different from any other trust that might have been awarded the contract.

Mr Donnelly: What is the staffing like at the minute out of 100% fully staffed?

Dr Owen: I cannot give a percentage. A couple of posts were created in the service as part of that. There has been a bit of movement among staff. A few more senior posts were created. More junior staff applied for those posts and moved up and left gaps underneath them, so it is still a fluid picture as they settle down and work through that.

Mr Donnelly: Is there a reluctance to work in that area?

Dr Owen: You can probably imagine, given the number of issues that have been raised, how public this has been over the past two years. Staff in some of the laboratories are working at a low grade. When they are constantly listening to the news, reading the media and looking at social media, with issues being raised about the — [Interruption.]

The Chairperson (Ms Kimmins): That is the emergency weather alert.

It is my new way of telling people that their time is up. [Laughter.]

It is a reminder that there is a red weather warning.

Dr Owen: If you are in a lab doing that type of work, you are under huge pressure, looking around at what has happened in other labs and at staff being referred to the professional body. I imagine that it is extremely difficult for the individuals who are still there. When you talk to the staff who work in the labs, you will discover that they are not highly paid but are extremely proud of the work that they do. They are extremely committed to the work that they do, and there was a lot of disappointment among the staff in the labs that did not get the contract for the new service. They are extremely proud of what they have done for the women of Northern Ireland over the years, and it has been difficult for them to see what has been happening. Also, they are looking at their colleagues and seeing what has happened to people being referred to their professional body.

There has been a lot of focus on screener performance. There must be the fear of, "What if I miss something?". Everybody will miss something at some point, but, if they miss something, the pressure that that puts those members of staff under is extremely difficult. Trusts have had to do a lot of work with occupational health and everybody in supporting those staff during this because they have been under extreme stress. Also, because they do such an intense and critical job, you do not want them to be under stress. If people are under stress, that is when they can start making mistakes. Therefore, a huge amount of work has been put into supporting those staff.

Mr Donnelly: I appreciate that, and, as Alan pointed out, they are doing a life-or-death job. It is incredibly important, and it clearly has huge ramifications for the people involved.

I want to ask just one more thing. This has been ongoing for 13 years. Do we know whether people — [Interruption.]

The Chairperson (Ms Kimmins): Sorry, Danny. Go ahead.

Mr Donnelly: It is grand.

I imagine that people move between trusts to new jobs. During that 13-year period, did people involved in the scanning process in the Southern Trust move to other trust areas, such as the Belfast Trust? Has that been followed up?

Dr Owen: There is little movement of staff around those laboratories. Occasionally, there is, but there does not seem to be a huge amount. If anyone in the Southern Trust about whom there were concerns had moved elsewhere, their performance would have been reviewed after they moved as well. The whole picture is looked at.

Mr Donnelly: So, if somebody moved to another trust, their performance at the Southern Trust would have been reviewed and picked up in the new trust: is that the case?

Dr Owen: Their performance would have been reviewed when they moved to their new trust. Just to give you some assurance, when anybody moves or if a locum is employed to do that type of work, they have to provide all their performance data and things from the past.

Mr Donnelly: Over multiple years?

Dr Owen: I cannot answer that — a laboratory person would have to answer that — but I know that they are asked to provide their performance data before they are allowed to start screening in the lab. They often do a period of settling in as part of their induction. Things would be double-screened initially just to ensure that people are happy with their work before they do it on their own. Systems are in place for new staff.

Mr Donnelly: Do you know whether anybody who was known to have been underperforming at the time moved to another trust?

Dr Owen: I think that it is recognised in the RCPath report that there was one screener in the Southern Trust during that period who moved to another trust.

Mr Donnelly: Do you know whether their underperformance was picked up in their new trust?

Dr Owen: Their performance after they moved to their new trust was reviewed, and it was fine. I do not think —.

Mr Donnelly: What about their previous underperformance?

Dr Owen: What they did somewhere else five years ago was not reviewed. That is not normal practice; it certainly would not have been normal practice at that time.

