Tag Archives: CervicalCheck

This morning.

At a meeting of the Oireachtas Health Committee.

Officials from the Department of Health and the HSE are giving an update to the committee on CervicalCheck – including Secretary General of the Department of Health Jim Breslin and HSE interim director general Anne O’Connor.

In the last few minutes, Ms O’Connor said:

A key risk to enable cervical screening to continue in Ireland was the extension of the laboratory contracts. The HSE has a signed agreement with one of the private providers and are working through the detail of a contract with a second provider with whom we have a heads of agreement.”

Watch proceedings live here

Almost 80,000 women waiting up to 27 weeks for smear test results – HSE (Jennifer Bray, The Irish Times)

From top: CervicalCheck logo; Dr Gabriel Scally; a letter a woman received on Monday informing her she needed to have a repeat smear test as a consequence of a test she had in the summer of 2016

Yesterday, we reported about the letters from the HSE sent out to 6,000 women informing them that they need to have a repeat smear test.

Their previous tests, some taken as far back as 2015 and which would have tested positive for low-grade abnormalities, were not subsequently tested within the recommended time limit for HPV by Quest Laboratories.

The HSE stated it was first notified of this issue with HPV testing at the end of November

A woman who received one of the letters, writes:

“Was Dr Scally [Dr Gabriel Scally, whose scoping inquiry of the CervicalCheck screening programme was published last September) aware of the 6,000 women when he made this recommendation: ‘The Scoping Inquiry considers there is no reason, on quality grounds, why the existing contracts for laboratory services should not continue until the new HPV testing regime has been introduced.'”

Anyone?

Previously: CervicalCheck: Two Lists

CervicalCheck And 6,000 Letters

CervicalCheck log; Mary Regan, of RTE

Last week, several matters emerged concerning the CervicalCheck programme.

One of these was that some 6,000 women were to be written to and advised to return to their GPs for repeat smear tests.

This is in relation to a cohort of women who would have and initially tested positive for low-grade abnormalities after having a smear and who would have then been advised to have an additional HPV test within 30 days of the initial smear test.

In the cases of 6,000 women, their additional smear test was tested by Quest Laboratories for the HPV virus beyond the 30-day limit.

[The practice of being advised to have an additional HPV test, on foot of a test showing up low-grade abnormalities, began in Ireland in 2015]

Further to this..

This afternoon.

In respect of these 6,000 women, Mary Regan, on RTE, reported:

Letters have been issued to those women today, and to their GPs, and they should receive them on Monday, advising them to go back for a repeat smear test.”

Meanwhile…

On Virgin Media One…

Previously: CervicalCheck: Two Lists

From top: Sinn Féin TD Pearse Doherty; Labour leader Brendan Howlin; Tánaiste Simon Coveney

In the past 24 hours.

Several matters have emerged concerning the CervicalCheck programme.

A backlog in tests – following on from an extra 84,000 women coming forward for tests last year in the wake of the CervicalCheck scandal in April 2018, and Minster for Health Simon Harris announcing the provision of free repeat smear tests – has led to 1,000 women having to have repeat tests because the backlog caused their initial tests to expire and become invalid.

The figure of 1,000 emerged last night after Fianna Fáil TD Micheál Martin raised the matter in the Dáil yesterday.

It’s now the case that women have to wait, on average, 22 weeks to get the result of a CervicalCheck smear, as opposed to the usual two to four weeks.

Separately.

It’s emerged some 6,000 women will be written to next week and advised to return to their GPs for repeat smear tests.

This is in relation to a cohort of women who would have initially tested positive for low-grade abnormalities and who would have then been advised to have an additional HPV test within 30 days of the initial smear test – but their additional smear test was tested for the HPV virus beyond the 30-day limit.

