Kathleen Funchion (Carlow-Kilkenny, Sinn Fein)
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Amendments Nos. 1; 3 to 12, inclusive; 14; 19; 21; 46 to 48, inclusive; 51; 71 to 73, inclusive; the amendment to amendment No. 14; and amendments Nos. 1 to 5, inclusive, and amendment No. 7 to amendment No. 19 are related and may be discussed together.

Stephen Donnelly (Wicklow, Fianna Fail)
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My understanding is that we are starting the debate on the amendment to amendment No. 14, which is in this grouping, although the earlier amendments were not disposed of on the previous occasion. I propose, therefore, that Deputy Kelly, who tabled that amendment, resume the debate.

Alan Kelly (Tipperary, Labour)
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Okay, I do not mind. To be fair, it is a little confusing because there are three sets of amendments to the initial set of amendments. In any event, we will work through them.

On the basis of discussions we have had, I probably will not press my amendment, but the spirit of it was based on ensuring there would be a full understanding of what was required to ensure there would be open disclosure throughout services and screening. My amendment will provide for an obligation for patients to be informed of their right to make a request for a Part 5 review. As part of this, patients will be told they can do so at the point of screening or before that. We wanted to ensure something that was a strong request of the patient advocates, including the 221+ group and everyone else, namely, that this would also be done should somebody be diagnosed with cancer. It would not necessarily have to be done imminently, given it is a difficult period for people, but within a reasonable timeframe, such as three or six months. That is what our amendment seeks to provide for, although subject to how the Minister responds, we will decide whether to press it.

This is a critical issue because of cases such as that of Irene Teap, who found out during the birth of her child about her cancer diagnosis. Women have been told previously that they have the option of undergoing a patient review, but four or six years later, will they remember that? The key ask of the advocates was that if somebody has been diagnosed with cancer, within a given timeframe after that they would be reminded of that option. This was the most important issue we felt was not covered by what had been provided for, and it was deemed essential that this be dealt with.

Under our amendment, therefore, patients will be told post diagnosis that they have this option for a patient review and that will be done within a reasonable timeframe. For me, that would be three to six months. I understand that the Minister will table an amendment to ensure this is covered and that this will be future-proofed by communication he will give directly to the HSE. This is critical. We would not have been able to move forward today if we had not resolved this issue in communications we had before Christmas, last week and even yesterday.

There is one other issue I want to highlight as part of this and I might as well raise it now as it comes under the same bracket. It is an issue that might have got a bit lost in much of this conversation, namely that the audit stopped. Once Vicky Phelan went out to the steps the audit stopped then until now, effectively, and probably will be stopped until this legislation is enacted and operable. What are we going to do to ensure that those women, in particular, have the same access to review as everyone else?

I thank the Minister's officials for the work they have done over the past few weeks, and the past few hours in particular, but I understand that when it comes to legislation that we pass in this House there are often legal issues around retrospection and so on. However, I am sure that as part of this process, the way that the Minister implements this and directs this and directs the HSE to implement it that he can deal with this issue. Anywhere between 1,000 and 1,500 women could have the opportunity to look for that review. Based on the figures that I have calculated with others, that is the number of people who might do that. Although it might only be a fraction who do it, they have to be treated the same way as all the others before that. I have often pointed out, for those women all the issues, around the time lines of what happened to Vicky Phelan, Lorraine Walsh, who is sitting in the Gallery tonight, Irene Teap, Ruth Morrissey and everyone, the variables have not changed in respect of the labs, the process etc. for a considerable period. There have been improvements in the past number of years but for a considerable period after the time that Vicky Phelan's case was settled and dealt with and she came out because the audit stopped those women have not had the same look-back. They have not had the same opportunity. To be frank about it, if they are not a part of it then that is not open disclosure but that is hiding that opportunity from them. As part of this process, I would like the Minister to deal with that.

The amendment tabled by myself and Deputy Duncan Smith was to deal with patients being told post diagnosis that they would have the option of a review. If the Minister's response in the form of his amendments and what he is going to say to this House is acceptable, we will not push the amendment but I want to make it clear here that I expect that to be amendments that will deal with reviews being post diagnosis that will happen after screening that will be a combination of what is in this legislation, a combination of a letter that will be written by the Minister to the HSE directing it on that, that the Minister will stipulate that the patient representatives will be part of the process of putting this in place and, of course, there will subsequently be the two-year review. On that basis I will not press the amendment based on the Minister's reply.

Róisín Shortall (Dublin North West, Social Democrats)
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Two months have been lost on this and, hopefully, it was worth that delay. I want to welcome the fact that agreement was reached with the 221+ group last week around clarification on the notifications that would be provided to people to make them aware of the option of the Part 5 review. While that was provided for in the original legislation, it is good that there is additional clarity being brought to that about the points along the way when that information is to be provided to people who availed of the screening programmes. That is a good thing. On the process that is to be followed, it is good that there will be further consultation with the 221+ group and that there will be a review of the legislation in two years. All that is positive and I pay tribute to both the officials in the Department who have been helpful over recent months on all aspects of what is quite a complex Bill and the 221+ group, who has been active on this and who have engaged positively and constructively with the Department.

We just received the Minister's amendment this afternoon. I do not know why it was late as I understand that agreement had been reached a while ago on it but it is welcome nonetheless and I am happy to support it when it comes for decision. I will make some other points on this that arise from this group of amendments. I am seriously concerned that the recommendations made by Dr. Scally have not been taken on board fully. He did an excellent job over an extended period. His latest report that was published in October, and many from this House and others were at that briefing, identified a number of issues in particular. The key points he made at the press conference was to urge the need for a duty of candour on healthcare workers and organisations; the Bill is too narrow in the circumstances for mandatory open disclosure; it deals with the more serious end of errors that are made; and nearly all those circumstances in the Schedule relate to death so there is a whole range of other circumstances that could arise for which it is important that there be a duty of candour. In particular, given the issue before us of cancer screening, I am concerned that the points Dr. Scally made were not taken on board. Equally, he recognised that the Government amendments may deal with shortcomings in the Bill but he called for an amendment to establish a clinical complaints system. This would provide patients with answers to their concerns and remove most of the need for patients to take legal action. That is an important recommendation. It is true that, particularly in light of two high-profile cases in the news yesterday, there are significant lessons to be learned about the practice of the HSE and the State generally in not addressing serious errors that are made and putting families and individuals through the ringer over an extended period, leaving people who need financial support because of the need to provide services for a person with a disability as a result of negligence or errors and leaving a person for many years in some cases without that kind of financial support. There is the financial aspect of that and the further traumatisation and deprivation of people who have been affected by serious incidents where they have to do without services and supports that they need because of the long delay in addressing these cases. From the point of view of the individuals and families, there is the additional trauma, worry, concern and time taken up for the families. We saw an example of that yesterday. I am concerned that this issue has not been addressed in the context of this legislation. It is an associated issue to CervicalCheck but something has to be done about the kind of legal advice that is given to the Government to fight people all the way - we had a discussion about this last week, and it is continuing, around historical cases - when what people essentially want to know is why a serious incident happened, what is going to be done to prevent such incidents recurring and amends have to be made with financial compensation. That is one lesson out of this.

The other thing I wish to raise is the limited scope of the Bill. That is problematic. The Bill only specifies the mandatory requirements for open disclosure in the case of 13 categories. I tabled an amendment which was ruled out of order. I cannot understand why that is the case. Dr. Scally made it clear that the vast majority of the circumstances listed in the Schedule - 12 out of 13 - relate only to circumstances where a person dies. There is a range of other circumstances where there needs to be open disclosure. I cannot for the life of me understand why my amendments were ruled out of order. It should not have happened. What is the point of commissioning a person of the status of Dr. Scally, who is held in such regard by everybody, when some of his key recommendations are being ignored?

David Cullinane (Waterford, Sinn Fein)
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It has got very messy when we have four or five amendment lists, amendments to amendments and so on. The manner in which this Bill was crafted and worked its way through the Oireachtas was a bit chaotic. Notwithstanding that, I thank the Minister for his co-operation in recent weeks. We did the right thing in December in pausing this and taking the time to engage with the 221+ group. I told the Minister in this Chamber and in private briefings that my view was that group was not supportive of the Bill as it stood. That was the case, as we have now seen. We have had intensive engagement and if there is a lesson to be learned, it is that the engagement could have happened much earlier with the 221+ group. However, I welcome that it happened and also the Minister’s contribution, which got these amendments over the line.

I understand these are complicated issues and, for all the right reasons, the Minister’s officials will give him sound, clinical advice. We have to take all that advice and try to frame a Bill, which is complicated because we can have an intention to do something but providing for something complex in legislation can be difficult. I accept that and thank and commend the Minister for his co-operation.

The amendment we are discussing will be superseded by an amendment to amendment No. 19, which the Minister is bringing forward. I think that is the one we now want to see put in place. The establishment and implementation of procedures on how we give women further information is important. Will the Minister clarify - I am sure we will get to this if we get to the amendment in question - that the 221+ group will be central to that process and its input will be important when its gets to implementing the processes and procedures? It is important that when there is a diagnosis women are informed of the right to initiate a review at the point of entry into the system and in as many ways as possible. We need to make sure it is done at the right time. The right time for one patient might not be the right time for somebody else. The concern was that the point of diagnosis, when a patient is being informed he or she has terminal cancer, may not be the best time to tell somebody that he or she has a right to a review. From my understanding of a conversation I had with the Minister and the 221+ group, the details of that will be done separately. That makes sense and I support it. I imagine, in the context of the Minister’s amendment which we will get to, the amendment we are now discussing will be withdrawn.

I will not push any of my amendments to a vote. We have had a good engagement and discussion. It is a good day when a Minister is prepared to listen and work with the Opposition on a sensitive issue. Consensus on this issue was and is important. I said when we first discussed this Bill and again on Second Stage that I wanted to support it. I wanted a Bill the 221+ group could buy into and support and one that was fit for purpose.

There will be different arguments down the road on the type of audit that may or may not be put in place. That is not part of this Bill, as such. The Department has not agreed what an audit will look like. We can come back to that later. I ask that when we do that work there will be a role for the Joint Committee on Health. Once the audit is agreed, it could come back to the committee for consideration and there could be further engagement with the 221+ group. I will not rehash all the arguments on that issue because we have made significant progress. I have spoken in recent days to members of the 221+ group and they are pleased we have got to a point where they can give their support to a Bill. It is a good day for them and for patients.

There are recommendations, as Deputy Shortall said, in the Scally report which still have not been implemented. One is that people cannot make a complaint about clinical decisions. That was a concern Dr. Scally had. I accept that is a difficult and complex area but we have to have further discussions on it. We cannot pass this Bill and park all those other issues, notwithstanding the fact they are complicated. Dr. Scally also called for a greater duty of candour generally in healthcare. He was critical of that not being dealt with in the Bill. I accept the complexities of that as well. None of this is easy. It is difficult to legislate for these matters. Sound clinical judgments and arguments come back to us. We had discussions with the chief clinical officer, Chief Medical Officer and chief nursing officer. They made sound clinical arguments on why certain things are not possible. We understand the complexities. We all accept that but we had an independent report from Dr. Gabriel Scally that made recommendations, not all of which are dealt with in this Bill. I see this as work in progress. This is an important first step.

I thank the Minister for his co-operation. It was worthwhile. It is not often we see it from a Minister. Very often, that is not the way we do business in this House but, given the sensitivities of this issue and the journey we have all been on in supporting the 221+ group and all of the women involved, it was the right thing to do to reach consensus in this Chamber and have their support as well. The fact we are at that point makes this a good day for politics, as well as for the members of the group and their families.