Miss McAllister: This has been a long meeting, so I will ask my questions really quickly. This is a very important issue to scrutinise. It has been mentioned by a lot of people that you were not in post at the time, and I appreciate that you do not have all the answers about what happened then. That speaks volumes as to why we need a public inquiry. The people who have those answers and know what went on at the time should be questioned.

I want to go back to the beginning with regard to the screeners. Why were they underperforming? I am sure that people have been spoken to and that there have been interviews and discussions.

Dr Austin: Do you mean the reasons why people might underperform and what sort of things —?

Miss McAllister: Why were those screeners in particular underperforming?

Dr Austin: We will never quite know. It would be challenging to ask people retrospectively about what happened 10 or 15 years ago. My understanding of why people underperform is that it can be to do with being under stress for particular reasons. They could have become distracted. It is a challenging job: they have to look at various things, which requires an attention span. Some of the cells that they are looking for are of different characters. There is a grading process for that that colleagues may speak about.

Some changes are easier to spot than others. Some things in a slide are clear-cut, while others are really quite subtle. I am not a pathologist, but I know that, when they look at a slide, they have to focus in and out on different layers. The cell is not just like a picture book. It is complex work. There are lots of factors that require them to do that. They are also required to do that within a time period, so they have to scan in a methodical way, and there are different ways in which to do that. You might never know why, because, again, even in the —

Miss McAllister: Did you ask? Has the trust asked them? I am not talking about the ones going back even 10 years; what about the ones in more recent years?

Dr Austin: No, I do not think that we have asked them about that in particular.

Miss McAllister: Why? Why do we not ask why they were underperforming? If you are not meeting your targets in your job, you have one-on-one meetings. You need to ask why that is happening and what can be done to fix that. Will that take place?

Dr Austin: The difficulty is that the staff may not know why they are underperforming. If they knew why they were underperforming, they could adjust things. We do the performance monitoring to look for things and put in place the recognised training. We do not necessarily rely on the staff, and that is why we have the [Inaudible.]

Miss McAllister: The training did not change anything when an isolated incident was picked up in 2013. Was training initiated then?

Dr Austin: The staff would have gone through the recognised training. They would have had double-screening or gone to an annual course to make sure their screening was up to the specification. At the time, that was the process.

Miss McAllister: But it did not help.

Dr Austin: Obviously, it did not help, no. The data clearly tells us that.

Miss McAllister: That is really important. Why exactly did they underperform, and who else knew about it? We all know about the neurology inquiry and the colleagues who knew about Dr Watt at the time. Everyone, apparently, knew about him and was concerned about him. Nothing was done about it. It is never just the people sitting beside you who know about it; it is always much wider than that, and that brings me to the timeline question. The report published in December states:

Escalated to whom? The issue was "escalated" and there was "a detailed review". What does that mean?

Dr Austin: The staff realised that there was an issue. They had stopped the screening. They gathered information to understand what they were doing, and they provided the report, and, in due course, it went to the senior management team of the trust.

Miss McAllister: Who was the issue initially escalated to? Who made the decision to take the detailed review from 2008? Was that the senior management team?

Dr Austin: Sorry. Can you say that again?

Miss McAllister: The timeline is that:

it is in the report —

Then a comprehensive report was collated, and that was presented in July 2022 to the Southern Trust senior management team. Who was it escalated to in October 2021?

Dr Austin: The lab staff realised there was an issue. They did the analysis of the screening performance that you mentioned. The management team of the lab service compiled a comprehensive report on the results, and that was escalated to the senior management team of the trust.

Miss McAllister: Did the senior management team know before July 2022 that it was happening?

Dr Austin: The review? As I understand, there had been some previous discussion about the ins and outs of that in the few months prior to the preparation of the paper.

Miss McAllister: Was the PHA aware that it was taking place from October 2021 to July 2022?

Dr McClean: I will check the timeline with Tracy, but I think that we were first informed in July 2022, after it went to the senior management team.

Miss McAllister: The report states:

Why was that decision taken only in July 2022 instead of in October 2021, when a senior staff member noticed something that was so concerning?

Dr Austin: The difference is that the staff members were considering whether there was something there or not. The senior management team of the trust were considering whether there was a need to look back at the patients. Therefore, they looked at the departmental look-back review guidance, and part one of that is a specific risk assessment, and there is a formal process to do that. At the time, the senior management team of the trust said, "There is a possible risk", and recognised there might be a need to consider whether a look-back review was needed, and, therefore, they followed the guidance. A risk assessment is the first thing they are mandated to do by the departmental guidance.

