In June, I informed Parliament of a serious incident in the cervical screening programme. I am here to set out how we continue to address that issue and to reassure members that steps are being taken to prevent similar incidents in the future.
As I am mindful of the complexity of the issue, I again ask for a degree of patience while I summarise the background. In December 2020, a national health service board, following its annual invasive cervical cancer audit, discovered that a small number of women had been incorrectly excluded from the cervical screening programme and had subsequently developed cervical cancer. As I explained in June, sadly, one of those women has died.
That happened because the women were incorrectly recorded as having had total hysterectomies when they had, in fact, had subtotal hysterectomies. Members will remember that women who have had their cervix completely removed do not need to be screened for cervical cancer but women should continue to be screened if they have had a subtotal hysterectomy, which leaves some or all of the cervix.
I confirmed in June that immediate safeguards were implemented to ensure that similar mistakes could not happen again. An urgent review into exclusions was also conducted by an adverse event management team consisting of senior gynaecologists, pathologists, public health experts and others.
That review confirmed other instances of incorrect exclusions across Scotland. For clarity, I will update on the work in three parts: the first part of the audit, which reviewed exclusions where records indicated that a subtotal hysterectomy had been performed from 1997 onwards; the second part, which reviewed exclusions where records indicated that a subtotal hysterectomy had been performed before 1997; and plans for a wider audit of other exclusions from the cervical screening programme.
In June, NHS boards sent letters to 434 individuals who had been excluded despite indications on their records that a subtotal hysterectomy had been carried out since 1997. The audit focused on that time period because records of procedures before 1997 are stored differently and can be more difficult to access. Contacted individuals were either reinstated to the screening programme and asked to make an appointment with their general practitioner or offered gynaecology appointments when they were above the upper age range for screening or their records could not conclusively show that their exclusion was correct.
I confirm that, of the 220 people who were asked to make a GP appointment to be screened, 112 have had samples taken. Those who have not yet made an appointment will be contacted again by the NHS, and I urge anyone affected who has not yet made that appointment with their GP to do so. You will be prioritised and will find supportive and understanding staff when you go.
I also confirm that 130 out of the 215 people who were invited have attended a gynaecology appointment. Of those, 90 people were found to have a cervix but only 65 required to be reinstated into the programme because they remain in the eligible age range for screening. A small number of people have not yet attended a clinic because they chose to reschedule their appointment to a later date, and 68 people did not attend, declined or cancelled their appointment without rescheduling.
Again, my advice to anyone who has not yet attended is to please contact your health board—it is not too late to rearrange an appointment. The clinic will be aware of your situation and they will do everything that they can to support you.
Members will understand that some results are still being processed, but only seven people seen at either their GP or a clinic have so far needed to be referred for further investigations, and no cases of cancer have been detected. In those seven cases in which pre-cancerous cell changes have been found, those involved have been treated through our standard care pathways.
The second part of the audit focused on people who had a subtotal hysterectomy before 1997 and had been excluded from the screening programme. That work concluded as expected at the end of July, and letters were sent to around a further 170 individuals by 18 August. I once again offer my sincere apologies to anyone who has been affected for the anxiety that I know this will have caused.
Thirty-nine people were reinstated in the programme and were invited to make an appointment for screening with their GP, and 132 were offered a gynaecology appointment. Where possible, I will keep members informed of the outcomes in future updates.
Jo’s Cervical Cancer Trust continues to make its helpline available for anyone who is affected or concerned by this issue. It can be reached by calling 0808 802 8000 or via email at email@example.com.
To ensure that care for those affected is prioritised, the Scottish Government has provided additional funding to health boards so that gynaecology appointments can be offered as quickly as possible. In total, we have now provided more than £60,000 to support both reviews, and we will continue to make financial support available for boards that require it.
