Patient Safety Bill passed by Oireachtas

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The Patient Safety (Notifiable Incidents and Open Disclosure) Bill 2019 passed through all stages in the Houses of the Oireachtas at the end of April.

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. The Department said this would ensure that patients and their families had access to comprehensive and timely information, including an apology where appropriate, in relation to serious patient safety incidents.

It said a second core purpose of this new legislation was to enable national learning from these serious patient safety incidents and to support health service-wide improvements so that harm to other patients could be prevented. This would 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.

The legislation 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 HIQA. The Chief Inspector of Social Services or the Mental Health Commission as appropriate, within seven 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 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.