Meeting of the Parliament (Hybrid)

Meeting date: Thursday, June 24, 2021

Official Report 944KB pdf

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Cervical Screening

The next item of business is a statement by Maree Todd on cervical screening. The minister will take questions at the end of her statement, so there should be no interventions or interruptions.

14:01  

I regret that I am here to inform Parliament of a serious adverse event in the Scottish cervical screening programme. In December 2020, a national health service board conducted its annual invasive cervical cancers audit and discovered that a very small number of women had developed cervical cancer after being wrongly excluded from the screening programme following a hysterectomy that was carried out more than 20 years ago. I am extremely sorry to say that one of those women has died.

I offer my sincere condolences and whole-hearted sympathies to the women and their families; I also offer them the absolute reassurance that the Government is treating the issue with the utmost seriousness. The board has contacted those affected to apologise and to offer further discussions with clinicians. I know that this event will be enormously distressing to them, and that they, along with many members, will question how it happened. That is why I am now updating Parliament on what we know about the errors and on how we are responding.

To prevent causing undue anxiety and distress to the women involved, I have waited until the NHS has completed the first part of a national review before making this statement. These matters are complex, Presiding Officer, and I ask you and members to have patience while I explain the background and nuances.

The Scottish cervical screening programme began in 1988 and routinely invites everyone with a cervix, between the ages of 25 and 65, for regular tests. People might be invited up to the age of 70, to follow up a test that requires further investigation or treatment.

Anyone who has had a total hysterectomy that involves the complete removal of the uterus and cervix can be excluded from screening as there is no risk of cervical cancer, but those who have had a subtotal hysterectomy, in which part or all of the cervix remains, should continue to be screened. This is true no matter how small the remaining part of the cervix is.

Although this will be of little comfort to the women and families affected, the incorrect exclusions were uncovered as part of our quality assurance processes, which require health boards in Scotland to conduct regular audits to review the cervical screening history of all patients who are diagnosed with cervical cancer.

Once the exclusions were discovered, NHS National Services Scotland assembled an adverse event management team of senior gynaecologists, pathologists and public health experts, among others, to address the problem. At their direction, all NHS boards conducted an urgent review to assess the risk of other people having been incorrectly excluded. Unfortunately, that review confirmed instances in which exclusions have been wrongly applied across Scotland. It also revealed that the issue is extremely complex, spans a number of decades and involves a variety of potential errors.

The first hysterectomy-related exclusion dates back to 1959—almost 30 years before the screening programme began. Therefore, there is more to do to uncover the full extent of the issue. However, I will provide an update on what we know and what has been done so far.

First, immediate remedial work to address the failure has been completed. NHS Scotland has strengthened procedures to ensure that full details of hysterectomies, including whether the cervix was completely removed, are clearly recorded and communicated to the cervical screening programme. Secondly, to date, no other routine audits in NHS boards have found any further instances in which someone has developed cervical cancer after having been incorrectly excluded from the programme.

Thirdly, the adverse event management group identified as an immediate priority a review of individuals who had been excluded from the cervical screening programme but whose records indicate that they had a subtotal hysterectomy. There are around 1,500 individuals in that group. Of those individuals, around 500 had hysterectomies before 1997—that information is recorded in an older part of the medical records system. Their records are being fully reviewed, but it is a time-intensive process, and it is not yet complete. Therefore, today, I will focus on the audit of more recent records, but I assure members that work is proceeding urgently to review the records of those who had subtotal hysterectomies before 1997.

I know how concerning the situation will be. I do not want to minimise the seriousness of the incident, but I do want to provide reassurance that the risks of cervical cancer are low. In the United Kingdom, among women and people with a cervix, fewer than one in 100—less than 1 per cent—will develop cervical cancer in their lifetime.

I hope that the actions that I will outline now will demonstrate that we are doing everything possible to provide effective support for anyone who has been incorrectly excluded.