Stephen Donnelly (Wicklow, Fianna Fail)
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There is quite a bit to unpack. If I go slightly over the seven minutes allotted, I ask the Acting Chair and colleagues to please bear with me.

I thank several groups of people for where we have got to, which is the right place for this Bill. First and foremost among these are the patient representatives, including the 221+ group. Members of that group and other patient representatives who are here this evening have been involved for the past two years in detailed design of the patient-requested review, not just in these aspects. We had a very productive meeting recently. My officials were engaged yesterday through the night and the wording was agreed this morning, which is why it came through. I thank the patient representatives for all their work, not just over the last few weeks but the last few years. I hope they will stay involved and I thank them in advance for that. It is a serious time commitment for people who have many other things going on in their lives. I thank everyone involved and note their presence this evening. It is great to see.

I also thank my Department officials. A huge amount of work has been done on the Bill. We have focused on one important part of it but this is a comprehensive Bill. Officials in the Department working with colleagues in the HSE have put a vast amount of work into it. They worked through the weekend, having worked right through since we discussed Report Stage previously.

I thank Oireachtas colleagues. This can be a messy process.

Some of Deputy Cullinane’s colleagues were suggesting that it is no way to make law on Report Stage; maybe it is. This is the legislative process. This is where we listen to each other and make changes. This is probably partly how we should do business. I acknowledge the work of colleagues across the House on this.

What is the Bill ultimately going to do? It will lead to better outcomes for patients and better clinical and health outcomes. It will also lead to a better experience for patients and some much needed transparency. It is important from that perspective. While there is, very understandably, a focus on cancer screening services and cervical cancer screening services, the Bill is much wider than that. Obviously, it covers the whole health service. It is absolutely correct that the genesis of the Bill comes from cervical screening, however, and from the women and men who stood up and said we are just not having this anymore; this is no way to run this and treat patients and we have had enough. We all know those involved, some of whom are here this evening and some who are sadly no longer with us. Their work and the stance they took, not just then, but in the work they have done right through since we started debating these issues back in 2018, has led to this Bill and other things that are happening.

On cervical screening, for example, this Bill is one part of the change that is happening. We introduced the human papillomavirus, HPV vaccine and the Laura Brennan HPV catch-up programme. We introduced a HPV test as part of the screening services. The new laboratory is now built in the Coombe. I was there a few weeks ago and it is state-of-the-art. It will be ramped up over time to take on the vast majority of cervical screening samples. A whole new workforce is being built up, or dare I say rebuilt, with new professionals being trained up. I spent quite a bit of time with them few weeks ago and they are absolutely committed and dedicated to that work and to this Bill as well. Thanks to the bravery and determination of so many people going back to start of what happened with CervicalCheck, all of these things have happened, including this Bill. Our health service and cancer screening services are in a completely different position now than they would have been without that and, ultimately, a lot of lives will be saved. I thank them for all of that.

I will very briefly go through the Bill because it is very important. Initially, the Bill aimed to do three main things, one of which was to bring in mandatory disclosure for patient safety incidences. Deputy Shortall raised the point around the Schedule being a very short list. That Schedule is not meant to be there as a complete list; that is the Schedule no Minister can take out. These are the patient safety incidences that would require the Oireachtas to change. The intention is that a much longer list will be developed through regulation. The reason this is through regulation rather than statute is because the nature of those incidences change. Some procedures may not happen anymore and new procedures will be added. They might be changed or updated in certain ways. That is the intent of this. The only reason that Schedule is there is to say that regardless of what any Minister thinks, he or she cannot actually remove these without amending the legislation and, therefore, the agreement of the Oireachtas.

That is the first issue. The second is that the Bill provides a framework for clinical audit. Deputy Cullinane asked whether we can include Oireachtas colleagues or patient representative groups in the future and ongoing design. Yes, absolutely we can. It will be very useful to have the Joint Committee on Health involved in that. The third thing the original Bill aimed to do was expand HIQA's power to the private hospitals, which we are all agreed is essential. That was the original intent.

I then sought to add to add three additional amendments at Report Stage, which we all agreed at Committee Stage. The first of those was that we further extend HIQA's powers to nursing homes. With regard to many of the patient safety incidences that happened in nursing homes during Covid-19, HIQA had no statutory ability to go in on individual patient safety matters. That has caused a real problem. We cannot put it that in retrospectively but we can at least put it in for the future. That is a new power HIQA will have, which is really important.

The second thing is mandatory disclosure of patient-requested reviews. Deputy Kelly raised the point, which he and I talked about previously, around patients who have a diagnosis pre-audit, which is, essentially, from 2018 until now. The answer is that all of them will have access. The way the patient safety reviews are being set up is that any patient can initiate a review within ten years of the diagnosis. Therefore, anyone who got a diagnosis in 2018, 2019, etc. are all covered. Indeed, someone with a pre-2018 diagnosis from BreastCheck or BowelCheck may within ten years of the diagnosis want to avail of the same thing. That is covered.

The third thing I sought to introduce at Report Stage was a review after two years. That will be taken very seriously. It is a statutory review as per the termination of pregnancy review, which we will have very shortly. We then had a very constructive Committee Stage-----

Kathleen Funchion (Carlow-Kilkenny, Sinn Fein)
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I am sorry; I am trying to be fair but the Minister is one full minute over time. He will have an additional two minutes to come back.

David Cullinane (Waterford, Sinn Fein)
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I am okay with it.

Alan Kelly (Tipperary, Labour)
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We are happy. It would probably be helpful if we could let the Minister continue.

Kathleen Funchion (Carlow-Kilkenny, Sinn Fein)
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Is everybody agreed?

Stephen Donnelly (Wicklow, Fianna Fail)
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I am sorry; there is quite a lot to get through.

Kathleen Funchion (Carlow-Kilkenny, Sinn Fein)
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I am okay with it as long as everybody else is. I want to be fair to everybody.

Alan Kelly (Tipperary, Labour)
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He is motoring.

David Cullinane (Waterford, Sinn Fein)
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We are more than happy to let the Minister respond.

Stephen Donnelly (Wicklow, Fianna Fail)
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Following the debate we had before Christmas, we essentially have three more pieces we are introducing again this evening. The first is mandatory informing of patients of their rights to a patient-requested review before or during screening. The second is mandatory informing of the right to a patient-requested review after screening and that the process needs to be put in place for that, which is contained within the wording. The third then is mandatory provision of information on the process online. Those are the three additional pieces we are seeking to add.

This has been the subject of much discussion. I thank the 221+ group for its engagement and support. Its intent, and that of mine and colleagues, is that the reminder, if you like, would happen at an appropriate time after diagnosis. We could not put it in exactly like that for drafting reasons but I want to be very clear that that is the intent. That is exactly what the Department, patient representative groups and HSE will be designing. I will be writing formally to the HSE stating that is my wish and the wish of the Oireachtas. That is how it will work. Appropriate information that has been designed with patient groups will be provided to inform before or during the screening and then at a reasonable time after diagnosis. We will leave the detail of that to the patient groups, the Department and the HSE to work out. For example, various patient representatives I met who have been through this said they would not have wanted to know during the same meeting in which they got the diagnosis, and that they might have wanted to know one week, one month or six months later. We will leave that to the team in place to decide what is most appropriate and then we can review it. It probably will not be all right the first time around so we will review it. I acknowledge that is what we are going to do. Something that was invoked very reasonably in this Chamber previously was whether this would then pass the Vicky test. Certainly, the letter I received from the 221+ group today suggests that in its view, this combination does pass the test.

Deputy Shortall raised points about complaints and I agree. This opt-out or subclause in the 2004 Act, which the Deputy has in as amendment no. 20, is in a different grouping. I agree; we can come to it later but this is not what this Act is for. There is a separate process going on to look at exactly those kinds of issues, however. It is quite an extraordinary clause whereby a person can make a complaint but not one related to a clinical issue. I agree with the intent, but we will solve it in different way.

I appreciate I am way over time but I will speak now to the main points of this because we did not quite get to them the last time. The new piece we are bringing in this evening includes three subclauses. The amendment provides that the health service provider shall inform the patient of his or her right to a Part 5 review before or at the time of screening. The new patient-requested review has been developed following guidelines, obviously, from the expert review group, ERG, and designed in consultation with the patient groups, including the 221+ group.

It will be mandatory to fully disclose the results of the reviews to patients. It is worth noting that we are doing well on this in Ireland. Very few countries have patient-requested reviews, with only a small subsection of them having mandatory disclosure of those reviews. Very few countries in the world have this combination of patient-requested review and mandatory disclosure thereof.

Before patients participate in the screening programme and have their test, they will be fully informed by the health service provider that reviews are available. The new amendment puts the obligation to inform a patient of his or her right to a review on a statutory basis for the health service provider. On Part 5, we never discussed the patient-requested review the last time, so I will briefly go through this before stopping. I thank the Acting Chair, Deputy Funchion, for her indulgence.

I have set out details of the amendment to the new section 36. I will return to amendment No. 19. I flagged on Committee Stage that I would introduce the amendment on Report Stage to ensure that open disclosure applies to completed patient-requested reviews. The approach is based on the expert reference group report into interval cancers. It was deemed appropriate to follow the group's recommendations regarding individual patient-requested reviews. The amendment we discussed in the debate on 7 December is quite a lengthy document, comprising 21 sections. It is necessary to provide full provision for mandatory open disclosure for patient-requested reviews for cancer screening similar to the provisions already in the Bill for mandatory open disclosure of notifiable incidences. The amendment ensures that open disclosure applies to completed patient-requested reviews of cancer screening.

I am now proposing that a patient-requested review of the patient's cancer screening will be provided for in a new Part 5 of the patient safety Bill. Essentially, this is to differentiate a look-back review from being a patient safety incident in and of itself, which it is not. It is separate from a patient safety incident. The review itself is not an incident and so we have separated it into its own Part in the Bill. This will ensure the current provision for open disclosure of a notifiable incident will be replicated in the new Part. All reviews will have to be disclosed regardless of whether there is a discordance.

The amendment proposed provides for the insertion of a new Part 5 in the patient safety Bill 2019 for the purpose of providing for open disclosure of completed patient-requested reviews of HSE cancer screening services. Such a review will be defined in the body of the Bill and will involve similar statutory requirements to those prescribed for a patient safety incident.

Alan Kelly (Tipperary, Labour)
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I thank the Minister. I also thank the Acting Chair, Deputy Funchion, for indulging all of us in this debate. It was necessary for the Minister to provide that outline.

Perhaps we can pull back and put a structure on this amendment. I will not be pushing the Labour Party amendment but I seek clarification one or two minor matters. Based on the new amendment the Minister has brought forward and to which we were privy, I welcome all of the work done. I, too, thank the Minister for the manner in which he dealt with this legislation before Christmas. The time and engagement have been necessary. The fact is that the 221+ group would not have supported this Bill if we had not taken the time to do what we did over the past few days.

I have been raising the issue of the absence of audits for the past couple of years and long before we got back to this patient safety Bill. I am glad the Minister said this will be over ten years. That is good information, which I did not have. I want to check a point with the Minister. Obviously this will cover bowel screening, breast screening and so on. Are there any issues around someone being statute barred given the time period? I know the period is ten years but are there any other consequential statute issues that I would not be aware of legally? I am just checking this. I do not believe it is the case but I am making sure, to be sure.

The Minister referred to the process and the wording around post-diagnosis. I take everything the Minister says here on the floor of the Dáil as being 100% correct but I presume he will put that in writing to the HSE as a result of this legislation.

