Alan Kelly (Tipperary, Labour) | Oireachtas source

I apologise that I will not be here for the second round as I must be in the House for Leaders' Questions. Last night I had the pleasure of being at the official book launch of Vicky Phelan's amazing book, which I am pleased to say is number one in the non-fiction chart. I met a range of people there who are very much affected by this crisis. I took the opportunity to scan their views and to listen to them for hours with a view to the questions I would pose this morning. The seven questions I will ask are based on doing this. I will ask them together, as it will make the best use of time. I ask that everyone answer them fully and directly, not in a generic fashion, as they are quite specific.

I listened to Mr. McCallion provide the basic information on the 221 and the laboratories, what labs were used and on what dates, etc. I have good time for Mr. McCallion but I just do not buy this and I am not sure that Mr. McCallion does himself. Tony O'Brien, to be fair to him, said in May last year that this information should be available within weeks. The 221 have asked for this information in that detail since last December. It is now September. There is a reason why this information is not being given out. Will Mr. McCallion be honest and tell us?

If we have learned anything over the past year or so, it is that we must be open and honest with the 221 campaign and the patient representatives, Lorraine Walsh and Stephen Teap. Mr. McCallion is saying that it will take another four weeks to collate this information. The information is available to him. I can guarantee that. If the patient representatives write to Mr. McCallion today and ask for the information, as he currently has it, in whatever state it is, will he give it to them? That is my first question. That information is available and Mr. McCallion should not tell me that it is not. If it is not collatable and available, there is a level of incompetence in the HSE that means that we have bigger issues than those about which we already know. This is a very simple desktop exercise. It could be done in one hour, never mind a year and a half. I ask Mr. McCallion to answer this very directly. We need to know the information. I have information from my own sampling, which suggests certain trends but we need the real facts.

My second question is specifically for the Irish National Accreditation Board, INAB, and the Department. I acknowledge the apology and regret for what happened by the representatives from INAB. What happened is very unprofessional and unacceptable. I have been trying to piece together a jigsaw around Dr. Scally's second report and what happened. The report was due in the middle of February but was suddenly postponed for many months. Responding to several of my questions and at committee meetings, Dr. Scally has stated there was no exact date when he discovered the laboratory in Salford was unaccredited. I have listened to him dance around the issue and I have listened to INAB do the same. On what date did INAB find out that this laboratory was not accredited and by whom? Will INAB provide the committee with all communication, written in any format, electronic or otherwise, from its parent Department, namely, Health, the HSE or the Scally inquiry or both, as well as from any members of its team, to this committee in respect of the issue of this lab? I want to know the date when they found out this was not accredited. Moreover, in a question to which many people want an answer, how can a lab be accredited retrospectively? I could read out a dictionary definition of quality assurance. How can INAB guarantee that everything that went on in that lab was to the standard required? We ought not forget that between 2016 and 2018, 91,000 smear tests went through there, not counting the free smears as we do not have those figures.

The third question is probably for Dr. McKenna or whichever representative on that side wishes to take it. On colposcopy waiting times, we are told that CIN 3 should be four weeks. The target is 90% in four weeks; it is now 70% and getting worse. CIN 1 should be eight weeks. The target is 90% at that level, but is also at 70% and getting worse. This is a serious problem. What is being done to address this? Given that HPV screening is being introduced, which I greatly wish to see, and accuracy levels will improve and so on, how will we deal with that as the number of referrals should increase in a good way? What plans are being put in place to deal with that?

My next question is for the representatives from the Department of Health. Dr. Scally visited seven of the 16 laboratories. He accidentally gave us misinformation regarding his visit to the laboratories, which, in fairness, he corrected. We now know that there was retrospective accreditation of one laboratory. He also stated that it was surprising and disturbing. I have the schedule of all of the non-visits to all of the other laboratories. How can we be guaranteed that there was not outsourcing, in any capacity, in any of the other laboratories ever over that period? I have a real concern on that issue and I would like to get some answers.

My next question concerns the RCOG review. I have to acknowledge, first, that there has been some learning in the area of communications. The HSE believes that 40% of all slides will have some form of different outcome. Some 1,047 women are involved in that review. Using that 40% percentage means that 430 women will have a different outcome. That seems high but 40% is referenced in the steering group minutes of July 2018. How can that percentage be explained? I ask the representatives from the Department of Health to please not insult me by stating that it is down to site review, bias or anything like that. Why do the representatives from the Department think that it is going to be 40%, as referenced in the minutes?

My next question is interconnected. This 40% is referenced the July minutes. Regarding the current position, I have raised for the past year and a half the fact that I believe it is wrong that the audit has just stopped. That is going to cause serious issues in the future. I do not have time to discuss this now, but it will cause serious issues and that must be faced up to now. The quicker this issue is dealt with the better. The trajectory of discordance of sampling, I have heard, is continuing post the audit. I want to know when the audit will be brought back, what proposal there is to do that and why the Department of Health continues to ensure that it is stopped. I ask that because, if we look at this based on what is going to come out in the RCOG review, the Department is going to have a much more serious problem, given the statistics it has stated itself.

Regarding what happened with the accreditation of the laboratory in Manchester, it is obvious that there was a breach of contract in some way. The Department of Health found out about this some significant time ago. I am not fully sure of the dates because they seem confusing. I have been given multiple dates. The Department, however, found out about this in January or February of this year. I presume it was before 14 February. That was when Dr. Scally was meant to publish his report but the date was pushed back following questions of the Secretary General of the Department at this committee. He stated that it was imminent but then the publication date suddenly changed. Obviously, that had something to do with the laboratory in Manchester and other quality assurance issues.

There is, however, a contractual issue in this regard. Any competent organisation will deal swiftly with a contractual issue of this seriousness and magnitude, which is causing such public concern. Will the representatives from the Department of Health provide the committee with all the details, in writing, of the efforts that the Department has made, and contact it has, with the organisation I referenced in trying to deal with that contractual issue? Will they also update this committee now on what has been done with company concerning that contract? This is an issue that the Department would have to have dealt with swiftly by now.