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Patient Safety

Dáil Éireann Debate, Tuesday - 30 January 2018

Tuesday, 30 January 2018

Ceisteanna (473)

Peadar Tóibín

Ceist:

473. Deputy Peadar Tóibín asked the Minister for Health the status of the recommendations of a commission (details supplied); and if he will make a statement on the matter. [4606/18]

Amharc ar fhreagra

Freagraí scríofa

The Commission on Patient Safety and Quality Assurance was established in January 2007 and reported to the Minister of Health in July 2008. The report was considered by government in January 2009 which agreed the implementation process. The overall objective of the Commission was to develop clear and practical recommendations to ensure that safety and quality of care for patients is paramount within the healthcare system.

The Commission made 134 recommendations concerning the provision of a high-quality health service delivered in an effective way in a safe environment. The recommendations covered a broad array of areas, including issues related to:

- Involvement of Patients, Carers and Service-Users, including communications and open disclosure;

- Leadership and Accountability in the system, including governance, management and reporting structures, education, training and research;

- Organisational and Professional Regulatory Framework, including licensing of healthcare facilities, regulation of healthcare professionals and credentialing; and

- Quality Improvement and Learning Systems, including clinical effectiveness evidence-based practice, clinical audit, adverse event reporting, medication safety, health information and technology.

The implementation plan endorsed by the Commission recommended the immediate establishment of an Implementation Steering Group (ISG) to report to the Minister for Health and Children regarding progress on the implementation of the recommendations of the report. Government approval was given on 27 January 2009 to set up such an ISG to drive the implementation of all the recommendations in the Commission’s Report. The ISG was set up in May/June 2009 and met 12 times in the period June 2009 – December 2010. The Implementation Group published a Report on 10 March 2011, which is available at

http://health.gov.ie/blog/publications/final-report-of-the-implementation-steering-group-isg-on-the-recommendations-of-the-report-of-the-commission-on-patient-safety-and-quality-assurance/ .

Key areas in relation to patient safety and healthcare quality continue to be developed. An update on these items is set out below. It should also be noted that the National Patient Safety Office (NPSO) was established by the Minister for of Health in December 2016 and is progressing a programme of legislation, policy changes and the promotion of the clinical effectiveness agenda.

Programme of Patient Safety Legislation

Legislation on licensing of public and private healthcare providers – the Cabinet approved the general scheme of the Patient Safety (Licensing) Bill in December 2018 and it has now been forwarded to the Oireachtas in order for drafting to commence and to allow the Bill to undergo pre-legislative scrutiny by the Oireachtas Health Committee. The Bill will introduce a licensing system for all hospitals, public and private, as well as certain designated high risk activities which take place in other settings. The Bill will provide for regulations which licensees must abide by, while the Health Information and Quality Authority (HIQA) will be the licensing authority. The Bill will also place a heavy emphasis on clinical governance arrangements, to ensure that hospitals are engaging in best practice with regard to accountability mechanisms.

Mandatory reporting of serious adverse events is provided for in the patient safety elements of the Health Information and Patient Safety (HIPS) Bill, which underwent pre-legislative scrutiny in January 2016 at the then Oireachtas Committee on Health and Children. In relation to the policy of open disclosure on patient safety incidents, Part 4 of the Civil Liability (Amendment) Act 2017 provides a framework for clinicians and other relevant personnel to engage in open disclosure with a patient and their families when an adverse incident has occurred. Regulations arising from the passage of the Bill will be brought forward shortly.

Standards

HIQA have statutory responsibility for the formulation of standards, which are then forwarded for consideration by the Minister as to whether they should be introduced into the healthcare system. The National Standards for Safer Better Healthcare, in place since 2012, provide the overarching framework for the current approach to standards, with others e.g. the National Standards for Safer Better Maternity Service (December 2016) flowing from that. HIQA also develop standards for Health Information governance, to ensure interoperability of systems.

Clinical Effectiveness - National Clinical Guidelines and Clinical Audit

The National Clinical Effectiveness Committee was established in 2010. Its terms of reference are:

1. Provide strategic leadership for the national clinical effectiveness agenda.

2. Contribute to national patient safety and quality improvement agendas.

3. Publish standards for clinical practice guidance.

4. Publish guidance for National Clinical Guidelines and National Clinical Audit.

5. Prioritise and quality assure National Clinical Guidelines and National Clinical Audit.

6. Commission National Clinical Guidelines and National Clinical Audit.

7. Align National Clinical Guidelines and National Clinical Audit with implementation levers.

8. Report periodically on the implementation and impact of National Clinical Guidelines and the performance of National Clinical Audit.

