Tag Archives: CervicalCheck

Health Minister Simon Harris; Lorraine Walsh, Stephen Teap and Vicky Phelan surrounded by some of the 221 cervical cancer patients affected by the CervicalCheck scandal outside Leinster House yesterday

Earlier this morning.

Morning Ireland‘s Audrey Carville asked Health Minister Simon Harris about the apology Taoiseach Leo Varadkar delivered in the Dáil yesterday to those affected by the CervicalCheck scandal.

Mr Varadkar had apologised for the “humiliation, the disrespect and deceit” caused to those affected.

Ms Carville also asked him about the forthcoming Patient Safety Bill.

From their discussion.

Audrey Carville: “What was deceitful about what took place?”

Simon Harris: “Quite frankly, I think the concealment of information from women. Deceit refers to having information and not telling people.”

Carville: “And do you believe that was deliberate?”

Harris: “You know what I’m actually not sure it was deliberate. It sounds to me more like a situation whereby they intended to disclose and then, as we all know, Dr Scally reports there was a complete and utter litany of failures in terms of closing that loop.

“But regardless of the deliberate nature or not, it was extremely hurtful and extremely painful…”

Carville:But that’s what deceit is, isn’t it? It’s intent.”

Harris:I think it often does involve intent. But, certainly, what the Taoiseach’s words yesterday were, were a reflection of how the women and their families felt. And they certainly felt deceived and I can fully understand why they did.”

Carville:What do you believe was the most scandalous element of what took place?”

Harris: “I genuinely think the non-disclosure. I mean audit is a good thing, we should be auditing and checking and making our systems better and making our screening service better but the idea that you would set up an audit that intended to disclose and then not disclose, and then add insult to injury, and I don’t wish to open, you know, old wounds here. I know it’s been a very, very painful time for so many people.

“But people have been really, really hurt and certainly in my own statement yesterday to the Dáil, I made the point that, you know, partial information, having to be drip-fed into the public domain because all of the facts weren’t there added insult to injury and worried people well beyond the 221+ group. Women were looking to me and others for reassurance that quite frankly we weren’t in a position to give them. And so, for that, I’m very sorry.”

Carville: “So it all centred on the women not being told and as part of his speech to the Dáil yesterday, Leo Varadkar said there is no information about a patient that a patient shouldn’t know. And yet, in the Patient Safety Bill, for which we were told full, mandatory disclosure was going to be part of, you talked about it, almost as soon as the Vicky Phelan case was complete 18 months ago. There are going to be exceptions to that?

Harris: “Well, I’m going to work with the Oireachtas to identify what those are. I mean there’s a very big difference, as I think everybody listening will appreciate, between mandatory disclosure of a serious reportable incident and between the day-to-day issues that can arise at a hospital.

“Like between maybe, you know, the food not being adequate and the like. That’s a very different situation to the very serious issues.”

Carville: “But is the option of not telling a patient about a mishap or an error – will there be that option in the Patient Safety Bill?

Harris:Absolutely not and I thank you for asking me the question because it’s important to give that assurance. I mean serious reportable events will refer to anytime, anything went wrong in relation to your care. Anytime there is information known about your well being that obviously has to be shared with you so we will bring, I will bring the full Patient Safety Bill to Cabinet next month…”

Apology ‘a reflection’ of how women felt – Harris (RTÉ)

Listen back in full here

This afternoon.

“Ceann Comhairle,

“As Taoiseach, on behalf of the State, I apologise to the women and their loved ones who suffered from a litany of failures in how cervical screening in our country operated over many years.

“I do so having met and listened to many of those affected and I do so guided by the Scally Inquiry report.

“Today we say sorry to those whose lives were shattered, those whose lives were destroyed, and those whose lives could have been different.

“We know that cervical screening programmes cannot detect all cancers, however we acknowledge the many failures that have taken place.

“We are sorry for:

failures of clinical governance
failures of leadership and management
failure to tell the whole truth and do so in a timely manner
the humiliation, disrespect and deceit
the false reassurance
the attempts to play down the seriousness of this debacle

“We apologise to those who survived and still bear the scars, both physically and mentally. As do their families.