Alongside that audit, clinical teams have completed a review of the cancer registry to ascertain whether there are other cases in which an exclusion may have contributed to cervical cancer. In most cases, they were able to establish that the exclusion was not associated with the development of cervical cancer. However, I am sorry to say that, while it is still not possible to be certain, there is a high level of clinical suspicion that in one case inappropriate exclusion from screening may have resulted in a cervical cancer diagnosis. Separately, there is another very complex case in which several factors may have contributed to a diagnosis of cervical cancer, including an incorrect exclusion from cervical screening.
I have explained that the audit of women who had subtotal hysterectomies and were excluded from the programme was prioritised because those are the cases in which there was most reason to suspect errors. When I last spoke to the Parliament, I said that work was under way to consider the appropriateness of around 2,000 permanent exclusions from the cervical screening programme, which have been made over decades. I can now say that the adverse event management team has recommended that all of those records should be individually reviewed.
I must be open with you that, given the complexity and the numbers involved, it is likely that more people will be discovered to have been wrongly excluded. I know that that will concern people who have been excluded, but I hope that I can offer some reassurance. First, the overwhelming majority of those exclusions will be correct. We know that around 95 per cent of the hysterectomies that are carried out in Scotland are total, and women who have had a total hysterectomy do not need to be screened. Secondly, the risk of cervical cancer in general affects fewer than one in every 100 women in Scotland across their lifetime. Thirdly, there are dedicated NHS staff who are committed to completing this work as quickly as possible and to bringing all their considerable expertise to doing so. To them I offer my thanks for all the hard work that I know it will involve.
Planning and conducting the audit is extremely challenging, both because of the sheer scale of the task and because of the sometimes complex nature of the hysterectomy procedure. However, the NHS is working to develop and test a robust process involving teams of administrative and clinical staff spanning primary and secondary care, which will ensure that all records can be reviewed consistently. As members will appreciate, that will be an especially challenging task as the NHS continues to recover from the impacts of Covid-19. As the methodology is still being developed and the timescales are not yet finalised, I must say now that the wider review is likely to take at least 12 months to complete.
However, the records that are to be reviewed will be prioritised on the basis of risk, informed by clinical advice. Work to complete the audits will happen in parallel with work to care for those who have been identified as wrongly excluded. The NHS will not wait for the full audit to complete before beginning to contact and assess those affected. I recognise that people whose records are being reviewed will want and need to know how long they will have to wait for the outcomes of the review. The NHS will make sure that those affected are informed about progress, and I will update the Parliament as often as is required.
It is vital to stress, once again, that the safety of the screening process itself is not in doubt. What happened here involves errors regarding who should be invited for screening; it does not reflect on the way in which samples are taken or analysed. Everyone should be clear that screening is the most effective way of preventing cervical cancer—it can and does save lives. It is for that reason that we must maintain confidence in the programme and ensure that everyone who needs screening has the opportunity to receive it.
Our priority has been to address the current errors and do all that we can to prevent anyone else coming to harm. It has become apparent that some instances of incorrect exclusions were discovered in the course of previous data checks, incidents and reviews in 2006, 2015, 2016 and 2017. Those were more limited reviews, which were conducted within narrower parameters than those of the current audit. The errors that were uncovered at the time were corrected, and it was believed that all issues had been resolved. Nonetheless, I am acutely aware that we must consider whether opportunities were missed to identify the wider issues that are now being investigated. That is essential if we are to fully understand what happened in the past and prevent similar incidents in the future.
Therefore, I have commissioned Healthcare Improvement Scotland to carry out a review of the processes, systems and governance for the application and management of permanent exclusions in the cervical screening programme in Scotland. The review will draw on lessons from past adverse events, as well as on the learning from other screening programmes in Scotland and elsewhere in the United Kingdom. It is important to acknowledge that significant strengthening of national screening programme governance has already taken place over recent years, including the development of a robust process to manage adverse events.
The review will be led by an independent chair from outwith Scotland and supported by an expert review group. I have asked Healthcare Improvement Scotland to take forward the work with urgency, and I will update the Parliament when that appointment is made.
It is important to stress that the cervical screening programme continues to be the best way to prevent cancer before it starts. However, it is also important to say again that anyone who has any concerns about the symptoms of cervical cancer—including unusual discharge, bleeding between periods or after sex, and bleeding after the menopause—should contact their GP straight away for an appointment.
