The Department of Health is committed to driving openness and transparency to ensure patient safety. I believe that all staff must be open and honest with patients. Patient safety is fundamental to the delivery of quality healthcare and to public confidence in the health system, and open disclosure is an integral element of patient safety incident management and learning.
Patient Safety Legislation Programme
In line with international best practice, the Department has been driving a progressive legislative framework to build an open and just culture for patient safety which balances the need for an open and honest reporting culture that facilitates a learning environment, and quality healthcare with accountability for both individuals and organisations. Disclosure and reporting are opportunities to learn, to improve, to address errors that have happened and to apply the lessons to make the service safer for the next patient and the patient after that.
Civil Liability (Amendment) Act 2017
Part 4 of the Civil Liability (Amendment) Act 2017 provides the process and procedures for voluntary open disclosure. The Act of 2017 covers the open disclosure of all patient safety incidents, unintended and unanticipated, including near misses. It provides provisions to create a safe space for staff to be open and transparent with patients in order that they would be given as much information as possible, as early as possible, including an apology where appropriate. The Commencement of Part 4 of the Act of 2017 and the Civil Liability (Open Disclosure) (Prescribed Statements) Regulations 2018, came into effect on 23 September 2018.
Patient Safety Bill
During the Report Stage debate of these provisions, I also committed to examining how legislation could be expedited to provide for mandatory open disclosure to patients of serious incidents. The general scheme for the Patient Safety Bill approved by Government on 5 July 2018, provides the legislative framework for a number of important patient safety issues, including: mandatory open disclosure of a list of serious patient safety incidents and the notification of same externally to the Health Information and Quality Authority and the Mental Health Commission to contribute to national learning and system wide improvements. The Bill will also contain provisions in relation to clinical audit and the extension of the Health Information Quality Authority's remit to private hospitals.
The Bill is part of the broader programme of legislative changes and policy initiatives being taken by the Department so as to improve the ability of the health service to anticipate, identify, respond to and manage patient safety issues. Creating a culture of open disclosure and learning from the things that go wrong is the bedrock of making services safer.
The general scheme of the Patient Safety Bill underwent pre-legislative scrutiny at the Oireachtas Joint Committee on Health on the 26 September 2018. The Bill will build on the foundations provided for by the Houses of the Oireachtas in relation to open disclosure as set out in the Civil Liability (Amendment) Act 2017. Officials of my Department and the Office of the Parliamentary Counsel are continuing to progress this legislation. It is intended that the Patient Safety Bill will be introduced in the Autumn Dáil session.
In addition, in June 2019 the HSE published their revised Interim Open Disclosure Policy in line with the recommendations from the:
- Scoping Inquiry into CervicalCheck Screening Programme (Scally 2018);
- Part 4 of the Civil Liability (Amendment) Act 2017 and the Civil Liability (Open Disclosure) (Prescribed Statements) Regulations 2018;
- Assisted Decision Making (Capacity) Act 2015;
- National Standards of the Conduct of Reviews of Patient Safety Incidents (Mental Health Commission and Health Information and Quality Authority 2017), and
- Incident Management Framework (HSE 2018).
The policy update has incorporated learning to date from the roll out of the 2013 open disclosure programme nationally.
The Department has also funded the establishment of the National Open Disclosure Office within the HSE, which has been set up to provide strategic governance and oversight for the HSE on the implementation of (i) the HSE Open Disclosure Policy and accompanying guidelines, (ii) Part 4 of the Civil Liability (Amendment) Act 2017, (iii) the Civil Liability (Open Disclosure) (Prescribed Statements) Regulations 2018 and (iv) the provisions relating to open disclosure within the forthcoming Patient Safety Bill. The function of this office is to:
- Support health and social care services and staff in the implementation of open disclosure.
- Support compliance with the stated policy, guidelines and legislation
- Provide and support on-going education and training programmes on open disclosure.
- Disseminate evidence based open disclosure resources and tools.
- Support systematic reviews of policies and practice to enable compliance with open disclosure.
- Ensure service user and patient involvement throughout all aspects of the work.
Independent Patient Safety Council
In addition, the Department will is in the process of establishing a new Independent Patient Safety Council. The first task of the Council will be to undertake a detailed review of the existing policies on Open Disclosure across the whole healthcare landscape. The resulting policy will have legislative underpinning. It also will operate across the whole health service and its implementation will in turn be overseen by the Independent Patient Safety Council. The Independent Patient Safety Council will include strong patient and public representation and international patient safety expertise.