Tuesday, 18 June 2019

Questions (325)

Micheál Martin


325. Deputy Micheál Martin asked the Minister for Health if he or his officials have spoken to or written to a company (details supplied) after receiving the Scally report in which it concludes that the HSE and his Department should have been informed before or at least when laboratories were changed in the United States of America; and if he will make a statement on the matter. [24927/19]

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Written answers (Question to Health)

The Supplementary Report of the Scoping Inquiry was received in my Department on Tuesday 4 June. The Report was published following a Government decision on 11 June.

The report found that the number of laboratories involved in CervicalCheck work was greater than was originally thought, 16 in total, and that the use of many of these laboratories was not approved in advance by CervicalCheck, nor was it known to it.

Crucially, however, on the basis of the information available to the Inquiry, the use of these additional laboratories did not result in a reduction in the quality of the screening provided to Irish women and there is no evidence to suggest deficiencies in screening quality in any laboratory. All Quest Diagnostics laboratories, including the four additional laboratories identified in this report, were accredited at the time they were providing the services, and the Supplementary Report finds that the two major accreditation standards in use (ISO and CAP) are comparable.

Two additional recommendations are made in the Supplementary Report, which relate to contract specifications and quality assurance. Government has accepted these recommendations, which will be implemented along with Dr Scally’s existing recommendations. These include seven recommendations of Dr Scally’s Final Report in relation to procurement, and recommendations relating to laboratory services and wider screening services included in the Final Report of the Scoping Inquiry. Implementation of these recommendations is well underway, and progress to date includes recruitment of a National Laboratory QA lead, and development of a project improvement plan for screening quality assurance programmes based on international best practice. Dr Scally acknowledged in his Supplementary Report that substantial and important progress has been made in implementing his recommendations to date. A progress report on implementation for Quarter 1 2019 is published on my Department's website.

While Dr Scally is clear that he considers the lack of transparency by the laboratory companies about the precise location of their screening services provided to CervicalCheck, the Deputy may wish to note that Dr Scally's report does not suggest Quest should have informed my Department of the use of additional laboratories. The contract for the provision of services by Quest Diagnostics is with the HSE and engagement with Quest is a matter for the HSE rather than for my Department. The Deputy will be aware that the HSE recently concluded negotiations with Quest Diagnostics to provide additional laboratory capacity which will ensure that the CervicalCheck programme can continue to operate. In addition to the capacity at its current laboratory, new capacity has been provided by Quest at four other Quest facilities in the United States, all of which have been inspected and approved by the National Screening Service.