 We will move to the next item of business, which is a statement from Marie Todt on an update on cervical screening. The minister will take questions at the end of our statement, and so there should be no interventions or interruptions. cher Richardroc jeddwar diwedd,社ul yn tytwm wedi ei mewn cwrstech surprisingu. In June, I informed Parliament of a serious incident of cervical screening programme. I am here to set out how we continue to address that issue, and reassure members y cyfleiddau fyddon nhw nesaf i gael i'r ffordd yn llefnodol yn yr hynny. Asgol yw'r cyfleiddau gyrraeth y byddwn i'w hunain a gael i ddaf yn siŵr i gyfleiddau gyda chi fod yn gyntaf mewn bethau. Yn dwylo'r 2020 ar gyfer gyfer sgwrs anoolig o ddweud y cyfnodau cyfnodau cerddurau cynllun ac swyddwyr aethau yn gwneud ar gyfer rennod bwrn ymwysig gan gymrydol ac yn fwyfyr unrhyw ddweud cyfnodau cyfnodau cyfnodau. As I explained in June, one of those women has sadly died. This happened because the women were incorrectly recorded as having had total hysterectomies when in fact they had had subtotal hysterectomies. Members will remember that women who have had their cervix completely removed do not need to be screened for cervical cancer, while women should continue to be screened if they have had subtotal hysterectomies 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, amongst others. This review confirmed other instances of incorrect exclusions across Scotland. For clarity, I will update in the work in three parts. The first part of the audit, which reviewed exclusions where records indicated a subtotal hysterectomy had been performed from 1997 onwards. The second part, which reviewed exclusions where records had indicated 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 the 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 GP or offered gynaecology appointments where they were above the upper age range for screening or where their records could not conclusively show that their exclusion was correct. I can 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 would urge anyone affected who has not yet made that appointment with their GP to do so. You will be prioritised and find supportive and understanding staff when you go. I can also confirm that 130 people have attended a gynaecology appointment of 215 who were invited. Of those, 90 were found to have a cervix, although only 65 were 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 either 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 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. Where, in those seven cases, precancerous cells 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. This 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 affected for the anxiety that I know that this will have caused. 39 people were reinstated in the programme and invited to make an appointment for screening with their GP and 132 were offered a gynaecology appointment. Where possible, I will keep you informed of the outcomes and future updates. Jo's cervical cancer trust continues to make their helpline available for anyone affected or concerned by this issue. It can be reached by calling 0808 8028000 or via email at helpline at joastrust.org.uk. 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 over £60,000 to support both reviews and we will continue to make financial support available for boards who require it. Alongside the 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. I am sorry to say that, while it is 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. Secretly, there is another very complex case where several factors may have contributed to a diagnosis of cervical cancer, including an incorrect exclusion from cervical screening. Presiding Officer, I have explained already that the audit of women who had sub-total hysterectomies and had been excluded from the programme was prioritised because these are the cases where there was most reason to suspect errors. When I last spoke to Parliament, I also said that work was under way to consider the appropriateness of around 2,000 permanent exclusions from the cervical screening programme, which has 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, based on the complexity and the numbers involved, it is likely that more people will be discovered to have been wrongly excluded. I know that this will concern people who have been excluded. However, I hope that I can offer some reassurance. Firstly, the overwhelming majority of these exclusions will be correct. We already know that around 95 per cent of hysterectomies carried out in Scotland are total, and women who have had total hysterectomies do not need to be screened. Secondly, the risk of cervical cancer in general is 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 of their considerable expertise to doing so. To them, I offer my thanks for all the hard work that I know that this will involve. Planning and conducting this audit is extremely challenging, both because of the sheer scale of the task and 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 that will ensure that all records can be reviewed consistently. As members can appreciate, this will be an especially challenging task as the NHS continues to recover from the impacts of Covid-19. While the methodology is still being developed and the timescales are not yet finalised, I must say now that this wider review is likely to take at least 12 months to complete. However, the records 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 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 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 Parliament as often as required. It is vitally important 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 that samples are taken or analysed and 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 also ensure that everyone who needs screening has the opportunity to receive it. Our priority has been to address the current errors and do all 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 and again in 2016 and 2017. Those were more limited reviews conducted within narrower parameters than that current audit. The errors 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 now being investigated. That is essential if we are to fully understand what happened in the past and to prevent similar incidents in the future. I have therefore commissioned Health Care Improvement Scotland to take forward a review of the processes, systems and governance for the application and management of permanent exclusions in the cervical screening programme in Scotland. That will draw on lessons from past adverse events as well as the learning from other screening programmes in Scotland or elsewhere in the UK. 