Supplementary Report of Scoping Inquiry into CervicalCheck Programme: Discussion

The purpose of the meeting is to discuss the supplementary report of the scoping inquiry into the CervicalCheck programme. On behalf of the joint committee, I welcome Dr. Gabriel Scally, Dr. Karin Denton and Mr. Shane McQuillan and thank them for coming. Mr. McQuillan is a partner in Crowe Ireland who leads the team that is providing logistical project management, investigative and analytical support for the inquiry.

By virtue of section 17(2)(l) of the Defamation Act 2009, witnesses are protected by absolute privilege in respect of their evidence to the committee. However, if they are directed by it to cease giving evidence on a particular matter and continue to so do, they are entitled thereafter only to qualified privilege in respect of their evidence. They are directed that only evidence connected with the subject matter of these proceedings is to be given and asked to respect the parliamentary practice to the effect that, where possible, they should not criticise or make charges against any person or entity by name or in such a way as to make him, her or it identifiable. I also advise that any opening statement made to the committee may be published on its website after the meeting.

Members are reminded of the long-standing parliamentary practice to the effect that they should not comment on, criticise or make charges against a person outside the Houses or an official, either by name or in such a way as to make him or her identifiable.

I invite Dr Scally to make some opening remarks.

Dr. Gabriel Scally

I thank the joint committee for having me back again. I am very pleased to be here to discuss my supplementary report which was published a couple of weeks ago. As the committee knows, when I started the scoping inquiry in May last year, there were six laboratories that we knew about. By the time I had finished and published my main report in September the number was 11. We had only uncovered some of them shortly before I published the report. As I was not convinced that we had got to the bottom of the matters to do with the additional laboratories, I suggested to the Minister that there be a supplementary report on them. That is what is before the committee. As committee members know, by the time I had finished my supplementary report the number of laboratories had risen to 16. As well as dealing with those issues, the report also deals with the accreditation systems.

We found out that there were two accreditation systems. Questions were raised about the comparability of those two systems, and rightly so. That is an issue we looked at and reported on in the supplementary report. At the heart of much of what the report deals with are the issues of procurement, contracting and how those were conducted and enforced, or not enforced and not operated. There is one final section, which is short, but which outlines how we deal with error and my concern that the system for dealing with clinical error is not fit for purpose. That is a brief summary of what is in the report. My colleagues and I are happy to take any questions.

We will try to keep it to one round of questions. We need to be conscious of the time because Dr. Scally has to leave at five o'clock.

I welcome Dr. Scally, Dr. Denton and Mr. McQuillan. I want to start by thanking the witnesses and acknowledging the work they have done. They were brought into the eye of a storm with a lot of political heat, but much more importantly, there were a lot of women all over the country who were very worried and scared about questions on the clinical quality of the testing that had been done, the labs that were being used and so forth. The expertise and hard work of the witnesses over the past year on several reports has gone a long way to addressing that, so I acknowledge that work and thank them for that.

In a few minutes I will get into some of the questions on these extra labs. Many of us were shocked, as I imagine the witnesses were, that we went from six labs to 11 labs to 16 labs. That raised serious questions around how this happened and if the labs were of sufficient quality and so forth. That was detailed in the report and I will move to that in a second but before I do that, I want to step back from the detail. There are still many women around the country whose confidence in this programme has been shaken. My understanding of the programme is that it has been highly effective in terms of clinical outcomes, with about a 7% reduction year on year in cervical cancer that can be linked back to the start of the programme. It was not happening anyway. There is a link there that presumably is a causal relationship. As an ancillary, there will be many other people looking at the other screening services and asking if bowel screening and breast screening are in good shape because these questions have been raised about CervicalCheck.

My understanding of Dr. Scally's first report is that at a clinical level, putting aside the real issues around governance that were uncovered, the programme as it ran and as it still runs to this day, is of the highest quality and the issues that have surfaced are issues of governance and non-disclosure, which are very real issues around a patient's right to know. Ultimately, however, at a clinical level, this has been and remains clinically sound at the top international levels and women in Ireland who are looking at CervicalCheck have every reason to have confidence in the clinical efficacy of the programme and its ability, imperfect as it is, to help to detect and treat cervical cancer and pre-cancer. That is my understanding but I would really like the witnesses' views. Is that still the view of the witnesses, having had many more months to look into the weeds even further?

Dr. Gabriel Scally

That is a good point and it is worthwhile to reinforce that it is a good programme and that is has produced real results. The potential for it produce outstanding results is great. That is ironic because it is almost as a result of the attention that has been paid to it in recent years. I know from talking to the women and the affected families that they want it to be an excellent programme and they are totally committed to it. At some of the meetings, it has been interesting to see that if there is criticism of the programme, it is not about the principle of the programme or the general operation of same, it is about the way this particular issue was handled.

On international comparability, CervicalCheck stands up well. We looked at the quality assurances around the other screening programmes during the main report but we did so on a very superficial level. As the Deputy will appreciate, we got into far more problematic areas in the cervical screening programme than I could have ever imagined so that is where our concentration was. We did not find majorly problematic areas in the other programmes.

I am pleased that some of the changes the HSE has put in place have not just been around the cervical screening programme, but across the whole management of the programmes. It has brought in people who I am convinced will improve the situation, improve the management and improve the coherence of it.

I ask Dr. Denton to comment on this because she has a considerable amount of international experience and this issue of comparability is something that she and I discussed recently.

Dr. Karin Denton

It compares well with cervical cancer prevention strategies that are operable in many other countries. When it comes down to it, it is an organised screening programme with a high uptake and with strong pathways to make sure women are followed throughout their lives so that it is not just a series of one-off tests. There are not so many countries that have an organised screening programme like that. It is starting off in a positive position and, as Dr. Scally said, the moves to improve the sensitivity of the test by moving towards HPV screening as a primary screening test are under way as I understand it. That will lead to further improvements in the international league tables. Ultimately, it compares well with what is available in many other European countries as well as more widely.

Dr. Gabriel Scally

I will add one more point. If there was one thing that would really improve the screening programme, it would be for the programme to reach out to all those women who have not come forward yet to be screened. That is where the big gain for the women of Ireland will be. If the programme could reach those women, convince them and really improve the screening rates, that would deliver enormous benefit.

There are three issues with this where there has been much focus over the past year, one being the issue of non-disclosure. Is it Dr. Scally's view that there is no clinical link between the cases of non-disclosure which have been identified and clinical outcomes for the women? Having had more time to look at it, is it Dr. Scally's view that, while the non-disclosure was unacceptable, that had there been a timely disclosure it would have affected the clinical outcome for the women involved?

Dr. Gabriel Scally

It would not have. These women were already in treatment for cervical cancer, which is why a look back was performed on their previous slides, and I cannot see any real reason there would have been an effect on the clinical outcome. The clinician who was treating them knew the results of the audit. The fact that they did not disclose that to the women should not have altered their treatment of them in the slightest.

Dr. Karin Denton

I agree.

I thank the witnesses for that because that got lost last year.

Dr. Gabriel Scally

There was a lot of misleading commentary around that issue at that time.

Of the areas looked at and on which the public focused, one was the issue of non-disclosure, which we have talked about. It should never have happened but it did not have a clinical impact. We have all become aware of the second area, namely, the imperfections of the test. Unfortunately, it is an imperfect test and we know that. The third area is the hopefully very small number of cases where there was negligence and where the misses were beyond the imperfections of the test.

Obviously, that is a matter for the tribunal and the courts to decide. In that light, Dr. Scally believes that the programme is and has been sound from a clinical perspective and women should have confidence in it.

Dr. Gabriel Scally

Absolutely. One area of non-disclosure about which I am greatly concerned is not its effect on treatment in the past, but rather its effect on the relationship between women and their clinicians after the women found out. The women felt betrayed. In some cases they were lied to. That damage to the patient-clinician relationship is deeply unhelpful, particularly when the woman does not really have a choice. That is where the problem is in terms of clinical services, which is why I have always advocated for an attempt at reconciliation between the clinician and the woman. I know women who have taken the matter into their own hands. I have spoken to their clinicians and made it a point specifically to discuss what happened and find the truth about the non-disclosures. That has greatly helped the clinical relationship in those cases. That is the area of clinical care about which I have a concern and I have expressed that concern.

