Catherine Connolly (Galway West, Independent) | Oireachtas source

Then let me just highlight some. Two recommendations follow on 50 and we will come back to them during the questions. The reason for the supplemental report was that there were issues about which Dr. Scally was worried in respect of tendering, contracting and the operation of laboratories. There were not six laboratories but 16, as my colleagues have said. The use of the laboratories was not approved in advance. One laboratory in England was retrospectively accredited and the system in place for responding to errors in Ireland to the screening is inadequate to the task. That is pretty damning. I would like to go through the findings in detail in respect of the three companies involved but my time is limited. I will go straight to the key statements of Dr. Scally. "It is profoundly disappointing that the Scoping Inquiry only learnt about the additional laboratories as a result of our extensive and intensive probing." That was in addition to people coming forward and alerting the inquiry about possibilities of laboratories in other areas including Mexico and India. I hope I will have time to come back to that. Dr. Scally says it is disappointing that not one of the bodies involved retained complete records for a period of time over the last decade. No knowledge of the laboratories on the part of the screening service and the HSE meant that the national cancer screening service had no means of assessing the accreditation, quality standards, governance or other critical features regarding the suitability of these laboratories to undertake cervical check work. Dr. Scally says:

The most benign interpretation [I certainly would not agree with him. I would give a different interpretation] of these events is that neither party [imagine that] appears to have understood, or articulated, the importance of the role of the NCSS in monitoring the quality and safety of the laboratories and the importance of documenting how and where the work was being done, how it was monitored, and by whom.

Dr. Scally says, "it is disappointing that it took Quest more than six months (from the time of the Scoping Inquiry’s first engagement with the company) to disclose the involvement of these four laboratories." It is extraordinary that Dr. Scally goes on to take their word later in respect of there being no laboratories in India or Mexico. They have not proved it and had not complied with their word prior to that. Dr. Scally says that "the lack of transparency by the major private sector laboratory companies about the precise locations of their screening services provided to CervicalCheck, and therefore to Irish women, is entirely unsatisfactory." He states that "the tendering process appeared to move over time to place an increasing emphasis on price rather than quality." I would have thought that might be something the Minister would have focused on. The report states that, "the use of additional laboratories, without express authorisation, lay outside the bounds of the contracts and [...] the introduction of additional laboratories with no previous experience of CervicalCheck did introduce a potential risk." Most importantly, it states that, "the reasons for requiring prior written permission to use additional laboratories were to ensure accreditation and quality of service, to enable CervicalCheck to monitor and gauge risks, and to maintain overall transparency within the screening programme." If the organisation responsible for looking after women's health is not in a position to carry out quality assurance because it does not know the laboratories exist, we have a serious problem. Is that not right?

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