Minister for Health, Simon Harris TD, has today (Thursday, December 5th) published the new Patient Safety (Notifiable Patient Safety Incidents) Bill 2019, which will legislate for a number of important patient safety measures.
Speaking today, the Minister said
At the heart of many patient safety issues has been poor communication between patients and health practitioners.
I want us to have a culture of open disclosure, where health practitioners are supported and where patients’ voices are heard.
It is so important that things go wrong, a sincere and genuine apology is offered; that there is an understanding of what has happened; and an assurance that what happened will not happen again.
This new Patient Safety Bill will focus on open disclosure and will signal a new era for the health service.
This legislation establishes a robust and future-proofed framework for mandatory open disclosure. The Bill contains a list of specified patient safety incidents which will be subject to mandatory open disclosure but importantly, the Bill includes a new process by which the Minister for Health will designate other patient safety incidents for which mandatory open disclosure must also occur.
This flexible approach will ensure that the list of serious patient safety incidents subject to mandatory open disclosure can be kept up-to-date.
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.
The new Bill will require notification of these serious patient safety incidents externally to the Health Information and Quality Authority (HIQA), the Chief Inspector of Social Services (CISS) and the Mental Health Commission (MHC) to contribute to national patient safety learning and improvement. Importantly, mandatory open disclosure and the notification system for these serious patient safety incidents will apply to both public and private health services.
The Minister added:
This new legislation seeks to support a just culture in our health services, which is focussed 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.
For this reason, the new Patient Safety Bill places clear responsibilities and obligations on the health services provider to ensure that mandatory open disclosure occurs and that external notification to the regulator takes place. This is to ensure health service employers take responsibility for ensuring the appropriate governance, systems, processes and resources are in place to support health practitioners in making disclosures.
The Minister said:
When this legislation is enacted, Ireland will have made another great stride forward in our suite of patient safety legislation. I look forward to continuing to work with all of the stakeholders, but with patient representatives in particular, on the implementation of this Bill and my Department’s legislative programme to support patient safety across the health services.
The Bill is also part of the broader programme of legislative and policy initiatives to improve the ability of the health service to anticipate, identify, respond to patient safety issues and improve the quality and safety of health services for patients.
The Minister concluded:
Creating a culture of open disclosure and learning from the things that go wrong is the bedrock of making services safer. That requires a commitment from every single one of us in the health service to engage openly and transparently with patients.
Notes for Editors
In May 2018 the Government directed that the patient safety elements of the Health Information and Patient Safety Bill dealing with the external notification of patient safety incidents, clinical audit and extending the Health Information Quality Authority’s (HIQA) remit to the private hospital system should be incorporated into a new Patient Safety Bill. In addition, it was agreed that provision should also be made for mandatory open disclosure of serious patient safety incidents in the Bill, further to the undertakings provided by the Minister to the Oireachtas during the passage of the Civil Liability (Amendment) Act 2017.
The Government gave its approval on 5 July 2018 to the drafting of provisions of a new Patient Safety Bill along the lines of the general scheme of the Bill. Furthermore, the recommendations contained in the report of the Scoping Inquiry into CervicalCheck by Dr. Scally relating to open disclosure also informed the legislation.
Main Provisions
The Bill is divided into 8 parts with 54 sections, as follows:
Part 1: Preliminary and General
Part 2: Open disclosure of notifiable incident
Part 3: Procedure for making open disclosure of notifiable incident
Part 4:Notification to certain bodies of notifiable incident
Part 5: Clinical Audit
Part 6: Amendment of Act of 2007
Part 7:Offences and penalties
Part 8: Miscellaneous and general
Schedule 1: Notifiable incidents
Schedule 2:Amendments of Act of 2017
The Patient Safety (Notifiable Patient Safety Incidents) Bill will provide the legislative framework for a number of important patient safety measures, including–
- mandatory open disclosure of specified serious patient safety incidents, including a process to designate other patient safety incidents in line with advancements in clinical practice,
- the notification of these serious incidents externally to the Health Information Quality Authority(HIQA), the Chief of Inspector of Social Services (CISS) and the Mental Health Commission (MHC) to contribute to national learning and system-wide improvements. It should be noted that mandatory open disclosure and external notification of notifiable incidents will equally apply to the public and private health services,
- provisions regarding clinical audit, and
- extending HIQA’s remit to private hospitals.
Mandatory open disclosure and notifiable patient safety incidents
The Bill provides that where a health services provider is satisfied that a notifiable patient safety incident has occurred (whether the incident occurred within their service or during the provision of a service by another health services provider), a disclosure must be made to the patient or their relevant person (in most cases a family member) with regard to the information known to the health services provider at that time. This mandatory requirement for open disclosure will ensure that patients and their families receive appropriate, timely information in relation to a serious incident that may have occurred concerning their care.
Importantly, the Bill provides a dual and flexible approach to the identification and listing of notifiable patient safety incidents which are the subject of mandatory open disclosure to the patient and their family and must also be externally reported to the relevant regulator. Firstly, the Bill contains a Schedule listing a number of the most serious notifiable patient safety incidents which are subject to mandatory open disclosure. Secondly, the Bill contains a new process by which the Minister for Health will, through Regulations, designate other patient safety incidents for which mandatory open disclosure must also occur. This approach will ensure that the list of serious patient safety incidents subject to mandatory open disclosure can be kept up-to-date in line with advances in healthcare services and international developments in patient safety.
Procedures for Open Disclosure (what patients and families can expect)
The Bill places the patient and / or their family at the centre of the open disclosure process. As soon as practical after a notifiable patient safety incident becoming known to the health services provider, they must disclose all information known about the incident at a meeting arranged with the patient and / or their family. In addition, the patient and/or their family will also be entitled to receive comprehensive, accurate and timely information about the incident at the meeting on within 5 days of the meeting. The Bill also contains provisions which enable patients and their families to defer the open disclosure process, should they wish to do so.