Obviously, much of the focus of Dr. Scally and his team has been on the extra ten labs. My understanding of his conclusion is that although we all accept that, clearly, this should not have happened and represented a risk. Having looked into the risk Dr. Scally did not find evidence of poor practice and poor quality. Women have told me that is great and reassuring, but they have also pointed out that some of the labs have closed and asked about Dr. Scally's level of confidence regarding sufficient access to data relating to the closed labs. His investigation found no evidence of substandard quality. How close is that to being confident that there was no substandard quality? They are different tests.

Dr. Gabriel Scally

Of course, they are and the Deputy is correct to point out the difference. We are only able to make a judgment with the caveat that it is on the basis of the information we have. We encountered a great deal of difficulty, first, in finding out about the existence of laboratories and, second, in getting data for those laboratories, especially those which had closed. We must remember that for most of these labs we are talking about events that took place nine or ten years ago. As such, many staff members were not available to be interviewed. Nevertheless, members of our team visited the companies and many of the labs and went through the data for the labs for all of the Irish women's slides that were sent. There was no indication that any of the labs were particularly problematic. That said, we may learn more from the Royal College of Obstetricians and Gynaecologists about whether there is a statistically significant pattern. That is a judgment for later. Dr. Denton may wish to comment on the issue.

Dr. Karin Denton

The original report has several recommendations around the quality of data. We must remember that data on key quality issues for these labs was received, but it was aggregated into the whole return for each supplier or company. It is included, but it is merged with a much greater volume from the main sites. The same caveats apply to the analysis we were able to do on the data available across the board.

Before I bring in Deputy O'Reilly, an issue which is probably not covered in the report is that of the front-line staff delivering the service, including those taking smears, those in offices answering questions from women, and the staff in colposcopy clinics. They are under severe stress because of the anxiety the issue has raised. Obviously, many women are very uncertain and anxious about delayed tests and they may question the accuracy of the test results when they get them. There is probably more pressure on colposcopy clinics because there are more referrals as people are worried and anxious to ensure they do not miss anything. Do the witnesses have any view on how those staff can be supported? Many such staff have resigned and others have become ill from stress. It is a significant problem in trying to cope with the provision of the service.

Dr. Gabriel Scally

It is a problem. In addition, the greater emphasis on the outcomes for individual cytoscreeners places pressure on them in the labs. I am concerned about the staff, especially having met many of them in Limerick and CervicalCheck. They have done a fantastic job under very difficult circumstances and significant pressure. I understand that there are difficulties in this regard. I discuss them with the HSE regularly and I know the team understands that and is trying to take action to fill posts and create additional posts where needed. Some people were doing more than one job and had their jobs merged. There is also a need for better job definitions because there is nothing worse than people not knowing what their job is. In my main report, I identified that one of the major problems was that very few staff members had a current job description. I have discussed that with the HSE. The Chair's question is a good one and it should be addressed to the HSE. I will continue to discuss the matter with it. As the Chair is aware, the Minister has asked me to review the implementation of the recommendations. I will discuss these matters further with the HSE.

Dr. Scally may tell me this is not a fair question, but I would like to put it to him anyway. In a recent judgment, Mr. Justice Cross spoke about absolute confidence in the reading of smears and stated that if there is any doubt in the mind of the smear reader, it should not be deemed a normal smear. Does Dr. Scally have any comment on how that will be viewed? I am aware that the judgment is under appeal and I am not asking Dr. Scally to comment on the case. How does the term "absolute confidence" fit into-----

Dr. Gabriel Scally

I do not wish to comment on the judgment which, as the Chair stated, is under appeal. In the supplementary report, I pointed out the difference between screening programmes and normal healthcare. Screening programmes are done on a mass basis and are reliant on the quality of the tests and those who read them when there is a visual element. They are also reliant on the cost-benefit aspect. A very good example is the decision of the United States to shift its guidelines from having annual tests to having three yearly or five yearly tests. It did so on the basis that if it tested too often, such as annually, more women would be identified with problems which, over time, would resolve by themselves. Those women would undergo unnecessary treatment. The side effects of some of that treatment, such as premature labour and miscarriage, may outweigh any potential benefit from a problem being picked up on in the test. There is a balance to be struck, although that does not enter into a judgment in an individual case in which an issue that ought to have been identified was not.

The overall balance of a screening programme is different from the balance of any one case.

I refer to the question of the absolute certainty of someone carrying out a screening test. I have been a doctor for a long time and have been involved in many problems in medical care, and I worry whenever I come across doctors who are absolutely certain they are right. I would rather see doctors with a degree of scepticism, who are rethinking their judgments all the time, triangulating them, and making sure they are right. I have no doubt that will all play out in the Supreme Court and I wish them luck with that.

I thank Dr. Scally. I call Deputy O'Reilly.

I thank the witnesses for coming in this afternoon and for always making themselves available to answer questions. It is very welcome. The witnesses have said that CervicalCheck is a decent programme for an organised screening programme. That is true. I am more than happy to say that I am a beneficiary of that programme in more ways than one and am grateful for it in many respects. When this issue first came to light, many disrespectful comments were directed at the women who use the service, implying that we did not understand that it was a screening service or that we thought it was diagnostic. We did not think that, because most of us speak to our doctors. We are adults, otherwise we would not be having the test in the first place. The problems lay in the withholding of information, which is a fundamental aspect of this report.

It strikes me that Dr. Scally's job in chasing down where the issues were would have been much easier if those laboratories had been based here in Ireland. The decision to outsource the testing was political rather than clinical, according to the Academy of Clinical Science and Laboratory Medicine, which never advised it. In fact, the opposite is true, in that it sought a small amount of investment from the Government at the time to upskill labs and make them fit for purpose in order that we could continue to test here. That is not to say that the same issues regarding withholding information would not have occurred here. That may have still been an issue but we would have had the capacity to cite the laboratories and find out exactly where the tests were. Many women were concerned when they found out first that there was outsourcing, which was bad enough, but that the tests were then re-outsourced and in some instances even re-outsourced again. That is worrying. I refer to page 36 of Dr. Scally's supplementary report, which states:

The NCSS specifically stated that they would ‘not be supportive of this aspect of the plan ’, but when issuing a new request for tender later in the same year, the NCSS reduced the focus on capacity by almost eliminating it from the scoring despite these issues having occurred.

The report also shows that quality assurance declined from a 25% weighting in 2008 to a 15% weighting by 2012. That is screening on the cheap, to use layman's terms. It reduces the emphasis on quality and capacity and increases the emphasis on price. CervicalCheck was chasing down costs and was not keeping a close eye on quality. My understanding is that site visits for quality assurance purposes were not conducted. That is clear, because if they had been conducted we would have known where the sites were. I asked Dr. Scally about this when we met previously, but I am interested in why price reductions were pursued instead of quality and capacity. The outsourcing of the tests occurred because we were told there was a capacity issue at the time. That could have been dealt with here in this State but was not, and was then outsourced for that reason. Are the witnesses confident that, when the television cameras are shut off, a heavier emphasis on quality will now prevail, in order to ensure this does not happen again? Could they also offer a view as to who was driving the agenda?

Dr. Gabriel Scally

Perhaps Mr. McQuillan would like to come in on this at some point. The situation is slightly worse than it would appear on the bald reading of the figures. Some things would have changed regardless, because certain factors were altered during subsequent tenders so that instead of giving a weighting, they became pass or fail issues. One would then expect the factors that were left to have an increased percentage rather than staying still or decreasing. The Deputy is quite right on that. We did not come across any reason in the documentation for why those factors were subject to such substantial reductions in weighting. One can only assume that price became a much more important factor in the process and CervicalCheck was seeking to stimulate as much competition as possible and to drive down the price. I cannot see how there could be any other explanation for it.

Mr. Shane McQuillan

It was stated in the final report from September of last year that much of the original procurement process documentation, from ten or more years ago, was incomplete. Much of it was missing and we could not get many of the documents regarding the procurement issues at the time. We do not know when the criteria were set as they were, but it is surprising that a qualitative criterion of 40% would be reduced to 15%. That suggests the service was seen more as a commodity than as something driven by quality. It is surprising that it was at such a low level.

As Dr. Scally mentioned earlier, we have been engaging recently with the HSE to look at the implementation of the recommendations from September of last year. We believe there is now a much greater focus within the HSE on the qualitative aspects of the tests, both in the arrangements it is currently entering into with laboratories and in the inspections and detailed work it is undertaking to visit sites and examine the arrangements in place. It is fair to say that the HSE has learned its lessons. As to why things happened ten years ago, much of that insight has been lost in the absence of documentation.

