Ms Eil?sh Hardiman:

Good afternoon. I thank the Chairperson and members for the opportunity to address them. I am joined by Dr. Allan Goldman, chief medical officer, Ms Paula Kelly, clinical director and paediatric orthopaedic consultant and Dr. Ike Okafor, clinical director and a consultant in paediatric emergency medicine.

We appear before the committee representing the 4,845 people in our services in Temple Street, Crumlin, Tallaght and at Connolly Hospital who work diligently at the front line of healthcare, delivering care through 39 clinical specialties, serving 25% of the population for their national paediatric specialty needs, as well as the secondary paediatric care needs of children and young people in the greater Dublin area. Our teams treat and care for more than 153,000 emergency department attendances, around 26,000 day cases, 23,000 inpatient admissions and carry out in excess of 15,500 theatre procedures per annum. The team at Children’s Health Ireland deliver excellent care to children and young people every day, despite in most cases dealing with outdated and inadequate infrastructure. I am proud of our staff, the work they do and the positive healthcare outcomes they deliver.

The focus over recent days has been on matters of serious concern in Children’s Health Ireland at Temple Street. The vast majority of our services in Temple Street and across CHI are not in any way implicated or subject to the reports that we are discussing today. CHI and specifically the team at Temple Street are proud of the history of care provision from that hospital, and rightly so.

I begin my remarks this morning by reiterating the apology CHI has previously made to the children, young people and families included in the internal and external reviews we published last week.

These reports show what we had feared when we commissioned this work. Children did not receive the level of care they were entitled to and deserved. For an organisation that exists with a singular focus, that being to deliver safe, quality care to those we serve, these findings are distressing. I know that, for the patients and families involved, it is even worse. We are deeply sorry the children, young people and families did not get the care they deserved and we apologise unreservedly for the harm they endured.

Tragically, one child included within the reviews has died. The child’s case is the subject of a coroner’s review and is also the subject of a serious incident investigation. These processes will determine the sequence of events that led to this tragic outcome, and we are committed to providing the child’s family with the incident review report as soon as it is completed. All of us at Children's Health Ireland, CHI, are distraught at this outcome. I offer my sympathies and profound apology to the family involved. I also want to apologise to my colleagues and the entire team in CHI for the negative focus these events have brought upon Temple Street and CHI as a whole and to thank them for their continued dedication and commitment to the children, young people and families for whom they care.

Things happened in CHI at Temple Street that should not have happened. Decisions were made, certain procedures were carried out, children were subjected to a higher than expected number of unplanned return trips to theatre and, alarmingly, unapproved, non-medical-grade devices were implanted in three children. This is a shocking litany of events. CHI decided to commission two reviews into complex spinal surgery for patients with spina bifida in Temple Street. These were completed in July 2023. They were triggered following the occurrence of two serious incidents and concerns raised by staff about the surgical outcomes for these patients. The reviews were undertaken by a leading international children’s hospital. These reports will feed into the independent review that is now under way under the governance of the HSE. We welcome this external review and will co-operate fully with it. It is essential that all aspects of these events be fully investigated, that any individual or individuals responsible be identified and, more importantly, that any institutional or systemic issues that contributed to enabling these events to happen be found and addressed immediately.

I assure the committee that actions have already been taken to prevent a recurrence of these events. As the reports identify, as soon as we became aware that the outcomes of these surgeries were not what they should have been, we acted. In response to members' questions, Dr. Allan Goldman, chief medical officer, can outline the steps we have taken. There is work ongoing with each of the patients included in the reviews to ensure continuity of care. Each child and family has received a copy of the reports and all, except for one due to personal reasons, have had a clinical review by another paediatric orthopaedic surgeon and a dedicated care pathway commenced. As members will also know, the clinician at the centre of the review is the subject of human resources and Irish Medical Council processes and we are precluded to some degree from commenting further, although we will endeavour to provide as much information to the committee this afternoon as we can while respecting due processes and natural justice.

In addition to the apology we have already issued, I apologise to the children, young people and families for poor communication on our part across the past week. While we spoke to and met all of the 19 families whose children were the subject of the reviews, I am aware more could have been done. I am aware, too, that there are families who, while their children were not the direct subject of the reviews, also feel hurt and upset. I know children with spina bifida, others on the spinal surgery waiting list and their families have been distressed by the findings of the reviews and I apologise to them that this has added further to their concerns and has caused upset.

For more than 150 years, excellent clinical care has been provided to children and young people in Temple Street by dedicated, passionate and talented people who get up and come in night and day to meet the needs of their patients despite inadequate infrastructure. I have heard the hurt and distress that the focus on CHI and Temple Street has caused to staff. I want to say to them and to all the children, young people and families that continue to come through our doors that best-in-class care and treatment are provided to those who need us every day and every night of the year. I reassure parents, guardians, children and young people that high-quality and safe care is being delivered by our team of excellent staff.

As to how it came about that issues relating to complex spinal surgeries came to our attention, I will start by saying that spina bifida services for children are delivered in Temple Street through a well-established and large multidisciplinary team charged with their care. Spinal surgery by an orthopaedic surgeon is one element of this specialist service. There have historically been long waiting times for access to spinal surgery for children in Ireland, including patients with spina bifida. This was exacerbated by the recent Covid-19 pandemic and by the cyberattack, of which members are aware. Supported by the increased HSE funding of €19 million to address these increased waiting times, a number of actions were taken. In April 2022, CHI at Temple Street increased the volume of complex spinal surgeries undertaken, including for patients with spina bifida, to improve access to services.