9. Establish sub-committees for NCEC workstreams.

Publish an Annual Report.

To date the NCEC has published 16 National Clinical Guidelines and one National Clinical Audit.

Health information and ICT:

The Government approved and published the eHealth strategy in 2013 for developing eHealth and ICT capability in the Irish health system. This strategy sets out a number of objectives and a road map for the delivery and implementation of eHealth for the benefit of patients by supporting a more patient centred approach and also underpinning patient safety and efficiency. The Knowledge & Information strategy, published in 2014 by the Office of the Chief Information Officer in the HSE, builds upon the eHealth strategy and outlines how integrated information and enabling technology will support the delivery of innovative, safe and high quality patient care to meet the needs of our population across all patient pathways and care settings.

Significant progress has been made on both strategies since their publication. This includes the establishment of eHealth Ireland, the appointment of a Chief Information Officer for the HSE, the establishment of the eHealth Ireland Advisory Committee and the Irish eHealth Ecosystem.

Progress has also been made in relation to the implementation of the Health Identifiers Act 2014, which provides for a system of unique identification for patients, professionals and providers, via an Individual Health Identifier (IHI). My Department has worked closely with HIQA on the development of a system of identifiers. The Individual health Identifier initiative aims to enhance patient data security and confidentiality and support administrative efficiency. This was a key recommendation of the Commission on Patient Safety.

On 30 May 2017, a Commencement Order and Regulations under the Health Identifiers Act 2014 were signed, allowing the further progression of the implementation of the IHI.

The HSE have also developed a business case for the implementation of an electronic health care record (EHR) in Ireland. The roll-out of electronic health records was also a recommendation called for in the Commission on Patient Safety. The business case sets out a number of investment scenarios including timescales for implementation and roll out. The Department of Health is currently working closely with the Department of Public Expenditure and Reform on an approval mechanism for the EHR business case.

Progress has been achieved with the roll-out of the Maternity and New-born Clinical Management System (MN-CMS), which is the design and implementation of an electronic health record for all women and babies in maternity services in Ireland, went live in Cork in December 2016 with Kerry following in March 2017, the Rotunda in November 2017 and the National Maternity Hospital in January 2018. In each location the new MN-CMS successfully replaced paper processes with efficient digital processes.

The delivery of digital health care services will require a robust legal framework to ensure confidentiality and security of patient data consistent with the new EU data protection regulation, Regulation (EU) 2016/679 (General Data Protection Regulation). The GDPR will have a significant effect on how and where data is gathered and the purpose for which it is used. My Department is currently examining the appropriate information framework that will provide the optimum environment to support future developments in eHealth. In this context, a public consultation was carried out in late 2017 seeking views of the public and other stakeholders on the proposals to inform the drafting of a national health information policy in 2018. My Department is working closely with the Department of Justice and Equality in relation to Data Protection Bill 2017 which will provide mechanisms to enable the health service to develop legislative capability to support the processing of personal health data in and across the health system that promotes health services goals and builds public confidence in how health information is used in the context of the General Data Protection Regulation. In addition to the provisions in the new Data Protection Bill there are also legislative provisions in the Health Information and Patient Safety Bill that will provide robust support for the best use of information to support health and social care goals.

Increases in capital spending and resources have been facilitated and the capacity and capability of HSE ICT to successfully undertake large scale ICT projects have been further developed, which will see continued progression on the area of ICT and eHealth. Delivery of eHealth is also being examined in the context of the Sláintecare report, which advocates the “Continued strong support of the e-health strategyparticularly ensuring the necessary funding for timely roll-out of the EHR system ”. The report is currently being reviewed by my Department in the context of its implementation and with a particular focus on further implementing the eHealth strategy and a National Electronic Health record. Additional investment in eHealth and ICT was secured for the period 2018-2021 as part of the Mid-Term Capital Review. The capital provision for eHealth and ICT for 2018 to 2021 is set out below and will allow for a multi-annual rolling programme of work on multiple projects including the capital ICT elements of the New Children’s Hospital.