The NHS has established and delivered a pathway for those affected by the incident, and it is developing plans to review the records of all those who have been permanently excluded from cervical screening.
Finally, I have commissioned a review to look back and ensure that we can learn lessons, so that arrangements around exclusion are strengthened for the future.
Once again, I extend the offer to meet Opposition spokespeople should they wish to discuss the matter further. I will continue to update the Parliament as the work progresses.
Thank you, minister. I appreciate the importance and sensitivity of the statement, although I am slightly concerned that we have run over time, which will eat into the time that is available for questions. Perhaps we can revisit how we will manage such situations in the future.
I will allow about 20 minutes for questions, after which we will have to move on to the next item of business. Any member who wants to ask a question should press their request-to-speak button or type R in the chat function.
I thank the minister for advance sight of her statement.
I echo her remarks that the cervical screening programme remains the best way to prevent cervical cancer.
The error has had a profound effect on the women involved, so they deserve answers as soon as possible. Will the Scottish Government commit to the independent review being a full inquiry into why the women were excluded unnecessarily and the effect that that has had?
I a pologise—my team has just contacted me to say that I inadvertently said that 2,000 records were to be reviewed, when I should have said 200,000.
The women are absolutely at the heart of the decision. I put on the record how heart sorry I am that we are in this situation. Our concern for the women who have been affected and their families, and the need for sensitive care and communication, have been at the heart of development of our response to the situation. I assure members that the women will be kept informed about how we progress and how the situation unfolds.
Again, I give the assurance that I will keep Parliament informed. I am more than happy to keep Opposition spokespeople informed, as well.
The matter remains, unfortunately, a huge scandal. Concerns were raised in 2015, 2016 and 2017. In 2016, there were 29 inappropriate exclusions and in 2017, there were 11 inappropriate exclusions. Why were all the cases of women who were wrongly excluded from cervical cancer screening not picked up after the 2016 audit or, indeed, after the 2017 audit? Why did we have to force that information from the Government using freedom of information requests? Why did we need to wait until another case was discovered in December 2020 for that wider review? On what basis does the minister say it was believed that all issues were resolved, when clearly they were not and recommendations were ignored?
After her previous statement, I specifically asked the minister why the issue was not picked up by previous audits and her response was that
“no cases were found through that national audit system until 2020”.—[
24 June 2021; c 30.]
That is patently inaccurate, given the previous audits. I hope that the minister will correct the parliamentary record.
However, more important is that we will never know whether that gross oversight contributed to the deaths of three women who deserved so much better. Will the minister apologise for the Scottish Government’s failure and assure the chamber that it will never happen again?
The audits, incidents and reviews that previously took place were all more limited in scope, with very different starting points from the current incident and a narrower focus of investigation. Because of that, those historical audits could not have picked up the wider issues that we have now identified. In particular, none of the previous reviews would have picked up the small number of cases that first brought the incident to light when they were discovered by one health board in December 2020.
Furthermore, and importantly, there was consensus among Scottish screening exercises that the errors that had been identified in the earlier audits had been corrected, and that the issues that had caused them had been resolved. We have been advised by clinicians who are involved in the screening programme that, given the available evidence at the time, the audits were considered to be an appropriate and proportionate response.
However, like Jackie Baillie, with the benefit of hindsight, I can say that it is important to ask whether opportunities were missed to look further and to identify wider issues earlier. I understand that and agree that questions can and should be asked about whether opportunities were missed, which is why we are dealing with the matter as we are.
I, too, want the questions to be answered, which is why I have commissioned Healthcare Improvement Scotland to undertake a thorough review of the processes, systems and governance of exclusions in the cervical screening programme. That will include understanding how the processes have developed over time, and learning lessons from past audits and the adverse events. That will help to establish whether the issues could have been uncovered sooner.
Will the Scottish Government continue to provide funding to the charity Jo’s Cervical Cancer Trust to provide support to women who have been affected and the women concerned for as long as is necessary, particularly given the challenging circumstances that many of those women face?
