Press Release

Commission on Patient Safety and Quality Assurance established by Mary Harney, T.D. Minister for Health and Children

The Minster for Health and Children, Mary Harney T.D., announced today that she had set up a Commission on Patient Safety and Quality Assurance.

The Commission will be chaired by Dr Deirdre Madden, BL, a leading expert on medical law and ethics. It includes nursing and medical representatives, management representatives and, importantly, two representatives of patients and carers. It will report to the Minister within eighteen months.

The Minister said:
“I am very pleased that Dr Madden has taken on this important task.  I am confident the members of the Commission are well placed to develop clear and practical recommendations.  The aim is to make our health system a place where the highest possible standards of patient safety and quality care are pursued and implemented rigorously by all who work in the health services.

The Lourdes Hospital Inquiry and other health care inquiries have underlined the need for a broad review of patient safety and quality right across our health system. I am determined that we learn the lessons from instances where patients have been harmed.  While individual error may play an important part in adverse events we must examine how hospitals and other services can be managed to create an environment in which safety and quality are central to everyone’s job.

In short, we must do everything necessary in management and organisation to eliminate, as far as humanly possible, what have been called ‘system failures’. 

Patient safety and quality of care are central, and will drive reform of our health services.  I want every patient to have the highest possible confidence in the safety and quality of their care.”

The Minister has asked the Commission to develop proposals for:
– greater accountability within our health system for performance in relation to patient safety;
– more effective reporting of adverse clinical events and complaints in order to learn from them and ensure that the rest of the health system learns from them;
– a clearer role for patients and carers in feeding back on care received;
– ways to ensure health care practice is consistently based on what has been shown to work in other centres; – a statutory system of licensing of public and private providers of health care; and
– better integration of the work of the different regulatory bodies in the health system in order to achieve a joined up approach and a sharing of best practice.

Note for editors:
Commission Membership
Chair: Dr. Deirdre Madden, Lectures in Legal Studies, University College Cork
Dr. Richard Brennan, General Practitioner, Kilkenny
Tracey Cooper, CEO, Interim Health Information and Quality Authority
Dr. Philip Crowley, Deputy Chief Medical Officer, Department of Health and Children
Mary Duff, SRN, Director of Nursing St Vincent’s Hospital
Edwina Dunne, National Head of Quality of Risk, Office of the CEO, Health Services Executive
Paul Fox, Process Engineering Manager, Bausch and Lomb, Waterford
Dr. Mary Hynes, Director of Quality and Risk, National Hospitals Office, Health Services Executive
Professor Fergal Malone, Professor of Obstetrics, Royal College of Surgeons in Ireland
Margaret Murphy, Patient/Carer representative, Cork City
Dr Alf Nicholson, Consultant Paediatrician, Our Lady of Lourdes Drogheda
Tiberius Pereira, Patient/Carer representative, Dublin
Dr. Ailis Quinlan, Clinical Indemnity Scheme
Dr Gabriel Scally, Regional Director of Public Health for the South West Region of England, Bristol, England
Dermot Smyth, Assistant Secretary, Department of Health and Children

Background Several international studies suggest that adverse events in health care affect many people who access hospital services. This causes significant suffering to patients and their families. Most errors appear to result from one or more of the following factors: system design; product safety; service environment; communication failures; and institutional culture. A safe clinical environment requires clear leadership from the top of the organisation to ensure that quality of care and clinical outcomes are subject to continuing audit review and action. The evidence suggests that quality of leadership and management of health care services determines the degree to which the care is safe and of high quality.

Inquiries into adverse clinical events The Lourdes Hospital Inquiry revealed a hospital that operated without any effective external scrutiny of performance and an obstetric unit where management operated in isolation from, and unaware of, the daily operation of clinical services. The report also raised concerns about the performance of training standards bodies.

The whole system (clinical and management) failure identified in the Lourdes hospital is not unique to Ireland. Similar inquiries have been needed in other countries arising from significant system, management and clinical failures. Inquiries in Bristol England, and Canberra and Queensland Australia have highlighted common factors in significant health systems failures, viz.:

  •   in many cases recurrent failures in clinical practice were not identified;
  •   the institutional culture was identified as being a problem because of its closed nature and its focus on blame when problems arose;
  •   clinicians felt accountable to their college rather than their hospital;
  •   senior management failed to realise the seriousness of the clinical failure and failed to act upon it; and
  •   there is a need for clarity of responsibility for patient safety and heath care quality.


All the reports proposed new organisational arrangements to improve clinical quality incorporating national standards, comprehensive adverse clinical event reporting, clinical audit, accountability of senior clinicians, performance monitoring and clinical governance. The reports proposed the promotion of a no-blame learning and questioning culture, executive leadership to promote quality, staff involvement and partnership with patients.

These reports point to the need for:

  • a process to ensure that the environment in which health care takes place is supportive of safe and good quality care;
  • greater accountability of institutions and their management for institutional performance;
  • greater accountability in the different bodies that regulate clinical practice;
  • a strengthened system of information on adverse clinical events and complaints; and
  • a clearer role for patients and carers in feeding back on care received.

There are already a number of local and national initiatives underway to address some of the issues raised in the Lourdes Inquiry. However, the failure in the health care system identified in the Lourdes Inquiry demands a system-wide response to address health care quality and health care outcomes.

Proposal to establish a Commission to examine: ways of establishing responsibility and accountability for quality and safety at appropriate levels within the system;

Clinical governance There are a number of bodies and many measures that currently seek to address different elements of the patient safety/quality of care agenda. However, we still do not have a safe health care system. Patient safety and quality of care must be at the core of how services are planned and delivered.

There is a need to develop a framework for the Irish health services that will embed a clear senior management role to ensure that the clinical environment in their organisation is conducive to quality and safe practice, to evaluate clinical and managerial performance and to investigate and address any areas where performance may give cause for concern. This corporate management of clinical standards would also seek to ensure that systematic audit of clinical performance becomes a standard feature of our health services. The policy framework in which health service quality is delivered must be supportive and ensure that the maintenance of patient safety is a primary consideration.

Licensing The Minister has previously signalled her intention to consider the issue of a licensing system for public and private health care providers with an associated enforcement regime. Ireland is out of step with most developed countries in not having such a system of registration for hospitals and clinics (other than psychiatric facilities). A requirement for all healthcare providers, public and private, to be licensed for service delivery by the State would ensure that minimum standards of professional qualification and premises quality would need to be complied with.

Regulatory regime There are a number of bodies tasked with regulating professional groups in the health area. However, there is currently no general oversight of their work and no structure to facilitate the interchange of best practice between them. The Commission will review the governance of the regulatory bodies in the health system and their role in the oversight of training standards. It will develop proposals to achieve better integration of the work of the individual bodies.