Written answers

Wednesday, 28 November 2018

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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198. To ask the Minister for Health if he will report on the implementation of a patient safety, complaints and advocacy policy. [49680/18]

Photo of Simon HarrisSimon Harris (Wicklow, Fine Gael)
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The Department of Health has been engaged in the development of policy in relation to the areas of Patient Safety, Complaints and Advocacy for considerable period of time. Notably, in December 2015, the Government approved the establishment of a new Patient Safety Office to bring forward legislation and provide the policy lead for patient safety.

Patient Safety Complaints and Advocacy Policy

In approving the Memorandum to Government on Patient Safety, the Government also directed the National Patient Safety Office in the Department of Health to undertake:

- A review, in association with the Health Service Executive, the Office of the Ombudsman and the Department of Public Expenditure and Reform, of S.I. No. 652/2006 Health Act (Complaints Regulations 2006 with a view to enhancement of the statutory provisions for management of complaints within the health services;

- Establishment of a patient advocacy service.

Public Consultation for the Patient Safety Complaints and Advocacy Policy took place between June and November of 2017 and a report of its findings was published in July 2018.

Following on from that work, a tender was recently commissioned seeking bids for the establishment of a new Patient Safety Advocacy Service, with the successful tenderer expected to be announced before the end of this year.

Work has also been undertaken to develop a competency framework, and a training programme, that will be available to the advocates that will be employed by the new service. This will be available in early 2019, and will ensure that competent and trained advocates are provided to work in the service.

The Patient Safety Advocacy Service will provide free and independent advocacy for anyone wishing to make a formal complaint about the care or treatment they received in the health service and for anyone who has been involved in a patient safety incident. The service will initially be provided for in the public acute hospital sector and will then extend to the community.

Simultaneously, my Department is continuing to review Statutory Instrument No. 652/2006 - Health Act 2004 (Complaints) Regulations 2006 with a view to enhancement of the statutory provisions for management of complaints within the health services and to consider the inclusion of clinical judgment in healthcare complaints. This review process will also encompass inputs from the Health Service Executive, the Office of the Ombudsman and the Department of Public Expenditure and Reform. It is expected that this process will be finalised in 2019.

Patient Safety Legislation Programme

My Department 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.

In line with international best practice, my 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 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 and the Civil Liability (Open Disclosure) (Prescribed Statements) Regulations 2018, came into effect on 23rdSeptember 2018.

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.

Patient Safety Bill

The general scheme for the Patient Safety Bill provides the legislative framework for a number of important patient safety issues, including: mandatory open disclosure of serious patient safety incidents and the notification of same, clinical audit guidance against explicit clinical standards on a national basis and the extension of the Health Information Quality Authority remit to private hospitals.

The General Scheme of the Patient Safety Bill is intended to provide clarity and assurance regarding the requirement for open disclosure to patients and or their family with regard to serious patient safety incidents, the management of the incident itself and the need to ensure the dissemination of any learning from the review of the incident across the whole health system. This is further facilitated by the requirement for mandatory external reporting of those same incidents by health service providers to the appropriate regulatory authority and the State Claims Agency. The general scheme of the Patient Safety Bill underwent pre-legislative scrutiny at the Oireachtas Joint Committee on Health on the 26 September 2018 and is currently being drafted by the Office of the Parliamentary Council.

Patient Safety Licensing Bill

In addition to the legislation described above, my Department is also progressing a Patient Safety Licensing Bill. This will for the first time introduce a requirement to hold a licence in order to operate a hospital and will apply to both the public and the private sector. It will also be a requirement to hold a licence in order to carry out certain high-risk activities outside of a hospital setting, which will be designated by the Minister for Health. HIQA will be the licensing authority.

Once enacted, those entities in possession of a licence will have to operate in accordance with Ministerial regulations, so that there will be assurance that appropriate standards of clinical governance are being adhered to. This will also include a requirement to engage in open disclosure, as required.

Establishment of a Surveillance System

Research of patient safety frameworks in place internationally has been undertaken and the outputs of this are being evaluated for their applicability or relevancy to the Irish healthcare context. This research will inform the scoping work for the development of a national patient safety surveillance system. This patient safety surveillance system will build upon work already undertaken through the National Healthcare Quality Reporting System, the National Patient Experience Survey, Maternity Patient Safety Statements and Hospital Patient Safety Indicator Reports.

Clinical Effectiveness measures

The National Clinical Effectiveness Committee, the NCEC, also continues to lead an ambitious work programme. This year saw the publication of National Clinical Guidelines for the Management of Type 1 Diabetes and the early warning system for the Emergency Department that focuses on clinical deterioration of patients. There are now eighteen NCEC National Clinical Guidelines in the suite providing evidence-based guidance to clinical staff across the health service. In addition, the NCEC has published 2 guidance documents and tool-kits; one on public involvement in clinical effectiveness and another on implementation of clinical guidelines. Aligning levers of policy and implementation help create a more integrated and evidence based approach to patient safety.

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