Mandatory Open Disclosure – What Next?

Mandatory Open Disclosure – What Next?

The Patient Safety (Notifiable Incidents and Open Disclosure) Bill 2019 has now passed all stages in the Houses of the Oireachtas and was signed into law by the President in May 2023. Once the Commencement Order is signed by the Minister, the Patient Safety Act 2023, will come into force.

The Act provides a framework for the mandatory open disclosure of a list of specified serious patient safety incidents that must be disclosed to patients and/or their families. Therefore, hospitals and other health care providers will be required to inform patients of certain adverse incidents, or patient safety incidents, that occur during the course of their care.

Background

The law surrounding open disclosure was previously governed by the Civil Liability (Amendment) Act 2017. The 2017 Act provided the legal framework to support voluntary open disclosure of adverse incidents to patients and their families and was commenced on 22^nd September 2018. In 2019, in light of the cervical check scandal and the subsequent report into this prepared by Dr Gabriel Scally, the then Minister for Health, Mr Simon Harris, indicated an intention to introduce mandatory open disclosure into law. This took the form of the Patient Safety (Notifiable Incidents and Open Disclosure) Bill 2019, which has now been signed into law.

What is a notifiable incident?

The Act provides for the mandatory disclosure of specified patient safety incidents, including an apology where appropriate. The obligation arises when the health services provider is satisfied that a notifiable incident has occurred. Even if none, or not all, of the likely consequences of the notifiable incident have presented or developed, or not all of the information relating to the incident, including information relating to the cause of the incident, is available, open disclosure must be made.

The notifiable incidents are set out in Schedule 1 of the Act and are as follows:-

• Surgery performed on the wrong patient [resulting in unintended and unanticipated death which did not arise from, or was a consequence of, an illness, or an underlying condition, of the patient, or having regard to any such illness or underlying condition, was not wholly attributable to that illness.]
• Surgery performed on the wrong site resulting in unintended and unanticipated death.
• Wrong surgical procedure performed on a patient resulting in an unintended and unanticipated death.
• Unintended retention of a foreign object in a patient after surgery resulting in an unanticipated death.
• Any unintended and unanticipated death occurring in an otherwise healthy patient undergoing elective surgery in any place or premises in which a health services provider provides a health service where the death is directly related to a surgical operation or anaesthesia.
• Any unintended and unanticipated death occurring in any place or premises in which a health services provider provides a health service that is directly related to any medical treatment.
• Patient death due to transfusion of ABO incompatible blood or blood components and the death was unintended and unanticipated.
• Patient death associated with a medication error.
• An unanticipated death of a woman while pregnant or within 42 days of the end of the pregnancy from any cause related to, or aggravated by, the management of the pregnancy.
• An unanticipated and unintended stillborn child where the child 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.
• An unanticipated and unintended perinatal death where a child born with, or having achieved, a prescribed gestational age and a prescribed birthweight who was alive at the onset of care in labour.
• An unintended death where the cause is believed to be the suicide of a patient while being cared for in or at a place or premises in which a health services provider provides a health service.
• A baby who—(a) in the clinical judgment of the treating health practitioner requires, or is referred for, therapeutic hypothermia, or (b) has been considered for, but did not undergo therapeutic hypothermia as, in the clinical judgment of the health practitioner, such therapy was contraindicated due to the severity of the presenting condition.

To whom should the open disclosure be made?

Under Section 7 of the Act, open disclosure of a notifiable incident must be made to:-

• The patient concerned;
• A relevant person where (the patient is unable to participate in open disclosure; the patient has died; or the patient has requested open disclosure to be made to a nominated person); and
• Both the patient and the relevant person, where the patient requests the relevant person to assist the patient.

Procedure prior to making an open disclosure

Before disclosure is made to a patient or a relevant person, the principal health practitioner must:

• Consider the timing of such a disclosure, taking into consideration the circumstances of the patient and the nature and consequences of the notifiable incident;
• Determine if disclosure is to be made to the patient the relevant person or both;
• Determine, based on the nature of the incident if an apology is appropriate;
• Take all steps to present the information relating to the incident as clearly as possible; and
• Designate a liaison person.

Information and apology

Significantly, any information provided, and apology where it is made, at a notifiable incident disclosure meeting in respect of a notifiable incident, shall not:-

• constitute an express or implied admission of fault or liability.
• be admissible as evidence of fault or liability
• invalidate or otherwise affect insurance cover.
• constitute an express or implied admission, by a health practitioner, of fault, professional misconduct, poor professional performance, unfitness to practise a health service, or other failure or omission in the context of regulatory investigations.

Further key aspects of the Act

• All cancer screening services (CervicalCheck, BreastCheck and Bowel Screen), will be subject to mandatory open disclosure ensuring access to comprehensive and timely information;
• There is an obligation on health service providers to report notifiable incidents to the relevant regulatory body; and
• The Act provides for the expansion of the Health Information and Quality Authority’s (HIQA) remit into private hospital services. This will allow HIQA to set standards for the operation of private hospitals, to monitor compliance with them and to undertake inspections as required;

Conclusion

Mandatory open disclosure of serious patient safety incidents is soon to be enshrined into the law in Ireland. However, commencement of the Act is still awaited, and the Department of Health is due to provide practical guidance, which will be welcomed, following multi-stakeholder engagement.

If you would like any further information or advice, please contact Alan Martin from the Healthcare team.

*This information is for guidance purposes only and does not constitute, nor should be regarded, as a substitute for taking legal advice that is tailored to your circumstances.