The HSE and the CervicalCheck programme have tonight issued "its deepest apologies" to women for any worry caused by the evolving situation around the cervical screening programme and its recent audit process.
In a lengthy statement tonight the HSE said it was keen to provide reassurance to those who may be concerned following the significant media coverage in recent days.
To do so the Executive released an overview of what has happened to date and a summary of its advice for women.
It also pledged to release further information and updates to the public over the coming days on cervicalcheck.ie.
Read the HSE statement in full below.
The HSE and the CervicalCheck programme today reiterated its deepest apologies to women for any worry caused by the evolving situation around the cervical screening programme and its recent audit process.
The HSE is keen to provide reassurance to those who may be concerned following the significant media coverage in recent days. With this in mind the HSE is providing an overview of what has happened to date and advice for women below. Further information and updates for the public will be provided over the coming days on cervicalcheck.ie.
What has happened to date?
Over 3 million cervical screening tests have been performed in Ireland since 2008, and over 50,000 cases of pre-cancer and cancer have been detected and treated following cervical screening.
Approximately 3,000 women In Ireland have been diagnosed with cervical cancer since 2008, and approximately half of these cases were notified to CervicalCheck. When CervicalCheck is notified that a woman has been diagnosed with cervical cancer, the women’s previous screening history can be reviewed.
CervicalCheck carried out an audit of 1,482 previous cervical screening tests on women who were diagnosed with cervical cancer from 2008 to 2018. Clinical audit is used to test and assure the standard of work that is being done by a health service or facility.
Of 1,482 women who were notified to CervicalCheck as being diagnosed with cervical cancer, it was found that in the cases of 208 women, on look-back, the screening test could have provided a different result or a warning of increased risk or evidence of developing cancer.
Importantly, this audit was undertaken after the women were diagnosed. That is to say that the Cervical Screening Programme did not withhold information from any woman that delayed their diagnosis of cancer. Rather the audit process of their previous smears was undertaken as a response to them having been diagnosed and of this being notified to CervicalCheck.
The HSE Serious Incident Management Team (SIMT) has been working to uncover the details of what occurred in recent days and will continue to do so as the situation evolves. At this point it is clear that there has been a very serious breakdown in communicating to the women concerned that this audit was happening, and the outcomes of the audit. All those affected, who were not previously made aware of this, are now being contacted
The HSE supports open disclosure and believes that information should always be shared with patients relating to their care. It is not in keeping with our policy, and is not acceptable to us, that this did not happen in many of these cases. The independent statutory review now being established, will look at why this happened and what needs to be done to ensure that information is always shared with patients.
The HSE SIMT is also working with the National Cancer Registry to identify other women who have had cervical cancer during this time, and who may have been part of the cervical screening programme, and should be included in the audit of historical screening tests, and will review these if needed.
Reliability of Cervical Screening in Ireland
Cervical screening tests are used to detect early signs of pre-cancer and cancer and this is outlined in the information provided to women as they progress through the programme. Cervical screening tests are not diagnostic,
Cervical screening tests carried out by CervicalCheck are currently processed in three laboratories under contract: Quest Diagnostics Inc, Teterboro, New Jersey, USA; MedLab Pathology Ltd, Dublin; and Coombe Women and Infants University Hospital, Dublin. All these laboratories contracted by CervicalCheck have ISO accreditation, certified by the relevant national authorities.
These laboratories are contracted because there are not sufficient quality-assured laboratory services available in Ireland to meet the need of the screening programme. The HSE’s SIMT is assured that these services are being provided to the required standard and should continue to be used to process CervicalCheck’s screening tests.
Screening programmes are proven internationally to be of great benefit in detecting early cervical disease in women and preventing cases of cervical cancer. Cervical screening programmes by their nature, and like most clinical tests and processes, have a margin of error. In these types of ‘eye to glass’ testing of slides, a margin of human error is always expected.
No screening programme is 100% effective - this is the case internationally and is factored into how screening programmes are designed. For example; it is one of the reasons why we offer cervical screening tests every three years to women in Ireland. Routine screening i.e. attending for cervical screening test when called is the best way to remain vigilant and be assured about cervical health.
Women who have been diagnosed with cervical cancer
Approximately 3,000 women have been diagnosed with cervical cancer over the ten year period since 2008, and 1,482 of these cases were notified to CervicalCheck and included in this audit. The HSE SIMT is working with the National Cancer Registry to see if any other women who have had cervical cancer should be included in the audit of historical screening tests and anyone affected by this will be also be contacted.
If you have been diagnosed with cervical cancer since 2008, you may have been included in this audit after your diagnosis. If you have queries about your case, you can contact the CervicalCheck information phone line on 1800 45 45 55, they will be able to check the audit records for you and let you know if you are affected.
Women who have had normal screening test results
We know that cervical screening in Ireland is very reliable and effective. Over 3 million cervical screening tests have been performed in Ireland since 2008, and over 50,000 cases of pre-cancer and cancer have been detected and treated.
It’s very important that the health service works to protect women’s health and continues to prevent cases of cervical cancer where possible. The HSE is aware that the failures in sharing information and communicating with women about this audit have created an understandable level of concern and distress among women in Ireland and is committed to improving the process around this to ensure women are informed when they are part of an audit process.
Over 6,000 calls have been received by the helpline in recent days; many from people with normal screening test results. Every effort is being made to ensure these calls are returned in the coming days and additional staff are now in place in the helpline to deal with the high volume of calls. Due to the number of calls received, we are prioritising those women who were part of the audit, and ensuring their calls are answered as a priority. Frequently asked questions and any further information for women with concerns will be made available on cervicalcheck.ie over the coming days.
The HSE Serious Incident Management Team has reviewed the overall screening process and how it is affected by this audit, and is assured that women who have had normal screening results do not clinically require an urgent screening test. In the first instance people should talk to their GPs, who are being provided with information about this issue and about cervical screening. If, following that consultation, you or your GP are still concerned, you can access a screening test under the CervicalCheck programme.