Patient Safety Legislation and Advocacy

This Act provides a legislative framework for mandatory open disclosure of a list of serious patient safety incidents and their external notification; certain protections for clinical audit; and extending HIQA’s remit to private hospitals. It provides a requirement to report notifiable incidents to agreed notifiable bodies, currently listed as the Mental Health Commission and the Health Information Quality Authority. The requirement to notify is for all healthcare bodies including:

• HSE (including section 38 acute and disability sectors)
• Section 39s
• Private Hospitals
• Private health and social care providers such as GPs, Dentists, Pharmacists, etc.

The Act provides that the reporting of notifiable incidents should be facilitated by the use of the National Incident Management System.

The Act also provides for mandatory open disclosure requirements for completed individual patient requested reviews of their cancer screening by the Health Service Executive’s National Screening Service in a dedicated part of the Act. It also provides for an obligation for the Cancer Screening Services to inform patients of their right to request a review.

The Act passed by the Dáil also provides for reviews of serious incidents in nursing homes by HIQA.

The Act passed the Final Stage in the Dáil on 26th April 2023 and was signed into law by the President on 2nd May 2023.

The National Open Disclosure Framework aims to promote a clear and consistent approach to open communication, by health and social care organisations with patients and service users following a patient safety incident or an adverse event.

This Open Disclosure includes a discussion about what has happened, why it happened, and what is being done to prevent it from happening again.

The Framework provides overarching principles and a national, consistent approach to open disclosure in health and social care in Ireland which can then be drawn from to suit the needs of the various organisations. The Framework was prepared by the National Patient Safety Office of the Department of Health and informed by recommendations from the Independent Patient Safety Council.

Who does the Open Disclosure Framework apply to?

• public and private health and social care service providers (e.g., acute hospitals, private hospitals, nursing homes, etc.)
• service regulators (e.g., HIQA, the Mental Health Commission, etc.)
• health and social care professional regulators (e.g., the Nursing and Midwifery Board of Ireland, the Medical Council, etc.)
• health and social care educators (e.g., Royal College of Surgeons of Ireland, Trinity College, etc.) and
• other relevant bodies and organisations.

What is the purpose of the Open Disclosure Framework?

It is designed to be used in the development, or upgrading, of an organisation’s internal policies, processes, and practices regarding patient safety incidents and adverse events, and to facilitate open communication.

Individual organisations will need to implement the process outlined in this Framework within their existing internal policies, which may need to be changed or upgraded to facilitate the open disclosure process.

The Framework guides the operational procedures and standards which determine how patients/service users, their families, or support persons and carers are communicated when something goes wrong in the course of their care.

The Framework leads relevant health and social care service providers through the substantial culture change required to improve patient/service user outcomes and their experience in this area.

How will the Open Disclosure Framework be implemented?

The Department of Health will monitor the implementation of this Framework in keeping with the principles set out in the policy document. All relevant stakeholders will be required to submit an annual report to the Minister for Health outlining their compliance with each relevant section of the Framework.

The Minister and Department of Health will then publish an aggregated annual report on open disclosure to share the nationwide progress of the implementation of the open disclosure framework.

Timelines:

• October 2023 – Launch of the Framework
• January to December 2024 – Adoption of the Framework by relevant stakeholders and incorporation into their organisational policies and procedures.
• April 2025 – Submission of relevant stakeholders' progress report on the roll-out of the requirements of the Framework in their organisation.
• 2026 onwards – Ongoing annual reporting of compliance with the requirements of the Framework.

The Minister for Health awarded the contract for the new independent Patient Advocacy Service in December 2018. The service which has been operational since October 2019 is run by the National Advocacy Service for People with Disabilities.

The Patient Advocacy Service provides a free, independent and confidential advocacy service for users of public acute hospitals. The service can support you to make a complaint about the care you have experienced in a public acute hospital and provides support to those who may have been affected by a patient safety incident. Further information on the services provided by the Patient Advocacy Service can be found on www.patientadvocacyservice.ie, phone: 0818 293 003 or email: info@patientadvocacyservice.ie.

The service underwent an external evaluation in 2021 and the findings of this evaluation informed the tender process for the next iteration of the service. The tender process concluded in 2022 and a successful bidder was awarded a contract. The contract was signed by the National Advocacy Service for People with Disabilities for the continuation and expansion of the service from 2022-2027. The service will expand to private nursing homes over the course of the contract and examine the expansion of the service to mental health services. A link to the press release for the new contract and expansion of service is below:

Read more in the press release.

The Strategic Advisory Forum was appointed in February 2019 by the Minister for Health. The Strategic Advisory Forum was established to provide strategic advice on the establishment, development, evolution, performance and monitoring of the Patient Advocacy Service.

Terms of Reference

Membership

Agendas and Minutes

Annual Report

The department has prepared legislative proposals for a mandatory licensing system for public and private hospitals and other providers of high-risk healthcare activities. It is designed to improve patient safety by ensuring that providers do not operate below core standards, which are applied in a consistent and systematic way.

The general scheme of the Patient Safety (Licensing) Bill, was approved by Government in December 2017 and referred to the Oireachtas. It is intended that this Bill will ensure the need for all hospitals to have strong clinical governance and patient safety operating frameworks in place in order to be granted and maintain a licence to provide health services. Currently the Patient Safety Bill is going through the final stages in the Dáil; when enacted this Bill will extend the remit of HIQA to private hospitals.

The NPSO is working on the development of a patient representative policy, or Patient Voice Partners (PVP) policy as they will be called. Patient representatives play an important role in the development of health policy and the reform of health services. The Department places a high importance on identifying and including patient representatives as equal participants on strategic policy working groups and committees across the health service.

In 2021, a comprehensive stakeholder consultation was undertaken to ensure that a wide variety of views and experiences were heard and a number of key themes were captured which will inform the development of the Patient Voice Partners policy.

A public consultation on the draft policy will take place shortly in order give the wider public an opportunity to comment on and contribute to the final document, and to spread awareness of the proposed policy.

Once published, the policy will set out clear guidance on the selection and remuneration of certain patient voice partners for organisations across the public health sector.

The Independent Patient Safety Council was appointed by the Minister for Health, Simon Harris and held its inaugural meeting on 27th January 2020. The Council has been appointed to provide advice and guidance to the Minister for Health from a broad range of perspectives on the development of patient safety policy.

They will initially provide advice and guidance to the Department of Health for the development of an Open Disclosure Framework to assist organisations and clinicians to apply the principles of open disclosure to communicate with patients when healthcare does not go to plan.

They will initially provide advice and guidance to the Department of Health for the

development of an Open Disclosure Framework to assist organisations and clinicians to apply the principles of open disclosure to communicate with patients when healthcare does not go to plan. More recently the Council have provided advice on the development of a new national patient complaints and patient safety incidents policy covering both public and private health services.

Read more about The Independent Patient Safety Council