Michael Harty (Clare, Independent)
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Before we bring in the witnesses we will discuss some items of correspondence. Nos. 902 and 904 relate to CervicalCheck and those who had smears carried out in private clinics being excluded from public colposcopy clinics.

I also had this problem. When I became aware of this problem three or four months ago, I went to the Minister seeking the reversal of the CervicalCheck decision not to deal with patients who had sought private smear tests.

CervicalCheck sent letters to the public clinics stating that they should not deal with individuals who had been sent by their general practitioner to a private clinic, because the doctor was not getting the results of smear tests already and required to have the results fastracked, when the outcome was the need for the patient to go to a colposcopy clinic. When the person went to the colposcopy clinic in Cork, they were given a letter stating that because they had got the results from a private clinic they would not fall under the remit of the colposcopy clinic. They would have to have their smear done in a public clinic.

As a result of the constituent coming to me, I arranged for her GP to refer them to another clinic under the HSE. That clinic did provide care for the individual but within two weeks of providing care for them, it appears that clinic also got a letter from CervicalCheck advising them not to take people who had had their smear in a private clinic and had been issued with the results. The letters were circulated.

Alan Kelly (Tipperary, Labour)
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I thank the Chairman for dealing with this issue in public session because it is a very serious and worrying situation. Ms Healy has provided us with all the correspondence.

I have spoken to Claire Healy a number of times. She got this letter, on 22 July, stating that she was not entitled to be referred to a colposcopist because she went through CervicalCheck but she decided to get her smear done privately. As a result, a letter was issued on 11 June by Dr. Lorraine Doherty, which stated that anyone who went and had smears done privately could not be dealt with. In fairness to Dr. Nóirín Russell of University Hospital Kerry, whom I compliment, she outlined to Claire in a response letter that the letter of 11 June from Dr. Doherty had made this decision - we have a copy of that here as well. Subsequently, after a number of us raised issues with this, it was pointed out that there was a email from Mr. Liam Woods on 16 August changing this. As the Senator stated beforehand, there were emails issued to more than just Kerry hospital. This was across the board, as we know now.

What is deeply worrying is that we have a new director of CervicalCheck who was in here not so long ago and gave information here with which I need to join up the dots. Ms Healy is saying in her letter to us that what was said in here is contrary to her experience. Ms Healy is saying that there was a direction given by the witness, who was here at the time, on 1 June 2019 that she could not be part of CervicalCheck. There was a bit of flurrying around the edges about the fact that screening is not diagnostics. We all know screening is not diagnostic etc. This is not about that. This is about colposcopists and referral. Ms Healy's slides showed that there was an issue that needed to be investigated. Subsequently, after going to the colposcopist and eventually getting it done, it showed that she had a high-grade change which was just below cancerous and it was something to be very concerned about. I have a serious concern here - Ms Healy had high-grade changes - given everything that has gone on in relation to CervicalCheck, that somebody could unilaterally send out a directive such as this. There have obviously been more people affected than the two women we know about and have referred to. Anyone who was in a similar situation would have got the same treatment based on the letter sent in June by Dr. Doherty. I am also concerned, having read the transcript of her evidence to this committee, about the reasoning Dr. Doherty gave for this happening. In fact, at this stage, I think we need to go back and ask again. As a consequence of this episode, which raises deep concerns as regards how this happened and how unilaterally it could happen without the HSE at a higher level doing anything about it, and while I respect the fact that the issue has been subsequently dealt with, unless a couple of people - there could have been more - put this in a certain forum, it could have continued for a considerably longer period.

My concern relates to a number of matters. The first is the evidence given by Dr. Lorraine Doherty and I think we must have her back in. The second is how management in the HSE over CervicalCheck allowed this to happen. Third, if one looks at what they stated in committee, what they publish on their website and what is actually happening, this is an example of that trail not being accurate. We need to instill public confidence in all the screening programmes. We need to instill public confidence in CervicalCheck. How can we as a committee make sure that happens? I believe we must ask Dr. Doherty to come back in here to explain this. While it has corrected it now, I also believe we need to ask HSE CervicalCheck management to explain in detail the process by which this happened.

Michael Harty (Clare, Independent)
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I call Deputy O'Reilly.