It is regrettable that that documentation is not available. Dr. Denton referred to how well the screening programme compares with other programmes of a similar nature. However, those programmes may have more of an emphasis on quality. Am I right in saying that the things that work well in the programme are administrative details, such as the fact that every woman between 18 and 65 is included, and are written to and followed up with, rather than the practice? If we are comparing with other jurisdictions, I would like us to fare well in comparison with jurisdictions which emphasise quality. I say this as someone with a material interest in this screening programme. We can tick the box of the administrative stuff, in that women get their letters, their results, their follow-ups, and their next letters, and it is not easy for someone to slip through the system. If someone moves house and misses their letter, there is even an advertisement on the radio to remind them. It is well organised in that way. However, to compare favourably with other jurisdictions we should be doing well, not just on the administrative side, which we clearly are, but also in driving quality and capacity upfront, rather than focusing on price all the time.

Dr. Karin Denton

Yes. I would agree with that.

Dr. Gabriel Scally

Recommendation No. 22 in the main report, which is referred to, reads: "CervicalCheck should ensure that its procurement approach maintains a balanced focus on qualitative factors, supplier experience, and innovation, alongside cost considerations." Having been asked to overview the implementation, we will be looking at that. The Deputy is quite right, and this issue has been picked up on and mentioned to me by many women.

It is one of the natural consequences of outsourcing. Once one goes down that road, one is constantly chasing the price rather than other matters. When something is outsourced, one's capacity to oversee quality assurance is also outsourced to a certain extent. We see a very hands-off approach to quality assurance. I do not mean this disrespectfully but this retrospective accreditation presents a very big difficulty for me. Women have raised this issue with me. They have asked how something could be retrospectively accredited when it no longer exists. That is a serious difficulty. That sort of issue is a natural consequence of outsourcing.

Is it expected that the Royal College of Obstetricians and Gynaecologists, RCOG, review will include a breakdown on a laboratory-by-laboratory basis so that any cluster errors - I am not very technically minded but I believe that is the term used - which exist will be identified?

Dr. Gabriel Scally

I cannot speak for the review. As the Deputy knows, it was set up entirely and absolutely separately from us. I do not know whether Dr. Denton would like to say anything about it, but I do not know what its reporting mechanism will be or how it will structure its report.

The information to which Dr. Scally had access did not include a laboratory-by-laboratory breakdown.

Dr. Gabriel Scally

It did not.

Is such a breakdown available or did Dr. Scally just not feel it was necessary?

Dr. Gabriel Scally

We had real difficulty in even finding out the number of Irish women's slides that had been sent to some particular laboratories. Eventually we had to get some of the data via the laboratories' internal billing systems rather than their clinical systems. The chances of getting a broad range of clinical data linked to individual laboratories are low. It will be interesting to see how much information the RCOG has obtained.

On that basis, we may never know if there were cluster errors. As it comes out in the end, on balance it would not be possible-----

Dr. Gabriel Scally

It would be wrong of me to comment in advance of seeing the data.

Unfortunately, I have to vacate the Chair. This may be an opportune time for Dr. O'Reilly - I apologise, I mean Deputy O'Reilly - to take it.

I am getting a big promotion. That is excellent.

Deputy Louise O'Reilly took the Chair.

I call on Deputy Kelly.

I thank Dr. O'Reilly.

The doctor will see you now.

I thank the witnesses for coming in. I am sure they have been looking forward to today. I have many questions. I will not get through them all today; it is impossible in the timeframe. I have spent hours, days and weeks in discussions with patient advocates. The questions I have lined up are theirs. They have asked me to ask these questions. I will not get through them all today so I will write to Dr. Scally with many others. I am glad he is staying on to work with the Department so that he will be able to answer them. I have many issues to raise and questions to ask about gaps in the report. I have done a full chronology of what happened and how it happened since the last report was released and I am concerned about certain issues. I will ask about a few of them now and I will write to Dr. Scally regarding the rest.

Having regard to the patient advocates' questions, I have the terms of reference of the review to hand. At any point, was Dr. Scally of the view that it was not his role to investigate quality assurance in the laboratories?

Dr. Gabriel Scally

Was I of the view that it was not my assurance to investigate-----

Was Dr. Scally of the view that it was not his role?

Dr. Gabriel Scally

Was I of the view that it was not my role to investigate quality assurance in the laboratories?

It was part of the terms of reference. That is the only reason I ask.

Dr. Gabriel Scally

Yes. We did look at quality assurance in the laboratories. We looked at issues of laboratory accreditation in particular.

Accreditation and quality assurance are two different things.

Dr. Gabriel Scally

We looked at the quality assurance processes being applied to the laboratories by the HSE. On each of the laboratory visits that took place, the data regarding its quality performance were looked at. Yes, I think one could say that-----

Dr. Scally never communicated that quality assurance was not part of his role to any of the patient representatives.

Dr. Gabriel Scally

I cannot imagine that I did so.

I just want to be clear on that. Quality assurance and accreditation are two very distinct parts of the terms of reference. I have asked Dr. Scally the following question before and I have received a letter in response. The Minister read it out in the Dáil on Tuesday. I did not know he had been sent it because, according to my copy of it, it had not been cc'd to him. I still do not understand the situation, despite what Dr. Scally said in the letter. On what date did he find out that the lab in Manchester was not accredited?

Dr. Gabriel Scally

I can understand why the Deputy is not satisfied with the answer to that because there is no answer. This was an iterative process. When I found out about the Salford lab, I was very surprised.

How did Dr. Scally find out about it?

Dr. Gabriel Scally

We were told about it by the HSE in October. I believe I covered this in the report. It had been revealed to the HSE-----

Dr. Scally visited it in January.

Dr. Gabriel Scally

We visited it in January. I looked at the issue of accreditation, as we did with all labs. I looked at the accreditation schedule on the Irish National Accreditation Board, INAB, website and noted that only there was only one address on that schedule of accreditation.

The HSE did not tell Dr. Scally about the lack of accreditation, he found out himself.

Dr. Gabriel Scally

If the Deputy will let me continue, there was only one address, which was the Dublin address and not the Salford address. I asked about accreditation and was repeatedly assured by MedLab. Its position was, and remains, that the laboratory in question was accredited by the accreditation board, INAB. I explored that with INAB and it was quite clear in its view. It wrote to me on the subject and I quoted its response in the report.

I have read the report. Dr. Scally does not need to repeat it.

Dr. Gabriel Scally

It said that MedLab's past and current accreditation extends to all accredited activity undertaken by MedLab employees included within the scope of the accreditation assessment, including the cytology work carried out in Manchester. It says this covered all current and past activity. MedLab believes it is accredited, as does INAB. In the report I express my incredulity that INAB did not know of this laboratory and yet feels comfortable in saying that it was always accredited. That is the position.

I am not being rude but my time is restricted. I still do not understand how there is not one date on which Dr. Scally personally found out, by being told by someone or from his own research, that the laboratory was not accredited. To be honest, it just does not make sense. There has to be a date on which he found out it was not accredited. I want to confirm this. He did not find out from the HSE but through checking the website and the process he has outlined in my letter, which he also sent to the Minister. It is an issue that there is no single date on which he found out. The other thing is that Dr. Scally visited the laboratory in January and accepted what he was told. This turned out to be wrong, as he said in his report. It turned out that the laboratory was not accredited. That is a real issue for many of us but Dr. Scally accepted it. The concern is that, if he accepted that in this scenario and subsequently found out it was not the case, there may be other instances in which he accepted that a laboratory was accredited because the company told him so.

Dr. Gabriel Scally

I think we are at cross-purposes. According to the Irish National Accreditation Board, INAB, the laboratory in Salford is and always has been accredited. I cannot find out that it was not accredited and INAB tells me that it was always accredited. I have difficulty with the fact that INAB is prepared to make that statement when it did not even know of the laboratory's existence. That is my key issue.

Deputy Kelly asked a very specific question about when Dr. Scally became aware. Will he address that?

