Hansard

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 helpline@jostrust.org.uk. 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.