[The practice of being advised to have an additional HPV test, on foot of a test showing up low-grade abnormalities, began in Ireland in 2015]

The acting Clinical Director of the HSE’s cervical screening programme Peter McKenna this morning told RTÉ One’s Morning Ireland that he’s not sure how it happened but the laboratory [Quest Laboratories] which was testing the smears “started counting the 30 days from the time the smear came into the laboratory rather than from the time the smear was taken in the smear takers’ clinic”.

Mr McKenna said that the HSE was alerted to this problem with the additional HPV tests at the “end of November”, while the scale of the problem unfolded in December and the HSE has been trying to identify the affected women since the beginning of the new year.

Quest Diagnostics is the laboratory whom the late Emma Mhic Mathúna sued.

Several TDs raised the matters in the Dáil this afternoon, with Tánaiste Simon Coveney telling the Dáil that the Minister for Health Simon Harris was told about the additional HPV testing concerns in December.

Mr Coveney told Fianna Fáil’s Dara Calleary that the impression Mr Calleary was giving – that the Government is trying to hide something – isn’t true.

He said:

“The HSE has said that it was made aware of this issue in November, the minister was made aware of the issue regarding secondary HPV testing in December. The issue was discussed at the CervicalCheck steering committee including with patient reps who are working very hard at that committee on a range of issues involved and outlined in published weekly reports.

“The minister sought regular updates but a final report was not available to him in terms of the numbers involved or who they were. And so when this issue was raised yesterday, I don’t believe he did have the information to be able to provide it until that was available today.”

Sinn Féin’s Pearse Doherty and Labour’s Brendan Howlin also asked Mr Coveney questions about the matter.

Mr Doherty asked for Mr Coveney to be more specific about when Mr Harris was notified of the HPV testing issue.

[Yesterday Taoiseach Leo Varadkar said Mr Harris was notified of the initial matter – concerning the expired smear tests – “a few weeks ago”]

Mr Doherty said:

“How come it will be February before these women will be informed that they need to go through another test – two months later?

“What did the minister do in relation to this here? How come we are so late in the day and women haven’t been informed that the information that they may have received in relation to their second test, remember the second test was a result of an abnormality in the first, may be inaccurate and was carried it outside the manufacturing’s timeframe?”

“And how can we be assured that this is the end of it, minister? That there is no more women out there that will get a letter through the door or a phonecall from their GP telling them that information that has been relayed to them in relation to life-threatening screening may be inaccurate?”

Mr Coveney responded by speaking about the challenges facing the health system, that mistakes are sometimes made and that lessons need to be learned.

In relation to the HPV testing matter specifically, Mr Coveney said:

“An issue has emerged there in relation to one of the three labs that are doing this work and we are now working to correct that and that is what we’ll continue to do.”

Mr Doherty pointed out that Mr Coveney didn’t answer any of the questions he asked and repeated them.

He also further pointed out that Mr McKenna had confirmed the HSE still doesn’t know how Quest Diagnostics made the error – despite the problem being identified in November.

Mr Coveney still didn’t answer Mr Doherty’s questions.

But he said:

“The HSE has advised that all of the evidence suggests that even though the test was done outside of the 30-day window, the original results are still very reliable. So can we please try to reassure people here there is not a cause for undue concern.

This is about, this is about full transparency, that is what patients should be entitled to expect and it is about correcting a mistake that shouldn’t have happened and to give women a reassurance by having a repeat smear test.”

He added:

“The information that I gave earlier to this house, is that the HSE became aware of this issue in November, the minister became aware in December, had discussions in relation to it, has asked for reports in relation to it and hasn’t got a complete report yet in relation to it. And so the information that I’m giving to the House today is current.”

Mr Howlin said:

“The delay in getting the CervicalCheck is now 22 weeks according to the HSE. Where there is a problem with a check and recheck is required, that means another 22 weeks.

“For many people availing of private healthcare options, to get a faster check, but that’s not an option for everybody. It’s another example of the two-tier system. I was contacted by somebody today who said, when they were told of this inordinate delay, ‘we can get a fast one, if you pay’.”