Dr. Gabriel Scally

I became worried about the issue when I went to check the schedule of accreditation and only found one address on it. I do not know how much that means. That second address has now been added. It was added at the end of May this year. The Salford address is now on the schedule of accreditation but it was only added-----

The Vice Chairman has been very helpful. Dr. Scally said it should have been listed on the schedule of accreditation. Instead of asking when Dr. Scally found out that it did not have accreditation, when did he find out that it should have been on the schedule and that it was not? There has to be a date for everything.

Dr. Gabriel Scally

I am not sure when the date was.

I asked Dr. Scally the same question when the report came out.

Dr. Gabriel Scally

Yes. It was an iterative process where I went through and looked for the schedule of accreditation. I also looked at INAB's capacity to accredit a place that was not in this jurisdiction, which is another issue. I eventually found, by reading its documentation, that it had a system whereby if a company was an Irish company and had a small satellite operation in another jurisdiction, INAB could accredit it. I examined the complicated arena of how INAB accredits laboratories on a series of dates.

It is not credible to me that there is not a date. There has to be a date.

Dr. Gabriel Scally

I am terribly sorry that I cannot give a precise date.

Dr. Scally might reflect on it. When it came to quality assurance and accreditation, we understand that he would have investigated the laboratories, unlike the case when he went to MedLab in January, took its word and subsequently went through the process that he outlined, which is confusing to the public. I am concerned about the chronology of what happened. I believe what the Minister said to me in a parliamentary question on 12 February was accurate, as was what the Secretary General said on 13 February about the report being ready. Dr. Scally had a meeting on 14 February and he has given a letter to us from 15 February. We now know what happened in Manchester in January and the process in which he subsequently had to find out that there were issues with accreditation even though Dr. Scally had to take MedLab's word for it previously. The women of Ireland and patient representatives really want to know if there was a thorough investigation by the team of all the laboratories rather than taking the word of the laboratories. How many of the 16 laboratories that we now know of, since the number has, incredibly, risen from six to 11 to 16, did Dr. Scally and his team physically visit?

Dr. Gabriel Scally

On the INAB question, it was entirely the opposite of what the Deputy said. I did not take the word of MedLab that the laboratory was accredited, which is why I checked the schedule. When I found that it was not on the schedule, I started to ask questions about that. I did not take the word of MedLab and would not do that.

Dr. Scally said to me that he did.

Dr. Gabriel Scally

It gave me an assurance that it was accredited but, as is fairly obvious, I did not take its word.

The HSE did not inform Dr. Scally that the laboratory was not accredited.

Dr. Gabriel Scally

I do not believe the HSE ever mentioned accreditation to me. Mr. McQuillan might address the number of laboratories that the team visited personally.

Mr. Shane McQuillan

We visited nine.

The witnesses might provide a schedule of dates.

Mr. Shane McQuillan

We can do so.

I have asked the Department a number of times but I do not think it wanted to provide it until the witnesses were finished here today.

Dr. Gabriel Scally

Some of the laboratories that provided a service for CervicalCheck no longer exist.

Seven of the 16 laboratories were not visited.

Dr. Gabriel Scally

That is correct. They either no longer exist or-----

I said earlier that, for purposes of quality assurance, the women wanted them to be investigated. Is it correct that that was not possible with seven of them?

Mr. Shane McQuillan

We did not visit seven of them. Some do not exist anymore. Two had very small volumes of activity. One was in Hawaii. We felt that it was probably not conducive to doing the project efficiently to visit that laboratory.

There were 16 laboratories and the witnesses have provided us with a schedule. Seven were not visited so they could not have been thoroughly investigated. Quality assurance and accreditation are two totally different things. Quality assurance needs investigation.

Dr. Gabriel Scally

Indeed it does. As we addressed earlier, the data for the companies were examined, including the data from all those laboratories. It was physically impossible for us to visit laboratories that no longer existed.

I accept that but some still exist.

Dr. Gabriel Scally

I am sure that Deputy Kelly will understand that the number of slides sent to some of the laboratories was so small that even if we looked at data relating to those slides, we would have found nothing statistically significant in the numbers.

The schedule will show all of that, to be fair to Dr. Scally. My last question relates to INAB. I believe that the committee should bring in INAB and the relevant people from the HSE at some point to fill in the jigsaw. It is under the Department of Business, Enterprise and Innovation, but that should not be an issue. All of us, including committee members and the witnesses, have an issue with retrospective accreditation, especially where there is no baseline. INAB could not have accredited it because it did not know it existed.

Dr. Gabriel Scally

That is absolutely correct.

When the witnesses visited in January, MedLab said it was accredited. Subsequently, through what was explained earlier, which I will digest, we found out that it was not accredited. Who told INAB that it was not accredited? The accreditation for the Sandyford laboratory is dated to 23 October 2018. INAB visited it on 17 April. Its subsequent accreditation, which is for Sandyford and Salford, is dated 30 May. Dr. Scally's report came out subsequent to that. I want to fill in the gap between the witnesses' visit in January and INAB's visit on 17 April. Who told INAB? Someone had to tell it because INAB did not know that the Sandyford laboratory existed.

Dr. Gabriel Scally

Someone told INAB of the laboratory's existence.

Who told it that it did not exist and did not have accreditation?

Dr. Gabriel Scally

I told INAB of its existence. There is a difference of opinion here. MedLab argues that INAB knew about its existence. If one looks at the chronology, which begins on 1 February 2016, the first communication which is mentioned between INAB and MedLab was in October of that year, in a chain of emails. It was mentioned by the by and was not the main purpose of the email.

INAB is in receipt of documentation for accreditation visits to Sandyford, which, in passing, mentioned the existence of Manchester, but in obscure detail. I do not regard that as adequate notification to INAB from MedLab.

Did Dr. Scally ask INAB to visit any-----

I call Deputy Durkan. We must move on.

I just want to ask-----

Time permitting, I will allow Deputy Kelly back in later.

I want an answer to my question. Did Dr. Scally ask INAB to visit any-----

Dr. Gabriel Scally

No, I did not.

We do not know who did.

I call Deputy Durkan.

I thank Dr. Scally and his colleagues for being here today. On the laboratories that are no longer in existence, do we know in what circumstances they became obsolete?

Dr. Gabriel Scally

Yes.

Mr. Shane McQuillan

With regard to Clinical Pathology Laboratories, CPL, in the United States, which is part of the Sonic Healthcare group, it had a laboratory in Orlando which closed a couple of years ago. It was one of the laboratories that had been involved in CervicalCheck work in 2010-2012.

Why did it close? Was there a particular reason for its closure? Were there complaints or was there an investigation? A laboratory does not usually close voluntarily when it has work to do.

Mr. Shane McQuillan

Our understanding is that it closed for commercial reasons within Sonic. We were not provided with the details as to why that had been the case. It was reported in the medical press in the US that it was closing for commercial reasons.

Would it not have been a good idea to probe why a laboratory that was providing a service decided suddenly to close? For example, did it close because there was something happening that it was worried about, because of complaints made or because management was not in accordance with the highest possible standards?

Dr. Karin Denton

We learned from a number of laboratories that it was for reasons not like that. Very often, they were small with a small number of members of staff who retired or left for natural reasons. In one case, a senior member of staff died. They were largely, but not entirely, small laboratories that wound down through natural staff turnover. The San Antonio laboratory is different in that it was established, we were told, to cope with the additional capacity for this particular contract. Once the contract was no longer being provided by CPL, the San Antonio laboratory was closed. There were a variety of reasons but as far as I recall, we were never told or shown any evidence, or found any evidence, that any of these laboratories had been closed because of complaints or the adverse findings at the time.

Dr. Gabriel Scally

This issue of very small laboratories troubles me. That is why I was essentially troubled about Salford? It is not a good thing for professionals not to be working in a team. Dr. Denton and I, in our previous roles responsible for screening in the regional south-west of England, put a lot of time into closing laboratories and stopping them doing screening work because small labs are bad news.

Insofar as Dr. Scally has been able to ascertain, there was no reason other than natural causes for the closure of these laboratories and there was no attempt to withhold evidence or information in regard to their closure.

Dr. Gabriel Scally

Not that we came across.

It was mentioned that the mechanism for dealing with errors in the system was not fit for purpose. Does Dr. Scally believe that the system is sufficiently updated now to deal with errors and to do so effectively?