Stephen Donnelly (Wicklow, Fianna Fail)
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What will I put in writing?

Alan Kelly (Tipperary, Labour)
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Will the Minister put in writing that his understanding and interpretation of the new amendment he is proposing in section 7 to provide for an obligation to inform patients of their right to make a request for a Part 5 review, specifically subsection (2) which he read out, is that anybody who has been diagnosed with cancer will be told within a reasonable timeframe that they will have a patient safety review option? Will he direct, in the form of a letter, that this is the intention of the legislation, even if we cannot put that into primary legislation, and that this is the stipulation? I understood the Minister will put that in writing. Will he confirm to the House that he will do that in order that anyone who wants a patient safety review will be able to have one?

Róisín Shortall (Dublin North West, Social Democrats)
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The Minister in passing referred to the new lab at the Coombe Hospital. By all accounts, it is a very fine facility. The big issue with it was that there were no staff. Certainly up to recently there were not adequate staff to deal with CervicalCheck smears. I asked a parliamentary question on this in December. The response indicated only private work was being done there. We were told the CervicalCheck programme smears would be processed at this lab very shortly. Will the Minister update the House on where we are at in that regard? When does he expect the new lab in the Coombe Hospital to be fully operational? It is a matter of serious concern that all of the CervicalCheck smears are going to the United States, notwithstanding that Dr. Scally said he did not have concerns about quality in that lab. That is an important point. The aim has to be to bring back all of the analysis of smears as quickly as possible.

I also raise with the Minister a question I raised previously regarding the Minister's amendment No. 19 on the Part 5 review. I believe that, in the main, the provision is good but there are two areas where I have proposed amendments. The first concerns the statement in respect of the procedure for open disclosure under Part 5. Again, this is a critical area. Section 41(2) states that, without prejudice to the generality of section 76, the Minister "may make guidelines". I propose that the word "may" be substituted with the word "shall", so we do not leave anything open to a lack of clarification and there is no confusion. If we are seriously committed to open disclosure, in my view the Bill should provide that "the Minister shall" make guidelines.

Similarly, section 51(1) concerning the review information states that "A health services provider may, at any time after the holding of the Part 5review disclosure meeting, provide information" on the guidelines. My amendment would change this wording to provide that a health services provider "shall" make guidelines. It is only fair that if there is a serious commitment to open disclosure, we would be absolutely clear about that, there would be no confusion about it and the onus would be on the Minister and healthcare provider to make those guidelines, rather than having this left as a possibility. We should be very clear that there "shall" be guidelines provided. I ask the Minister to look favourably on my two amendments in that regard.

David Cullinane (Waterford, Sinn Fein)
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I welcome the Minister's comments on the lab at the Coombe Hospital. Obviously we want to see a ratcheting up and expansion of services at the Coombe Hospital. If we can repatriate a large part of the screening services for CervicalCheck in that facility, it would be really welcome. I ask that the Minister keep us informed of the ratcheting up of staffing and capacity as it happens.

That is to be welcomed in the first instance. There is a lot to be done there yet. While we still have a long way to go, I understand that the lab itself is a first-class facility and we must make the best use of it. Am I correct in saying the Part 5 review will be in place for all cancer screening services?

Stephen Donnelly (Wicklow, Fianna Fail)
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Yes.

David Cullinane (Waterford, Sinn Fein)
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It is important as well for that information to go out. This will not just be for CervicalCheck; it will be for all cancer screening services.

I welcome the Minister's commitment to work with the Oireachtas Joint Committee on Health and to keep us informed on what the audit will look like. I also welcome his commitment that the 221+ group will be consulted on that element of it as well. That is very important.

We discussed with the Minister some outstanding issues from the Scally report. What is his expectation and plan to deal with those issues, which were not addressed in the Bill? We all attended the briefing Dr. Scally gave. He published his report some months ago, some time before Christmas. He outlined areas where there was movement and progress, which he welcomed, and he also outlined areas where there was no progress. What is the Minister's intention regarding how that will be addressed? That will be a very important issue for us as we go forward. We accept the Bill, and we will pass it, but there is a role for the Oireachtas and the Opposition on those issues that have either been parked or not addressed because they are still under discussion. I would like the Minister to outline, as best he can, his views on the outstanding areas from the Scally report that have not yet been implemented.

Stephen Donnelly (Wicklow, Fianna Fail)
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I wonder if I could get two minutes apiece for my responses. It is very difficult to respond to colleagues in approximately 45 seconds each. I wonder if we could stretch it to two minutes.

Alan Kelly (Tipperary, Labour)
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Deputy Sherlock has just taken the Chair. We are ad libbing a bit because we are getting through the Bill quicker by doing it this way. You could give him a bit of time, Acting Chair.

Seán Sherlock (Cork East, Labour)
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I am very happy to facilitate colleagues. If they have a system agreed among themselves, I am very happy to facilitate that.

Stephen Donnelly (Wicklow, Fianna Fail)
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Thank you, Acting Chair. We are in danger of getting on with each other.

Seán Sherlock (Cork East, Labour)
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That is okay.

David Cullinane (Waterford, Sinn Fein)
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It will not last.

Stephen Donnelly (Wicklow, Fianna Fail)
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I will get back to Deputy Kelly on his first question on cases being statute-barred. I will ask officials to get back to him with a legal opinion. Like himself, my understanding of how the statute would apply is that it would be X number of years from when a patient finds out.

Alan Kelly (Tipperary, Labour)
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That is what I understood.

Stephen Donnelly (Wicklow, Fianna Fail)
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However, let us make sure. I will ask the officials-----

Alan Kelly (Tipperary, Labour)
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There were some issues with the Royal College of Obstetricians and Gynaecologists. That is the reason I ask.

Stephen Donnelly (Wicklow, Fianna Fail)
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Yes. My understanding is that the time is from when you know, but let us get a legal view on that.

In response to Deputy Kelly's second question, there will be several matters on which I will be writing to the HSE. Yes, it is my intent, and I will be including this in writing to the HSE, to say that what we mean in the second sub-clause by "after screening" is what the 221+ group means, which is at, or a reasonable time after, diagnosis and, critically, that patient representatives including the 221+ group will be included in the design of exactly that.

In response to Deputy Shortall, the Coombe lab is a very impressive facility. It is now staffing up with histopathology and various other skill sets, but because screening was shut down in Ireland, it is having to train up a whole new group of healthcare professionals because the skill set has been lost to some extent. That does take a little bit of time. It has started with CervicalCheck samples in recent weeks. The aim is to get up to about 10% of those samples this quarter and then to ramp up as quickly as possible. The kind of timeframe I was discussing with the lab was about five years. What was said is that we will always want some samples going abroad. This is backed up by Dr. Scally's report. We do not want to be reliant on just one lab.

In terms of the five years, I did press and ask if we could go faster. The lab will if it can. The point it made was that it is about training up new healthcare professionals. Even quite skilled clinicians who are coming in require several years of training to be able to analyse the individual slides and samples. It is not a funding issue. It is nothing other than that it just takes-----

Róisín Shortall (Dublin North West, Social Democrats)
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It is a planning issue.

Stephen Donnelly (Wicklow, Fianna Fail)
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-----time to train the healthcare professionals.

I am not in a position to accept the specific amendment on "may" versus "shall" for a technical reason. Guidelines will not be required in every circumstance from the Minister and, regarding the second piece, from the healthcare provider. There may not be any additional information in every case. We would be putting an obligation on the Minister of the day and on the health service to provide guidelines where that simply may not be possible. It is not something we can provide for in law.

Deputy Cullinane raised the Part 5 review. Yes, that is for all cancer screening services. His final question is a very interesting one, namely, where we go with the rest of Dr. Scally's report. I might suggest a health committee session on that. It is a broader conversation than we can have here this evening. I had a very good meeting with Dr. Scally on the morning he launched his report. Some of his report was based on the non-amended version of the Bill, so some of the issues he raised have been covered by the addition of amendments. There are some other outstanding issues that he has raised. If the health committee is up for it, we might do a session on that, or perhaps we could all meet informally to discuss it and see where we go. Some of it is within the bounds of this Bill and some of it is not.

Seán Sherlock (Cork East, Labour)
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In that spirit of collegiality, could I take a view from the Members as to whether we can move on?

Alan Kelly (Tipperary, Labour)
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To bring you up to speed, Acting Chair, we started off with the amendment tabled by me and Deputy Duncan Smith. Based on the Minister's contribution and the way in which he has dealt with this, we will not be pushing it. We will support the Minister's amendment.

Seán Sherlock (Cork East, Labour)
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Amendments Nos. 2, 22 to 45, inclusive, amendment No. 1 to amendment No. 26, amendment No. 1 to amendment No. 34, and amendment No. 1 to amendment No. 35 are related and may be discussed together. Is that agreed? Agreed.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 2:

In page 5, line 17, to delete “private hospitals” and substitute the following: “private hospitals, to provide for the review by the chief inspector of certain incidents occurring in the course of the provision of a health service to a person by certain entities”.

This group of amendments - group 2 - concerns the nursing home amendments and giving HIQA the important power to intervene. I flagged this amendment on Committee Stage when I advised the committee that I proposed to give the HIQA chief inspector of social services "a discretionary power to carry out a review of certain serious patient safety incidents that occur during the provision of healthcare where some or all of the care of the patient is carried out in a nursing home". This policy was approved by the Cabinet in October 2021. This proposed amendment will seek to support patients and their families when something goes wrong with the clinical care they received in a nursing home. It will ensure appropriate external processes are in place to review serious patient safety incidents.

The amendment follows the report of the Covid-19 nursing home expert panel recommendations that called for suitable structures to be put in place for external oversight of individual care concerns arising in nursing homes. This power will not replace the responsibility of nursing homes to address concerns that are raised by patients and families. It would put in place an appropriate escalation pathway to ensure the concerns are addressed in a way that will provide answers to patients and their families.

In effect, the amendment will give HIQA the discretionary power to review an individual serious patient safety event, called a "specified incident" in this provision, in a nursing home that may have occurred when clinical care was being delivered. The amendment will seek to support patients and their families when something goes wrong with the clinical care they received and ensure that the appropriate external processes are in place. Pending completion of broader work on clinical complaints legislation, which we discussed, and policy across the health and social service sector, priority is being given to providing HIQA with this discretionary power.

David Cullinane (Waterford, Sinn Fein)
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I will support the amendments. I met HIQA representatives regarding these amendments a number of weeks ago. They made some interesting points that surprised me. The first was that they believed most of the powers being made available through these amendments are already available to HIQA. I got the sense that they did not see great value in what is being proposed.

I was a member of the Covid committee that met in this Chamber for some time. For me, one of the issues that arose during the Covid pandemic is that there are serious incidents - the Minister talked about specific incidents - that HIQA obviously can and should investigate but there are also issues that amount to neglect. That can be subjective but there were many complaints where a family member may have complained that his or her loved one was neglected in a nursing home. There are examples I could go into but I will not because these related to individual issues in nursing homes, some of which were brought to the Minister's attention by some of his Government colleagues, as he knows. The problem was there was no power to initiate investigations by safeguarding teams, social care teams or HIQA into individual issues of neglect. That was a problem. It does not seem this is captured by these amendments. The Minister might clarify that.

Róisín Shortall (Dublin North West, Social Democrats)
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I share that concern. It is not exactly clear. It may be in the small print but I cannot see where that power has been given to HIQA.

In a general sense, I welcome the Minister's amendments relating to extending the powers of HIQA in certain respects. Of course, those powers will only be useful if the consequent resources are provided. What are the proposals to increase the resources of HIQA to enable it to carry out these additional duties?