“…How much scandal can the screening programme take? We are absolutely in favour of screening but the problems besetting CervicalCheck programme indicates that something is deeply wrong.

“These problems are further eroding confidence in screening and people are anxious.

“So, I want to ask specific questions: Can you, Tánaiste, on behalf of the Government, confirm how much additional funding was allocate last year to CervicalCheck.

“Two, will the Government commit to full staffing and funding, so that we can get CervicalCheck back on track and deliver the quality service that we all want.

“And finally, as a result of what’s gone on, now, as an emergency measure, will the Government undertake to refund the cost of private checks, which might be in the order of €100 to €200 per patient, in order to address the backlog and remove the inequality between those who can pay privately.”

In his response, Mr Coveney said:

“What we have is a new issue, that we didn’t know about. That needs to be addressed, that was raised with the minister in December… And was subsequently raised in a CervicalCheck steering committee.

“It is absolutely appropriate that patients’ reps and the steering committee would be the first to hear about this and indeed patients themselves would hear before the Dáil hears about these issues. And the minister … asked for, and was awaiting, a report in terms of the detailed numbers on this issue when it was raised yesterday and it became a political issue in the Dáil. And that is why we’ve had to respond today in the way that we have.”

Mr Howlin asked Mr Coveney if he could respond to his specific questions in writing.

Investigation after smear test time limit ‘confusion’ (RTE)

From top: Fianna Fáil leader Micheál Martin and Taoiseach Leo Varadkar

This afternoon.

In the Dáil, during Leaders’ Questions.

Fianna Fáil leader Micheál Martin raised the recent death of Orla Church – who was the 21st women to die in relation to the CervicalCheck smear test scandal.

Mr Martin said, it was his understanding that, some free repeat smear tests conducted in the wake of the scandal have been rendered invalid because the tests expired due to delays caused by a backlog.

The provision of these free repeat smear tests ended on December 31, 2018.

Mr Varadkar confirmed some tests have expired.

Mr Martin raised an article in The Journal on January 9 which showed that the Minister for Health Simon Harris had been advised against providing free repeat smear tests, as it would cause delays and damage the “efficacy of the programme”.

Mr Martin also pressed Mr Varadkar to explain when the Minister for Health Simon Harris informed Mr Varadkar of this situation.

From their exchange in the Dáil…

Micheál Martin: “On average, CervicalCheck tests about 230,000 smears annually. The Minister’s decision last April added an extra 90,000 to 100,000 to that volume. The Minister was warned repeatedly over a long period that this was wrong yet he proceeded without any additional resources being provided. The additional volume of tests as a result of the decision has created an unacceptable and enormous backlogs and women have been waiting for up to six months for the results of their tests.

“There is a further problem. I understand that the delay has impacted on the quality and efficacy of the tests and has rendered a significant number invalid.”

“… I asked the Minister, Deputy Harris, a specific question on this issue on 15 January. I asked for the rationale of announcing the repeat cervical smears against expert advice and why he did not make that public at the time. He avoided answering that part of the question and I have officially complained about this under Standing Orders. The Minister has withheld information from the Dáil and the public on developments in the CervicalCheck programme that are clearly in the public interest.”

“….Was the Taoiseach made aware of the serious developments by the Minister, particularly regarding the validity of a significant number of tests that had been rendered null and void because of the delay? Normally, the virus would be tested for within ten days, yet people are facing six-month delays. This was discovered last year but not revealed by the Minister or anyone. In essence, that information has been withheld. That is why the service was discontinued, Taoiseach. The minister’s decision was against expert advice that warned him, repeatedly, that this would damage the entire programme.

“It is my understanding and it is my information that the programme is in jeopardy because of all of this. And further there’s significant decisions and communications would have to occur because of this. I asked were you made aware of this by the minister?

“Would you please answer that question.

