Episode 11: England & Norway Chart the Course
Both England and Norway have recently established national agencies solely focused on addressing safety problems in health care. Could a similar independent, nonpunitive federal agency be the missing piece to finally put the U.S. on a clear path to improved healthcare safety? Join host Karen Wolk Feinstein and guests Dr. Carl Macrae, professor of Organizational Behavior and Psychology at Nottingham University Business School in England, and Dr. Siri Wiig, professor of Quality and Safety in Healthcare Systems at the University of Stavanger in Norway, for an inside look into the forces that inspired action on patient safety and the tactics that helped to build broad support for the endeavors.
- Karen Wolk Feinstein, PhD, President & CEO, Jewish Healthcare Foundation & Pittsburgh Regional Health Initiative
- Carl Macrae, PhD, professor of Organizational Behavior and Psychology, Nottingham University Business School in England
- Siri Wiig, PhD, MSc, professor of Quality and Safety in Healthcare Systems, the University of Stavanger in Norway
Referenced Resources (in order of appearance)
- Introducing national healthcare safety investigation bodies (British Journal of Surgery, 2018)
- Healthcare Safety Investigation Branch (HSIB) (UK Government)
- England Care Quality Commission – About Us
- SHARE-Centre for Resilience in Healthcare (University of Stavanger)
- Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry (UK House of Commons, 2013)
- Martin Bromiley (Patient Safety Movement)
- James Titcombe, OBE (Patient Safety Movement)
- Blog Article: James Titcombe: Speaking up for Patient Safety across the United Kingdom (Patient Safety Movement, 2020)
- Oral Statement to Parliament: The Morecambe Bay Investigation (UK Government, 2015)
- F.A.A. Grounds U.S.-Operated Boeing 787s (NYTimes, 2013)
- Charles Vincent (Experimental Psychology)
- Learning from failure: the need for independent safety investigation in healthcare (Journal of the Royal Society of Medicine, 2014)
- Public Administration Select Committee: Investigation clinical incidents in the NHS – Sixth Report of Session 2014-2015 (UK House of Commons, 2015)
- ‘A body drifted past the window’: surviving the Ladbroke Grove train crash (The Guardian, 2019)
- Rail Accident Investigation Branch (UK Government)
- Act on the Norwegian Commission of Inquiry into the Health and Care Services (LOVDATA)
- The Norwegian Commission of Inquiry into the health and care service (Ukom)
- HSSIB Bill: HSIB’s journey to full statutory independence (HSIB)
- Carl Macrae: Healthcare safety investigations must offer a safe space for learning (BMJ Opinion, 2018)
- What is Human Factors and Ergonomics? (Human Factors and Ergonomics Society)
- Tesla Crash Investigation Yields 9 NTSB Safety Recommendations (NTSB, 2020)
[00:00:00] Siri Wiig: … I think building trust in the healthcare system is very important in this early phase. Building trust with patients and families…
[00:00:14] Carl Macrae: … a lot of work we did initially was on the criteria for how to actually select what are the most important, invaluable areas to investigate…
[00:00:23] Siri Wiig: … there were a lot of cases in the roll for several years, and it went into that topic to see how was that possible, why did it happen, how can we prevent it from reoccurring, what needs to be done with the system…
[00:00:37] Carl Macrae: … going to create a new space for learning and improvement, which otherwise would not exist…
[00:00:43] Karen Wolk Feinstein: Welcome back to Up Next for Patient Safety, where we envision a world where medical errors, adverse events, and preventable harms are avoided and where we examine the most promising paths to prevent these tragedies before they occur. I’m your host, Karen Feinstein, CEO and president of the Jewish Healthcare Foundation and the Pittsburgh Regional Health Initiative, which is a multi-stakeholder quality collaborative. We’ve been working to reduce medical error for over 20 years, mostly unsuccessfully, but we can’t give up because there’s too much at stake. And that is the loss of approximately 250,000 lives a year, and long-term injuries for many.
It should be reassuring to know that both Norway and England have already created a government agency that functions similarly to how our proposed National Patient Safety Board would work here in the United States. Today, we’re joined by two esteemed international guests, who will give us an inside look into their respective countries efforts to improve patient safety. They provide an important roadmap for us as we move forward. So I’m looking forward myself to learning from these two powerful examples. I am delighted to welcome Dr. Carl Macrae and Dr. Siri Wiig.
