 Felly, wrth i amdoddiw nhw'n ei gweld mewn byw yr adael cyfan pasoch ar y cymru yn 2023. I'm not received any apologies for today's meeting, but I've, on my website, the rest of us are in-person. The first item in our agenda is to decide whether to items 3, 4 and 5 in private are we agreed? Agenda item s3-4 Agenda item 2 is never in session on the Patient Safety Commissioner for Scotland Bill. Felly, er agonnyddu, rydyn ni'n fflaenwedd y reitio a bod yn gyd am y gwasanaeth hwnnw o'r perioedd y cysylltau o'i sicr o b banquetiol a'r gyferan ac yn gofynu y gyferan ac yn gofynu i'r gwaith sydd gweithio gwn nhw i gynllunio'n gyflugwll. Rydyn ni'n gweithio gweithio'n gyflugwll syddiadau, ac mae'r gym complain yn perif ychydig o'i gwaith i'r gyflugwll i'r gyflugwll i'r gyffreidau. The Bill Before Us proposed the creation of a Patients Safety Commissioner for Scotland, which will have a broader remick covering patient safety across all healthcare settings. The evidence that we hear today will be in relation to issues highlighted as part of the Cumberlidge review, but also in relation to the wider patient safety issues in Scotland. As such, some of the content of this meeting may be sensitive or potentially distressing The committee encourages anyone affected by any of the issues that are discussed today to seek support. In particular, breathing space is a free confidential service for people in Scotland who is able to provide a range of supports on its website. That is breathingspace, all one word, dot scott, or you can call 0883 85 87. If any of those attending today needs to take a break during the session, please just indicate that to me or my clerks and we will allow you to take that break. I want to welcome to the meeting Charlie Bethune from Valparate Scotland. Sodium Valparate has been a treatment for epilepsy since it was licensed in the 1970s. However, it has been known to carry a risk of birth defects if taken by women of childbearing age. We have Marie Lyon from the Association of Children Damaged by Hormone Pregnancy Tests. Plymouthos was a hormonal pregnancy test drug administered to women in the 1950s, the late 1970s, and it is associated with miscarriages and some birth defects. Fraser Morton was among a number of families who called for a public inquiry into infant deaths at Crosshouse Hospital Maternity Unit. Online joining us is Irene Oldfather from the Health and Social Care Alliance Scotland. We will be speaking from the perspective of her organisations that work with women affected by complications following transvaginal mesh surgery. Bill Wright from Hemophilia Scotland will be speaking from the perspective of those affected by the contaminated blood scandal, where a large number of people, most of whom had hemophilia, were affected by hepatitis C and HIV in the 1970s and 1980s. I want to thank you all for coming along. I know that some of you may be sharing personal experiences with the committee in relation to the bill, and it is greatly appreciated by us and instrumental to inform in our scrutiny. However, there is no pressure or expectation that you need to share any personal experiences as well. We are now going to move on to questions. I would like to ask all of you in the round the question specifically about the proposed establishment of a patient safety commissioner. First of all, what are your views on that establishment? Do you think that a patient safety commissioner would or could have made a difference for those that you represent or for you personally if it has affected you? As I say, I will go to Charlie first of all. People who have been affected by a Valprate would really think that a patient safety commissioner would be a fantastic improvement to what has happened. The Valprate was first prescribed in the 1970s, and the issues around Valprate were known about within a few years. It is something that has been going on now for almost 50 years and nobody listened. For years and years, the voices were just getting ignored by the medical provision, by the regulators, by everyone. Our view is that if there had been a patient safety commissioner at any point in the past 50 years, the time to get this resolved would have speeded up. However, the problem at the moment is that the issue is not resolved. We need the patient safety commissioner to finish the work that we as campaigners have been doing for the past however many years. We need the patient safety commissioner to help us, because we still get fobbed off. We still get told and there are still delays, and we still do not have the services that are required. We still have a situation where women are being prescribed. In England last year, there were 258 women who gave birth to children while they were prescribed sodium Valprate. That is another 110 children—40 per cent get significant impact from that—who will be needed to be cared for by the health system and the Government for the rest of their lives. In Scotland, we assume that that is 10 per cent is normally the Scottish proportion. It is a significant number of people who are still being affected by this drug, so we need to get it stopped. I was infected with hepatitis C in 1986. I now have liver cirrhosis. I am one of the lucky ones. I appeared in front of this committee over 20 years of the truth. Prior to that, we had served a petition—one of the first petitions in this Parliament in 1999—a petition PE-45 seeking a public inquiry. We were obstructed by Government in getting to the truth. It elected instead to have an internal investigation led by the then Deputy Chief Medical Officer. The Deputy Chief Medical Officer himself had come from a background in hematology and had used the very products in York Hill hospital that had infected many young children who then died. I have just come back from being in London the whole of last week when the closing submissions were made to the UK-infected blood inquiry led by Sir Brian Langstaff. The closing submissions were harrowing, just like the stories that you will hear from my colleagues here today. During the course of that inquiry, which is the biggest ever inquiry in Britain on any subject, during that four and a half years, there have been a further 104 people in Scotland who have died, largely because they have been infected by hepatitis C, but some were also infected with HIV. 104 is now 105 because I was at yet another funeral two weeks ago for someone who had a liver transplant and then went on to have a further tumour. During the intervening time, there was the internal investigation that I mentioned that was initially conducted or ordered by the then Health Minister, Susan Deacon. There was a question, and this is on record from the infected blood inquiry, from the then First Minister, Donald Dewar, that an open mind, in other words, an investigation might lead to an open checkbook. Susan Deacon's office responded in a handwritten note that it is only a PR exercise. That investigation was only a PR exercise. Despite the good efforts of your predecessors in this committee, who conducted their own inquiry and an inquiry led by Lord Ross, it then took another seven years until the now First Minister, Nicola Sturgeon, ordered the Penrose inquiry. The problem was that the Penrose inquiry did not look into the workings of government. However, in terms of reference of this inquiry, it has. If it is all sounding a bit raw—one of the stories that you are going to hear is—we have all waited a very long time to get to a point where something like a patient safety commissioner who might have championed our cause could have avoided all these many, many years of fighting, because one of the biggest, most important bits of evidence that has come out during the infected blood inquiry has been the compounding of harm. Everyone here and their families have suffered physical—there are physical elements to this, obviously, in terms of the physical harm. However, the fact that the obfuscation is not getting answers to questions and not having a champion is why we need this commissioner. Sorry, I have taken up your time. No, please do not apologise. We have asked you for your story and you have put that very powerfully. Mili, can I come to you? You can indeed, and I would definitely agree with both the people who have spoken to date. A patient safety commissioner is there to listen, to listen and to champion. Had there been available when Primeros was around in the 1960s and 70s, they would have had the authority to actually remove that drug from the market, make sure that it was safe before they actually put it back on if they were going to put it back on, and also make sure that there was enough of an investigation into the regulator at the time to make sure that they were doing the job that they were paid to do. Now, why is the PSD necessary? Well, simply because of the two people who have heard today, you've also got surgical mesh, which I know will be coming on. There was significant patient harm and there was no-one to speak for them. This actually resulted in unsafe care, which continued because there was nobody to actually say, well, actually, in 1916, what happened with Primeros? Should we actually be looking at the regulator? Well, the regulator today is still not fit for purpose and that's one of the biggest problems. One of the things that really concerned me was that unsafe care is believed to be within the top 10 leading causes of death resulting in 3 million deaths a year. The direct cost is estimated at around 13 per cent of healthcare and in Scotland that equates to £1.9 billion. It's a shocking amount, but that isn't even close to the devastating cost to the families affected. Compensation payments total £60.3 million in value and an unquantifiable level of distress to many families. Setting up an office of a PSD will not only improve safety for patients, but it makes financial sense. A proposed cost of only £644,000 per annum for the PSD is very, very, very much needed to make sure that this patient harm doesn't continue. The patient harm to our children could have been avoided if a commissioner had been appointed or a hormone pregnancy test would have been researched. Whereas what happened to us, the regulator, who was very close to the manufacturer when all the warnings came in, which they did from 1958—it was 1978 before they took those tablets off—in 1958, what they did was actually hid the evidence. We found it. They also destroyed evidence, and again, we found that. The regulator was supposed to look up to patients, actually looked after the drug company, wrote to the drug company and said, I found a five-to-two point of evidence that these abnormalities and deaths are caused by primidots. However, please don't worry because I've destroyed the records so no one can actually find out how I got to that conclusion. We then started a legal action in 1981. My daughter is 52, so I've been fighting for this for 52 years. That legal action we had to withdraw eventually, and the regulator had written to the manufacturer and said, because I'm a Government employee, I'm unable to appear in court. Would you please subpoena me? If you can subpoena me, I can then actually give evidence on your behalf against the patients. This is the kind of cover-up that we're looking at, not just with those, I'm sure, with everybody else. When you find that document and you know that in 1958, that would have saved thousands of babies. I have some pictures which will shock you, but I'm going to send them round because that will prove what the dreadful damage was. The other thing is we had a 97 per cent score that there was no congenital fault, so there was no abnormality within the genetic makeup of any of the families. The only common denominator was a neural hormone pregnancy test. With deaths, as you've just said now, we've actually lost four, seven of our young, for me young, 40 to 50-year-olds with the after effects of primidose just in the last months. We've lost 31 parents because, like me, we're all in our 70s now. They're still fighting or we're still fighting for their children because they're frightened of what care they will actually receive. I do have a list of some of the effects, which I won't go through now, but some of the things that these people need with 30 Scottish families who are desperate for support, but there's no one to talk to. There's no way that they can access the help that they need because they don't know where to go. Again, for me, the PSC has got to listen, and I'm sorry to say that the one in the UK is not listening. She is not meeting with patients. She's meeting with groups, so that has got to change. She needs to talk to the people who've had the experience, who are living with the experience today, as we are. Good morning. I've been in two minds about whether we need a patient's safety commission or not, mainly for the reason I don't believe he can vote on safety. I think it has to be woven through healthcare, and then I start to think about the scandals, the mesh scandal, the infected blood scandal, Ian Patterson, the surgeon, Professor Sam El Jamal and Tayside Mental Health Crisis, Vaila Leven, the dirty water infection patrol issues in Glasgow, and then you've got Gospot, Morecom Bay and Midstaffs, and although they occurred in England, the Royal College of Decisions of Edinburgh warned that repeating Scotland is a possibility. You've always got the recently, the Shrewsbury, Maternity Devs and the Nottingham Maternity Devs, and that I would, if you get an opportunity contrast, compare the Auckland report, where the report that Health Care Improvement Scotland carried out in 2017 in Ayrshire Maternity Devs. No, there's really a distinct difference, although I've done Morecom Bay. I was a wee bit surprised at the posity of that report, especially since our same order of time was actually on the Morecom Bay panel. I'm not sure, if I think you're in the situation, I'm not sure if the patient safety commissioner would be of any benefit. You know, we need to see how this evolves, just very briefly. You know, Lucas was categorised as a category three adverse event, that's a near miss. He was designated Stalborn, which denied the fiscal opportunity to proceed to a fatal accident inquiry, because he was denied a legal identity. There's doubts, serious doubts over where he was Stalborn, I can get to that later. The cause of death on his original death certificate, we got through, had to go through that process twice, was unknown, and also the death, Lucy's death was not reported to the Scottish Fatalities Investigation Unit, and that non-reporting is widespread, and I believe it's a deliberate attempt to evade exterms scrutiny and justice. Really bothered me that, I sent a FOI into the Crown Office several years ago, and I asked to routinely collate, monitor, audit and review the deaths reported to the In Beaches of Scotland's territorial health boards to identify any trends or patterns of concern, and the answer was no, which flies in the face of the recommendations from the Shipment Inquiry, and by a long way for that. And just, obviously, to pick up with Bausain, you know, all these issues, all these problems, having to fight for years, that actually compounds her grief, it makes it last longer, will never leave you, you know, that's, Lucy's dying, the actual way we were treated after it was, if the bit is bad it was losing, you know, it did compound things. And again, I'm not sure if the Patient Safety Commissioner would hold the health board to account on the issues, even what I just mentioned there, that's just a few of many issues being countered over the last few years. Thank you, Fraser, thanks for telling us that. I'm going to go to Irene Oldfather, who's joining us online to talk about the mesh survivors. Irene. Good morning, convener, and thank you so much for inviting us along and giving us that opportunity today to speak on behalf of both mesh women in relation to their experiences, and also we did hold an engagement event with our wide membership of people with long-term health conditions around the issue of a patient safety commissioner. So, the comments that I make today reflect those two key groups and the work that we do at the Health and Social Care Alliance. I've got some specific comments about parts of the bill, convener, but I think I'll just start with some general remarks. I mean, as the committee will know, the Alliance undertook work with women injured by mesh implants, and we have two reports in relation to that, which chart the women's views and experiences. And if you're content, convener, I'll lodge those two reports with the clerk for the information of members and deliberating around the work of the commissioner. In actual fact, if we look at what really happened in relation to the experiences of women, the complications that they experienced by far, the majority of women experienced complications immediately. The second highest group in relation to experience was within the first two years, and if you combine that, that makes up almost all women who experienced mesh injuries did so, either immediately or within the first two years. The catalogue of experiences that they have is around not being listened to, and when we analysed what they told us, we saw a very clear impact on physical health, but also on mental health, on family and partner relationships, on finances. If I can bring a quote from one of the women into the room, because I think it's really important that we capture those very personal experiences, and she told us, I have lost and mourn the person that I was. I absolutely loath the person that I have become. If it wasn't for my husband, my children and my grandchildren, I would absolutely, without a doubt, have taken my own life by now. That is by no means, convener, an isolated quote. It runs through often and frequently to different degrees. What we heard about the frustration from mesh injured women themselves. I think to say that they felt not listened to is an understatement. They were buying their head against brick walls. For me and for the Alliance, I think that a patient safety commissioner and the role that that office could have around data and trends, I hope, would offer that safety net to other people who experience some sort of patient safety issue, because there would be some way of picking up trends. Clearly, there were many women not just across Scotland but across the world who were experiencing similar complications. Most of them were about pain and urinary problems, and yet we weren't picking up somehow that that related to what had immediately happened to them in very recent times. That was mesh implantation. For us, we are very supportive of a patient safety commissioner. We feel that safety lies at the heart of delivering our health services, that we have to be able to instill in our communities, in our citizens a confidence and a trust