“I asked as to the rational behind the minister’s decision – against repeated expert advice and that this was not clinically warranted and it would damage the efficacy of the entire programme.

“Taoiseach if we’ve learned any lessons about this, the withholding of information, the secrecy and denial that was part of the first phase of this scandal is being repeated yet again.

“In terms of the lack of upfront, honest responses to parliamentary questions and the ducking and the diving and the papering over the cracks and the covering up that goes on then subsequently.

“So we’re now all led to believe that it just evolved that the decision was closed down in December. It didn’t just evolve. It was a discovery made, Taoiseach – that tests were invalid because the expiry date ran out because of the backlog and the delay. That has consequences Taoiseach in terms of many women involved.

“And we need, I would ask you Taoiseach will you ensure that the minster comes before this House and makes a comprehensive and transparent statement in relation to what I have asked today?”

Leo Varadkar: “Thanks Deputy. The rationale behind the decision by Minister [for Health Simon] Harris to offer free out-of-cycle smear tests back in May or June was to respond back to the anxiety by many women that their smear test may have been misread and it was done in good faith, in good faith, for good reasons.

It was never intended to be a permanent offering, it was only ever intended to last for a few months and those free tests cease to be available at the end of December this year [sic].

I was made aware of a backlog a few weeks ago and Minister Harris informed me a few weeks ago. I’ll answer your question if you’ll allow me to.

I was made aware by Minister Harris a few weeks ago that there was a backlog and this was creating problems and, as a result of that, some tests had expired and would have to be repeated. And the minister, for that reason, worked with, is working with the HSE to deal with that and to make sure that additional capacity is found in order to catch up on the backlog.

“I’m sure the minister will be happy to come before the House and make a statement on it.”

When Mr Martin pressed Mr Varadkar to state when he was specifically informed of the matter by Mr Harris, Mr Varadkar repeated it was “a couple of weeks ago, I don’t remember the exact date”.

Mr Varadkar said he didn’t want to mislead the Dáil and repeated that he couldn’t remember the exact date he was informed.

Previously: “I Don’t Believe I’m Being Told The Truth”

Watch Dáil proceedings live here

UPDATE:

This afternoon.

BBC  announced its list of “100 inspiring and influential women from around the world for 2018”.

Including…

(75) Vicky Phelan exposed the CervicalCheck Screening scandal in Ireland, after discovering she and hundreds of other women were not told they had been given incorrect smear test results.

In fairness.

BBC 100 Women 2018: Who is on the list? (BBC)

Social Democrats co-founder Catherine Murphy

This afternoon.

In the Dáil.

During Leaders’ Questions, which were taken by Tánaiste Simon Coveney…

Social Democrats TD Catherine Murphy raised the CervicalCheck controversy and the inordinate delay some women are experiencing in accessing their slides – having also raised it last week.

She said it’s her understanding that the National Screening Service ordered Quest Diagnostics – which was sued by the late Emma Mhic Mhathuna – to stop releasing slides back in August.

And she said she understands that some women are going to go to the High Court to force the release of their slides.

Ms Murphy said:

“They’re not people that should have to battle for anything else right now. Really, their whole focus should be battling in relation to staying as well as possible.

“But unfortunately, that’s not the case. And I want to draw attention to the absolute contradictions that exist between the information that’s being put forward by the Taoiseach, the minister, the HSE officials and CervicalCheck and the actual lived realities for the women and their families involved.

“Yesterday, I spoke to Cian O’Carroll, the solicitor representing many of the women impacted and he informed me, he is still chasing down slides from as far back as April or May.

“And the HSE put a protocol in place in August, following which Mr O’Carroll engaged with them to try and improve it. Yet, since the 10th of September, when he provided suggested improvements, they have had no engagement. He has no engagement from or by the HSE. That’s more than two months ago.

“The Taoiseach agreed with me in the chamber last week that there should be no further or undue delays. Previous to that, the Taoiseach told the house that no woman should have to go to court.