Carl Macrae is the professor of organizational behavior and psychology at Nottingham University Business School. He’s an applied psychologist who’s focused on the improvement of safety and resilience in complex systems in healthcare, and also transport, with a particular focus on the governance of artificial intelligence and autonomous systems. Carl, those are beautiful words to us. He learns and interprets from disruptive events. He is instrumental in setting up the Healthcare Safety Investigation Branch in England and has acted as a specialist advisor and expert witness to the Parliamentary Select Committee inquiries. He’s also national professional advisor for patient safety at England’s Care Quality Commission. So I think it sounds like the credentials will fit our themes here very well.
Dr. Wiig is center director of SHARE-Centre for Resilience in Healthcare in Norway, the largest research center investigating quality and safety in health care in her country. Her areas of interest include the perception of risk, patient safety, quality improvement, and learning in a number of different industries as well as health care, including petroleum. We may need you, Siri, in the coming months.
So, thank you both for coming. Let’s begin with the first and most obvious question: Where in your countries did the impetus, the energy, the force for creating an organization, one national organization, focused on patient safety originate? So Carl, why don’t you lead on this, and then Siri?
[00:03:57] Carl Macrae: Sure, thank you. Well, I know it’s great to join you. I suppose the real impetus and the context for this, certainly in England, was really a context of crisis. So, around 2012-2013 there was a major public inquiry into some really significant healthcare failings at a major organization, Mid Staffordshire NHS Foundation Trust, in the middle England, and the public inquiry found a whole range of really quite troubling issues, from the top of the health system down to the front lines. And I think what was particularly striking was around the time that inquire reported, another inquiry was launched into a separate organization in the northwest of England, which experienced similar, very tragic problems and a number of avoidable deaths with mothers and babies in the maternity care unit there.
So there was a real focus in the public mind, and particularly politically, a lot of awareness that there was some really significant safety problems across the NHS. So that was really the context, that a lot of this started around 2012, 2013. I think that the real engine and the force came probably from three areas, really, but interrelated one was patients and families affected, patients and families who’d experienced tragic events. And you know, there are too many people to really point out, but there are some specific campaigners who it’s worth mentioning. So an individual called Martin Bromiley, who’s an airline pilot and who tragically lost his wife, Elaine, in a routine operation, and he’d been campaigning for a number of years to improve safety investigation across the NHS. Likewise, James Titcombe, who lost who lost his son, Joshua, in the Morecambe Bay care failures and was a very vocal proponent for improving investigations across the system.
So, you had some real sort of figureheads amongst the patient and family campaign groups who were very acutely sensitive to the needs to improve investigation. And alongside that I’d been working for well, pretty much my whole career, in improving investigations and learning from incidents. And it was very clear that what happened in the NHS in health care was very, very different to what you see in other sectors, and it was quite striking, I think, for me, that around the time that the Mid Staffordshire inquiry reported was around the time that the 787 Dreamliner was grounded around the world – and my background was initially aviation, but primarily health care the last twelve years or so – so I started putting together some articles around 2013 highlighting the systemic responses to safety issues that you saw in aviation, which we didn’t necessarily have in health care. And that led to a paper that I worked on with Charles Vincent in 2014, where we proposed a very clear policy proposal around what was needed for a system-wide independent, learning-focused organization for the NHS.
So it was very much written for policymakers to try and generate a clear proposal for a solution. And by having networks with a number of the patient campaigners and family campaigners and groups, they were already involved with sympathetic politicians. And one in particular happened to be the chair of a Parliamentary Select Committee that was responsible for overseeing complaints in the healthcare system, or the ombudsman that oversaw complaints, who was very interested in and taken by this proposal and launched an inquiry into whether the NHS needed a body such as this, essentially an investigation body for health care there.
So there was an alignment, I suppose, between patients and families that the research work that myself and others had been doing for a number of years and a few sympathetic politicians. And I suppose, just to mention that was quite a curious stroke of coincidence. So this was Sir Bernard Jenkin, who was the chair of the Select Committee, who launched this inquiry, and he had just happened to be a shadow transport minister around 20 years beforehand, in the late 1990s, when there was a major rail accident in the UK, which led to the Rail Accident Investigation Branch. So he was already very familiar with these sorts of ideas. So there was this unusual confluence of events around the crisis, the campaign groups, the research and the sympathetic politicians coming together, and a long story since then as well.