At the direction of the adverse event management group, a multidisciplinary team was assembled in each NHS board to check the hospital records, laboratory records, general practitioner records and screening records of everyone who had been excluded from screening since 1997 despite having a subtotal hysterectomy recorded. That work is now complete. Of that group, more than one third have been correctly excluded and no further action is needed. However, 220 individuals in the eligible age range for screening were excluded in error. The NHS has written to them individually to apologise, explain the situation and offer personalised advice. GP practices have been asked to prioritise each of those individuals for a timely screening appointment, and I expect those appointments to take place within a few weeks.

There are also 149 individuals whose records are unclear about what type of hysterectomy was performed. Their health boards have written to them to explain and apologise, and to offer a gynaecological appointment and, if appropriate, a screening test. Similar letters have been issued to 65 individuals who were incorrectly removed from the programme and who are now over the age range for screening. Where necessary, the Scottish Government has provided funding to health boards to run additional clinics, so that those who require gynaecology appointments can be seen within the next four weeks without impacting other services.

A very small number of individuals have left Scotland. We are working with our United Kingdom counterparts to contact those people and advise on next steps.

Finally, 152 individuals in the group are now deceased. A full audit of those records is under way.

I know that anyone who receives a letter about the issue might be extremely anxious. I am sorry for that. The Scottish Government has provided additional funding to Jo’s Cervical Cancer Trust so that anyone who is concerned can contact the organisation and receive free and comprehensive support. Jo’s Trust can be contacted by calling 0808 802 8000 or by emailing [email protected]. More information about cervical screening is available on the NHS Inform website.

Work is also under way to consider the appropriateness of around 200,000 exclusions that are thought to have been based on total hysterectomies. I must stress that the vast majority of hysterectomies carried out in Scotland are total, so we can be confident that the majority of those exclusions are correct. However, based on our current findings and the range of errors involved, I hope that members will agree that it is prudent to look more closely at them. Once that work is complete, NHS health boards will write to anyone who requires further investigation.

Although I know that people who have had hysterectomies may be concerned, I urge them to wait for that work to finish and not to contact health services in the meantime, unless they are worried that they have any symptoms of cervical cancer.

Because we must learn from this incident and prevent future occurrences, we have alerted the other UK nations. We will work closely with them as investigations proceed.

Before I conclude, I will say a few words about the screening programme. Although today’s announcement will be worrying for those who have been directly affected and for others who have had a hysterectomy, screening continues to be the most effective way of preventing cervical cancer. Cervical screening is not a diagnostic test. It aims to detect cell changes before they become cancerous. It saves 5,000 lives in the UK every year, and prevents eight out of 10 cervical cancers from starting.

This incident does not detract from that, nor does it take away from the quality of screening tests or their findings. In fact, it is because the screening programme is so effective that we are doing all that we can to ensure that no one is excluded from it when they should not be. If you are due to make or attend a cervical screening appointment, I urge you to do so, and if you have not attended a screening before or you have missed your most recent test, please contact your GP surgery to arrange one.

In the meantime, I urge everyone, whether affected by this issue or not, to be alert for symptoms of cervical cancer. Anyone who is experiencing unusual discharge or bleeding after sex, between periods or after the menopause should contact their GP practice immediately and not wait for their cervical screening appointment. Those symptoms are not usually caused by cervical cancer, but it is important to have them checked. Further information on symptoms is available on NHS Inform.

This incident will be profoundly worrying to many people. For the women and families whom I referred to at the beginning of my statement, it has had devastating consequences, and nothing that I say can undo that. However, I make the commitment today that everything that we do surrounding this incident will be guided by three principles. Our focus will be on identifying and providing the appropriate support and care for anyone who has been wrongly excluded; we will be open, transparent and welcoming of the scrutiny that this investigation rightly deserves; and we will learn from the incident so that it cannot happen again.

On that basis, I reiterate that our immediate priority is to ensure that screening or gynaecological appointments are offered to everyone who has already been identified as having been incorrectly excluded.

The audit of anyone who was excluded from the programme who had a subtotal hysterectomy before 1997 will continue, and I expect that anyone who was excluded in error will be contacted in August. Investigations into other hysterectomy-based exclusions will continue.

Wherever there is concern, we will act, and wherever further changes can make our processes more robust, we will implement them. I have offered meetings to Opposition spokespeople, but if any MSP would like to meet to discuss the issue, I am more than happy to do so over the recess period. I will, of course, update Parliament again shortly after recess.

