By Lorraine Schwanberg, Assistant National Director Incident Management, National Quality and Patient Safety Directorate, HSE
Open disclosure is the right thing to do and it is HSE Policy. Significant work has already been undertaken on this important topic and it remains a key priority. This article will highlight some key national developments taking place in relation to Open Disclosure.
To further embed a culture of openness and transparency across the Irish healthcare sector the Department of Health has developed the National Open Disclosure Framework which is due to be launched this year. Additionally, the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 (the Act)was enacted by the President on May 2, 2023. The commencement date of the Act has yet to be confirmed but work has started toward its implementation. Here is a brief outline of both:
The Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023
The Act provides a legal framework for:
- The mandatory open disclosure, by health services providers, of certain incidents occurring in the course of the provision, to a person, of a health service. Specifically the Act describes 14 different incidents, termed notifiable incidents, whereby open disclosure must take place in line with the legislation. The notifiable incidents are listed below (Figure 1).
- The mandatory open disclosure, by health services providers, of reviews carried out in relation to cancer screening that were requested by the patient (breast, bowel and cervical screening)
- Legal protection in relation to the information shared at the time of open disclosure and any apologies made in the course of such disclosures.
- Procedures in respect of clinical audit, and the data obtained in clinical audits.
- Organisations to report notifiable incidents to regulators such as the Health Information and Quality Authority, Chief Inspector of Social Services and the Mental Health Commission and it requires such notifications to be made via the National Incident Management System (NIMS).
- Amendments to the Health Act 2007 to provide for the application of standards set by the Health Information and Quality Authority to private hospitals.
- The review by the Chief Inspector of certain incidents (termed specified incidents) where some or all of the care of a patient/service user was carried out in a nursing home.
- Amendments to Part 4 of the Civil Liability (Amendment) Act 2017.
What does the Act mean for you?
First, it is important for staff to continue to comply with their Open Disclosure Policy. In the HSE, that is the HSE Open Disclosure Policy 2019, which outlines the principles, responsibilities and processes regarding open disclosure. The bottom line is that where patients are harmed or harm is suspected following a patient safety incident, staff and organisations must be open and honest in relation to what happened and provide a meaningful apology irrespective of whether or not it will be deemed a Notifiable Incident. Staff should engage with those impacted compassionately and with empathy. The HSE Open Disclosure Policy 2019 will be updated to incorporate the requirements of the Act but these prerequisites will not change and the Policy is not limited to the 14 incidents specified by the Act.
There will be new reporting requirements to regulators, and specific requirements concerning the process of Open Disclosure including the provision of written communication to the patient/service user/relevant person following an open disclosure meeting. Exemptions to open disclosure are clearly described as only applying where the patient/service user/relevant person cannot be contacted or the patient/relevant person does not want to engage with Open Disclosure at that time. Non-compliance with the Act without reasonable excuse will be deemed an offence and subject to a financial penalty.
It is well recognised that the purpose of open disclosure is to be open and transparent and non-compliance can lead to mistrust in services and a poor patient/service user experience.
The HSE has established an implementation group to oversee implementation of the Act to help support the interpretation and application of the legislation across the organisation. Additional actions will include making the required changes to the HSE Open Disclosure Policy 2019, technical system updates (NIMS), training and resource development. This will be supported with communications and engagement across health and social care services.
Schedule 1 of the Act – Notifiable Incidents:
- Surgery performed on the wrong patient resulting in unintended and unanticipated patient death which did not arise from/was a consequence of an illness/underlying condition
- Surgery performed on the wrong site resulting in unintended and unanticipated patient death which did not arise from/was a consequence of an illness/underlying condition
- Wrong surgical procedure performed on a patient resulting in unintended and unanticipated patient death which did not arise from/was a consequence of an illness/underlying condition
- Unintended retention of a foreign object in a patient after surgery resulting in unintended and unanticipated patient death which did not arise from/was a consequence of an illness/underlying condition
- 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 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.
- Patient death due to transfusion of ABO incompatible blood or blood components and the death was unintended and unanticipated and which 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
- Patient death associated with a medication error and the death was unintended and unanticipated as it 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.
- 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, and which 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.
- 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, from any cause related to or aggravated by the management of the pregnancy, 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 child.
- 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, from any cause related to, or aggravated by, the management of the pregnancy, and the death did not arise from, or was a consequence of (or wholly attributable to) the illness of the child or an underlying condition of the child.
- 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,
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.
The National Open Disclosure Framework (2023)
The Department of Health has developed a National Open Disclosure Framework to provide a unified and consistent approach to Open Disclosure across public and private health and social care service providers, service regulators, and health and social care professional regulators, health and social care educators and other relevant bodies and organisations. The Framework is due to be launched and published this year.
The ethos of this Framework is to ensure that the rights of all patients/service users and health and social care staff involved in and affected by patient safety incidents and adverse events are met and respected and that they are communicated in an honest, open, timely, compassionate, and empathic manner and that they are treated with dignity and respect.
The Framework outlines its six principles that it is based on, namely:
- Principle 1: Open, honest, compassionate and timely communication.
- Principle 2: Patient/service user and support person’s entitlement in Open Disclosure.
- Principle 3: Supporting health and social care staff.
- Principle 4: Promoting a culture of Open Disclosure.
- Principle 5: Open disclosure for improving policy and practice in health and social care.
- Principle 6: Clinical and corporate governance for Open Disclosure.
What does the Framework mean for you?
The Framework builds on the HSE Open Disclosure Policy 2019 but clearly has a much broader scope as it incorporates regulators and health and social care providers and other agencies outside of the public sector. Each relevant organisation will be required to submit an annual report to the Minister for Health regarding their implementation of Open Disclosure and compliance with the Framework. For health care providers this includes reporting on the number of open disclosure events initiated and closed.
The HSE Open Disclosure Policy, training and resource materials will incorporate these two significant national developments. This work will be supported by engagement and communication with various HSE and HSE-funded services, patient partners and external organisations. Regular updates will be provided by the Open Disclosure Office of the Quality and Patient Safety Incident Management Team. If you have any questions or queries do not hesitate to get in touch and email the National Open Disclosure Office at opendisclosure.office@hse.ie or visit the Open Disclosure website page Open Disclosure – HSE.ie