Could I clarify one issue? The person who I dealt with was turned down by the Cork clinic and her GP referred her to the Kerry clinic, which treated her.

Alan Kelly (Tipperary, Labour)
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That is another complication.

Louise O'Reilly (Dublin Fingal, Sinn Fein)
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The issue here is a fairly serious one inasmuch as it raises further questions. I have spoke to Ms Claire Healy as well. She should not have been obliged to talk to politicians. It should have been dealt with.

We need to get Dr. Lorraine Doherty back in because there are questions to be asked. For example, one of the excuses offered as to why there may have been an issue with tracking the results is that if one goes from the private system to the public system, somehow one's identification, ID, changes. Clearly, it does not because the CervicalCheck ID was used by the GP and used by all of the tests at that time. That is not an excuse for what happened.

We need to get the bottom of how somebody can come in and intimate to this committee that she did not know how the decision happened when clearly she was central to it, and how many women are involved in this. I am aware, from within my own social circle, of at least one. I would imagine, if we scratch the surface, there are many women who would have been impacted like this on the basis that the waits were so long and any woman who was worried would either do it herself or, as in the case of my friend, be pressured into doing it by her husband on the basis of the need to get it done. The CervicalCheck programme should know how many women are involved in this. We need to get to the bottom of it.

It is essential that women have their smear tests but it is also essential that they have confidence in the system for handling those. We would be doing Claire and all of the other women impacted by this a grave disservice if we did not follow up on it. I believe we have a duty to so do.

Stephen Donnelly (Wicklow, Fianna Fail)
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I agree there is more to be done on this. It is worth noting the HSE's response last week. I put its clarifying statement to it and stated that while it was regretting that there was confusion caused, it clearly instructed hospitals not to treat particular people, there is no confusion about that and it made a mistake, and asked would its representatives admit that they have made a mistake and let us move on. I am open to being corrected but I am fairly sure they did not say, "Yes, we made a mistake." They danced around it being an awful situation that such confusion was caused. I reflected on it afterwards and concluded it is more serious than the usual hedging one gets, because this is about CervicalCheck, which came to light because of non-disclosure and because of people not putting their hands up and saying that they got something wrong. We are all fallible and people get things wrong. Within a functioning healthcare system, our officials and clinicians must be able to put their hands up and say that they made a call, be it a management call or a clinical call, and it was the wrong call. That must be acceptable within the system.

If those running the system - last week we had the Minister, the Secretary General and the head of the HSE before us - refuse to say that they got that wrong, it should not have happened and it will not happen again, that sends a message to every healthcare professional, official and manager working within the system that says it is business as usual; hedge, fudge, obfuscate and never accept that one has done anything wrong. It is regrettable.

I will ask a question for consideration at the committee.

I agree that we should find out the scale of this issue regarding CervicalCheck. However, it opens up the broader question of where else in the system this is happening. Women were waiting up to nine months for smear test results from CervicalCheck but people are also waiting between three months and two years for access to an MRI, a CAT scan, or various other diagnostics. Inevitably, people are being advised by their GPs that, as they will be waiting years for diagnostics on the public system, they should get them done privately. The GP can then look at the results and refer them to a consultant in the public system if there is something there. Patients feel compelled to get such tests done privately because of the huge waiting lists for public diagnostics. Is it HSE policy that such patients will not be seen across the public system? If a person has a diagnostic result that shows he or she needs specialist medical care, will the HSE do what it did to Ms Claire Healy? The HSE knew her results indicated that she needed specialist care, but it would not allow her access to the public system. She was told to get back in the queue and that she would be put on a list once she had gotten the same results in a year and a half from a public MRI machine. The committee should ask the HSE where else this practice is going on. The waiting times for diagnostics across the system are not normal.

Michael Harty (Clare, Independent)
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It is not uncommon for a public consultant to recommend that a public patient get a private scan and come back with it, because the doctor would not have access to that scan in the public system. That would be a very common statement to make to patients. Consultants are encouraging people to get private scans and people are happy to do so if it speeds up the process. It does not preclude them from getting back into the public system, in my experience.

