THE ACTING HEAD of the HSE has issued an apology for the confusion and alarm which was created in relation to the Cervical Check programme “as a result of the failure to communicate with the women affected”.

Speaking before an Oireachtas committee this morning John Connaghan said that failure had “ultimately impacted on every female in Ireland, their families, their spouses and their children”.

“I want to sincerely apologise on behalf of the HSE and Cervical Check to the women and their families who have been directly affected by what has happened,” Connaghan said.

He said he wanted to extend that apology to “all of the women of Ireland who have been understandably frightened and concerned of what they have read and heard”.

He said the organisation must learn lessons from what had happened and that he wanted to assure the public that he was determined HSE staff would take those lessons on board and bring about changes to make sure nothing similar happened in the future.

Cervical Check is vital to women’s health, and confidence in the programme must be restored, he said.

Connaghan, who has only occupied the Director General role for three days in the wake of Tony O’Brien’s premature departure last week, was one of several senior health officials called before the Health Committee today to address the Cervical Check scandal.

In his testimony, the Chief Medical Officer of the Department of Health Dr Tony Holohan confirmed to the panel of TDs and senators that no ministers were informed of the delays in telling women the results of an audit of cervical cancer screening results.

Documents released yesterday showed that the Department of Health was aware of Cervical Check’s stance of not informing some women of the outcomes of reviews into their cases.

A memo sent in October 2016 showed that Holohan was told that legal proceedings had been taken by one of the women affected by the audit of cases.

The documents show that clinicians were told to use their judgement in “selected cases where it is clear that discussion of the outcomes of the review could do more harm than good”.

Earlier this week the HSE confirmed that 18 women affected by the controversy have died. The previous figure was 17 women. The organisation said 203 of the 209 women (or their families) whose smear test results could have been incorrect have now been contacted.

How did we get here? 

The CervicalCheck scandal came into the public eye last month when Vicky Phelan, whose cervical cancer is now terminal, settled a High Court action against the HSE and the US-based Clinical Pathology Laboratories (CPL) for €2.5 million over incorrect smear test results from 2011.

Phelan, who is also due to address an Oireachtas committee later today, only learnt of the 2011 error through a chance reading of her medical file while waiting for an appointment last year – even though the information had come to light in a 2014 audit.

“It has become clear that the non-disclosure of clinical audit findings was widespread,” Holohan told the Oireachtas Health Committee this morning.

It has also become clear that the issue of disclosure was the subject of dispute among the relevant clinical community.

Holohan said the decision not to escalate to the Minister for Health was a fair and reasonable decision, telling the panel:

It was reasonable because the information provided in the briefing notes provided by the HSE to the Department was evidence of ongoing improvement to how the service was being delivered, rather than the identification of a problem which, of its nature, required escalation to ministerial level.

The HSE has and will confirm that within their systems no escalation of concern in relation to the implementation of this audit programme took place.

Defending his decision not to inform his minister, he said he had a long established practise of appropriate escalation of issues to ministers, “often in circumstances where the issues being escalated are difficult and challenging and may pose political challenges for the ministers in question”.

Chief Medical Officer of the Department of Health Dr Tony Holohan Oireachtas.ie Oireachtas.ie

Holohan also said he believed the characterisation of the Department of Health, of himself and his colleagues in the media in recent days had been unfair, telling the committee:

The Department is far from an organisation that is unwilling to seek proper disclosure to patients, that is unwilling to directly performance manage the HSE, and to escalate appropriately to ministers.

Any fair assessment of our work record will show that this is simply untrue.

Open disclosure questions 

The documents released yesterday showed that in June 2016, Department of Health officials were told that women whose smear tests were audited should be informed “if the woman herself asks about her screening history”.

A memo from Cervical Check stated that while it supported the principals 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”.

Addressing the committee today Holohan said he did not regard open disclosure as optional and that it should happen in the right way “in every circumstance in which it is indicated”.

“Patients simply must be informed. I know that this can be a challenge for the medical profession internationally, but professionals in this country are rising to that challenge.”

He added that “our legislative approach is to encourage doctors to do the right thing in circumstances where disclosure is required”.

“We know from the evidence internationally that one of the reasons that disclosure does not happen is that doctors fear the medico legal consequences. We have directly addressed this fear through the voluntary disclosure legislation which we have introduced.

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“That legislation provides that if doctors disclose appropriately, they will not contribute further to any legal risks they may have.

That is intended to create a safe space and encourage people to do the right thing.

Pressed about the issue of open disclosure under questioning by Fianna Fáil’s Stephen Donnelly, Holohan said that a key consideration for the Department was that the HSE policy did not say “disclosure in every circumstance irrespective of every consideration”.

He said there were mitigating circumstances taken into account by clinicians.

“For example we do know that in respect of screening of this kind, international evidence will tell us that up to 40% of patients would not wish to have this information disclosed, so that’s one factor I would point to

“It cannot be seen as something that happens in every situation irrespective of the considerations

An approach to non-optional disclosure does not mean that clinical considerations or the realities of individual situations between clinicians and patients aren’t taken into account in precisely how and when that disclosure takes place.

Fianna Fáil's Stephen Donnelly Oireachtas.ie Oireachtas.ie

Disclosure was not seen as “an event” or the simple handing over of a piece of paper or information, he said, but was done in the context of an ongoing trusting relationship between doctor and patient.

The Government last week commissioned a leading UK expert, Dr Gabriel Scally, to conduct an inquiry to review all aspects of CervicalCheck.

Also speaking to the committee, the Secretary General of the Department of Health Jim Breslin said he and his officials were determined to do everything to assist that review and to find out “what happened and why it happened”.

Vicky Phelan will address the Dáil Public Accounts Committee at 5pm this evening alongside Stephen Teap, whose wife was one of the 18 women who have died.

More than 16,500 calls have been answered by the HSE’s Cervical Check freephone helpline since 28 April.

If you’re concerned about the results of your smear test, you can contact the helpline as follows:

• From Ireland: 1800 45 45 55
• From outside Ireland: +353 21 4217612