Open disclosure: Managing notifiable patient safety incidents 

Dr James Thorpe outlines what medical professionals should know about the new Patient Safety Act

The HSE has defined open disclosure as an open, consistent, compassionate, and timely approach to communicating with patients and, where appropriate, their relevant person following patient safety incidents. In a long-anticipated development, the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 was signed into the law in April. On commencement, a specific list of notifiable incidents must be disclosed to the patient and/or their relevant person and reported to HIQA or the Mental Health Commission. Examples of notifiable incidents include ‘wrong-site surgery’ and ‘death due to medication error’. 

The Act applies to both public and private patients and includes criminal sanction for non-compliance with a fine of up to €5,000. Whilst the requirement to disclose a notifiable incident falls to the healthcare provider, such as the hospital or the GP practice, it is essential that all healthcare professionals familiarise themselves with the new legislation. Individual clinicians will be expected to inform the healthcare provider when a notifiable incident has occurred and many doctors, in particular doctors with management responsibility and GPs, will be responsible for ensuring disclosure and notification of incidents.

It is, of course, inevitable that treatment or medical advice will occasionally go wrong, so it is vital that doctors are well equipped to act promptly and effectively when a patient safety incident occurs

In a similar way to the Civil Liability Act of 2017 which dealt with voluntary open disclosure, information provided and any apology made at a notifiable incident disclosure meeting shall not constitute an express or implied admission of fault or liability in regulatory of clinical negligence proceedings arising from the same event, provided that the procedure as set out in the Act has been followed.

It is, of course, inevitable that treatment or medical advice will occasionally go wrong, so it is vital that doctors are well equipped to act promptly and effectively when a patient safety incident occurs. Whilst serious notifiable patient safety incidents covered by the Patient Safety Act will hopefully be rare, Medical Protection has long advocated that whenever something goes wrong in healthcare, patients and their relatives are entitled to honest, open, and prompt communication, as well as an appropriate apology.

Whilst it takes courage to face up to the anger and disappointment that are sometimes expressed by patients or their family when an error is disclosed, there is a growing body of evidence to suggest that patients can be surprisingly forgiving and appreciate being given an honest account when something goes wrong.

Ethical guide

All doctors have a professional and ethical duty to have an open and honest discussion with patients following a patient safety incident or an adverse event. This is emphasised in the Medical Council’s Guide to Professional Conduct and Ethics for Registered Medical Practitioners (the ‘Guide’).

The current edition of the Guide states that: “Patients and their families, where appropriate, are entitled to honest, open, and prompt communication about adverse events that may have caused them harm. When discussing events with patients and their families, you should:

• Acknowledge that the event happened;

• Explain how it happened;

• Apologise, if appropriate; and

• Assure patients and their families that the cause of the event will be investigated and efforts made to reduce the chance of it happening again.”

Following the CervicalCheck revelations, Dr Gabriel Scally recommended that the Medical Council “should put into effect its stated support for the concept of a duty of candour by insisting that doctors ‘must’ be open and honest rather than using the word ‘should’, which leaves it to the doctor’s judgement as to what, if anything, happens”. 

It will be interesting to see if this recommendation is taken forward in the next edition of the Medical Council’s Guide. It is likely that the guidance will also reference registrants’ responsibilities under the Patient Safety Act. 

With the recent significant changes in the medico-legal landscape related to open disclosure, please contact your medical defence organisation for further advice regarding disclosure of a particular incident. 

What is in the Act?

The Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 provides a legislative framework for the mandatory open disclosure of a list of specified serious patient safety incidents that must be disclosed to patients and/or their families. This will ensure that patients and their families have access to comprehensive and timely information, including an apology where appropriate, in relation to serious patient safety incidents.

A second core purpose of this new legislation is to enable national learning from these serious patient safety incidents 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.

The Act also provides for the expansion of HIQA’s remit into private hospital services. This will allow HIQA to set standards for the operation of private hospitals, to monitor compliance with them, and to undertake inspections as required.

The Act provides for the mandatory open disclosure of a patient-requested review of a cancer screening. Known in the Act as a “Part 5 review”, a patient-requested review, which is carried out by the cancer screening services currently operating (CervicalCheck, BreastCheck and BowelScreen), will be subject to mandatory open disclosure ensuring patients have access to comprehensive and timely information.

The Act also gives the Chief Inspector of Social Services a discretionary power to carry out a review of serious patient safety incidents in nursing homes.

Minister for Health Stephen Donnelly brought the legislation through the Committee Stage in March 2022, the remaining stages of the Dáil in February 2023 and more recently through all stages of the Seanad where it successfully passed with cross-party support.

Speaking about the legislation, Minister Donnelly said: “The introduction of mandatory open disclosure of notifiable incidents in this Act is a watershed moment for patient safety in our health services. It will contribute to embedding a culture where clinicians, and the health service as a whole, engage openly, transparently and compassionately with patients and their families when things go wrong with the care they receive.

“This new legislation seeks to support a just culture in our health services, which is focused on openness, learning and improvement rather than blame.

“In many situations where patients are harmed, the error or mistake occurred because systems were not in place to support the healthcare professional or team in identifying and avoiding that error.

“Creating a culture of open disclosure and learning from the things that go wrong is the bedrock of making services safer.”

Medical Protection members can sign up for a webinar in August about responding to adverse outcomes at medicalprotection.org/cpd.

Reference available on request