Dr. Gabriel Scally

My comment was about what happens when things go wrong. I recall that on the day I was appointed I made the point that when things go wrong people generally want three things: they want to know the truth about what went on; they want to know that it will not happen to anyone else; and they would really like someone who was responsible and involved to say sorry to them. All of the evidence shows that achieving those three things can resolve a huge number of the concerns of the patients involved. My experience in dealing with the CervicalCheck problem is that people are often resorting to legal action because they cannot get any answers any other way. I think that is a terrible pity. It should not be like that. I am not convinced that, having gone through a legal action, it necessarily gets a person to the truth either because judges are in a very difficult position in that they can only make a judgment on the basis of the evidence that is placed before them. They cannot have an investigatory element to their work and so they have to decide a case for or against. I do not think this necessarily brings closure for people. I know from talking to the women and the relatives that they are interested in knowing what went wrong and why it went wrong, and they would really like someone to say sorry, particularly to the women who were so badly treated in the open disclosure. They would like an apology, not in a letter from someone they have never heard of high up in the organisation but from the people who did not treat them properly. I think those are all reasonable things. Our current system does not, it seems to me, provide an opportunity for that sort of process to happen.

Dr. Gabriel Scally

Yes, it is still true. It is a matter that requires to be reflected upon and thought about over a period in order to shift the position. I mentioned the move towards a no-fault compensation scheme. That would be, undoubtedly, an assistance but it still does not address the basic fundamental human need for an apology, for the truth to be told and so on. It needs to be developed, preferably with patient advocates and patient safety advocates. I think a system could be developed. For the reasons I have laid out, screening services are the right place for that to be taken forward.

Does Dr. Scally believe that a debate or dialogue between the clinicians and, perhaps, legal advisers and patient advocates needs to take place now to bring about an ongoing improvement in the system?

Dr. Gabriel Scally

I do.

Is Dr. Scally saying it needs to be done as a matter of urgency?

Dr. Gabriel Scally

I would rather it was done well. It requires reflection. I am hopeful that when I finish my work on the inquiry I will be able to put some time and effort into working with legal and medical professionals and patient advocates to start a dialogue on how we can address these issues.

Dr. Scally will, I am sure, hope to make recommendations to that effect?

Dr. Gabriel Scally

I am not leaving the field.

It has come to my attention that one of the gaps in the system is the consistency of the evaluation process and dealing with errors. Unforeseen gaps in the system can occur from time to time even in the best run organisations, which can lead to errors. In various businesses, there are errors that cannot be avoided and there are enforced errors, which should not be happening. Would Dr. Scally differentiate between the existence of either or both in terms of delivering a quality service such that the women who seek to avail of it can have full confidence in it?

Dr. Gabriel Scally

A wide range of errors can occur and we have seen many errors in that range occur, as illustrated in the CervicalCheck problems, from poor staffing to the wrong skill mix of staff, for example, in the construction of the screening programmes.

There were real failures of audit in the construction of what was a flawed audit. There were failures in the transmission of key information between the HSE and National Cancer Registry Ireland in data about the occurrence of cancers. There were many errors.

The way to address it is from a patient safety perspective, and I look forward to the changes that are happening around giving higher priority to patients' safety. That is the way to tackle it, and one of the best ways to do so is by encouraging patient advocates, promoting patient advocacy and involving patient advocates in all of the systems.

Is Dr. Scally satisfied, within reason, that those issues can be addressed to improve the quality and reliability of the service?

Dr. Gabriel Scally

Is the Deputy referring to the screening service?

Dr. Gabriel Scally

Those issues are being addressed. As far as we have gone in reviewing the implementation of our recommendations, there is definite progress being made. There is more to be done and it will take time, but I must pay tribute to some of the people in the HSE who have taken on that work and have done a good job. The HSE has made some good appointments. There is more to be done and I will return to that now that we have finished this supplementary report and the inquiring part. We will now be looking at implementing the recommendations and will come back to the Minister with a report on that implementation.

The Chairman will be glad to know I will come to a conclusion shortly. Dr. Scally mentioned that non-disclosure should not have happened.

Dr. Gabriel Scally

Yes.

However, the fact of it did not necessarily have an impact on the welfare and well-being of the patients.

Dr. Gabriel Scally

It is more nuanced than that. The non-disclosure had a very big impact when it was learnt of.

Does Dr. Scally mean that in terms of confidence?

Dr. Gabriel Scally

I absolutely do. The thing that illustrated that for me, and I recounted or at least touched on it in my first report, was at one of the early meetings with the women and their relatives. Two young women came in and sat beside each other and discovered they knew each other. They were from the same area. They were both talking about how the non-disclosure had affected them and they had lost confidence in their clinician. They were both, independently, thinking of shifting to the other woman's clinician. They told that story and it was the only humorous part of that entire meeting. Those women found it humorous but it was also tragic because they had lost confidence in their clinicians. If one has a serious illness, like cervical cancer, one really wants to have confidence in one's clinician more than anything else. The non-disclosure had a devastating effect on many women.

Does Dr. Scally think that the non-disclosure and the lack of confidence arising from it can be and is likely to be addressed? Does he also think the clinicians and all those involved, laboratories and others, have had the need impressed on them to be sufficiently frank with their patients and disclose the information to the patients as and when it is available?

Dr. Gabriel Scally

Yes.

As opposed to concealing information from patients.

Dr. Gabriel Scally

We are on a journey here. The HSE has produced a new open disclosure policy which is an improvement on the previous policy. It remains to be seen how that will be implemented and how many resources the HSE will put into the training process. One criticism in my main report was that the HSE put very few resources into implementing its previous policy. I am encouraged by the discussions that have taken place between some of the patient advocates involved with the 221 women affected and some of the leaders of the medical profession at the highest level. Those discussions have been fruitful and have had an effect on the thinking at the top of the profession. We are at the beginning of a long process but I am optimistic that progress will be made.

Would a code of conduct be of any assistance? One would have expected one to be in place.

Dr. Gabriel Scally

I am a great believer in codes of conduct. I was on the General Medical Council in the UK for ten years and we introduced quite a rigorous code at that time. In my first report, I was not particularly happy with some of the content of the Irish Medical Council's code, especially its use of the word "should" rather than "must". I do not think open disclosure is an optional extra. It must be at the core of everything the professionals do. I hope someone at some stage in the next year or two reviews all of the codes of conduct for all health professionals to see what is in there and ensure that expectations of all our health professionals include that they are open, frank and honest with patients. That includes the ability of health professionals to say they do not know something or are uncertain. That sort of honest dialogue is crucial.

Adherence to a code of conduct would actually protect the clinicians, the institutions and confidence in the system.

Dr. Gabriel Scally

Indeed it would.

Before I come to Deputy O'Connell, I want to ask about the laboratories that were closed. Our guests expressed a view about whether there had or had not been any adverse incidents. Was that a result of an investigation or was it an impression?

Dr. Gabriel Scally

Dr. Denton will address that.

Dr. Karin Denton

It is difficult because many of the former provider laboratories have not provided for many years. Many of them had only done it for a short period of time in 2008, 2009 and 2010. There was a limit to the amount of information we could get but we were never told of any laboratory that had closed due to an adverse incident. I cannot recall but I think we asked specifically about that.

I thank our guests for their work. We all have different roles here so I apologise in advance. I want to focus on the guy in the laboratory in Salford or Manchester first. My concern is that I have never heard of retrospective accreditation. To my mind, accreditation is the competence to do a test, and it is a bit late to get it when the test has already been done.

I read the report when it came out and read it again last night. How could Dr. Scally assume that a lack of accreditation had no impact? I hope I am wrong but my argument would be the following. There is a test with an accuracy rate of 70% and someone in a laboratory is getting a certain number of slides which then go into the mix with the rest of the medical laboratory slides. I know, from our most recent meeting, that it says on the slide which laboratory it was tested in. I imagine that is how our guests found out although perhaps it is not. Those slides are then thrown in with all the other slides and all the different cohorts of patients as we have discussed over the past year. I am trying to be as helpful as possible, but if the man from that laboratory in Salford had just left those slides in the boot of his car and, when the deadline to return them arrived, brought them in, signed his name on them and never tested them, it would make no material difference to the end figures because he was doing so few of them. That man's baseline, or that of his laboratory, was never tested. How can our guests definitively say it had no impact? I believe he could have left all the slides in the boot of the car.

Dr. Gabriel Scally

Dr. Denton will be able to answer that.

Dr. Karin Denton

CervicalCheck diligently collected individual screener data.

Dr. Karin Denton

CervicalCheck.

