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Cervical Check scandal: Acting HSE boss says sorry for 'confusion and alarm'

John Connaghan said women in Ireland had been “understandably frightened and concerned” by what they had read and heard.

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”.

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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”.

t1 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.

“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.

donn1 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

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21 Comments
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    Mute Cranky
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    May 16th 2018, 1:09 PM

    How many women in his family had checks in the past 2or 3 years and where were they done? I doubt the senior management of the HSE risked their own family’s lives.

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    Mute BananaRepublic1922
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    May 16th 2018, 3:40 PM

    @Cranky: Probably went private as they have the means…..now that’s saying the company that the HSE farmed out the scans too would have come back with a different result but the turn around would have been faster, again once your paying.

    14
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    Mute Hans Vos
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    May 16th 2018, 1:10 PM

    They didn’t tell because they didn’t wanted a controversial when they could save the at leased 18 woman
    Now they still have the controversial with 18 woman past away because of that decision.

    35
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    Mute Hans Vos
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    May 16th 2018, 1:15 PM

    @Hans Vos: I M O involuntary manslaughter.

    36
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    Mute Charliegrl80
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    May 16th 2018, 2:22 PM

    He made a statement that the organisation must learn lessons and that staff would take those lesson on board. More TRIPE the HSE or our government will never LEARN we have one scandal after another in this country, one new investigation after another and one tribunal after another and what has the out come being in all of these inquiries and how many people were held accountable for any of the scandals committed? The HSE has an insurance company and a team of the best lawyers money can buy and can take you through the courts for years, their policy is to beat you down and hope you give up or die, its only the strongest that will win out other have their mouths closed for ever with the threat of prosecution.

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    Mute mursim
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    May 16th 2018, 2:43 PM

    “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.”

    So he saying that criminal liability for the manslaughter of 18 Irish women lies with the HSE.

    It is time to immediately disband the HSE – these killers cannot be trusted.

    As for the department of health – Varadkar and co need to be investigated as well and face criminal charges if they knew about any of this.

    HSE management is worthless, useless, unaccountable and criminal.

    The HSE needs to be dismantled in its entirety.

    27
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    Mute Damon16
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    May 16th 2018, 5:12 PM

    @mursim: This story has been on-going for weeks yet people are still people are completely confused to what its about. The failure here was a failure to inform women who had already been diagnosed with cervical cancer that their previous smears had been reviewed (as per protocol) and that they showed false negative results. The cervical smear is 70% accurate and false negatives are a inevitable consequence of cervical smear tests, they occur in all cervical screening programmes and are a statistical inevitability. The irish false negative rate is within line with our peers, as was the false negative rate for the US lab that was used to process the results.

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    Mute mursim
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    May 16th 2018, 5:30 PM

    @Damon16: Who failed to inform women?

    The HSE?

    Criminal investigation; suspension of pension and dismantling of this disastrous, failed experiment is immediately needed.

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    Mute Damon16
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    May 16th 2018, 8:43 PM

    @mursim: Agreed. They failed to inform these women of the review. The HSE is a mess. However, saying the HSE is responsible for manslaughter is absurd in the extreme

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    Mute Pat O'Looney
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    May 16th 2018, 11:29 PM

    @mursim: These problems in the HSE will NEVER be removed unless and until every person in the chain of responsibility is gone – that includes all the HSE officials, the doctors AND the ministers for health who served during this period. Anything else is just kicking the can until another crisis and cover-up occurs.

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    Mute Nuala Mc Namara
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    May 16th 2018, 1:57 PM

