Last week, the Government approved the Patient Safety Bill to provide for mandatory open disclosure of serious reportable patient safety incidents, notification of reportable incidents, clinical audits to improve patient care and outcomes and to extend the remit of the Health Information Quality Authority to private health services.
This is an important step in ensuring open disclosure becomes part of the culture in healthcare in the Republic of Ireland and to create opportunities for learning across the health system. The duty of candour has been brought in to the spot light by the recent cervical check controversary and the cases of Vicky Phelan and Emma Mhic Mhathuna.
The Bill goes further than the legislation in England and Wales where the duty of candour only applies to organisations and not individual health professionals as intended in this Bill.
Serious safety incidents which shall be subject to mandatory open disclosure are defined as (but not limited to) any unintended or unexpected incident or harm that occurred in the provision of a health service including patient death, permanent lessening of bodily, sensory or intellectual functions.
Examples of serious patient safety incidents include wrong site surgery, patient death or serious disability associated with a medication error, death or associated disability associated with diagnostic error, serious errors that emerge in screening programmes, maternal death, perinatal death occurring of a term infant, stillbirths, patient death or serious disability due to the administration of incompatible blood or blood products.
The Bill provides that when a health services provider discloses an incident in accordance with the legislation and an apology is made, this will not constitute an admission of liability or fault and will not be admissible in civil proceedings relating to liability for injury or death.
Under the provisions of the Bill, health service providers (public and private) must also notify such serious patient safety incidents and reportable incidents to the State Claims Agency and either to the Health Information and Quality Authority or the Mental Health Commission as appropriate. The incident shall be reported as soon as the body becomes aware of the incident and, in any event, not later than 7 days after becoming so aware.
Head 12 of the Bill is concerned with ensuring that learning from patient safety incidents notified to the State Claims Agency is disseminated to promote patient safety awareness through publishing information and analysing trends that appear relevant.
The registered health service shall be guilty of an offence if the provider fails to make a mandatory disclosure of a serious reportable incident and penalties on conviction are fines or imprisonment.
This Bill, if passed by the Oireachtais, will be a milestone in patient care in Ireland.