“But I’m being told that there’s an appeal, that there will be an appeal to the High Court to force the release of the slides for these women and their families.

“And they’ll be put through that torture, it’s totally unnecessary Tánaiste.

Seven women have come forward to me, to tell me, they’re part of the 221-plus group, to tell me that they’re waiting an inordinate amount of time for access to their slides.

“Yet that jars completely with what the HSE told the Public Accounts Committee last week. They said the average waiting time, for women who had requested the slides, was 22 days and that the HSE had put a specific unit in place, just to deal with this.

“Yet, here we have these women saying that that’s not the reality that they’re experiencing.

“And I understand that the National Screening Service ordered Quest Diagnostics, back in August, to stop releasing slides.

“I also understand that where previously it was the norm to include the accompanying laboratory reports with the slides, they’re not now being released.

“So it’s clear that the experiences and the information given to me, that the HSE have become far more legally focused and less patient focused on this issue and the goalposts are moving for these women and their families and they can’t continue to be treated like this, Tánaiste.

“I have just one question: Can you please outline the process and timeline whereby these women will be given access to the slides and associated reports.”

During his response, Mr Coveney said:

“I can assure that the Department of Health, the HSE, and the Government wants to ensure that we treat families as quickly as possible, protecting the integrity of the process, of course, to make sure that families and loved ones and women can get access to their own slides, their own medical records effectively, as quickly as possible, without any undue delay.”

“...We don’t want any woman or any family to have to go court here to be able to access slides that they should be entitled to access quickly without any undue delay and it’s the procedures we’re putting in place to make sure that happens is what we want to focus on.”

Ms Murphy, somewhat incredulous, responded:

Seven people who have contacted me, who are caught up in this, who are directly impacted on it, why would they be contacting me? What would they be doing that for if this was working?

“Just ask yourself that question. I’ve been told that the HSE has been put on notice that there will be a case in the High Court to demand these slides, why would that be happening if this was working satisfactorily.

“This is not working satisfactorily and it’s absolutely, it’s absolutely unacceptable that they should be forced to go to court, just to get their medical information.

“Can I ask you to go back and review this today.”

“…I don’t believe that I’m being told the truth.”

Last week, Ms Murphy told the Dáil she had been in contact with women who have been waiting six months for their slides.

She said:

“I was contacted by the husband of one of the 221 women who have been caught up in the scandal. He told me that the majority of women who requested their slides have not got them six months after they requested them. Some time ago I looked at the MedLab Pathology and Quest Diagnostics contracts and raised the matter at the Committee of Public Accounts.

“The contracts provide that the HSE can retrieve these slides within three days, so there is no question as to ownership of the slides.”

Taoiseach Leo Varadkar said he’d look into the matter and couldn’t understand that women were waiting months when it should take a “couple of weeks”.

Watch Dáil proceedings live here

The Meenan Report on an Alternative System for Dealing with Claims From CervicalCheck

Yesterday, The establishment of a judge-led tribunal was recommended to deal with claims arising from the CervicalCheck programme.

A report by Justice Charles Meenan advises the setting up of a compensation tribunal that can determine liability on the part of CervicalCheck and award damages.

The Report considered, but rejected, the possibility that awards would be made without the women concerned having to prove fault on the part of CervicalCheck.

The basis for this conclusion is that a ‘false negative’ result could arise in the absence of any fault; therefore it would be unfair to impose no-fault liability. The hearing of the claims will be heard in private.

Dr Primum Non Nocere writes:

‘In the case of the 221 women whose smears were read wrongly, is it really appropriate to require them to prove fault?

The Report took the view that they should, on the basis that a ‘false negative’ may arise for a number of reasons, without going into the reasons.

Let me tell you the reasons why a false negative may arise and you will see that this reasoning does not justify requiring the 221 women whose smears were misread to prove liability in this case.