Specialist consultants dealing with women's health are not allowed to be part of the CervicalCheck screening programme. If a consultant feels that someone needs a smear test, he or she has to refer them back to their GP. CervicalCheck will not take any referrals or test results from a consultant dealing with women's health. No consultants are included in the GP programme, which is causing its own problems. I know of a case where a GP who was dealing with a patient for a number of months became concerned and referred them to a consultant. The consultant saw the patient within two days because the GP had contacted the consultant themselves and expressed concern. Within three days, the consultant had that person on an operating table because of the issues that had been identified. If that person had gone through the public system, they would have been waiting at least two or three months for what was deemed an urgent operation. There is something wrong in consultants with specialisation in certain areas not being included in the CervicalCheck programme.

Michael Harty (Clare, Independent)
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For clarification, when Mr. Paul Reid was before this committee last week, he said:

It should not have gone out in the manner it did. We were happy that we clarified it on 16 August. It should not have been communicated the way it was.

That was his response to Deputy Donnelly pushing him on the point. Are members happy with that comment?

Alan Kelly (Tipperary, Labour)
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No.

Stephen Donnelly (Wicklow, Fianna Fail)
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I am not proposing that the committee goes any further with this issue. I am making the point that senior people in the system must give a full and clear acknowledgement, because that sends out the right message to everybody else. The HSE's response felt hedged. However, I am not saying that anything else needs to be done with that response.

Louise O'Reilly (Dublin Fingal, Sinn Fein)
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There is an issue regarding movement from the public system to the private system. I spoke to a woman who had her smear test done privately and it showed that she needed an urgent intervention. However, because she had a test done on the public system in the previous year which was clear, she could not get back into the system as an urgent case, though her GP tried very hard to do so. They would not acknowledge the private result, only the public one. That woman then went into the private system and underwent an urgent procedure very quickly after seeing a consultant. This issue is not isolated to one or two cases and we therefore need to have a broader discussion on it. I appreciate the points made by Mr. Reid. He said that the instruction went out but I do not believe it was heeded by everyone in the system. The responses we received were not good enough and we have a role to investigate that further.

Alan Kelly (Tipperary, Labour)
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I agree.

The results also seemed to have gone out to different clinics at different times.

Louise O'Reilly (Dublin Fingal, Sinn Fein)
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There is no consistency.

Michael Harty (Clare, Independent)
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I propose that we write to the medical director of CervicalCheck expressing our dissatisfaction with the answers we have received so far and asking her for specific clarification on the background to the original letter.

I agree with that.

Alan Kelly (Tipperary, Labour)
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I do not believe that is sufficient. I also have concerns about other issues which I will not yet speak about here. There is a direct contradiction in the evidence and documentation that Ms Claire Healy has given us. In fairness to Ms Healy, she sent us documentation from people in the HSE, which verifies what happened and others in the HSE have also noted the contradiction. The issue is between the letters from Dr. Lorraine Doherty and Mr. Liam Woods. What happened in between those two letters being sent out? How were they distributed across the various different areas in the HSE? How many people were subsequently affected? The second letter from Mr. Woods clarified the issue and totally changed what Dr. Doherty had said. Did the issue continue after the date of that letter?

I agree with Deputy Donnelly that the HSE should just admit that it made an error and got it wrong. However, I do not believe a letter from the HSE is going to sufficiently deal with that. We need to tease this out, perhaps in a limited period of an hour or so within this committee. We must do so because of the concerns raised. This is not any other screening programme; this is CervicalCheck and so we need to be absolutely clear that this should not have happened and is unacceptable. The HSE's attitude has been laissez-faireand given the screening programme in question, that needs to be looked into.

Michael Harty (Clare, Independent)
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I propose that we write to the director of CervicalCheck asking her for complete clarification of what has happened. We will then act based on her response.

Alan Kelly (Tipperary, Labour)
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We should ask that she sends the letter to the committee by next week, because I do not want this to drag on. We can make a decision on it next week.

Michael Harty (Clare, Independent)
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Is it agreed that we will write to her asking for clarification on the points raised this morning? Agreed.

Louise O'Reilly (Dublin Fingal, Sinn Fein)
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We should heavily emphasise that she should reply to the committee within a week.

