Michael Harty (Clare, Independent)
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I apologise for detaining the delegates. The purpose of this morning's meeting is to hear from officials from the Department of Health on the legislative provisions that will support open disclosure to patients. On behalf of the committee, I welcome the delegates from the Department: Dr. Tony Holohan, chief medical officer, Dr. Kathleen MacLellan, director of patient safety, Ms Susan Reilly from the patient safety unit, and Ms Bernie Ryan and Mr. Peter Lennon from the corporate legislation unit.

I draw witnesses' attention to the fact that by virtue of section 17(2)(l) of the Defamation Act 2009, witnesses are protected by absolute privilege in respect of their evidence to this committee. However, if they are directed by the committee to cease giving evidence on a particular matter and they continue to do so, they are entitled thereafter only to qualified privilege in respect of their evidence. They are directed that only evidence connected with the subject matter of these proceedings is to be given and they are asked to respect the parliamentary practice to that effect where possible. They should not criticise or make charges against any person or persons or entities by name or in such a way as to make him or her identifiable. I also wish to advise them that any submission or opening statements they have submitted to the committee may be published on the committee's website after the meeting.

Members are reminded of the long-standing parliamentary practice to the effect that they should not comment on, criticise or make charges against any person outside the Houses or any official either by name or in such a way as to make him or her identifiable.

I invite Dr. Tony Holohan to make his opening statement.

Dr. Tony Holohan:

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.

Michael Harty (Clare, Independent)
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I thank Dr. Holohan for his submission. I shall open the discussion to the floor and Deputy Kelleher.

Billy Kelleher (Cork North Central, Fianna Fail)
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In terms of open disclosure, has there been full co-operation and an embracing of the open disclosure concept by the professional bodies that oversee the various medical entities in this country? The Minister, who I am sure would agree, was here a number of weeks ago. He said that how we have handled the incidents of adverse effects on patients over the years has been a shameful indictment of the health services and broader society. He said it is something that we need to address very quickly. In the area of maternity services, for example, there have been some sad and tragic episodes and the findings were delayed or not divulged in time. The families have had to go to extraordinary lengths to find out what happened to their loved ones when they were entitled to know what happened early on. As Dr. Holohan has said, very often an apology is given on the steps of a court. Very often, an apology is dragged out of somebody at some stage just outside of the Four Courts. The only people to gain from doing this are those who represent the various bodies. The families are left to endure a traumatic period and then have to endure an apology that has been dragged out of somebody as opposed to being offered. We need to change that concept.

At times the senior management in the HSE has become completely unaccountable. It is always the clinician who is found to be at fault. Even in today's presentation it is the senior clinician who speaks to the patients to make an admission and apologise. It is not always the clinician's fault that something goes wrong and there may be other reasons and factors such as poor infrastructure or equipment. Why has senior management been completely removed from accountability? They are not even accountable half the time when they come in here. Is there a need to ensure that people cannot hide behind clinicians? I would like to hear the Department's views on the matter.

Families often say that there must be a cultural change in the HSE, governing bodies and professional bodies in order for them to embrace the concept of open disclosure. Obviously the Department has looked at other countries where open disclosure is more advanced. What countries have a model of open disclosure that we should aspire to and that has similar legal positions and other similarities?

Dr. Holohan has said in the above context that the apology cannot be interpreted as an admission of liability. An individual is entitled to his or her good name and for his or her professional competency to remain intact until such time as proven otherwise. In terms of reporting and bringing forward legislation, reports are now quickly conducted and disseminated so the laws of libel become irrelevant once the matter reaches social media. Is there any way we can encourage open disclosure? We need to consider this matter in order to ensure people keep their good name even though they have admitted a patient or an entity has experienced an adverse effect while under their watch, without an admission of liability. Many good clinicians could find their names badly damaged without an opportunity for recourse.

Dr. Tony Holohan:

I ask my colleague, Dr. MacLellan, to assist me in responding, in particular to the question on what we have learned from other jurisdictions. We do have an amount of experience in terms of that matter.

In respect of the point made about apologies coming too late and having to be dragged out of people, we completely agree with the Deputy. This is a consequence of the culture that exists and is not an easy thing to change. We have direct experience of this matter. As the Deputy may know, both Dr. MacLellan and I were directly involved in carrying out the examination of what happened in Portlaoise when the case of four deaths of normally formed enfants occurred in the early part of 2014. It was clear to us, and by no means confined to Portlaoise in our view, that the way in which the patients were treated was nothing short of unacceptable. Far from failing to provide open disclosure in that context, there was an active, and in many respects, a determination almost not to reveal full and clear facts to patients who clearly were entitled to have them. We are a long way away from addressing the context in which such cases arise. Unfortunately, there have been others cases which involved the kind of response that was far from what we would need to see.

