Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023

In recent weeks, my colleagues and I in the Medical Negligence Department at Cantillons were pleased to learn that the long awaited “Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023” (“The Act”), which was signed into law last year in May 2023, had finally come into effect.  In short, what this legislation means in practice for patients and/or their families is that specified serious patient safety incidents (known in the Act as “Notifiable Incidents”) must, by law, be disclosed to the patient and/or their family by healthcare professionals, in what is commonly referred to in the legislation as an act of “open disclosure”.  The Act also provides for the mandatory external notification of those same events to the appropriate body. This, we hope, will enable trends to be identified and for mistakes to be learned from, thereby improving patient safety overall.

Notifiable incidents for example include, but are not limited to, as follows;

1. A baby who is referred for, or considered for, therapeutic hypothermia (i.e. a type of treatment to lower the body temperature).

2. An unexpected and unintended stillborn child, that was born without a fatal foetal abnormality and with a prescribed birthweight, or has achieved a prescribed gestational age, and who shows no sign of life at birth, from any cause related to the management of the pregnancy, and the death did not arise from an underlying condition of the child.

3. An unanticipated death of a woman while pregnant, or within 42 days of the end of the pregnancy, related to the management of the pregnancy instead of the illness of the woman or an underlying condition that she had.

4. A death of a patient who has undergone surgery as a consequence of the unintended retention of a foreign object (eg. a swab/needle).

5. A death following the wrong procedure being performed on a patient, or on the wrong site.

6. The unexpected or unintended death of an otherwise healthy patient undergoing an elective procedure where the death is directly related to a surgical operation or anaesthesia (including recovery from the effects of anaesthesia).

7. A death of a patient due to the transfusion of incompatible blood or blood components

8. A death of a patient arising from a medication error where the death did not arise from an underlying condition or illness of the patient.

Prior to the commencement of this Act, health practitioners were not obliged, by law, to tell their patients/ families of patients the truth when mistakes were made. While the Irish Medical Council Guidelines clearly state that patients and their families are entitled to an honest, open and prompt communication about adverse events which may have caused harm from their healthcare providers, we have seen in practice, how these guidelines are not always adhered to. (In some respects, the Medical Council Guidelines go further than the Act and of course, should still be complied with by doctors).

Therefore, the introduction of this legislative framework is welcomed as a first step by my colleagues and I as too often we see families/clients left “in the dark” with no other option but to instruct solicitors to get the answers/information that they were not provided by the healthcare providers in question. Oftentimes, such information can take months/years to obtain due to delays in getting records from hospitals and thereafter, reports from suitable experts. The delays can cause further harm to those affected.

The requirements of the Act apply to all healthcare bodies including, but not limited to:

• The Health Service Executive;
• Private Hospitals;
• Private health and social care providers such as GPs, Dentists and Pharmacists.

As regards how compliance will be safeguarded, the Act provides for example that where a Notifiable Incident is not disclosed, and the person(s) have no reasonable explanation for the failure to disclose, that person(s) will be liable on summary conviction to a Class A fine (up to €5,000).

We hope the commencement of this Act will, as intended, lead to far more incidences of open and honest disclosure/transparency, between patients, relevant persons’ and health services providers, and importantly, on a timely basis.

Contact us at Cantillons Solicitors at +353 (0)21 4275673 or info@cantillons.com if you would like more information.

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