[00:08:58] Karen Wolk Feinstein: Thank you so much, Carl. So Siri, in Norway, let’s just assume that patients and their families are going to be supportive, enlightened academics, certain figureheads, particularly those who’ve experienced a tragic event. Who supported this idea? Where did it come from in Norway, and most importantly, did you have the support of politicians and hospitals, doctors and employers… some of the big players, were they with you early on?
[00:09:34] Siri Wiig: Well, our story started back before 2010, and it started with the families who, in particular two families, who lost their children, and it was terrible. It was two terrible cases, and it was mostly terrible because of the follow-up afterwards and the lack of follow-up, and the coverups and everything. And they didn’t settle down with this follow-up. So they just started campaigning for the similar type of investigation more that we have in transport. So they didn’t think it was good enough. The regulatory investigations were really not good. And they started back then campaigning, and in Norway, they started very early on to contact politicians, in particular those politicians in opposition, and they were on board.
And we had a national law committee that I was part of that was set down in 2013. And this law commission was going to look at the entire system we have in Norway of handling adverse events in health care. So we looked into this and also part of that mandate was to establish a suggestion for a law, for an independent safety investigation work.
So we did that in this law commission. We worked for two years and have this law commission finalize the reports, and it was sent on for public hearing, and nobody wanted it… the commission and the board and not the public or the state organizations like regulatory bodies and stuff. They didn’t want it because they argue, we already have this system in place to investigate because in Norway we have a regulatory body going in and investigating this.
But these families, they had the politicians – some of the politicians on board, not all of them – and the majority of the politicians at that time was also against it, and the safety scientists like myself. I have a safety scientist background and we had the policymakers with research with information for the decision makers based on what we need to know about learning processes, the repertoire that you need for different kinds of investigation methods, and so on. So you can find that in these reports, in the end there was a shift in the government in Norway, and we got the law approved by the parliament, and this organization was set up, and in the public hearing, you will find a lot of organizations that was against it.
So the politicians actually approved the law despite large resistance, but those who wanted it was the safety scientists. It was the patient organizations and some of the hospitals as well. Then I would say the hospitals where you find strong patient safety research groups; you could see how they had a different response, I would say. So it’s fascinating to see the different responses in Norway at that time. Still, there are people wanting to take it away, but now it’s been in operation since 2019. Of course, the COVID situation has been challenging for such a new organization, but yeah, it’s in place. And now it’s acknowledged as an important tool in the toolbox for patient safety.
[00:13:04] Karen Wolk Feinstein: We know this, that any new idea brings opposition. There’s going to be some, though they’re not even sure what their fear is. It’s just that it’s the unknown and anything unknown could be worse. So could both you and Carl give us some of the tactics you use, things you did deliberately, as best you could, to win people over to the idea of it, a national research investigative study branch on patient safety.
[00:13:34] Siri Wiig: I can start. I would say when I’m thinking back about the tactics, I would say one of them is for a researcher like myself, I’m a safety scientist researcher. I don’t have a formal role in the Norwegian investigation branch. It’s important to share all the information that we have from a safety science perspective from the research and focus on research on learning and the foundations for learning and how to bring information in the safe space. Ally with the politicians–I think that was really key for the patient campaigners, but they also got the support from the safety scientists, with the kind of the safety arguments based on the literature, which I think is also fundamental.
So you need different pillars here. You need the patients and the family voices. You need the research voices, and then you should also have, of course, the organizations and the hospitals and the primary care services and nursing homes, because it’s all covered in Norway in this system. So, and of course we’re close with these in the process. I think that has been one of those tactics.
And for me, I’ve been in public hearings, I’ve traveled to the capital to spend one minute to talk to the politicians in these public hearing processes. And I think that’s probably one of the most important things that we can do show up, show our opinion and show our research, to give information to the policymakers. So that’s my tactic. And also you can see the tactic from the patient organizations, they use the same tactics, I would say.
[00:15:19] Karen Wolk Feinstein: Excellent. Carl, talk a little bit about what tactics you used in England to get your legislation passed.
[00:15:27] Carl Macrae: Yeah, it’s interesting. I guess the situation in England is also interesting because our legislation still hasn’t passed. It is currently going through parliament at the moment so that there was very much a move by, I mean, the background is the Department of Health and Social Care essentially set up the organization very rapidly back in 2016, essentially to get it operational and is now sort of back-filling the legislation to provide the legal framework that it needs to operate, but in terms of actually getting the, I think, engaging with a lot of people, they had some very legitimate concerns about an organization and a function such as this.