I will make a point in respect of a matter that arose during this morning's meeting of the Joint Committee on Health, when the Secretary General of the Department appeared before us. About a year or so into the Covid pandemic, an expert group was established to report on the response to Covid-19 in private nursing homes. One of the recommendations made by that group was to carry out a full review of the use of private nursing homes in the context of the extent they are being used at present, with 80% of all nursing homes now in the private sector. Serious issues undoubtedly arose with Covid-19 in respect of the shortcomings of such a heavy dependency on private nursing homes. I asked the Secretary General where that review was at and whether it had commenced. He and none of the people with him were aware of that recommendation from the expert group. This is an important area.

In 2020, I recall that then Taoiseach, Deputy Varadkar, said on one occasion that we needed to do a comprehensive review of the model of care that we are using for the care of older people, meaning that congregated settings in the private sector are not necessarily the best care arrangements to provide. Of course, the vast majority of older people want to have support to stay in their own homes. I am concerned that this important recommendation from the expert group could be lost. I ask the Minister to respond regarding where the review is at present or, if he cannot answer, to at least come back to me with a note.

Richard O'Donoghue (Limerick County, Independent)
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I will respond regarding the complaints about nursing home care throughout the Covid pandemic, whether these were from family members or HIQA. From the perspective of nursing homes run by the State and those run privately, and smaller versus bigger nursing homes, the report showed that smaller nursing homes had fewer complaints. They were better run and there were fewer complaints about them. These are the same nursing homes that are fighting at present to keep their doors open due to the economic pressure of the rising cost of energy.

These amendments give powers to HIQA to carry out investigations and extra powers to go into nursing homes. HIQA is now going into smaller nursing homes where there are very few or no complaints. It is putting extra pressure on these homes to change to different models, even though they do not have any complaints from any of their residents. HIQA is pressuring them to spend more money at a time when small nursing homes are running at a loss. I am talking about nursing homes that range from 25 to 30 beds that are under fierce financial pressure to keep the doors open. HIQA is now telling them to increase room size by 1.5 sq. m to meet the guidelines. Yet, there are no complaints in the sector regarding the care being given by those particular nursing homes.

On the one hand, I welcome HIQA coming in and enforcing from the perspective of healthcare for people who are in nursing homes. However, we also have to look at smaller nursing homes that have been there for many years, need our help to stay open and have had no complaints from families or residents. We should protect them as well.

Stephen Donnelly (Wicklow, Fianna Fail)
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I can respond to Deputy Cullinane's questions on HIQA having these powers by confirming that it does not currently have the powers under this Bill. Under section 9, HIQA has powers to intervene but only in very specific circumstances. I engaged directly with HIQA on one particular patient safety incident, for example, and the point was made to me that, in this case, which was not a good one, it had no power to intervene. It will now. This legislation will give it the additional powers it needs.

The Deputy quite rightly raised the question of neglect as opposed to an individual incident where HIQA can go in. That is being dealt with but it is outside the scope of this Bill. It is being dealt with through the complaints work that is going on. It is quite likely that new legislation will be brought forward around complaints, including, I imagine, repealing exactly what Deputy Shortall seeks to repeal through amendment No. 20 around the 2004 Act. That is where issues of neglect can be dealt with.

To Deputy Shortall's question on HIQA resources, I will get her the detail. HIQA will be provided with resources. Its remit is expanding in quite a few areas based on this Bill and it will be resourced accordingly. I will get back to the Deputy regarding the private nursing homes review. One thing I found quite alarming is the lack of standards for private nursing homes in matters such as building regulations. It is something the Minister of State, Deputy Butler, has spent a lot of time on. We are bringing in HIQA as regards patient safety but guidelines on the architectural design of nursing homes, communal areas, single room occupancy, etc., are also very important. There is a programme for Government commitment around a commission on ageing. That is one area where some of the issues raised by the Deputy can and should be addressed.

Finally, to Deputy O'Donoghue's point, the changes HIQA is making are important and are aimed at improving patient care. However, they come at a real cost to the nursing homes, particularly, as the Deputy said, the smaller ones. I can confirm that in just the past few weeks the nursing homes renewing with the National Treatment Purchase Fund, NTPF, under the fair deal programme have seen quite a significant increase in the weekly payment per resident, and that is in recognition of exactly the point the Deputy has raised. Furthermore, payments are going out under the inflation fund or the energy fund in the winter to these nursing homes, again in recognition of the fact that their costs have gone up and that a lot of the smaller nursing homes in particular are really struggling to pay the bills based on the previous fair deal rates that are in place.

David Cullinane (Waterford, Sinn Fein)
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It remains to be seen how these amendments will work out in practice, but the substantive amendment in this grouping, which is amendment No. 26, seems limited in subsection (10) to long-stay residential facilities. Again, one of the issues HIQA raised with me was that this does not cover patient safety incidents in centres for people with disabilities, for example, or in other healthcare facilities. The Minister might confirm if that is the case and, if so, why.

Stephen Donnelly (Wicklow, Fianna Fail)
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I might get back to the Deputy specifically on that. The initial view is on long-term residential care, but I will get back to him with a note on the question raised.

Richard O'Donoghue (Limerick County, Independent)
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I thank the Minister for his comments earlier. All payments are welcome.

Recently, a new alliance for smaller nursing homes was set up. I think it counts 18 or 19 nursing homes and more than 1,000 patients. The alliance feels that the new payments coming out are still not adequate for the smaller nursing homes. If there are new, increased payments, the alliance would like the Government to look at the smaller nursing homes first and to see where the shortfall is. The larger nursing home businesses in the system can run a lot more smoothly per patient because of their size, whereas the smaller nursing homes - and I go back to point that we have heard either no complaints or only minute complaints - are the ones that are really suffering. The Minister might look at the smaller nursing homes.

The alliance met with the Minister of State, Deputy Butler, and told her of the smaller nursing homes' plight and the problems they are having keeping open. They told her of a nursing home that would close within a week unless there was an intervention. That nursing home has gone, and two more are looking at closing in the next two weeks because of the costs incurred. I ask the Minister to look at those nursing homes. I can give him personally a list of all the ones affected. If he would look at them, I would appreciate his help.

Nursing homes create a home for the people who are there, and the smaller nursing homes are a home away from home. I talk to people who own large nursing homes and smaller nursing homes. They tell me that the homely care in the smaller nursing home setting is better and that people there get better care. They are in an environment where they actually think they are at home. I ask the Minister to look at this.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 3:

In page 5, line 24, to delete “Notifiable Patient Safety Incidents” and substitute “Notifiable Incidents and Open Disclosure”.

Seán Sherlock (Cork East, Labour)
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Amendment No. 3ahas been ruled out of order.

Seán Sherlock (Cork East, Labour)
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I now move to amendment No. 4 on the first additional list of amendments, dated 9 February 2023. This amendment is in substitution for amendment No. 4 on the principal list of amendments, dated 6 December 2022.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 4:

In page 6, between lines 13 and 14, to insert the following: “ “additional Part 5 review information”, shall be construed in accordance with section 52;

“additional Part 5 review information meeting” shall be construed in accordance with section 52;”.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 5:

In page 6, to delete line 33 and substitute the following: “ “designated person” means—

(a) in the case of a notifiable incident, the person designated under section 16; or

(b) in the case of a Part 5review, the person designated under section 46;”.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 6:

In page 7, line 17, after “than” to insert “screening carried out by”.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 7:

In page 7, between lines 25 and 26, to insert the following: “ “making an open disclosure of a notifiable incident” shall be construed in accordance with section 9:

“making an open disclosure of a Part 5review” shall be construed in accordance with section 39;”.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 8:

In page 7, to delete lines 30 and 31.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 9:

In page 7, after line 36, to insert the following: “ “open disclosure of Part 5review” shall be construed in accordance with section 39and references to the open disclosure of Part 5review, or open disclosure in relation to a Part 5review shall be construed accordingly;”.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 10:

In page 8, to delete lines 1 to 4 and substitute the following: “ “other than in person”—

(a) in relation to a notifiable incident disclosure meeting, an additional information disclosure meeting or a clarification given under section 23, and

(b) in relation to a Part 5disclosure meeting, an additional information disclosure meeting or a clarification given under section 53,

means holding such meeting or such clarification by means of the telephone or the internet (or other similar method of communication);”.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 11:

In page 8, between lines 7 and 8, to insert the following: “ “Part 5review” means a review conducted in accordance with section 35and includes—

(a) a request for a Part 5review,

(b) the process undertaken by the health services provider to carry out the review,

and

(c) the findings of the review;

“Part 5review disclosure meeting” shall be construed in accordance with section 48(1);”.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 12:

In page 8, to delete lines 17 to 20 and substitute the following: “ “relevant person” means in relation to the making of an open disclosure of—

(a) a notifiable incident, a person specified in paragraphs (a)to (f)of section 7(2), or a person nominated pursuant to section 7(3), or

(b) a Part 5review, a person specified in paragraphs (a)to (f)of section 38(2), or a person nominated pursuant to section 38(3);”.

Seán Sherlock (Cork East, Labour)
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Amendment No. 13 has been ruled out of order.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 14:

In page 8, to delete lines 23 to 29 and substitute the following: “(2) References in this Act to—

(a) “information provided”, or “an apology made” at a notifiable incident disclosure meeting or a Part 5review disclosure meeting,

(b) “additional notifiable information provided”, or “apology made”, at an additional notifiable information meeting, or at an additional Part 5review meeting, or

(c) information provided in a clarification under section 23or section 53, as the case may be, includes information that is provided, or an apology that is made, orally or in writing.”.

Seán Sherlock (Cork East, Labour)
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Amendments Nos. 15 and 50 are related and will be discussed together.

David Cullinane (Waterford, Sinn Fein)
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I move amendment No. 15:

In page 10, after line 38, to insert the following: “Report on Operation and Scope of the Act by the Patient Safety Council

4.(1) The Patient Safety Council, so established by the Minister for Health, shall furnish to the Minister a report, subject to subsection (2), within the first 3 months of each year.

(2) The Report of the Patient Safety Council shall review the operation of this Act in the prior year and shall include:

(a) the views of stakeholders referred to in this Act and others as the Patient Safety Council may decide relevant to the responsibilities of the Patient Safety Council;

(b) the number and nature of incidents notified under this Act in the prior year;

(c) recommendations for amendments to this Act and any other Act as may be deemed relevant by the Patient Safety Council;

(d) recommendations for addition to Schedule 1;

(e) any other details which the Patient Safety Council may deem pertinent.”.

Stephen Donnelly (Wicklow, Fianna Fail)
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On Committee Stage, I committed to table an amendment on Report Stage to include provision for a review, so I think this amendment is superseded by my amendment committing to a review after the two years.

The amending provision I am putting in today introduces the fact the Minister shall initiate a review of the operation of the Act no later than two years from the date of commencement. This provision closely mirrors those in other existing health Acts, like the Health (Termination of Pregnancy) Act 2018. Two years are required to allow sufficient time for the provisions of the Act to become embedded within the health sector, allowing for initial learnings to be assimilated from the experience of the various organisations that are carrying out its implementation. The amendment will also make provision for the Minister to consult widely while carrying out a review, engaging with any person, body or organisation, including any appropriate Minister of the Government, having regard to their work or function. This enshrines in statute a robust basis for ensuring that any review is carried out extensively and widely. The scope of the review will be the operation of the Act throughout the health sector. Many other Acts have such a review provision included and it is a good idea. I am essentially agreeing with the Deputy’s amendment but bringing in my own one, which is broadly the same.

