Procedures to prevent newborn brain damage were the biggest safety issue reported to Hiqa

Certain incidents must be notified to Hiqa under the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023.

The biggest single patient safety issue about which HSE hospitals notified the health watchdog under new mandatory reporting requirements were procedures to help prevent newborn baby brain damage.

Neonatal hypothermic treatments, also referred to as neonatal cooling, were the subject of of 121 patient safety notifications received by the Health Information and Quality Authority (Hiqa) from September 2024 to September 2026.

They made up the highest notification type, followed by 56 cases of what were classed as “unintended, unanticipated death directly related to any medical treatment”.

The third highest type of notifications were those classed as an unanticipated and unintended baby death.

There have also been 14 unanticipated deaths of healthy patients undergoing elective surgery, and eight deaths “associated with a medication error”.

In addition, there have also been eight suspected suicides and three deaths of women who were either pregnant or who had recently given birth.

Certain incidents have to be notified to the watchdog by health service providers under the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023, which came into force in September 2024.

Every notification is reviewed by an inspector and risk-rated by Hiqa, which can take a number of actions in relation to the information received.

This includes requesting additional or further information under Section 31 of the Patient Safety Act or carrying out an inspection of the service for which Hiqa has a monitoring role.

More than 55% of the notifiable incidents it has received since September 2024 required some form of follow-up with reporting services, such as seeking further information and/or further assurances.

Hiqa said no follow-up was required due to there being sufficient information in just 5.3% or 12 cases, while a further 24.7% or 56 cases were closed, but their details were “retained for information for future inspections”.

Another four cases are currently being reviewed by Hiqa inspectors, nine are the subject of “escalation activities", and further information and assurances have been sought in 145 cases.

Of those where further information has been sought, 64 cases related to a baby referred for therapeutic hypothermia and 28 cases related to unanticipated baby deaths.

Another 28 cases of unanticipated deaths directly related to any medical treatment.

A 'point in time' reference

A Hiqa communications spokesperson said: “The numbers of notifiable incidents and regulatory actions arising from Hiqa’s receipt of notifications are part of a live process and should be considered as a ‘point in time’ reference.” 

He said Hiqa has conducted inspections arising from its assessment of notifiable incidents, but not all of them were solely because of notifications received under the 2023 act.

He said: “The occurrence of a notifiable incident must be managed by each health service provider in a culture that learns from errors and takes corrective action to improve patient safety.

“When things go wrong, health service providers need to act in a transparent, standardised, and systematic way to review the incident and learn from it."