Seanad Éireann díospóireacht -
Thursday, 4 Oct 2007

Vol. 187 No. 5

Cancer Screening Programme.

Senator Frances Fitzgerald

I thank the Cathaoirleach for the opportunity to raise this important matter. Last week, Fine Gael used its Private Members' time in the Seanad to debate health. We focused on the need to restore confidence in cancer services. In a number of instances patients were misdiagnosed, errors occurred in mammograms and we had questionable treatment practices in some hospitals.

A somewhat worrying situation was reported in the Irish Medical Times and elsewhere regarding the accuracy of cervical smear tests. The Irish Medical Times reported that a number of cervical smear tests which were sent to the United States by the HSE for analysis had to be sent back for review after staff at Cork University Hospital discovered at least two patients were at risk of cervical cancer. The smear test for one of these patients was previously diagnosed as negative.

The HSE has had a business link with Quest Diagnostics in Texas since last January. I understand this arose because laboratories in Ireland could not deal in sufficient time with the volume of cases and tests sent for analysis. Women had to wait a long time for results and the solution was to go to Quest Diagnostics in Texas. What is the cost of this exercise? It was predicted that approximately 25,000 tests would be processed in total. The contract signed by the HSE stated 2,000 slides at a time would be sent to Quest Diagnostics from Cork University Hospital, the Royal College of Surgeons in Ireland and St. Luke's Hospital in Dublin. This involves tests from throughout the country.

In principle one might argue there is nothing wrong with this until one realises the method of rescreening slides in the United States differs significantly from Irish methods. In the United States only 20% of negative cases are rescreened whereas the recommended procedure in Ireland states all negative tests are rescreened. This means the HSE allowed the safeguards put in place to maximise the accuracy of results and increase patient safety to be diluted in this business deal.

Through a freedom of information request the Irish Medical Times established that problems with translating the results sent back to the United States also arose earlier in the year. This was due to the difference in testing and reporting methods in the United States and Ireland, a matter I raised some months ago. If we send tests away we must be careful to ensure the methodologies used are the same. General practitioners had difficulties assessing the results which came back.

Will the Minister of State outline to the House what action the Minister for Health and Children has taken on this matter? Are tests still sent away? Have concerns been raised about the difference in the way the tests are done in the United States and the different criteria used for retesting and analysing the results? It could lead to misunderstandings and has the potential to put women's lives at risk.

Minister of State at the Department of Health and Children (Deputy Brendan Smith)

I thank Senator Fitzgerald for raising this important issue. I will reply on behalf of the Minister for Health and Children, Deputy Harney, who is unavoidably absent.

To address unacceptable delays in processing smear tests, from January this year, the Health Service Executive outsourced the processing of more than 35,000 smear tests to a fully accredited United States laboratory. Quest Diagnostics Corporation in the US is College of Pathologists and clinical laboratory improvement amendment approved. This means that its laboratory facilities are inspected and accredited by the College of Pathologists which is a deeming authority recognised by the federal authorities to visit and inspect every two years. It has stringent and detailed quality monitoring processes and is internationally recognised.

The HSE has informed the Department of Health and Children that these tests were all processed and reported on by the end of June. The HSE has confirmed that all laboratories are achieving a turnaround time of four to five weeks in the reporting of smear tests. In all laboratories, before a result is issued, a rapid 60 second review of every negative and unsatisfactory smear is done as part of normal quality assurance procedures.

It is important to note that a smear test is not a diagnostic test. The limitations of cervical screening are such that there may be false negative and false positive results. It should also be noted that more than 80% of smears taken are reported negative or no abnormality detected, requiring no follow up for the client. Since the introduction of liquid-based cytology, the rate of unsatisfactory reports has dropped on average from 10% to below 3%. All Irish public laboratories have converted to liquid-based cytology with the exception of Cork University Hospital where this process is under way. Medial laboratory scientists sign out negative smears and pathologists sign out all the abnormal cases.

The roll-out of a national cervical screening programme is the most efficient population approach to preventing and controlling cervical cancer. The Minister allocated additional revenue funding of €5 million to the national cancer screening service this year for the roll-out of the Irish cervical screening programme, and an additional 30 posts have been approved. The programme will commence national roll-out in January 2008.

The national cancer screening service plans to have cervical screening managed as a national call-recall programme via effective governance structures that provide overall leadership and direction in terms of quality assurance, accountability and value for money. All elements of the programme — call-recall, smear taking, laboratories, colposcopy and treatment services — will be quality assured, organised and managed to deliver a single integrated national service.

Roll-out of the programme will be based on a turnaround time of four weeks for programme smears. The service is developing new contractual arrangements for tests in 2008 which will include service level agreements to achieve this objective. It has the Minister's support in this regard.