A false negative may arise because the location of the abnormalities in question are such that they do not show up on a smear.

This could be because the smear has not been properly done, or because the location of the abnormalities are such that they do not feature on a smear even if properly carried out.

In such cases, there may not be negligence on the part of the person reading the smear (unless it is obvious that the smear was not properly carried out, in which case they should send it back).

However, this type of false negative does not arise in relation to the 221 women whose cases gave rise to this Report.

The problem in their case was not that their abnormalities did not show up on the smear, but that the person who initially read the smear did not spot the abnormalities.

This is prima facie negligence, unless technology at the time of the initial reading was not capable of showing up the smear; no argument has been made in this regard.

Given the circumstances of their particular ‘false negative’ and the deplorable failure to inform, is it really either humane or cost effective to require these 221 women to go through the process of (a) proving liability to the Tribunal and (b) dealing with the subsequent delay and costs risk involved in a High Court hearing if the Tribunal’s finding of liability is appealed by CervicalCheck?

There might be some public benefit in a hearing on liability, albeit at considerable financial cost to the public, delay and emotional cost to these women, if and only if the proceedings of the Tribunal were public.

This would at least have the benefit of conclusively clarifying what happened regarding the reading of these smears.

However, if the proceedings are to be heard in private, one wonders if there is any benefit from an examination of liability?

I can understand how the women concerned might not want to have issues relating to the damage suffered by them heard in public; however surely if liability is in dispute it should be possible for the portion of the hearing dealing with liability to be heard in public, with the woman’s name not being made public?

It does not seem to me that her testimony would be required for a determination as to liability.”

Anyone?

Yesterday: A Private Tribunal

previously: A Doctor Writes

This afternoon.

RTÉ’s Health Correspondent Fergal Bowers is reporting that High Court Judge Mr Justice Charles Meenan’s report on potential alternatives to the court process for women affected by the CervicalCheck scandal is now with the Government.

Mr Bowers said it’s expected that Judge Meenan’s report will be published within the next hour or so.

Ahead of this, Mr Bowers reported:

“His report was given to the minister last night and brought before Cabinet today. Probably, it will be published in the next hour or two. And as I understand it, I mean, alternatives are limited but I believe it’s going to recommend, particularly, that they go down the route of a compensation tribunal.

“And we’ve had similar compensation tribunals here for people infected with Hepatitis C and HIV through contaminated blood.”

“…The nature of these tribunals are that they’re held in private, and people can go in with or without a legal advisor, make their case and then an adjudication will be made, an award recommended.

“If somebody isn’t happy with that award, they can go to the courts.

“The big question, of course, is the State funds the tribunal. That’s the taxpayer and so will the State then pursue other parties, say some of the laboratories, to recoup that money. That might be tricky but that’s obviously an important point.”

Tribunal could be set up over CervicalCheck crisis (RTE)

UPDATE:

The 33-page report can be read in full here

This afternoon.

Kildare Street and Merrion Street, Dublin 2.

The hearse with the coffin of CervicalCheck cancer victim Emma Mhic Mhatha passes by the Dáil (Leinster House) and Government Buildiings (above).

Sam Boal/Rollingnews

Earlier: At Dublin’s Pro Cathedral

Sam Boal/RollingNews

Meanwhile…

Dr Gabriel Scally arriving at Leinster House to take questions from the Joint Health Committee this morning

Members of the Scally Review have expressed concern that there may be other women affected by the CervicalCheck crisis, not included in the group of 221 identified by the Health Service Executive.

Dr Gabriel Scally, who led the review and Dr Karin Denton, a UK consultant cytopathologist who assisted, said they have been asking the HSE more questions this week about this issue and the protocols used to identify the original group of 221 women.

Dr Scally described that protocol as flawed and said he was not aware of any basis for the way the HSE identified the group of 221 women.

Protocols used to identify women in CervicalCheck crisis ‘flawed’ – Scally (RTÉ)