in the NHS, but they are not going to go to the NHS and end up in the situation that many of those women have found themselves leading lives around disability and sometimes even further and more serious health problems. For us, a patient safety commissioner would allow us, we would hope, to identify trends and to collect data early on. We believe that that is saving lives. At a practical point, saving compensation problems for the NHS, but for us, the issue of saving lives is just so important. We see the opportunities around the patient safety commissioner and, certainly, that is supported by a membership as a way of addressing some of the imbalance that currently sits within the system, where, often, professionals are seen as being in charge. We know that, with realistic medicine and everything else, we need to start to listen to the experiences of people themselves. I have some more detailed comments around parts of the bill, convener, but perhaps you would like me to wait. We will probably come to that. I just wanted to give everyone the opportunity to put down how a patient safety commissioner, with other general thoughts on it and their particular history, is well in relation to that. I will pass on to my colleagues now, who have a number of questions. Emma Harper. I am interested to know about what your thoughts are for the patient safety commissioner in Scotland, having a wider remit than what has been implemented in England, for instance, so wider than mesh and wider than sodium valprate and primidors. I am interested to hear what your thoughts are about whether the patient safety commissioner should have a wider remit in Scotland. I am not sure if you want to direct that to anyone in particular. Obviously, some individuals for whom it was not medical, it was not drugs, it was not devices, so maybe if we go to Bill and to Fraser and then to Irene initially for this, because I guess that is the widening of the remit, it would include your situation. I hope, convener, that you will understand from my first remarks, having fought for 25 years on the question of blood and blood products, why we feel so strongly about this. If it might be so bold, convener, actually the number of people infected with hepatitis C in particular was actually mainly through blood transfusion rather than hemophilia. It is just a simple blood transfusion that any of you might have experienced. I think that it is important to understand that blood and infections for us are very close to home. In some ways, it is a wee bit of an accident that the original proposal from the Cumberlidge review was on medicines and medical devices, because they were asked to look at primidos, valparate and mesh. If, for example, a Baroness Cumberlidge had not been asked to look at mesh but to look at valparate, primidos and blood, that would not seem fair to those with mesh. We pressed the Scottish Government to have a wider remit. We think that it is the wide, absolutely correct remit, because the experience of those who might—there may be something that comes out from left field—who knows. The whole point is to look ahead at what might happen. I would suggest that if someone gets infected in a hospital, not from medicines and medical devices, then why shouldn't they have the same services as someone who has had a pharmaceutical that went wrong? Speaking to patient safety campaigners and families in England that I have got to know over the years, they believe that the restriction in the patient safety commissioner in England is wrong and I tend to agree with them. I said earlier that I was unsure about having a patient safety commissioner. That relates more to what powers have gone half. That is yet to be decided, but the current situation is that the media in Scotland is currently, by default, our healthcare regulator. We do not have a healthcare regulator. There is also the patient safety commissioner and a family advocate rolled into one. I do believe that the patient safety commissioner needs a broad scope. Thank you. That is certainly Baroness Cumberlatch who agreed with that last week. Charlie? From the Valprate perspective, everybody wants their own condition to be addressed and whatnot, but, as a group, the key thing that we see about the patient safety commissioner is that we do not want this kind of thing to happen to other people in the future. We are not precious about this. We want the patient safety commissioner to look at the issues that are standing at the moment, but to be able to look at whatever patient safety concerns that are that come up in the future. We do not have a crystal ball to see what is in the future. I do not think that we should be restricting the scope of the commissioner in any way. I am also thinking about what you were saying earlier. I have written notes, listened, advocated champions, and, in my head, I am thinking about risk assessment and risk management. I am being heard. That is something that I do not know if that has been missing in the past. I think that Fraser was something that might have been new experience as well. In looking at the Health Improvement Scotland website, one of the first things that it says is that the affected person receives the same high-quality response. Organisations are open, honest and supportive to the affected person. I apologise for any harm that occurred. That information was an update to the adverse events that had happened previously. I am also interested in hearing your experience with interacting with the current systems of scrutiny and clinical governance. Where do you think that the gaps and weaknesses in the current systems are, and how will the patient safety commissioner help to fill in those gaps? Maybe Fraser would want to come in on that one. I appeared at this committee before Emma. I do not know if you were on it at the time. I think it was in 2018, and it was to give evidence on clinical governance. In preparation for today, I just printed off my 2018 notes because one may have further followed. If you look at the current systems of scrutiny and governance, I have just got to be listed. In 2008, the Scottish patient safety partnership was launched. One of its three core components is the Scottish patient safety learning system, and NHS Ersin Arran was one of its four original test sites for roll-out. Fast-forward to 2012, a whistleblower claimed that avoidable tests were being covered up in Ersin Arran, and the then health secretary, Nicola Sturgeon, ordered a review. In 2013, a follow-up report by HIS gave him a clean ball of health. That consisted of an analysis of evidence provided by the NHS Board. In 2013-14, another kind of surveys, management of adverse event reports for all the remaining NHS boards in Scotland. There was further progress meetings in 2014-15. Again, there were two summary reports on progress in November 2014 and in May 2016. In 2015, that is when we lost Lucas and NHS Ersin Arran. They listed his death as unknown and a near miss. It was only falling on adverse media publicity after a year of frustration. They wanted to know that Shona Robison instructed Healthcare Improvement Scotland to undertake an independent review on the Ersin Maternity Unit. If we fast-forward to Jeane Freeman's tenure 2019, Jeane wrote to Healthcare Improvement Scotland and asked him to bring a more consistent approach, stating that we have one NHS in Scotland and expect now to see greater consistency. In September 2019, the NHS Board published a self-evaluation document. Up to January 2022, there was a follow-up report that says that adverse events notification system update reports that significant work is required on the national reporting system for patient safety incidents. We are almost 15 years away from the creation of the self-proclaimed world's leading Scottish patient safety partnership, and I do not believe that things have improved. I agree with my colleagues that we would be looking for the widest possible scope that the commissioner can have in order to future-proof against events that we might not know about or situations that we might not know about at this point in time, but we would not want to see a replication of the situation around bodies that we have heard today or mesh-injured women. As an organisation, we have noted in our response to you, commissioner, convener, that there is no mention of human rights within the bill. For us, we believe that patient safety is a global health priority, and it is a fundamental component of how we strengthen and ensure trust in healthcare systems. If we are committed to and believe, and as we are in Scotland, sustainable development goals are then gentle to the delivery of those sustainable development goals as patient safety. We have to ensure that quality services are therefore delivered. For us, an approach that would encompass equalities and human rights for all citizens in Scotland is something that we would like to see built into the actual architecture of the bill itself. We would welcome explicit reference within the bill to the rights of people who are accessing healthcare services. In relation to the gaps, I feel a little bit—this is just working over 10 years with people across the whole sector of lifelong health conditions—that there are gaps in the system and that the system is a bit siloed. I think that there is something about the patient safety commissioner having a role but not allowing other parts of the system to abdicate responsibility. I think that there should be a package around this that ensures that, where there is responsibility in other bits of the system, like the health boards, for example, and the seers, the adverse incidents, the duty of candor and so on, that we take a really tough approach to that and that maybe the patient safety commissioner has a role in ensuring that we have a much more joined-up system that is responsive to the individual needs and respects the human rights of citizens across Scotland. Thank you. I am going to bring in some colleagues who are off the back of Emma's question. Colleagues, can I say that I would like you to direct your questions to individuals, but our panellists, if you want to come in, just let me know and I'll bring you in if you've got something to add because we have a lot of people that I want to ask questions. Thank you very much, convener, and thank you to everybody for being here today. It is hugely appreciated and very, very important. A question really for Irene, based on what she's just been saying there, and we've heard today in her evidence already about how people are not listened to. I think that we've heard that from everyone, that people need answers to questions when it is to ensure that there are investigations, and it's all about saving lives and saving trauma to people. The commissioner would largely define their own role, and I'm wondering if you're talking about having as wide a scope as possible, including equalities and human rights. I'm wondering, Irene, if some people could be looking at that and thinking that that might be quite overwhelming, but is there that idea that it can maybe pull together everything that is already happening there as well? I was just wondering if there are any specific recommendations, is there anything missing from the bill, or is there any comment that you've got on that pulling everything together? I could say in the first year of the commissioner's role there could be a danger of becoming overwhelmed. I don't think that the commissioner should look at individual cases, particularly in that first year, but I think that there should be a lot of work around gathering data and trends. Of course, the role of the advisory group will be absolutely crucial, and I'll maybe come back to that in a minute. However, there are parts of the system that, to be honest today, do not function very well. Certainly in relation to the message of women, I've really let women down. I don't think that it should be the commissioner's job to take on responsibility for all parts of the system. We have to be working, and we have to make them accountable. I was involved with David Strang in hearing the voices of people with lived experience in relation to mental health services in Tayside. Again, I felt that in some ways we let people off the hook too easily. There has to be accountability within the present systems, and I feel that there is still a little bit of that lacking. We need to make sure that this is a whole package. The commissioner has roles and responsibilities, and one of the things that I think is really important is that we make those roles and responsibilities very clear and that there is a communication programme around them. I know that in the evidence session that we held ourselves and spoke to women and others about the role of a patient safety commissioner, some people did feel that they should deal with individual complaints. I think that, at least in the first year or two, we should look at the wider system issues, but that should not allow people who really have a responsibility within the boards and in other parts of the system to respond individually to people's complaints. We have to hold them to account and we have to hold feet to the fire. I feel very strongly about that, and the current system is very fractured, it is very siloed. It is not working together and connecting for the benefit of people. We have to correct the problems in the present system and then add the patient commissioner on to that as something that hopefully can look across the case and join things a little bit together. I have got some views on the advisory group, convener. I do not know if you would like me or Ms Callaghan. I do not know if you would like me to make those at this point and I will come back to them later. I will come to Paul Sweeney after this. We are very pleased to note that the advisory group should have people with lived experience on it and that there is a proposal around expenses and remuneration. We feel very strongly that that should not just be a tech box exercise and that it should not, at the end of the day, just come down to expenses because in order to give this the gravity and the impetus that it needs, we believe that people should be paid for the work that they do and that just because they have lived experience should not mean that they only get expenses, so that is something that we would want to emphasise. Section 16, 4C mentions people who appear to the commission We felt that working with a little bit wooly and we thought that that could be strengthened. It is not about appearing, it is about demonstrating, so people who demonstrate a commitment and we wonder if the committee might consider that, convener, as an amendment to the legislation. In that advisory panel, we would welcome protected characteristics and, in particular, women to be represented because, clearly, women felt that they were not listened to in the system. I think that it is really important that there is sufficient protection to ensure that there is a strong voice for women in the advisory group. The final point is that there is mention within the bill of providing a strategic plan and ensuring that that is consulted upon. Again, we would suggest going a little bit further than that and maybe co-producing it with people who have experienced patient safety issues across the piece. My main question is about the accountability of the commission. I know that Mr Wright made a powerful point earlier about the role of the executive in denying recourse or appropriate investigations. The bill is introduced and proposed that the commission will be independent of the Scottish Government executive branch and the national health service, and that it is accountable to this Parliament as a democratic body. Do you agree with that proposal and for what reasons might you agree with that? I would probably direct that to Mr Wright in the first instance. You might not be surprised to say that I strongly agree with it, because any progress that was certainly made in the early years of this Parliament was thanks to the efforts of your predecessors on this health committee. Given that the report from the PSC will come to Parliament, it will probably end up in your doorstep, and I think that that would be entirely appropriate. Many of the faces are new to me because I used to be very familiar with them in the early days when we were pressing on this issue. However, it is vital that it is independent of Government, because the problem was in the early days that it was the Government that had its hands all over this issue. By being independent—and there is an issue about funding there, of course—the funding would, of course, come from Government, and therefore that potentially limits power. On governance, because who you report to is part of your governance, could I maybe just return to that question? What is absolutely vital here? You asked a question about being listened to. Being listened to in governance is not too separate issues, because it comes down to the access to information. I would suggest that one of the problems is medical records. One of the biggest problems is that patients still, even now, have to struggle to get access to their medical records. In our submission to the Infective Blood Inquiry, one of the points that we made is that you, in this day and age, should be able to get your medical records through electronic means. I can get my bank account or my phone every transaction, and yet we live in a situation where you have to ask—I have a hospital appointment tomorrow and I'll say, can you send me a letter, whether I get it? It may be debatable. It's such starting points in terms of the access to medical records to then bring the issues to those who are governing the situation and empowering the situation that really matters. I would like to bring in other members. Sorry, I'm having to curtail a wee bit of question. I'll bring you back in later, Paul, but Evelyn has a question on this. I've just reminded people that we're halfway through our session with everyone. I'd like to give most of the time to the panellists to speak, so, Evelyn. My question is to Fraser. It's just a follow-up and a couple of the comments that you've made. Thank you for sharing your family's experience. That was really powerful. I'm interested in what you've said about the powers that the commissioner would have or not have. If the commissioner had been in place at the time of your case, what would you have been looking from for the commissioner? What would have made you feel listened to, supported, and how might that have taken your case forward to your satisfaction? We'll just pick up on the point about the commissioner not taking on individual cases. That is the current case with Healthcare Improvement Scotland. They don't take up individual cases because I contacted them at the time. I also don't believe Healthcare Improvement