Minister welcomes passage of the Civil Liability (Amendment) Bill Part 4 of which provides for open disclosure.
The Minister for Health, Simon Harris TD, today welcomed the passing of the Civil Liability (Amendment Bill) 2017 on its return to the Seanad.
Minister Harris said “Patient safety and quality are at the heart of our health services and it is important to keep our patients and service users at the centre of everything we do. Delivery of healthcare is, however, inherently risky and while it is inevitable that things may go wrong, there is much that can be done to prevent harm or error, identify and act on when it occurs and to learn from this to improve services. Creating a culture of open disclosure and learning from the things that go wrong is the bedrock of making services safer”.
The legislative provisions on open disclosure are a key element of building a culture of patient safety. The goal from the outset has been to create a safe space where there can and should be full disclosure of the facts surrounding a patient safety incident and of the implications, if any, for the patient’s care and treatment. It is important that where an apology is warranted it is made when the facts of the incident are known and not years later. These open disclosure provisions will support the on-going implementation of the HSE Policy on Open Disclosure.
The Minister continued “The objective is to create a system where the risk of an incident occurring is minimised; when such an event does occur, to ensure that the patient is informed and appropriate remedial actions are taken immediately; and to enable appropriate reporting, and reviews of incidents so that any lessons which can be learned as a result of the incident are disseminated throughout the system as quickly as possible to reduce the likelihood of a recurrence”.
The Minister for Health launched the joint HIQA and Mental Health Commission Standards on the Conduct of Reviews of Patient Safety Incidents last month.
The Director of the National Patient Safety Office (NPSO), Dr Kathleen MAC Lellan, said, “The open disclosure provisions are one part of a number of initiatives to promote a comprehensive patient-centred approach to preventing, managing and learning from incidents. We will continue through the NPSO to advance key actions to build a strong patient safety culture including the introduction for the first time of the national patient safety surveillance system. We will use this information to identify gaps and patient safety priorities in order to direct the health system and make good patient safety policy. This is with the aim of enhancing patient experiences, preventing harm, improving patient outcomes and saving lives and ensuring robust patient safety systems are in place. ”
The Minister also intends to shortly bring forward the general scheme of a new Patient Safety Licensing Bill, which will introduce a regulatory system through licensing for all hospitals in Ireland, as well as certain designated high risk activities that take place outside a hospital setting. This new licensing system, where HIQA will be the licensing authority, will promote the development of robust clinical governance frameworks throughout the health service and serve to aid in the effort to ensure a safe, responsive and accountable approach to the delivery of health care.
Note for Editors
What is Open Disclosure?
Open Disclosure is an open and consistent approach to communicating with patients and their families when things go wrong in healthcare. This includes expressing regret for what has happened, keeping the patient informed, providing feedback on investigations and the steps taken to prevent a recurrence of the adverse event. Open Disclosure is important for building patient and public trust in the health system. An open disclosure that represents a timely explanation when something goes wrong may also reduce litigation that might have been initiated by the patient out of frustration or the need for information.
The purposes of Open Disclosure overall are to:
• ensure that patients are informed when adverse events happen,
• assist in supporting appropriate patient care,
• increase trust between patients and their clinicians,
• support staff in managing adverse events, and
• improve patient safety and quality of care through organisational learning.
Open Disclosure can be viewed as an integral element of patient safety incident management and it is government policy that a system of open disclosure is in place and supported across the health system.
The provisions in Part 4 of the Civil Liability (Amendment) Bill 2017 are designed to support open disclosure in our health service. Part 4 sets out the detailed information to be given to the patient and gives legal protection for the information and apology made to a patient when made in line with the legislation. The apology cannot be interpreted as an admission of liability and cannot be used in litigation against the provider. This approach is intended to create a positive voluntary climate for open disclosure and will support the National Policy on Open Disclosure which was developed jointly by the HSE and the State Claims Agency in November 2013.
What are the benefits for the patient?
Patients receive open disclosure in an open and consistent approach when things go wrong in healthcare. This legalisation supports a safe space for staff to be open and honest with patients. 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.
The provisions support the policy of the Health Service Executive that incidents are identified, managed, disclosed and reported and that learning is derived from them.
The provisions support an open and just culture for patient safety balancing the need for an open and honest reporting environment that facilitates a learning environment and quality healthcare with accountability for both individuals and organisations.
What is the National Patient Safety Office?
The Minister for Health launched the National Patient Safety Office (NPSO) in December 2016. Located in the Department of Health, the NPSO was established to oversee a programme of patient safety measures and advise the HSE, HIQA and health professional regulatory bodies on patient safety issues.The NPSO has 3 streams – clinical effectiveness, patient safety surveillance and patient advocacy and policy. The programme of patient safety centres on initiatives such as new legislation, including the provisions for open disclosure, hospital licensing, complaints and the extension of HIQA’s remit to the private sector and complaints, the establishment of a national patient advocacy service, the measurement of patient experience, extending the clinical effectiveness agenda and setting up a National Advisory Council for Patient Safety. Some key areas of work include:
Commitment to listening and learning from patients and the public through partnership with HIQA and the HSE on the National Patient Experience Survey, public consultation on patient safety complaints and advocacy policy and the National Clinical Effectiveness Committee (NCEC) is finalising its Public Involvement Framework.
An outline of the work of the NCEC which includes the quality assurance of 15 National Clinical Guidelines in areas of patient safety such as early warning systems and sepsis; and 1 National Audit in the area of trauma.
A new Patient Safety Surveillance function which will publish annually on a set of patient safety indicators in addition to the annual National Healthcare Quality Reporting System.
Work on a Policy on Patient Safety Advocacy and Complaints to guide the establishment of a National Patient Advocacy Service external to both the Department and the HSE.
The National Action on AMR 2017-2020 (iNAP).
What are the Standards for the Conduct of Review of Patient Safety Incidents?
The Department of Health commissioned HIQA and the Mental Health Commission to jointly develop national standards for the management of patient safety incidents for acute hospitals. These new provisions, which will provide standards for conduct and type of reviews for patient safety incidents in addition to a set of standard definitions, are being launched at the National Patient Safety Conference. They will complement the National Standards for Safer Better Healthcare.
What is the HSE National Policy on Open Disclosure?
The legislative provisions also support the National Policy on Open Disclosure which was developed jointly by the HSE and the State Claims Agency and launched by the then Minister for Health in November 2013. The Policy is designed to ensure an open, consistent approach to communicating with patients and their families when things go wrong in the provision of their healthcare. HSE policy is that the service user must be informed in a timely manner of the facts relating to the incident. The service user should also be informed if an adverse event is suspected but not yet confirmed. No harm events should generally also be disclosed.
In the case of near misses, HSE policy is that near miss incidents should be assessed on a case by case basis, depending on the potential impact it could have had on the service user. If, after consideration of the near miss incident, it is determined that there is a risk of/ potential for future harm from the incident then this should be discussed with the service user.
The HSE is implementing the Policy across all health and social services. The handover of responsibility for open disclosure to the hospital groups, ambulance service and Community Health Organisations for the further implementation of the HSE national open disclosure policy became effective on 31st December 2016. This handover requires leadership and accountability at all levels in the system and requires buy in from National Directors, CEOs, Chief Officers and Quality and Patient Safety Leads.
Open disclosure leads and champions have now been identified in all Community Health Organisations, hospital groups and in the national ambulance service. Site leads have been identified in many hospitals.
To date some 17,143 HSE staff have either been briefed in open disclosure (12,910) or attended a half day training (4,233). Indeed, HIQA in its recent inspections has noted the knowledge and adherence to open disclosure provisions across hospitals.