IRELAND’S CERVICAL CANCER screening programme could be rendered “financially unsustainable” due to an “exponential increase in the number of legal cases arising from participation” in the programme, according to a WHO report.

The WHO’s International Agency for Research on Cancer has published a report examining best practices for cervical screening programmes from legal, ethical, communication and professional competency perspectives.

It said that the limitations of cervical cancer screening must be communicated to patients – it is impossible to achieve zero-error screening – as poor communication can lead to loss of trust in the programme, trauma for patients and risk of legal action against the programmes.

The report said: “Although the Irish cervical screening service has consistently met the highest international performance standards, since the audit incidents there has been an exponential increase in the number of legal cases in Ireland arising from participation in screening programmes.

“As of August 2022, the estimated potential liability of legal claims is up to €300 million against a 2019 operating budget of €34 million; this could render screening financially unsustainable.”

Ireland’s CervicalCheck screening programme has been heavily scrutinised since April 2018, when it emerged that some women diagnosed with invasive cervical cancer were not told that their previous smear tests had been audited.

Audits of previous smear tests are standard practice when a woman who has previously had a smear test is diagnosed with cervical cancer.

The 221 women affected – or their families, in the cases of women who had since died – were not informed that a review concluded a different action could have been taken, either for another smear test, a smear at an earlier stage, or a cytology examination.

The report stated that operators of cervical cancer screening programmes have an ethical obligation to carry out audits that seek to improve patient care and outcomes, “and to take action to improve care when standards are not met”.

It said that while “it is not possible to achieve zero-error screening in standard practice, no matter how high the quality of cancer screening is”, “recent incidents in Ireland have demonstrated that gaps in communicating audit outcomes in a timely, efficient, and transparent manner may lead to confusion, psychological trauma, litigation, and loss of trust in the programme”.

“Regarding legal liability for errors in screening, it should be possible to make a claim for negligence with respect to cervical screening, but the standards applied by courts in assessing such claims should accommodate and reflect the reality of cervical screening, including hindsight bias in an audit of cancers.”

“The determination of whether the particular screening error was serious enough to be categorised as negligent and/or serious enough to entitle the participant to compensation needs to consider the inherent limitations of cervical screening.”

It said of the CervicalCheck programme: “Although the programme management aimed to communicate the audit outcomes to patients with cancer, there was hesitancy and delay in communicating the results, and this led to a public outcry. The perception grew that the nondisclosure of the audit result had led to delayed treatment for women.

“Many people were convinced that finding discordant cytology results on review meant that the cervical screening programme in Ireland had performed poorly and had tried to cover up inadequacies.”

It continued: “Communication with all other stakeholders is essential to build relationships of trust that will facilitate the implementation and operation of the screening programme … The content and delivery mode of the messages must be tailored to the intended audience and must consider cultural norms and
sensitivities.”

In 2018, public health expert Dr Gabriel Scally conducted a sweeping, four-month inquiry into the CervicalCheck screening programme, finding significant failures in its governance structures and making a series of recommendations for the Department of Health, the HSE, and the Irish government.

He said the biggest failure he identified was the non-disclosure of information from audits to patients – the same devastating error discovered by Vicky Phelan as she studied her own medical files.

The report also made a number of recommendations for health professionals involved in screening programmes

• They need to be able to foster a relationship of mutual trust, understanding, and
  commitment
• They must be able to communicate information in a way that conveys the information that a specific patient needs, and that overcomes any barriers related to low health literacy or cultural contexts
• They must be able to manage uncertainty by acknowledging it and providing further
  information, support, and cognitive strategies
• They need to support shared decision making through active involvement of the patient and their family members at all stages of the screening process, including before a patient decides to be screened
• They must enable patients and their families to navigate the health system by providing suitable guidance on seeking appropriate care and finding further information

The report said: “Best practice is not about perfection or setting the gold standard. It is about learning from others and avoiding similar mistakes in order to develop and implement solutions adapted to similar health problems in different situations.”

The full report is available to read here.