Scotland is a patient safety regulator. They're a quality assurance body. Their whole ethos approach is based on TQM, total quality management, no things for industry, high volume output, and I think they conflate quality by safety. Where would we go if there was a patient safety commissioner at that time? I would like to think because I've already put a look through her post mortem to finally get his cause of death, his perinatal hypoxia at birth. I'd like to think that we could avoid that. I'd like to think that we could hopefully avoid a review that was edited by NHS Ayrsyn Arran's medical director. One of the many findings in the review is that the review team acknowledged the complexity of managing a system of learning and improvement from adverse events but also expected material progress to have been made since the previous failings were initially identified by 2012. That's from 2017. The Scottish patient safety partnerships 2008, so there's no material progress at all. To be honest, I'm really not sure. To be honest, in terms of the powers or proposed powers of the patient safety commissioner, I believe our former health secretary, Jim Freeman, is on record claiming that the health and safety executive are the default regulator for healthcare in Scotland. I would ask you to look into the powers of a health and safety inspector, section 20, the Health and Safety Work Act, and you'll see what's been proposed for the commissioner followed far shorter at it. In terms of where we wanted to go, I wanted to go for... Well, the fiscal wanted to proceed with a failed accident inquiry. I was wanting to go for a prosecution under health and safety legislation. Now, Ayrsyn Arran, I believe, preceding Lucas, were prosecuted twice on ligature points, I believe, in the mental health unit. There was 26 members of staff short in that maternity unit. They failed to learn the lessons through 2012, so a lot of people think it's just a maternity issue, and because of the narrow scope in terms of reference, it focused on maternity. But the adverse event framework for the whole hospital wasn't applied correctly, and that meant that various departments, and it still puzzles me to restay why there wasn't at all through every department to see if anyone slipped through the net. But that's where I'd like to go, and I don't believe that's what I'm going to be in the commissioner's remit. But the strange situation is, I pushed the Crown Office for a prosecution under health and safety legislation. Lucas' designation of Stalburn removed his legal identity, but you don't need to have a legal identity to get a prosecution under health and safety legislation. But they came back to me and said, because Lucas' death was due to failings in clinical governance, it was outwith their remit. I've got a letter from the CEO and medical director at the time, my version, Aaron, saying that they have complete faith in the clinical governance in the maternity unit. So these two dimensionally opposed opinions remain unresolved to this day. We move on to questions around monitoring and information gathering, which has been mentioned already very briefly, but from Paul O'Kee and Paul. Very much, convener, and good morning to the panel. Thank you for this very important testimony this morning. I suppose that I really just want to expand on how we might use the safety commissioner in terms of understanding emerging themes and patterns that might actually be able to prevent some of the issues that we are discussing. My first question is really around to what extent do witnesses consider that their own experiences are rooted in that failure to pick up on early signals of adverse outcomes. I think that we've heard some of that already, so I suppose that the follow-on to that is what confidence would witnesses have that the patient safety commissioner could improve the capacity to actually pick up on early signs of adverse outcomes. I wonder if, maybe Fraser, Mary, wants to comment on that. So what's Mary first? It's quite difficult to answer that, because with our story being historical, I can only look at what would have happened with us, and the pattern would have been identified very quickly. If the patient safety commissioner did what she hopefully or he hopefully will do, which is to speak to patients, I agree that they cannot solve any of the issues that arise, but they can actually monitor, they can actually share that information, and that then would have meant that this would have been picked up far earlier. I think in relation to the current situations as well with the other panel members, once there are issues that are identified, there then should be consequences, and I think that the big problem has always been that they've been identified. As Fraser's just said, there have been so many people looked at these things, a report has been produced and nothing happens, so for someone to actually collect that information, look at all the reports, understand it isn't an isolated incident, nothing has been done to actually solve it, and that then leaves the door open for further harm in other areas. I do think that the remit should be extended apart from the three campaign groups, however I think the reason that the three campaign groups originally were cited was literally to kind of get the patient safety commissioner to to be able to show that they could resolve some of the issues very quickly in something that was quite high profile. However, as I've already said with the UK, the patient safety commissioner, that's not happening, so my confidence isn't particularly high that this will happen unless those conversations continue. Can I bring in Charlie, who wanted to come in? Over the years, one of the concerns that we've had is that a lot of what's happened in the past has been people marking their own homework and making available information that they want to give to the other side, and it's been a massive struggle on Valprate, certainly, and I know on the other areas, in getting access to the information. Even now, we have a situation where the information is not always available when you would think that, given that with Valprate it's been in the political sphere for quite a number of years now, and still we can't actually say how many people are affected by Valprate in Scotland, it's estimated that there are 2,000. We can say exactly how many people were affected by this 50 in Scotland. We know that with Valprate there's around about 2,000, but the problem is there's no statistics, there's no expertise in Scotland. We had to take our daughter to Manchester to get a diagnosis because there was nobody in Scotland that could give a proper diagnosis. With that diagnosis you can't get the proper services and care and support that you need. There are hundreds of people in Scotland who have suffered from Valprate who perhaps don't even know that at the moment and are getting treated and given the wrong support. Some of our members only discovered that their children were affected by Valprate when they were in their 20s. I'm sure that the doctors must have known, but they didn't expose that or tell them that they were just fobbed off with things. It's absolutely essential that the patient commissioner is independent so there's no mark in their own home. One of the things that people have been talking about is what powers the commissioner should have. Actually sitting here today thinking, one of the powers that would be really good would be to actually instruct people to collect the right data because often we get told, oh sorry, we don't have that information. How many pregnant women were prescribed Valprate in the last few years? Well, I think that they are collecting it now because we've been pushing it, but they weren't able to tell us that when we started having the discussions with the Scottish health agencies only a year or so ago. Can I bring in Fraser and then I'll move on to another colleague's questions? Just picking up on Charlie's point, I'm marking her own homework. I believe that was the finding of the OECD in the current situation, scrutiny situation in Scotland, from 2016 and I believe that they recommended that healthcare improvement Scotland is split into two separate departments and there's been no work done in that. In terms of trend analysis and data, during Covid, I got most of my news and made me use, got it from the same source, an app called Traveling Tabby. I was really impressed with what one student could do with a laptop and I think it was sometime in 2018 when we met with Gene Freeman and I asked Gene if it would be possible to establish a real time, there's always a lag, but it's nearest possible a real time safety dashboard. This we did active intervention to prevent deaths rather than a reactive approach and Gene replied we're a long way from that and we're just as far away as we were in 2018. I think back to the data, having the real time data would possibly point us towards a proactive report rather than reactive and I also believe, I think it was sometime maybe 2017 when I was watching this committee online, I think it was Donald Cameron and I asked possibly Robbie Pearson from Healthcare Improvement Scotland if he could provide any examples of Healthcare Improvement Scotland intervening proactively and of their own volition and I believe his response, if it was Robbie, I believe the response was the intervene at some hospital but it was based on the hospital standardised mortality ratio for counting bodies before we react for counting deaths if they're above the upper, no the upper limits. In terms of the commission on the bill, it's don't make for new deaths scandals to emerge well for the past or you're doomed to repeat it and I believe in a provision in section two or four, the bill was proposed that allows the commissioner to learn from the past so I take the point that possibly or initially he or she doesn't take up the individual cases but that doesn't mean they can learn from. Okay, thank you. Now move on to the commissioner's appointment process and questions. I've got three colleagues down for this starting off with David Torrance. Thank you, convener, and good morning to witnesses. Questions aimed at you, Bill, first considering your answer on the independence of the commissioner. Do you think the bill, as it is in its form, will actually allow that the commissioner to be independent? Well, to that extent, that really depends on you guys with the greatest respect because given that the commissioner would report to Parliament and one wouldn't expect you know it to be, it may be noted at First Minister's questions but it wouldn't actually take up a great deal of time in the debating chamber. Nevertheless, the annual report, I would anticipate hope and pray would be from the commissioner, time would be devoted to that within your business plan for the year. I think that that's vital that once this bill has passed it's really important that there's follow-up on this. We rely on you to ensure and successive health committees to ensure that that happens and also perhaps where there are issues arising that perhaps you invite us back in order to say whether or not we think that the BSc is doing their job properly. I know we're tight for time so I'll ask Bill this question but I'm sure other members will have views on it as well. Bill, do you think people with lived experience should play a part in the recruitment process for the commissioner? Oh boy. Well that's a tricky issue because I think the experience we've all had is that we try, I'm always wary of using the word represent as the chair of a charity for people with hemophilia. We seek to support people and not everyone with hemophilia is a member of hemophilia Scotland or everyone who's got infected blood is a member of either hemophilia Scotland or the Scottish Infected Blood Forum. I'm not suggesting those of you who've had to stand for election would necessarily be in a position, I mean there may have to be some sort of application process. I'm just thinking you need to have an application process for the panel that was then going to receive the applications from the prospective patient safety commissioner. It's a very tricky issue because it relates also to the advisory group supporting the patient safety commissioner in terms of, I think the issue that I would find is amongst my community Charlie and Mary would be the same as well. Why is it them rather than someone else who's actually on this particular advisory group? Because we actually did that with the UK patient safety commissioner, we were asked as a panel members' widow of experience to actually do a pre-assessment of the candidates which we did virtually. Those candidates, we then fed back what we felt in relation to these trends and weaknesses of each and what their position was. They then were, all those feedbacks were sent to the panel, Julie Cumbillage, I don't know who was on that, the eventual panel and they then made the decision but we were allowed to actually look at the candidates, give the feedback, I'm not sure how helpful it was but it did actually give us a sense as well of the quality and we were disappointed to a man, to the whole panel, we were disappointed in the quality of the candidates that were put forward and one of those candidates was eventually appointed. Although we were there, I wouldn't say we really made much of a difference because we did feed that back. Can I bring in Aileen quickly? Aileen has to leave after this so I'm going to bring in Aileen and I'll come to you, Charlie. Aileen. Thanks so much, convener. Just a few brief points on independence and your future role and how we future proof and I don't think we should underestimate the role of Parliament and your own committee and, as others have said, I think the role of Parliament is crucial and I've had many discussions with previous ombudsmen including the commissioner for older people in Wales and various commissioners and inevitably once they're in the role for a little while they see things that they would like to change themselves. I mean the present SPSO added whistleblowing to our role and I think there should be an opportunity one or two years into the role for the commissioner themselves to be able to review and say that this bit is working really well but that bit I could do with a little bit more scrutiny powers in relation to that and I hope that's a very co-operative and constructive relationship that I think could develop with Parliament through annual reports and so on, could really produce an on-going audit monitor and review because I do think it is really important because things change and people have different approaches to the role. I've said earlier about the advisory group and I think that's really important and how we ensure that that's a constant sounding board and kind of audit monitor and support to the commissioner and also working very much I would say working very much in partnership with Parliament and you know I'm a wee bit biased here I suppose but you know members of the Scottish Parliament continually hear through their constituency casework about issues that are being raised and you know that they want further attention to be given to so I think there's a very potential constructive relationship that could be built there but I do think we need to ensure that there is some sort of opportunity for audit monitor and review within the system. Thanks so much, convener. I'm afraid I have to go now but it's been very interesting listening. Very quickly it was just to say the key thing about the appointment is that the patient groups have got to have confidence in the person and that's both at the appointment stage and afterwards so you know we need to make sure that there's a mechanism by which if we lose confidence in the patient safety commissioner for whatever reason that there's some way in which they can be removed or replaced or whatever because you know we couldn't we couldn't envisage a situation where somebody gets appointed and they don't do the job and they're biased or doing all the kind of things that we're trying to fight against and there's no way of sorting that out. Paul Sweeney, you have a follow-up question on this. Thank you, convener. I think it's just really about how could the bill be strengthened in terms of accountability of the bodies to the recommendations of the commissioner, you know, what kind of, is there a specific measure you might like to see, like the ability to levy fines against health boards, for example, or is there any powers that we could implement, what could the Parliament potentially do in addition to backing up the commissioner's recommendations to hold public bodies to the account, is there any specific measures? That's one of the first things. There could be accountability in consequences and people up to now have tended to, as everyone said, get away with it. So there's never been accountability, there's never been a consequence and there needs to be a mandate for the patient safety commissioner to actually implement those kinds of actions because it's no use saying we will learn because they don't learn and I have the same experience with the market of their own homework because the MHRA did the inquiry, the initial inquiry for us and that was into the commission, the commission on safety of medicines who were the initial MHRA. So, you know, it's like the police, again, you know, investigated their own officers. So the patient safety commissioner has got to have an independent mandate to actually say, this has not happened, this is the consequence and this is the action that we're going to take and that person should then basically be named and shamed. Thank you. Can I move on to, I think, Tess, you want to ask some questions on more recommendations? Thank you, convener. My questions to Fraser, if I may, Fraser. You've talked through today, talked us through about follow-up in Towards Action and you raised concerns in your submission to the committee that no person or organisation would be compelled to accept or implement a recommendation. So based on your experience, how likely do you think that a recommendation would not be implemented by a public body? That's the first question. With your experience, what specific ways would you like to see so that the powers of the PSC are strengthened to enforce their recommendations? If I just back up, I mean, obviously we're talking about data analysis earlier and what data is useless unless it's transformed into information and information then becomes useless when it's issued in the form of recommendations. The trouble with recommendations is their recommendations. In terms of just picking up what Paul said about what powers, the powers, the statutory powers already exist, but they're just held by the health and safety executive. They can put in enforcement orders, they can issue