As the Taoiseach has just told us, the Cabinet discussed today the draft terms of reference of the scoping inquiry into the scandal of non-disclosure in CervicalCheck. Reports indicated that the scoping inquiry will look at the outsourcing of services and the background to non-disclosure. However, the grave concern and public alarm about CervicalCheck and the audit testing remains, and we are no closer to the truth.

This day last week, I raised with the Taoiseach a number of serious concerns about the responses then under way, and little has improved on that front since then. As of yesterday, as the Taoiseach has indicated, there were 11,000 calls, 8,000 people had requested a callback and only 2,686 have received it. That left 5,000 people still waiting for a callback. Many people have been referred to their general practitioners, GPs, but GPs are contacting us to tell us that they have not been properly informed as to what to tell them. What has the Minister told GPs, and what additional resources have they been given?

The key question from a patient safety perspective, however, is whether the cervical cancer screening programme was and is currently within acceptable parameters, both in administering the tests and, as importantly, interpreting the results. Vicky Phelan's case was that her 2011 screening test was wrongly interpreted. On proper reading interpretation, she should have been referred for further treatment. As we understand it, the HSE set out a CervicalCheck clinical audit to examine the screening history of all cases of cervical cancer, including Vicky Phelan's case. Of the 1,482 cases notified, 442 cases - 29% - were flagged for review of one or more elements. The most common review was of the smear test due to its known inherent limitations.

Tony O'Brien confirmed last week that in 208 cases the review team's interpretation of the smear result was different from the original reading of it. Further, he said that the difference in interpretation in those cases would have led to a different clinical escalation in 175 cases or a recommendation for an earlier repeat smear in 33 cases. The figure of 208 cases out of 1,482 is 14% of the total, or approximately one in seven. To be clear, that is 14% mistakenly read, not 14% mistakes, due to the inherent limitations of the screening system itself.

The key question for those women that the Taoiseach is telling to go back and have repeat smear tests if they are concerned and who are due to have normal clinical smears this week is whether this 14% reader error falls within acceptable or normal test standards. That is the question I am asking the Taoiseach to clarify now for the thousands of women and their families who are fearful about smear tests they have had and concerned about having it repeated. Is a 14% misreading level an acceptable international standard?

First, in regard to CervicalCheck, a daily report and update is being provided by CervicalCheck on its website. That comes out at about 5 p.m. every day. If the Deputy goes to the CervicalCheck website, he will see it gives detailed guidance for GPs and smear takers as to what is happening and it gives them advice and guidance as to how they should communicate with patients who come to see them. That has been on the CervicalCheck website now for a number of days.

One of the aspects the inquiry will look into is absolutely that question to ensure and give us assurance that our cervical screening programme is up to international standard in terms of the accuracy, false positives and false negatives, and also to look at the issue of the different laboratories, labs, and whether there is a statistically significant difference in the number of false negatives identified in one lab versus the other labs. As the Deputy knows, three labs are used, two in Ireland and one in the United States. It is important once again to put on the record of the House the inherent limitations that exist in cancer screening. Screening tests are not diagnostic, nor are they designed to be; they are screening tests.

The whole idea or concept behind screening is that a patient is invited to come in long before they have any symptoms of cancer. By screening, one can pick up many cancers early before they become symptomatic, but one does not pick all of them up. Even the best test done by the best people will have a proportion of false negatives but those who are picked up early can get treatment earlier, which, of course, improves their outcomes and life expectancy immeasurably. We know from the Cochrane review, which was the highest level of clinical audit or study across the world, that roughly for every 1,000 women who go for a smear test, 980 can be given the all clear and assured that there are no abnormalities whatsoever, roughly 12 women will have abnormalities detected and can then go for colposcopy, which will prevent them from developing cancer or being diagnosed with cancer at that point, and eight will be false negatives. It is understood, therefore, that for every 1,000 smear tests, for every 1,000 women who goes through the door of their GP's surgery for a smear test, there will be a false negative in roughly eight out of 1,000 cases.

False negatives do not necessarily equal incompetence, negligence or failure on the part of the pathologist looking at the slides. It is understood that this is a limitation of cancer screening. We must bear in mind that in the clinical audit that was done, what is called retrospection bias would have been understood from day one. Essentially, when one looks at these slides under a microscope, one is looking at cells dyed with a coloured dye. One tries to see whether or not there are abnormal cells in the pattern. When the audit was done and they looked back at the 1,400 or so individual slides, they looked back with a different set of eyes. They looked back knowing that these women had already been diagnosed with cervical cancer. When one already knows the outcome and what one is looking for, one is more likely to find it. All of these things must be teased out in the period ahead both by the scoping inquiry, which started today, and the clinical review, which is being carried by the Royal College of Obstetricians and Gynaecologists.

The Taoiseach did not really answer the question so I will put it again. There is a huge difference between the known limitations of a screening test and cases where cancer should have been detected but were missed beyond normal error. An error that reflects known limitations is a normal error. The question I am asking relates to missed positives where the actual smear was misread. We are told the rate is 14%. For the women who are going to have smear tests today, tomorrow and next day before the scoping exercise is complete, I am asking the Taoiseach whether a 14% misreading is within international norms and, if not, can we do something now to improve it?

I again want to put on the record that we have no evidence that our cervical screening programme is below international standards in any way. We do not have any reason to believe that our cervical screening programme is any less accurate or is poorer that any cervical screening programme, but it does have limitations. Let us not forget that in the past ten years, 50,000 women have had lesions identified and because we had a cervical screening programme, those 50,000 women were treated early and many did not go on to develop cancer as a result. We should not forget that because this is a programme that works and saves lives. The biggest tragedy that could come out of this would be a significant fall off in the number of women going for smear tests because that will certainly cost lives and in some cases, cost women their fertility if they manage to survive.

It is a fine line. Discovering the difference between normal error and negligent error will be a fine line. We are talking about something that was within the limitations of screening compared to something that should not have been missed under any circumstances. It will not be as simple as just saying black and white. There will be areas of grey in between and that is part of what the scoping inquiry and the clinical review will have to work out. I explained earlier what I meant by retrospection bias. One cannot use that clinical audit and extrapolate from it that there is a 14% error rate because when they did the audit, they looked back at those slides knowing that these women had been diagnosed with cervical cancer. Therefore, they knew that it should have been positive.

That is not the same as looking at slides and samples de novo when one does not what one is supposed to be looking for on them.