Episode 01: Medical Error & the NTSB

Join special guest host Harry Litman, the host of the Talking Feds podcast, as he interviews Robert L. Sumwalt, former chairman of the National Transportation Safety Board (2017-2021), and Dr. Karen Wolk Feinstein, president and CEO of the Pittsburgh Regional Health Initiative, as they explore this persistent problem in health care and a new proposed solution: a National Patient Safety Board (NPSB) modeled after what has made airlines one of the safest industries in the country.

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Episode Transcript

[00:00:00] Harry Litman: Hello everyone. I’m Harry Litman, the host of the Talking Feds podcast and I’m a born and bred proud Pittsburgher. And this is the first episode of Up Next for Patient Safety. We’re here today to shine a spotlight on an acute crisis in healthcare in this country that most people scarcely know. It’s medical error.

Believe it or not, medical error is the third leading cause of death in America. I’m just going to repeat that because it boggles the mind. Medical error is the third leading cause of death in America. Every year, 250,000 people die because of preventable medical error. Think about instruments left in patients during surgery or infections acquired in the hospital or medications that are inaccurate or delivered in the wrong dose, or that are not delivered on time. And that 250,000 figure of course has been compounded in the last 18 months or so by the 600,000 plus deaths from COVID-19 untold numbers of which were preventable with better crisis, man. This podcast will untangle the web of causes for our high medical error rate and discuss a promising solution with experts in the field.

I’m joined today first by Karen Wolk Feinstein, President and CEO of the Pittsburgh Regional Health Initiative, who has been fighting a battle against medical error for over 23 years. And she is now trying to promote a new solution that could literally save millions of lives because there is no government agency tasked with preventing medical error, which is tragic. And so much of the horrific consequences would be sharply reduced by the sort of expert oversight and coordination we’ve employed with great success. In other areas, Karen envisions an agency focused solely on preventing serious medical harm to patients and workers from both annual medical errors and pandemic deaths.

We want to look closely today at one of the most successful models, the government has devised, and that is the National Transportation Safety Board or NTSB. Most people know that air and train travel is remarkably safe, but that didn’t just happen, it was propelled in large part by the specialized focus of a federal agency created for that purpose. And we have the perfect guest to explain the model and why it’s been so successful. Robert Sumwalt, the chair of the NTSB from 2017 until just a couple months ago. So, welcome Karen and Robert. And I hope in a few short minutes, you can help people understand the grave current crisis and preventable deaths from medical error and the promising model that the NTSB presents for reducing them.

Karen, let me start with you if I can. So, the Institute of Medicine released a groundbreaking report – at least it was thought of that way – over 20 years ago in 1999, entitled, To Err is Human. That report found that 98,000 people were dying every year due to preventable medical error. What’s changed since 1999 in patient safety?

[00:03:31] Karen Wolk Feinstein: Well, Harry. I have bad news, not much. Now, my opinion is one thing, but the National Academy of Science, Engineering and Medicine took a look at our progress over 20 some years and concluded that we’ve made almost no progress, it’s pretty discouraging. We have little blips of progress, but then it doesn’t get standardized, it doesn’t get spread, and so it doesn’t get sustained. In one area, central line infection, we’ve been able to hold our improvements and change the outcomes of care, but that’s about it. So, I think sadly the conclusion is bleak.

[00:04:13] Harry Litman: Well, and if I read it right, it’s not just, it hasn’t gotten better. We’ve gone from a hundred thousand to 250,000 in these 20 years of supposedly modernized medicine. Is that accurate?

[00:04:28] Karen Wolk Feinstein: Accuracy to something that’s a little complicated. It’s how you define an adverse event and how much you’re able to detect from the EHR, the electronic health records, and other data sources. So, I would just say it’s always been bad and we’re getting our arms around the fact that this is a real crisis in American health care.

[00:04:53] Harry Litman: All right. So, it sounds like at a minimum, not any kind of dramatic improvement in the last 20 years. Robert, can I turn to you then as the former NTSB chair, how has the aviation industry innovated in safety in the past, say same period, 20-22 years?

[00:05:14] Robert Sumwalt: All right. It’s a great question and good to be with you and Karen, let me present you with some figures that are really mind boggling. There was an air carrier, an airline crash going into Buffalo in February of 2009. Unfortunately, that crash claimed 50 lives. The next passenger fatality on board, a U.S. scheduled carrier was in April of 2018 in a very freak accident where a woman was partially injected through a window. In those nine years, 6 billion passengers flew safely on U.S. airliners. That is incredible. 6 billion people. Over a nine-year period without a single fatality. And I think that there’s a lot of reasons why the airline safety record has gotten as good as it has.

[00:06:07] Harry Litman: Well, let’s zero in though, if we can, because we’re thinking about applying it to patient safety – you probably saw the recent article on the wall street journal about the outsized success of the NTSB. I’m sure that got around from your staff, the airline safety revolution. So, you know, how might you summarize the aspect of NTSB intervention that is responsible for such a dramatically, you know, pristine safety record?

