I thank the committee for the opportunity to address it this morning. I will keep my statement short to allow as much time as possible for questions, which we will be happy to take. As the Chairman said, I am joined by Dr. Kathleen MacLellan, who is director of the national patient safety office in the Department, Ms Susan Reilly from the same unit, and Ms Bernie Ryan and Mr. Peter Lennon from the corporate legislation unit.
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 health care is inherently risky and while it is inevitable that things will go wrong, there is much that can be done to prevent harm or error, to identify harm when it occurs, to act on it and to learn from this to improve the safety of services for the future.
The Department is Health is fully committed to progressing the programme of major patient safety reforms the Government had an opportunity to consider and approve last November. These measures include a range of actions on legislation, the establishment of a national patient advocacy service, the introduction of a patient-safety surveillance system, extending the clinical effectiveness agenda, a national patient experience survey, which will commence early next year, the establishment of the national patient safety office in the Department, and the setting up of a national advisory council for patient safety. Within the programme of legislation, we intend to progress the licensing of our public and private hospitals, the health information and patient safety Bill and the provisions the committee is discussing this morning on open disclosure. There is a lot covered in these measures. If the committee has any interest in returning to any or all of them, we will be very happy to assist.
The committee will already have a copy of the general scheme for open disclosure approved last November and an information note forwarded by the Secretary General in July of this year with certain documents from the HSE on open disclosure, including the HSE policy. Creating a culture of open disclosure and learning from the things that go wrong comprise the bedrock of making services safer. Recent reports, some of which we were involved in creating, highlight that service users have at times felt unsupported by the system, have not always been afforded adequate explanations following adverse events and sometimes find the health service complex to navigate, particularly following adverse events.
Open disclosure is an open and consistent approach to communicating with patients and their families when things go wrong. It is a human experience for all involved and one that should not be hindered by other concerns or fears. That view has shaped our approach, which recognises the importance of the quality of the open disclosure engagement by the health professional with the patient over a period of time. It is not always a single event. It can be a matter of supporting a patient over a period of time to understand what has happened.
The background to the proposed legislation lies in the Commission on Patient Safety and Quality Assurance, chaired, as the Chairman will be aware, by Dr. Deirdre Madden of UCC. The commission recommended that legislation be enacted to provide legal protection and privilege for open disclosure of adverse events to patients. The provisions are therefore designed to give 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 that was developed jointly by the HSE and the State Claims Agency and promulgated from November 2013.
Our 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 be made when the facts of the incident are known and not years later, perhaps on the steps of a court.
The Ombudsman is clear that many people who complain to his office say that what they are looking for often is for the service provider to acknowledge something went wrong and to receive a meaningful apology. People say they want to be listened to and to be reassured that lessons have been learned and that the same mistakes will not happen again to other patients. The evaluation of the 2013 HSE national open disclosure policy, published in July this year, provides valuable lessons to us for building a culture of open disclosure. It identified that one of the persistent barriers was the perceived fear of the medico-legal consequences of open disclosure on the part of health professionals. These barriers are similar to those identified in other jurisdictions and written about extensively in the literature.
The legislative provisions are, therefore, being drafted to ensure there is clarity for everyone involved in the open disclosure process and that there is appropriate consistency across the various parts of the health system regarding how open disclosure is understood and delivered. It will only be where there is compliance with the primary legislation and the regulations under that legislation that these protections will be available. The information note of 28 July from the Secretary General explained why we are now focusing on the development of regulations rather than standards, as in our original approach. The provisions are intended to support an environment where the patient's information needs can be addressed as soon as possible. In a hospital setting, for example, the open disclosure should usually be made by the lead clinician in charge of the patient's care. The current draft provisions state the disclosure should be made as soon as practicable and that the information given should cover a description of the patient safety incident, the date it happened, the date the provider became aware of the incident and how the provider became aware of it. Information must be given on any known physical, psychological or emotional effects arising from the incident and how these are to be managed. The patient is also told about any actions being taken to ensure learning from the incident to avoid a recurrence. This is clearly a lot of information for a patient to take in, often is a situation in which he or she may be traumatised. The intention is that the Minister will prescribe a form to be given to the patient under the legislation so that we will have uniformity in the provision of the information across the health services. While the oral information and the information in writing in the form cannot be used in litigation, the patient could, of course, use his or her medical records if taking legal action.
Open disclosure is about building patient and public trust in the health system. For that reason, it is important to make clear today that there is no question that the provisions seek to provide safe haven for incompetence, negligence or other unprofessional health care. Such a scenario would completely undermine what we are trying to achieve in a wider sense in regard to patient safety and changing the culture. Organisations and health professionals continue to have accountability mechanisms within their individual professional regulatory mechanisms, as members will be aware. An open and just culture for patient safety balances the need for an open and honest reporting environment that facilitates a learning environment and quality health care with accountability for both individuals and organisations.
Disclosure and reporting provide opportunities to learn, improve, address errors that have happened and apply the lessons to make the service safer for the next patient. The open disclosure provisions form part of a number of initiatives to improve the management of patient safety incidents, as I have mentioned. HIQA and the Mental Health Commission are at an advanced stage of development of standards on the conduct of reviews of patient safety incidents that expand on the standards for safer, better health care that were approved in 2012 under the 2007 Act. This set of standards, along with the mandatory reporting of serious reportable events - there will be a prescribed list of very significant events in the health information and patient safety Bill - and the provisions intended for open disclosure will provide a comprehensive patient-centred approach to preventing, managing and learning from these incidents.
In terms of timelines, the intention is to include the provisions to support open disclosure in the Civil Liability (Amendment) Bill. As members will be aware, the legislation is being progressed by the Department of Justice and Equality and it is expected to be published, as we understand, during this session.
As I have outlined, the provisions for open disclosure form part of a broad and ambitious programme of reforms. We are happy to brief the committee, if they so wish, at any point in the future. I thank the members for their attention. I look forward to hearing questions and will try to address them.