Miss McAllister: The risk assessment was not done until July 2022, yet they found out in October 2021. That is important, because the regulatory body, at the hearings that took place, I think, in November, deemed it sufficient for suspension action. The regulatory body also outlined that people were not protected enough and sufficient protections had not been put in place. Notwithstanding the 13- or 14-year gap, there was a gap between October and July during which decisions and actions could and should have been taken.

I highlight that because, historically, in the trusts — not just the Southern Trust, to be fair — there has been a reluctance to have transparency, especially when it comes to any serious adverse incident or any other incident that takes place. It almost seems like a covering of tracks — I am not saying that that took place in this instance — rather than full transparency from the outset. I do not understand why a risk assessment was not carried out for some months following the first person — supposedly, the first person — noticing that there was a concern. During that intervening period, while the report was being compiled, was there no one in the senior management team or anyone else to speak about and assess what was going on and to look at whether it was a much wider and bigger picture, as well as the individuals in the laboratory management, given that it was such a difficult issue?

Dr Austin: To think a bit further about that, the staff who realised the issues when they were reviewing the stuff did their own, individual, professional risk management. They did not do the formal risk assessment: it was done by the Royal College of Pathologists, which is the external party that was asked to do the formal look-back guidance. The staff did their own assessment because, obviously, they had to do a risk assessment to see whether they needed to escalate the issue. Therefore, they did something but not the formal assessment. I am not sure whether that helps. There will have been various stages to that.

Miss McAllister: It gives us a lot of food for thought as to how we change things, moving forward, in managing and assessing risk and preventing issues from day one. Again, I recognise that it is not just the Southern Trust; there are other trusts concerned.

I will come back to the Department and its role in the look-back review guidance. That is not on you; it is for the Department to answer those questions.

I have another question on the quality assurance for the PHA. I understand that it is every three years. Is that what you said? Is it annually? Keep me right.

Dr Owen: We look at annual data; it is done as a once-off on an annual basis.

Miss McAllister: During the 13 or 14 years, did you ever ask about those who were underperforming? Did anyone in the PHA ask why or try to find out why they were underperforming? Is there a paper trail anywhere that highlights the steps that were taken and why each stage was signed off?

Dr Owen: We do not sign off.

Miss McAllister: I know that you do not; I am using that as a loose term.

Dr Owen: If, in those annual meetings with the trusts and labs, we identify that there is a performance issue, we ask questions about what the trusts have done. We ask how they managed that, whether they have a protocol in place for managing underperformance and whether they followed it.

Miss McAllister: Did that happen at the time?

Dr Owen: That would have happened at the time.

Miss McAllister: So the trust would have been aware at the time that the screeners were underperforming significantly.

Dr Owen: If that was the data that was shown to us at that time and that was what we looked at, that discussion would have taken place, yes.

Miss McAllister: So it goes back to the trust again that there were people outside of the senior staff who knew. That is important. I recognise that you cannot answer, but it is important. It is not about being able to publicly shame any individual; it is about a collective responsibility within the management of each trust for what happened. Furthermore, there should have been a paper trail that highlighted significant underperformance over those years and what was done. We will not get those answers today; they will be received in an inquiry, going forward. One thing that we will take on is the Department's look-back review guidance, on which you will not be able to answer. We can go to the Department on that.

Mr Donnelly: Did that conversation happen multiple times each year?

Dr Owen: That conversation will have happened, looking at the specific data, at any lab that was visited due to issues being raised. Understanding the performance of an individual screener requires much more than one statistic. That is looked at. Those staff also undergo external quality — proficiency — testing. They do test slides twice a year that they report on. That happens across the whole of the UK. They are scored, and they have to score a certain level in the test. There are different levels of how their performance is managed and assessed. Any bit of data that is reviewed is reviewed in that wider context. What is happening in the lab? What are their scores on other performance data? Are there any particular issues with that person? Have they been off on extended or sick leave? That may be an issue. Those discussions happen.