Dr. Karin Denton

It had a standard return form called Cyto1 which listed each individual screener in a coded, anonymised way.

This listed each individual screener in a coded, anonymised way.

In America, Salford, Sandyford, everywhere.

Dr. Karin Denton

Yes.

Dr. Karin Denton

Yes. That was one piece of information that was collected. Had there been a screener who did what the Deputy suggests, I believe it would have been detected.

Dr. Karin Denton

The system that was in place should have detected that.

I do not think we ever heard about a list of screeners before in here. I do not ever remember hearing that.

Dr. Karin Denton

It is in the original report.

All the screeners in all the labs - Mr. X, his sensitivity rate - that is all documented.

Dr. Karin Denton

Yes.

Dr. Gabriel Scally

They would be given a number. It would not be with names. In respect of Salford, MedLab operated that really as a satellite so the IT systems and everything were identical. That screener was a numbered screener within the returns from MedLab Dublin. Those returns have been looked at.

Dr. Karin Denton

Correct.

He was looked at as an individual. We know his competency level.

Dr. Gabriel Scally

At an individual level, yes.

We know the competency rate.

Dr. Gabriel Scally

We know there is no identifiable problem.

Okay, this is reassuring. If there is a range of 70% sensitivity but in some cases it is 85% or 90%, if he was at the lower end, and if the patient cohort was young and unlikely to have cervical cancer, it could technically be an outlier.

Dr. Gabriel Scally

There are a number of checks. Each slide is examined twice.

In Salford, but not in America.

Dr. Gabriel Scally

In America as well, yes. Could I just correct that?

I want to get to that, too. I do not want to spend too long because I have limited time.

Dr. Gabriel Scally

Very quickly, the standard process in the States for American women has been that the slide is screened once. For the Irish slides, part of the contract was that they were screened twice by two separate screeners.

Do we know that the same standard applied when they sent them off to the secret labs? When they subcontracted out to the lab down the road, did they apply the Irish standard or the American standard?

Dr. Gabriel Scally

We have seen the data for the number of first screens carried out in each lab and secondary screens carried out in each lab, which clearly indicate that they were seen twice. There are two checks, the individual check and the concordance between the two, and one would note a difference in the results from the two.

In 2009 a big document was produced by a group on standards for quality assurance. I have it here. It is 320 pages. I had a little look at it last night. The same document on eTenders changed subsequently. The 2009 document is very comprehensive and a very comprehensive group of people fed into it, chaired by Dr. Gráinne Flannelly. It refers to ISO accreditation; I know we have been around the block on this and Dr. Scally has addressed it in his report but I am still not happy. I am just really uncomfortable with it. The 2009 document says the lab has to be ISO accredited. In the 2012 iteration, it says "ISO or equivalent". Did Dr. Scally find out anything about who made that decision and diminished the standard? Who is responsible for that action?

Dr. Gabriel Scally

I do not believe we saw on any documentation who was responsible at the time.

I am kind of suspicious of it. Dr. Scally knows how I feel about it and I have read his document a few times. At the end of the day, ISO is international, proper accreditation. In his report, Dr. Scally has basically said it is six of one, half a dozen of this other.

Dr. Gabriel Scally

Yes.

The fact remains that when we went out, we said we wanted ISO. The contract happened. In the contract, it says we want ISO. The contracts were signed. They were not ISO, they were College of American Pathology, CAP. I thought perhaps the labs were in breach of contract. I think I read that somewhere along the way. But really if whoever was in charge at the time was fool enough to sign a contract with the wrong standard, it is their fault, not the company's fault. Then for some bizarre reason in 2012, in the document on eTender, it changed to "equivalent". I am suspicious as to who did that. Did someone cop on somewhere along the way that it was different? Was this emerging slowly over time? I am just suspicious of how that changed. Did Dr. Scally get to the bottom of it?

Dr. Gabriel Scally

I do not know who was responsible for the change. In fact, either way it was wrong. When they specified ISO, as the Deputy correctly said, a lot of the labs did not have ISO, they had a different system. We could not find any correspondence about any challenge of that at all. Even though they inserted "or equivalent" we saw no correspondence that would indicate that anyone had ever asked the HSE to judge the CAP as equivalent. That, along with other aspects of the contract, was never actually implemented properly. The contracts were not properly implemented or placed.

It was done from the start. That is how I see it now. I want to address the position of the Irish National Accreditation Board, INAB, in all this. INAB is the accrediting group; it has a very serious role and is aligned with its international counterparts. Would Dr. Scally be concerned about the retrospective accreditation issue as somebody who, I am sure, is all about standards? Following on from Deputy Kelly's questioning about how we could have ended up where the lab was never visited, there are limitations in INAB's role outside the jurisdiction - it ticks so many boxes that are wrong. I am really concerned. That is why we have to bring INAB into the committee. If we are seen to have a lab accreditation body not accrediting labs, doing so retrospectively or messing about, it is very serious. The Vice Chairman is nodding; I will have to be cut off or I would stay here for the evening.

I looked at this last night. I had never gone onto eTenders before. They publish the questions that other companies ask. Labs apply for tender and they are not actually accredited and they are told. They can see the answer from before that it is not good enough. It is all there already. There was a guy doing veterinary lab work in Ireland who was trying to do some State work. It is very clear in the history of the correspondence that it takes about a year to get INAB accreditation. It is a long process. It is not a case of the lab in Sandyford ringing up and asking if it is good to go and being told yes. It is not like that. There is almost an impression out of this that it is a box-ticking exercise. Getting a lab accredited is really serious. We have to bring them in here to find out what the hell they were at and who thought it was okay. Did someone ask them to retrospectively accredit their lab? Why would they do so? Why would anyone ever expose themselves like that for a private company? To me, it is really concerning.

Dr. Gabriel Scally

Absolutely, Deputy, I share that.

We have unanimity on that one.

Dr. Gabriel Scally

We have, and the important thing is not the date of who knew what around anything-----

It does not matter about that.

Dr. Gabriel Scally

We have been basing a lot of our work on the fact that the accreditation system is in operation. We are really concerned to check that places are accredited and we need an accreditation system that everyone can rely on. I had expected another outcome to this, to tell the truth. I had expected that INAB would tell me it had never heard of this lab and never visited it and that of course it was not accredited. That is not the answer I got back, which is why I said it was straining credibility. I absolutely share the Deputy's concern.

As legislators, we are really concerned about this. INAB is getting State funding. Its job is to accredit laboratories. It is retrospectively stating "That's grand lads, keep going". It is a matter of concern that this is really what is happening. We cannot have it because our international standing is really important. Deputy O'Reilly referred to the weighting. When was the weighting changed from money being more important than quality? Was it 2012?

Mr. Shane McQuillan

There were three iterations of the contract. There is a tabular representation of this on page 34. The three contracts-----

The weighting in question started at 15% in 2012. Did the change in weighting happen gradually over a period or did it happen in 2012?

Mr. Shane McQuillan

The dates in the table on page 34 are those on which the tender processes were operated. The table sets out the percentage weightings that applied in the tender exercises.

The weighting applied to quality assurance changed from 18% to 15%. There was a good drop in 2010.

Mr. Shane McQuillan

The critical one that would denote concern in our minds is the doubling of the fee weighting between 2008 and 2012.

Yes. The cost became more important.

Mr. Shane McQuillan

It increased to a point at which it outweighed every other-----

I would argue that such a decision was definitely not made by someone with a clinical background.

Mr. Shane McQuillan

It was mentioned earlier that it is difficult to try to find out why the decision to change the percentages was reached because the documentation no longer exists.

Having read various transcripts last night, I am aware that the committee has spent a lot of time on quality assurance, QA. Our guests were not involved at a meeting of the Committee of Public Accounts at which we were assured that QA visits were taking place. A pathologist went over at one stage. I read through the relevant transcript last night. There were random visits. Did the inquiry team get anywhere? Did it find out how many QA visits were made? Obviously, it did not know about half of the laboratories. What was the trigger for the QA visits? Was an invitation issued by the laboratory? Were these visits made on the basis that the weather was particularly good in a certain part of the United States? What was the trigger for the QA visits? Do we know what happened when these visits were made? Did those involved sit down for a cup of tea?

Dr. Karin Denton

The QA visits were scheduled as part of the specification agreed with the laboratories. They were initiated by CervicalCheck. There was not really a definite or adequate programme, policy or specification for what the QA visits would entail. That was raised in the original report.