And I suppose we in England, we had almost three phases where there was the sort of campaigning phase, which was what I alluded to earlier, where we were writing papers and working with campaigners and engaging with politicians. And during that time, you really are talking to people who agree with you. You’re engaging with your sort of like-minded fellow travelers. Then once the inquiry was launched, the select committee inquiry, that really sort of opens the flood gates to all sorts of organizations and stakeholders who are obviously invited and open to submit their positions and make their case.
And I think that is serious, that really identified a number of areas where there was opposition in some concerns and pushback, and similar to Siri describes, that there was some patient campaigners and family groups who are focused very much on justice and accountability and making sure that individuals are held to account and that they had certain concerns around particularly things like, in terms of, sort of safe space protections to keep information protected within investigations so people can’t be prosecuted or have regulatory sanctions for the information they provide. There were genuine and I think legitimate concerns around those sorts of issues, particularly given that, you know, some people’s experiences have just been appalling in terms of information being hidden and cover-up in what’s happened to that family members and relatives.
So I think that there were different approaches to how this was, you know, how you can engage with these sorts of challenges. For me, one of the primary important areas is to really be very, very clear about what you’re proposing and what you’re not proposing. I think a lot of the concerns and challenges were actually in response to things which fell outside of what the now-HSIB safety investigation branch, it was actually there for the concerns that, for example, the concerns that clinicians perhaps wouldn’t be held to account for things that had gone wrong. But nothing is going to stop the current regulatory or legal system from carrying on doing that.
You know, that it was, it was around being very, very clear in the case that this new investigation branch is entirely separate to that sort of system. And people might have appropriate concerns that the current regulatory system has gaps or has problems in places, but this investigation is entirely separate to that. The regulators can still collect what information they may need, the police lawyers can still go about their process.
And I think what helped from my perspective was this drawing back into the academic literature. There’s quite a clear distinction between two types of accountability. Passive accountability, which is where you’re essentially holding people to account for things that have gone wrong, and active accountability, which is around essentially trying to generate responsibility for improving things in the future. And I think in healthcare systems, certainly in England, we’re tilted far too much towards this passive accountability of trying to find who was to blame for something that went wrong.
So it was very much around making a case and making it very clear that this is a new approach. It’s a system which isn’t going to impinge on or prevent the current regulatory or other activities. But it’s going to create a new space for learning and improvement, which otherwise would not exist. So I think there was something very much around making that, clarifying that argument. And as Siri said, you know, really engaging with people. Once the inquiry had recommended this body be established, the department of health then set up a committee to advise on what it should look like. And we ran a whole range of engagement events and workshops with people who have very, very serious concerns about this organization and with what was seen as withholding information and hiding information within investigation.
So, so there was, there was a lot of very, I think, sensitive and careful engagement and acknowledgement that the system as it stands does have gaps. But this is a new approach and so I think there’s something a bit about being very clear about what is being offered and what is not.
[00:20:29] Karen Wolk Feinstein: It’s so interesting listening to both of you. The crisis is recognized in our country. Like the media have done everything they can–you know, the numbers are out there. The large numbers of people who die every year or are disabled or disfigured from medical error. And then the individual cases, the really poignant stories of families and lost loved ones, needlessly. And so an interesting question, we’re getting ready for a panel we’re going to have at AcademyHealth coming up, and one of our questions to each other was what holds us back?
We now have a pandemic and people are well aware we have more errors than ever. And what holds us back? This has not been a hidden problem here. And listening to you, we have an expression in the United States. They say it’s like herding squirrels. And I love that, Carl, there’s not only passive and active accountability, but there’s also passive and active support. There’s passive and active opposition. And one of our problems is a lot of our support often becomes passive, you know, the same people who will call me and they’ve had a terrible tragedy of medical error. But then it’s like, we’re turning it over to you now, you know, we’re not going to be doing anything.
And you know that it’s sad that often here, the groups that basically support reform don’t support the same reform. So that may be your solution but it’s not my solution. So listening to you, I mean, we’re not alone in this, but somehow we give you both credit, both of your countries, but I know you both took leadership, somehow you herded the squirrels and got enough of the supporters to be active and maybe the opposition to be passive enough that you move forward. So thanks to you a wonderful thing would happen.