fines, they could take your liberty away in a serious incident. And if I go back to the inexperience, Lucas died in 2015. I've got a pile of action plans, a death similar to Lucas, which they failed to learn from. Going back to the system we've got in Scotland, health, care improvement Scotland and the Scottish patient safety programme. People go away, they must be training, SPSP training, and they come out their fellows and they've got cohorts and they put that after their titles. NHS Ayrsharnarn was a wash with fellows and cohorts for the Scottish patient safety programme, but not one of them, even the ones in the department, picked up that it was operating the 26 member of staffs short. In terms of enforcement and recommendation, I'm quite clear on that. It's got to be statutory powers. The Cymru review had a set of recommendations, and the Scottish Government committed to implement all of those, and we're three years down track, and the only one that, while two have been implemented, one was an apology, which is worth nothing, really. The second one is the patient safety commissioner. There is a whole set of other recommendations that have gone nowhere, and I think it's absolutely clear that it needs to be more than recommendations, so there's got to be some kind of way in which things can be made to happen. Now, we have talked about individual complaints throughout this session, but Gillian Mackay has got some additional questions. Thank you, convener, and good morning to the panel. In particular, do the witnesses agree with the view of Baroness Cumberlidge that giving a patient safety commissioner responsibility for handling individual cases would make it less effective in addressing wider systemic issues related to patient safety, and if not, why? Can I maybe go to the bill first? Well, this is a section of the bill where a haem adudes, because haemophilia is, if it makes sense, the most common of the rare diseases, and someone with a very rare disease may nevertheless suffer because of a systematic breakdown. The question that I have is at what point does one individual, two individuals, three individuals become a group of people where there is an apparent systematic problem? The other element of this that I think is really difficult and has been alluded to by colleagues is if you've had a problem because your son has been infected, harmed, killed even, where do you go? Do you go to that health board who themselves, through the health board complaints process, because that's the initial step, the very health board who will immediately be going to their lawyers, to their lawyers, a culture of defensiveness, not reflection? We've just had a series of apologies that we've waited 20-odd years for at the Infected Blood Inquiry. Finally, those apologies meant something, because they said, we apologise because we didn't do XYZ over a period of time, we were wrong, we regret it, we apologise. The culture in the health service of defensiveness needs to be changed, and that's where I have a doubt here, because if you take social care, for example, somebody's got a complaint about an elderly person in a care home or a care service, they go to the care inspectorate and that is fully dealt with in confidence, completely independent of the health, of the social care provider. So, you then go to Hiss, we've heard about Hiss earlier, who in Scotland is on the street has ever heard of Hiss? And that's why this patient safety commissioner needs to be set up there as the first point of call, not the last. That's really useful, thank you. Obviously you've all had through the groups that you're associated with similar, but varying experiences at the same time, if that makes sense, there's some common themes coming out. In each of your views, how could the patient safety commissioner effectively listen to and promote the voice of patients and wider campaigns such as yourself if it doesn't take on individual cases and complaints? It doesn't need to take on individual cases to solve them. I think this is the misconception. Individual cases should be looked at, there should be reviewed, there should be noted, there should be documented, and that then can form a pattern. She won't have time to actually solve each one, and neither should he. I keep saying she is because we've got a female on it in the UK. But it is perfectly right that she should be the first point of call for someone to be able to speak to, she should be listened, they should listen to what that person says, but the actual solving of the problem would be difficult. However, it doesn't stop that from them becoming a wider net, if you like, that they're controlled to find out if it happened to anybody else, has it been documented, has it been followed up, and it's the following up sometimes because all these things are said, they are listened to, but does anything happen to them afterwards? So it's the actions that are important for me, that someone actually does something, but also lets you know because it goes into a black hole, you never know what's happened to it, so there needs to be that accountability that we've listened, this is what we've taken from it, we're actually going to see if there's anybody else in the same position, and this is what we've done, and that's the step that's missing for me every time, what someone has actually done about it. And finally, convener, if I can, in term, obviously, these have been traumatic experiences for you all, what support would you like to see sit alongside a patient safety commissioner to support either groups or individuals when they do take these cases? Because, as you said, sometimes not hearing things, not hearing back, not getting that resolution to a case, can further compound the trauma that has come as part of a mistake or whatever else has happened to get that person to the patient safety commissioner. So, I wondered if any of you had any reflections from your experiences or the campaigns that you're part of? I think that it has been the case that, certainly in our experience, there's been very little support other than the support that the patients themselves have generated themselves, and certainly one of the things that we're looking for in terms of Valpray is actually implementation of the other Cymberlage recommendations, which are about specialist support and services to resolve that issue. But in terms of, in Barnas Cymberlage's session last week, there was a bit of conversation about the actual resources that were required. And actually, when you start thinking about how individual cases are going to have to be dealt with by the commissioner, there are a whole host of things that will spin off from that. We talk about the data and the importance of access to the data and looking at the trends and all that kind of things. But when you see what the actual recommendations and the actions are that come out of a particular investigation or whatever, then there's going to be a whole host of things with implications that are on that. And we would hope that the health boards and trusts and things get on board with supporting the patient safety commissioner. We would hope that everybody wants to make patient safety a priority in Scotland and not see this as somebody who's coming here to wield a big stick in whatever. This is about improving things for Scotland. And it's going to have ripples right down the whole set of things, right down to the patients and for everyone in between. So it should be a massive thing if this works and is effective. Fraser, I think you want to kind of genticate to me. I just did pick up in a couple of points and I'll address them all quickly about the appointment of the patient safety commissioner. Two of the most significant pieces of work in patient safety in the UK has been the Francis Inquiry and the Shipping Inquiry. So I would like to see the patient safety commissioner come from a legal background. Also believe it's no the role for an individual. If that individual is from a legal background, they need a team with a specific skillset suited to healthcare working with them. I've just looked at the ball that was proposed and failure to supply required information seems to have an escalation where the commissioner may report the matter to the court of session, but there's no such escalation process if they fail to implement the recommendations. And I also see that protection from actions of definition in point 18, it's like any statement made to commissioner that has absolute privilege. Any statement in the commissioner's report on investigation has absolute privilege, but appears any other statement made by the commissioner has qualified privilege. I would like that to be, you know, I don't know why that's watered down, I'd like that to see that absolute privilege. And I would also like to see that extended to the Scottish Parliament. I want to hear people's opinions before I falter. Thank you. Yes. Can I come in on this? During the last four and a half years of the Infected Blood Inquiry in relation to your point about support, the Red Cross were there every day with qualified people to actually support individuals who are going through having to relive very harrowing stories. And we've been successful in appointing specialist psychologists to support both those with hemophilia, but also those who have experienced infected blood. And I mean, that's been a welcome move in the part of the Scottish Government, but it took a hell of a long time in both cases to get those psychologists. And I think that, you know, we've all had different experiences due to the different circumstances, and it needs to be someone, not just a GP referral in terms of psychologists, but it actually needs to be someone who understands the issue. And if I go back to the actual patient safety commissioner here in terms of support, it needs to be someone of a character in terms of leadership and the clout that actually makes people feel that this is someone, this man or woman is our friend, and their staff are our friend against this system that we've constantly had to fight, backed by lawyers. Can I just, I will take a very small time, but this is an actual Scottish member and she has paid 2,000 for a special bed because she couldn't get anyone to step up. She's had to have a new hub and accessible smart oven because she has a wheelchair that has to go under it. She's paid for that herself. She's had to have a second amputation of her leg and she needs a second leg prosthetic, but told she can only have one. She needs a lightweight electric wheelchair to get upstairs. She's been using a chemical toilet, wipes and hand sanitizer for over 13 years. Who does she speak to? Because I don't have a clue and that is what the support needs to be practical. Someone needs to be able to say that's the department that you go to and this girl has done all this herself. So she's one arm, she's a prosthetic leg, she's other various complications and she carries on with life, but there's no one to help. So I said I'll bring it forward today. Thank you. Emma Harper, you have a question and then a final question from Sandesh Gullhane. Okay, thanks. It might actually be more relevant for the next panel because I'm thinking about like a punitive approach that is perceived by healthcare staff for reporting incidents and so near misses are maybe better dealt with than actually waiting for a significant adverse event and so like my background is 30 years of operating room nursing it's highly technical there's very unsafe sometimes and not unsafe in the practice but just like there's so many barriers sometimes and it's a team driven so and I know errors aren't intended but the Swiss cheese model comes to mind when we talk about patient safety. So I'm interested in to hear your thoughts about how we need to encourage reporting of incidents so that we can put effective measures in place to prevent them and then how that would maybe support a patient safety commissioner's work to look at encouraging reporting so that we can develop safer methods. It may seem to be locked out as a benefit. I think the problem is that reporting seems to be a fault based event and it isn't actually but it should be is looking at something seeing that it isn't right and the benefit is it won't happen to somebody else. It will save a lot of distress to a family it will save a huge amount of money and time so as long as the patient safety commissioner can basically share the fact that it benefits everybody to say when there's a problem as opposed to try and hide it. Could I pick up on this because I think this is absolutely fundamental to the whole situation and it comes down to I wouldn't particularly favour fines because all that does is extend the culture of defensiveness by health boards. It doesn't encourage learning, it doesn't encourage reflection and we've talked a lot about this in the infected blood story and particularly recently that there needs to be a situation where not only are patients listened to but not seen as a threat. We've all been seen as threats here because the health boards have thought what the hell are we going to do about this. Better take legal advice and we need to move on from that. It also comes down to the power relationships nurses in particular should be able to raise issues with the patient safety commissioner. They should be able to go directly because within hospitals look at the power. Where does the power sit within hospitals? Yes to a certain extent to hospital management but then it rests with the medical profession and we've found that of course what happened in our story was that the reasons the predecessor to the Scottish executive in the old days when we had pre-evolution they were simply listening to the chief medical officer who of course was listening to the doctors. We need to get beyond that and this comes back to the point about medical records, access to medical records, interpretation of that and indeed I mean I would add the medical profession to that. If they see issues a junior doctor way down the food chain should be able to go to the patient safety commissioner if they think there's something wrong. Thank you. I just wanted to touch on something that the bill you had said and then I want to ask my question. With the culture of defensiveness I think what happened in the past is very different to what goes on now. Doctors certainly do whistle blow and we've seen that on a number of occasions and you know as a doctor one of the first things I do is apologise when I make a mistake. We all make mistakes because that's the reality and I hope that that comment was really about that higher level, board level than you were talking about those individuals and just if I could just move on to my question. The only thing I want to say is in general NHS Scotland and the NHS in general is fantastic but I'm realistic enough to know that there are improvements that can be made and from what I've been hearing it seems that everyone is keen for the commissioner to take and listen to evidence from individuals but we need to be clear that that will potentially be thousands of people that will be writing or seeing the commissioner so my question is based around the fact that current budget is for four members of staff plus the commissioner. Do you want to see a significant increase in the budget and thus the number of staff that work for the commissioner and Bill, can I start with you? I fully accept what you say that things have moved on in terms of the medical profession. Thank goodness because certainly in the 1970s and 80s we were very much victims of paternalistic approaches. I think that you're right about the budget. I mean we actually need to get this commissioner in place first and the initial staff and I go back to my theme throughout this in terms of the importance of this committee and all of that in the Parliament in this because everyone's accountable to someone and given that the patient safety commissioner is going to be hopefully accountable to Parliament it's really important that time is devoted by the Parliament to looking at those issues and actually that the the PSC is someone of sufficient character in clout to be able to say well actually we've had a thousand people approaches in the last year we can only deal with so much we need our budget double treble quadrupled so in terms of the governance that I accept the point it's hard to see how they would even in the initial stages you know develop this with four people but I think let's get them in place because the other proposal is that the principles under which the PSC will work have to be the first patient safety commissioner actually has to develop those principles under which they would work. Can I just add to that as well that there was a suggestion about hybrid working arrangements which I do not think would work because if you're talking about the team actually speaking by zoom and not actually being in a room together like this to discuss the issues I think that that would actually have a negative effect on the the working pattern of the PSC. Thank you. Last word to Fraser. I think what Sandy is referring to was a no blame culture and I believe that that's derived from the aviation industry but I'm not totally convinced for that I think you're comparing apples with oranges if you go back to real time data gender analysis etc aircraft of black boxes your flight recorders your voice recorders the air traffic control has voice recorders every input is recorded so it sets it apart from healthcare and I think it was bald kirkup I'm paraphrasing here because I can't remember the exact quote but to air is human to cover up and conceal is unforgivable so that's how you distinguish two parties thank you very much I want to thank all four of you in front of us and obviously Irene online for the time this morning it's been very important to hear your stories and and your thoughts on the patient safety commissioner we're going to suspend for 10 minutes thank you welcome back we now continue our scrutiny of the patient safety commissioner bill with witnesses from organisations relating to patient safety now welcome to the committee Rosemary Agnew the ombudsman of scottish public services ombudsman Alison cave chief safety officer medicines and healthcare products regulatory agency dr Aaron Chopra medical director for the mental welfare commission scotland dr Anna Lamont the medical director for procurement commissioning facilities for NHS national services scotland and Simon Watson the medical director for health improvement scotland a few of you were in the public gallery when our representatives from patient groups were given their thoughts on the patient safety commissioner and I think I would like to ask on your thoughts to to some of the criticisms they made about the existing systems and structures that there are in order for patients to