We use Google Analytics to see which pages are read and how the site is used, so we know what to improve. This only runs if you accept. See our privacy notice for details.

Dáil
‹ Leaders' Questions

Mandatory open disclosure and HIQA inquiry

Summary

Deputy Joan Collins argues the scandal reflects a deeper culture of denial, lack of resources and the need for mandatory open disclosure, urging immediate legislation. The Taoiseach says all original smears in the affected cases were rechecked, a more accurate test is being moved toward, and a HIQA inquiry is needed to establish the full facts.

Pat the Cope Gallagher An Leas-Cheann Comhairle Fianna Fáil

I call Deputy Joan Collins on behalf of her group.

Comment on this

This scandal is and will go down in this State's history as one of the worst instances of serious medical neglect, particularly of women, along with the ingrained culture in the health service to deny and cover up this scandal. The response of the health service to the hepatitis C scandal, the deaths of babies in Portlaoise hospital, the cases of national maternal deaths and catastrophic injuries, symphysiotomy etc. has been to admit nothing and make patients jump through emotional and financial hoops to prove their case. That has been the history of this State.

The HSE eventually came out yesterday and confirmed at least 208 women, who have since been diagnosed with cervical cancer, were initially told their tests were negative, and of those, 17 women have died. In 173 cases women would have been given a different clinical treatment if earlier smears had been read correctly and 162 of the 208 were not told a review had been conducted by CervicalCheck or of the outcome. Cian O'Carroll, the solicitor acting for Vicky Phelan, for whom I have huge respect and admiration - we should be not only angry but livid about what is after happening in these cases - believes all 1,482 cases should be subjected to independent review.

Could this situation have been prevented? In 2008, the then Fianna Fáil-Progressive Democrats Government made a political decision to outsource our smear testing to private companies overseas. Why? It was because they made a political decision not to resource the services here. Sam Coulter-Smith, a former master of the Rotunda Hospital, said he warned the Government a decade ago against testing being moved to private companies overseas because he was worried that resulting problems would mean cancer cases being missed. He said: "Our cytology system in the Rotunda Hospital, which was well developed, fully accredited and world class, with very good quality assurance systems in place and numerous people analysing smears - two looks rather than one - the quality assurance was at a much higher level than the US."

Dr. David Gibbons, who was chair of the cytology-histology group within the national cervical screening programme, with a number of his peers, has stated that they raised with the then CEO of the National Cancer Screening Service, Tony O'Brien, their serious concerns. He said he warned Tony O'Brien when he saw the figures from the United States were showing one third fewer high grade dysplasias compared with Ireland. It was 1.8 in Ireland and 1.2 in the US. He was concerned about a mismatch of systems. Ireland tests for cervical cancer every three years where the US system would test annually. He predicted in 2008 that up to 1,000 women per year would be affected and that this would become apparent ten to 15 years down the line.

That has happened. It is a reality for the women affected by these reviews and it must be seriously taken on board. Somebody has to be answerable for this. People in this country are sick and tired of these cases. In the hepatitis C case the CEO walked away with a gold-plated pension and people like Brigid McCole had to go to the courts to fight their cases.

I reiterate the call from the Sinn Féin Deputy that Tony O'Brien or somebody should be held to account. The political system should be held to account for this as well. An international peer review is being done on the screening. The Taoiseach said approximately half are done in the United States or outside the country and the other half are done here. We should have a clinical assessment of the exact number that came from the US and from here.

Comment on this
Pat the Cope Gallagher An Leas-Cheann Comhairle Fianna Fáil

Deputy Collins, your time has expired. I call the Taoiseach to respond and he has three minutes.

Comment on this

Everyone else got extra time.

Comment on this

A Leas-Cheann Comhairle, everybody else got over a minute and a half or two minutes extra time on this.

Comment on this
Pat the Cope Gallagher An Leas-Cheann Comhairle Fianna Fáil

Yes, but you are a minute over time-----

Comment on this

Everyone else got more than a minute extra.

Comment on this

I am 47 seconds over time.

Comment on this
Pat the Cope Gallagher An Leas-Cheann Comhairle Fianna Fáil

I am taking note.

Comment on this

I wanted to make the point about mandatory open disclosure. Deputies Clare Daly and Wallace last year brought an amendment to the Civil Liability (Amendment) Bill 2017 for mandatory open disclosure. It was rejected-----

Comment on this
Pat the Cope Gallagher An Leas-Cheann Comhairle Fianna Fáil

The Taoiseach to respond.

Comment on this

-----and Fianna Fáil abstained.

Comment on this
Pat the Cope Gallagher An Leas-Cheann Comhairle Fianna Fáil

Deputy Collins will have another minute.

Comment on this

That mandatory disclosure could have been in place at present and it could have affected those cases where women had the right to that disclosure. Would the Minister please bring in the Health Information and Patient Safety Bill immediately, not six months down the line?