For instance, if we would ever get our legislation passed, if there would ever be an NPSB. The challenge isn’t over the day that an entity is created, and I know we’ve had some great discussions with both of you. Talk about the challenges that appear once an entity is established. And Siri, do you want to go first on this one?
[00:22:52] Siri Wiig: Yeah, I can do that. Carl, he has been working more into the organization more than I have in Norway. I’ve not been part of establishing the organization, but I’ve been part of, kind of setting the scene around the organization. And they are located in Stavanger where my university is because of our strong patient safety group here, partly. So, setting up a new organization in Norway, we are a very small country, and that it is also part of the picture, why sometimes this is difficult, because people know each other, 5 million people, and then you have the regulatory bodies and you have an independent safety investigation board, and people work all over the place, and they have part-time positions.
So that’s been part of this picture of setting up a new organization, because they shouldn’t be working on all the same cases. So kind of finding their way through this and then set up the organization with the multidisciplinary competence and how to select the cases they were going to get started with, the methods development, what was their method, and how would they involve patients? Because in Norway, we have the law established. It sets very clear that you have to involve the patient and families. Patient, if they are alive, and their families. And so if you don’t succeed with involving patient and families, if you don’t succeed with making sure that the healthcare professionals can share information in a safe space, you will not succeed in our country.
And so, the most disciplinary setup was also a challenge because this organization is set up to do 20 investigations a year. It’s set up with around 20 people employed. So it says of course, we cannot take on every case. I think that is also part of the challenges you face when setting up this new organization. You are not established to cover all of the – we have around a thousand of the most severe cases in Norway reported, and they are also reported to this board – so among these 1,000 – 1,200, very sad cases, they have to choose, and they are expected to produce 20 reports a year. They are not close to it yet.
So I think building trust in the healthcare system is very important in this early phase, building trust with patients and families. There are a lot of challenges that needs to be solved, I think, when setting this up, and of course in Norway, they have now started to have the law. And I think that is very important for how to then continue the work. They were very certain that this law was kind of their law. They were going to operationalize it. They could show to the law when they set it up.
So I think those challenges, and I think there is not just one challenge, is building new organizations from the start is very challenging anyway, and we didn’t have many countries to look to so we could look to England. We could of course look to other investigation boards, but still it’s some hard work to be done. And of course, that’s why we need to evaluate these kinds of organizations. And if we succeed or not.
[00:26:12] Karen Wolk Feinstein: I was struck when we talked and you emphasized that again, we have so many errors, and errors in different parts of the healthcare system and wherever we begin, it’s going to disappoint some. And I really resonated with that because if you lost a loved one to a certain infection or to a knife slip, or many of them… many things like undetected sepsis, we can go down a long list, you know, I can understand that there are going to be many groups who are passionate, “begin here, begin there.” And there’s so many places to enter.
Thank you, Siri. Carl? Any additional observations?
[00:26:57] Carl Macrae: Yeah, absolutely. And I suppose as Siri mentioned, all of those issues I was involved in, you know, as an advisor to the inquiry and then on the health committee, and then I actually advised and ended up taking a break from my academic career to go and work in healthcare investigation at HSIB, the healthcare investigator, during its early years. So I was very much engaged with some of these really deep operational challenges of how to set up a new body like this. A few things strike me, and I guess we’ve mentioned, you know, just the sheer volume of, unfortunately, the serious adverse events in health care. And I suppose one thing that was striking as Siri said when we talked about the support and opposition to the idea, actually was that the initial Department of Health submission to the inquiry was somewhat lukewarm to the idea, primarily because of this issue, that there are just too many incidents to investigate… logistically too complex on how to think about addressing this.
To his credit, the secretary of state for health and social care, Jeremy Hunt, when he appeared in front of the inquiry, was very, very supportive and became the driving force behind creating the agency. So I think this issue of what to investigate is a real challenge. And HSIB has been set up in such a way that it doesn’t negate or remove the requirement for local level investigation. So any family or patient that experiences an adverse event, a serious event, should be involved in an investigation locally. The purpose of the national bodies is to take the system, the more systemic risks, the major risks across the system. But of course, that doesn’t necessarily address the deep disappointment perhaps of many, many patients and families who might expect a body like this to actually engage with their case.