Yes—absolutely. As I mentioned earlier, Jo’s Cervical Cancer Trust’s helpline will remain open and available for anyone who is concerned about or affected by the issue. We will continue to provide additional funding if it is needed, so that the charity can provide support through its helpline. It is important to put on the record that the trust has established links with each NHS board, so there is no need for boards to have their own individual helplines. I state again that the helpline can be accessed by calling 0808 802 8000 or by emailing firstname.lastname@example.org. Jo’s Cervical Cancer Trust has a huge amount of experience in supporting people who have questions and concerns about cervical cancer. Again, I record my thanks to the trust for the work that it has been doing in supporting people who are affected by the incident.
Cervical screening is safe, effective and saves women’s lives. I urge women, or anyone with a uterus, please, not to lose confidence but to attend the screening programme. To give women reassurance, can the minister say what safeguards were put in place in June to prevent such an incident from happening again, and when an audit will be run to find out whether it has happened again?
I confirm that, as soon as the issue was discovered, immediate steps were taken to ensure that no one else was excluded in error from the programme. Cervical screening labs will no longer add hysterectomy information without confirmation from the operating gynaecologist that the cervix was completely removed during a hysterectomy procedure. Also, at present, general practitioners can no longer add exclusions; that will remain the case until we can be absolutely assured that a robust process is in place to verify GP exclusions.
As I mentioned, Healthcare Improvement Scotland has been commissioned to conduct a full review of the incident. It will look at the governance processes and at whether there were opportunities to learn about the scale of the incident earlier than we did. I am sure that the review will fruitfully bring forward suggestions on how we can make sure that it never happens again.
I appreciate the minister’s update on this serious situation, but my question is about the future of cervical cancer testing in general. Could the minister give an update on the status of the roll-out of human papillomavirus home sample tests and say who will be eligible for them?
Self-sampling is still a relatively new innovation, and the United Kingdom national screening committee—NSC—has not yet recommended that self-sampling be incorporated into the cervical screening programme. The NSC continues to gather and evaluate evidence on the matter; it is not possible to say when that process will be complete. However, Scotland is playing an active part in supporting that work. We will also take the necessary steps to ensure that we can roll any recommendation out as soon as possible, once one is made. At all times, ensuring patient safety will remain key, so we will not act until we are sure that it is safe to do so.
Some members will be aware that NHS Dumfries and Galloway is currently carrying out a pilot, which involves sending a self-sampling kit to all screening participants aged 25 to 64 who have never attended for cervical screening or who have defaulted on their most recent appointment. Findings from that pilot will inform our work, going forward.
I am glad that the Government is finally instituting the Healthcare Improvement Scotland review that Scottish Labour asked for, but will the minister clarify the terms of the review, when she expects it to report and how far reaching we can expect it to be in order to prevent further instances from happening?
As I said, we have commissioned a review by Healthcare Improvement Scotland, which has a long track record in improving quality and safety in Scotland, to look at the incident in its entirety, including the records of all those who were affected, and the governance processes. An independent chair will steer the review in order that we can be 100 per cent sure that we learn everything that we need to learn from the incident.
The review will look not simply at the incident that we have uncovered and the governance that is in place, but also at other screening programmes that are in place in Scotland, in order to see whether we can learn lessons from them. It will also consider asking for learning from the other UK nations and Ireland in order to see whether there are things that we can learn from their screening programmes that would make ours safer.
Tha t is an excellent question, because we know that participating in the cancer screening programme is one of the best ways to detect cancer early. That is why we are so concerned about the women who have been wrongly excluded from the programme. We have continued to invest in our screening inequalities fund in order to tackle inequalities in the national population screening programmes. We have committed £2 million over the next two years to tackle inequalities, including those that have arisen as a result of Covid-19. That is in addition to the £5 million that we have put into the fund so far.