    1)In documents released yesterday re 29/6/16 Dept of Health,NCCP&NSS document re 8: National Screening Service (ii) Cervical Check:”The clinical audit is ongoing,a total of 120 letters have been issued so far WITH NO ADVERSE REACTION!!What does that mean?
    2)What happened in April’16:’ Cervical Check-Disclosure of review finding from Cervical Check Clinical Audit Process:page2: Cytology contract:Contracts to expire 31/7/16.An Expression of Interest EOI to participate in a mini competition for cytology screening AND HPV testing services with the current services.If parties don’t agree to participate in the programme by 27/4/16 there will be a full public procurement tender for services for a 12-20month period.So what happened?
    3)Re documents: Cervical Check Update on Cervical Cancer Clinical Audit Process: Briefing note Oct ’16 re Audit Review Outcome:End June ’16 1214 cases of cancer notified to programme:718 though abnormal smear,142 with no prior screening with 16 previous normal smears but overdue for retesting.A screening history was present in 349 cases with 258 with cytology review done,58% of these in the review interpretation differed from original cytology interpretation.Can the public receive an explanation of the 58%??I know that reviews interpretation are twofold 1)where the difference didn’t merit referral to colposcopy (no significant change)or where difference merited referral to colposcopy (significant change)
    It’s good that 718 abnormalities were discovered in smears that eventually got cancer diagnosis.I think there should be a public information campaign to explain in detail all aspects of not just cervical screening but other screenings also.
    It’s about time now that those in high positions in HSE,Dept of Health etc realise these are patient safety issues re their healthcare and confidence in our health care services!

    16
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    Mute mursim
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    May 16th 2018, 2:37 PM

    That response is wholly inadequate

    1. Who is being held accountable for this entirely avoidable fiasco/
    2. Who in the HSE has lost their jobs for their utter incompetence?
    3. Will arrests be made while criminal investigations are ongoing?
    4. Has the lab in the US that gave these false readings been fired?
    5. What immediate steps have been made to make the HSE completely accountable to the Irish people for these types of murderous mistakes?
    6. Has John O’Brien’s pension and pay-off been suspended pending outcome of criminal investigation into his conduct.

    Or is Connaghan just another lying clown with his greed snout in the trough?

    26
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    Mute Adrian
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    May 16th 2018, 3:10 PM

    “All the checks failed”, it’s like the financial crash all over again.

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    Mute Adrian
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    May 16th 2018, 1:19 PM

    Bit of an idiotic organization when the boss doesn’t know what’s going on in his own organization. It boils down to the fact the minister for health and the gov wouldn’t want to know anyway because they wouldn’t know how to fix it because of their incompetence. Also how ironic that all the politicians in the PAC committee putting on their best authorative faces for the cameras but could in theory be the boss here as minister for health. So the whole thing is a right mess.

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    Mute Pavel Shipilov
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    May 16th 2018, 4:55 PM

    Its shocking that former CEO was unable to recognise the grave concern of this matter, his stance is unpardonable.

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    Mute mursim
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    May 16th 2018, 5:32 PM

    @Pavel Shipilov:

    Tony O’Brien needs to be facing criminal charges – as does Varadkar.

    Involuntary manslaughter of at least 18 people deserves jail.

    What is being done to recover the payout to O’Brien.

    Is his pension suspended pending outcome of criminal investigation?

    8
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    Mute Kath Noonan
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    May 16th 2018, 5:32 PM

    Where are all the current tests now being sent to be reviewed? Not the same lab that caused this mess I hope?

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    Mute Thomas Francis
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    May 16th 2018, 6:31 PM

    Ah that’s OK then; they’re sorry…

    Just as sorry, sincere and heartfelt as any expression of a political body (individual or corporate) can be. Lessons have been learnt; individual cases can’t be discussed; it’s sub rosa; we need to move on blah blah blah. Horlicks.

    And we’re supposed to trust this gang with legislating for the protection of the unborn should the 8th be removed ! ! !

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    Mute Tim Brennan
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    May 16th 2018, 8:52 PM

    Sometimes Sorry is not good enough and this is one of those times.
    HSE are in free fall

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    Mute Johnnie Sexton
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    May 16th 2018, 5:58 PM

    I bet he is…… a tad late with all the farsical apologies. Wonder what and when the next health scandal will be?

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    Mute geraldo
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    May 17th 2018, 12:31 AM

    It’s time Ireland adopted the duty of candour like the nhs
    (Not always easy to divulge regarding mistakes whether big or small but probably saves a lot in long run ) , promoting openness and honesty about mistakes. People on the whole are understanding that mistakes are inevitable

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