The Department of Health was aware of CervicalCheck’s policy not to inform patients of the outcomes of reviews of their cases when it was clear it “may do more harm than good,” newly released documents have shown.

A batch of files was released by the department on Tuesday showing the extent of the material it received on CervicalCheck’s review into the cases of women who had developed cervical cancer.

The files show that CervicalCheck had forwarded documents to the department showing the advice it was offering to medical professionals on how to handle the outcome of the review.

The documents confirm that in July 2016 it was CervicalCheck’s policy to note the outcome of the review in cases where a woman was found to have died. It does not advise informing their next of kin.

As a general rule of thumb, it says the outcome should be communicated to the woman. However, it adds that clinicians should use their judgement.

The department has been under fire to outline what it knew of the decision to withhold the outcome of a review of cervical cancer cases to the patients affected.

Pause

Controversial memos released last week showed the National Screening Service had advised the Health Service Executive of its decision to pause the distribution of letters to the women affected, seek legal advice and prepare a media strategy to combat headlines.

The previously undisclosed documents show that department officials were sent notes prepared by CervicalCheck revealing concerns about whether “open disclosure” should apply in the case of telling women about incorrect smear tests in the past.

It is the first time that publicly released documents show discussions around open disclosure – Government policy since 2013 – and concerns raised about whether it should be followed when it came to telling affected patients about incorrect smear tests.

On June 29th, 2016, department officials were forwarded a briefing note drafted by the screening programme for treating clinicians and a question-and-answer doucment “in the event of any media interest.”

“While CervicalCheck supports the principles of open disclosure, it is recognised that there are limitations to its universal implementation, particularly for screening services where there is an inherent recognised error rate,” the note says.

“The assessment of avoidable harm that doctors are asked to make, which should be done in consultation with the relevant consultant doctors, should take this into consideration.”

The briefing note was sent by Simon Murtagh, then acting head of the National Screening Service, to Michael Conroy, a principal officer in the department’s cancer unit, at the department’s request following a meeting earlier on the same day.

Legal case

The documents released on Tuesday also show the Department of Health was made aware in September 2016 of a legal case taken by a woman who had since died.

The National Cancer Screening Service told the department it had received four additional legal letters from women diagnosed with cervical cancer seeking copies of all medical records.

The department has briefed Opposition political leaders on the files and is expected to face questioning from the Oireachtas health committee on Wednesday.

No evidence has been found to suggest that the information was communicated to Minister for Health Simon Harris or Taoiseach Leo Varadkar, who was minister for health in early 2016, the department said.

Meanwhile, Dr Gabriel Scally, the independent chair of a scoping inquiry into the CervicalCheck controversy, has raised concerns about the “fevered atmosphere” surrounding the matter.

In a letter to Jim Breslin, secretary general of the Department of Health, Dr Scally advises of some of the difficulties he is encountering in his work.

It is believed he is making reference to the work of the Oireachtas health committee and the Dáil’s Public Accounts Committee, who have been questioning health officials and others about the controversy.

‘Distracted’

Dr Scally wrote: “It is apparent to me that some key individuals and organisations are being distracted by the necessity of preparing to appear before committees and answer questions on very specific aspects of this substantial system failure that has led to such genuine concern and heartbreak.

“The correct way forward to analyse a system failure is by detailed and systematic analysis of that failure. To do that to any satisfactory extent I need to be able to gain the full attention and co-operation of the key individuals and their organisations.”

Dr Scally was appointed by the Government to assess the facts surrounding the controversy and is due to report by the end of June.

The inquiry will examine the issues surrounding the CervicalCheck programme, highlighted first by the case of terminally ill Limerick woman Vicky Phelan (43). She settled a High Court action against a US laboratory used by CervicalCheck for €2.5 million at the end of April.

It subsequently emerged 209 women had been affected by the screening scandal, many of whom were not told of “false negative” screening results, and 18 women subsequently died.

The letter was shown to members of the Cabinet on Wednesday morning. It is understood correspondence identified on the issue found within the Department of Health is to be issued later today. Opposition spokespersons were to be briefed this afternoon.

Meanwhile, the Oireachtas health committee has called on the Public Accounts Committee (PAC) to stop its investigation into the controversy.

Michael Harty, chair of the health committee, said it was not appropriate for the PAC to examine these matters. Ceann Comhairle Seán Ó’Fearghail is to consider the issue at a meeting later on Tuesday.