The minister will now take questions on the issues raised in her statement. I intend to allow around 20 minutes for questions, after which we will have to move on to the next item of business. It would be helpful if members who wish to ask a question pressed their request-to-speak buttons now.

I call Annie Wells, who is joining us remotely.

I thank the minister for her statement. She has shared deeply distressing news with the Parliament. My heart goes out to the family of the woman who has tragically lost her life, and to all the women affected. As the minister said, many women will be concerned after today’s revelations, and I echo her statement that anyone concerned should contact Jo’s Cervical Cancer Trust.

The minister mentioned 500 women who had hysterectomies before 1997, and that those are recorded in an older part of the medical record system. How long will it take for a full review into the records, and has any of that already been completed?

The same adverse event management team that oversaw the review of the post-1997 group will continue to oversee the review into those who had their subtotal hysterectomies before 1997. That expert group includes very senior and experienced clinicians, pathologists and public health experts.

The work of auditing the records will be carried out by individual health boards, as was the case for the participants who had subtotal hysterectomies after 1997. That work has already begun. I hope that it will be concluded by the end of July, and that those who are identified as wrongly excluded will be contacted very shortly after the work is completed.

This is an extremely serious situation, and our thoughts are with the women who have been affected. The truth is that we do not yet know the full scale of the error; it could impact on many more women than the 220 excluded from the screening programme since 1997. It is critical that women are contacted urgently and offered information and support.

Why was the issue not picked up by audits of the screening programme in the past? When will all the women affected be not only identified but seen by a clinician? Will there be additional specialist clinics in every health board area?

The minister will be aware of the concerns about capacity and a significant backlog in screening, with something like 180,000 tests delayed because of the pandemic and delays of six months or more for those who have been screened and need treatment. Therefore, what additional resources will be provided—urgently—to cope with the serious situation that we are discussing as well as to catch up with the backlog?

As I said in my statement, around 500 people—I think that it is 434—have been contacted this week. However, because of the range of errors involved, we think that it is prudent to go back and examine the records of all women who have had hysterectomies to ensure that no errors have occurred. That means that the number of women who might be involved could be larger.

I said in my statement that the number is about 170,000 women; however, bearing in mind that the vast majority of women who have hysterectomies in Scotland have total hysterectomies, we expect that the vast majority of those women will have been correctly excluded. I know that it is uncomfortable to have to wait to be contacted, but we are working as fast as we can to resolve the issue.

In relation to additional resources, around 200 women have been asked to attend their general practitioners for a screening. I do not expect that to produce an undue burden on general practices; very few will have more than one woman involved. In relation to the two groups of women who have been called, had their letters and been given an appointment at the hospital, we have provided extra resources to several health boards who wanted to put on additional clinics to ensure that that did not impact on the services that are currently being provided.

On invasive cancer audits, the new national methodology was introduced in 2014. Health boards were doing audits before that. I can say only that no cases were found through that national audit system until 2020.

Jackie Baillie raised some points that I also want to mention; I will dig a little bit deeper. The situation is clearly worrying for the women affected and their families. I understand from the minister’s statement that women have now been contacted to take forward the next steps of their care.

In case any women are concerned that they may have been affected but have not heard anything, can the minister outline what support is in place for them to raise those concerns? The minister mentioned Jo’s Cervical Cancer Trust, but might contact with it lead to referrals? Given that there are general concerns that GPs are not doing many face-to-face appointments, can she give reassurance that affected women are not only being contacted but being given urgent and one-to-one in-person appointments?

The women who have been wrongly excluded have been contacted by letter. Those letters went out on Tuesday this week and so should have arrived yesterday or today. The letters highlight to the women that, if they are required to make a GP appointment, they are to telephone and highlight that they have been contacted by letter and wrongly excluded. We also sent letters to the women’s GPs and we have briefed a variety of professional groups, including medical directors, directors of public health, NHS boards, NHS executive directors of nursing, GPs, the Royal College of Obstetricians and Gynaecologists, the Royal College of General Practitioners, the Royal College of Nursing and cervical screening programme leads in all four nations and Ireland. The reason for that briefing is to make sure that everybody is aware of how high a priority the women are. We have also added a digital tag to their records so that, at every stage of the system, as those women progress through the process of checking their situation, they are prioritised and fast tracked.

