Dr. Kathleen MacLellan:

We have taken time to look at the international models that have been utilised around open disclosure. How open disclosure, or duty of candour, is managed is, in a sense, an early science. Most countries dealing with the patient safety community are struggling to see the best models or methodologies for the future. We also found very limited evaluation of the models of open disclosure, or duty of candour, that are utilised that could potentially provide us with some good research or scientific evidence. We looked at a number of things across a number of countries. We looked at Canada, Australia and our close neighbour, the United Kingdom. In general these countries all have a set of principles around what is called open disclosure, or duty of candour, which are very similar to what we have utilised in the HSE and State Claims Agency policies. We are very much in line with the processing approach and that fits with our legislative intent. In most countries, the health professionals would have either an ethical or a professional obligation to disclose and to interact in a professional manner with patients when adverse events happen and on how that could happen. Some countries have very good models as to how that can happen. In the UK, both the General Medical Council and the Nursing and Midwifery Council have come together to produce joint standards around duty of candour and delivery of it. Interestingly, most countries that we looked at, which included the eight provinces in Canada, Australia, the UK, England and Scotland, have apology laws. These are general apology laws that provide for individuals, including health care professionals, providing an apology without that being capable of being utilised in terms of liability or against an individual professional. While that is helpful, it is very important in our system that we introduce some form of protections for our professionals that are within the context of best practice. That apology is very important but it needs to be given in the context of the whole care of the patients, the continuity of care and how that health professional actually interacts with that patient and how we support the health professional as well. The apology is one component of a number of elements that have to happen for a person to ensure we look after him or her and then to ensure we take that learning forward. Generally, a lot of the open disclosure policies that one will see across the world are in the context that there are general apology laws in place, which is one thing we noted clearly.

We know that in the UK, both England and Scotland have moved towards a statutory duty of candour for organisations and that organisations would be mandated to participate in some form of open disclosure with their patients for a defined list of very serious reportable events. We gave due consideration to whether that would be an appropriate consideration in this country. We spoke to a number of the various patient safety experts across the system and we have some good contacts with organisations such as the International Society for Quality in Healthcare, ISQua, and we have had quite a lot of dialogue as to what is the best approach. We really want to support our professionals to engage in this wholeheartedly, because hearts and minds are in play when doctors or nurses sit down with a patient, so that they do so willingly, and they sit down feeling free to engage with their patients, feeling they can go forward. We are not convinced that making that mandatory actually is the best way forward. What we are convinced about is that we need to move forward our culture of patient safety, we need to support our professionals to engage and we need to view the open disclosure legislation, which will support our health professional within the broader package of patient safety reforms. We will be moving forward on a health information and patient safety Bill and in that Bill, we have required mandatory reporting of this list of serious reportable events to the various agencies. HIQA standards for better health care provide for open disclosure.

Deputy Kelleher raised the issue of the management of patient safety in general and we have been working very closely with HIQA and the Mental Health Commission around standards for the management of patient safety incidents, including the length of time it takes to conclude required reviews or investigations in the interests of making it a better service for both our patients and for our health professionals.

We also have another broader package of patient safety reforms, which Dr. Holohan has identified. The open disclosure provisions are to sit within the broader package so that we see patient safety as a system for all of our staff. We will start looking at high reliability organisations and we have talked about a just culture, so that it is not all about a blame game but it is about the whole system taking responsibility.

I might pick up on the point as to who does the open disclosure. In our review of what happens internationally, it is generally the lead clinician who is either the identified doctor or the identified nurse in the system but that is part of a broader open disclosure team, which is actually what we have within our own open disclosure policy. That team may have management but it may also have a liaison person who will work with a family over a period because some adverse events that require open disclosure are events where the family will need to engage with the health system over a long period. We have approached this with the intent that we want to protect that health professional relationship with the family and the patient as they move forward. I hope that has clarified some of the decision-making around our approach to the open disclosure measures.