“We apologise to those who are here in our presence. To those watching from home who have kept it to themselves. We apologise to those passed on and who cannot be here.

“We acknowledge the failure that took place with CervicalCheck.

“Today’s apology is too late for some who were affected. For others it will never be enough.

“Today’s apology is offered to all the people the State let down. And to the families who paid the price for those failings.

“A broken service, broken promises, broken lives –a debacle that left a country heartbroken. A system that was doomed to fail.

“We apologise: to our wives, our daughters, our sisters, our mothers.

“To the men who lost the centre of their lives and who every day have to try and pick up the pieces.The single fathers and grandparents.

“To the children who will always have a gaping hole in their lives.

“To all those grieving for what has been taken from them.The happy days that will never be.

“A State apology may not provide closure, but I hope it will help to heal.

“I have met with some of you and your families and I have heard your stories, told to me with dignity, courage and integrity. Families turned upside down.

“The grief of losing loved ones.

“The guilt of those who survived, thinking they were the ‘lucky ones’. Those who have lost their jobs and careers, their ability to have children, their feeling of self-worth. Who feel mutilated inside, who feel they have robbed their partner out of the possibility of having a child. A future stolen from them.

“A State apology will not repair all that has been broken, nor restore all that has been lost, but we can make it count for something.

“Thanks to Dr Scally’s three reports into CervicalCheck we have discovered a lot of truths.

“We now know a lot of facts.

“Some things we will never know.

“But what we do know we can act on and make sure this doesn’t happen again.

“The Government accepted all of the recommendations that were set out in Dr. Scally’s reports and all will be implemented.

“Now, in the words of Vicky Phelan, I want something good to come out of all of this.

“Speaking as a doctor, as well as a politician, a brother and a son, I know the lessons we must learn.

“We need a better culture in our health service, one that treats patients with respect and always tells the truth. One that is never paternalistic – doctor doesn’t always know best. We must always share full information with our patients, admit mistakes, and put the person first. There is no information about a patient that the patient should not know. No patient should ever feel stonewalled by the system. We should never act or fail to act out of fear of litigation or recrimination.

“The involvement of patient advocates like Stephen Teap and Lorraine Walsh and others has shaped and enhanced our response.

“We have revised the Open Disclosure policy so that in future patients will have full knowledge about their care and treatment.They will be informed when things go wrong, met to discuss what happened, and receive a sincere apology if an error was made while caring for them. Above all, patients will be treated with compassion and empathy.

“The new Patient Safety Bill will provide for the mandatory reporting of serious reportable events and will establish a statutory duty of candour.

“Soon, we will establish a new Independent Patient Safety Council. The first task of the Council will be to undertake a detailed review of the existing policies on Open Disclosure across the whole healthcare landscape.

“As a State we aim to make cervical cancer a very rare disease in Ireland. It is almost impossible to eradicate a disease but we can get very close.

“So, we are switching to primary HPV screening, and Ireland will become one of the first countries in the world to adopt this new more accurate screening test.

“We are also extending the ever developing HPV vaccine to boys.

“We are educating and informing parents about the benefits of the vaccine.

“We are investing in better facilities in Ireland like a national cervical screening laboratory, in conjunction with the Coombe. This enhanced facility will take some time to develop but will provide a better balance between public and private provision of laboratory services to the cervical screening programme, always putting quality ahead of cost. It will bring more testing back to Ireland.

“We need to restore confidence in screening.

“We also need to listen to those who have suffered and learn from their stories so we can find justice.

“In July we established the CervicalCheck Tribunal, a statutory tribunal to deal with the issue of liability in CervicalCheck cases. It won’t be perfect but it will be quicker, with a dedicated judge and independent experts, less adversarial than court.

“Women will still have the right to go to court.

“We established an ex-gratia compensation scheme for those affected by the non-disclosure of the Cervical Check audit to provide financial compensation without the need to go to court.

