‘Considerable number of cases’ not covered by CervicalCheck audit

Harris tells Dáil many smear tests not included in sample which revealed 208 false negatives

A "potentially considerable number of cases'' notified to CervicalCheck have not been subjected to an audit of their screening history, Minister for Health Simon Harris has revealed.

He said he had been previously advised, and it had been commonly understood, that the CervicalCheck clinical audit had covered all cases notified by the National Cancer Registry.

But he had been informed on Tuesday afternoon that this was not the case.

Mr Harris told the Dáil those were not new cases of cancer.

“Nor is it a group of women wondering if they have cancer,’’ he added.

“These are women who have already been diagnosed with cervical cancer, and treated as such, but their cases have not been included in a clinical audit.”

After an audit, the HSE said on Monday in the case of 208 women a negative smear test result was reversed. In total, 162 of these women – 17 of whom are now dead – were not told.

The controversy arose after Limerick woman Vicky Phelan settled her action against a US laboratory, subcontracted by CervicalCheck, who had incorrectly said her test for cervical cancer was clear.

Mr Harris said the Serious Incident Management Team (SIMT) who had passed the information to him, would take steps to identify any additional cases of cervical cancer not audited.

“The screening history of these additional cases will be established, and if any of these women were screened through the CervicalCheck programme, their case will be reviewed in further detail with a cytology review where necessary,’’ he added.

Mr Harris said the situation was evolving as he was giving as much information as he had to the House.

He said that primary HPV screening would be introduced later this year.

“I understand that the accuracy of HPV testing is significantly higher than liquid-based cytology testing, which is the testing used now, and is expected to result in fewer women receiving a false negative result,’’ he added.

He said as part of a Hiqa investigation, an international peer review group would be established to examine the cervical screening programme against international best practice and standards.

He had also, he added, decided to appoint an international expert clinical panel to provide the women concerned with an individual clinical review.

A liaison nurse specialist would ensure the women involved received all the support they required.


Earlier, it emerged that Mr Harris was advised by his officials prior to the hearing of the legal case taken by Ms Phelan that it was likely to attract publicity.

The Minister was told that the Department of Health was in consultation with the HSE regarding the preparation of a press statement on the case.

The briefing note also reveals that the head of the National Cancer Control Programme, Dr Jerome Coffey, had advised the Department of Health in writing that the issues arising from Ms Phelan's case did not constitute a patient safety incident "but rather a reflection of the known limitations of the current screening test".

The briefing note which was given to the Minister on April 16th was published on Tuesday by the Government under pressure from the Opposition in the Dáil who were seeking answers about the background to the current cervical screening controversy.

The briefing note sets out the details of the claim taken by Ms Phelan.

Ms Phelan discovered that a 2011 smear test that had initially shown no abnormalities was, three years later, found to be inaccurate, but she was not told of the false test until September 2017. She is now suffering from terminal cancer.

The briefing note drawn up by the cancer, blood and organs policy unit in the Department of Health advised the Minister of the background to the case and set out information on the screening programme and the audit process.

It told the Minister that the case involved claims by Ms Phelan that the screening test she had in 2011 was falsely reported as negative and that separately she had not been told about a CervicalCheck standard review process – known as a clinical cancer audit – and its outcome.

The Minister was advised that the State Claims Agency believed that "a claim for exemplary damages in relation to the non-disclosure of the Cervical Check standard review process is likely to fail/be dropped in the absence of any evidence of bad faith by the HSE in this regard".

The Department of Health said the State Claims Agency also believed that the while the case was likely to be settled before going to court, that “publicity around the case and/or settlement is likely”.

The briefing note said that at the time the clinical cancer audits in question in the case, “were intended for use in supporting continuous process improvements and in supporting education and training only”.

It said that: “In 2015 a decision was taken in the HSE, in line with best international practice, to provide information on outcomes of clinical cancer audits to treating clinicians for onward communication to patients as appropriate.”

“The outcomes of all current and historical clinical cancer audits were subsequently communicated to treating clinicians in 2016 (including the case of Ms Phelan)”.

It said that more recently women were informed of this audit process “and they have the option to request information on the outcomes of these reviews, which are sent to the treating doctor for discussion with the patient”.