Mr. Damien McCallion:

Good morning Chairman and members of the committee. I thank the committee for the invitation to attend this meeting. I am joined by my colleagues, Dr. Colm Henry, chief clinical officer, HSE, Dr. Lorraine Doherty, clinical director, CervicalCheck, and Ms Michele Tait, implementation lead for the Scally report, HSE.

The HSE remains extremely conscious of women’s concerns regarding cervical screening over the past year and, in particular, many women’s anxieties due to the delays in reporting on smear test results. The HSE is doing its utmost in order to find solutions to these waiting times and we apologise to the women for these delays and for the upset caused. We continue to address and manage a vast range of issues that have emerged as a result of the crisis in the CervicalCheck programme last April. Our priority areas include stabilising and strengthening our cervical screening programme; continuing to support women and families who were directly impacted by the CervicalCheck crisis; implementing Dr. Scally’s recommendations; strengthening governance arrangements; enhancing the quality assurance of the programme and advancing the implementation of HPV primary screening. This report, previously circulated to the committee, updates on these key areas of priority.

In the area of supports to women and families, our information line continues to provide information to women who are understandably anxious at delays in accessing their results. We also 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. The client services unit in our national screening service continues to support this process and, to date, 118 out of 125 slide requests have been dealt with, on average, within 27.5 days while seven requests are currently work in progress.

We continue to support the women impacted through the 221+ group through our community liaison officers. The community liaison officers support women and their families in provision of the support packages provided to government. We are also developing a public and patient inclusion plan for our screening services. We have established a patient panel for cervical screening that has already provided critical input into aspects such as communication and Dr. Scally’s recommendations. We have also brought patient representatives on to a number of key project groups within our screening services. We are very grateful to the many patient representatives who voluntarily give up their time to support our screening programmes. We have made a start in this area and remain committed to bringing patients to the centre of our screening programmes.

We are continuing to support the independent international expert panel review being undertaken by the Royal College of Obstetrics and Gynaecology, RCOG, which was established by the Minister for Health, for women who were diagnosed with cervical cancer. The HSE supported the consent process, established a national helpdesk, developed an eligible dataset with the National Cancer Registry and implemented a client management system to support the RCOG. In recent weeks the laboratories have commenced the transfer of slides and the RCOG estimates that it will take six months for the process to conclude.

On programme turnaround times, in 2018 around 370,000 women presented to the programme, an increase from 280,000 in 2017, or approximately 90,000 in total. We remain concerned at the length of time being taken for reporting of cervical smears. Over half of samples received are being processed within 15 weeks, although it can take up to 33 weeks for the report to be provided. There is currently a backlog of some 79,500 slides.

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 by a reduced cytology requirement as countries implement HPV primary screening, which sees a reduction of approximately 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. While this is very undesirable, our clinical advice is that this poses a very low risk to women. Notwithstanding this, we recognise that these delays are extremely difficult for women and we are making every effort to improve this situation. We have made significant improvements in the turnaround times with two of our three laboratories and are working closely on an improvement plan with the third laboratory. We are absolutely focused on reducing waiting times for results as quickly as possible.

A key risk to enable cervical screening to continue in Ireland was the extension of the laboratory contracts. The HSE signed agreements with both providers to enable continuity of the programme. The HSE also made a decision to expand the public laboratory capacity and an agreement was reached with the Coombe Women and Infants University Hospital to do so. This will provide a better balance between public and private laboratory capacity provision.

An initial capital allocation was made to develop a national cervical screening laboratory at the Coombe. A project steering group and project team are now in place with building and workforce plans being developed. While we are planning for a rapid building programme through a modular development, it will still take a number of years to implement, primarily due to the workforce challenges.

We are progressing plans to introduce HPV primary screening. A project team is in place and is progressing the seven work streams involved in the project. We have completed a review of international HPV primary screening implementations. The review informs us that our critical path will be the availability of a provider and the timescales to implement the ICT systems to support HPV primary screening.

Furthermore, ICT testing is under way, 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.

A contract notice is about to issue, which will seek formal bids from laboratory service providers. Our market engagement has identified significant challenges and concerns in the provider community that we are addressing as we move into the tendering process, to ensure that we are successful in acquiring a laboratory service provider. We remain committed to implementing HPV primary screening as soon as possible, with the critical path to be determined by the tender process that is under way.

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, Ms Tait, to oversee the implementation and established a HSE implementation oversight group, jointly chaired by our chief clinical officer and deputy director general of operations. We have now developed a set of 101 actions arising from recommendations that are the responsibility of the HSE to implement and we are reviewing appropriate actions against each recommendation as the implementation progresses. 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 open disclosure policy has been completed and approved by the HSE directorate and the process of communicating this and ensuring its implementation throughout the system will commence in the coming weeks pending a more detailed review in late 2019. The HSE has also reviewed and updated its national financial regulations policy on procurement documentation. All six recommendations from Dr. Scally's interim report have now been fully implemented, resulting in significant improvements in the information and supports provided to women and other service users on our cervical screening programme. The HSE has maintained open communication with patient representatives on the implementation plan and will continue to work collaboratively with them throughout 2019.

We have continued to strengthen the governance and management of our screening services. We have established an interim management team in the national screening service, with the reassignment of senior people to key positions while we fill these positions on a permanent basis. We recently appointed a director of public health and CervicalCheck clinical director, Dr. Doherty, and a CervicalCheck laboratory quality assurance lead. In addition, a risk committee for our screening services, which is independently chaired, was put in place in the third quarter of 2018. An interim quality and risk manager was also appointed in the third quarter of 2018 and implementation of Dr. Scally’s recommendations on strengthening our quality assurance processes has commenced. We have also identified a number of priority positions for implementation, which are currently going through the approval process.

I assure members that the HSE is absolutely 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.

Following the recent untimely death of Laura Brennan, I want to take this opportunity to acknowledge Laura's work in promoting the HPV vaccine and the importance of cervical screening in the most difficult of personal circumstances. I had the privilege of meeting her and I know that she was an inspiration to us all through her dedication, bravery and humour. We all have a responsibility to take up her crusade to eliminate cervical cancer in Ireland. Our thoughts are with her family and friends at this most difficult time.

This concludes my opening statement and, together with my colleagues, we will endeavour to answer any questions committee members may have.