Part of the picture is a perceived risk. Sometimes clinicians, and I do not just say doctors but often doctors, perceive themselves to be putting themselves at risk by being forthright and clear about what happened in a particular context and perhaps apologise. Part of our strategy, as well as being clear through open disclosure policies, about what constitutes good open disclosure and what the expectations are, is to try to remove some of those things that we know are barriers to that happening. Our strong sense is that when something goes wrong in the care of an individual patient - as I say, it does happen - we can work to reduce such occurrences. However, when it does happen there is really only one good opportunity to try to get things right and that is the point of first interaction with the patient, which is often with senior medical and nursing staff. If trust and confidence breaks down at that point and there is not full disclosure, and there is then a clear attempt to try to ensure that the trust and confidence of that patient is maintained thereafter then no amount of activity after the fact will make up for what happened at the outset. Very often, investigations and other responses from the patient's point of view are incapable of fully compensating for what happened. He or she is certainly unable to get back into a situation where his or her trust and confidence in the service that he or she may often have to continue to use, is capable of being restored.

A lot of our effort is about trying to support through training and standards, on the one hand, and then also looking at the legal environment and the perceived risk that people believe themselves to be at, to ensure that they engage properly with patients. Also, to ensure that they do not circle the wagons and stop interacting and communicating with patients and families in those circumstances. In many respects, it is a time when patients and families need them the most. That is at the core of many of the significant patient safety incidents that we have seen in this jurisdiction. It is at the core of many of the significant patient safety incidents that have been written about extensively in the literature. Services and service providers stop communicating, stop being full and open and stop being truthful about what has happened. As a result, trust and confidence breaks down on the part of patients. No amount of compensatory actions after that fact are capable of redressing those deficiencies.

In terms of the point made about a lack of accountability by senior management, the Deputy made a good point that we need to ensure it is not just a matter that the quality of care patients receive is only seen as a matter for the doctors, nurses and other health professionals providing a service. In a situation where an adverse event occurs, where a patient has been harmed and where there may be changes in the treatment provided to him or her, their might be life altering outcomes for those patients as a consequence. All of that interaction will need to happen with clinicians who are capable of explaining and interpreting that for those patients and supporting and continuing the provision of care. As the Deputy has said, behind that there needs to be accountability when it comes to the management of the system.

Members will be aware of the framework for accountability as it has been much talked about.

Much of the emphasis in public discourse has been around the financial components of the framework. There are four elements to the framework, one of which includes patient safety and quality. We must have a situation whereby senior managers and policy-makers in the system accept accountability for the environment in which clinical care happens because, as Deputy Kelleher rightly said, it is not just clinical service, there is an interaction between a variety of different factors that increases or reduces the risk of an incident occurring. Some of those factors will not be in the control of individual doctors or nurses. Often it is not a case of incompetence or even poor performance. Sometimes adverse events occur when things go wrong but sometimes they occur when things have not gone wrong. Adverse outcomes are part of the imperfections in the science but there clearly needs to be accountability. We want to see more in the way of specific provisions in those systems so that there is more measurement and reporting, more transparency in terms of quality of care and specific measures that speak to the nature of the quality and safety of service put in place if they are deemed to be important parts of the provision of service. We see health service management right up to the top of the HSE accepting, and being asked to accept, accountability for performance across the so-called balanced scorecard, which does not just look at money. It looks at money, access, HR and patient safety and quality. We do not want to end up pursuing a high standard of accountability, for example, in regard to finance, while inadvertently compromising issues in regard to safety and quality. We must have a balanced approach to all things.

In the jargon, and I do not want to slip into using jargon, people talk about clinical governance. In essence clinical governance means there is corporate accountability for the quality and safety of services delivered to patients. It cannot be seen, as might have been the case heretofore, and not just in this country, by the senior leaders in the health care environment that quality and safety of services are really matters for the doctors and nurses and are nothing to do with the people in the boardrooms and offices. That is old thinking. The international community, as we do, understands patient safety very well and we need to ensure that accountability reaches all the way into the boardrooms and the senior management rooms of the operation and delivery of the service.

I will ask my colleague, Dr. Kathleen MacLellan, to give a brief account of the systematic look we have had at other countries and what we have learned from that.

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.

Michael Harty (Clare, Independent)
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I thank Dr. MacLellan. In relation to this proposal on open disclosure, is it a voluntary proposal? Is there a mandatory element to this document?

Dr. Kathleen MacLellan:

There is no legislative mandatory element in this document but there are other measures, such as required accountability, be that through the professional bodies, the organisational responsibilities, the adherence to the standards per sefor better health care and so on.

Michael Harty (Clare, Independent)
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If the health professional makes an open disclosure through the criteria laid down in this document, there is some legal protection in that one is stating that something went wrong but is not admitting any liability in respect of that statement. It is informing the patient that something went wrong or could have gone wrong but did not go wrong or there was an error that did not result in any harm but potentially could have caused harm. Is that the case?

Dr. Tony Holohan:

Yes.

Dr. Kathleen MacLellan:

Yes, the intent is that we are trying to create a safe space so that where there is a view that something has gone wrong, and at that stage we will not necessarily know why it has gone wrong, the health professional can feel comfortable in sitting down with the patient and saying to Mrs. X that he or she is very sorry something has happened here, the implications are whatever and this is how we will look after her and her care going forward. We are going to take this learning and see if there is something immediate in the system that we need to address. Is there something longer term that we need to promulgate, not just within the hospital or the organisation but across the whole health system?

I suppose it is trying to create an atmosphere where we turn things upside down, things are not covered up and instead of people feeling fearful in coming forward, they actually feel safe to sit down with their patients with their organisation supporting them to feel safe. We want to start opening the issues out. That is the international experience. When we start talking about patient safety incidents, measuring and knowing what is happening, we will make genuine moves to make the system safer.

