None of us expect to be harmed as a patient in healthcare. Yet in Ireland as many as 1 in 8 patients suffer harm while using using healthcare services. Here our Johan Verbruggen addresses queries he has received about the Patient Safety Bill(2019), which is currently before the Dail.

What is meant by patient safety?

Patient safety is defined by the World Health Organisation as “the absence of preventable harm to a patient during the process of health care and reduction of risk of unnecessary harm associated with health care to an acceptable minimum.” Patient safety is of paramount concern to doctors, nurses and the health services in our country and around the world. It was always the case.

Providing necessary healthcare may involve interventions such as surgical procedures which are inherently risky; there are unpredictable and unpreventable harms that can occur. Patient safety however, is concerned with recognising the preventable harm or injury that may occur to a patient, or future patients and taking appropriate steps to guard against the risks of that happening.

Further, where a patient has been injured in the course of receiving medical treatment, the clinicians and hospital staff ought to try to understand how the injury came about, to learn all that can be learned from the circumstances, and to improve services.

What is meant by open disclosure?

Open disclosure is the process of doctors, nurses and hospital management communicating honestly and comprehensively with patients and/or their families, as soon as is practicable, where something has gone wrong while the patient was receiving healthcare.

The Health Service Executive acknowledge in their ‘Open Disclosure’ Policy that “this means that we will keep you fully informed of the facts in relation to what has happened. We will also talk to you about your on-going care and treatment.”

Why do we need the provisions in the Patient Safety Bill, if the HSE already has a Policy?

Unfortunately, while the HSE has had an ‘Open Disclosure’ Policy in place since 2013, it continues to be the experience of many of our clients that hospitals have failed to communicate with them about what has happened in the course of their treatment to cause their injuries or the death of a loved one. They feel unsupported by the system; they are not afforded explanations following adverse events and out of frustration and a need for answers, they seek legal advice.

The Civil Liability Amendment Act, 2017, provided the legal framework to support voluntary open disclosure. It provided that where a patient safety incident occured in the course of the provision by a health services provider of a health service to a patient, the health services provider may make an open disclosure of the patient safety incident. The Act also provided that an apology could be provided but that apology could not then be used in litigation.

What is the Patient Safety (Notifiable Patient Safety Incidents) Bill 2019?

The Patient Safety Bill is a Bill that provides for Mandatory open disclosure. This means the required disclosures of any serious patient safety incident that is any unintended or unanticipated injury or harm to a service user that occurred during the provision of a health service. A key provision of the Bill is that hospitals and other healthcare facilities will be required to have in place, governance systems to support health practitioners in making disclosures. Hospitals will face penalties if staff do not notify patients of serious adverse incidents under proposed new legislation.

What is the goal or objective of the Patient Safety Bill?

The Patient Safety Bill will introduce what is termed ‘mandatory open disclosure’ of adverse events during the provision of healthcare. We currently have voluntary open disclosure where doctors and medical staff are encouraged to communicate honestly and transparently with patients about an incident that has or is likely to have an adverse outcome for the patient. This has been shown to be inadequate and it is one of the main reasons that there is such a strong desire among victims of medical negligence to introduce mandatory open disclosure.

What kind of incidents are covered by the Patient Safety Bill?

The Bill contains a list of ‘Notifiable Patient Safety Incidents’ including:

  • 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
  • The wrong surgical procedure is performed on a patient resulting in unintended death
  • The unintended retention of a foreign object in a patient after surgery resulting in an unanticipated death
  • Any unintended and unanticipated death occurring in any place or premises in which a health services provider provides a health service related to medical treatment not wholly attributable to the illness
  • Unanticipated death of a woman while pregnant or child born without a fatal foetal abnormality
  • Surgery is performed on the wrong patient or wrong site resulting in unintended death
  • An unanticipated and unintended stillbirth
  • Unanticipated patient death linked to medication error

Where a hospital or health service provider was satisfied that a ‘notifiable patient safety incident’ had occurred, a doctor or practitioner would be obliged to inform the patient and hospital of the incident. Under the proposals, failure to comply with this requirement on disclosure would mean the health service provider would be penalised. The nature or extent of the proposed penalties is not yet known.

Will the Patient Safety Bill cover both Private and Public facilities?

The Patient Safety Bill will cover public and private facilities.

When will the Patient Safety Bill become law?

The Bill was presented to the house of the Oireachtas on 5 December 2019; the general principles of the Bill were debated on 12 December 2019. The Bill has been through the Committee Stage. At this stage, the Bill was examined section by section and amendments may have been made.

The Bill is currently at the fourth stage where any amendments arising out of the Committee Stage will be considered. Thereafter a statement will be made and it will be sent forward to the Seanad. As such, it is difficult to estimate when the Bill with be passed into law, and of equal importance, when it will be commenced by the Minister.

Johan Verbruggen is an Associate Solicitor in the Medical Negligence Department at Callan Tansey Solicitors based in our Galway office. If you or your family have any questions about this article please contact Johan at 091 865 000 or