James Reilly (Dublin North, Fine Gael) | Oireachtas source

I thank the Chairman and committee members for giving me this opportunity to speak to them. I will keep my introductory statement as brief as possible and will be happy to reply to comments and questions. As the Chairman pointed out, we are joined by the chief medical officer, Dr. Tony Holohan, and the chief of the clinical effectiveness unit, Ms Kathleen MacLellan, not to mention our other friends from the HSE, Ms Laverne McGuinness, Mr. Ian Carter and Mr. David Walsh.

I reiterate my thanks, as the Chairman has done, to the families concerned who, in the face of their individual tragedies, had the courage and tenacity to ensure their babies’ stories were heard. I assure them that we have listened and learned and are fully committed to embedding that learning in all health services. Families and patients at Portlaoise hospital maternity services, PHMS, were not treated with an acceptable level of care, compassion and respect. I was so distressed by the experiences of the families I had met that I immediately requested the chief medical officer to conduct a review of safety at PHMS. This review was completed in three weeks and highlighted some critical issues for the health service.

The chief medical officer’s report is far-reaching. It makes 11 overall and 42 specific recommendations, all of which I have accepted. It not only sets out the immediate requirements for assuring safety for women attending PHMS but it also provides the strategic direction for maternity services in Ireland generally. Clear failures were identified in this preliminary risk and patient safety assessment of PHMS. This conclusion is drawn from Portlaoise hospital’s own assessment of its risk management processes; current risk management arrangements in place; monitoring of the implementation of recommendations in various investigations of adverse events in Portlaoise hospital; and findings made by the chief medical officer regarding patient safety and care. These failures were at both local and national level.

The critical initial question which the report addresses is whether the service provided by PHMS can be considered safe now and into the future, given the events reported in public and Portlaoise hospital’s response to them. I understand the significance of these patient safety failures and I am clear about the next steps that need to be taken. I have decided on a twin-track approach, providing specific directions and requests for both HIQA and the HSE. In addition, I will be requiring a number of assurances from my Department.

I reiterate a statement that I made to the families and the public last Friday. Portlaoise hospital maternity services could not be regarded as safe and sustainable within the existing governance arrangements, as they lacked many of the important criteria required to deliver, on a stand-alone basis, a safe and sustainable maternity service. On this basis and with immediate effect, I requested the HSE last Friday, 28 February, to put in place a transition team to assume control of the maternity service at Portlaoise hospital. This team, consisting of appropriate clinical and managerial expertise, will oversee the planning and execution of an orderly integration of PHMS within a managed clinical network under a singular governance model with Coombe Women and Infant University Hospital.

The HSE responded to my request immediately and a new general manager and director of midwifery were appointed to the hospital the same day. This interim management team will remain in place until a new governance arrangement is put in place for PHMS. Dialogue has also commenced with the Coombe Women and Infant University Hospital about how best to provide support to PHMS in a collaborative working arrangement into the future. I met some members of the board yesterday. Furthermore, I have requested the HSE to conduct a review of PHMS in respect of services for the infant and the family following a perinatal death.

The HSE must ensure effective systems are in place, including the provision of training where necessary, to ensure senior clinicians are competent to take responsibility for dealing with serious adverse events when they occur, including dealing appropriately with patients in such circumstances. The chief medical officer’s findings cannot be restricted to the maternity services at Portlaoise hospital; there are also ramifications for other services at the hospital and, to this end, I have requested the HSE to address the implications of this report for these services. In addition, I have asked that the HSE also look at other similar sized maternity services around the country and consider their incorporation into managed clinical networks within their relevant hospital group.

The HSE is about to commence a midwifery workload and workforce review in maternity services in Ireland. This project has been jointly commissioned by the HSE office of nursing and midwifery services director and the joint standing maternity committee of the Dublin maternity hospitals with the approval of the director of the HSE’s obstetrics and gynaecology programme, national director clinical strategy and programmes division, national director of quality and patient safety and the support of the chief nursing officer in the Department of Health.

The failures identified in this report were at both local and national level. I am acutely conscious that there is enormous pressure on the staff of the PHMS and of the need to rebuild their morale and confidence so that they can rise to the challenge of providing a safe and quality service. I have, therefore, requested the HSE to provide support to the Portlaoise hospital senior management team. This should lead to a wider programme of support for front-line leaders, particularly in smaller hospitals, to ensure they can, and do, provide safe and effective care. I want the HSE to ensure, in the first instance, every maternity service, and, thereafter, every health care service provider, is required to complete a patient safety statement, which is published and updated monthly. The statement will include information such as birth rates, adverse events and others and should be a requirement of hospital licensing.

