Tuesday, 26 November 2019

Ceisteanna (52)

Bríd Smith

Ceist:

52. Deputy Bríd Smith asked the Minister for Health his plans to investigate further the significant statistical difference between laboratories in terms of the number of slides reviewed as a percentage of their overall intake, as per the report on the 221 patient group laboratory audit results profile; the reason the 38 slides that showed no difference in grading were not removed from the total of 343 slides in the analysis; and if he will make a statement on the matter. [48816/19]

Amharc ar fhreagra

Freagraí ó Béal (8 píosaí cainte) (Ceist ar Health)

My apologies but I do not have a copy of the question. I ask the Minister to proceed.

In fairness to the Deputy, we have now reached a position where four Opposition Members have failed to turn up to ask their questions. I do not know where they could be or what is more important than asking the questions they have tabled in the Dáil.

The Deputy's question relates to the statistical difference between laboratories vis-à-vis the number of slides reviewed as a percentage of the overall intake. She referred specifically to the 221 patient group laboratory audit results profile report. This report provides information as to which laboratories carried out cervical screening tests for the women in the 221 patient group. The HSE has been clear that the data presented in the report, which relate to 343 slides in total, represent a minute subset of the overall screening data for CervicalCheck, which has completed in excess of 3 million screening tests since 2008. We are talking about 343 slides out of more than 3 million. As such, while these data are accurate as to which laboratories were used for women within the 221 group, I am advised that they would not be statistically sound for the assessment of the performance of any of the laboratories.

It should be noted that the HSE engaged intensively with the patient representatives on the report and agreed its contents with them in advance of publication. I thank them for their work in that regard. The purpose of the report was to provide a summary laboratory profile report on the 221 women for whom the CervicalCheck audit found that a different interpretation could have been provided for their previous slides. The 38 slides to which the Deputy referred are part of the screening history of this cohort of women and the HSE has advised that there is no reason to remove these slides from the analysis. It should also be noted that in the report of his scoping inquiry, Dr. Scally has said he found no evidence of deficiencies in screening quality in any laboratory.

I have asked similar questions to this one many times seeking more precise information on what happened with this group of slides, how they were examined and delved into.

It strikes me that we should know what happened, what the rate of error is and what those errors are. I imagine the Minister would want to know that too. The Minister may not have the report in front of him - I am not saying he should - but table 4 is quite clear that the rate of error in some of the US labs is significantly higher than that of the Coombe laboratory, which is a native lab. I have long contended that we should be looking at why, how and if this happened. Errors in labs which conducted these tests, based in the US or elsewhere, have been clearly admitted and acknowledged. They have made serious financial settlements, not out of the goodness of their hearts but because women and their representatives were able to prove that there was a significant error in the testing. Perhaps we could have a further discussion on that table, which is on page 8 of the report.

I do not have the report in front of me but I may have some of the material from it. This information was requested by women and their families, and by a number of Deputies, including, principally, the Deputy herself. The report was finalised in September following engagement between the HSE and the 221+ patient support group. The report was prepared by a group of four specialists with expertise in cytology, pathology and laboratory quality assurance. I am sure the Deputy has their names. The objective for the results profile was set out by the HSE CervicalCheck screening group and aimed to provide a summary laboratory profile, including overview of laboratory quality assurance, factors affecting the laboratory performance profile, and the laboratory profile specific to the 221 women audited by CervicalCheck. This report was not intended to be a clinical review. Additionally, it did not look at individual women's information and therefore did not report on the degree of change noted in the slides under consideration. It is noted in the report that a cytopathology review would be required to confirm that degree of change, which was not within the report's scope. The information in the report represents a very small subset of the overall data for CervicalCheck, which has completed in excess of 3 million screening tests. We are talking about just over 300 slides out of 3 million. I will have more to say about the Coombe and repatriation in a moment.

The Minister might look at the table to which I have referred later, but I am sure he and his Department have studied it.

The table shows that the rates of error in the Quest laboratories in Illinois and Teterboro, and the Clinical Pathology Laboratories, CPL, in Texas, were five, three and seven times that of the Coombe, respectively. I would not be alarmed if the difference was only 0.5% or so, and neither should the Minister be. However, he should be alarmed at this rate, compared to the rate in the Coombe. If we had included the 38 slides that showed no change in this analysis, would that have changed the statistical information? All or a significant number of those slides could have come from the Coombe. We knew from the get-go that the labs in America were substandard, that they were not ISO accredited at the time, and that each laboratory technician examined 100 slides a day as opposed to the 60 slides a day examined in the Coombe. We did not know whether the standard of education was the same as in Irish laboratories. When we outsourced this service, everything was at a lower standard in the American labs than in the Irish labs. We knew that because there were huge protestations from clinical laboratory technicians, professional organisations and politicians in this House. This report gives us a glimpse into why that might have happened.

I cannot agree with the Deputy's use of words such as "substandard", because I have to base my assessment on the reports and analyses that have been conducted. Dr. Scally found significant failures in Quest Diagnostics and MedLab not informing the scoping inquiry of all the locations used at the earliest opportunities. There were also issues relating to appropriate accreditation, which I accept. Those are clear findings. Crucially, Dr. Scally's report also stated that, on the basis of the information available to him, the use of additional laboratories did not result in a reduction in the quality of the screening provided to Irish women, and that there is no evidence to suggest deficiencies in screening quality in any laboratory. That is what I am taking from the report.

On the broader point, about which I know Deputy Bríd Smith is concerned, of whether we can do more in Ireland or repatriate our service, it is our intention to significantly expand those services and create a national screening laboratory in the Coombe. The move to HPV testing, as well as reducing the number of false negatives and positives, will provide an opportunity to do more here in Ireland.

Questions Nos. 53 to 55, inclusive, replied to with Written Answers.