“However this was never about money. This was about accountability, discovering what happened and why, providing justice and finding peace. It was about making a meaningful acknowledgement of what happened, and give an assurance that this won’t happen again to anyone else.

“We have seen further errors in some of the laboratories since the publication of the Scally Report, causing confusion and anxiety, so we have more to do to restore confidence. We are determined to do so.

“Ceann Comhairle,

“What happened to so many women and families should not have happened. While every case was not negligence, every case was a lost opportunity for an earlier diagnosis and treatment.

“It was a failure of our health service, State, its agencies, systems and culture.

“We’ve found out the truth and the facts.

“We’re making changes to put things right.

“We need to restore trust and repair relationships.

“On behalf of the Government and the State, I am sorry it happened. And I apologise to all those hurt or wronged. We vow to make sure it never happens again.”

Taoiseach Leo Varadkar (top) apologises for the “’humiliation, the disrespect and deceit” shown to those affected by the CervicalCheck controversy.

Taoiseach apologises for ‘disrespect and deceit’ over CervicalCheck failures (RTÉ)

Earlier.

Vicky Phelan

RTÉ reports:

The State is expected to offer a formal apology today for failures in the CervicalCheck service to women and families affected.

Taoiseach Leo Varadkar is due to address the issue in the Dáil this afternoon.

More than 1,000 women and families have been affected by the CervicalCheck crisis.

The failures first came to light in April last year, with the settlement in the Vicky Phelan High Court case.

…The author of two reports into the CervicalCheck controversy [Dr Gabriel Scally] said the issuing of a formal State apology is “a momentous step and quite unprecedented.”

Taoiseach to deliver State apology for CervicalCheck failures (RTÉ)

From top: Former CervicalCheck director Grainne Flannelly; An event at Holles Street in November

Further to news of a state apology to the victimns of the CervicalCheck scandal…

Pooter writes:

Dr Grainne Flannelly,former clinical director of Cervical Check – is still in the system...

Good times.

Earlier: ‘A Momentous Step’

National Maternity Hospital GP Study Day (NMH)

Previously: Compare And Contrast

Rollingnews

This afternoon.

On the set of The Letters by director Robbie Walsh (far right).

Actor John Connors (second from left) instagramz:

On set for for Robbie Walsh’s new feature “The Letters” a story about four women who fell victim to the Irish state’s cervical [cancer] scandal. A really important film. I play the nurse! Great to share a scene with my old mentor Kathleen Warner Yeates [above centre] who is eclectic in this film. Don’t miss this one.

The Letters (Kickstarter)

Last week: Innocent Boy Wins Love Of Virgin

Chief Medical Officer at the Department of Health Dr Tony Holohan; Lorraine Walsh

This lunchtime.

RTÉ’s health correspondent Fergal Bowers, on foot of a Freedom of Information request, is reporting on correspondence he has seen between the Chief Medical Officer at the Department of Health Dr Tony Holohan and CervicalCheck patient advocate Lorraine Walsh from March of this year.

Ms Walsh, from Galway, who was one of the women caught up in the CervicalCheck scandal last year, cannot conceive due to having had cervical cancer.

She is also one of the Government’s appointees to the CervicalCheck steering group.

Mr Bowers has reported that Dr Holohan – who is co-chairperson of the CervicalCheck Group – wrote to Ms Walsh on March 13  of this year taking issue with comments she had made on social media, and to print media, about him.

He reported the letter said her claims about him were “baseless” and it warned her that if she repeated the claims in public, there would be a “very strong response”.

He also asked her to withdraw the claims.

Mr Bowers reported that the letter was also released to Labour TD and the party’s health spokesperson Alan Kelly, following a parliamentary question and separate FOI request by him.

On RTÉ’s News At One, Labour TD Alan Kelly told Mr Bowers:

 “I sought this information under parliamentary question in early July. The department refused to give it to me. I had to chase this for two months.