Following the resulting increase in complex surgery activity between April and August 2022, it became evident by September that patients having complex spinal surgery were having longer hospital stays. Concerns on surgical outcomes were raised by members of the multidisciplinary team looking after these patients. These concerns related to higher than expected complication rates seen in this cohort of patients, particularly a high rate of unplanned returns to theatre and post-operative infection rates in patients with spina bifida undergoing complex spinal surgery.

Following two significant incidents involving spinal surgery in CHI at Temple Street over the summer of 2022, a review of patient outcomes was commenced. The aim of this clinical review process was to assess if the clinical outcomes for these patients were in keeping with other similar centres around the world, to evaluate if there were specific safety concerns requiring a response by CHI, and to seek recommendations to improve continuously the treatment and management of this complex group of patients. These surgical procedures are extremely complex and involve the insertion of metal rods into the patient’s spine in an effort to correct its curvature. These are high-risk surgeries, with high post-operative complication rates. Concurrently with commissioning this review in November 2022, the clinician elected to pause the most complex spinal surgery, known as a kyphectomy procedure, for patients with spina bifida until the outcome of the external quality review was available. This decision was supported by CHI.

Members will of course be concerned about the unauthorised use in spinal surgeries of unapproved non-medical-grade devices or, in other words, springs. Quite frankly, this is an unprecedented occurrence and is truly shocking. The facts around this matter will be the subject of a serious incident investigation. The investigation will examine end-to-end processes within the hospital, including procurement and custody of these items. It will also look at who knew that non-medical-grade devices were being used, how they were procured and why at no stage did someone say "Stop". While innovative approaches to care might be considered on one-off compassionate grounds, it is unheard of for any clinician to determine to use a non-approved non-medical-grade device in a patient. It is simply not done. No approval was granted and none would be granted for a non-medical-grade device to be implanted.

Obviously, I am aware there is justifiable scrutiny, not just of the complex spinal surgeries of concern to the review process but of the wider spinal surgery and scoliosis programme in CHI. While the ongoing issues relating to access to surgery and unacceptably long waiting times are not the subject of the review, they are a subject of concern for us. We are keenly aware of the significant problems caused to children, young people and their families due to long waiting times and we are happy to discuss this issue with the committee as well. I wish to put on the record that, on foot of the increased funding I referred to, CHI and our colleague hospital, the National Orthopaedic Hospital Cappagh, had completed 509 spinal procedures by the end of 2022. This was a 47% increase in activity compared with 2021, equating to 162 more children who had their spinal surgery. Unfortunately, there has also been a 57% increase in children seeking spinal fusions added to our spinal surgery waiting list. We are doing all we can to reduce waiting times and will continue to do so. These surgeries are happening every week in our hospitals and are making a profoundly positive impact on the lives of the children who receive them. The 2023-24 scoliosis and spina bifida action plan is a two-year plan that builds on the work completed in 2022. The plan has been developed taking into account the learnings from 2022, particularly the impact of increased complexity of care on the acute hospital setting. The aim of the plan is to treat children and young people on the waiting list for complex spinal surgeries. The methods of enhancing the capacity to support these are listed in my submission, which I will take as read.

As has been stated in the reviews, CHI staff are committed and motivated to provide safe, effective, patient-centred and efficient care to patients with spina bifida to improve clinical outcomes. We care deeply about the quality of that care. We have already spoken to the families of those patients whose cases are the subject of this review and have shared the findings. I want to put on the record, too, that last week we also spoke to four advocacy groups and briefed them on the review’s findings, although I accept their unhappiness at that communication process.

Without in any way seeking to qualify the apologies that we have given, it should be said that complex spinal surgery in spina bifida children, unfortunately, has a high complication rate. However, in these cases the level of infection was above what would have been expected and is unacceptable. Children’s Health Ireland has already acted on the recommendations made in the two reviews published last week and are committed to fully co-operate in the external review that has been announced by the HSE. In particular, complex spinal surgery procedures for patients with spina bifida will now take place in CHI at Crumlin.

Open disclosures commenced in August for patients and families in these reviews. Serious incident investigations are well advanced for the two spinal surgery incidents, with open disclosure and sharing of investigation reports with families. The roll out of the CHI professionalism programme and the changes in quality and safety measurement and monitoring will be taken forward to address issues relating to culture and supporting our clinical teams to speak up about concerns. We value patient safety, and we want our team members to speak up when they want to or when they feel they need to. As I have said, the surgeon involved in these cases is no longer carrying out these surgeries and is in a human resources and Irish Medical Council process.

We are reviewing all aspects of our governance and risk and safety processes and procedures. As one CHI, and prior to our move to the new children’s hospital, massive change and integration is under way. Since April of this year, we are working as a cross-city site rather than as individual hospitals. This has resulted in more consistency and streamlining of processes, policies and procedures. Quality, risk and safety has been overseen and managed by a single framework rather than on a site-by-site basis. We will, in time, develop one single set of processes and guidelines across all our sites. While we cannot do this overnight, our priority is to ensure that any gaps identified in those processes are addressed as soon as possible. To be clear, we are implementing the review recommendations now; 20% are already completed with the remainder are all under way, scheduled to be completed by the end of this year.

To conclude, our job now, in implementing the recommendations of the reviews published last week and in working with the HSE on the wider review, is to ensure with certainty that the highest quality, safe care is provided to all children and young people at all times, as soon as is possible. We have listened to the issues raised by the advocacy groups and intend to improve our communications. While we have a road to travel, we will then focus on rebuilding trust and confidence among the children, young people and families who need services in CHI at Temple Street. We have listened and work with children, young people, families and their representative bodies, all of whom have suffered as a result of what happened. We will also provide whatever supports are necessary for patients, families and staff who have been hurt and upset by these revelations.

I thank the committee for giving me the time to address members and I look forward to hearing their thoughts and answering their questions.