have their complaints dealt with and their views heard really some quite upsetting testimony from them where they felt that they weren't listening to and that the systems just weren't in place in order to give them that support and I think that that seems to me that the need for a patient safety commissioner is also something that they are relying on to fill that gap but I would like your reflections on some of the some of the points that they made around not being listened to and the systems not been there currently for their voices to be heard and if I can go around the whole panel I would really appreciate it rosemary I knew you'd start with me good morning thank you for the opportunity to speak I mean I've heard the patients who were speaking before speak a few times and you can't help but be moved by the stories and what they say and what I would say about what we're essentially thinking about here is this cluttered landscape where there is a combination of different types of organisation some are oversight some are scrutiny some are commissions some are commissioners and individually and I'm part of that landscape individually we do well I think we all do and understand our remit I can take personal complaints that is you know I would say a third of my remit I'll come back to others in a minute so the individual side of things the redress side yes you can look at and there are complaints where we do identify systemic issues give you examples later on but I think there is something in there about a gap or a lacuna where the almost the patient equivalent of a whistleblower doesn't always get their voice heard because you end up I think having to go to one organisation after another after another and it's not that we as this landscape don't want to share this and don't want to talk about these things often we can't because the way our legislation is set up precludes us doing that so there is absolutely a gap I think for patients to be able to just go and tell their experience their story their feelings their views but particularly their experience and know that it will be heard not hope it will be heard so yes there's a gap yes I think it needs filling but I don't think it's because the current systems don't work I think it's because we're not always unable to work together in the way that we would like to and a patient safety commissioner will be an essential part of helping that landscape work together thank you Alison hi good morning everyone and thank you for the opportunity to be here yes very powerful testimonies and I think reflecting on the postcumbalage environment so first of all my role is a new role at mhre which I was appointed in January sorry July 21 and part of that is to bring together all of our thinking and responses to the cumbalage report and also to bring together our activities around both medicines and medical devices which used to be separate more separated activity more siloed activities I think in thinking about the role of a patient safety obviously we've been engaging with the English patient safety commissioner since she was appointed and have regular interactions and we're developing how we can best work together synergistically to support her in her role but also to ensure patients feel that they are heard more I personally answer many questions every week directly from patients and we have postcumbalage set up a customer service centre which handles about 50 000 inquiries per year so we we do try very hard to respond to patients I think we've also transformed our organisation which I've indicated to try and design in more safety to sort of patient involvement sorry to enable patients to feel that they're more engaged with the regulatory process and have more of a voice in the in the in the process of drug development but also drug authorization but then in particular the safety assessment having more meaningful engagements listening to patients bringing them into our benefit risk assessments I could talk more I don't know how much time you have very happy to discuss I just if I can intervene I mean we heard we heard Charlie Bethan talk about evapolite there I mean yeah that's a specific that's he he flagged up but that's still been prescribed yes so sodium evaporate is a drug used to obviously treat epilepsy but also bipolar uh syndrome so it it has a lot of restrictions around it is a known to ratogenic but there are some individuals who have drug resistant epilepsy for whom evaporate may be the only effective or tolerated treatment to control their seizures so what we're trying to do is to ensure that the benefits outweigh the risks we have a very strong pregnancy prevention plan in place for sodium evaporate which requires that no woman receives sodium evaporate unless it's ensured there's no effective other effective or tolerated treatment and that they are registered on the pregnancy prevention plan and that they are on effective contraception so this has been in place since 2018 and if you look at we since 2018 we have also put in place in England an anti epileptic registry to monitor the prescribing of sodium evaporate in women of childbearing age and we have seen a drop in prescribing it's not as far as we would like to see the drop and there are remain approximately at the last count about three exposed pregnancies per month do you think of there had been a patient safety commissioner in place that that's the sort of thing that would have been in place a lot earlier and we could have seen the prevention of some of these these children it's hard for me to look back historically at 2012 13 14 those sort of but that's obviously what you're talking about is maybe as a result of the campaigning that's happened yes and also we're becoming more aware we understand more about the biological mechanisms understanding the tratogenic effects of sodium evaporate but it has been known for decades that this is a tratogenic medicine but I think and yes I would say that potentially those measures should have been put in place earlier to try and reduce that prescribing it's a difficult situation when doctors are telling us that this is the only effective treatment to control seizures in some individuals so that is the conundrum really with the medicine what we're trying to do is reduce it to the absolute minimum so that we're absolutely confident that no one receives valprate when there is other effective or tolerated treatment and we are just putting in new motions for that specifically because but it is an example of maybe if we had a patient safety commissioner yes might might have made a difference so I'll I'll leave it there and dr troffa morning and thanks for the opportunity to speak today I was sitting at the back during that session that we heard this morning and I thought it was very powerful testimony and I thought it was very accurate testimony as well both on the investigations point that's or the lack of a focus around investigations the issues that were raised about governance the lack of a regulator was brought up and this committee's 2018 report was brought up and I think the observations from that committee hold true today the focus around quality assurance and quality improvement as the predominant model was brought up and I agree with the observations there and I thought that the observations that were made around a focus for human rights and equalities were well made those points and I think that would be a key to the success of a patient safety commissioner one of the things that wasn't brought up I know there was a discussion about certain other regulators and scrutiny bodies or kind of scrutiny bodies within the landscape the mental welfare commission for Scotland for which I'm the medical director is taking a human rights based approach to the care of people who use mental health services and patients and I think one of the ways in which we do that is the forward facing phone line and I heard what Allison was just saying about the ability to receive information the commission takes 4 000 phone calls a year through its advice line which enables it to hear what patients carers and people who use services and professionals are saying and I think that's crucial and I think we may come on to resources at some point but that is a powerful factor also undertakes visits where it gets to hear what people are saying about the places where they are liable to be detained or detained in and also it takes investigations both individual investigations and thematic investigations when you're combining systemic factors or kind of systems based issues I think that might be something that we touch on again when we talk about the role of investigations but it is crucial to bring those points and I thought that the session that you heard this morning I thought that was that was powerful I think some of the points that were being made about the role and the wish list for the powers of the commissioner actually started to veer on to the powers of a regulator rather than a patient safety commissioner whose role must be to amplify the patient voice and I think that's the most powerful thing that the patient safety commissioner needs to do. Good morning and thank you committee so I too heard the patients speaking about the concerns and agree that these are accurate concerns certainly within national services Scotland we very much support the commissioning of a new patient safety commissioner it is about supporting that patient voice a holistic view national services Scotland is a organisation of multiple parts including blood transfusion service incident reporting procurement and specialist services and all parts of those do listen to patients that is partly through networks of clinicians a lot of this has to do with collaboration with UK organisations and one of the areas that we're very keen to see that a patient safety commissioner works with is collaborating and working with the organisations that are already in place within the incident reporting centre for national services Scotland we do receive patient reports and these are incorporated into the concerns and I think particularly concerning things like mesh which we are producing a six-month report for Scottish Government and follow-up we received 35 reports last year and most of those were from clinicians but we do receive some from patients as well overall though in national services Scotland our role is to work with other clinicians and with other organisations and we're very keen that actually whatever is put in place can say a commissioner works in a holistic way and works with the existing organisations including healthcare improvement Scotland and the Scottish patient safety public safety ombudsman as well Simon thank you thank you very much I wasn't in the room but the parliamentary staff are kind enough to let me watch this on the tv outside and I agree it was powerful and rightly I found it distressing to listen to and I can only imagine what the people who were giving you testimony must have gone through and how hard it was to repeat that today so I'm very grateful that they did I would agree with the ombudsman the all organisations have remits and sometimes you have you know yours have to operate within your remit but of course we're human beings as well and if people come to us in extremists in those very difficult situations even if it's not within our power to deal with the issue they've raised we need to have the intelligence to help them find the help they need and of course have a have a moral obligation to you know provide support for that to be done as easily as possible we in healthcare improvement Scotland have a range of mechanisms of listening to the voices of those with live experience patients relatives and others most formally that's through our community engagement directorate which does what you would imagine it is there to make sure in particular that NHS boards have the right mechanisms skills and approaches in place so that they hear the voices of the patients and those using their services but also more general supporting functions so that everybody including our organisation does that so they're not just externally facing the help all of us do it all of our programs whether they're relating to medicines technologies guidelines improvement support and assurance have mechanisms to connect to the public and patients so that our work is informed the word improvement is in the middle of our organisations title and that applies to ourself as well so i'm not going to say that everything's perfect and we're all satisfied we we must try harder and we do try harder um and i think if i can make a final point i think this in my view is particularly relevant to the patient safety commissioner um the cases that led to testimonies you heard this morning are awful and they're extremely distressing but at the root of avoiding people in the future having to go through things like that is to get it right all the time in everyday provision of healthcare it's not just about the things that go very badly wrong and lead to these appalling awful tragic cases it's getting it right every time with what some might call the small details but this is healthcare it's really important the details matter so a big focus of our organisation is how do we help healthcare providers to improve to get things right at every level and avoid these terrible cases that we've heard about and i think that it's particularly important that the issues that matter to the public and to patients get the prominence that they deserve inform what it is we actually do and our organisation definitely does see a potential for the patient safety commissioner to help identify what those issues are get them on the table and hold everybody including ourselves to account for making sure that they inform what we do to improve healthcare so so i mean if i can just ask you a follow-up question before i let my colleagues to come in i mean we obviously heard this morning some instances where people were describing that already had been a pattern of errors in particular health board areas and that their particular personal experience had just been you know one other part of that and the assumption that they had made that assumption that lessons hadn't been learned in that sort of case where how would like health improvements scotland work in investigating that alongside a patient safety i mean where would there be a partnership working would there be an overlap i mean i i know i would like to understand where you see that work happening thank you thank you very much so so strictly speak as an organisation we wouldn't ond mae'r ddechrau yn gyfieicio gyda'r sreifetau, ac mae'n gwybod i'r provided, ac mae'n ddysgu'r sreifetau gyda'u cyfieicio gyda'u cyfieicio gyda'u.attersgau yma, a'r blawnd meddwl mewn i'r prif, a'r諮dd yma i ddefnyddio, ac mae'n ddigwydd, oherwydd mae'u digyfl sy'n ymgylch chi'n dod y pathenion, ac mae'n amlwg Pathenion cyd-igwstwyl. Mae'r ddifrwg fyddion, nid yw adrodd yn ysgolion, yn unig o'r syfang eu gweithio ar y cysylltu'n gyfnwys hwn o'r roi gwerthu eich octon. Mae'r cyffin gwybod ar hyn o'r panthorol oherwydd hwn o'r cyffinno'n gyflym wneud o'r cyffinno. Rwy'r cyffinno'n rydych chi'n medry enw i ypyffaeth, rwy'n gweithio i i'r cyffinno'n'r cyffinno'n gwreithi'r ysgol yr ysgol yn cyfrifodol, ac mae'n wneud gwybaroddau yr unrhyw gwaith i gael. Felly, ygold hwnna'n gweithio bod y cyfle wedi helpedu a'u hollu'r byddo ar hyn y credu y ceisio cyfan, y byw'r perffieroedd cyffredinig yn ei chymniadau, ei ddefnyddio i wneud gael ddwyolyg wedi'u cyfrannu, a'i gael ddarl iawn fod yn ei ddeddygad a'u cyffredinig? Mae'r perffieroedd y bydda'n gweithio fydd rydyn ni wedi ei wneud ei ddefnyddio roedd yn cael perffieroedd. Felly mae'n cael ei ddefnyddio i gael deall yr argylcheddau. My intention would be that, if a patient safety commissioner was created, we would work with them in partnership and in particular seek to hear the issues that they are bringing from patients in the public to inform them. Including them saying to you where they feel that you could be stepping up or doing things differently. Absolutely. Pass on to my colleague Tess White. Thank you convener and it builds on the previous questions. So my question is direct to Rosemary and Simon, if you could take Rosemary first and then Simon. So I was particularly interested in the comments about the breadth of remit of the PSC and the lack of clarity about the roles relationship with the existing clinical guidance landscape. So two questions really. The first one is how would you envisage your organisation working with the PSC and secondly are you concerned about the potential for duplication and overlaps? Thank you. I'll come to the first one first. I think in a way I would echo some of the things that Simon's just said. For me it's about being able to work jointly. I think the investigatory remit of the PSC is going to be important, is important. But I keep bringing myself back to what the fundamental objective of this is and that is about ensuring that there is a patient safety voice that is heard and is amplified. So the starting point for the investigatory powers has to be to have enough of a breadth of remit to not be restricted to individual issues but to be very clear about how you would be investigating to test what you have heard. I suspect to come on to data later but data is only helpful in context and the context that doesn't always, I don't think, get picked up when you're looking at data holistically is the context of the patient voice, the experience that led to some of that data. So in terms of how we work together I think there is huge opportunity for information sharing. There is huge opportunity if the legislation allows us for joint working. We also have to be realistic about what each of us can achieve and be very clear about signposting, so I'm referred to a moral duty. We already do a lot of signposting but I think I would want to be able to signpost with the confidence that I'm not just passing somebody on, that something would happen as a result of that. Now in terms of, am I concerned about overlap? I'm concerned that there is a risk of overlap but this is where I think we need to be realistic about the individual remits and this enabling of working together. So the obvious area of overlap would be looking at individual cases seeking individual redress. I have my doubts that that's a patient safety commissioner function. I can see there would be opportunities to look at recommendations for collective redress. We recommend that the government put something in place to provide these services. But I think when it comes to individual cases they have to remain within the current remits that they're in. What would change though is the context perhaps in which my organisation would look at an individual complaint because we might have better intelligence and data to know