“I had to repeatedly go to the Ceann Comhairle and it was only after the Ceann Comhairle wrote to the minister that basically, telling him, that this was against the constitutional responsibilities of a minister, that we’d got to a point where this information was released to me.

“I had no faith that this information was going to be given to me so I had to put in a Freedom of Information request on top of my parliamentary question.

“TDs shouldn’t have to put in Freedom of Information requests because they believe that their parliamentary questions are not going to be answered.”

Mr Bowers told News At One that a spokesperson for the Minister for Health Simon Harris said Mr Harris was not aware of the letter in advance of it being sent from Mr Holohan to Ms Walsh.

Walsh warned over repeating CervicalCheck management criticisms (RTE)

Rollingnews

CervicalCheck; Dublin City University president Prof Brian MacCraith

The Irish Times is reporting that a woman, who wants to be identified as Ms Scullion, made contact with the newspaper in the wake of Dublin City University president Prof Brian MacCraith’s report on delays in the issuing cervical screening HPV retest results to women.

The delays related to a Quest Diagnostics’ laboratory based at Chantilly in Virginia, USA, and Prof MacCraith found that 4,088 cases were affected by an IT problem.

Some 873 women who had repeat HPV tests were not sent results while, in the case of the remaining 3,215 women, results were sent to GPs but not to the women themselves.

Ms Scullion told The Irish Times that she was one of the 873 women and that she received a letter on Tuesday, August 6, telling her that she tested negative for HPV in her HPV retest.

But, Ms Scullion told the the newspaper, she is HPV positive – and she knows this from a previous test.

Further to this…

Marie O’Halloran reports in The Irish Times:

…The HSE on Wednesday confirmed that almost half of the 873 women received a letter in the last week from CervicalCheck that “contained an inaccuracy”.

…In a statement, the HSE said in the letters sent out, “we also confirmed that the result of these women’s HPV re-test was unchanged ‘and remains HPV negative’. However, for some women, this should have read ‘and remains HPV positive’. This was an error on our part and we are very sorry for any confusion it may have caused.”

*Thud*

CervicalCheck sends letter with incorrect test results to 400 women (Marie O’Halloran, The Irish Times)

Previously: No Checks

This afternoon.

Smock Alley Theatrte, Dublin

Professor Brian MacCraith talks to the media about the series of events within the HSE CervicalCheck Programme that occurred following IT issues in Quest Diagnostics relating to the HPV test results for a number of women.

Prof. MacCraith found the provision of Quest Diagnostics Chantilly Laboratory as a CervicalCheck test facility took place without proper operational due diligence and risk assessment,

The report also found there was a gross underestimation of the scale and implications of the problem.

The primary casualty was communications with the women and GPs, with the breakdown in automated results generation, it concluded.

The report said there was a decision not to communicate with women, about the IT problems and its implications for a full six months in 2019.

Professor Brian MacCraith has said that between February and last week, there was no communication with the majority of women involved.

“Throughout this review there was a constant theme of women frustrated by poor service and lack of information, their information,” Prof MacCraith said.

Lab was added to CervicalCheck programme without checks (RTÉ)

Eamonn Farrell/Rollingnews

Minister for Health Simon Harris

This morning.

It has emerged that 52 of the 800 women impacted by the reported IT problems in the Quest Diagnostics laboratory have contracted the HPV virus.

Social Democrats co-leader Róisín Shortall has called on the Minister for Health Simon Harris to “provide immediate answers” to the following:

1. Have all 52 women who tested positive for HPV on the Quest retest been notified of their results?

2. Have they all been referred for appropriate follow-up?

3. Have the other 750 women and their GPs been notified of their retest results?

4. What is the level of clinical risk for the 52 women who tested positive?

5. What action was taken by the HSE in February when they became aware of these problems with Quest?

6. Why were the Patient Advocates not informed of these issues at the Steering Group meeting on 26th June?

7. What action does the Minister intend to take to restore public confidence in CervicalCheck?

8. Does the Minister intend to review the Quest contract in light of these quality control failures?”

Anyone?

