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Reviewing patient safety incidents

High-profile tragedies in our health services, such as the death of Savita Halappanavar and a number of infants in regional maternity units, have brought the issue of patient safety to the forefront of the national health agenda in recent years. There is a recognised need for patient safety incidents to be managed in an open culture that learns from errors and takes corrective action to improve patient safety. 

Aside from the terrible consequences a medical error can have for a patient and their family, it is frequently unacknowledged how they can also have a significant and serious effect on the health and wellbeing of staff. The potential effects of an incident and the subsequent burden of a review on staff is something that health services are now under greater pressure to recognise. The values as to how patient incidents should be conducted are contained within HIQA’s National Standards for Safer Better Healthcare, in particular, Standard 3.3, which states patient safety incidents should be “managed and reported in a timely manner in line with national legislation, policy, guidelines and guidance, where these exist”. They are also part of the Mental Health Commission’s (MHC’s) Quality Framework for Mental Health Services in Ireland, which aims to promote improvements in how services conduct reviews these incidents. 


HIQA and the MHC have now jointly developed Draft National Standards for the Conduct of Reviews of Patient Safety Incidents, which were recently published by HIQA.

These standards were commissioned by the Department of Health and are underpinned by findings from the Chief Medical Officer’s 2014 Report on Perinatal Deaths in HSE Midland Regional Hospital Portlaoise, which recommended the development of national standards on the conduct of reviews of patient safety incidents, following the identification of shortfalls with the current system in Ireland. The report highlighted that there was confusion regarding incident classification and method of review required and inconsistency in the time taken to conduct and complete reviews. It also said the quality of the reviews was variable and that there were insufficient procedures for unique anonymisation.

On a practical level, the standards endorse the establishment and implementation of structures and procedures for conducting reviews of patient safety incidents

The Department requested that a phased approach be taken towards the development of these standards with an initial focus on service-specific standards for acute hospitals under HIQA’s remit and mental health services under the remit of the MHC. Designated centres for older people, people with disabilities and children under the Health Act 2007 are not within the scope of these standards and should refer to the relevant HIQA standards and regulations for information on conducting reviews of incidents in social care services.


On a practical level, the standards endorse the establishment and implementation of structures and procedures for conducting reviews of patient safety incidents. 

“As the size and scope of health and mental health services differ across the country, a one-size-fits-all approach does not recognise the diverse nature of incidents, the context in which they could occur and the range of approaches that may be undertaken to conduct reviews of patient safety incidents,” according to the standards document.

“Conducting a review of a patient safety incident is a complex process which requires services to weigh the outcome or potential outcome of the incident with the complexity of the incident. An incident which resulted in severe harm or death may have a very clear root cause and not require a comprehensive review. Similarly an incident with lower level of harm may have occurred on a repeat basis with no clear reason; this may require a comprehensive systems analysis.”

 The standards also seek to recognise that incidents may not be detected at the point of occurrence, but may become apparent sometime later, for example, during a look-back review. The document states that incidents vary in terms of degrees of harm; numbers of people involved; risk exposure; financial loss; media interest; and the need to involve other stakeholders. Any review would have to recognise these differing causes and circumstances. 

According to HIQA, the majority of patient safety incidents should continue to be managed at a local level, within the standing quality, safety and risk structures, and do not require a formal review or involvement from the HSE’s Serious Incident Management Team. The Team will oversee the management of incidents requiring a formal review. 

In the report, HIQA states the Team will ensure a review is commissioned to determine the identified key contributory and causal factors and determine what learning can be derived to improve patient safety. 

The methods and time-frames for reviews of patient safety incidents must be appropriate to the nature, severity and complexity of the incident but above all, reviews must be focused on learning and improvement for the future.

“These standards promote the timely review of patient safety incidents and services must be cognisant of the need for a timely review of the evidence and their duty of care to respond to those involved in the incident,” according to the report.

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