Dr. Tony Holohan:

There is, and this has been part of the some of the public discourse on the issue, a clear policy choice as to whether one would seek to put these types of protections around a process which is voluntary or to put some mandate and some obligation in statute around what doctors and nurses would do. We have formed the judgment that the former is more appropriate. We think that a balanced assessment of the international evidence on this issue says there is a risk in the first instance that we may increase the fears on the part of doctors and nurses that if something is prescribed around their behaviour, it might contribute further to their sense of legal liability. There is a risk we might get a tick-box style of compliance, so that open disclosure is now a case of "I have to tell you, so therefore I am telling you." However, the hearts and minds Dr. MacLellan has spoken about is about getting doctors and nurses into a space and then protecting them in that space to allow them to do the job in the way it needs to be done. As I said in my earlier statement that can be a process, it might not be a single event for the patient but may be a process over a period of time and much more than ticking a box. Doctors and nurses will have to understand what to do, why they are doing it and, in a sense, to feel supported in doing it. That is the reason we have gone down that road. I know there has been some criticism of that particular determination but we have a good and strong rationale as to why we think that is necessary.

There are areas in legislation, and we can point to examples of it, where behaviours and notifications and so on in respect of health professionals are mandated in legislation but very often do not occur. When one looks at the international evidence, one will find that in countries where there is such a requirement on doctors and nurses, large percentages of them do not know such a requirement exists. It might feel like that it will address something, it seems intuitively the right thing to do, but our view is it might actually contribute to a further likelihood of doctors and nurses not doing the right thing or perhaps not doing it right.

Colm Burke (Fine Gael)
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I thank the witnesses for their presentations. Open disclosure is very important. I am a little concerned about the capacity to deal with it within the HSE and will give one or two examples. First, an adverse event occurred and it was agreed by all of the medical staff in the particular hospital that there should be an independent review to make sure full information was given to the family. The hospital identified an independent person to carry out a review who was outside of the HSE group but still within the HSE. The decision was overruled by a person in administration in the HSE and 18 months later, the independent review has not been carried out. Surely, this should not arise.

While I know it is not tied into Dr. Holohan's area, a second issue that is causing a great many problems for families, especially where somebody has died, is that there is no obligation on coroners to hold an inquest within a period of time. My understanding is there is no provision in current legislation that a coroner must hold an inquest. If there is a delay, there is the immediate presumption by the family that something is being covered up. That needs to be addressed immediately.

Third, on the question of support for staff where there is an adverse event, I am not at all clear there is support for hospital staff, be they nurses, junior doctors or even administrators, because when there is an adverse event in a hospital, it affects everyone working in the hospital. What is being developed to provide that support? I am aware of a number of incidents, in which no support of any description was given to staff and as a result, the number of staff members on sick leave increased because they had been adversely affected. What are we doing in regard to setting up support mechanisms for staff?

Nearly every week we have a situation where there is some reporting of an adverse event in the maternity services. The big problem with independent reviews is that because we have a shortage of medical personnel in maternity services - in that the number of consultants is lower than in other jurisdictions - we have a shortage of personnel to carry out independent reviews from outside the HSE group and it falls to a consultant in another HSE group to carry out the review. As a result the process of review is very slow. Maternity cases are significant and all of the relevant information must be provided in the fastest possible time. What mechanism is the Department and the HSE considering to deal with that area in particular?

Dr. Tony Holohan:

Senator Colm Burke's final point relates to the first point on the length of time it takes to get through some of the reviews. Frankly we share the Senator's concern and understand exactly what he is saying. Perhaps for reasons that might be understandable and particularly as it applies to maternity services as a result of some incidents that occurred - the Senator may remember some of the particular public criticism was for a failure to conduct or complete reviews in some cases - when more incidents occurred in the more recent past, there has been a determination to get the review process into place. In our view it is not always necessary to do the scale of review of the kind that is prescribed in each of these situations in every circumstance.

I might go back as to why one should do these reviews in the first instance. The most compelling reason to do a significant review when a patient safety incident has occurred and that speaks to the urgency and so on is if there is a reason to have a suspicion that there is a continuing concern about the safety of a service. The most important question to address is whether there is a risk attending to the patient who is coming tomorrow to use this service that needs to be addressed and there is an urgency around that. The next most important is if there has been a group of patients who have used the service in the recent past who might have been harmed and who need to be identified through a look-back and to be provided with some further service. We have had some examples of that. Obviously the individual patients who may or may not have been harmed will wish for a review of the circumstances of their own cases. That might not always be the most important reason for a review to be undertaken. We may have slipped into committing to doing too many of these large-scale independent reviews in circumstances where they are not always necessary when one thinks about the purpose to get to the learning and understanding of what has happened.

To return to the point we made earlier, if the disclosure of what is known at the start happens in the right way and is provided by the right people in order that trust and confidence is maintained on the part of patients and families, sometimes many of the questions patients have can be appropriately answered in that context without the need for recourse to independent processes and reviews. I am not at all saying we do not need independent reviews as part and parcel of our process.