The amendment specifically references the Independent Patient Safety Council, providing advice and guidance to the Minister from a broad range of perspectives. It was originally appointed by the then Minister for Health in 2019. The broad range of perspectives in patient safety policy provided by the council include the patient and service user perspective. The council is chaired by Noeline Blackwell, CEO of the Dublin Rape Crisis Centre, and does not have a statutory footing. The Deputy’s amendment stipulates that the Independent Patient Safety Council would provide an annual report to the Minister, which would contain a review of the operation of the Act. It would not be appropriate to put the advisory body in a review of legislation. It is common practice that this is a function of the Minister as provided, for example, in the Disability Act 2005, and the Health (Termination of Pregnancy) Act 2018. However, under the amendment I will be introducing, provision will be made for the Minister for Health to consult widely on the operation of the Act.

We do not want to refer to a non-statutory body within the legislation but I can confirm to the Deputy and colleagues that in the same way we approached the termination of pregnancy review, it will be a wide consultation and we will engage with patients, clinicians and a variety of other stakeholders that are involved.

David Cullinane (Waterford, Sinn Fein)
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On that basis I will withdraw the amendment.

David Cullinane (Waterford, Sinn Fein)
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I move amendment No. 16:

In page 12, between lines 33 and 34, to insert the following:

“(2)(a) A health services provider shall ensure and make every effort to ensure that the patient and relevant person are informed as to the potential for engaging and sourcing a patient advocate.

(b) A health services provider shall ensure a relevant patient is aware of the Patient Advocacy Service, and shall ensure the involvement of the Patient Advocacy Service where a patient wants to avail of such services.

(c) A health services provider shall ensure the inclusion of the patient and/or relevant person’s chosen advocate, whether of the Patient Advocacy Service or otherwise, throughout the disclosure process as a relevant person.”.

This amendment seeks to ensure we provide greater assurances of access to patient advocacy services. It also seeks to place obligations on the service provider to make a disclosure to ensure that a patient has been fully engaged and made aware of the possibility of patient advocacy services. We all know that patient advocacy services play an important role and this is to ensure that there is as much information given to patients as possible, and that they are fully made aware of what advocacy services are available in their respective areas.

Michael Collins (Cork South West, Independent)
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I fully agree with Deputy Cullinane's amendment. We have been discussing a lot of issues since we started this debate to do with nursing homes and community hospitals. Patient advocacy services are a channel for people who witness or encounter difficult situations, not in every nursing home, but in some and in some community hospitals. Families came to me to say the standards in community hospitals were not up to HIQA standards and a lot of questions need to be answered. Those families are not sure where those questions can be channelled through. I hope this amendment helps them in some way. There is the Independent Patient Safety Council and the patient advisory services.

I know the following is a slightly different issue but it is an important one to touch on. I was contacted by the family of a gentleman who was killed in a hospital in Cork recently and they are very upset. They need to be able to channel their sadness and hurt. That family has strong connections with west Cork and that gentlemen encountered a shocking situation. We support this amendment and we hope that the standards in most of our community hospitals, such as the top class standards in St. Gabriel's Community Hospital in Schull, are in every community hospital and nursing home in our country. After working hard for all their lives our elderly people deserve to have comforts and their families deserve to have the comfort of knowing they are safe, comfortable and happy at a very delicate time in their lives. In this situation, unfortunately it was found that this was not the case for some hospitals. Every opportunity to open up the discussion on why this happened must be taken. People might be found guilty of wrongdoing. We cannot have reports out there but at the same time not have anything acted on because I know the HIQA standards were not met in many of the hospitals. We will support this amendment going forward.

Mattie McGrath (Tipperary, Independent)
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I want to support Deputy Cullinane's amendment as well. It is so important. Patient advocacy groups try so hard and they are there to help patients. The vast majority of patients get top-class treatment but sometimes people fall through the cracks in some hospitals and sometimes some of the nursing homes are not up to standard either. You will hear different reasons and excuses for it but these are so important for elderly people who have worked so hard in this State, built up the State and raised families. Some of them have no families and they have no one to advocate for them; it depends on the advocacy services there are. It is so important that where there is any sniff or wrongdoing, it must be dealt with firmly and it must be stamped out. Unfortunately we have growing incidences of staff being assaulted and threatened with violence, and the utmost care must be taken to protect them because they have a challenging, caring, loving and dignified way of looking after people. They must be protected in any area where that is needed.

As the Minister knows, in some hospitals, including in my local hospital in south Tipperary, it is impossible to get a visitor, never mind an advocate, in. This has been ongoing for a long time due to bugs and whatever reasons. I was in a hospital two weeks ago tomorrow and I could walk in with no problem in the world. It was St. Vincent's University Hospital and I got well treated in that public hospital with no hassle, and there was somebody with me. However, people cannot get access to South Tipperary General Hospital, apart from on a limited basis. This has been ongoing since Covid and it is distressing for both the patient and their husband, wife or siblings. We need to move on. I know that infection control is important and vital but we have to be able to have patients have visitors. They recover better if they have visits from some of their loved ones and they do not feel as isolated as they were.

I have some scary stories of different nursing homes in different counties as well. People contacted me about bad experiences where there were not enough staff and where people were not properly cared for, which is not acceptable. Hopefully this legislation will do something about that.

Stephen Donnelly (Wicklow, Fianna Fail)
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We discussed this amendment on Committee Stage as well and I acknowledge the intent of it. This amendment has a constructive intent. However, I cannot accept the amendment because the Independent Patient Advocacy Service is not a statutory one. Therefore, we cannot refer to a non-statutory service in statute. However, there are various things we can do and are continuing to do. We need significant investment in awareness training and in campaigns, not just in cancer screening but right across the HSE so that people are aware of patient advocacy, including the patient advisory service. The Deputy understandably references that there should be patient advocacy involved in the part V review. I would agree wholeheartedly with that. Rather than that being in statute, for the reason I have laid out, as part of the ongoing design of the patient-requested review, which is done with the patient groups, we can identify exactly what the most appropriate way for that is in a way that works for the patient.

I will take this opportunity to commend the work that the Independent Patient Advocacy Service does.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 7 to amendment No. 19:

To delete section 36 and substitute the following: “Obligation to inform patient of right to make request for Part 5 review

36.(1) A health services provider shall, in relation to a patient in respect of whom a cancer screening is to be or is being carried out, inform the patient in writing, either before or at the time that it carries out the cancer screening on that patient, of his or her right to make a request under section 35for a Part 5review.

(2) Without prejudice to the generality of subsection (1), a health services provider shall, in relation to patients in respect of whom a cancer screening has, on or after the commencement of this section, been carried out by the health services provider establish and implement procedures for the further provision of the information given under subsection (1)to those patients in respect of their right to make a request for a Part 5review under and in accordance with section 35.

(3) A health services provider shall publish the procedures referred to in subsection (2)on a website maintained by or on behalf of the health services provider.”.

Stephen Donnelly (Wicklow, Fianna Fail)
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I thank the Leas-Cheann Comhairle for allowing a waiver for us to include that amendment at very short notice this evening. It is greatly appreciated.

Catherine Connolly (Galway West, Independent)
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I thank the staff for the work that went on behind the scenes.

Róisín Shortall (Dublin North West, Social Democrats)
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I move amendment No. 20:

In page 49, between lines 5 and 6, to insert the following: “Amendment of section 48 of Act of 2004

40.Section 48 of the Act of 2004 is amended by the deletion of paragraph (b).”.

This amendment arises out of the report by Dr. Scally. He was commissioned to carry out a number of reports on CervicalCheck. It does not make sense that the Minister is not taking on board Dr. Scally's recommendations and providing for them in law under the Bill. Amendment No. 20 relates to the need to amendment the Health Act 2004. In relation to a culture of openness and patient rights, Dr. Scally stated "In relation to a culture of openness and patient rights, I find it extraordinary that in the Health Act 2004, there is a legal prohibition on anybody making a complaint to the HSE about the clinical judgement of a doctor or other health professional providing care funded by the HSE." The Act states:

A person is not entitled to make a complaint about any of the following matters: ... (b) a matter relating solely to the exercise of clinical judgment by a person acting on behalf of either the Executive or a service provider...

Section 48(b) of the 2004 Act states, "a matter relating solely to the exercise of clinical judgment by a person acting on behalf of either the Executive or a service provider”. That is what open disclosure means in relation to a clinical judgement. Section 48 of the 2004 Act is the obstacle here. In line with Dr. Scally's very clear recommendations, I propose we amend the 2004 Act to remove (b), which is the obstacle to clinical open disclosure. I cannot understand why the Minister has not taken that recommendation on board and why he does not provide for the amendment of the 2004 Act, in line with the clear recommendation of Dr. Scally. We previously had a situation similar to this in 2015, where the then Minister promised full, open disclosure. However, he backed off from doing that following substantial lobbying.

I would have thought, in light of everything that has happened in recent years, that the current Minister would be determined to address this matter. It is regrettable that he has not chosen to do so in this Bill. He did reference this earlier. He said he would do it on another occasion. We have heard this before and I am not prepared to accept it. The Minister has not set out any cogent rationale for not dealing with it in the Bill. It is for this reason that I have tabled the amendment. If we are serious about open disclosure, the Minister must take this amendment on board.

David Cullinane (Waterford, Sinn Fein)
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I support the amendment. This section is problematic. This goes back to what I said earlier about Dr. Scally's report, which is this is one of the areas he is most certainly not satisfied that enough has been done. He specifically cited this part of the Act as problematic. A number of high-profile cases have come before the High Court in recent weeks, regarding mistakes and errors that formed part of clinical judgments. These were often in cases of clinical negligence or questionable clinical judgments being made by clinicians. This will happen in any health service. We accept the vast majority of judgments are, by and large, the right judgments. However, when a patient determines the judgment to be wrong, there is no option for the individual to make a complaint. We need to be looking at something, such as a health oversight body, that could deal with some of these issues. It is an area we need to look at.

In the context of what the Minister said earlier and the offer of the Oireachtas Committee on Health in respect of looking at the outstanding elements of Dr. Scally's report, this is one of the critical elements for me. I appreciate the issues we are dealing with are complex, which is why we need to tease them out and to make sure we get them right but there seems to be a difficulty here. People come to us as politicians all the time and ask us to make representations on their behalf in regard to health issues. They are not satisfied that they might be waiting six months for a procedure. Sometimes a family will say to me as a public representative that they are not satisfied with the clinical decision that was made for a relative or themselves. I always make the point that I am not a clinician. Clinicians have to make decisions. I cannot second-guess what a clinician does. It is not part of my role as a public representative. There should be a process, which does not exist at the moment, for a patient or a family acting on behalf of a patient to make a complaint. Complaints are only complaints and, obviously, they then have to be adjudicated upon. In many situations, it is possible the complaints would not be upheld because the clinical judgement may be independently determined to be right. However, at the moment there is no avenue for people.

There are lots of high-profile cases that end up in the courts where damages are paid on behalf of the State, and rightly so, to people who have been wronged. Part of the problem in some of those cases is the area of clinical judgement. It is not the only factor but it is part of it. For that reason, I do not understand why this was not dealt with. Perhaps the Minister will explain why that element of Dr. Scally's report on this critical issue was not dealt with. During the pre-legislative scrutiny of the Bill in the Oireachtas Committee on Health we had a constructive but quite lengthy discussion on this. At that point, I was not clear on why there was resistance, other than the reason that it was complex. Of course, we have to properly tease out all of these issues but I was not satisfied that I was being assured as to why this was not dealt with.

