Charles Flanagan (Laois, Fine Gael) | Oireachtas source

These amendments relate to section 8, the section that defines the key concept of what constitutes a patient safety incident. It is an important definition based on the World Health Organization international classification for patient safety. That definition covers three concepts: incidents that caused unintended or unanticipated injury or harm to the patient; incidents that did not result in injury or harm at all, known as no-harm incidents; and incidents that were prevented from happening by timely intervention or by chance, commonly described as "near misses". In the case of no-harm incidents, section 8 refers to the health service provider having reasonable grounds for believing the incident placed the patient at risk of unintended injury or harm. Similarly, in the case of near misses section 8 refers to the health service provider having reasonable grounds for believing that, in the absence of the incident being prevented, injury or harm could have occurred to the patient.

The intention behind these amendments is to cover any no-harm incident or any near miss where any person has the reasonable belief that the patient was put at risk. It would usually be the provider that would have the knowledge that a no-harm incident has occurred, or that there has been what can be described as a "near miss". The Minister for Health appreciates that the intention behind the amendments is to cover where the patient or family believes a no-harm incident or near miss has actually happened. His view, however, is that it is the provider which makes the disclosure of the no-harm incident or the near miss, and it should therefore be because the provider reasonably believes the patient had been placed at risk or that an incident had been averted, rather than because somebody else has that belief. If a patient or his or her family has a concern that a no-harm incident has happened or that there has been a near miss, they could, of course, make the provider aware of the concern, and the provider could then look into the issue. If the provider came to the conclusion that there had been no harm incident or a near miss, it could make the open disclosure then. Therefore, I do not intend to accept the amendments.

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