The point Senator Burke is rightly identifying is that many obstetricians and other senior people are engaged in conducting large numbers of reviews from a limited capacity and then these reviews are not being done within the prescribed period, which for the HSE is a four-month period. I know the quality assurance and verification division in the HSE, which has responsibility, and HIQA are both doing important pieces of work in this situation. One in the HSE is to try to look at the different types of reviews that will be necessary in different setting. Sometimes, a quick analysis of what went wrong at a very early stage might be enough to address the question of continuing safety and does not need an elaborate and lengthy process that can take weeks or months to complete. One cannot have a process lasting weeks or months that leaves open the question of whether a service continues to be safe.

There is a question of horses for courses in the context of the type of incident and review. The HSE is now considering this very carefully. We are also working with HIQA, which is carrying out a review of national standards again. This is based on a recommendation that arose from the work we did in Portlaoise two years ago to examine developing national standards for different types of reviews in different settings. It is a matter of having the right type of review and not ending up with large numbers of busy front-line clinicians tied up with reviews that are not always of the right type in the circumstances. Addressing this will help to improve the circumstances that have been referred to.

The point made on the support of staff is a good one. The open disclosure policy and some of the other policies in the HSE will make this clear. There is an issue arising regarding the capacity of services in this regard and regarding the provision of the appropriate support. It is a matter of doing so in a way that recognises that the second victim is often the health care professional at the coalface. That individual might feel responsible. He or she might represent the final step in a chain of things that went wrong but may feel responsible. As was rightly said, he or she needs to be supported appropriately and to have his or her confidence rebuilt. Sometimes staff find themselves taking sick leave owing to stress. Alternatively, unsupported staff may continue to provide services without sufficient assistance and support while no longer in a position to do so as safely as possible. They may be seeing another patient later that day, the following day and so on. All these factors need to be considered as part of how we respond.

As a consequence of the additional moneys made available to the HSE for the provision of health services, we would like to see some of the resources dedicated to ensuring there is greater capacity at the front line for dealing with these matters. We can talk about all of these matters in terms of the right thing to do but if we do not invest in the development of front-line capacity and capability, there is little point in having numbers of staff such as ourselves in Hawkins House and Dr. Steevens' Hospital working on patient safety. It does not have to involve a large number of people but there must be staff whose day job is to ensure arrangements are in place to provide, where necessary, services to support staff members in the circumstances described. Meaningful investment has got to happen at the front line. We want to see some of the resources dedicated to developing capacity and capability at the front line.

Colm Burke (Fine Gael)
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What about the Coroners Act?

Dr. Tony Holohan:

I am not dodging the question in any way by saying the Senator will be aware the coronial process and the legislation are the responsibility of the Department of Justice and Equality. We have our own views on some of these matters and will be working with the Department of Justice and Equality, which I know has been considering this area in recent years. We know there is a variation in practice between different coroners. There is no standard of the kind that the Senator speaks of. The variation in practice is such that in some areas coroners' inquests are carried out quite quickly relative to the events while, in other areas, coroners might save up a number of events and hold a single set of hearings in a short space of time, the result being that it takes a very long time before the holding of inquests in respect of certain incidents. That contributes significantly to the harm. We have our own experiences and have heard directly from patients about the trauma of being part of an adversarial inquest, with staff members being significantly represented by counsel and senior counsel, etc. Patients may go through the process feeling quite vulnerable and unsupported. We want to ensure this is borne in mind in any review of the coronial process. We would like to work with our colleagues in the Department of Justice and Equality on this. We would like to see a process that is much more patient centred if this is to be an important part of our response regarding incidents and when they occur.

There is probably a lot of knowledge gleaned from inquests right around the system but we need to be much better at pulling that knowledge together from separate coronial processes conducted in each of the different jurisdictions with a view to learning from it and using it to inform our activity to prevent the kinds of cases that arise on coroners' desks.

Louise O'Reilly (Dublin Fingal, Sinn Fein)
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I have a number of difficulties with what we are dealing with here. Many of them stem from my experience as someone who would have supported health professionals through the system. As the system stands, it is incredibly adversarial, not just for the patients, who, of course, must be central, but also for the staff themselves.

Regulated health professionals have an arena in which issues relating to them can be investigated and in which they very often are. Many of my colleagues within the various representative bodies for health professionals and I have experience of ongoing investigations within the HSE. The Nursing and Midwifery Board of Ireland and the Medical Council investigate regulated health professionals regarding incidents where there may be a suspicion of poor professional performance, for example. There is another group of people who do not face investigation at that level but who are very often central to the incidents. They do not have their own regulatory body. Since the requirement is not mandatory, there are those involved who do not have any compunction to disclose. Whatever is done by regulated health professionals is examined in another arena but there are staff who are central to the process but who do not have any regulatory body. If the requirement is not mandatory, there is no onus on the latter staff, although they are central.

Much of this seems to hinge on the investigation taking place. There seems to be over-reliance in the HSE on investigations. As was pointed out, one could be doing well to get out of an investigation in 18 months. Some can take years. Meanwhile, other matters arise.