I support the amendment. I imagine the Minister will not be accepting it. He will probably argue the matter is complex and that it will take more than the amendment to deal with the issue. This is in addition to all of the intended, and possibly unintended, consequences that might flow from this amendment being accepted. That is the reason we need to come back to this. The Minister needs to make a commitment to look at this issue. I have met many patients over the past number of years who have made the point they cannot make a complaint and that there is nowhere for them to go. The Ombudsman is not an option. There are no options for them. For that reason, I will be supporting the amendment.

Richard O'Donoghue (Limerick County, Independent)
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I also support the amendment. We have been talking about high-profile cases, and we have mentioned the case of Jessica Sheehy before. This is a high-profile case that has been going on over three years that has not been dealt with. People are making complaints, as the Deputies have said. There was a petition signed not so long ago in regard to 15,490 people on trolleys in Limerick in 2022. The figures were calculated by the Irish Nurses and Midwives Organisation. What scares me is that the research indicates that one of every 82 people who are on trolleys or in chairs for more than five hours will die. One of every 72 people who are on trolleys or in chairs for between six and 12 hours will die. People ring us on a daily basis to complain about different services and clinicians and state that they did not get the proper care. I appreciate that certain things have changed, but this is not good enough, particularly when individuals in the medical profession are asking us to ensure that people have a proper framework to allow them to make complaints. Not only is that the case for patients and their relatives, it is also the case for health workers. The latter should be able to make complaints, through their own reporting systems, in respect of the safety of their patients.

HIQA came into University Hospital Limerick and looked at the situation. A reporter said that there should be no more patients on trolleys there. If officials from HIQA were able, as is the case with nursing homes, to go into the hospital on spec tonight, they would see people on trolleys in the wards because the staff have been told to keep them out of the accident and emergency department in order to keep the numbers down. This is being done because of the media presence in the hospital. People on trolleys have been moved into wards and nursing staff have indicated that this is not safe. We have to listen to the medical professionals. People have to have the right to voice the concerns of their loved ones in hospitals. They must be able to make complaints and there must be a process of accountability. There has to be accountability when this is affecting people's lives.

I will not delay on this point any longer, but I have one more instance to highlight. I am aware of a case involving a patient who was on a trolley and who needed oxygen. The oxygen was in a canister. It was necessary to get a porter to come and change the unit. The patient died while waiting for this to happen. That was because the hospital did not have the proper oxygen available through the plug-in system. The patient died on a trolley while waiting for oxygen in a hospital. Patients have to have the right to complain and the mechanism to learn how to fix these problems. Until this incidents are reported by means a proper process, no lessons will be learned. It all comes back to accountability and structures.

Stephen Donnelly (Wicklow, Fianna Fail)
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This is something we need to do but we have got to do it right. It is being looked at. Dr. Scally quite rightly pointed it out. We have discussed it before. However, we have to do it right. Extensive work is going on around new complaints policies including legislative change. There needs to be funding allocation, training and clinical governance pathways put in place. There is an entire process that has to be put in place for the patient to make sure that those complaints are dealt with in the right way and in a way that is appropriate for the patient. Yes, it is important but it is also important we do it right. A commitment I would like to give to colleagues is a session with myself and with Department of Health officials to discuss the work that has already happened and where we are at in terms of bringing forward new legislation. Critically, we are not looking at just this clause within the 2004 Act. There may be much wider changes to the Act and additional legislation may be brought in to provide for clinical complaints. I imagine we are all agreed on the requirement for patients to be able to make complaints in respect of clinical issues. There is probably a very interesting story behind how that clause managed to find its way into the 2004 Act. I agree entirely with the intent, but I ask colleagues to take it in good faith that we have to do it right. I would certainly be very happy to facilitate a meeting with Department officials soon, either informally or formally, through the health committee, to get feedback on this specific issue so that it is done properly, with policy, funding, the requisite training, clinical governance and with whatever legislative changes are required, which will probably include this but which will probably go further that it.

Róisín Shortall (Dublin North West, Social Democrats)
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I do not accept what the Minister is saying. This is yet another long-fingering of a critical aspect of healthcare, namely, the duty of candour. We have talked about this for many years. It is absolutely central to so many of the cases we see resolved in the High Court, the Supreme Court or on the steps of the courts. Earlier, I referred to the two cases yesterday. We cannot continue to dodge this issue. In fairness, the Minister had plenty of notice of this. Dr. Scally has been absolutely clear about the importance of the duty of candour in open disclosure from the very start. He has been an advocate of this for a very long time. We know the experience of 2015, when the then Government backed off this issue. We should not allow it to continue any longer. At the top of the relevant section in Dr. Scally's report, in the context of the duty of candour, the following appears:

I deserve to know the truth

To be told the truth

I deserve answers

I deserve justice

I deserve for this never to have happened

I deserve closure

I deserve for it to be over

Those things will never happen until there is an absolute duty of candour, which will ensure that clinicians, hospitals and healthcare bodies do not try cover their tracks with regard to serious incidents, fail to provide clear answers or fail to be straight up with people from the outset. That is what people who are the victims of serious incidents want. They want honesty. They want openness. The idea of kicking this down the road until other legislation, which we may or may not see during the term of this Government, is drafted is simply not acceptable. For that reason, and in deference to the very clear recommendations from Dr. Scally, I will be pressing the amendment.

David Cullinane (Waterford, Sinn Fein)
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I support those sentiments. I accept that the offer the Minister made was made in good faith, but he should accept that Dr. Scally's report was published a long time ago. The most recent report was a progress report. It was an implementation report so it was a scorecard essentially on what was done and what was not done. There was sufficient time for the Government to have dealt with this issue. It was something that the Joint Committee on Health spent a lot of time on during pre-legislative scrutiny. There are many complicated amendments that the Minister was able to bring forward, including those on nursing homes, so this ended up being a catch-all Bill. Ultimately, it is almost a miscellaneous provisions Bill. The Minister said earlier that this may be the way to do legislation. I am not quite sure that it is. Some of the issues could have been dealt with separately. They should have been dealt with previously. Notwithstanding that, they are obviously dealt with in the Bill.

On this particular issue, while the Minister says there is work being done - and while I accept that and acknowledge the offer that was made for hearings - sometimes that can seem to be a case of kicking the can down the road. The Minister has provided some insight as to what has been done. I may be wrong, but I imagine that it would be a long time before we see the legislation to which he referred come before the Houses. Yet Dr. Scally's report, as the Minister knows, is many years old and is one of the central planks in the context of what we are doing. I strongly endorse what has been said. I will be supporting the amendment.

Alan Kelly (Tipperary, Labour)
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We will be supporting the amendment as well. I respect everything the Minister said and the manner in which he has dealt with this issue. This Bill has been broadened out. The reason we need a vote on the amendment to bring to people's attention the fact that this matter has to be dealt with. Deputy Shortall quoted the Scally report.

The fact that we have not had progress is ridiculous. The fact that this is outstanding is ridiculous. We will support the amendment on the basis that this needs to be dealt with. As legislators, we should not be dealing with this now. This should have been dealt with some time ago. We need to bring a huge amount of urgency to this and that is why we will support the amendment.

Richard O'Donoghue (Limerick County, Independent)
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I will also support the amendment. The State incurs legal expenses while trying to fight cases in the HSE system and Government due to incidents which could have instead been dealt with so that people could learn from, admit to and work on them for the future and use them as a learning curve. People could admit they got things wrong and have to fix them, learn from what happened and move on. The legal fees incurred by fighting and holding things in the courts for years are more than what it would cost if people came out and said they got things wrong, need to fix them and make sure the same does not happen again. The legal fees over the past number of years would exceed the cost of fighting this.

Stephen Donnelly (Wicklow, Fianna Fail)
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I accept the good intent in the amendment. I would reiterate that this is not a Bill about complaints; rather, it is a Bill about open disclosure and regulation. I want to be very clear. The open disclosure in the Bill covers clinical instances. The issue in the 2004 Act is not about open disclosure; rather it is about who people complain to. The 2004 Act states that if a patient wants to make a complaint about a clinical issue, he or she does so through the professional body. Non-clinical issues go to the HSE. That is what the Act says. The argument put forward in the amendment is that a clinical complaint should not go to a professional body but rather the HSE. That is what the amendment deals with. It is nothing to do with the right to know and be told the truth. All of those issues are covered in the Bill under open disclosure.

I want to be very clear. We can disagree on whether we change the rules around complaining to professional bodies versus the HSE. Clearly, that is not within the remit of the Bill. It is something that needs to be looked at. If we were to do it now it would create serious issues in terms of processes. It would end up disempowering patients, because at the moment there are at least governance processes in place where complaints go to professional bodies. If we remove that, what governance and protections for patients, transparency and accountability will be in place? The answer is there would be none.

Róisín Shortall (Dublin North West, Social Democrats)
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It does not stop a person being able to make a complaint to a professional body.

Stephen Donnelly (Wicklow, Fianna Fail)
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We would actually be exposing patients to not being able to use the processes that are in place. We all agree that the complaint should still go to a professional body but should also be something that is dealt with by the HSE. It is not within the remit of the Bill to address that. It is something that has to be looked at in a way that works for patients. Simply deleting a specific sub-clause of the 2004 Act will not give us what we want for patients.

Róisín Shortall (Dublin North West, Social Democrats)
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It has to be said that the experience for patients in working through professional bodies has not been good. In terms of adverse incidents, generally speaking the HSE is the body named, as well as the hospital and individual. Allowing a person the opportunity to make a complaint about clinical judgment to the HSE does not preclude a person from making a similar complaint to a professional body.

The legislation is very clear. A person is not entitled to make a complaint about certain matters, the stand out of which is a matter relating solely to the exercise of clinical judgment by a person acting on behalf of the executive or a service provider. That is an outrageous situation. A person cannot make a complaint about clinical judgment. In many cases, adverse incidents cover the whole question of clinical judgment. We have to remove that section of the 2004 Act. Dr. Scally has called for this and it has been talked about for a very long time. It is important that the Minister's hand is strengthened in regard to this by people expressing their concern about the current situation. The Minister also needs to be pressed on this because there will be many excuses provided to him for not doing this in a timely manner, within the next year or two while he is still in office. This is a matter that has to be pressed and I intend to do that in order to underline its importance.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 21:

In page 49, between lines 9 and 10, to insert the following: “‘cancer screening service’ has the same meaning as it has in section 2of the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2022;”.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 22:

In page 49, between lines 9 and 10, to insert the following: “ ‘complainant’ shall be construed in accordance with section 41A(5);”.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 23:

In page 49, to delete lines 10 and 11 and substitute the following:

“ ‘health service’ means the provision of clinical care or any ancillary service to a person for⁠—

(a) the screening (other than screening carried out by a cancer screening service), preservation or improvement of the health of the person,

(b) the prevention, diagnosis, treatment or care of an illness, injury or health condition of the person,

(c) the performance or surgery, or a surgical intervention, in respect of aesthetic purposes, or other non-medical purposes, that involves instruments or equipment being inserted into the body of the person, or

(d) without prejudice to paragraph (a), a cancer screening service;”.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 24:

In page 49, between lines 14 and 15, to insert the following: “ ‘patient’ has the meaning assigned to it by section 41A(10);”.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 25:

In page 55, between lines 13 and 14, to insert the following:

“Amendment of section 41 of Act of 2007

45.Section 41 of the Act of 2007 is amended, in subsection (1), by the insertion of the following paragraph after paragraph (c): “(ca) undertake reviews in accordance with section 41A,”.”.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 26:

In page 55, between lines 13 and 14, to insert the following:

“Review of specified incident by chief inspector

45.The Act of 2007 is amended by the insertion of the following section after section 41: “41A.(1) This section applies where it appears to the chief inspector that a specified incident has occurred, following⁠—

(a) the receipt by the chief inspector of a complaint in relation to the specified incident concerned,

(b) the notification of the specified incident concerned to the chief inspector by a relevant entity, or

(c) the chief inspector otherwise becoming aware of the specified incident concerned.

