Patient safety incident?
The Civil Liability (Amendment) Act 2017 defines a ‘patient safety incident’, in relation to the provision of a health service to a patient by a health-services provider, as “an incident which occurs during the course of the provision of a health service” which (i) “has caused an unintended or unanticipated injury, or harm, to the patient; (ii) did not result in actual injury or harm to the patient but was one which the health-services provider has reasonable grounds to believe placed the patient at risk of unintended or unanticipated injury or harm; or (iii) unanticipated or unintended injury or harm to the patient was prevented, either by ‘timely intervention or by chance’, but the incident was one which the health-services provider has reasonable grounds for believing could have resulted in injury or harm, if not prevented”.
What is open disclosure?
This means communicating honestly and in detail with a patient or their family when there has been an unexpected harmful event in the course of their treatment in a hospital or under the care a doctor.
The concept of open disclosure is nothing new. In the 2008 report by the Commission on Patient Safety and Quality Assurance, Building a Culture of Patient Safety, it was said that “open disclosure following an adverse event should be supported through appropriate policies and practices which are well publicised and instituted widely”.
The commission recognised then that every patient is entitled to open and honest communication regarding his/her healthcare, and to be informed regarding diagnosis and prognosis, treatment options and chances of recovery, if possible.
The authors further stated: “If something happens to a patient in the course of treatment and care which impacts or could impact on the person’s health or quality of life, that patient should be informed of this event, given an adequate explanation of the event, and reassured that measures have been taken to prevent such an event occurring again in the future to him/her or to anyone else.”
Since 2013, the HSE’s National Open Disclosure Policy has set out the professional and ethical approach to adverse incidents. There was a legislative footing for voluntary open disclosure in part 4 of the Civil Liability (Amendment) Act.
There has always been a concern that voluntary open disclosure does not work in a health system that does not encourage it.
There was subsequently the HSE’s Incident Management Framework, which reformed the previous approach to responding to patient-safety incidents and adverse events. It considered open disclosure to require an immediate action after an incident had occurred and had been identified.
It is also stated in the framework that, where an incident involves a patient/service user, attention and effort must also be given to initiating open disclosure, as prompt, open, and transparent communication with the person affected and their support person is required.
Narrow definition
Schedule 1 of the Patient Safety Act 2023 sets out the list of ‘notifiable incidents’ that are now subject to mandatory open disclosure.
These are solely concerned with incidents resulting in death, including:
- Wrong site surgery or wrong surgical-procedure surgery resulting in unintended and unanticipated death,
- Unintended retention of a foreign object after surgery, resulting in an unanticipated death,
- Any unintended and unanticipated death occurring in an otherwise healthy patient undergoing elective surgery, or where a health-service provider provides a service that is directly related to any medical treatment (the death must not have arisen from the illness or an underlying condition of the patient),
- Patient death associated with a medication error or due to transfusion of ABO-incompatible blood or blood components,
- An unanticipated death of a woman while pregnant, or within 42 days of the end of the pregnancy,
- An unanticipated and unintended stillborn child or perinatal death,
- An unintended death where the cause is believed to be the suicide of a patient within a health-service setting.
Section 8 of the act enables the minister to define additional circumstances as ‘notifiable incidents’, provided they meet certain criteria.
There are, of course, a great many injuries sustained by patients every year that are not fatal, but that can prove catastrophic, lifechanging, and life-limiting. These injuries and the circumstances that gave rise to them would not be the subject of a mandatory open disclosure under the provisions of the 2023 act.
Duties to notify
Section 5 requires that, where a health-service provider is satisfied that a ‘notifiable incident’ has occurred, it shall hold a meeting in order to make open disclosure of the incident to the patient and/or ‘relevant person’.
The responsibility falls on the health-service provider, potentially allowing for selective disclosure.
The timing and structure of that meeting is important. The Minister for Health and the HSE should act quickly to establish the appropriate procedures and mechanism around ‘open-disclosure’ meetings.
The dignity of the patient should be the paramount consideration. Section 6 sets out the obligation on health-service practitioners to notify the health-service provider of the occurrence of the notifiable incident, as soon as practicable.
Section 27 requires the health-service provider to notify the relevant external body within seven days. Depending on the provider involved, this will be HIQA, the Chief Inspector of Social Services, or the Mental Health Commission.
It is therefore imperative that the minister expand the list of notifiable incidents to capture the more serious types of injury that some have been left with due to negligence, to ensure that they are informed properly of what has gone wrong in their treatment.
Guideline implementation
Section 77 provides for the issue of guidelines “for the purpose of providing practical guidance as regards the operation of, and compliance with, this act”.
This guidance will be crucial to the successful implementation of the new legislation. Until such time as the procedures around notification and the timing of notification meetings are clearly set out, there will continue to be a concern that patients are not informed as early as they ought to be about a harmful event.
Stakeholder engagement in guideline and procedure formulation must involve patients and patient-advocacy groups, if their rights and dignity are to remain front and centre.
Information
Section 18 outlines the information to be provided at the meeting, including the date and description of the incident, when it came to the attention of the healthcare provider, and the physical/psychological consequences for the patient. It also provides for the making of an apology, where appropriate.
Importantly, for health-service providers and their insurers, section 10 provides protection, in that any information provided during the course of the open-disclosure meeting, including an apology, shall not:
- Invalidate insurance,
- Constitute admission of liability,
- Be admissible as evidence in proceedings.
What is difficult to comprehend, but which is entirely possible, is a situation where a patient may be told frankly that their injuries are the result of negligent acts or omissions at the ‘open-disclosure’ meeting.
Then, when litigating, they could be faced with a full defence, made to wait years for a hearing, and sit through a trial where an outright denial of liability is maintained.
The patient, the doctors, and the lawyers would, in essence, have to pretend that information shared at the meeting, such as an admission of negligence, was not said.
Who does that serve? Not the patient, and certainly not the taxpayer.
Cultural change?
It is said that the intention of the new act is to instil a cultural change in the doctor/ patient relationship, to enhance learning, and ensure that openness and transparency are embedded across the health service.
The threat of a ‘Class A’ fine to drive a change in attitude is not conducive to an atmosphere of openness, and it remains incumbent on the HSE, hospital management, and the Department of Health to demonstrate through their actions, beyond implementing this act, that to acknowledge the harmful event and to discuss it openly with the patient is the right thing to do. That will take time.
The HSE has operated an open disclosure policy since 2013, but many patients injured in the last decade will not have felt that they were communicated with properly, or at all, about what went wrong in the course of their treatment.
A welcome development is the creation of the National Open Disclosure Framework, prepared by the National Patient Safety Office of the Department of Health.
The framework, informed by recommendations from the Independent Patient Safety Council, aims to provide overarching principles and a consistent national approach to open disclosure in health and social care in Ireland, which can then be drawn from to suit the needs of the various organisations.
The Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 represents a meaningful step forward in patient safety, but the legislation – even when fully implemented – will not be a silver bullet.
The concerns raised in this article emphasise the need for early action from the health service and Government, continuous scrutiny, and refinement in the implementation of this legislation.
Johan Verbruggen is partner and head of medical-negligence claims at Fieldfisher.
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