[00:06:38] Robert Sumwalt: Well, I think the NTSB really by statute is an accident investigation agency. So, they are looking at bad outcome in arrears. They are looking at something bad that happened and figuring out what happened so that they can issue recommendations to keep it from happening again. Collectively though, I think what the airline industry has done very well at is doing about three things that I think have greatly contributed to this successful safety record. They have successful incident reporting systems whereby employees freely will admit errors that they committed or safety hazards that they see. They can do this because the airlines have basically a non-punitive culture where people feel free. They’re even rewarded for reporting bad outcomes.

There’s another thing is that airlines are routinely monitoring their normal flights. Every flight they are monitoring various aspects of that to see how the system is working. And I think the third thing that the airlines are doing very well with is that they are openly sharing de-identified data with each other and with the regulator so that everyone in the industry sees where these problems are. And I think collectively those things have greatly contributed to the good safety record of the U.S. scheduled passenger airlines.

[00:08:03] Harry Litman: Got it. Just a quick follow-up and then Karen you can probably guess I’m going to ask you for a comparative picture in the healthcare industry, but this culture point, the first one that you raised… what explains it? I mean, you know, that is remarkable. I certainly know, as a lawyer, that the healthcare industry is very different and there’s fear and loathing of punitive measures and lawsuits and the like. Are there any… is there anything either the airlines themselves or the NTSB has done to foster this non-punitive culture?

[00:08:42] Robert Sumwalt: Yeah, the airlines have, over time, learned the importance of something that we call a just culture. And it is that the honest mistake, if you will, of those who go out and are well-trained and well-intentioned, and then go out and commit an error, if they report that, they’re not going to be punished. And I don’t think that model necessarily exists in the healthcare business. And I think that’s one of the successful things that the airlines have done is establishing that just culture. Now, it’s important to point out that a just culture is not a get-out-of-jail-free card.

That’s not that at all. There is accountability in the system. If someone blatantly does something wrong, if they show up for work after having consumed alcohol or something. Yes. There will be consequences for that. But the honest mistake, if you will, that is not punished at all. They try to learn from that and use it as a learning opportunity.

[00:09:43] Harry Litman: Got it, so Karen, and not just on culture, but the three aspects that Robert mentioned. I know, as you said, it’s a little hard to, you know, one of the big problems here is to get our arms around the data and the different chronicling of problems. But how would you compare the medical industry? What’s lacking there? What pangs of envy did you have as you heard Robert detail the aviation industry’s basically fine record?

[00:10:14] Karen Wolk Feinstein: Well, I literally drool with envy. So, I’ll use the constant reference to psych 101. Look at the incentives, right? There are many industries, not only aviation, that have gotten incredibly safer over the last three decades and if they don’t get safe, they close or fail. It’s their incentives. People won’t buy their product or they have federal agencies that will close them down if they’re wildly unsafe. But in healthcare, we don’t have those incentives. First of all, safety is expensive, and nobody pays for it. It’s an added expense for which there is no reward because there’s no market in healthcare.

In other industries, people have information to choose. But in healthcare, the patients seldom have the information or the purchasers, and those are the employers like myself. So, they don’t reject unsafe doctors and hospitals because they often don’t know. And the data that are out there are very confusing. They get data from different sources, but they often contradict each other.

So, you know, your other big issue. Who asked for accountability, right? I mean, if you’re able, very few industries say, make me more accountable and who’s going to press for this? So you know, the patients are overwhelmed and what has happened is the task of oversight of accountability is parceled out over dozens of federal agencies and independent organizations.

In a sense, you say, well, maybe that’s good. The more players, the more they pile on… actually not. The problem we have is with all this confusion, it’s very hard to make public the safety record of institutions. And you’d have to ask yourself how much does this trouble them.

[00:12:12] Harry Litman: Yeah. I mean, first of all, I can say, just as a normal patient, looking, at the behemoth of the healthcare industry, if something goes awry, you have no idea what it was and what happened. But I also just want to echo the point you just made because it’s not – as you say – a boon, but rather a problem to have many different agencies, because what happens is you have these inter-agency working groups that blah, blah, blah, over white papers and never really get something done. Whereas, if there’s someone really in control and accountable for the bottom line – I’m thinking NTSB – I’m also thinking of the recent, creation of the Consumer Finance Protection Bureau. It really does make a difference. There’s a single cop on the beat.

All right. Well, let me ask, I know you’ve been working tirelessly at this Karen for 20 plus years. Is there a ground swell, if not from individual patients, at least from groups who are concerned with healthcare or consumer representatives, for some kind of better outcomes and structure here? Is anybody out there making the case for it?

[00:13:28] Karen Wolk Feinstein: Here’s the problem you might ask – any of us would ask – look, with a quarter of a million people dying a year, and these stories are – the media’s done a great job of covering many of the horrible incidents that happen – so it’s not as if this is a secret, but the public, I think, approaches this the way they do climate change. It’s kind of amorphous, long-term, out there and it’s not visible. It’s not like the reaction parents have when someone puts a cell phone tower near a school, right. Even though by the way, there is no proof of that cell phone tower does any damage. They can see it. And it’s right there near their kids and they get worked up.

