Guidance for Registrants on Open Disclosure
On 26 September 2024, patient safety legislation was commenced that requires mandatory open disclosure processes in specific, rare, but very serious, circumstances. Additionally, a National Open Disclosure Framework has been produced that sets out requirements and expectations across all health and social care settings and seeks to ensure a clear and consistent approach to open disclosure in practice.
What is open disclosure?
Open disclosure is an open, honest, empathic, and timely approach to communicating with patients and their families when things go wrong in healthcare.
Sometimes, and in other jurisdictions, you might see open disclosure referred to as ‘open communication’, ‘duty of candour’, or ‘being open’.
The HSE Open Disclosure Policy defines open disclosure as “an open, consistent, compassionate, and timely approach to communicating with patients and, where appropriate, their relevant person(s) following patient safety incidents. This includes expressing regret for what has happened, keeping the patient informed, and providing reassurance in relation to on-going care and treatment, learning, and the steps being taken by the provider to prevent a recurrence of the incident.”
The principles of open disclosure are required for entry to registers and set out in each Registration Board’s Standards of Proficiency and in your profession’s Code of Conduct and Ethics, where open and honest communication, legal and ethical practice, and person-centred care are incorporated throughout.
What are the legislative provisions around ‘Open Disclosure’?
On 26 September 2024, the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 commenced. This Act provides a legislative framework for mandatory open disclosure and aims to embed openness and transparency in healthcare settings in Ireland, including in private healthcare. The Act contains a list of very rare, very serious incidents. These specific notifiable incidents are explicitly bound by legislation in how they are responded to and are subject to mandatory reporting through the National Incident Management System (NIMS). You can find more information on NIMS on the HIQA website, including specific guidance for health service providers on how to notify HIQA of a notifiable incident under the Patient Safety Act.
The Department of Health has also developed a guidance document to assist stakeholders in understanding the provisions of the Act.
In addition to the legislative requirements for defined notifiable incidents, the National Patient Safety Office (NPSO) of the Department of Health developed The National Open Disclosure Framework.
The Framework seeks to further embed structures for transparency and open communication from all health and social care professionals with service user/patients following a patient safety incident or an adverse event.
The Framework outlines six key principles which include open, honest, compassionate, and timely communication, acknowledgment and genuine apologies, and support to the health and social care staff involved in the incident or event. The principles promote a culture of open disclosure providing a unified approach to open disclosure across public and private health and social care service providers, regulators, professional regulators, educators, and other relevant bodies and organisations.
You can read more about these in the Framework.
Patient Safety Incident or Adverse Event
Mandatory Requirements
Applying to all public and private health services and staff, the Act prescribes the mandatory requirements for open disclosure of specified Notifiable Incidents, including the process and reporting obligations.
A Patient Safety Incident during the provision of a health service includes:
- Unintended or unanticipated injury or harm
- Where harm did not occur, but the health service provider has reasonable grounds to believe there was a risk of harm or injury
- Where harm or injury was prevented but the health service provider has reasonable grounds to believe it could have occurred without prevention.
An adverse event is “an incident which resulted in harm that may or may not be the result of an error.” Where a Notifiable Incident has occurred, the Act would come into force with the legal requirement for disclosure.
Only the Notifiable Incidents identified in the Act require an open disclosure process. This process includes:
- service users and their families having access to comprehensive and timely information.
- an apology or ‘expression of regret’ where appropriate.
- a timeline – with relevant consent, open disclosure must happen within 24 – 48 hours of an incident occurring. Consent in this context relates to communicating with younger people under the age required for medical consent’ or engaging with the relevant support person service user is unable.
- mandatory external notification of the event; and
- key personnel to be involved, including the ‘Designated Person’ who is responsible for the process.
What does the Framework mean for a health and social care professional?
For the delivery of health and social care services then, the Act and Framework require health and social care professionals:
- are aware of the mandatory open disclosure provisions in the Patient Safety (Notifiable Incidents and Open Disclosure) Bill 2019 (including the list of Notifiable Incidents);
- are aware of their roles and responsibilities;
- understand the incident management process;
- document a record of the open disclosure meeting provided to patients/service users and/or their relevant person(s);
- are aware of the support services available to them following patient safety incidents;
- are aware of their role in supporting staff following patient safety incidents; and
- undertake mandatory training requirements for open disclosure.
To help health and social care professionals understand these new processes and how they will apply in practice, the HSE provides health and social care staff with mandatory E-learningprogrammes and supplementary support guides and resources. Open disclosure training is mandatory for all staff working in the HSE and in HSE-funded services with refresher training required every three years. All staff must complete Open Disclosure e-learning “Communicating Effectively through Open Disclosure” with additional training available for staff who may be involved in formal open disclosure.
Training is available at Open Disclosure Training (Mandatory) - Corporatewith resources for healthcare workers and trainers, and additional supporting material such as the HSE 2020 Incident Management Framework & Guidance, the HSE Just Culture information and documents, The National Healthcare Charter 2012 and HSE Policy for Preventing and Managing Critical Incident Stress 2012.
In addition, HIQA provides f urther guidance and resources for service providers and practitioners, including a Frequently Seen Questions (FAQs) section and bespoke Guidance for health services providers on notifying HIQA of notifiable incidents under the Patient Safety Act, available at: www.hiqa.ie/areas-we-work/healthcare-services.
Similarly, the Mental Health Commission’s website outlines resources, including Regulatory guidance in relation to notifiable incidents at www.mhcirl.ie/what-we-do/regulation/notifiable-incidents-patient-safety-act