Mr. Terry Casey:

The MLSA is deeply saddened by the impact of CervicalCheck's system failures on individual women and on public confidence in the cervical screening programme. The screening programme has saved lives but it is now clear that it did not operate to necessary standards, culminating in the serious failings in the CervicalCheck audit and communication process.

Cervical screening was first introduced in Ireland in the 1960s. Although discussed at the time, a national screening service did not materialise. By the mid-1980s, there were 15 laboratories providing both a diagnostic and cervical smear screening service, with an estimated 145,000 smears per year throughput and many laboratories experiencing significant backlogs. In 1987, the then Minister of Health set up a working party whose terms of reference included recommending how to improve arrangements to deal satisfactorily with the workload. While the final report concluded that no extra Exchequer resources would be made available to the service, it recommended that three regional laboratories be developed to provide a diagnostic cervical cytology service rather than a screening service and that turnaround times should not exceed one month. However, the continued failure to resource the service appropriately resulted in continuing delays in issuing timely results to patients.

In 1996, the then Minister for Health advised the setting up of the Irish cervical screening programme, ICSP, based in Limerick. It reported that in 2001, 217,898 smears were received by cytology laboratories and 203,868 were reported. It noted that double screening was carried out for 17% of all smears, rapid review was performed in 13 of the 14 laboratories, one laboratory reported complete rescreening on all smears, and waiting times ranged from one week to more than three months.

In 2004, the ICSP published a commissioned report by Dr. Euphemia McGoogan, a leading UK expert, who reviewed the first pilot phase of the ICSP, now CervicalCheck under the National Cancer Screening Service, NCSS, in the mid-west and made recommendations for a successful national screening service roll-out within an acceptable timeframe. Among the recommendations of Dr. McGoogan were the need to develop and redesign the existing laboratory structures into four regional screening centres that would “serve a defined population through a network of professionals working in primary care, laboratories and colposcopy”, and it was envisaged this would be in line with what was developed for the BreastCheck screening programme. In addition, a single standard screening should be agreed and a move to liquid based cytology, LBC, should be developed which would greatly increase laboratory capacity by increasing the number of slides screened daily by laboratory staff. Furthermore, each laboratory should employ a quality manager to assist with obtaining laboratory accreditation.

In June 2006, in response to continuing backlogs, the HSE with the NCSS took a decision to outsource the backlog of cervical smears on an ongoing basis from 1 August 2006 up to 31 July 2008, with an option to extend the service for two years. On the basis of "urgent medical need", the contract was awarded without a tender process to Quest Diagnostics, an American based international company. During this period, Irish cytology laboratories were undergoing transition from conventional Papanicolaou, Pap, smear tests to LBC preparation in addition to working assiduously through the process of achieving accreditation in preparation for the roll-out of the National Cervical Screening Service programme. Some laboratories had already achieved accreditation. At the same time, laboratory workloads were increasing year on year and the HSE staff moratorium from 2006 was also having an effect on staffing levels in laboratories. Following a tender process in May 2008, the National Cancer Screening Service awarded the full contract for screening to Quest Diagnostics.

The Medical Laboratories Scientists Association, MLSA, warned the HSE and the NCSS in 2007-2008 of the risks of the short-term decision to outsource testing to the USA, due to the different testing and screening protocols in place and the disconnect between the outsourced screening programme and the clinical services in Ireland for women subsequently diagnosed with cervical cancer. Concern was also expressed about the loss to the State of the skills to provide the service.

As a result of the outsourcing of the testing, more than 60 highly skilled medical scientists performing cytology testing in Ireland were redeployed to other areas in pathology laboratories, with a consequent loss of their skills. As a result, the overall majority of Irish cytology laboratories were not in a position to tender for subsequent NCSS contracts since 2010. Following the decision to outsource the testing, the NCSS, the Department of Health and the HSE expressed no interest in the development of a cytology screening service in Ireland, in line with the recommendations of the McGoogan report, advising instead that it was their preference to close existing screening services in Ireland and redeploy staff to other laboratory disciplines.

The MLSA welcomes the upcoming review into the service and calls on the HSE to invest in the retraining and upskilling of medical scientists so that the testing service can be returned to Ireland. It must be acknowledged also that the recent controversy has also impacted greatly on all the staff who have worked diligently over the past decade to provide the CervicalCheck screening service in Ireland. Our members hope that lessons have been learned by the HSE and Department of Health about the need to invest in Irish clinical pathology laboratories so that such vital services can be provided within the State in accredited laboratories with essential links to clinical services.