(2) Subject to subsection (4), the chief inspector may undertake a review of the specified incident where he or she considers it appropriate to do so, having regard to all of the circumstances, in order to⁠—

(a) identify, in so far as possible, how the specified incident concerned occurred, and

(b) make any recommendations of a general character arising out of any findings under paragraph (a) that can be implemented to reduce risk and to improve the safety, quality and standards of services provided by the relevant entity or relevant entities, as the case may be, where the specified incident occurred.

(3) The chief inspector may decide not to undertake a review under this section, or decide to discontinue such a review, if⁠—

(a) subsection (1)(a) applies and the chief inspector believes on reasonable grounds that the complaint is frivolous or vexatious,

(b) the specified incident, the subject of the review concerned, has already been subject to a review under this section,

(c) the chief inspector believes on reasonable grounds that the incident the subject of the review concerned is not a specified incident,

(d) the chief inspector believes on reasonable grounds that the subject matter of the review concerned has already been resolved or substantially resolved,

(e) the subject matter of the review concerned is the subject of criminal proceedings, or

(f) the review concerned is the subject of an investigation by An Garda Síochána.

(4) The chief inspector shall not undertake a review of a specified incident under subsection (2)⁠—

(a) where subsection (1)(a) applies, after the expiration of one year from the later of the following dates:

(i) the date on which the specified incident occurred;

(ii) the date on which the complainant knew or could reasonably be expected to know that the specified incident occurred,

or

(b) where subsection (1)(b) or (c) applies, after the expiration of one year from the date on which the specified incident occurred.

(5) Without prejudice to Part 9 of the Health Act 2004, each of the following persons may make a complaint to the chief inspector in relation to a specified incident, and where he or she does so each such person shall, in this section, be referred to as a ‘complainant’:

(a) the patient;

(b) a parent, guardian, son, daughter, spouse or civil partner (within the meaning of the Civil Partnership and Certain Rights and Obligations of Cohabitants Act 2010) of the patient;

(c) a person who is cohabiting with the patient (including a cohabitant within the meaning of section 172 of the Civil Partnership and Certain Rights and Obligations of Cohabitants Act 2010);

(d) any person who, by law or by appointment of a court, has the care of the affairs of the patient;

(e) any legal representative of the patient;

(f) any other person, with the written consent of the patient.

(6) Where a review under this section is being undertaken in respect of a specified incident, the chief inspector shall⁠—

(a) give notice in writing to the relevant entity concerned of the matters to which the review relates, and

(b) give the relevant entity concerned a copy of any document which in the reasonable opinion of the chief inspector is relevant to the review.

(7) A review of a specified incident undertaken under subsection (2) shall not⁠—

(a) consider or determine fault, or assign civil or criminal liability,

(b) consider or determine whether any action should be taken in respect of an individual by any panel, committee, tribunal or professional regulatory body, or

(c) be admissible as evidence of fault or liability in a court in relation to the specified incident, or a clinical negligence action which arises (whether in whole or in part) from the consequences of that specified incident.

(8) Nothing in this section shall be construed as preventing a relevant entity from undertaking a review of a specified incident that may have occurred.

(9) The chief inspector shall ensure that a review under this section does not interfere, or conflict, with the functions of any statutory bodies.

(10) In this section⁠—

‘complaint’ means a complaint, in any form, made by a complainant in relation to a specified incident that may have occurred during the provision of a health service by a relevant entity to a patient;

‘patient’ means a person to whom a health service is, or has been, provided by a relevant entity;

‘relevant designated centre’ means a designated centre to which paragraph (c) of the definition of ‘designated centre’ in section 2 applies, that is registered in accordance with section 49 and includes⁠—

(a) a designated centre whose registration has been cancelled under section 51 where an appeal against the cancellation has been made and has not been determined or withdrawn or in respect of which an appeal has been made under section 62 and that appeal has not been determined or withdrawn, and

(b) a designated centre in respect of which an application was made to the District Court under section 59 and the application has not been determined or withdrawn or in respect of which an appeal has been made under section 62 and that appeal has not been determined or withdrawn;

‘relevant entity’ means⁠—

(a) a service provider to which paragraph (a), (b) or (d) of the definition of ‘service provider’ in section 2 applies,

(b) a relevant designated centre that is not a service provider referred to in paragraph (a),

(c) a person carrying on the business of providing a prescribed private health service, or

(d) the Executive;

‘specified incident’ means an incident that occurs on or after the coming into operation of this section⁠—

(a) that may have resulted in the unintended or unanticipated death or serious injury of that patient, and

(b) that has occurred in the course of the provision of a health service to a patient by a relevant entity, where some or all of that health service was provided in a relevant designated centre.”.”.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 1 to amendment No. 26:

In section 41A(10), inserted by section 45, to delete the definition of “specified incident” and substitute the following: “ ‘specified incident’ means an incident that occurs on or after the coming into operation of this section—

(a) that may have resulted in the unintended or unanticipated death or serious injury of a patient, and

(b) that has occurred in the course of the provision of a health service to that patient by a relevant entity, where some or all of that health service was provided in a relevant designated centre.”.”.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 27:

In page 55, between lines 13 and 14, to insert the following:

“Amendment of section 72 of Act of 2007

45.Section 72 of the 2007 Act is amended, in subsection (1)⁠—

(a) by the insertion of “or a review referred to in section 41A” after “section 41”,

(b) in paragraph (a), by the insertion of “referred to in section 41 or an inspection relating to a review referred to in section 41A, as the case may be” after “the inspection”, and

(c) in paragraph (b), by the insertion of “referred to in section 41, or to a review referred to in section 41A” after “the inspection”.”.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 28:

In page 55, line 16, to delete “subsection (1)(b)” and substitute “subsection (1)”.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 29:

In page 55, line 16, to delete “subparagraphs” and substitute “paragraphs”.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 30:

In page 55, line 17, to delete “subparagraphs (i) and (ii)” and substitute “paragraphs (i) and (ii)”.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 31:

In page 55, line 23, to delete “and”.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 32:

In page 55, between lines 23 and 24, to insert the following: “(b) by the insertion of the following subsection after subsection (2):

“(2A) If the chief inspector considers it necessary or expedient for the purposes of a review referred to in section 41A, the chief inspector may enter and inspect at any time any premises⁠—

(a) owned or controlled by [a relevant entity within the meaning of section 41A, or

(b) used or proposed to be used for any purpose connected with the provision of a health service by a relevant entity within the meaning of section 41A.”,

(c) in subsection (3)⁠—

(i) by the insertion of “or a review referred to in section 41A” after “section 41”, and

(ii) in paragraph (b), by the insertion of “in the case of an inspection referred to in section 41, or any premises referred to in subsection (2A) in the case of a review referred to in section 41A”,”.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 33:

In page 55, to delete line 26 and substitute “provider,”.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 34:

In page 55, between lines 26 and 27, to insert the following: “(c) by the insertion of the following subsection after subsection (4):

“(4A) A chief inspector, in respect of premises referred to in subsection (2A), may⁠—

(a) inspect, take copies of or extracts from and remove from the premises any documents or records (including personal records) relating to the services provided by a relevant entity within the meaning of section 41A,

(b) inspect the operation of any computer and any associated apparatus or material which is or has been in use in connection with the records in question,

(c) inspect any other item and remove it from the premises if the chief inspector considers it necessary or expedient for the purposes of a review referred to in section 41A,

(d) interview in private any person⁠—

(i) working at the premises concerned, or

(ii) who at any time was or is in receipt of a service at the premises and who consents to be interviewed,

and

(e) make any other examination into the state and management of the premises or the standard of any services provided at the premises.”,

(d) in subsection (5)⁠—

(i) by the insertion of “or (2A)” after “subsection (2)”, and

(ii) in paragraph (ii), by the insertion of “or a review referred to in section 41A” after “section 41”,

(e) in subsection (6), by the insertion of “or (2A)” after “subsection (2)”, and

(f) in subsection (8)⁠—

(i) by the insertion of “or (2A)” after “subsection (2)”,

(ii) by the substitution of “an inspection referred to in section 41 or a review referred to in section 41A” for “an inspection under this section”,

(iii) by the substitution of “subject of the inspection or review” for “subject of the inspection”, and

(iv) in paragraph (b), by the insertion of “or review” after “the inspection”.

Amendment of section 74 of Act of 2007

46.Section 74 of the Act of 2007 is amended by the substitution of the following subsection for subsection (1):

“(1) In this section, ‘dwelling’ includes⁠—

(a) any part of a designated centre occupied as a private residence by the registered provider of the designated centre or by a member of the staff of the registered provider, and

(b) any part of the premises of a person carrying on the business of providing a prescribed private health service occupied as a private residence by that person or by a member of the staff of that person.”.”.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 1 to amendment No. 34:

To delete paragraph (d) and substitute the following: “(d) in subsection (5)—

(i) by the insertion of “or (2A)” after “subsection (2)”,

(ii) in paragraph (ii), by the substitution of “section 41, or of a review referred to in section 41A” for “section 41”, and

(iii) by the insertion of “or to the review” after “is relevant to the inspection”,”.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 35:

In page 55, between lines 26 and 27, to insert the following:

“Amendment of section 75 of Act of 2007

46. Section 75 of the Act of 2007 is amended⁠— (a) in subsection (1)⁠—

(i) in paragraph (a), by the substitution of “section 8(1)(d),” for “section 8(1)(d), or”,

(ii) by the substitution of the following paragraph for paragraph (b):

“(b) in relation to any premises referred to in section 73(2) or (2A), the chief inspector conducting an inspection referred to in section 41 or a review referred to in section 41A,”,

(b) in subsection (2)⁠—

(i) in paragraph (a)⁠—

(I) by the insertion of “or, in the case of a review referred to in section 41A, section 73(2A)” after “section 73(1) or (2)”,

(II) in subparagraph (i), by the substitution of “section 8(1)(d),” for “section 8(1)(d), or”

(III) in subparagraph (ii), by the substitution of “section 41, or” for “section 41,”, and

(IV) by the insertion of the following subparagraph after subparagraph (ii):

“(iii) the chief inspector considers it necessary to inspect for the purposes of a review referred to in section 41A,”.”.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 1 to amendment No. 35:

In section 46, to delete paragraph (a) and substitute the following: “(a) in subsection (1), by the substitution of the following paragraph for paragraph (b):

“(b) in relation to any premises referred to in section 73(2) or (2A), the chief inspector conducting an inspection referred to in section 41 or a review referred to in section 41A,”,”.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 36:

In page 55, between lines 26 and 27, to insert the following:

“Amendment of section 78 of Act of 2007

46.Section 78 of the Act of 2007 is amended, in paragraph (ii), by the insertion of “or section 41A” after “section 41”.”.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 37:

In page 55, line 34, to delete “and”.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 38:

In page 55, line 35, to delete “section 9.” and substitute “section 9, and”.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 39:

In page 55, between lines 35 and 36, to insert the following: “(c) any review carried out under section 41A.”.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 40:

In page 56, between lines 9 and 10, to insert the following:

“(4) In the case of a report which includes information on a review referred to in subsection (2)(c), the chief inspector shall also give to the patient and, as the case may be, the complainant to whom the review relates an extract from the draft report which relates to the review concerned along with a written notice stating that the person may, not later than 21 days from the date on which the notice was received by him or her, or such further period as the chief inspector allows, make written submissions to the chief inspector on the extract from the draft report.”.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 41:

In page 56, line 11, to delete “subsection (3)” and substitute “subsections (3) and (4)”.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 42:

In page 56, line 12, to delete “that subsection” and substitute “those subsections”.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 43:

In page 56, line 19, to delete “or”.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 44:

In page 56, line 21, to delete “registered provider.” and substitute “registered provider, or”.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 45:

In page 56, between lines 21 and 22, to insert the following: “(f) in the case of a report which includes information on a review referred to in subsection (2)(c), the patient and, as the case may be, the complainant.”.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 45a:

In page 56, line 22, to delete “(5) Without” and substitute “(6) Without”.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 45b:

In page 56, between lines 25 and 26, to insert the following:

“Amendment of section 78 of Act of 2007

47.Section 78 of the Act of 2007 is amended, in paragraph (ii), by the insertion of “or section 41A” after “section 41”.”.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 46:

In page 57, between lines 34 and 35, to insert the following: “(5) A person who fails to comply with section 36(1) without reasonable excuse shall be guilty of an offence and shall be liable on summary conviction to a class A fine.