People were going on QA visits without having a list of what they were going to do when they got there. Would that be a fair summary?

Dr. Karin Denton

More or less, yes.

Do we know what sort of people were going? Were they doctors? Were they people who were rolling about in CervicalCheck?

Dr. Karin Denton

We know who did the QA visits. The team included an external expert cytopathologist and staff from CervicalCheck.

Was the same expert cytopathologist used for every visit?

Dr. Karin Denton

Yes.

Dr. Gabriel Scally

We attempted to contact the cytopathologist, but the person in question was not available to us.

Of course. Who else was on the team? Were there people from CervicalCheck on it?

Dr. Karin Denton

Yes.

Can we have their names?

Dr. Karin Denton

The committee can have their names, but that information is not available to me at the moment.

Perhaps we could be told what grades the staff in question were serving at.

Dr. Gabriel Scally

Yes.

I want to know how many visits were made by this team and who was on the team. Where was the expert cytopathologist from? Was there a tendering process for an expert? Maybe they got the expert in the place where they keep people like Dr. Scally. Were there clinical people and doctors on the team? I would have assumed that GPs, as the people actually doing the smears, were represented on the team. I want to know what they were doing.

Dr. Gabriel Scally

We know the composition. The cytopathologist was the only clinician who was part of the QA team.

One expert had to be brought.

Dr. Karin Denton

One expert pathologist-----

Did the inquiry team find out what this team was doing when it travelled to the United States? It did not have a plan when it was going over. Do we know how long it spent there?

Dr. Karin Denton

Yes. We have reviewed the reports written by the team. It was in each laboratory for a full day.

To which laboratories is Dr. Denton referring? The team visited the laboratories about which it knew.

Dr. Karin Denton

I am referring to the laboratories it visited. As we have established, it did not know about many of the places where the work was being sent. We have never seen any indication that the people who carried out the QA visits were made aware that some of the work was being sent off site.

How many laboratories did they visit? Did they visit three, five or seven laboratories?

Dr. Karin Denton

They visited-----

Did they visit all the laboratories we knew about?

Mr. Shane McQuillan

The principal visits would have been to Teterboro, New Jersey and Austin, Texas.

Mr. Shane McQuillan

When we visited Austin, Texas, we were surprised to learn that at the time those visits took place, a large proportion of the work that was going to Austin was then being shipped out to San Antonio. It has been mentioned that the small laboratory in San Antonio was set up specifically and solely for the purpose of servicing the CervicalCheck work. Even though the visit was took place at a time when the work was being shipped out to San Antonio-----

What proportion of the work was involved? Were 90% of the slides going off somewhere else?

Mr. Shane McQuillan

Just under 40% of the work that was going through Austin was being shipped out to San Antonio.

It is important to clarify what Mr. McQuillan is saying. When a self-appointed or self-accredited QA team, including an external expert cytopathologist, went to Austin, Texas, 40% of the samples were going to San Antonio. Everyone came home delighted. They were none the wiser about San Antonio.

Mr. Shane McQuillan

They were completely unaware of that. When we visited Austin, it was disclosed to us, approximately ten minutes after we entered the building, that a large proportion of the work had gone to San Antonio.

We will be given the list and we will be told how many days they spent there. Who funded that trip? Is there a budget for such trips? Who paid for-----

Dr. Gabriel Scally

Is the Deputy asking about the QA visits?

Dr. Gabriel Scally

They were funded by CervicalCheck because they were visiting on behalf of CervicalCheck.

We are going to get a document that sets out who was there and where they went.

Dr. Gabriel Scally

Yes. I am not sure which would be the best organisation to provide the committee with that information. It might well be the HSE that will provide the information because the visits took place on its behalf.

They took place on behalf of all of us.

Dr. Gabriel Scally

Indeed.

Deputy Michael Harty resumed the Chair.

I apologise for my absence. I understand Deputy O'Reilly has another question. We might even get Dr. Denton and Dr. Scally out before 5 p.m.

I think we will. I assure the Chairman that the meeting was ably chaired in his absence.

I thank the Deputy.

I am much more of a pushover. I gave everybody a lot of leeway. I share the horror of others regarding the failure of people who were on quality assurance visits to realise that they were not where they should have been or where the majority of tests were taking place. I do not know whether "horror" is too strong a word, but I will use it in any event. In the last line of his letter to the Minister, which is dated 15 February, Dr. Scally indicated that he had found no reason to revise the view he took in his main report that "As far as can be ascertained, all the laboratories have performance which is acceptable in their country".

Dr. Gabriel Scally

Yes.

Okay. I suggest that Dr. Scally's statement that he had no reason to revise the opinion was not a massive ringing endorsement. That does not matter. We know that a lot of information was missing. This meant that Dr. Scally could not necessarily make such a judgment. I presume the reference to "performance which is acceptable in their country" is based on an acceptance that there are variations in standards across various jurisdictions.

Dr. Gabriel Scally

There are several variations across jurisdictions. Would Dr. Denton like to address that?

Dr. Karin Denton

The bottom line is that it is very difficult to find out the actual sensitivity of a test. How would that be found out? The only way to get a fairly robust answer is in the context of randomised control trials which are not possible or desirable in this setting. We must examine other markers, things that are based on process. As we mentioned before, there is the question of whether a slide is screened once or twice. If two separate people are screening a slide, then more abnormalities will be detected than if only one person screens it. The US requirement is for only one person to screen the US-derived slides and to do a 10% rescreen. Therefore 90% of its negative slides are only being screened by one person. What was, and still is, being offered to Irish women in those settings is better because they are all having two screens.

We are not able to say that the sensitivity of the test in country A is one thing and in country B is another because it is simply not measurable. What we can say is that the processes being used are as specified and acceptable in the countries in which they are being used.

That is where my issue lies. We know some countries compare more favourably for all sorts of things. Saying that a performance is the same as an emerging economy jurisdiction is not the same as saying it is of a sufficiently high standard. If we consider ourselves to have a high standard, should we compare ourselves with country A which has relatively low standards and all the labs perform to the standard required in that particular country? There are different standards in the US than here. There are many unknowns. Some labs which were testing are now closed and there has been no on-site quality assurance. It is a little disturbing to hear it is up to their standard, when that might not be up to ours.

Dr. Gabriel Scally

I completely understand. It is a difficult issue. Another difference, and Dr. Denton will keep me right on this, is that here a slide is examined twice. One is a primary screen, which is for a longer period than the secondary screen. That is the norm in the UK and Ireland. In the United States, the labs do not do secondary screens. The Irish women's slides which went to the United States had two primary level screens which involved the cytoscreener examining the slide for a longer period. In theory, it might be postulated, they should have fewer false negatives because they have more intensive screening, but it means that the data are not easily comparable with anywhere else. Those are the sorts of complications that make comparability really difficult.

Nonetheless, on the basis of that, Dr. Scally was able to ascertain confidence.

Dr. Gabriel Scally

My language around that is very careful, as the Deputy will see. On the basis of the information available to us and our professional judgement, we have not found serious deficiencies in any of the laboratories.

Before we finish with Deputy Donnelly, I will ask a question that may have been asked in my absence. It was the carrying out of the audit that has led to what has been going on for the past year and a bit. This was a named audit. Is it the gold standard of a screening programme to do an unnamed audit or would an unnamed anonymous audit be a better way of reviewing the situation?

Dr. Gabriel Scally

There is not a common pattern of audit in the screening programmes. In fact they differ quite markedly where they are carried out at all. This is a matter that Dr. Denton has been discussing with colleagues internationally recently. She might like to comment.

Dr. Karin Denton

In many countries, the issues around doing a named audit are only just becoming apparent. There is a history of people thinking it would be a good thing to do and it is always with the best of motives. People want to learn about where things have gone wrong and how things could be improved, and perhaps use it to focus training or new skills development. However, it fails to think through some of the consequences or to plan in advance with how they will deal with the information. I believe that anonymised audits have been done in some places. It is not normal practice in the UK or any European country that I am aware of. The challenge is that it cannot be done in a completely anonymised way because it is not only about reviewing the cervical cytology preparations but also examining the patient history, when they attended for screening, whether they were invited correctly, whether the colposcopy and follow on investigations were done correctly, and so on. It is not possible to take one bit of the pathway and do that. To link all that information, it must de-anonymise it. It is very difficult to do a whole screening programme audit anonymously.