Alan Kelly (Tipperary, Labour)
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We need a response before the next committee meeting. If we do not hear from her by then we should call her in.

Michael Harty (Clare, Independent)
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I thank the members. Deputy Kelly wished to discuss another issue.

Alan Kelly (Tipperary, Labour)
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I want to raise two issues. The first is the profile of the 221 patient group laboratory audit results. I pressed the HSE for this report and it was subsequently sent to patient representatives, to the 221+ patient support group, and to this committee. It breaks down the figures by laboratory and shows where the 221 breakdown is. In May 2018, the then director general of the HSE, Tony O'Brien told us that the HSE would be able to break this down for us.

Louise O'Reilly (Dublin Fingal, Sinn Fein)
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He said that to me, but he never got back to me.

Alan Kelly (Tipperary, Labour)
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It was a matter of weeks. He stated that it would take two weeks or a similarly short period. I need to check the record in that regard. The big issue is that we still do not know the dates in question. If the HSE is incapable of giving a full matrix of the breakdown of these slides, it must be dysfunctional. This work should barely take a couple of hours, never mind a couple of years. There is a reason the information is being held back. The patient representatives on the CervicalCheck steering group have asked for it ad nauseam. It has been asked for in many ways and on many occasions. The most recent occasion on which they asked for it was in writing last December. What has been provided is tokenistic. It is trying to get us off the information trail. There is a reason that the full information is not being provided. It is totally unacceptable. My concern with regard to what is happening is being strengthened. There is no reason CervicalCheck cannot provide this information. It is quite basic information which the organisation has held for years. Why is it not providing it? If it cannot give us the information, there must be a reason for that which we are not being told, or else the organisation is completely and utterly dysfunctional. All it needs to do is include another couple of table lines in order to provide the information required. It has the information. All it needs to do is provide different bundles of the various labs and dates and what happened. It is quite simple, but CervicalCheck either cannot or is refusing to do it. The deeper question is why it is refusing to give patient representatives and the committee this information.

Louise O'Reilly (Dublin Fingal, Sinn Fein)
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The initial request was made by me and Deputy Bríd Smith, and possibly others. The issue has been raised countless times. Each time we raise it, including directly with the Minister, we are told that everything is grand and that the information will be provided very quickly. It still has not been provided. It has been sought for years. The HSE is well aware that the information we are seeking is not contained in that documentation. In fact, that documentation adds nothing to our understanding of the issue. A representative of the Academy of Clinical Science and Laboratory Medicine appeared before the committee and was clear that the potential for clusters existing needs to be investigated. That is what we were told we would be getting, but we did not get it or any version of it. The committee may have written to the Minister to request this information. It has definitely been requested by me and other Oireachtas Members on numerous occasions, as well as by the patient representatives. It would be in order for us to seek further information in that regard. We are not seeking a massive amount of information. It would be shocking if the HSE did not have the information. Of course, it has it. The question is why is it not sharing it with us when we have requested it umpteen times.

Michael Harty (Clare, Independent)
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What is it proposed that the committee should do? Should we write to the Minister or to CervicalCheck?

Louise O'Reilly (Dublin Fingal, Sinn Fein)
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We should write to both, to be on the safe side. We should definitely write to CervicalCheck requesting a full breakdown, including dates. We need meaningful information. The Chair read the report provided. There is nothing in it.

Alan Kelly (Tipperary, Labour)
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Patient representatives have been in contact with me in the past few minutes. They have asked for this information numerous times. We should write to CervicalCheck in the strongest terms possible. Damien McCallion is its administrator. We should also write to the Minister and tell him that we want the information by this day next week. There is no reason it could not be provided. Tony O'Brien was telling the truth when he told the committee he could provide it within two weeks.

Michael Harty (Clare, Independent)
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We will write to CervicalCheck and the Minister.

Alan Kelly (Tipperary, Labour)
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There is something going on. This information has been hidden for a reason.

Michael Harty (Clare, Independent)
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We will write to the director of Cervical Check, Mr. McCalllion, and to the Minister.

Alan Kelly (Tipperary, Labour)
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I ask that we seek a reply within one week, please.

