Ms Anne O'Connor:

I thank the Chairman and members of the committee for the invitation to attend the committee meeting. I am joined by my colleagues, Mr. Damien McCallion, national director of screening services; Dr. Peter McKenna, clinical director of the women's and infants' programme; and Dr. Lorraine Doherty, clinical director from CervicalCheck.

Our focus continues to be on supporting women and their families who were impacted by the CervicalCheck crisis. We have continued to provide a wide range of supports in line with those agreed with the Department of Health. These have included the provision of 602 medical cards and the upgrading of eligibility for another 91 medical card holders, provision of access to a broad range of HSE and HSE-funded supports, and the reimbursement of €1.2 million in expenses and costs to those affected. In addition, we recently completed a detailed piece of work that updated the information on the group of 221 patients. This was done in conjunction with the 221+ patient representative group and will help inform the provision of future supports for the group of 221 patients. We also continue to support women and their families in the provision of access to their records and ensuring women get their slides from laboratories where required for legal review. A new client services unit was established in our national screening service to support this process. A total of 109 out of 118 slide requests have been dealt with in 25 days on average, and there are only nine requests still being processed.

We continue to support the independent international expert panel review being undertaken by the Royal College of Obstetricians and Gynaecologists, RCOG, which was established by the Minister for women who were diagnosed with cervical cancer. The HSE supported the consent process which has seen 1,072 women or their next of kin consent to participation out of an eligible group of 1,702. This included establishing a national help desk, developing an eligible data set with the National Cancer Registry, and implementation of a client management system to support the RCOG. In recent weeks, the laboratories have commenced the transfer of slides. All slides have been transferred by the Coombe Women and Infants University Hospital.

Quest Diagnostics and Sonic Healthcare have also commenced the transfer process with the imaging of slides for transfer, and a transfer schedule is being agreed this week with those laboratories.

We remain concerned at the length of time being taken to report cervical smears, which is on average at 93 days although it can take up to 27 weeks for the report to be provided. There is currently a backlog of approximately 78,000 slides. In 2018, around 370,000 women presented to the programme, which was an increase from 280,000 in 2017. This increase of approximately 90,000 was a result of the uptake of the out of cycle smear test and more women presenting to the programme, which would in normal circumstances be a positive step. We have worked with existing private providers, other private providers and public service providers in other countries to try to grow our laboratory capacity. Some of our existing providers have managed to reduce the wait times and we continue to work with others to try to find additional capacity. While we continue to pursue active leads, this has proved very challenging due to the global shortage in cytology. This has been caused as a result of the reduced cytology requirement as countries implement HPV primary screening which leads to a reduction of 80% for cytology requirements. We are actively trying to identify possible solutions that will help reduce the wait times which we know are causing a lot of anxiety for women.

As part of the laboratories' quality assurance process, we were also made aware of an issue with regard to HPV tests expiration at Quest Diagnostics. While the clinical risk was deemed very low, we have contacted all those affected and a number of women are being retested. These tests will be expedited by Quest Diagnostics to ensure a timely response for those women requiring a retest. A key risk to enabling cervical screening to continue in Ireland was the extension of the laboratory contracts.

The HSE has a signed agreement with one of the private providers and is working through the detail on a contract with the second provider with whom we have a heads of agreement. We also made a strategic decision to develop a national cervical screening laboratory in conjunction with the Coombe Woman and Infants University Hospital. This included an initial capital allocation of €5 million to progress the development of the laboratory. A project team and steering group has been put in place to oversee all aspects of this project. While this will take some time to develop, it will provide a better balance between public and private provision of laboratory services to the cervical screening programme.

The HSE is progressing plans to introduce HPV primary screening. A project team is in place and is progressing the various work streams. We have completed a review of international HPV primary screening implementation, and ICT testing is under way. The development of education and training materials has commenced, and our procurement team has started the tender process for laboratory services, with a pre-tender market engagement session held before Christmas. We remain committed to implementing HPV primary screening as soon as possible.

The HSE has contributed significantly to the development of an implementation plan in collaboration with other State agencies in response to the Scally review recommendations. We have appointed a senior manager to oversee the implementation and established a HSE implementation oversight group, jointly chaired by our chief clinical officer and deputy director general for operations. We have developed a set of 94 actions arising from recommendations that are the responsibility of the HSE to implement. Examples of progress to date include key appointments and governance changes. An organisational review of risk management structures has also been commissioned by the HSE in addition to the establishment of an expert group within the national screening service to review clinical audit processes across all screening programmes. An interim revision of the HSE's open disclosure policy has commenced and will be communicated and implemented throughout the system pending a more detailed review during 2019. The HSE has also reviewed and updated its financial records management policy. All six recommendations from Dr. Scally's interim report have been fully implemented. The HSE has maintained open communication with patient representatives on the implementation plan and will continue to work collaboratively with them throughout 2019.

The HSE has continued to strengthen the governance and management of screening services. We have established an interim management team with the reassignment of senior people to key positions while we fill key positions on a permanent basis. We have recently appointed a director of public health, a CervicalCheck clinical director and a CervicalCheck laboratory quality assurance lead. In addition, a risk committee for our screening services, which is independently chaired, has been put in place since quarter 3 of 2018. An interim quality and risk manager was also appointed in quarter 3, and the implementation of Dr Scally's recommendations on strengthening our quality assurance processes has commenced. I assure members of the committee that the HSE is focused on stabilising the cervical screening programme to enable us to progress the introduction of a new enhanced HPV primary screening testing methodology. All possible resources are being directed at this challenge. My colleagues and I will endeavour to answer any questions from the committee.