Comment on this
Leo Varadkar The Taoiseach Fine Gael

To clarify, in all 1,400 cases the original smears have been rechecked. The way the audit worked is that if a woman was diagnosed with cervical cancer between 2008 and 2014, they went back and checked all of the smear tests to see if there were false negatives or false positives. To reassure people, in all 1,400 cases those smear tests were rechecked already. That is the way this audit cycle works.

In relation to the laboratories, I hope I answered already - if I did not I am happy to repeat it or clarify - that we are moving towards a new more accurate test. No test is 100% accurate. There will still be false positives and false negatives, but we are moving to a new test which is a HPV-based test for cervical cancer screening. That new test will come in later in the year. That offers us an opportunity to reconfigure the laboratories and review which laboratories we use.

Whatever we do, it should be based on facts. We are letting women down and letting people's health down, in particular women's health, if we make decisions that are not based on facts. As I explained earlier, 50% of smears are checked in cytology laboratories here in Ireland and 50% are outsourced. Three different laboratories are used - two in the United States and one in Ireland - and so far there is no evidence that any of those laboratories is less accurate than the others in terms of false negatives in a statistically significant way. Whatever we do, it must be based on facts. We should not merely sack somebody or change the laboratories for some reason. In the interests of women and their health and doing what is right, we must base our decisions entirely on facts and evidence.

In terms of resignations, it is worth noting that the head of the programme, its clinical director, Professor Gráinne Flannelly, has already stepped down. We accept that she has made that decision, taking accountability for the appalling communication failures that occurred. However, it is also important to note that she is somebody who was involved in bringing in this programme over the years and, as a consequence, helped not only to save many women's lives but also to ensure many women had much less invasive operations because their cancers were picked up earlier. We should be balanced in our response and recognition of that.

On the duty of candour issue, as I said, duty of candour is already in the medical council guidelines.

On the decision taken last November on mandatory open disclosure, this commitment was given to Deputy Clare Daly, who brought the amendment forward and made some good points in that debate in the Dáil, by the Minister both verbally and in writing that on foot of the legislation for voluntary open disclosure, which was passed by these Houses a few months ago, he would bring forward mandatory open disclosure in line with the programme for Government in cases where it is a serious reportable incident or error. The Minister is developing that legislation. It will be in the patient safety Bill. The Minister expects to bring a memorandum to Cabinet next week and we will get that legislation done as soon as possible.

If people think that merely changing the law or guidelines will resolve this problem once and for all, it will not. What is required is a change of culture in our healthcare. We need to move towards a culture of truth and that is something I would like to speak about later.

Comment on this

I honestly believe this is not merely a communication failure. It is a service and resource failure. Mr. Tony O'Brien, in 2008, stated, "At the time there was not sufficient capacity of that type in Ireland." It was not resourced and they had to go abroad to private companies overseas. That is a fundamental issue in our screening.

I would like to get the facts. The Taoiseach correctly states we should get the facts.

The fact of the matter is we have women dying here because their screening was not tested adequately. They were screened in 2011, their smears came back negative and they were retested. That is the information I read and which the Taoiseach said he read over the weekend. If corners are cut it does not work. More often than not, in the longer term one pays more both financially and in terms of the human cost. At this point we should be looking at bringing all our screening back. Even if we bring in new HPV screening, it still has to be checked to World Health Organization standards. We should be looking at that now rather than waiting for reviews and peer reviews. I would like the Taoiseach to come back on that. Sam Coulter-Smith has said that very clearly.

Comment on this
Leo Varadkar The Taoiseach Fine Gael

I am still trying to figure out all the facts. I appreciate the Deputy's sentiment that decisions we make on this should be based on facts. We are really letting people down, particularly the women of Ireland, with regard to women's health if we make decisions that are not based on fact. We do not yet have all the facts. That is why we need to have the HIQA inquiry. That is why we need a little bit more time to get to the bottom of this. I want to get to the bottom of this. I want to know all the facts. I want to make sure we can restore confidence in our cancer screening service. If one takes the entire audit, which I think included 1,400 cases in total, there were 208 false negatives. That is 208 people who had smear tests that were reported as normal but who then went on to develop cancer. We cannot say how many of those were false negatives yet within the margin of error. We cannot say for certain. Very sadly, those 208 people have cancer. Some of them are very sick and 17 have passed away, very sadly. We cannot say with certainty that had there been a different test done in a different lab that those cancers would have been picked up. I see from one of the notes today that a slide was looked at by eight specialists - eight cytologists. They are scientists who are experts in this field. Eight of them were asked to look at a sample. They were told the woman had been diagnosed with cancer; five of the eight could not see the cancer cells and three could. These tests are not 100% accurate. They are subjective. There is a degree of margin of error. We will do our best over the coming period to try to explain.

Comment on this