The documentation states it is not proposed to include a mandatory requirement concerning open disclosure but that it will be reviewed in line with experience. Making it mandatory could be reviewed in line with experience also. There are patients and also staff who have been battered by the system and the culture. The culture needs to change. I am not convinced it will necessarily be changed in a voluntary way. The reason I say this is that staff must be supported, and they must also be trained. However, without making this requirement mandatory, the training may not happen because there is always a draw on the budget. There is always something else that needs resources and somewhere else to direct the money. Unless the requirement is mandatory, the training may not happen. If not, the staff will not feel supported. I am interested in knowing how the staff will be supported through training. How can it be done? I am not convinced it will happen if the requirement is not mandatory. That is not because anyone wants to avoid responsibility but purely and simply because there is always a draw on the budget. There will always be something else. I would like to see this front and centre. Support for staff must be in place.

Consider what will occur in the context of an open disclosure. I am not referring to an admission of guilt but a statement that a bad thing happened regarding which those responsible wish to offer an explanation. The patient will be advised of the incident, albeit not by mandatory requirement at present, and the lead clinician will be the person who will sit down with him or her. Dr. Holohan said there are very many people involved so there can often be a chain of events and that, at the end of that chain or perhaps the beginning, there are staff who might not have the status of a lead clinician.

Forgive me if I have missed it, but I do not see anything that provides for information to be provided to all of the people there. Lead clinicians will sit down with patients to tell them a bad thing happened and that it should not have. They are talking about staff who have been involved in that patient's care. Do the witnesses have a view on whether we should strengthen the provisions in order to ensure that everybody involves knows what is happening?

We know the culture is not great and we have seen where it is important to find somebody to blame rather than the heart of the incident, which is not the fault of any one person - it is the adversarial nature of the system. There is a fear among staff that they are being spoken about and because the culture is one of blame rather than getting to the heart of the matter, there is a fear that in looking for someone to take the fall one is not involved in the conversation. I am sure that lead clinicians, in providing explanations, are doing their best but there is fear among staff other than lead clinicians that some blame is being apportioned. Can we do something to strengthen that and ensure that does not happen?

I refer to my earlier point with regard to investigations. A lot of this seems to hinge on the provision of investigations, which often take a very long time. I ask the witnesses to outline the timeframe they envisage from an initial explanation of what happened onwards. If there is an investigation thereafter, is it envisaged that all of the parties will be involved? I ask in the context of sharing information with people.

The lives of some patients have been destroyed because following an adverse incident they feel they have to go to battle with the system. I have also seen staff whose lives have been destroyed. They are out on sick leave because they have been traumatised by what has happened. The purpose of this is to stop that happening. I fear that unless it is mandatory, we will not get the culture change that is so desperately required.

Dr. Tony Holohan:

I thank the Deputy. She commented very clearly on the adversarial nature of the system and the length of time investigations take to complete. Some of the measures that are proposed, such as this one, and those for the Civil Liability Act are about trying to make that process shorter and more efficient, including the pre-action protocols, periodic payment orders and open disclosure.

As the Deputy is aware, there is a commitment in the programme for Government on this area. The Department of Justice and Equality is taking steps to initiate the process and we will be anxious to engage with it to examine the whole system of medical negligence and whether we continue with the current system which is based around tort, negligence and the adversarial nature and consequences of the process or consider committing to examine the issue and all of the issues that arise in terms of medical negligence and with which we have to deal in terms of the consequences. We will look to engage with the Department of Justice and Equality in regard to that.

I cannot predict or guess what will happen. I have a view on where, ideally, the process would take us. Making the current process more efficient is one legitimate strategy. We can then examine whether, in fundamental terms, we need to change the whole system on which our current system of medical negligence is based, and its adversarial consequences whereby often years elapse before patients can be dealt with. This includes, by extension, the professionals involved, over whom questions might continue that might get answered in the final analysis even where they may never have arisen in the first instance. Justice is not being offered to anybody when long periods of time elapse.

I responded to Senator Burke's question on the number of investigations. I agree with his point regarding the number and frequency. To be clear, we do not think that open disclosure depends on the outcome of an investigation. There should be enough known at the early stages for that information to be passed on to patients as soon as possible. It is not dependent on information being complete. It might well be the case that, in good faith, a doctor or nurse is disclosing something to a patient that he she believes to be the case that on subsequent investigations or examinations turn out not to be true. Again, the principle of open disclosure is that the fact is revealed when it becomes known.

Louise O'Reilly (Dublin Fingal, Sinn Fein)
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May I clarify something? I do not want to labour the point but I referred to the context of an investigation. As a result of the adversarial nature of investigations, the length of time they take and the fact that people can end up with representation from legal personnel or trade unions it turns into an adversarial process. This is where the training element comes in. The person who is talking to a patient will be very mindful of the fact that what he or she says might end up as part of the investigation and, therefore, given the nature of investigations, their length of time and adversarial nature, they might end up in a situation whereby they think they should not say something. That goes back to training and support. Investigations will obviously be necessary, but we need to give people confidence at an early stage that they can simply say-----

Dr. Tony Holohan:

That is precisely our strategy, namely to try to give people a degree of confidence that this is a safe space. If information is disclosed, that clearly needs to be done in an appropriate manner and we will prescribe what that manner is. If people disclose information they will be entitled to protections in regard to the information being used. That will give people the confidence that they are not increasing their or other people's liability by doing what is, in effect, the right thing in terms of patient care.

