Tag Archives: CervicalCheck

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…

 

 

Minister for Health Simon Harris; Quest Diagnostics

Last night.

It emerged that approximately 800 women who had CervicalCheck tests carried out between October 1, 2018, and June 25, 2019, have not received their test results because of an IT issue at a Quest Diagnostics laboratory in Virginia in the US.

It followed one woman affected making inquiries about her own test results.

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

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

This morning, Fianna Fáil TD Stephen Donnelly told Seán O’Rourke on RTÉ’s Radio One:

We need to understand why the HSE took so long to inform the department. We know last year, when CervicalCheck [scandal] broke, that actually the Department and the HSE had been going back and forth and it was in reference to preparing the minister for the fact that Vicky Phelan’s case was about to break and that that could lead on to knock-on implications as of course it did.

We want to know why the department wasn’t informed. And, indeed, maybe they were informed but they were informed informally.”

“…Why wait until an hour after the Dáil goes into recess to let the information out publicly. Why, if it’s not a big deal, were the minister, or the HSE, a no-show on Morning Ireland this morning?

If this is not a big problem then we need to hear from the political leadership and the administrative leadership to explain that.”

Mr O’Rourke told his listeners that his programme also asked both the minister and the HSE for a spokesperson but neither were available.

Listen back in full here

800 women did not receive CervicalCheck results after IT issue at US laboratory (RTE)

Rollingnews

Dr Gabriel Scally this afternoon

This afternoon.

More as we get it.

Rollingnews

Hand THEM a leaflet at the door.

Dani McCabe writes:

I am writing to you on behalf of Standing 4 Women, a group that was formed a year ago in response to the Cervical Check Scandal.

We have launched our most recent campaign, Canvass Your Candidate, with the intent to make sure those who would ask for our votes can align with us in Standing 4 Action against the continues failures of Cervical Check, the HSE and the Irish Government.

Above are the leaflets that accompany the campaign that your readers are welcome to save and print at home from our Facebook page (at link below).

Many local Standing 4 Women groups all over the country will be knocking on doors and holding stalls ahead of Local Election Candidates to encourage voters to ask these questions and push for commitment from those who’d take positions in local government to actively resolve the many issues still with no progress or resolutions.

Standing 4 Women


Ruth Morrissey and her husband Paul outside the High Court this morning

Orla O’Donnell, of RTE, reports:

Ruth Morrissey has won her High Court action over the alleged misreading of smear tests and the failure to tell her about it.

The 37-year-old and her husband Paul have been awarded €2.1 million in damages.

Ms Morrissey and her husband, Paul, of Monaleen in Co Limerick, sued the HSE and two laboratories – Quest Diagnostics and MedLab Pathology Limited.

It is the first such case to have been heard in full and to be the subject of a High Court judgment.

Terminally ill woman awarded €2.1m in smear test case (RTE)

Ms Morrissey spoke to reporters after the judgment.

At one point she said:

“What can I say, I didn’t think I’d be in this position because our Taoiseach told us none of us would have to go through this but unfortunately I’m one who had to. So I hope that’s a positive thing for the women who are left – that they don’t need to do this.

“To fight for what is there right to have a good life of what they’ve left.

I’d encourage every woman to continue on getting their smears because it’s very important even though it failed me but it does save many, many lives and it’s a screening programme that we need. The HPV [vaccine], if you’re eligible, please get it. This is not a cancer that you want.

“And I’d just like to thank this man here [Paul] for being my rock through everything.”

UPDATE:

UPDATE:

From top: Fianna Fail leader Mícheál Martin; Taoiseach Leo Varadkar; FFl TD Stephen Donnelly at an Oireachtas health committee meeting this morning; a tweet from Health Minister Simon Harris on April 28 last, offering women free repeat smears 

This afternoon.

In the Dáil during Leaders’ Questions.

Fianna Fáil leader Mícheál Martin raised the submission made by the former clinical director of CervicalCheck Gráinne Flannelly to the Oireachtas health committee – revealed this morning – in which she said she warned the Department of Health against offering free out-of-cycle smear tests to concerned women following the Vicky Phelan case last April.

As the Minister for Health Simon Harris previously stated he didn’t receive any warnings against the decision to offer the extra tests, Ms Flannelly’s submission has led some to claim Mr Harris misled the Dáil.

Fianna Fail TD Stephen Donnelly told the health committee this morning:

“What she [Gráinne Flannelly] says directly contradicts the minister’s position.

“And what she says suggests that the minister has, in fact, misled the Dail.”

Minister Harris has since said today:

I never received any contrary advice in relation to the provision of free repeat smear tests.

“It is clear that after the decision was made that some in the CervicalCheck programme did express some concerns about the operationalising of it.”

According to Ms Flannelly she was told of the move to offer the tests at lunchtime on April 28, 2018 – while Minister Harris announced the move at 5.13pm that evening on Twitter.

During Leaders’ Questions Mr Martin told Taoiseach Leo Varadkar that Ms Flannelly’s claim “flatly contradicts” that of Minister Harris.

He asked the Taoiseach if he’ll ask the minister to address the Dáil and explain the full sequence of events. He also said the minister’s response to the matter “lacked character”.

Mr Varadkar told Mr Martin that the minister has previously answered questions on the subject and would be happy to do so again.

He then said:

“I think your approach here and your attack here also lacks character. Remember what you said about these people, what you said about the senior people in CervicalCheck on the 1st of May [last year].

“You said that they were cold and calculating. You suggested that they may have been involved in illegality and you suggested that they could have been involved in a conspiracy.

“So perhaps you should reflect on that and if you now hold the views you hold today, you may wish to correct the record and withdraw those remarks that you made about those senior clinicians and senior people in CervicalCheck back on the first of May.

“The reality was that the situation at the time was that there were a lot of women who were really concerned about the accuracy of their smear tests. They were attending their GPs, looking for a repeat smear test.

“They were contacting the helpline looking for a repeat test, there were some doctors calling for repeat smear tests to be allowed. When it was done, patient advocates were calling for it too.

“When it was done, it was welcomed by the Opposition and it was agreed by the IMO. So this wasn’t just a decision made by the Minister for Health. And it was also made with agreement for the Chief Medical Officer.”

Ms Flannelly says she warned that the offer of extra tests would ‘fundamentally undermine the screening programme’. She resigned on the same day the offer was announced.

Last month, Mr Harris told the Dáil that before the decision was made to offer these extra tests, neither he nor his officials received advice against the move.

It’s since emerged almost 80,000 women are now waiting up to 33 weeks for results of their smear tests when the normal waiting time is five to six weeks.

Earlier: Compare And Contrast