In undertaking an audit to assess the quality and accuracy of the reading, will it open up litigation, anxiety and worry for the 221 women who have been identified as having a discordant reading? I am not suggesting that it should not be done, but if the audit is done, does it put the programme at risk?

Dr. Gabriel Scally

Audits should always be done. The decline of clinical or medical audit over the past decade or two is deeply regrettable. It is a question of how it is done, the purpose for which it is carried out and the rigour with which it is applied. Also, in the conception of the audit, attention must be paid to the communication of its results and the aftermath of any errors. As I noted, we do not have a good system for dealing with clinical error when it occurs and responding as a society to clinical error. The audit cannot merely be entirely clinically driven without paying attention to all those downstream elements. In some jurisdictions, those elements are so difficult to deal with that they do not do audits. Instead, they rely on accreditation, quality assurance and training to generate assurance that the system is good because it is a very difficult area to get into.

In his first report, Dr. Scally mentioned moving to a no-fault compensation scheme. Would that solve the issue of litigation?

Dr. Gabriel Scally

In fact it was in the current report. I mentioned it as part of a package but it must involve the other elements, such as the truth telling and the support for the person.

I am struck by the compensation scheme in the UK for dealing with vaccinations, which has operated successfully for quite some time and has avoided-----

There is a line in the programme for Government about replicating that.

Dr. Gabriel Scally

Yes. As I wrote in my report, a good place to start would be with the public health screening programmes. They differ dramatically. It is not sick people coming to see the Chairman or any other doctor. Rather, these are well people and the state, in deciding to run the programme for the whole population, is reaching out to them and offering them a service for their and the state's benefit. Therefore, we have a particular duty of care towards the patients involved, including a duty of caring for them if the system fails them in any way.

I thank Dr. Scally.

I would like to conclude with Dr. Scally's two recommendations, the first of which is that it be made even more explicit in the contracts between the HSE and labs that there can be no unilateral onward contracting and the primary contractors cannot just subcontract the work. Dr. Scally has stated that this provision is already in the contracts but that he would like it to be made more explicit.

Dr. Scally's second recommendation is that a consistent quality assurance process be developed and implemented globally so that, rather than consider the accreditation from another country, CervicalCheck or the HSE would not be interested in that accreditation and would instead set out the accreditation in Ireland that people would have to meet.

I am curious to know why what happened with the subcontracting happened. The HSE contracted in good faith, but it turns out that the lab subcontracted. I am not going to say whether that was in bad faith, but it certainly seems to have been in breach of contract. I have reached an observation from our examination of CervicalCheck. We all think of these State programmes as well-resourced, well-financed and slick operations with plenty of staff, doctors, accountants, lawyers and administrators to do all the work that needs to be done. CervicalCheck was a world-class programme, but it was actually being run on spit and boot polish. It was about half of Dr. Flannelly's time and there was a very small staff, including the staff processing the slides and the management staff. Is it Dr. Scally's conclusion that the HSE and CervicalCheck never spotted this subcontracting because they did not have the required legal expertise? This is serious stuff involving contract enforcement and supervision and carrying out on-site audits. Is it the case that the HSE and CervicalCheck did not have the facilities to do that? If they did, is this something that they should have spotted but failed in their duty to do so? Where do matters stand today? It is one thing for us all to talk about what the good people of CervicalCheck should be doing in terms of contract enforcement.

Dr. Scally's second recommendation was on developing a robust global quality assurance protocol and enforcing it. There is no point in just having a document on the shelf. There must be the scientists, doctors, lawyers, accountants and so on to get on planes and physically travel. Did CervicalCheck have the requisite firepower to do this? Does it now have the firepower to implement these recommendations properly?

Dr. Gabriel Scally

Those are good points. I do not believe that CervicalCheck had the capacity in terms of the quantum of staff nor the skill mix. Deputy Donnelly mentioned Dr. Flannelly. She worked on this two days per week. She was a colposcopist, yet this programme was heavily based on cytopathology. CervicalCheck had no in-house cytopathology expertise, which was a difficulty. It is a public health programme, yet there was no consistent public health input. That would have avoided some of the problems with the construction of the audit. All of that left CervicalCheck weak in the contracting and tendering arena. Mr. McQuillan might comment on its capacity in that regard, but it looked to me to be light as well. CervicalCheck did not manage these contracts. The contracts should have been actively managed. CervicalCheck was a passive recipient of what the laboratories chose to give it. That is my summary. CervicalCheck needs the capacity to manage contracts actively.

There is a positive. For a long time on behalf of the Department of Health, Mr. McQuillan and I have been examining the public health system and the organisation of public health medicine in the State. The situation has not been good. That public health weakness is to the detriment of health and health services in many ways. However, I am pleased that actions are now being taken to strengthen them. I hope that these important public health programmes will operate within a staffing structure that can actively manage them on public health principles and deliver maximum benefit for the population.

I might summarise. Does Dr. Scally believe that CervicalCheck has the capacity right now to implement the two recommendations?

Dr. Gabriel Scally

Certainly as far as the professional realm is concerned, it has acquired the staffing it currently needs. In terms of contracting and tendering, though, I do not know. We will examine that question as part of our review of the recommendations' implementation.

Mr. Shane McQuillan

I might address that point. As far as the contracting, tendering and business side of things is concerned, we are aware that the HSE has taken good steps towards strengthening it considerably. It is fair to say that it has probably flipped the other way, in that what was light and weak before is now very strong. However, we are still examining the issue and will report on it in the coming months.

I thank the witnesses.

Next is Deputy O'Connell, whom I know does not want to be responsible for our witnesses missing their flights.

When was the San Antonio visit that Mr. McQuillan referenced?

Mr. Shane McQuillan

CervicalCheck did not visit San Antonio.

I apologise. I meant the other one in Austin, Texas.

Mr. Shane McQuillan

Was it 2010?

Dr. Karin Denton

It was 2011.

Is the lab in Sandyford ISO accredited?

Dr. Gabriel Scally

It is.

Under one of the rules on ISO accreditation that I read last night, there have to be contingency plans and all subcontractors must have ISO accreditation. That is an issue for the lab in Sandyford if it subcontracted.

Dr. Gabriel Scally

It was not subcontracting. Its conception was-----

It believed that it had another lab that was accredited.

Dr. Gabriel Scally

-----that the setup in Salford in greater Manchester was actually a part of the Sandyford lab even though it was in a different country.

It would say that, though.

Dr. Gabriel Scally

Of course. I think-----

In Dr. Scally's experience, is he-----

Deputy, please be conscious of the time.

Dr. Gabriel Scally

I am all right for a minute.

It was mentioned that the contracting and tendering side was changing. That is retrospective governance again. Was Dr. Scally shocked by what he found? I think he was. Dr. Denton was definitely shocked. These labs were not even known about. Has Dr. Scally ever seen the like?

Dr. Gabriel Scally

I have never seen the likes of this in my long career. I really have not.

I imagine not. Every time I read this, I find out something else that has me asking what they were at. In terms of governance and how people should go about delivering something, would it be true to say that this is as bad as it gets?

Is there any good bit of it?

Dr. Gabriel Scally

That would be overstating it. At no stage in all of my inquiries have I found anyone acting with malign intent.

Dr. Gabriel Scally

All too often, we have had cases of people who have been grossly incompetent and sometimes acting with malign intent. That happens in these professions, unfortunately. Organisationally and structurally, I have never seen anything quite as wrong as this was from top to bottom.

I do not expect Dr. Scally to answer this question. If what was going on in CervicalCheck has been replicated across the wider HSE, we would have a massive problem, would we not?

Dr. Gabriel Scally

Yes, of course. I have no reason to believe that is the case. That is a question, however, to be posed to the HSE rather than to me.

I thank Deputy O'Connell. We have actually finished on time. I thank her for her conciseness. I thank Dr. Scally for continuing to support the committee with his reports. I will finish by stating that it is important that women continue to engage with CervicalCheck and participate in the screening programme. The 20% of women who do not participate need to be encouraged to engage and to be confident now that the service is of an extremely high standard.

Dr. Gabriel Scally

I agree absolutely and I thank the committee.

I thank Dr. Scally, Dr. Denton and Mr. McQuillan.

The joint committee adjourned at 5.01 p.m. until 9 a.m. on Wednesday, 10 July 2019.