The Deputy went on to make a point on a disclosure being made by a lead clinician. It is a good point and speaks to some of the surprising things that occur as a consequence of our existing system. We have come across situations where some parts of the disclosure to patients when things go wrong involved one clinician pointing the finger in the direction of other members of the clinical team. That is entirely inappropriate and unacceptable. One can guess at the motivations behind that and go into further details on specific examples. We know that happens. One may be in a situation where that the kind of culture, namely, that disclosure to a patient involves somebody pointing the finger in one direction in order to ensure the finger is not pointed back at oneself. To me, that speaks to how far we have to go on this journey to get ourselves into a situation where this is happening in the right way.

Each issue is interconnected. In some of the adversarial processes about which the Deputy spoke, the length of time it takes to get justice from the point of view of patients or professionals contributes to the sense of liability, risk and people seeking to protect themselves. It is all part of the just culture Dr. MacLellan spoke of, and she might comment on some of what I have just said.

The Deputy's point on training is good. We have drawn a different conclusion to the Deputy in regard to the role mandatory versus voluntary would play. I will not say that I think the Deputy is wrong and we are right. It is a judgment we have made. It is not perfect. Our view is that encouraging people to do the right thing and giving protection to them when they do the right thing is likely to lead to more reporting. That is the point to where we want to get. We want more disclosure, and for that disclosure to happen of the kind of quality way that it should be. Our fear is that if we simply mandated that the culture might be to tick boxes and not support patients through processes, that would have the opposite effect of what we intend

Louise O'Reilly (Dublin Fingal, Sinn Fein)
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That is not what anyone wants. I have a very firm view that if there is mandatory disclosure obligation or otherwise, then training would be mandatory. If training is no mandatory we are doing health professionals and health workers a disservice.

Dr. Tony Holohan:

I wish to say a word on training. Dr. MacLellan might be able to add a little detail to that.

Dr. Kathleen MacLellan:

The points on training and preparation of staff are really well made.

The reality is that any type of open disclosure is not easy. It is not easy, obviously, for the patient and family, but it is also not easy for staff. We have a responsibility and duty to support our staff.

The State Claims Agency in partnership with the HSE has been in the process of rolling out a training programme which has been evaluated. The evaluation of the open disclosure pilot was published earlier this year. We understand that 2,813 staff across the HSE have been trained on open disclosure, with around 8,000 briefed on open disclosure. People across the system have been trained as "train the trainers". Based on our discussions with the HSE we believe that is very helpful; it is a start. The open disclosure pilot makes it very clear that there are a number of key success factors in being able to change the culture on open disclosure. Those factors are continuing education, continuing support for staff, clear leadership and buy-in and support across the whole system, involving not just the health professionals, but also the management.

We agree that staff should be provided with training. That training should be ongoing and there should be debriefing for staff. That will form part of the discussions on our priorities for the service plan for patient safety. We have a clear view on patient safety for the health system. It needs to start to be taken very seriously. We cannot just keep talking about it. It is very important and requires capacity and capability but also expertise and real buy-in and support. The Deputy's point that it will not happen without training is absolutely correct and the international experience indicates it is critical for us to provide the training and support for staff.

I refer to something we discussed earlier which might be of interest to the committee, relating to the standards for patient safety instances, and the concerns about the length of time and types of reviews. Those standards, which we commissioned through HIQA and the Mental Health Commission, are up for public consultation on HIQA's website. The committee may be interested in the content of that and the direction in which it is heading. In the absence of standards coming from the regulators we have difficulty with the variability in how those investigations and reviews happen across the system.

Kate O'Connell (Dublin Bay South, Fine Gael)
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I am delighted that this is in process. Is it proposed to roll out open disclosure across all sorts of services within the HSE or will we target a particular area? While I do not want to give false information, I believe that more than 50% of State claims are maternity-related. They are heavily weighted towards events that happen in our maternity hospitals. Has consideration been given to rolling it out there first, seeing how it goes and then moving on to other areas?

Has this process been included in the new national maternity strategy? We hear anecdotal evidence of many doctors and nurses practising open disclosure for many years and it seems to work out fine for them. I have spoken to a number of people about it recently. How can we guarantee a standardised approach to the patient? From my limited experience, working as a cleaner in a hospital for a long time and then as a pharmacist in a hospital and having been there having children for the past few years, it is clear to me that these places are busy. Is it realistic to have a lead clinician available in the hospital in Holles Street of an evening if there is an adverse event? If we are to do this, can we be realistic about who that person would be? Following on from Deputy O'Reilly's point on training, if things are going wrong, there is a sense that if we have a consultant knocking about we will grab him and if not we will get the other person. It is very important to have a standardised approach.

How do the current systems of reporting of adverse events fit into the new proposal? Have they been evaluated? Have we taken anything good from them and used them in this approach?

Deputy O'Reilly spoke about the protection of professionals. As we know, many health-care professionals are regulated by their own professional bodies. It appears that a lead consultant of a team in a hospital does not have much input into who forms part of that team even though the consultant is ultimately responsible for the team. I am very concerned about the protection of people's good names. We often see reports on the television news of a particular doctor in a particular location and the immediate reaction is that I will never go to that hospital or I hope I never meet that lad. However, he may have done nothing wrong at all. It is important to protect our professionals. There is a difference between the management staff and those to whom they are accountable. Having to face Medical Council hearings is a very stressful process for a medical professional. It can be very difficult for their professional and personal lives.