52 more positive for HPV in test scandal (Irish Examiner)

Yesterday: When Did he Know?

Meanwhile

Minister for Health Simon Harris

This morning.

Via RTE:

Correspondence obtained by RTÉ News has revealed that a private secretary to the Minister for Health wrote on 6 June to the woman whose case exposed the latest CervicalCheck crisis.

The letter to ‘Sharon’ says that: “The Minister for Health, Simon Harris, T. D. has asked me to thank you for your correspondence concerning CervicalCheck and would like to again apologise for any distress this delay has caused you and reassure you that this is a priority for his Department and the Health Service Executive (HSE).”

Last weekend, the department said that it became aware of the existence of an IT issue on 25 June through information supplied by the Health Service Executive.

Minister Harris has said the matter was first escalated to him last Wednesday evening, 10 July.

Minister’s office wrote to woman at centre of latest CervicalCheck issue on 6 June (RTÉ)

Previously: ‘I’m Still Kind Of Flabbergasted’

Rollingnews

RTÉ’s Áine Lawlor; Dr Peter McKenna of the HSE

This afternoon on RTÉ’s News At One.

Journalist Áine Lawlor spoke to Dr Peter McKenna, the clinical director of the women’s and infants’ programme with the HSE – after nobody from the HSE was available to speak to RTÉ’s earlier shows Morning Ireland or Today with Seán O’Rourke.

The lunchtime interview followed it emerging last night that approximately 800 women who had CervicalCheck tests carried out between October 1, 2018, and June 25, 2019, have not received their test results.

This has been blamed on an IT issue at a Quest Diagnostics laboratory in Virginia in the US.

Most of the women affected were getting repeat tests for the human papillomavirus HPV – which can cause cervical cancer – because Quest had previously failed to carry out HPV testing on the women’s initial smears within the 30-day limit.

RTÉ reported last night that the HSE told the Department of Health on Wednesday that it became aware of the IT problem in June.

This lunchtime, Dr McKenna told Ms Lawlor that the HSE knew there was a “computer glitch” in February.

From the interview:

Áine Lawlor: “The lesson on Gabriel Scally’s report about open disclosure and honesty and transparency with the women who are fundamental to the future of CervicalCheck and who depend on CervicalCheck – that lesson has not been learned by the health service.”

Dr Peter McKenna: “I wouldn’t agree with that, in principle. I think that there’s elements of this problem that only emerged to the HSE in the last ten days or so. And the extent of what needs to be communicated with women is not yet currently absolutely certain.”

Lawlor: “OK, well let’s try and establish the facts. So we’re talking about 800-plus women who had repeated cervical smear tests done between October 2018 and June 2019. Is that right?”

McKenna: “Yes, and these are women whose cytology results were known and they had a minor degree of abnormality and in order to see whether they needed to go for coloposcopy or not, an additional test of HPV was carried out.”

Lawlor: “So, in lay person’s language, they had had a previous smear test that had shown some abnormalities related to HPV and this was a repeat smear test to see whether there’d been any changes. Is that right?”

McKenna: “It’s a refinement, it’s a, a papaloma test, rather than a repeat smear test.”

Lawlor: “OK, so it was a more advanced test.”

McKenna: “It was a more advanced test, now, if you…”

Lawlor: “And the computer broke down when?”

McKenna: “No, no, sorry, just to go back even further than that. These 800 women were women who had had a HPV test carried out but, as you may remember, towards the end of last year, it transpired that the tests had been done on an out-of-date kit. I don’t know if that…”

Lawlor: “I think everybody remembers every twist and turn of this unfortunately Dr McKenna. So they had gone for tests again after that, is that right?”

McKenna: “No, so the kit was out of date. And those women that had come back as positive – they were treated as if the result was correct.

“And those women, who the result had come back as negative, it was said ‘no, we should take this seriously and we will repeat the test’. And so, 800 of these women, whose tests have come back as negative initially on the HPV, were then retested.”

Lawlor: “OK. And when did the computer breakdown?