So a lot of work we did initially was on the criteria for how to actually select what are the most important, valuable areas to investigate. And I developed some of the initial criteria and that there are around 25 sort of sub-indicators that we use, but broadly it was around the overall impact in terms of harm across the system, but the potential for learning, and also the degree of systemic risk, you know, the extent to which it featured as a risk across the system. And there’s some information on the HSIB website and some broader work that I’m still doing on that. But I think that the key is it’s really, really tough to actually focus your resources on what are the most important issues.
And I’m not sure HSIB is, you know, it’s still in its early days. It’s still working its way through what that should look like. So that’s a really big issue. I think and particularly, Siri said this sort of 20 investigations for you come in Norway, and in England, it’s 30 for the HSIB, which I think in itself that arbitrary choice of a number has been a real challenge actually for the organization. It was budgeted for initially around 2 million pounds a year. And I was deeply involved in the process throughout and I’m not sure where this 30 investigations a year came from, actually, and it’s to me it seems almost like the tail wagging the dog in that you’re almost predetermining the scope and the scale of an investigation. If you were saying you have this much money, this many people, and you need to produce this many investigations… I’m not sure that that’s a useful way of scoping the activity of an organization like this. So that’s one issue.
I think related to that as well, operationally a big challenge is the need to be operational or to be seen to be operational. And I think there was a lot of expectation, everybody like this, both internally that then the people that were recruited were keen to get going, keen to get started. The investigators tend to like investigating and they’re oriented to action and there was an eagerness to sort of head out the door and just get going and equally politically there’s a sense that you have to be seen to be delivering.
So I think there’s something in terms of, actually to my mind, that there wasn’t that space created to accept that this is a developmental, almost experimental operation for the early years, and it needs to be treated as such. It needs to, as Siri says, it needs to be closely evaluated. The methods and the processes, all of this needs to be done in public so people can be learning alongside at what works, what methods work and those sorts of issues. And I think the challenge for HSIB was to literally be seen as being turned on. You know, switched on in 2017 and operationally just go and investigate. And I think that there needs to be a sense that this isn’t an operational organization like British Airways or United Airlines or something. This is more like NASA where you’re sort of having to learn as you go in and do experimental developmental work.
So, I think there’s something there to perhaps in your experience that may be reflected to actually create that space for, even once it’s established, to be very clear that here’s a lot of learning and a little bit experimentation to be done. I mean, there’s a whole other session I could pick up on the challenges of operationally getting these things going, but that’s when we said enough to start.
[00:32:26] Karen Wolk Feinstein: Well, NASA can put an astronaut on the moon or have a little helicopter hop around Mars, and we can’t get people out of outpatient surgery without getting infected. So I like the analogy that NASA made it happen.
Carl, you have a background in human factors engineering, autonomous systems, and both you and Siri have worked in other industries. Talk to me, will your agencies, as you see it, go everywhere from studying preconditions, understanding what happens that precedes a medical error that suggests an error has great potential? Are you going all the way to solutions? Will you be offering solutions and autonomous digital solutions as well? Will they be tech-enabled?
[00:33:13] Siri Wiig: You’re talking about the preconditions, if they will go way back in time to look or to, to look at the neck of causality. That’s what you mean?
[00:33:23] Karen Wolk Feinstein: Well, understanding the whole chain of events from the things that might suggest that harm is going to happen all the way to the solutions. How do you prevent harm, and best yet, how do you prevent harm, of course, before it happens?
[00:33:42] Siri Wiig: Yeah, I would say that’s what they will try to do. And they will focus on all these cases that they choose, but they will also choose topics–investigation themes, not just single cases. We just had a recent report that came out on invasive surgery methods and development, and there were a lot of cases in a row for several years, and they went into that topic to see, how is that possible? Why did it happen? How can we prevent it from reoccurring? What needs to be done with the system?
So I think they have a kind of a methods repertoire or a possibility of a very wide repertoire to go into, to the cases and to topics they can choose. For example, to go into a major change process in the hospital – because we know that change processes that’s involving risk as well – and maybe these organizations are not as well equipped to look into that as, for example, the oil and gas business in Norway. So when I started working in oil and gas business, they talked about change and risk and the regulatory bodies went in to inspect Statoil, the Norwegian national oil company at that time, and now it’s called Equinor. They went in to look into that, but in the hospitals, we had the big, big merger of all the hospitals in the Oslo region and nothing happened from the regulatory side.