I declare an interest as a practising doctor.

My thoughts and prayers go out to the women and their families who have been affected by this terrible error. It is simply awful. It might shake women’s faith in the cervical screening programme and, as a GP, I must be clear that attending cervical screening is vital. I promise that the swabs that I and other GPs take perform early warning detection of potential cancer, so please attend appointments, and do not be put off. If people experience any symptoms, they should please contact their GP.

Is this a failure of coding by the operating surgeon, a system-wide issue or an information technology issue?

As might be expected, we have looked closely at the points where the errors appear to have occurred, and there are potentially four such points. For some women, there has been a mismatch between the operation that was proposed and the operation that was done. That usually happens for technical reasons that occur during the surgery and, as a consequence, a proposed total hysterectomy becomes a subtotal hysterectomy. That fact might not be noted in the discharge summary and instead the discharge summary letter will be based on the theatre list—that is, based on the planned operation. The GP will see that and request removal from the call-recall system.

A second error that might have occurred is that of subtotal procedures being incorrectly coded in theatre, reflecting a mismatch between the proposed and actual operation or simply a misunderstanding of what a subtotal procedure is. There has also been some incorrect coding in labs; subtotal specimens might contain some cervical tissue and have been incorrectly coded as total hysterectomies when those patients were being considered for continuation on call-recall. Finally, the patient may have been removed from call-recall despite accurate information being conveyed to primary care following surgery where the cervix is retained.

There are many reasons why women might be reluctant to attend their screening test. Those range from difficulties in attending or being examined due to physical disability to cultural and language barriers, lack of awareness and uneasiness. What action is the Scottish Government taking to break down those barriers and help more women attend their appointment when called?

Those are complex issues. I am mindful that there is not a single solution, but I agree that those are important matters to tackle. I will outline some of the work that is already happening. In initial sample-taking training, NHS Education for Scotland provides information for sample takers to help them address the potential issues in assisting disabled people at their cervical screening appointment, along with many other groups that might experience barriers to screening.

Further, our advice for sample takers is set out in national guidance. If someone is unable to leave their home for a cervical screening appointment, their NHS board can use a multidisciplinary team member to provide support that will allow them to have their sample taken. That is done on a case-by-case basis, depending on the needs of the individual.

The Scottish Government has made funding available through its screening inequalities fund to allow health boards to tackle inequalities in access to screening. In addition to the £5 million that we have made available over the past five years, we will be exploring how best to use an additional £2 million over the next two years to drive long-lasting sustainable change in cancer screening programmes. That will align with the work of the national screening oversight board, which also has a key focus on tackling inequalities across all our screening programmes and is developing a strategy to do so.

This incident is obviously a serious failure that must not be allowed to happen again. I ask my question on behalf of women who had subtotal hysterectomies before 1997. To reassure those women, I would like to press for a date on which the audit of those cases will be completed. How long will it take for individuals affected to be contacted? In cases involving individuals who have passed on due to complications relating to cervical cancer, will their families be contacted?

I can assure the member that we are working as fast as we can through those records to identify women who have been wrongly excluded pre-1997. I am afraid that I cannot give her an exact date, but we aim to have that work completed by the end of July and to inform those women as soon as we can after that, which I would expect to be early August.

On the second point, we are conducting an audit of all women who have died of cervical cancer, and we will examine whether they are involved in this incident. If they are, the NHS will get in contact proactively with those families to explain the situation.

Human papillomavirus is known to cause 99 per cent of all cervical cancers, as well as cases of head, neck and anogenital cancers, so an HPV vaccination programme was introduced for secondary 1 girls in 2008 and for boys in 2019. Can the minister provide an update on how lockdown has affected implementation of the HPV vaccination programme over the past 16 months and say how that will be taken forward?

I am afraid that I do not have that data in front of me. I am willing to write to the member to update him on that issue as soon as I can get my hands on those figures.

I, too, extend my sympathies to all of those have been affected and their families.