However, this is not enough. I consider that a thorough investigation is required and in accordance with section 9(2) of the Health Act 2007, I have directed HIQA to undertake an immediate investigation of PHMS and to report to me by the end of 2014. I anticipate that many of the as yet unanswered questions will be addressed in the course of the HIQA investigation.

A culture of quality and of safe care is one in which there is open, kind, transparent, compassionate and sensitive care, effective team communications and a commitment to prevention of harm. A positive patient safety culture is focused on enhancing every aspect of the experience of a patient. It is well established in evidence that culture and behaviour are critical components of safe and effective care. To this end, I have requested that HIQA should also conduct an immediate assessment of the patient safety culture at Portlaoise hospital. I have also requested HIQA to adopt a standard tool for the assessment of patient safety culture and team working and to use its independent monitoring role to ensure it is implemented throughout the health care system.

In addition, I have asked HIQA to develop national standards for the conduct of reviews of adverse incidents. In this context, I have also requested that the HSE should issue a directive to all providers to require them to notify the director of quality and patient safety and HIQA of all "never events". In this case "never events" will include perinatal deaths from low risk pregnancies. A "never event" by its nature cannot always be prevented, but the very fact that it happens should mean an urgent examination by the hospital in question of all its systems. My Department will, through the forthcoming health information Bill, make the notification of "never events" a mandatory requirement.

An outline of the patient safety risk profile of hospitals in general and for PHMS specifically was not available in the preparation of this report. The requirement to pool information that may exist across agencies to create better risk and safety profiling of services is a critical gap in our patient safety functions nationally. To this end, I have recommended the establishment of a national patient safety surveillance system by HIQA. HIQA will use this information for risk stratification and guiding the targeting of their standards monitoring programme. My Department will examine any amendments to the Health Act 2007 that may be required.

A broader finding identified in this report was the systematic under-reporting of perinatal deaths due to inconsistencies in Ireland's perinatal data collection. Specifically, this requires a single definition of a perinatal death for the Irish system. This will require changes to the Civil Registration Act 2004 and in this regard, my Department will work closely with the Department of Social Protection to ensure that all official perinatal mortality rates are calculated using a common definition. I have asked my Department to immediately actively pursue all actions identified for it in this report. I will require regular patient safety assurance reports from both the HSE and HIQA to inform me of the progress on the implementation of all recommendations in this and all other reports. I will not tolerate any delays in progressing the critical patient safety issues that have been identified.

The report into perinatal deaths at the Midland Regional Hospital Portlaoise is far reaching. It not only sets out the immediate requirements for assuring safety for women attending PHMS but also provides strategic direction for maternity services in Ireland generally. The report will not only inform, but underpin the planned development of a national maternity service strategy which will be delivered this year. This strategy will provide the strategic direction for the optimal development of our maternity services to ensure all women have access to safe, high quality maternity care in a setting most appropriate to their needs and it is my intention to publish the strategy this year. We need to learn from past mistakes and move on to rebuild confidence in the safety of our maternity services. The new strategy will determine the future model of our maternity services to ensure they are fit for purpose and in accordance with best available national and international evidence.

The report shows that the planned patient safety agency, PSA, has a vital place in our health service, which is why it is included in this year’s HSE service plan. The agency will be established shortly and applications for a chief executive officer will be invited. The PSA will be a "patients’ champion" supporting patients to ensure they receive an appropriate response to the safety issues they raise. The PSA will also promote and disseminate learning on how we can build and enhance a safety culture in all our health care services.

As Minister, I am acutely conscious of the importance of patient safety. The stories of babies Katelyn Keenan, Joshua Keyes-Cornally, Mark Molloy and Nathan Molyneaux made a significant impression on me and I am sure everybody present. I would like once again thank their parents Sharon, Thomas, Natasha, Shauna, Joey, Roisin and Mark who brought the serious failures identified in this report to light. I listened to the parents when they said they wanted their local services to be safe and I assure them and other parents that the Department, HSE and I will do everything within my remit as Minister to ensure every step is taken to prevent such events occurring in the future.

I will hand over to Dr. Tony Holohan, chief medical officer of my Department who will give a brief presentation and overview of the report he prepared on the perinatal deaths at Midland Regional Hospital Portlaoise. I would like to express my thanks to the Chairman and the committee members for listening.