that it's not necessarily an isolated incident. Equally we might only get one or two cases about a specific issue but when we are able to share that information and data and I can see a role for a patient safety commissioner in that that's when we might see the pattern emerging that is actually borne out by the lived experience and the voice. So long story short I would envisage us working jointly. I think we have to manage the risk of not overlapping. I think there would be some help in clarity about testing what the patient voice is saying in the context of data. I would really hope that on the face of the legislation it's enabling everyone to work together, not creating a further silo. Dr Chopra. I am quite worried about the potential for duplication and for people having to retell their stories to multiple commissioners. That can be very traumatising and Simon mentioned how difficult it must have been for people who you heard from earlier to have to retell their story. Now if you think about someone with learning disability we know people with learning disability are more likely to have delays in receiving sepsis or there was a report from his just earlier this month that showed people with learning disability didn't have their chronic pain believed. Now if they are going to have to tell that story to the mental welfare commission, to their own board or partnership and have that escalated to the SPSO, if that is going to be collected through the community engagement aspect of his and if it is also going to go to the patient safety commissioner that is a huge risk for people. So we need to be absolutely clear about what the remit will be for the patient safety commissioner. The point that builds from this though is within the bill at the moment there is a requirement or kind of within the remit section there is an idea about the patient safety commissioner requiring health boards to work together. I think it would be helpful for that power to extend to making sure that scrutiny bodies existing are working together. I think in an earlier session with Simon Whale and Baroness Cumberlidge I think the term that was used was golden thread pulling these things together and I think that would be a helpful thing to extend in the bill to actually require the scrutiny bodies to work together. A couple of colleagues want to come in, Sandesh. Thank you. I just want to suppose me to pick up on something that you said in your opening statement about sort of patient whistleblowing and I'm not talking about the extreme situation as Simon was talking about. So my experience pre-COVID in hospital was when there were long waits or patients were in wards where it was particularly hot in the summer and they just were feeling overwhelmed they would tell me as their doctor, they would tell our nursing staff but they wouldn't put a complaint in because they were too worried about the staff. They said you're working as hard as you can it's not your fault but what I found was despite us saying it it didn't make a difference until patients complained so we were encouraging patients to complain. So do you feel that the patient safety commissioner would be a good place for stories like that to pick up as we heard about the golden thread or actually is that local complaints procedure maybe the best place for that to be? I think the answer is all of that but the point I would make is that I actually think the front line is where the voice needs to be heard. If the voice was heard at the front line you wouldn't need a patient safety commissioner. So the question then becomes how do you capture and listen to that voice and act on it? And I can understand why people might not want to make a complaint because it is a challenging thing to do and you're not feeling the best of health yourself. But also there are occasions I think where it's a patient experience but not necessarily about their treatment and there is sometimes a gap of knowing who can I say. I don't feel unsafe by it but the whole patient experience would be improved if the ward was a bit cooler. Now I think that should lie with the board. They should be listening to that. A patient safety commissioner if they also heard that could then challenge your board and saying how are you capturing feedback because that's about feedback and if you extend that then to issues about I've seen something that I think is unsafe. If you're a member of staff or you're delivering the service we now have a completely different whistleblowing regime than we had two years ago but if you're a patient and you see something that might not necessarily affect you directly or which hasn't caused you to be unsafe but you might want to report it to somebody else. I was a bit warm but I could go and sit by the window and there was a lady in the bed next to me and she really looked like she was going to pass out with the heat. I tried to tell somebody but there was nobody around because everybody was really busy and I didn't want to bother people. Now that's the sort of, it might sound very minor in the grand scheme of things but if a few people said there is an issue about patient experience and is this a risk where if you heard it, I think we talk about data in lots of times I think if you hear something a few times and it's hearing the stories and I don't mean tales, I mean the experiences and stories that I think a patient safety commissioner could help with because we also are sort of veering towards this view of a commissioner who might be critical or might say put this right but you could turn that the other way round and say if we had somebody who could capture and amplify that voice it might be support that's needed at the front line, not criticism so there's as much about working with organisations to help them learn and improve so coming back to your initial starting point I think there is a place for patients to be able to give feedback and it should be the front line but as soon as there's something that concerns them about what might appear to them unsafe or risky then they might not feel safe themselves saying that like we hear often whistleblowers will come to us first because they want the reassurance that they can trust the system I can see a patient going to patient safety commissioner in just that way as well Tessa's questions, I'll bring you back in Sorry, did you want me to speak now? Yes Yes, thank you very much Just to pick up the previous question that was addressed to Rosemary and myself I think that many of the points have been made but the critical one for me is for the patient safety commissioner to have the potential to be the voice of those less heard and I think some of that was touched upon in the previous discussion I think it's absolutely critical that if people see something that's concerned about the safety of care they speak up whether a member of staff or a patient or a relative that that is listened to and I believe that is happening and I believe it's happening much better than it did 20 years ago but I don't believe it's happening enough because there's something about picking up those individual stories and turning them into a signal that's an issue that we might that we need to do something about and I think that is something that a patient safety commissioner could really help with to help us and other organisations encourage that speaking up and getting these things out in the open but secondly to tease those together to issues that are new or that perhaps haven't had as much attention or maybe in some cases things that we thought weren't problems anymore now we're hearing that there are this is incredibly important intelligence and in terms of working together I spend a lot of my time working with other national organisations on issues of safety I would certainly see our organisation wanting to work with the commissioner particularly to get that intelligence but also to be challenged back and the motivation that would provide us to make sure that something happened with it I'm happy to comment on the duplication issues but I think those have probably already been made Patience should be able to do this anonymously Do you think that? Excuse me? Do you think that patience should be able to do that feedback anonymously? I think that's important I think it's a really good question I suppose it depends on the issue Ideally you would have a culture where people didn't feel the needs to be anonymous but if it encourages people to be open and candid by having that anonymity then at the end of the day the most important thing is finding out what the issues are I'd just like to pick up that point about anonymity if I may there's a difference between anonymously and confidentially and this is something that experience of whistleblowing has really brought home that often people want to be anonymous because they don't have confidence that it will be treated confidentially and one of the challenges I think will be, as Simon says, to try and encourage people to speak openly but it should be in an environment where they're confident that their name's not going to appear all over everything that the issue will get looked at so it becomes about the issue, not the person I guess the reason I'm asking is particularly Bill's comments from the last panel about you were making complaints that you were seen as being almost like the enemy and I think that that came across very strongly Sorry, I have butted in I was going to bring in Paul Sweeney Thank you, convener, and thanks to the panel for your comments so far, I just wanted to pick up what Dr Tropram and Mr Watson had said about the issues around inclusivity it's such a vast remit with quite a narrow resource base and there is a tendency towards the sharpest elbows get attention, well-resourced campaigns get attention how do we make sure there are protocols and mechanisms in place to ensure that it remains inclusive obviously we heard last week, for example, about areas of medical devices impacting on women disproportionately for example, and often being ignored and sort of dismissed by the medical profession how do we ensure that these things are addressed adequately by the commissioner I think your question actually echoes the conversation that the convener and Rosemary were just having about anonymity and confidentiality because actually how we ensure that we're hearing the voices of marginalised groups is the kind of root nub of that question because I think if you ensure that we're hearing the voices of those groups who have struggled the most to get their points across I mean, in the earlier panel we were talking about valproate predominantly women we were talking about the mesh, again women and there was a consistent theme about women and voices heard in the profession we know that people coming from other marginalised groups ethnic minorities are not represented in the data around patient safety and we know that actually patient safety events predominantly affect marginalised groups so I think it's fantastically important that actually we collect protected characteristics I was somewhat disappointed when I was seeking to find out what boards received in terms of feedback and asked the question whether feedback that's received at the most basic entry level at board level is stratified by protected characteristics and they said no we can't do that it's just not done so we don't know whose voices we're not hearing in terms of how do we build this so that we make sure that we're hearing and we're picking up the right signals I think we need to be collecting the board feedback we need to be looking at the sort of things that are reported to his under adverse events notification systems the information, the sort of data that comes to the commission on a daily basis through phone calls and complaints and all of those data sets need to be brought together in one place and that might arguably be part of the strategic plan for the patient safety commissioner on day one to bring these data sets in so that they can hear the signals and then relay them back to people like us to say what are you doing about them Simon Thank you very much that's an excellent question I think when the committees considering the legislation and parlance considering it and also the resourcing one of the important dimensions is the quality assurance aspect of the work and something that the commissioner will need in my view and our view internally is a system to make sure exactly what you said that the quality assurance on we're listening properly we are hearing marginalised groups we are getting proper samples of what we are doing it's not my area of expertise but I know the expertise lies within our organisation again predominantly in our community engagement directorate and I'll speak for our organisation we would be more than happy to help the commission to set that up if it wasn't going to compromise their independence but those standards exist part of the resource they'll need is the quality assurance so they can internally assure themselves that they're getting it right and I suppose the final point is to strengthen those who are often unheard in the legislation would help set if you like the culture and the expectation thank you and can I move on to questions from Emma Harper Thanks convener and good morning everybody I was going to pick up on some of the questions about the remit of the patient safety commissioner because originally Barnas Cumballage's report wanted it to look at medicines and medical devices and that's what the commissioner in England is doing but the remit seems to be broader and just thinking about all the people involved in promoting safe patient care there is a bit of a crossover that I'm worried about as well but I'm interested to know how you feel about the widening of the remit for the patient safety commissioner here from people who have had put experiences I'm happy to go first for me there's a difference between remit and scope and the current scope of what the patient safety commissioner can look at is very broad but I was taken with something one of the previous panel said about it's all very well to identify the things from the past but you don't know what the things are going to be in the future so our systems that we have in place what the patient safety commissioner will hopefully be doing is finding a way of identifying those early warning signals I think that Simon referred to where it sets a flag and so you go and look into it now your remit is the extent to which you're able to do that and I think it's right personally I think it's right that it covers more than just the two areas of known problem the remit has to be wide enough to be able to react to and follow up on whether something new may come up the challenge I think it will provide is the resourcing and the strategic planning of this so the setting clear principles and I don't think that's about the patient safety commissioner setting their own agenda I think it's these are the principles that I will work to to ensure that the patient voice is heard and acted on and listened to so yes it's I think absolutely appropriate that it's more than just the two areas that the patient safety commissioner in England has but the scope or the extent to which they can be looked into I think is the detail of how far those investigatory powers go how you work with others so we have to make sure collectively that the commissioner is able to follow up on those voices as far as they need to but it doesn't necessarily have to just be a voice about those two issues the patient safety commissioner scope is about listening to patient it's about taking that holistic view and about identifying what we don't have already if it was purely about identifying what we know in terms of complaints or concerns then we have those systems in place at the moment and what we're looking for here is something that can take that overview, holistic view that provides the nurturing and learning culture that encourages looking beyond what we already know to reference back to the previous question there's a barrier to presenting a complaint to presenting a problem and the patient may not actually be aware themselves of what actually is underlying their concern they will have observed something they'll be concerned about something but it's important that the safety commissioner has the scope to be able to investigate and consider all the aspects to that patient's experience in the incident reporting investigation centre which is part of national services Scotland experiences shown that even small numbers of events one or two events which are identified perhaps not even just in Scotland but actually can be shared across systems can then identify something that is at risk for actually far more people but hasn't met that barrier and what we're trying to do here is to identify trends before they cause harm so I think it is important that the patient safety commissioner has that scope so that even small numbers, individual concerns can be raised to identify what the underlying issues are and actually understand whether there's something that can be put in place to avoid harm or to avoid that so that there's no evidence for the people Simon Woods Thank you very much It's an excellent question and you could argue that both are right in some respects I've been a doctor for 27 years and there's plenty to keep the patient safety commissioner in England occupied around medicines and technologies they bring an awful lot of good but the complexity of healthcare means they bring safety issues as well however I think the opportunity is to actually have a very good chance of understanding some of the more profound issues that might manifest with safety concerns in particular areas so for example they might spot patterns where there are safety issues around medicines or clinical practice or something else that are all linked together by a common issue of and this is speaking very hypothetically leadership in a particular organisation or resourcing or changes in the way that staff are used or any number of things and logically the broader if you like the radar is set up the greater the opportunity to spot these issues that are if you like give a more profound knowledge of the safety issues and then give us the opportunity to go and address those issues and if you like solve a number of problems at once so I think that's the opportunity that still requires quite a lot of resource and support to do that but I think that's a really important aspect of the commission's potential that would be good to keep sight of Doctor Trapper wants to come in Emma I think the commission supported the broader scope outlined in the Scottish bill as compared to the English one and not just focusing on medicines and medical devices but looking across healthcare I think that's important because most patients and members of the public