Mandatory Open Disclosure – Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023

Yvonne Joyce, Partner, CKT reviews the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 which commenced on the 24^th September 2024. This has introduced for the first time in Ireland mandatory open disclosure by health service providers where certain healthcare incidents occur.

What is the purpose of the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 (the “Act”)

The Act for the first time –

1. Introduces a new requirement for mandatory open disclosure to be made by health service providers of specific serious patient safety incidents referred to as notifiable patient safety incidents;
2. Schedule 1 lists a number of notifiable incidents for which mandatory open disclosure must occur and allows the Minister for Health make regulations to regularly update this;
3. Provides certain protections regarding the admissibility of information and/or apology given as part of the process for the purpose of clinical negligence actions, indemnity and regulatory complaints.
4. Requires health service providers to notify serious notifiable patient safety incidents to either HIQA, the Chief Inspector of Social Services or the Mental Health Commission as appropriate to ensure there is national learning and health service wide improvement.
5. Extends HIQA’s remit to private hospitals
6. Contains provisions supporting the conduct of clinical audit in the health service.
7. Sets out penalties for non-compliance.
8. Mandatory open disclosure and external notification of notifiable incidents applies to both the public and private health services.
9. Introduces “Part 5 Reviews” in cancer screening services, which allows a patient to request a review screening results carried out by CervicalCheck, BreastCheck and Bowel Screen in relation to the patient.

Mandatory Open Disclosure – What is a notifiable incident?

At present, notifiable incidents as listed in Schedule 1 of the Act, include deaths which are unintended or unanticipated (and do not arise because of an illness or underlying condition of the patient) from:

A. Surgery on the wrong patient or performed on the wrong site or as a result of the wrong surgical procedure.

B. Unintended retention of a foreign object in the patient after surgery.

C. An elective surgical operation or anaesthesia (including recovery from the effects of anaesthesia).

D. Any medical treatment (and not a consequence of the patient’s illness or underlying condition).

E.Due to transfusion of ABO incompatible blood and blood components

F. Due to medication error.

G. Maternal deaths from any cause related to or aggravated by the management of the pregnancy.

H. Stillbirths, where the child was born without fatal foetal abnormality and had reached a prescribed birth weight/gestational age, from any cause related to or aggravated by the management of the pregnancy.

I. Perinatal death where the child was born having achieved a prescribed gestation age/birth weight who was alive at the onset of care and labour, from any cause related to or aggravated by the management of the pregnancy and the death is not as a result of an illness or an underlying condition

J. Suicide

It also includes a baby who, in the clinical judgment of the treating health practitioner, requires or is referred for therapeutic hypothermia or has been considered for, but did not undergo therapeutic hypothermia.

Who is responsible for ensuring the notifiable incident disclosure meeting occurs?

Health practitioners have a duty to inform the relevant health service provider when they are of the opinion that a notifiable incident has occurred.

The duty is then on the health service provider to ensure that open disclosure occurs.

Procedure for making a notifiable disclosure

The procedure set out includes:

• Appointing a designated person to liaise with the patient and their family
• Information that should be provided at the meeting and in writing at or after the meeting.
• Providing any clarifications that may be required.
• What to do if the patient/family does not want to engage in open disclosure at that time
• Records that should be kept by health service providers

Who makes the notifiable disclosure?

The principal health practitioner involved in the care of the patient makes the open disclosure to the patient and their family.  If they are not available, or not in a position to carry out the open disclosure, then the health service provider must ensure that another appropriate person can make the open disclosure to the patient and their family instead.

What information must be disclosed?

The Notifiable Incident Disclosure meeting must generally be held in person and the information to be disclosed includes:

• The names of the people at the meeting
• A description of the incident
• How the health service provider became aware of the incident
• The effect that the incident might have on the patient
• The treatment and care plan the patient might need
• Any steps that have been taken to investigate the incident to prevent it happening again
• An apology, if that is appropriate in the circumstances
• In relation to the written statement to be given to the patient and their families, this could take the form of a letter explaining what happened. This statement can be given at the meeting or five days after the meeting and should be signed by the health practitioner on behalf of the health service provider.

The Act also makes it clear that patients do not have to participate in an open disclosure meeting if they do not want to.  They have up to 5 years to change their minds.

Protections for information and apology

The information and/or apology given in the context of an open disclosure meeting or in the follow-up written information does not constitute an express or implied admission of fault or liability in a subsequent clinical negligence action, will not invalidate a policy of professional indemnity insurance or contract of insurance and shall not constitute an express or implied admission of professional misconduct, poor professional performance  or unfitness to practice in any regulatory complaint.

Penalties

A Health service provider found guilty of failing to comply without reasonable excuse with the Act will be liable on summary conviction to a Class A fine. If the offence was committed with the consent or connivance or was attributable to any wilful neglect of a person who was a director, manager, secretary or other officer of the health service provider, that person, as well as the body corporate, will be guilty of an offence.

If a health practitioner does not engage in open disclosure as they are required to do under the legislation, this will be a matter for the relevant health professional regulatory body.

Comment

The HSE, the Irish Medical Council, and medical indemnifiers have long supported the practice of Open Disclosure. The implementation of this Act aims to benefit both healthcare providers and patients by fostering a culture of openness and transparency within healthcare settings.