At the moment, we are focused on making sure that future projects are sustainable and will deliver real impact. A workshop was held recently to gather the views of a wide range of stakeholders on how the money can best be spent, and discussions are on-going about how to make the best use of the funding.
I assure the member that we are determined to identify and remove the barriers that exist to participation in the screening programme, because we know just how preventable the illness is. We want to ensure that women can participate in the programme as it is so effective in preventing cancer.
The Government waited until after the election in June, and for months after it had discovered that there was a problem, to tell Parliament that a woman had died after wrongly being excluded from screening. Today, we have learned not only that two more women have cancer after being excluded, but that a review of 200,000 women’s records is under way.
How were indications of this public health scandal detected on four separate occasions without that triggering a full-scale investigation? Will the Government as a basic courtesy now write to the 200,000 women whose records will be reviewed in order to keep them updated and give them agency to seek help if they want to?
Screening systems are inherently complex and they require complex quality assurance mechanisms. We can anticipate that there will always be incidents in which we are required to undertake further checks and investigations, and that is what happened in the previous audits. The changes to screening governance—including the establishment of the programme boards for each screening programme, the development of a formal adverse event management process for screening and the establishment of a national screening oversight function last year—demonstrate the Government’s consistent, on-going commitment to improving the governance and oversight of our screening programmes.
We will press forward with the review of women who have been permanently excluded from the cervical screening programme. The work is complex and we will face many challenges in progressing it in a period of unprecedented pressure on the NHS, but we are determined to find every last case where an inappropriate exclusion might have occurred. I assure the member that we will write to the women involved. They will know that their records are being examined and reviewed and we will keep them updated.
I have four members who still want to ask a question and less than two and a half minutes in which to bring them in. I would appreciate brief questions and very brief responses, please.
As I said in my statement, the work to review the pre-1997 records concluded at the end of July. Letters were issued by 18 August to 170 individuals who were identified in the second part of the review as being, or potentially being, wrongly excluded. Some 39 people were reinstated in the programme and were invited to make an appointment for screening with their GP, and 132 women were offered a gynaecology appointment. The next step is to consider the larger cohort of 200,000 women whose records feature permanent exclusion from the screening programme.
The first point to stress is that the overwhelming majority of permanent exclusions will be correct. As I said in my statement, around 95 per cent of hysterectomies performed in Scotland are total. However, because we know that there is a possibility that some exclusions will be incorrect, we are taking a rigorous approach to reviewing every single record.
I fully expect that the people affected will want to know as a matter of urgency whether their exclusions are correct. I assure them that we are working as fast as we can, but it will take some time to work out the procedure so that we do not overburden the NHS during a period in which it is under immense pressure. The exercise will be like trying to find needles in a haystack. However, because even one person developing cancer is too many, we are absolutely committed to finding each and every woman who has been harmed or who could be at risk of future harm.
For those who find themselves needing further treatment, that could be a traumatising event. What other, wider support, such as mental health support, is available for those who need it?
We have made extra money available to health boards to ensure that gynaecology clinics are available, and we have put extra money into the Jo’s Cervical Cancer Trust helpline to ensure that it can meet the needs in relation to the incident. I suggest that the first place that women go to is Jo’s Cervical Cancer Trust. It has absolutely wonderful people who are used to giving individual advice to women and who are well prepared and well versed in supporting women through this particular incident. Should mental health support of a different or more individualised nature be required, I would expect women’s general practitioners to refer them on.
I confirmed in my answer to Sandesh Gulhane that, as soon as the issue was discovered, immediate steps were taken to ensure that no one else was excluded from the programme in error. As I mentioned, Healthcare Improvement Scotland has been commissioned to undertake a wider review of the processes, systems and governance for the application and management of permanent exclusions in the cervical screening programme in Scotland in order to ensure that the issue does not happen again. In particular, the review will look at how processes have developed over time and at lessons from audits and adverse events.
The changes to screening governance in Scotland that I have mentioned—they include the establishment of programme boards for screening, the national screening oversight board and the adverse event management process—provide reassurance that there is robust national oversight of and quality assurance for Scotland’s screening programmes.