(6) A person who fails to comply with section 49(9) without reasonable excuse shall be guilty of an offence and shall be liable on summary conviction to a class A fine.

(7) A person who fails to comply with section 50(5) without reasonable excuse shall be guilty of an offence and shall be liable on summary conviction to a class A fine.”.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 47:

In page 58, line 3, to delete “subsection (1), (2), (3) or (4)” and substitute “subsection (1), (2), (3), (4), (5), (6) or (7)”.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 48:

In page 58, line 10, to delete “subsection (6)” and substitute “subsection (9)”.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 50:

In page 58, between lines 34 and 35, to insert the following: “Review of operation of Act 52. (1) The Minister shall, not later than 2 years after the coming into operation of this section, carry out a review of the operation of this Act.

(2) In carrying out a review under subsection (1), the Minister may consult with such persons as he or she considers appropriate.”.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 51:

In page 59, lines 9 and 10, to delete “Notifiable Patient Safety Incidents” and substitute “Notifiable Incidents and Open Disclosure”.

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 71:

In page 67, to delete lines 20 to 29 and substitute the following:

"

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 72:

In page 67, to delete lines 20 to 29 and substitute the following:

"

Stephen Donnelly (Wicklow, Fianna Fail)
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I move amendment No. 73:

In page 71, to delete lines 21 to 24 and substitute the following:

"

Stephen Donnelly (Wicklow, Fianna Fail)
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The Leas-Cheann Comhairle showed some strong experience there. It was very impressive.

Alan Kelly (Tipperary, Labour)
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Serious experience.

Catherine Connolly (Galway West, Independent)
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I get worried when I hear that. I am seriously in trouble.

Alan Kelly (Tipperary, Labour)
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I want to thank everybody. I thank the Leas-Cheann Comhairle for the way in which she dealt with this. I thank the Minister for the way in which he engaged. I thank his officials and particularly thank the Deputies who sat through this, Deputies Cullinane and Shortall, for the way that we have dealt with this Bill.

For me, on a personal level, this is probably the most important piece of legislation I have ever done in my life because of the way, in an accident of politics and work, I became very close to Vicky Phelan in particular. I want to say how important this legislation is. Vicky made this legislation front and centre of everything she wanted achieved. It was core to everything. I had my last conversations with her and I spoke to her about what she wanted us to do. I made a commitment that we would pass this legislation. Vicky had a way in her life when she was dealing with all of us as friends, and there are some watching down here, including John Wall, that she never left anything unsaid. Everything had to be said and dealt with; your feelings and how you expressed your relationship with her and to her. Her deal with me was that nothing would be left unsaid.

My condition and my promise was that nothing would be left undone. We have done so much regarding HPV screening, testing and bringing the labs back but we have more work to do. There were other pieces of work regarding the civil liability Bill and on dying with dignity. They are broader issues but for me, this Bill is Vicky's legacy. It brings a certain benchmark and closure and that is why it is so critically important to me, Lorraine Walsh, Stephen Teap and everybody else. I want to acknowledge them and the 221+ group.

Vicky's favourite band was The Stunning. I went to see them with her a number of times. She was such a ball wrecker that the song "Heads are Going to Roll" was nearly written for her. You think of her. There are two lines in that song which I asked friends to draw out for me because they are important:

Down through the ages we're tearing the pages;

There's more of the book still to write.

Posthumously, there is another chapter to go into Vicky's book. That chapter is the legacy of what Vicky has achieved and will achieve. This Bill is one of the most important components and the one she wanted front and centre. I thank everyone collectively for working with me and with others and everyone who has been involved in this legislation. It is a very momentous occasion and a very emotional occasion for me. Thank you.

David Cullinane (Waterford, Sinn Fein)
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I, too, remember Vicky Phelan and all the other women who, unfortunately, are not with us today and their families. The 221+ group has done a phenomenal piece of work over recent years in campaigning on a range of issues, and this is one of those core issues for the group. I commend each and every one of them and all those with whom I have engaged on their courage and the respect and strength they have shown in making sure we get this right. It was an inspiration to all of us. Again, I thank the Minister for his co-operation, all the staff in the Department and the HSE and all those who were involved in drafting what was in the end very complex legislation. It was quite difficult towards the end to follow all the amendments to amendments we had to go through, but the fact that we were able to admit that we had not gone far enough and then keep going until we got it right is a victory for all of us and certainly a victory for the 221+ group.

Mandatory open disclosure is really important. We talked about this for a long time. It is great that we now have a Bill that we in this House can now pass which passes the Vicky test, which was always the key issue for those of us in opposition and, I would argue, for the Minister.

I also welcome the fact that we are seeing a greater use of the lab in the Coombe. I want to see more progress in that area. That is again something Vicky had campaigned for. I am conscious that there was a lot of hurt and a lot of pain that many families, two in particular, had to go through because of the CervicalCheck scandal.

We should also pay tribute to Gabriel Scally for the work he has done because his report and the recommendations he made are in part a reason we are here today as well. While we are paying tribute to people, we also have to accept that we still have a long way to go in terms of many of the issues Dr. Scally recommended. We had some discussion on them earlier, so they cannot be long-fingered. The issue of being able to make a complaint on an issue of clinical judgment is not one that we can now just forget about and put on the long finger as many other issues will of course overtake what happened here in terms of this Bill.

I commend everybody involved. My thoughts and solidarity are with the 221+ group tonight. All of these Bills are, in and of themselves, imperfect and issues may arise from time to time but the commitments given to engage with the 221+ group on the processes and procedures which will have to follow the passing of this Bill in the Dáil constitute a big step forward.

Róisín Shortall (Dublin North West, Social Democrats)
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Tonight is an important and positive occasion in finalising the important legislation before us, but it is also a poignant occasion. Throughout the debate, we have held those women front and centre and thought of them continuously. That includes those women lost their lives as a result of what happened with CervicalCheck and those whose lives were turned upside down but who have survived. We also think of their families, who have had a terrible time, whether those families were bereaved or are coping with very serious diagnoses and all the treatment involved with that. This is an enormous tribute to the memory of all of those women and other women and men in the 221+ group who have not let this issue rest and have campaigned vigorously in recent years to ensure we do not repeat the mistakes of the past and that we put robust legislation in place. The 221+ group has done an extraordinary job and deserves huge thanks for the advocacy work it has done and will, no doubt, continue to do. We desperately need it to continue to do that work.

I also pay tribute to all the staff in the Department involved in bringing the legislation forward. It is undoubtedly complex and comprehensive legislation and required a huge amount of work and working through different key issues. They were available on a number of occasions to provide briefings to us and to the 221+ group. I welcome the meeting of minds that has taken place recently between the group and Department officials.

I thank the Minister for the important work he has done in prioritising this legislation. It is great to see it reach this point. As a result of the campaigning work that has gone on, we have improved services and improved legislation, and we hope there will be an improved culture, but we are not there fully yet. It is a work in progress to continue the improvement of services, make them more patient-focused, make legislation more patient-focused and, most of all, to change the culture within our health service to ensure higher quality and more responsive services, as well as greater transparency and accountability. I thank everybody involved. It is a really important night.

Stephen Donnelly (Wicklow, Fianna Fail)
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I thank colleagues and, along with them, I acknowledge we are here this evening with this Bill because of Vicky Phelan and others who made a brave and difficult stance, including Lorraine and many others. They did something difficult and important.

This is about 115 pages; it is complex and important legislation. It expands HIQA’s remit into nursing homes and private hospitals and brings in mandatory open disclosure, the framework for the patient-requested reviews and the additions provided for through this evening’s amendments around mandatory information for patients. It is one of several important changes. The credit for those changes goes back to Vicky Phelan and the others who took a stance and, critically as colleagues said, continued to advocate and fight after that. Years of work has gone into it.

We now have HPV screening, HPV vaccines and the catch-up programme. It is important to say cancer survivorship rates in Ireland are going in the right direction. They are increasing. Our goal is to eradicate cervical cancer in Ireland. Patients going for screening is a part of that. Screening services are essential and the people I have met who work in those services are passionate and dedicated to making sure they provide the best possible outcomes for patients.

We are doing other things in this area. The Bill will go to the Seanad and then hopefully be signed by the President. Then it is about implementation. We have to get into the programmatic audits and make sure they are back up and running as quickly as possible. We have to finalise the patient-requested reviews, including all the details discussed this evening. We need that in place. We need to continue and accelerate the work.

I accept the reasonable challenge from colleagues on the complaints processes and procedures. We need to put that in place. We have a review around medical negligence claims. First and foremost, it is about identifying the cause of the medical negligence and doing the root-cause analysis to make sure everything is done to stop it happening in the first place. Some 70% of allocated awards are around obstetrics and childbirth. There is a big focus there but there needs to be a focus on other places as well.

It is critical to find better way for patients to be compensated in the event there is an issue. I think we all agree the current process does not work for patients. The remit under which the State Claims Agency is obliged to work under statute is not working for patients and has not worked for patients.

Alan Kelly (Tipperary, Labour)
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Hear, hear.

Stephen Donnelly (Wicklow, Fianna Fail)
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Several meaningful pieces of work are going on, such that we can, in the first instance, reduce adverse events as much as possible. That is not just on a one-off basis, to which Deputy Shortall alluded, but it is so we have a culture, training and processes in place such that continuous learning and feedback happen to constantly identify and eliminate the causes of adverse events, while accepting in a health service things will unfortunately inevitably go wrong, hopefully as rarely as possible. Things will not always work out. In those situations, it is first and foremost that the patient is told what happened and told in a way designed to work for the patient and not for anybody else.

If there is a situation where compensation is warranted, it is important that there is a process in place. Anyone has recourse to the courts, but that should not be the only recourse. We should have more appropriate processes in place that start and end with the patient.

I agree with colleagues that this is a journey. Some really important things have happened in terms of services being put in place and changes made. Tonight is an important step but only one step on a journey to getting our health service where we want it to be, whereby patients get the best outcomes, have the best experience of our health service, including those dealing with extremely difficult situations, and, critically, when things go wrong, that there are appropriate patient-centred supports and processes in place to deal with those.

I thank colleagues again. It has been a very constructive debate. I thank the Leas-Cheann Comhairle for facilitating the debate and the additional amendments tonight. Finally, I go back to where we started and thank the patients who have worked so hard to ensure we got to where we are this evening.