So this, you come can go into these kinds of topics, themes, and they will look a lot around, but to come up with solutions, I don’t think that they will come with solutions because that is a risk, I would say from this organization to come back with solutions. They will come with recommendations, and they will come with targeted recommendations to the specific levels. And also they can actually look into all the stakeholders in the system, including the ministry, including the regulatory bodies… what’s their role?
So that’s the big, big difference to have a system-wide perspective, independence, they can go investigate all actors and then they can come with recommendations, but not solutions. I would not recommend them to come with solutions because I don’t think they are necessarily the right body to come with solutions, but they could come with recommendations of how to solve these problems, and then the right bodies should focus on the solution. That’s also very much according to how the Norwegian healthcare system is set up. It’s regulated with a high degree of enforced self-regulation, meaning that service providers know best the risk, and therefore they should also know best how to find the solutions to handle the risk. And that’s kind of relevant to all levels in the system, from the sharp end to the ministry end. And if that was a response to your question, I hope so.
[00:36:35] Karen Wolk Feinstein: And Carl, do you want to make some comments on this?
[00:36:41] Carl Macrae: Yeah, I just, I suppose want to emphasize what Siri described. I think there is, there’s an important distinction between making recommendations for change in response to a particular safety issue or risk and actually developing solutions, which, as Siri indicated, that these investigation bodies generally need to stop well short of actually developing or recommending a particular solution, in part, because if that solution turns out not to be particularly effective in five years’ time, who’s going to be able to investigate an issue associated with it? They’re no longer impartial if they’re actually contributing to the development of a solution.
So I think what’s the big opportunity for these sort of bodies as Siri says, is that they’re system-wide. They’re able to investigate at any level in the system and should think about how regulations are made, whether standards are appropriate and how standards have been developed, and whether their health standards are implemented in different ways from the very frontline to the sort of top of the hierarchy as it were. But I think that the opportunity is that the safety recommendations should actually take the chance to focus on actual system redesign and system reform. So it’s not just everything from the redesign of the standards for medication packaging or whatever that might be through to the design of care pathways, and actually these recommendations should be, I think, an opportunity to bring together a new coalition of organizations to think about redesigning parts of their healthcare system.
One of the challenges that HSIB has faced to date has been sort of squaring the circle of investigating fairly localized events, incidents as safety incidents are always highly personal and locally involving a patient, a team, a family, and actually being able to connect to that with more systemic recommendations at a national or a system level effectively. And I think the challenge has been, perhaps not to be that they haven’t yet been robust enough or perhaps confident enough to actually begin investigations, which consider how the regulator is doing their work. And I say that as someone who now actually works a day a week at the regulator, but there’s a real need to think about how recommendations can really lead to the change of the design of how care is delivered and how healthcare systems are organized.
I mean, you have sort of, almost a great example of this in the National Transportation Safety Board (NTSB) in the US and their early investigations of autonomous vehicles and tiny automated vehicles, which they’ve done the past few years, where a lot of the recommendations have been focused on actually, what is the infrastructure that’s needed to collect safety data so that we can investigate these sorts of events? What are the sort of parameters that should be collected? And I think in health care, we’re almost at that point where these recommendations should be about, what are the standard metrics of safety that should be collected in particular areas? What should the system design actually try? So, yeah, I think a big focus should be on design and redesigning the system in its socio-technical sense, not just a piece of equipment and technology.
[00:40:11] Karen Wolk Feinstein: Thank you, Carl and Siri, for your enlightening conversation. This has really been helpful to us because we have so much to learn here in the United States from your efforts. You went first, and it was an honor to host you for this conversation. Thank you for joining us from England and Norway.
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If you want a transcript or the show notes with references to related articles and resources, that can be found on our website at npsb.org/podcast/. Up Next for Patient Safety is a production of the National Patient Safety Board Advocacy Coalition in partnership with the Pittsburgh Regional Health Initiative and Jewish Healthcare Foundation.
It is executive produced and hosted by me, Karen Wolk Feinstein. Megan Butler and Scotland Huber are my associate producers. This episode was edited and engineered by Jonathan Kersting and the Pittsburgh Technology Council. Thank you, Tech Council! Our theme music is from shutterstock.com. Social media and design are by Lisa George and Scotland Huber. Special thanks to Robert Ferguson and Steven Guo. Thank you all for listening.