The minister states that the risk of cervical cancer is low and that cervical screening is the best protection against cervical cancer, but many women’s confidence in the programme will have been undermined by today’s announcement, particularly when we are hearing more about how women’s health problems are being missed, ignored or misdiagnosed. What urgent action will the minister take to restore confidence in the cervical screening programme and encourage women to continue to attend their appointments?

Undoubtedly, we have to ensure that women have confidence in the system. As members have said, it is an extremely effective way of preventing cancer—around 5,000 lives are saved through it every year. We recently had cervical cancer week, for which Scottish Government buildings here in Edinburgh were lit up. Regular campaigning is conducted by Jo’s Cervical Cancer Trust and, later this year, the Scottish Government will be conducting a campaign to alert women to the practicalities of the screening programme and highlight just how important it is to have their cervical screening.

I note from the minister’s statement that some of the women are now beyond the eligibility age for screening, which I think is 64. Given that life expectancy for women in Scotland is over 80, is there any scope for extending automatic screening eligibility to at least age 70, for not just those but for other women?

At present, screening can extend up to age 70 for those who have had a non-routine result that requires follow-up or treatment, so those high-risk women are screened up until the age of 70. The UK national screening committee keeps the eligible age ranges for screening under review, using the best available evidence, and Scottish ministers would work to implement any change that the committee recommended.

I extend my condolences and thoughts to the women and their families who have been affected and I recognise that, for many people, the situation will be a source of significant anxiety. The minister mentioned possible funding. Is she able to say how much funding the Scottish Government has allocated to health boards for extra appointments and how much it has set aside? Given the obvious anxiety that the statement will cause to patients, will the minister consider additional funding for health board level helplines, so that patients can inquire about their records and, therefore, avoid GP surgeries being possibly but understandably overwhelmed by calls from worried women and their families?

Four health boards have requested funding to provide additional clinics: Lanarkshire, £28,000; Lothian, £8,098; Greater Glasgow and Clyde, £5,000; and Fife, £2,700. No other boards have requested funding, but we are happy to keep the situation under review and will provide further funding if needed.

We have also provided extra funding to Jo’s Cervical Cancer Trust. I fully appreciate how worrying the situation will be for people who have been affected. Everyone who is affected will receive a personalised letter from their health board to apologise for the situation and provide information about the incident in the cervical screening programme. Jo’s Cervical Cancer Trust has made its helpline available nationally for women to call. I advise against women contacting their GP to find out whether they have been affected. I assure them that anyone who has been identified as incorrectly excluded from the programme, because they have a subtotal hysterectomy, will receive a letter directly from their health board. Those who are within the age range for the screening programme will be asked to contact their GP to make a screening appointment.

The one exception that I make to that is that our advice remains that people should contact their GP straightaway if they experience symptoms of cervical cancer, which are unusual discharge, or bleeding after sex, between periods or after the menopause. Those symptoms are generally caused by something else, but it is vitally important that women who experience those symptoms attend their GP and have them checked out.

The news that we have heard will be deeply alarming to many women, and it is a tragic reminder of the importance of robust screening programmes. If, as the minister says, there are regular audits, how was that issue missed for so long? If it was first detected in December 2020, why are women hearing about it only now? Are all the 1,500 women aware that their records are currently under review?

As I explained, with regard to the invasive cancer audits, new national methodology was introduced in 2014, and health boards were doing audits prior to that. In 2020, that new methodology of auditing invasive cervical cancer identified the problem. The Scottish Government has known about the incident only since March.

The adverse event management team, which the NHS established to deal with the issue, met for the first time on 9 March and set to work immediately to determine the scope of the incident and how best to support those who were affected. As I have said, that expert group brings together senior gynaecologists, pathologists, public health experts and senior system leaders in screening. It established that the immediate priority was to find out how many of those who were excluded from the cervical screening programme had had a subtotal hysterectomy.

Multidisciplinary teams were established in every NHS board in Scotland, and they looked in detail at the medical records of those who had been excluded from the cervical screening programme despite their records indicating that they had undergone a subtotal hysterectomy. That painstaking process involved cross-checking a range of electronic and older paper records, including operation notes, pathology reports, hospital discharge letters and GP records. That took several weeks to complete.

