Briefing note to Health Minister: Vicky Phelan’s case ‘not a patient safety issue’

The head of the national cancer control programme played down concerns about cancer patient Vicky Phelan’s case, advising it was not a “patient safety” matter.

The advice was given to Health Minister Simon Harris just days before the dying mother went to the courts to seek redress over an inaccurate cervical cancer test.

The briefing note also seems to suggest that women were not automatically being told of smear test result changes.

In the appendix to the note for the minister, it said that all current and historical clinical cancer audits were communicated to treating clinicians in 2016. But it later states “more recently, women are informed” of this audit process. This would suggest women were not automatically told for some time.

The briefing document given to Mr Harris on April 16 warned that there may be “publicity around the case”. Despite this, there was no warning to other women affected who were diagnosed with cancer after an earlier false negative test.

The document has raised questions about what health officials knew about women or families who were not informed about earlier false negative cancer results, despite doctors knowing.

A key part of the department advice around Ms Phelan’s case to the minister said that “the national screening service and Jerome Coffey, head of the national cancer control programme, have advised the department in writing that they do not consider this to be a patient safety incident but rather a reflection of the known limitations of the current screening test”.

The note also spoke of pre-trial discussions and consideration by the state claims agency.

It advised the minister “that publicity around the case and/or settlement is likely”.

The document also advised that women who had their cases audited were being informed and had the right to request information. According to the document, the current CervicalCheck testing method “produces a not insignificant number of false negative results” — saying the “known limitation” is one of the reasons why women are screened regularly.

Mr Harris was also advised of the timeline whereby women were being informed of the test reviews and any changes.

It says that CervicalCheck carried out a review of Ms Phelan’s case in 2014. Then, the note says, outcomes of audits were used for training purposes.

By 2015, the HSE said that audits of women’s smear tests should be passed onto treating doctors. But doctors did not get these audits until 2016, the document says.

The memo also advised that no quality issues had arisen in relation to the US lab testing smears and that all the labs have to meet quality assurance standards. It told the minister that the case against the HSE was likely to be dropped but that Ms Phelan was also taking action against a US laboratory.

The document was given to the minister three days before Ms Phelan’s court case.

The note also said that the department and HSE were in discussion around a press statement for the minister.

Responding to the released document, Fianna Fáil leader Micheál Martin said he was surprised Mr Harris had not known about Ms Phelan’s case and others before the briefing note of April 16.

The claim that Ms Phelan’s case was not a “patient safety” matter was “worrying” added Mr Martin.

Mr Martin now wants to know what talks the department and HSE had on the case and the wider issue of women being told or not of results being reviewed.

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