While this may not fall into the scope of today's meeting, how do the professional indemnity insurance companies feel about this proposal? Is there any push-back from them?

When we are talking about providing support where the flowchart ends, we also hear of patients who have adverse events possibly with catastrophic outcomes and they cannot even drive past the hospital anymore; they do not want anything to do with that hospital. Is there any provision to help those people get care in another hospital? That is not to put blame on the place where the adverse event happened, but it is possible to understand from a psychological point of view that they would not want to go back to the place where they experienced an adverse event.

Dr. Tony Holohan:

The Deputy asked about rolling out to all services. She is right that a significant number are being seen in the area of maternity services. That may be more of a reflection on the extent to which questions about maternity services have been current in public discourse and what that leads to than a true variation in the actual risk that attends to maternity services, as compared with other hospital-based services.

In answer to part of one of the Deputy's later questions, we have had good experience in the programme to implement the national incident management system, which has been developed by the State Claims Agency and is now a significant national asset in terms of a standardised way of measuring and capturing all incidents. However, that is not to say that we believe we are seeing a full and accurate representation of all adverse events in what comes through that system.

While Deputy Harty might have a different view, I believe my profession does not have a good track record when it comes to reporting incidents honestly and openly. It is not because people do not actively believe it should happen. Doctors are just not as good at it as other professionals. Nursing staff in the main are much more responsive and responsible when it comes to those kinds of things. We have to take all this into account when we interpret what we see coming through these incidents.

Extrapolating from international evidence on the frequency of incidents, medication error is predominant in numerical terms - not always in significance terms - in patient safety incidence. It could be the wrong drug, the wrong dose or the wrong patient or a combination of those. It could be the right drug prescribed and the wrong drug dispensed. Numerically they contribute the most; we do not see that coming through our systems. It indicates it is unlikely that the pattern of adverse events is significantly at variance with that experienced in most modern developed health-care systems. We want this rolled out to all services. Where safety issues arise, people should be appropriately trained and supported in meeting their responsibilities and requirements.

With regard to the council, if I am getting a sense of what Deputy O'Connell has said, I think we are all disquieted by some of what we see on the news, in particular medical professionals, because of the nature of the process with people being followed by television cameras down the street when perhaps they have no case to answer. I would find it disquieting and Deputy Kelleher is quite right that everybody is entitled to their good name in the first instance. We have to have a situation where there is appropriate accountability and at the same time there is a balance between all of these things. One part of it is the nature of our complaints system. We are doing some work around this now with the Ombudsman, and it would be a matter ultimately for legislation to look at all of this, but the system now has an artificial differentiation between complaints that are clinical in nature and those deemed not to be clinical in nature, and between those complaints deemed to be applying to those that involve doctors and those that do not. We feel that is an outdated way of looking at complaints which sees that all incidents in which doctors are involved, and which become the subject of complaints, are really matters for the regulatory body. Again, I am not sure that is appropriate. In many situations, even when adverse events occur and even where there is a responsibility on the part of a professional, it might not raise a question of that individual's competence. Poor performance does not always imply incompetence and competence does not always imply good performance. There is a distinction to be made between a framework that exists in law around professional accountability, as provided by the Medical Council or the Nursing and Midwifery Board of Ireland, and an appropriate framework around accountability within a service that is provided by professionals, if the service cannot stand apart from its need to account to patients in the first instance for the appropriate provision of safe and high quality services. That is something on which we want to do some further work, to see if we can look at the whole issue of complaints and see how that works for patients.

The committee might be aware that the Medical Council has done some very good work in analysing some of the complaints that they have experienced from whatever source over an extended period of time. It brought quite a bit of intelligence into this area. It has shown that in fact it happens very rarely in relative terms that service providers make complaints against individual practitioners which would put us at odds with other jurisdictions. Across the water service providers are frequently those who provide a lot of audited evidence of poor professional performance when they believe there is a regulatory issue arising for an individual practitioner. That does not really happen at all, to any appreciable extent, in Ireland. The other analysis shows that the percentage of complaints brought by patients that come through to a significant sanction is really very low. As an avenue for patients to pursue an issue where they may well believe that a medical practitioner has a case to answer, it does not appear that the Medical Council and that route is one that brings any redress for patients. That brings us back to the idea that the service has a responsibility in the first instance. In many issues where adverse events have occurred to patients it is the service that needs to provide the answer and not always the individual practitioner. It rarely actually relates to competence.

Dr. Kathleen MacLellan:

Reference was made to our system of reporting adverse events and using that as a source of intelligence for us on what is happening in our system. We recognise that how we utilise that information has not been as optimum as it could be. As Dr. Holohan has said, there are a number of health care acquired conditions, if we were to call them adverse events. Internationally, it is estimated that 10% of patients will acquire something they did not have before they came in to the system. As part of the capacity building within the Department of Health, and from a policy point of view, we would like to see the creation of capacity to start looking at the surveillance of patient safety across the system. We have a lot of systems and we would see our National Incident Management System, NIMS, as a very important source of information; the types of incidents that happen, where and how they happen and how they are managed, along with other sources of information such as our hospital patient safety statements and maternity patient safety statements. We would like to take that information to guide where we go forward. A lot of what we are building now is built in the absence of a co-ordinated, planned for analysis of the information that we have around patient safety and patient safety incidents in the system. Part of what we want to do is utilise this information in a much more intelligent and informative way.

