Mandatory open disclosure – what lies ahead?

Ms Sile O’Dowd examines the implications of the new legislation on patient safety and what it means for medical professionals

On  2 May 2023, the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 (‘the Act’) was signed into law.

By way of overview, the Act provides a legislative framework for a number of important patient safety issues, including the mandatory open disclosure of a list of specified serious patient safety incidents that must now be disclosed to the patient and/or their family and notified to HIQA, Chief Inspector of Social Services or the Mental Health Commission (MHC). While the Act was signed into law in May, it is still awaiting commencement and it is expected that this will take place before the end of this year.

Voluntary open disclosure

Prior to now, open disclosure has been on a voluntary basis. The 2013 HSE Open Disclosure Policy initially laid the groundwork for open disclosure in the Irish health service. This policy applies to the HSE and HSE-funded organisations only.

Part 4 of the Civil Liability (Amendment) Act 2017 (‘the 2017 Act’) introduced the legal framework to support voluntary open disclosure; it applies to all patient safety incidents including near misses and no-harm events. It provides that where a patient safety incident occurred in the provision of healthcare by a health services provider, the health services provider may make an open disclosure of the incident to the patient. The 2017 Act provides that an apology can be provided but that apology cannot then be used in litigation. During the report stage of the 2017 Act in the Dáil, the Minister for Health committed to progress legislation on mandatory open disclosure for a defined list of serious events.

The Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023

The Act will introduce what is termed as “mandatory open disclosure” of adverse incidents during the provision of healthcare services, with the aim of ensuring that patients and their families have access to comprehensive and timely information, including an apology where appropriate, in relation to serious patient safety incidents. It applies to both public and private healthcare providers.

One of the other core purposes of the Act is to enable national learning from these serious patient safety incidents if they arise, and to support health service-wide improvements so that harm to other patients can be prevented. This will be achieved through the obligation on health service providers to report notifiable incidents to the relevant regulatory body.

In addition to the mandatory open disclosure provisions, the Act also provides for the expansion of HIQA’s remit into private hospital services to allow them to set standards for the operation of private hospitals; to monitor compliance with these standards; and to undertake inspections as required.

During the later stages of the legislative process, it was also decided to include provision for the mandatory open disclosure of a patient-requested review of certain screening programmes. These reviews are described as “Part 5 reviews” and will be subject to mandatory open disclosure of all the relevant information, in a similar manner to a notifiable patient safety incident elsewhere in the Act. At present these Part 5 reviews are limited to the CervicalCheck, BreastCheck, and BowelScreen screening programmes.

What constitutes a notifiable patient safety incident under the Act?

A patient safety incident can be described as an instance of preventable harm or injury which occurs to a patient during their care. Schedule 1 to the Act sets out a list of specific serious patient safety incidents that must be disclosed under the mandatory open disclosure process. These incidents are described as ‘notifiable patient safety incidents’ and include the following:

• Patient death associated with a medication error;

• Wrong site surgery or wrong surgery resulting in unintended and unanticipated death;

• Unintended and unanticipated death occurring in an otherwise healthy patient undergoing elective surgery;

• Unintended and unanticipated death occurring in any place where a health services provider provides a health service that is directly related to any medical treatment and the death did not arise from, or was a consequence of (or wholly attributable to) the illness of the patient or an underlying condition of the patient;

• 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;

• Unanticipated death of a woman while pregnant;

• Unanticipated and unintended stillbirth;

• A baby who was considered for, requires, or is referred for therapeutic hypothermia.

Notification to the health service provider

Where one of the notifiable incidents set out in the Act occurs, there is now an obligation on a health practitioner to notify the health services provider that was providing the service to the patient as soon as practicable. The health services provider is obliged to notify the incident to HIQA, the Chief Inspector of Social Services or the MHC, dependant on the types of health services provider involved, within seven days.

Notification to the patient

Where a health services provider is satisfied that a notifiable incident has occurred, there is also an obligation to hold a notifiable incident disclosure meeting to disclose the incident to the patient concerned and/or a ‘relevant person’.  A ‘relevant person’ may be notified instead of the patient where:

• Having regard to the patient’s age, capacity or health status, it is appropriate, in the opinion of the principal health practitioner, to disclose the incident to a relevant person. For example, if the patient has significant cognitive impairment;

• The patient has died; or

• The patient has requested that disclosure be made to the relevant person as well as themselves or alternatively has requested disclosure is made solely to the relevant person. 

Who discloses the information?

The Act provides that the patient’s principal health practitioner should make the disclosure on behalf of the health service provider, unless they are not available or not otherwise in a position to make the disclosure; or having regard to the circumstances of the notifiable incident, the health service provider or the principal health practitioner is satisfied that open disclosure should be made by another health practitioner. There is an obligation on both the health services provider and health practitioner to provide all relevant information during the open disclosure process to address the consequences of the incident.

The notifiable incident disclosure meeting

The Act sets out specific requirements about how the notifiable incident disclosure meeting (‘the meeting’) should take place and what information should be provided during and after the meeting. Firstly, it states that the meeting should generally be held in person unless requested otherwise by the patient or relevant person.

In terms of information to be disclosed, a description of the incident concerned together with the date on which it occurred; the date it came to the attention of the health services provider; and the manner in which the notifiable incident came to the attention of the provider should be disclosed. In addition, where, in the opinion of the health services provider, physical or psychological consequences of the notifiable incident are present or have developed, the patient and/or relevant person should be informed in respect of those consequences and of any other physical or psychological consequences the health services provider believe are likely to develop at any time after the meeting.

In the event the health services provider has determined that an apology is to be provided, this can also be provided at the meeting together with the details of any actions the health services provider has taken or proposes to take as a result of the notifiable incident. 

There are also specific requirements for the maintenance of records and the provision of statements to the patient and/or relevant person during and following the meeting within specified timelines.

Is there any legal protection during the open disclosure process?

The protections included in both the 2017 and 2023 Acts should serve to allay fears that information provided to patients in the spirit of open disclosure will be used against them in civil proceedings. In summary, any disclosure and apology made during the open disclosure process shall not:

• Constitute or be used as evidence of an admission of fault or liability;

• Invalidate any insurance or indemnity;

• Constitute an express or implied admission of professional misconduct, poor professional performance or unfitness to practise in any regulatory fitness to practise proceedings; or

• Be admissible as evidence of professional misconduct, poor professional performance or unfitness to practise.

Consequences of failure to comply

In light of the mandatory nature of the open disclosure process, there are serious consequences for non-compliance including the health services provider being charged with an offence and/or being liable to a potential fine of up to €5,000.

Be prepared

It is anticipated that the Act will be commenced later this year.  In the interim, the HSE has advised that they intend publishing its national open disclosure framework (2023) later this summer in order to support a consistent approach to open disclosure across all health and social care services in Ireland (public and private). This will include the provision of open disclosure training by way of e-learning modules.

Only time will tell the impact of these new mandatory open disclosure obligations of health services providers. It is of course hoped that the implementation of the protective provisions in the Act together with the development of a national framework will assist practitioners in making open disclosures, and encourage a culture of open and honest communication in all healthcare settings.