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, supported by an expert review group. I have asked Health Care Improvement Scotland to take forward this work with urgency and I will update 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, but 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 menopause, should contact their GP straight away for an appointment. The NHS has established and delivered a pathway for those affected by this incident and 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 exclusions are strengthened for the future. I once again extend the offer to meet Opposition spokespeople should they wish to discuss this further. I will continue to update Parliament as this work progresses. Thank you very much. Minister, I appreciate the importance and the sensitivity of the statement. I am slightly concerned that we have run over time that is going to eat into the time available for questions, but we can maybe revisit that in the future. The minister will now take questions. I will allow again around 20 minutes four questions, after which we will have to move on to the next item of business. Any members who want to ask a question, please press the request-to-speak button or place R on the chat function. I call Annie Wells. Thank you, Presiding Officer. I thank the minister for advance sight of her statement and I echo her remarks that the cervical screening programme remains the best way to prevent cervical cancer. The minister is involved and he deserves answers as soon as possible. Will the Scottish Government commit to the independent review being a full inquiry into why those women were excluded unnecessarily and the effect that this has had? Apologies, I have my team just contacted me to say that I inadvertently said that 2,000 records were to be reviewed when I should have stated 200,000. The women are absolutely at the heart of this decision. First of all, let me put on the record how heart-sorry I am that we are in this situation. Our concern around the women who have been affected and their families and the need for sensitive care and communication has been at the heart of the development of our response to this situation and I can assure you that they will be kept informed of how we progress and how the situation unfolds. I make this assurance again that I will keep Parliament informed and I am more than happy to keep Opposition spokespeople informed as well. Jackie Baillie. That unfortunately remains a huge scandal. Concerns were raised in 2015, then in 2016, then in 2017, in 2016, in 2009, in appropriate exclusions 2017, there were 11 in appropriate exclusions. Why were all the cases of women 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 this 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? In her last 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 the national audit system until 2020. That is patently inaccurate given the previous audit. I hope that the minister will correct the parliamentary record, but more importantly, we will never know if this gross oversight contributed to the deaths of three women who deserve so much better. Will the minister apologise for the Scottish Government's failure and assure the chamber that this will never happen again? I thank the member for those questions. The audits, incidents and reviews that previously took place were all more limited in scope with very different starting points than 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 those previous reviews would have picked up the small number of cases that first brought this incident to light when they were discovered by one health board in December 2020. Further and importantly, there was consensus among Scottish screening exercises that the errors identified earlier audits had been corrected and that the issues that caused them were resolved. We have been advised by clinicians 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 it is, I agree, it is really important to ask whether there were opportunities missed to look further at those wider issues earlier. I understand that. I agree that questions can and should be asked about whether the opportunities were missed. That is why we are dealing with this the way that we are. I also want those questions answered. That is why I have commissioned Healthcare Improvement Scotland to take forward a thorough review of the processes, systems and governance of exclusions in the Cervical Screening programme. We will include understanding how those processes have developed over time, the lessons from past audits and the adverse events and it will help to establish if those issues could have been uncovered sooner. Emma Harper will be followed by Sandesh Gulhani. Thank you, Presiding Officer. Will the Scottish Government continue to provide funding to the charity Joe's Cervical Cancer Trust to provide support to women affected and women concerned for as long as is necessary, particularly given the challenging circumstances many of these women face? I thank the member for that question. Yes, absolutely. As I mentioned earlier, the Joe's Cervical Cancer Trust helpline will remain open and available for anyone who is concerned or affected by this issue. We will continue to provide additional funding if needed so that they can provide support through