The Chairperson (Ms Kimmins): Last but not least, Órlaithí.

Ms Flynn: Thank you so much for the time that you have spent with the Committee today.

I will just finish off with two short questions.

It is important to say that, from the outset, Stephen, you have recognised that there was systemic failure and that it led to the situation that we are in. We acknowledge the apology that you gave at the outset.

My first question is to follow up on some of the issues that Danny raised about the staff and the management at the time, between 2009 and 2023. You mentioned, Stephen, that a lot of the staff and management are no longer there. How that has impacted on your internal investigations and reviews? Has it had an impact, in that people have moved on and are not there?

My final question is on the SAIs. Three SAI reviews are under way that will include people who have been impacted on between 2009 and 2023. My question is broad: is it normal for SAIs to be flagged up or taken forward in laboratory and screening processes? Is it a normal part of the process that, every now and again, an SAI review comes up?

Dr Austin: I will take the last bit first, on the SAIs. We are looking at a number of SAIs. Those are women who have had cancer; they are part of it. The reason that they get SAIs is, when they do the audit of invasive cancer, the slides are reviewed as part of the audit. They categorise the slides as follows. In the first category, there is no abnormality found. The second category is where there is something there but it is quite challenging to find and you would not expect people to find it because it is very subtle. The third category is where it is something a bit more obvious and you would have expected people to get it. That is a category 3, and all category 3 cases, under the guidance that was published in 2019, I think, produce an SAI. Any cases like that go forward to SAI investigation. That is to try to gather any learning. They will look at the broader picture of that lady to make sure that learning for the system comes out. Those are ongoing.

Any woman who has had cervical cancer goes through the audit. If there is a category 3 abnormality, they get an SAI as part of that, and the woman is invited to take part in it. Some of those are going on. All the trusts do those, all across the UK, when such things happen. That is just the process for doing that.

Ms Flynn: The reason I ask that question is that, if we were to go back earlier, pre-2009, when we are talking about a systemic failure, for how long was the systemic failure present in the system? Was it potentially in other trusts? I would like to pick up on that. Can you track that, when SAIs are filed?

Dr Austin: Part of the issue with this is that cervical screening — Tracy, will get this — started some time ago, but the service improved, changed and modified as it went along. Standards have improved as learning has come through across the UK, so they have put in new standards and guidance. Then they thought about the learning audit, and that came in at various stages. The further you go back, the less stuff there is, because the whole system has been improving. In 2019, as I mentioned, there was new guidance, and that provided a new classification. Further guidance was issued last year to tighten up again the categories that I have just talked about and to bring that forward. The whole system moves forward and brings learning across the whole UK. It is standardised. The standards that we have now are not the same system as was in place way back, and that is the challenge. The further back you go, the more you find that some of this did not exist.

Ms Flynn: I am just saying that the staff and management might have been in place at the time.

Dr Austin: One of the issues that I mentioned is that new staff had come in. They were looking at that and managing the service, and they picked up the issue. Previous staff had retired or left for whatever reason. That is one of the challenges of that case: the new staff spotted something and thought, "That does not look right". Fresh eyes are always helpful.

Ms Flynn: Is it the case, therefore, that, until this point, some of the senior staff or senior management who might have been involved at the time have not been contacted?

Dr Austin: There are entirely different people running the service now, and those people have left the trust. That is one of the challenges.

Ms Flynn: It is just to help to get to the bottom of it all and, of course, to help with the learning in the longer term.

The Chairperson (Ms Kimmins): Thank you, Órlaithí.

I appreciate that this has been a lengthy session. A lot of the people here have been with us for the whole day. We really appreciate the time that has been given. We know how difficult this is, especially for the women impacted and their families. That is why we dedicated so much time to the issue; we need to get to the bottom of it. We recognise that it is a multilayered issue, and, going by what we heard today, there is so much more to it. That is a concern: there are still so many unanswered questions. That is why we need to thoroughly pursue this.

Thank you all for coming today and for bearing with us. It has been an important session, and it is important that everyone has had the opportunity to ask the questions that they needed answered and to explore the issues. I am sure that we will hear more from you at different stages.

Thanks very much. Safe home.