Hansard

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 helpline@jostrust.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 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.