their helpline. It is important to put on the record the trust have established links with each of the NHS boards so there is no need for the boards themselves to have their own individual helplines. Let me just issue again the helpline can be accessed by calling 0808 802 8000 or emailing helpline at joestrust.org.uk Joe's Cervical Cancer Trust have a huge amount of experience in supporting people who have questions and concerns about cervical cancer. Once again, I want to put on record my thanks to them for the work they have been doing in supporting people affected by this incident. We are followed by Gillian Martin. Cervical screening is safe. Cervical screening is effective and cervical screening is going to save your life. I urge women or anyone with uterus to please not lose confidence but to attend the screening programme. To give women reassurance can I ask the minister what safeguards were put into place in June to stop that happening again and what they were and when will we run an audit to look at whether that has happened again? I can confirm that as soon as this issue was discovered immediate steps were taken to ensure that no one else was excluded from the programme in error. Cervical screening labs will no longer add hysterectomy information without confirmation in the operating gynaecologist that the cervix was completely removed during the hysterectomy procedure. Also, GPs can no longer add exclusions at present. This will remain the case until we can be absolutely assured that our 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, what governance processes and whether there were opportunities to learn earlier the scale of the incident than we did, and I am sure that that will fruitfully bring forward suggestions on how we make sure that this never happens again. Thank you, Gillian Martin to be followed by Carl Mullen. I appreciate the minister's update on this very 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 HPV home sample tests and who would be eligible for these? Minister. I thank the member for the question. Self-sampling is still a relatively new innovation and the UK National Screening Committee and the NSC hasn't yet recommended that self-sampling should be incorporated into the cervical screening programme. The NSC continues to gather and evaluate the evidence on this matter to see when that process will be complete. However, Scotland is playing an active part in supporting this work and will also be taking the necessary steps to ensure that we can roll it out as soon as possible once a recommendation is made. At all times, ensuring patient safety will remain key and we will not act until we are sure it is safe to do so. Some members in the chamber will be aware that a pilot is currently being carried out by NHS Dumfries and Galloway which involves sending all screening participants aged 25 to 64 years of age who have never attended for cervical screening or have defaulted on their most recent appointment a self-sampling kit. Findings from that pilot will inform our work going forward. I am glad that the Government is finally instituting the healthcare improvement Scotland review Scottish Labour asked for. Could the cabinet secretary clarify what the terms of the review will be? When you expect it to report and how far reaching we can expect it to be to prevent further instances of this happening again? Minister. I thank the member for that question. As I said, we have commissioned a review with Healthcare Improvement Scotland who have a long track record in improving quality and safety in Scotland to look at the records of all of those who have to look at the incident in its entirety and to look at the governance processes and also to ask for an independent chair to steer that independent review in order that we can be absolutely 100 per cent sure that we learn everything that we need to from this incident. That review will look not simply at the incident that we have uncovered at the moment and the governance that is in place. It will look at other screening programmes in place in order to see if there are lessons that we can learn from our other screening programmes in Scotland. Finally, it will also look at asking for learning from the other UK nations and Ireland to see if there are things that we can learn from their screening programmes that would make ours safer. James Dornan to be followed by Alex Cole-Hamilton. Thank you, Presiding Officer. Minister, I appreciate that this is a very sensitive and difficult subject. Could you tell us what actions have been taken to ensure that cervical screening are fully accessible for age groups that have low take-up and also for disabled women? Minister. It's an excellent question because we know that participating in the cancer screening programme has many ways to detect cancer early. That's why we are so concerned about these women who have been wrongly excluded from the programme and that's why we've continued to invest in our screening inequalities fund to tackle inequalities in the national population screening programmes. We've committed £2 million over the next two years to tackle inequalities including those that have arisen as a result of Covid-19 and that's in addition to the £5 million that we've put into the fund so far. At the moment, we're focused on making sure that future projects are sustainable and will deliver real impact. A workshop was recently held with a wide range of stakeholders to gather their views on how best that money could be spent and discussions on going as to how to make the best use of this funding. Let me assure the member that we are determined to identify the barriers that exist to participating in the screening programme and to remove those barriers just how preventable this illness is. We want to ensure that people, women, can participate in the screening programme because it's so effective at protecting cancer. Alex Cole-Hamilton Deputy Presiding Officer, thank you. The Government waited until June after the election and months