don't make a differentiation between their medicines and the systems through which those medicines are derived so that was the reason why we were quite supportive of that broadening of scope in fact in some ways it may be too narrow I mean the issue that's currently causing many of the people who phone us and things that we pick up on our visits the most concern is delayed discharge from hospitals and delayed discharge causes harm and actually I wonder whether the remit focusing purely on healthcare actually goes against the grain of where we're trying to go with integration and so it might be important to think about health and social care so that's something that needs to be thought about as to how that fits across the integration agenda so that's kind of suggesting that we may need to broaden the remit and then there is that question then about what would you give up then because the resourcing is quite small I've already said I think the primary function is to amplify the patient voice rather than to start doing things around systemic improvement which fits probably more with his I'm also quite worried about the investigations because at the way the bill is currently written it's not very clear whether these are individual investigations or thematic investigations and from our experience of doing both of these type of investigations they are resource intensive and if the commissioner and four members of staff were to start going down the route of doing investigations I don't think they'd have the scope to do some of that bringing the data together stuff and investigating those all kind of being able to relay things I think they'd be solely focused down the investigations route I think a forward plan might be then to start small and start looking across that broader remit of health and social care but kind of focusing and that would be for the patient safety commissioner to determine the priorities but I think that might be the way forward over the next few years okay thanks just to pick up on what you said about amplifying patients voice but also Dr Lamont about avoiding harm in the first place or maybe addressing concerns so I'll use the example that I used last week people in the south west of Scotland get their radiotherapy in Edinburgh so it means to go four miles past the Beatson so I think it's like two hundred forty mile round trip but so the voices of the people in the south west of Scotland aren't being heard in order to look at cancer pathways for instance so is that something that the patient safety commissioner could adopt in order to help support like harm hasn't necessarily occurred but the simple fact that you're away for your family two hundred forty miles away Monday through Friday might actually lead to dropping off from your radiotherapy you can just say I'm fed up I'm not doing it anymore but is that something that might be part of a patient safety commissioner like drive to and then they would come to whether it's national services Scotland health improvements Scotland whatever pathway to help look at sorting that Dr Lamont so I think we have to recognise that resource limitation and providing resources and services from multiple sites is always desirable and at the moment we are considering expansion of some special services to multiple sites for exactly these sort of reasons and there is always a challenge because in a very resource constrained situation if you move resources to use in one site then you take it away from another and so I think there is a role here for taking that holistic view for taking that about where resources can be best used to provide the best for patient services I think the issue here for a patient safety ombudsman is there going to be a lot of issues for them to consider there's going to be a lot of demand for things that they might want to consider and so an important part of how this is going to be constructed is about how that's prioritised I think in the first instance it may be that actually responding to small numbers of adverse incidents and events and concerns that are raised and trying to identify trends and Baroness Cumberlidge's report was primarily about identifying trends about listening to small numbers of voices and to hear those and amplify them and to understand if other people have those concerns and so for me that is and for the organisations which we currently do listen to reports and professionals and receive many reports and patients and I think that's where the gap will be Paul Sweeney Thank you I think there was a really important point just made there about anticipating problems and service design inevitably is done in the context of resource constraints there's a finite resource that cannot neatly match demand and increasing demand and inevitably there will be safety implications and decisions that are made an example that I can think of just recently in the health and social care partnership I've advised that under the current settlement for local government they won't be able to meet their statutory requirement for service delivery in Glasgow there's clearly a patient safety consideration to be brought about there so as there are potentially scope for the commission to have a role in assessing decisions within different public bodies about the potential impact on patient safety and perhaps making a recommendation to Parliament on what they think the optimum balances in the context where it's not necessarily the patient referring an issue that they're reacting to is anticipating the allocation of constrained resources on a difficult environment such as we are looking at just now in the budgets and what impact that might have perhaps on discharging from mental health estates into more appropriate settings where patients will have to stay in hospitals as opposed to being discharged A reflection on the discussion that we're all having the patient safety commissioner is not going to be there to put the NHS right in every single way going and I in thinking about this because I've been involved in consultation I bring myself back constantly to the amplification of the voice and I think it would actually be quite helpful if it were more clearly articulated on the face of the bill that the patient safety commissioner is not simply an organisation with an interest and remit in patient safety but one with a clear and important focus on making sure the patient voice is heard Now I was also trying to think of examples from my own experience and those are really upsetting and tragic complaint we looked at about audiology services on board and one of the recommendations that I made in that was not go and do this, do this, do this it was about defining the outcomes that are needed for all patients receiving that service but recommending an independent audit from specialists and it was the independent audit from the specialists that actually were able to identify the very detailed clinical issues so I think we have to be careful that we within the remit of the patient safety commissioner give them the power to be able to recommend that others take action but not necessarily feel that they have to do everything themselves because just speaking from my own experience I have a whole a whole host of expert advisers that I can call on for complaint handling and I think the patient safety commissioner we run the risk of expecting so much from them that they can't achieve it all and get almost blinded in the headlamps Alison Kyff I think it's a really valuable conversation I'm reflecting on all the comments made about the scope is so broad that it's maybe impossible to achieve so we need to really think about how the patient safety commissioner would amplify the voice which I think is absolutely key and refers back to the question you asked me right at the beginning about sodium valparate amplifying that voice earlier might have led to earlier action I think it will be really important that they can identify gaps where systemic change could make a difference so if we reflect back to the Cymbridge report that was a small team and yet they reflected they identified systemic problems which could make a difference and even for the MHA they identified the system didn't know so that we needed a new comprehensive system to ensure that we were capturing those signals and we did understand and were able to know earlier where the harm was that it is important to reflect on the scope and as Rosemary was saying I also have people who would do extensive benefit risk reviews and I think it would be impossible for four individuals to be able to achieve that but obviously it's a case of charging other organisations within their health ecosystem to take up the challenges that they find or the gaps that they find I'm going to bring in Simon Watson to questions from Gillian Mackay I'm just letting members know that we're going to look at the medicines and medical devices aspect of things before I go back to data and information gathering Simon Thank you very much, I'll try and be brief the last two committee members points are very interesting and I'll just reflect that there is a duty to consult on major service change certainly across the NHS on all the boards and our organisation supports the processes to do that well and of course part of doing that well is that every solution inevitably will carry some risks that need to be monitored and making sure that the voice of the patients where those risks around patient safety is heard properly is something that all of our organisations have our own duties around but I could see how the commissioner could potentially add to that again amplifying and spotting the issues Gillian Mackay I think my questions will probably mostly be to Alison in this section How can the new patient safety commissioner add value to the existing monitoring systems around medicines and medical devices So as I indicated we do have something called the yellow card system which we've recently invested in significantly to upgrade and improve which collects spontaneous reports as we call the more suspected adverse events from the whole of the UK I was reflecting before I came on how a patient safety commissioner adds value and it is again about amplifying the voice of the patient because we have a report for not all of those reports do we hear the patient directly so that's a really valuable point I think also reflecting on what might be a local more of a local issue that may be leading to a safety concern or a safety issue whether that's be how locally healthcare is delivered or human factors locally in an area which may be harder for a UK-wide organisation to understand may be very valuable I think also very valuable in helping us communicate safety messages to ensure that they're heard appropriately and acted upon and as well as that helping us understand did they have the impact that we intended and if not were there unintended consequences to our actions which we should be aware of or indeed do we need to do further because they're not having the intended action so I think there could be a number of extremely valuable but we would obviously as the individual is appointed look to work with them to understand how we best can work synergistically rather than duplicating effort we touched on that duplication of effort across the UK with the other patient safety commissioner as well and you touched on that earlier what working arrangements do you think will need to be put in place to make sure that there isn't such duplication and that to be tackled but also some of that information shared where there may be a UK-wide issue I think it would be very important for us to have understanding about how we can share data and share information obviously we already have quite a complex ecosystem to help us we have a yellow card centre in Edinburgh we have an incident reporting investigation centre we have a network of safety officers who try and help and identify and spot trends so it will be sitting at this table so it will be important as we were reflecting on the conversation to say where are the gaps where are we missing things where are things falling through the cracks and work together to put in place a plan that this role has the greatest chance of an impact, a real meaningful in fact for patients so that they feel that they have that this makes a difference to their lives which is and improves ultimately patient's safety but I think it will require really careful reflection to make sure that we are not duplicating effort Thank you Can we go back to talking about data and information gathering and questions led by Evelyn Tweed Good morning panel and that was a really good question to ask Gillian because it segues nicely into my question Yes We've been speaking a lot about data about trends, we're hearing in evidence doesn't matter what committee meeting we do, this is where we need to be, we need to be on this and obviously this is key for the patient safety commissioner and the last point that you made Alison about that plan working strategically with the new patient safety commissioner is obviously going to be key to making sure that that works in practice and how we move forward how are you going to do that strategically as organisations and do you see any barriers to that? So I could start I mean in terms of the current English patient safety commissioner obviously she is relatively new in her role first 100 days report has just been released I am having regular meetings with her while setting up a framework under which we can work together because obviously it's very key that she retains her independence within any process so we're working very, and I would look to have the same framework with the Scottish patient safety commissioner where we have regular meetings regular interactions and together develop a framework which they think best supports them in their work and their strategic plan I think obviously talking about where we could see that better data gathering or better processes could improve patient safety would be really good to feedback if I think back to the Valparate issue what's been absolutely key there is understanding the impact of risk minimisation measures put in place in 2018 and understanding whether they have the required impact and I think those sort of processes data gathering, exercises and monitoring exercises would be really key to work with the patient safety commissioner to understand how we can best support each other thank you so I think there's an opportunity here for the patient safety commissioner to improve that data gathering to make it consistent at the moment for local authorities for health boards and for patients there are multiple different ways of recording this in fact actually if there are incidents within boards to report them locally and then to report them nationally there are different systems and systems don't at the moment talk to each other and collaborate so there is an opportunity here to prioritise that and bring that together working with other organisations existing safety organisations such as the yellow car system at the moment the way that is reported making that work better for us we're talking about duplication of roles but there's also duplication of reporting and sometimes it is quite difficult to understand the true numbers of incident reports because some areas will report more diligently than others and sometimes that's to do with the amount of time and resource that can be put into that at the heart of this it's about identifying trends and sometimes those trends are very small signals we're a quite small country and we do work with the other four nations and we understand that where there are signals that can be brought together and the MHRA is an organisation which then spans those countries and is a great example of how that signal can be amplified at the moment many of the systems are focused around reporting from professionals so there is an opportunity here for having parallel mechanisms to have that patient voice that then is amplified and where there are small signals within individual nations actually that can be brought together to recognise the concern which is applicable in Scotland many of the examples that I have from the incident reporting centre for national services of Scotland are around very small numbers two, maybe three, four, five events that have happened across the UK which then lead to investigations about concerns which then lead to collaboration with manufacturers to changing to checking to change the process which then leads to future patient safety so having that system mirrored within our patient voice is really where the opportunity for me is in terms of the patient safety commissioner thank you everyone can I move on to your colleagues sorry did Dr Trafford want to comment I think it's an excellent question really about how we use those data sets and some of it is improving the existing data sets I think when the patient safety commissioner comes into role one of the first things that they're going to grapple with is what are the signals and if you look at his adverse events notification system and they list the top five areas the top area for the most adverse events is mental health it's kind of dwarfs the other four put together but some of that is around standardisation of what gets reported and making sure that we're not comparing apples and oranges and we're actually making sure that upstream data sets are improved to a quality where they're meaningful for the patient safety commissioner to use that existing data the second point would be around merging the existing data sets that were already mentioned a few and we've spoken about some others but there's also care opinion which we use that would need to be brought in and that would be part of getting those data sets together maintaining the inequalities focus so we don't leave anyone behind but also and this is where the patient safety commissioner role could add value because those things are already in place I was speaking to Henrietta Hughes the English patient safety commissioner last week and I asked her in the area that I work in in mental health what are the top kind of things that you're hearing and she was immediately able to give me a response about suicidality related to people using particular medicines for skin conditions post serotonergic difficulties that people get when they have been on an antidepressant for too long and she was able to say these are the signals that she's picking up from emails and phone call conversations that her team are picking in and that adds value to the existing mechanisms that we have something to the data I think we can't also ignore there needs to be a culture of valuing data and what it is telling you I fully support everything that everybody has said but ultimately probably the most rich data will be within boards themselves and until you have