As well as establishing who had been affected, the group determined the correct care pathways and ensured that arrangements are in place so that everybody receives the same information and treatment, wherever they are in Scotland. As I mentioned before, that included making an IT update to flag the records of anyone affected, so that any further investigation of whether treatment is required as a result of the incident will be prioritised. That took several weeks to arrange.

It was absolutely vital that the NHS took the time to accurately understand each person’s circumstances and to make sure that arrangements were in place before we wrote to anyone to make them aware that they might have been excluded in error. To do otherwise, I believe, would have compounded people’s anxiety with long delays or uncertainty about how their cases would be managed.

I, too, extend my sympathies to all the women affected. Worrying research conducted by Jo’s Cervical Cancer Trust has shown that only half of the women who have HPV on their cervical screening results know what it is. With last week being cervical screening awareness week, will the minister outline what action can be taken to tackle the stigma and confusion surrounding HPV and to increase awareness for women who have been diagnosed and across the wider population?

I agree with the member that it is vitally important to raise awareness of what HPV is and what it means to have HPV. Jo’s Cervical Cancer Trust has told us that HPV is the topic that it hears most about through its support helpline. Callers are often confused, anxious or upset about what it means to have it, so we know that more work is needed to help people to understand those issues. NHS Inform already has information available to help and support people, and Public Health Scotland regularly does work to raise awareness on issues around cervical screening. This month, for example, during cervical awareness week, it shared information and posted on social media.

The Scottish Government has also funded Jo’s Cervical Cancer Trust to carry out work to raise awareness of HPV and its implications for screening, and I expect that work to pick up pace throughout the year. Finally, as I mentioned, later in the year we hope to launch a campaign to raise awareness of cervical screening. We will work to accompany that with wider messaging around HPV.

It is, indeed, a deeply concerning statement. I will ask about two points. When were the Scottish ministers first made aware of this serious adverse event? Given that this is not the first time, sadly, that we have heard of errors in the cervical screening programme—last year, NHS National Services Scotland had to apologise for a two-month delay to screening invitation letters for around 1,500 patients due to what it referred to as a technical fault—and given the pressures that the NHS is currently under, how are ministers working to reassure women that the screening programme is fit for purpose? Will the minister look at undertaking a review of the programme?

We have worked really hard. As I said in a previous answer, we were first made aware of this on 9 March 2021. Officials were made aware and ministers were also informed on the same day. Everyone involved has worked extremely hard to identify the women involved. They first ensured that the systems were corrected so that the error could not be made again and, secondly, ensured that we could correctly identify the women and contact them with high-quality information, providing access to tests and screening at their GP or gynaecological appointments, if that was the more appropriate route. At the moment, our highest priority is to ensure that we are completely aware of who is involved and to contact them as quickly as we can and ensure that they have an appropriate pathway forward.

The situation is, indeed, deeply concerning. Our thoughts are with all the women affected. I appreciate what the minister has said about funding for the Jo’s Cervical Cancer Trust helpline to support anyone who is concerned, but will she confirm that the funding will last for as long as it is needed and that all sufficient resources will be given to the trust to ensure comprehensive individual support? Further to that support, will the minister advise what is being provided to GPs and other health professionals, who may be the first point of contact for women but who are in the midst of remobilisation from Covid?

I thank Paul O’Kane for that question, which enables me to put on record that I am extremely grateful to Jo’s Cervical Cancer Trust for running its helpline. It has enormous expertise in supporting people who have questions and concerns about screening or the risk of cervical cancer. We have given extra funding to ensure that the trust can cope with the extra calls that we anticipate, and I would be more than happy to have discussions with the trust, should more funding be required.

As I said, the letters to the women who have been wrongly excluded from the programme went out on Tuesday. At the same time, letters went directly to their GPs. The letters to the women include not only details that are personal to them but an information leaflet with general information and frequently asked questions from women. A similar format was used for the GPs, who were sent information that included a set of questions and answers.

As I said in a previous answer, we have contacted many people in health boards and the royal colleges of various professions to ensure that, as far as possible, everyone who might ask questions about their situation will be well armed with information, in order to reassure women and give them confidence that their care is in safe hands.