The issue was raised of insurers and their views. The State Claims Agency has been a signed up partner around the open disclosure policy for the HSE and was a signed up partner also for the evaluation. The agency has stated very clearly and publicly that it supports open disclosure and early interactions with patients when adverse events have happened, to support patients. That is a very helpful position in moving forward. The more we are all co-ordinated in that regard, the better traction we will get around the whole patient safety culture.

Keith Swanick (Fianna Fail)
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I have two very brief points. Dr. Holohan said that the senior clinical physician may be engaged in the reporting mechanism. On a practical level, patients spend a lot more time in the community than they do in hospitals. How would Dr. Holohan envisage this reporting happening in a community or a primary care setting where the health professional might be working in isolation, be it a GP, a public health nurse, a physiotherapist or an ancillary member of the primary care team. Who would take the lead in the reporting mechanism in those instances? With regard to Deputy O'Connell's point about the legal protection offered for the health professional, and considering the soaring medical insurance costs at the moment especially for doctors in private practice who may not get some funding from the HSE, does Dr. Holohan believe this may foster a culture of unwillingness to co-operate with the whole process?

Dr. Tony Holohan:

I thank Senator Swanick. When we talk about lead clinician in this context we mean the most appropriate clinician in a particular situation. That does not always have to be the clinical director of an institution. It might well be the GP in a particular situation or it might well be another community based clinician who is not a doctor. It depends on who is in the position to know, understand and provide the information and to support a patient through that. If the incident is something that happens in a primary care environment then it is perfectly appropriate if the lead clinician is the person's GP. For its part, the Medical Council - probably more specifically than any of the other regulators - has set out its expectations of practitioners with regard to open disclosure and sees that applying to all registered medical practitioners. I may not have given a full response to Deputy O'Connell's question, but in a hospital the lead clinician may not always be the most senior person, who may not be available at evening time. If an incident occurs out of hours when it may well be more junior medical staff, it can still be perfectly appropriate for those to be the people who provide that information, if that is what the circumstances deem. It might be a situation where a senior clinician has to be called in. It would really be dictated by the nature of the incident and what the patient requires. Clearly, if it is a catastrophic or significant incident with life altering or treatment altering implications then a senior attending physician is going to be called to participate. It is reflecting the reality that from the point of view of a patient who is involved in institutional care and receiving care in a hospital environment, the person who is representing the service and speaking to them is the consultant in charge. That is what we are reflecting, but there is no reason it could not apply similarly in a community based or primary care setting with other professionals.

With regard to the soaring insurance costs, I cannot honestly give the committee an account of what each of the individual insurance providers would say themselves, but my general sense of insurance providers - and it is along lines of what has been said by Dr. MacLellan about the State Claims Agency being the largest indemnifier in the State but not the only one - is that a good standard of open disclosure is the right thing to do and actually leads to a reduction in terms of the risk of future liability. When these kinds of things occur it is less likely that patients whose trust and confidence in providers is maintained through incidents when things go wrong are actually capable of understanding and it does not always end up in litigation. Although there is not a lot of evidence around this, some of the international evidence suggests that engaging in this way can lead to a reduction in future litigation which one would expect to see having a deflating impact on indemnity costs.

Dr. Kathleen MacLellan:

Some of the softer information states that sometimes patients will go down the legal route because they are trying to find answers. They cannot find answers any other way and, therefore, if a process can be created whereby we can give answers early on, we may prevent that happening or reduce the time they are waiting. This will not be the case for everybody such as those with catastrophic or other injuries. Patients will make their decisions as to the route they go but there are opportunities. The soft evidence internationally and domestically indicates that if we can be honest and open with patients early on, we will not force them down a particular route to get answers and information on the care they require.

Dr. Tony Holohan:

Anecdotally, we have been made aware of examples but they are indicative of the culture that exists in some parts of the system whereby people who genuinely begin a process of simply seeking information are treated as though they are complaining. They may write a letter seeking information and get a letter back stating, "Further to your complaint...". They do not see themselves as making a complaint but sometimes the way in which their request for information is handled, it turns something that never began as a complaint into a significant and intractable complaint.

Michael Harty (Clare, Independent)
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So people are making observations rather than a complaint regarding their treatment. They are not necessarily looking to make an official complaint.

Dr. Tony Holohan:

Exactly.

Michael Harty (Clare, Independent)
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Is legislation in place to protect those who are disclosing information and to give them security that there is a legal framework underpinning how they do it?

Dr. Tony Holohan:

Yes.

Michael Harty (Clare, Independent)
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What happens after that depends on how the situation develops. Staff are given legal protection in respect of disclosing facts about something that happened and not necessarily implying that there was negligence or that any person was directly responsible.

Dr. Tony Holohan:

That is exactly right.

Michael Harty (Clare, Independent)
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The civil liability Bill comes under the remit of the Department of Justice and Equality. What is the status of the Bill?

Ms Susan Reilly:

We understand it is at an advanced stage of drafting and the Minister intends to publish it this session.

Michael Harty (Clare, Independent)
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It is close to completion. On behalf of the committee, I thank the officials for attending and for an informative and interactive discussion. Is it agreed the committee will decide on how it will proceed at its next meeting? Agreed.