McKenna:It was known in February that there was a computer glitch and…”

Lawlor: “Where was it known exactly, Dr Peter McKenna, because most of us knew nothing about this until yesterday and today. So the question is: this computer failure goes back to February.

Who knew about that back in February? And who has known about that since?

McKenna: “Well, my understanding is that, if I could just finish, that it was known in February and…”

Lawlor: “By whom?”

McKenna: “In whom the tests results altered were informed by CervicalCheck in February. So there was a small number of the 800 women, in whom the results were different, and they were informed directly by CervicalCheck. So the women who were affected were informed as soon as it was known.”

Lawlor: “But who knew about the fail…what does the computer failure involve? When did it happen and who knew about it?”

McKenna: “The computer is designed to…the computer of the labs overseas is designed to communicate with the computer here. And that triggers a, a cascade of letters. It was appreciated that wasn’t working and a manual system was put in place, as far as the HSE knew.”

Lawlor: “OK, it was appreciated by whom? Who appreciated this? And who made the decision to put the manual system in place? And why was none of this made public?”

McKenna: “Right. The answer to the names, I couldn’t give you. I don’t know. But however, it was appreciated within the screening service because the screening service put alternative, manual arrangements in place.”

Lawlor: “And did the HSE know that these computers weren’t working? And that manual arrangements were now being put in place to write to women? And was anybody checking that that was actually happening?”

McKenna: “The service did know that the computers were not speaking to each other – that is absolutely correct and the HSE were reassured by the fact that the women were being written to manually, or sorry, their GPs were being written to manually.”

Lawlor: “So the women’s doctors were being written to, by whom? Who was responsible for…”

McKenna: “By the laboratory.”

Lawlor: “By the laboratory.”

McKenna: “Yeah.”

Lawlor: “So CervicalCheck told the HSE and everybody understood that the laboratories would write to the women…”

McKenna: “Would write to the GPs….”

Lawlor: “Would write to the women’s doctors…”

McKenna: “Yeah…”

Lawlor: “And when did it emerge that this was not happening?

McKenna: This only came to the knowledge of the screening programme and the HSE in early July.

Lawlor:In early July, but a number of months had passed. Had it not occurred to anybody to get back and check, given the sensitivity and, as you say, there have a lot of twists and turns in all of this and we have had the Scally Report which has emphasised the importance of transparency – particularly if women are to go on turning up for smear tests as part of the cervical screening programme.”

McKenna: “I can absolutely understand that question. The HSE and the screening are very disappointed that the arrangement that they thought had been put in place wasn’t working. And this will be investigated as to why this element was not followed through by the contractor.”

Lawlor: “But this is what happened in the first place isn’t it? Somebody thought somebody was telling the women but nobody was?”

McKenna: “No, it’s not quite the same as that. That was the result of an audit. This is probably, in some ways, more important than actual clinical results – there was a delay in communication.”

Lawlor: I’m still kind of flabbergasted. Just one other thing – did the minister know? The minister’s department? We know that the HSE knew about this and understood it was being dealt with by the laboratory, and this only emerged in the last while, that you found out that the letters weren’t happening.

Was the minister’s office across this?

McKenna: “I would not…I don’t know the answer to that. I’m sorry.”

Lawlor: “OK, so you don’t know whether the Department of Health was involved?”

McKenna: “I don’t. No.”

Lawlor: “You said you can understand why women might not have confidence after everything. I mean this comes across like almost like a last straw, doesn’t it, for many women?”

McKenna: “It certainly doesn’t sound good. But I think it’s important to point out that these women have had cervical cytology – they do not have a severe grade of cervical abnormality. If they did they would have been referred directly to colposcopy. This is a delay in communicating the result of a second or a refined test which would indicate whether they should or shouldn’t go on to colposcopy.”

Lawlor: “Well we appreciate you coming on the programme to talk to us today.”

Listen back in full here

Earlier: ‘Why Wait Until An Hour After The Dáil Goes Into Recess To Let The Information Out Publicly?’

Meanwhile…