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Minister for Health Stephen Donnelly today welcomed the passing of the Patient Safety (Notifiable Incidents and Open Disclosure) Bill 2019 through all stages in the Houses of the Oireachtas.
Once commenced, the Bill will provide 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 Bill also provides for the expansion of the Health Information and Quality Authority’s (HIQA) 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 Bill provides for the mandatory open disclosure of a patient-requested review of a cancer screening. Known in the Bill as a “Part 5 review”, a patient-requested review which is carried out by the cancer screening services currently operating, that is CervicalCheck, BreastCheck and Bowel Screen, will be subject to mandatory open disclosure ensuring patients have access to comprehensive and timely information.
The Bill 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 Donnelly brought the Bill 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 Bill 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."
Minister Donnelly went on to say:
"While the focus of this Bill is much wider than cancer screening services, it is absolutely correct that the Bill has been informed by CervicalCheck and from the women and men who stood up and made their voices heard. The inclusion of the new ‘Part 5 review’ will enshrine in law for the first time, the right of patients to mandatory open disclosure of all information regarding a patient-requested review of their cancer screening."
The Bill will now go to the President before being signed into law.
The Patient Safety Bill is a comprehensive piece of legislation which sets out a number of new functions.
Part 2 of the Bill sets out the framework for mandatory open disclosure of a notifiable patient safety incident including the obligations on health services providers, and health practitioners in this regard, as well the certain protections for health practitioners who make an open disclosure as required under the Bill.
Schedule 1 of the Bill sets out the list of Notifiable Incidents. Once a health services provider becomes aware of the occurrence of a notifiable incident, it will have an obligation to conduct mandatory open disclosure and notify the incident to the relevant regulatory body. Where a health services provider fails to comply with these provisions, they will be liable for an offence as set out in Part 8, including a Class A fine of up to €5,000.
Part 3 establishes the procedure to be followed by a health services provider when making an open disclosure of a notifiable incident.
Under Part 4, notifiable incidents must be reported to the Health Information and Quality Authority (HIQA), The Chief Inspector of Social Services or the Mental Health Commission as appropriate, within 7 days from the date the incident occurs.
Part 5 of the Bill establishes the requirement for mandatory open disclosure of a patient-requested review of their cancer screening, known in this Bill as a “Part 5 review.” This will ensure that the similar obligations to those that health services providers have in relation to mandatory open disclosure of notifiable incidents will also apply to Part 5 reviews.
Part 6 provides clinicians with certain legal protection in relation to clinical audit. These protections are similar to those attached to mandatory open disclosure set out in section 10 of the Bill.
Part 7 will amend the Health Act 2007 and extend HIQA's remit to the private hospital sector. This will enable HIQA to commence their monitoring regime in private hospitals as well as public hospitals.
Section 68 is a key section which introduces a new provision giving the Chief Inspector of Social Services a discretionary power to carry out a review of serious patient safety incidents in nursing homes. This follows the report of the COVID-19 nursing home expert panel recommendations that call for suitable structures to be put in place for external oversight of individual care concerns arising in nursing homes. The review will cover certain serious patient safety incidents where some or all of the care of the patient was carried out in a nursing home.