2018

2019

2020

2021

€60m

€85m

€100m

€120m

Professional Regulation:

Nursing and Midwifery Board of Ireland

On 21 December 2011, the Nurses and Midwives Act 2011 was signed into law. This Act updated the provisions relating to the regulation of nurses and midwives. It has been commenced in three stages with the exception of Part 11 - Maintenance of Professional Competence, and any provisions of the Act associated with that part. The Board's functions are to safeguard the public - this requires the Board to establish procedures and criteria for establishing and maintaining the register of nurses and midwives. Additionally, the Board sets the standards for and approves education programmes for the purposes of registration and continued registration and keeps these programmes under review. The Board also sets standards of practice and provides support for registered nurses and midwives. This includes developing, publishing and reviewing the code of professional conduct and ethics and providing guidance on clinical practice. It also provides guidance on how nurses and midwives should provide care to patients, their families and society. Through its fitness to practice functions, the Board is responsible for considering complaints against nurses and midwives.

CORU

Work continues on the phased implementation of the Health and Social Care Professionals Act, 2005, with the number of professions designated for regulation under the Act having increased from 12 to 15 14 professions (rising to 16 in the coming weeks months). In terms of protection of the public, as of now, 12,500 health and social care professionals are registered by CORU. Eleven registers of the designated professions have been established and the titles of 7 now fully protected in law. Registration Boards for a further 3 professions are appointed and working hard towards opening their registers as soon as possible.

With a view to further strengthening protection of the public and ensuring more robust governance of health profession regulatory bodies a Regulated Health Professions Bill amending all five regulatory Acts is to be published in Q.2 and work has commenced on the preparation of the general scheme of a new Dental Bill.

Continuous Professional Development (CPD) is an integral component in the continuing provision of safe and effective services by health and social care professionals registered by CORU under the 2005 Act, for the benefit of service users. In order to ensure that registrants keep their professional skills and knowledge up to date, the Registration Board for each profession issues and updates CPD standards and requirements specific to the profession. Each registrant must engage in a range of CPD activities on an ongoing basis, complete 30 CPD credits in a 12 month period, demonstrate that the CPD activities are relevant to their professional role, taking account of current and future practice and maintain an up to date CPD portfolio.

A Code of Professional Conduct and Ethics is developed by each Registration Board and is specific to each profession. The code is developed following consultation with the general public, members of the profession, their representative bodies and employers. The Code sets out the standards of conduct, performance and ethics which a member of the profession must adhere to throughout the course of their work. All registrants must abide by the a statutory Code of Professional Conduct and Ethics and on applying for registration must verify that they have read, understood and agreed to abide by the Code for their profession. They must also sign a statutory declaration stating that fact.

Both the Code of Professional Conduct and Ethics and the CPD Standards are living documents which are reviewed and update on a rolling basis. Open communication principles, standards and patient safety /protection of the public are central to the provisions of these documents.

Medication Safety

A subgroup of the Medication Safety Forum was formed to prepare a report on the problems and solutions surrounding unlicensed medicines and medicines shortages. This report forms the basis of the work being undertaken by the Health Products Regulatory Authority (HPRA) in its new function of leading the coordination of efforts by national agencies to manage medicines shortages.

S.I No. 272 of 2012; S.I. No. 273 of 2012; and S.I. No 274 of 2012 transposed amendments to our national legislation to strengthen the European-wide system for monitoring the safety of medicines.

Since July 2012, all new medicinal products must now have a Risk Management Plan which focuses on the assessment and minimisation of important risks associated with the medicine throughout its life cycle.

Risk minimisation measures are interventions intended to: prevent or reduce the occurrence of adverse reactions; maximise the benefit risk; exclude patients where use is contraindicated; or educate a target audience about safe and effective use of medicinal products. Additional risk minimisation measures will be identified in the risk minimisation plan for a particular medicinal product.

Direct Healthcare Professional Communications (DHPCs) are used to deliver important safety information directly to healthcare professionals. These communications inform of a safety concern and advise on what action needs to be taken to minimise a concern. Periodic Safety Review Reports provide an opportunity to re-evaluate the safety profile of a medicine and to review any new safety information that has been reported. Pharmaceutical companies are legally required to prepare PSURs for all authorised medicines and these are then assessed by the HPRA either nationally or in collaboration with other regulatory authorities in other member states in the EU. Following assessment of the information provided, updates to the product safety information may be considered necessary or safety concerns which require further consideration may be referred for review at a European level.

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