Michael Harty (Clare, Independent)
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Okay. Is that agreed? Agreed. Does that complete our-----

Alan Kelly (Tipperary, Labour)
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No. That is only the précis. The big issue relates to the Irish National Accreditation Board, INAB. I have gone through all of the documentation provided. I do not know whether any other member has done so. I spent last night going through it. I have raised issues regarding INAB at the committee many times. Its representatives appeared before us. I refer to the issues regarding quality assurance at the Manchester laboratory. In fairness, I asked the representatives of INAB when it found out that the Manchester laboratory was not accredited. What is really scary is that for a long time I have been chasing up what happened in regard to the second Scally report. I have outlined the full chronology in this regard in the Dáil, at this committee and at another committee on numerous occasions. The report was due in February. Something happened to ensure that it was not delivered. I asked Dr. Scally and the Minister on numerous occasions and in various ways why the report was not delivered on the date it was due. I asked the Secretary General at a meeting of the committee on 13 February and he truthfully told me it was imminent. Dr. Scally was due to appear before us the following day. In reply to a parliamentary question asked on 12 February, the day before, I was told the publication was imminent.

I sought information from INAB in other ways and, to its credit, it provided it. I had to go through the committee and ask it to get all of this documentation. In a letter to INAB on 1 February regarding MedLab Manchester, Dr. Scally outlines that he is in the course of completing the supplementary report, the publication of which is imminent and indicates that he would be grateful if his questions could be answered as soon as possible. On 6 February, he again wrote to INAB and stated that he was in the process of completing the report and would appreciate a response sooner rather than later. On 13 February, the same day I asked questions at this committee and was told the report was imminent, Dr. Scally wrote to Adrienne Duff regarding the lab. He stated that he would operate on the basis that the Manchester screening facility was covered by the accreditation INAB had given MedLab, as he had been told by Ms Duff the previous day. We all now know the truth in that regard. In the letter, Dr. Scally goes on to inform Ms Duff that the relevant section of his report was being finalised that morning and seeks written confirmation of what she told him on the telephone.

In fairness to the Secretary General of the Department, he told me at the committee meeting on 13 February that all quality assurance issues were being dealt with, that the terms of reference which were published - I am not sure whether they were fully engaged with - would be dealt with and that the report was imminent. The reality is very different. As a consequence of what happened regarding the non-analysis of the contracts, the lack of information on the labs, the discovery of this issue relating to Manchester and the quality assurance concerns I raised at the committee following requests from patient advocates, the report was not published for many months. Given that the Manchester laboratory was not accredited by INAB - it did not even know it existed - the consequences for the report were immensely serious.

Everything changed around that time. This is a jigsaw on which I have been working for the guts of six to eight months. This is the final piece in the jigsaw. If the meeting of this committee on 13 February had not happened, would this report have been published - it was about to be published - and would we ever have known about the quality assurance that was needed, the lack of quality assurance, the issues that had not been covered by the first report, the details of what happened regarding the Irish National Accreditation Board, INAB, and the Manchester laboratory, the process by which what happened with the Manchester laboratory came about and the fact that it can never be guaranteed that no other laboratories were used by screening providers with outsourcing because some of them no longer exist? Would we have known about any of this without that meeting of this committee? The trajectory of this report - when and how it was going to be published - changed dramatically over those days. I am glad it did because we subsequently obtained all the information but I am concerned about how a report that was originally 16 or 17 pages long increased to the size it was in the end. Much of this information and analysis will have been missed. I am not convinced that-----

Michael Harty (Clare, Independent)
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What does the Deputy request that we do?

Alan Kelly (Tipperary, Labour)
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I am not convinced that the terms of reference were covered. I have a number of questions. I received all of this documentation yesterday, which was budget day, so I will return with a range of questions about this for the consideration of the committee. The real issue is the fact that the issues that were to have been covered in this report, which was to have been published in mid-February, were only covered because of the actions of this committee.

Michael Harty (Clare, Independent)
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So the Deputy will write to the committee about discussing this at a future date.

Alan Kelly (Tipperary, Labour)
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Yes.

Michael Harty (Clare, Independent)
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That concludes our business regarding correspondence. I propose that we suspend for a few moments to allow the witnesses from the Medical Council to take their seats.