after it discovered there was a problem to tell Parliament that a woman had died after being wrongly excluded from screening. Today, we learned two more women have cancer after being excluded. Not only that, a review of 200,000 women's records is under way. So can I ask the minister how are indications of this public health scandal detected on four separate occasions without ever triggering a full scale investigation? Will the Government now write to the 200,000 women whose records will be reviewed to keep them updated and also to give them agency to seek help themselves if they want to as a basic courtesy? Minister. Screening systems are inherently complex and that requires robust quality assurance mechanisms and we can anticipate that there will always be incidents where we are required to undertake further checks and investigations. That's what happened in those previous audits. The changes to screening governance in Scotland including the establishment of the programme boards for each screening programme, the development of a formal adverse event management process for screening, the establishment of a national screening oversight last year demonstrates the Scottish Government's consistent and on-going commitment to improving the governance and oversight of our screening programmes in Scotland. We are going to press forward with this review of women who have been permanently excluded from the cervical screening programme in Scotland. The work is complex and we will face many challenges taking it forward in a period of unprecedented pressure to find every last case where an appropriate exclusion may have occurred. I can assure the member that we will write to the women involved, to the women whose records are being examined, they will know that their records are being reviewed and we will keep them updated. I'm conscious, I've got four members who want to get in now and less than three minutes, two and a half minutes to get them in. I would appreciate brief questions and very brief responses. Rona Mackay, first. Can the minister reiterate what work has been carried out to investigate any issues prior to 1997? Minister. As I said in my statement, the work to review the records pre-97 concluded at the end of July. Letters went out to around 170 individuals who were identified in the second part of the review as being or potentially being wrongly excluded and they were issued by the 18th of August. 39 people were stated in the programme and invited to make an appointment or screening with their GP and 132 were offered a gynaecology appointment. The next step, obviously, is to consider that larger cohort of 200,000 records which feature a permanent exclusion from the screening programme. Minister Sue Webber. Thank you very much, Deputy Presiding Officer. We've heard a lot about the development of the review for the records of these 200,000 women that have been permanently excluded from the screening. How long does the minister expect this review to take? Minister. The first thing 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 totaled, but because we know there's a possibility that some exclusions will be incorrect, we are taking a really rigorous approach to reviewing every single record and I fully expect that the people affected will want to know as a matter of urgency if their exclusions are correct. I assure them that we will be working as fast as we can, but it's going to take some time to work out the procedure so that we don't overburden the NHS at a period of time when it is under immense pressure anyway. The exercise will be like trying to find needles in a haystack, but since even one person developing cancer is too many, we are absolutely, absolutely committed to finding each and every one of them, who have been harmed or who could be at risk of future harm. Gillian Mackay For those who find themselves needing further treatment, this could be a traumatising event. What other wider support such as mental health support is available for those who need it? Minister. We certainly made available extra money to health boards to ensure that gynaecology clinics are available and we've put extra money into gynaecological trust helpline to ensure that they can meet the needs of this incident. The first place I would suggest that women go to is Joe's Cervical Cancer Trust. They are absolutely wonderful people and they are used to giving individual advice to women and are well prepared and well versed to support women through this particular incident. Should mental health support of a different nature or a more individualised nature be required, I would expect women's GPs to refer them on. Finally, Audrey Nicholle, very briefly. Thank you, Presiding Officer. The minister has outlined that the urgent review uncovered that some exclusions had been wrongly applied across Scotland. Can the minister outline if there are further steps to be taken to ensure that those exclusions are not applied wrongly again? Thank you. Yes, I can. I confirmed in my answer to Sandish Gilhane that as soon as this issue was discovered immediate steps were taken to ensure that no one else was excluded from the programme in error. As I mentioned, Health 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 to ensure that it doesn't happen again. In particular, this will look at how processes have developed over time lessons from audits and adverse events. Finally, the changes to screening governance in Scotland, which I've mentioned before including the establishment of programme boards for screening, the establishment of the national screening oversight, the adverse event management process, all of those provide reassurance that there is robust national oversight and quality assurance for Scotland's screening programmes. Thank you very much indeed. I'm conscious we've slightly overrun but, given the nature of the topic under discussion, I wanted to allow as many members into question as possible to be a slight break now before we move to the next item of business. Thank you.