consistency between boards not just on what they collect but how they collect it it needs to be able to be used easily and I think it's important to look into an expectation of what happens with governance because it should be an integral part of a governance system that you use, make use, review and ensure the accuracy of your organisation's data Colleagues, I am going to move us on because we've only got 20 minutes left and we have two very substantive themes we've got the independence from the Scottish Government and NHS and the resourcing and I want to give these a good airing if I do have time at the end we can come back to any outstanding questions you have but I think it's really important that we allow these other two themes to get a good airing Can I come to the theme on independence from the Scottish Government and NHS questions led by David Torrance Thank you, convener and good morning to everybody Do you think that the Government and the NHS and if so does the provision in the bill ensure independence? When I was preparing for this I was using in my head words the benefits of independence I value independence but I've decided I treasure the independence I have because being completely independent of Government and of the NHS ensures not only that I can be objective but can be seen to be objective and it means any decisions I make on complaints or complaint standards what I investigate the scope of my investigations how I go about it supported by the powers I have to contain information are completely and utterly critical to this role because one of the or three of the consistent words I heard earlier were about confidence, trust and truth and if you don't have somebody who is not just independent but demonstrably independent then it's going to be hard to establish that confidence and trust the only question I would raise is the focus has been on it should be a parliamentary body and I know there's lots of debate about have we got too many or what have you but I think if you focus on the independence and what is the appropriate model to deliver that that's probably going to lead you to the answer that's appropriate can I ask if the patient safety commission has to be truly independent how can they embed themselves in the current system and still stay independent would anyone like to come in on that in particular or Dr Trunia? The mental welfare commission is independent of the Scottish Government and is independent of the NHS and I treasure that too because it's important to be demonstrably independent from both of those organisations I think it matters to people I think people notice biases or perceived biases and so I think that independence is crucial and I think this is the second part of your question how do you remain embedded within the system and at the same time retain your independence is a question about resources it's about how the commissioner discharges their function, how they do their outreach and how they cast how do they hear from people how do they visit, see hospitals or community we need to move focus into the communities and into social care so I think that will be the important but how do they receive the intelligence and that will allow them to be embedded within the system and yet retain their independence Simon Watson thank you very much excellent questions so we in healthcare improved in Scotland are part of the NHS we are there as a national organisation to drive improvement and much of our focus as I've already alluded is on getting it right first time out there in the system and how do we help others so that's a very specific role and actually there are advantages of being embedded within the NHS we have a role in independent healthcare as well but the NHS is where most of our work is focused there are advantages to that when we do our inspection work we do it with a high degree of independence we have a framework that describes how we do this and it's nobody's interest including ours not to follow that and I think we could demonstrate that we have but this is about a new role and I think the committee has talked about duplication and if I could put the focus on adding value I think it's what some of the colleagues have said there is I think the public would see a commissioner as their person who is there to listen to their views hear their stories and raise issues that either they themselves are seeing or their stories help to describe and if it's going to be their person if you like the purest way to do that is to give them that independence in terms of how they do that in the way that you framed your question it is complicated but my suggestion as a broad principle is to do and guide those of us in public bodies and others to new areas so not necessarily to focus on what we're already doing unless they think we're doing it badly in which cases they should call it out but actually to say you're all focused over there but I've been speaking to the public and I think there's something over there you need to look at and by definition if we're not there doing something about it we're not embedded so I know it's a bit of a conceptual answer but I hope that's helpful if I may add a brief point one of the benefits of independence is that the remit doesn't just have to be within healthcare although just I think probably is an understatement because it does the commissioner does also need to cover private sector, third sector and organisations which wouldn't necessarily be covered if they were associated with a house board or house services or authorities and it's recognising that care has a broader definition than just in terms of health and social care and it includes the element of harm as well that could happen because of lack of access to services which may then not be being provided so it may then not be an organisation that's actually then accountable at that stage OK, thank you continuing the same question from Paul O'Kane on the phone, unmuted Thank you I think very helpful in the whole kind of sense there about independence I want to pick up on that point from Dr Lamont specifically Do you see the patient safety commissioner having a wider role in social care and given the debates that we're having Parliament around the national care service potentially and the potential for the provision of care to change that the commissioner may be able to go beyond scope I suppose and then does that add another layer of how do we hold the commissioner accountable and the minister's accountable in that space So we've already said that it's important that the commissioner would have a remit broader than healthcare and premise because we've been speaking about amplifying the patient voice and the patient or the person doesn't necessarily differentiate between the care that's being provided by a health organisation a local authority or private sector or a third sector organisation so that independence has to be there that they can take that oversight We spoke earlier about having to be able to take a holistic view of that golden thread that we've serviced together and that is where we've identified as a gap so that independence then is required to be able to hold all of those services and to look at actually how that person's voice and journey between all services I think in terms of accountability that's outside of my remit and I think certainly it will be a question for government in understanding what that accountability will be of the commissioner and I think taking examples from other organisations that are here today of whereby they remain accountable but also independent Thank you. Would anyone else want to come in? Alison and then Rosemary I would just sort of add that transparency is going to be key in terms of ensuring that independence would also ensure the trust of the patients who come to the patient commission transparency in actions, transparency in governance framework and transparency in communications Rosemary We hear a lot about processes, systems legislation but if we reflect back on the voices we heard this morning this is very much about people and human beings and I think whoever the patient safety commissioner is is important so recruitment is important but also the values and principles that they put in place for their organisation and independence is what led me to that because it is one of my organisation's values it's not one I've imposed it's we as an organisation it is a value that we hold dear and that we strive to maintain and keep that independence so the person who becomes the patient safety commissioner is also really important because you can't amplify a voice if people don't talk to you Thank you. Paul, are you finished? Thank you I'll move on to our final theme which is resourcing and the resources that we have Thank you very much I asked the question to the patient panel and I'm keen to ask you the same question but bringing in threads of what has been said already so Dr Mont, you talked about how the commissioner needs to hear from individual patients Simon you spoke about catching patterns and also ideally how individuals will be speaking to the commissioner the commissioner resource of four staff the commissioner clearly there's going to be a lot more if patients are going to go to the commissioner there'll be thousands potentially do you feel that we need to significantly increase the number of staff and do you feel that we need to significantly increase the budget? I'll give the example of the incident reporting centre that we currently have in Scotland as four staff and that is for receiving all the incident reports when we're turning to states, facilities and medical devices across Scotland and that works because there is a network of safety officers across all local authorities and boards and that's a requirement for all the boards and they work together and I think it will be necessary for any commissioner to work with existing networks it's not for me to state that the proposal will be effective to do that but it's important that we don't try and remake existing networks link in with existing services like the MHRA like healthcare improvement Scotland and utilise what is already there and if it can be made to work then we have to try and work within existing facilities because as I said earlier we are working within a very resource constrained service at the moment across health and social care and so we have a responsibility to try and work with existing services and existing budgets wherever it's possible Thank you very much yes it's a critical question if I could perhaps mention the passages on investigation and the investigatory aspects of the role so we operate close to that space and that we do reviews we do inspection work and we know how important it is I think for obvious reasons to get that right but to get that right in a timely way and if we've learnt anything about patient safety issues over the last few decades it's that what might seem straightforward on the surface is usually very tangible and complex underneath and teasing it apart requires clear methods, skilled people doing stressful jobs and a lot of support from managers and as I've alluded to the previous conversation quality assurance to get that right and as you start to describe that you suddenly see an expanding array of resource you need to do all of that so I think a central question for the role the commissioner is if independence is going to be a key feature of the role is it acceptable for them to do they need independence of all of that investigatory machinery or can they work in partnership with others who may already have that and use their knowledge and I think that's quite a tricky one to answer because it could be perceived that if they're using other people's investigatory work then they are dependent they're not independent so I think for me I would see in that investigatory remit and how broad that is possibly one of the more significant factors and how big the resource needs to be and if the committee wish to see further information on what we do about that we'd be happy to provide that and you might want to look at what others like the HSIB in England does to get information there as well Thank you Can I bring in Rosemary? I thought I'd share a lived experience of taking on new functions and this was when I took on the independent national whistleblowing officer function there was very little data around about the number of whistleblowing cases within boards and when you first it's our experience that when you first set up these organisations you actually don't really know now the very first bit of funding comes from government they directly gave us some funding to do a bit of research to do some setting up but then because we're a parliamentary body the annual budget then becomes part of the Parliament's budget now the issue will be that you don't really know at the start what you're going to need two years down the line and how it is set up in the first place particularly the financial planning for it is really important because if it's a significant increase that is decided it's needed how does that then reflect a government effectively what was a government policy because it becomes part of the parliamentary budget making system so I think you could argue that this is or isn't the right amount of resource I think it probably comes down to being realistic about what you can achieve with the level of resource you're given as an office holder I have that question every day but I do think that it's not just about how the organisation is funded and set up it's also about the planning for review and how it can adapt once it has a better understanding of how its role has evolved if you listen to all the discussions we've been having you could set this organisation up in so many ways but you don't really know until you start so it may be a case of starting small but with the framework for getting bigger and a clear plan of how that is likely to happen if it's needed Dr Sharper, did you want to come in? Briefly, I think duplication needs to be avoided but the point that Simon began to make around investigations is probably crucial from my perspective because we've been making some comparisons between the roll down south and Baroness Cumbull had said very clearly to this committee the patient safety commissioner doesn't do investigations and Henrietta Hughes said the same thing to me that does leave a gap then as to who does those sort of individual investigations in our landscape now in England the health safety investigation branch which is going to become a statutory body HSSIB undertakes that undertakes training around that and I think that that's the sort of gap that may be remained so I think this committee's deliberations on whether that investigation function needs to remain in or not is probably crucial to thinking about whether this resource is adequate or requires to be expanded to sort of to replicate the landscape in other parts of the UK Sandesh, can you ask your final question then I'll go to test for the final absolutely and thank you for those answers Simon we absolutely would love to see that information can I just just come back to Rosebury what you said and I think this is probably quite important I know I'm veering a little bit outside of resource which is the theme but if we set up an organisation with scope to expand what is our measure of success to say we need to expand well you could argue that your measure of success is that you don't need to expand but I I think I'll just reflect back actually it's Henrietta Hughes when she took up the national guardian role in the first couple of years they didn't have a lot of thing cases taken to them but they grew exponentially and I think it's it's probably something quite basic like volume because what the exponential rise in her cases or what she was hearing represented was a growth in confidence that they could go there but equally I think the other measure and I don't know precisely how you'd do this but there would have to be a measure of impact of so you've amplified the patient's voice what happened what impact did it have is there another way of demonstrating that actually patient safety has improved and this is where I think the combining of data is going to be important and why this overview of data is important because some of the indicators are not going to be within the patient safety commission's specific remit they may well come from his data or the mental welfare commission data that demonstrates something has changed in terms of straightforward things I think it's going to be a matter of you will do what you are able to do and if your budget does not extend to investigation because it is resource intensive that may be a strategic decision that a patient safety commission has to take strategically I'm listening to my advisory board actually identifying the issues and getting them looked at somewhere else is actually really important and the success measure there is were they listened to and taken seriously did something happen as a result thank you apologies to all of our members that want to come in and ask more questions we really have run out of time so we'll have to go to test for a final question very quick question then thank you to Rose Marie Agnew so the finance and public administration committee recently highlighted the concerns regarding the financial impact of having yet another commissioner so in terms of your view and it builds on what Dr Gilhane said what resourcing is necessary for this job holder to be effective that's quite a hard question because the resourcing that's necessary is enough and I'm not being flippant when I say that it actually comes back to all of these points about the remit if there is a serious requirement for an investigatory capacity then they will need more staff than they have currently got if the remit is about amplifying the patient's voice and focusing on the awareness raising the passing on of further of issues to other organisations then what they have may be enough but I come back to the earlier point I made about you don't really know until you start I think it's a very small resource I mean if I just look at my own organisation it's not just about the team that answer the phone give advice, sign post it's also about a communication team who we struggle to have the level of stakeholder engagement that I would like us to have so there's always going to be a balance between what's available and what you can do with it but I do think instinctively this does feel a bit light if I'm honest sadly we have run out of time but I want to thank all of our panellists for what they have told us and their opinions that they have given on the patient safety commissioner bill we'll continue our scrutiny of the patient safety commissioner for Scotland in our next meeting but that does conclude the public part of our meeting today thank you