But the American public seems to think that medical errors are just some sort of invisible amorphous problem of which they may get and be the victim, but they’re not going to die. The other is I think it’s kind of a religion or an unfathomable mystery. It’s just too complicated. And it’s too scary that the settings that are there to help you heal could actually hurt you. I think people just don’t want to deal with that. So, yeah you reference many excellent organizations like AARP, FamiliesUSA, Patient Safety Movement, MedStar, and Stratis Health. I mean, there are organizations that care a lot about this issue, but we don’t have the groundswell that say Robert would get when an engine falls off a plane outside of the Denver airport.

[00:15:00] Harry Litman: Yeah. So let me follow up and double back to you on that, Robert, because it’s not as if the transportation industry is uncomplicated, but it does seem that it’s you know, the problems there are so isolated and spectacular is probably the bad word to use, but I mean, really attention-riveting. Can you sort of connect that up though, to how the agency works with transportation providers, transportation agencies, how do you, what do you have a, an established protocol for when you get involved to investigate things, how you work with regional state or local authorities and how tangibly you have a sort of… from problem to recommendation, to ameliorative step process.

[00:15:52] Robert Sumwalt: There are a lot of questions, right there. A lot of points right there in that one sentence…

[00:15:56] Harry Litman: I can shorten it. Maybe you can just walk us through a typical NTSB investigation process.

[00:16:03] Robert Sumwalt: Yeah, the NTSB has the statutory authority and responsibility to investigate every aviation accident, every civil aviation accident that happens in this country that meets a certain criteria and the criteria would be you know, it’s a legal definition of what constitutes an accident, substantial damage and serious injury, hospitalization, more than 24 hours or something like that. So we – and it’s hard for me to quit saying, we, because I just left the board just about five weeks ago – but, they do investigate every accident. And so we’ve got a finite, a closed data set if you will. We know of every accident. I’m not sure that’s the case in the medical community where…

[00:16:47] Harry Litman: Domestic or international? As long as it’s in our jurisdiction. I mean any airline at all?

[00:16:54] Robert Sumwalt: Yeah. Any aviation accident that occurs in this country the NTSB will investigate and the board would also be a part of international investigations. If it involves a U.S. manufactured, designed or registered designed or manufactured product. So, the board looks at a lot of aviation accidents.

Let me go back to something that Karen said. She said a quarter of a million people die each year in this country due to medical error. Compare that to 2 million passengers flying every day, 2 million a day in the U.S. airspace system without fatality. And so, there’s a really a striking difference in the in the safety record of one domain versus another.

[00:17:39] Harry Litman: Yeah. So, Karen, you’ve been really thinking about this for a long time. You’ve come to the conclusion that a NTSB type model agency would work best. And I think in your mind, you’ve got more than a little bit of the blueprint, can you kind of share with us your thoughts about if we had a National Patient Safety Board, how exactly it would work.

[00:18:02] Karen Wolk Feinstein: I’d say I’ve thought about it. So have others. Although we’ve been pushing for this for about a decade and a half, I’d say over three decades, the idea keeps surfacing and then for some reason it doesn’t get done. I think of a National Patient Safety Board an NPSB as a giant think tank and it could do the kind of national studies to understand what conditions precede medical mishaps and also, how do you anticipate it? How do you correct for it? This is no mystery. This is what other industries do because they use the frontiers of technology and data analytics to do just that. And many of these autonomous solutions that have been proposed and adopted from the NTSB could also be applied to healthcare.

We just haven’t done that. We rely a lot on medical doctors and nurses to do this kind of frontier technology and analytics thinking for which they were not trained. My sense is that if you had an organization like the NTSB, we could on a national scale start taking the burden off the front line and come up with some of these same autonomous solutions.

[00:19:25] Harry Litman: Yeah, that’s an excellent point. There’s no specific reason to think that people who are trained at doing surgery or, changing bed pans or whatever are our best position. Obviously, there’s some really big pieces missing in data management and everything about a bird’s eye view that are just not being brought to bear. So, it does sound like largely a think tank model and they would develop proposals and what, propound them to Congress? Or have you thought about it logistically to that?

[00:19:56] Karen Wolk Feinstein: The best thing that I love about the NTSB, maybe why it’s so popular, they put the solutions out there and then it’s up to the other agencies that regulate, that standardize, to either put them or make them required or else just have the people/airlines adopting because they don’t want to have a mishap that could have been prevented.

And I see this working in the same way. Maybe some recommendations would be adopted by the Joint Commission, so that accreditation would depend on you having, for instance, standardized defibrillators – it still kills me that our defibrillators aren’t standardized, not only, not standardized, they’re sometimes contradictory – but these will be things the Joint Commission could pick it up, the Centers for Medicare and Medicaid could pick it up, or they could just be out there in the public domain so that if you don’t adopt them, you’re an outlier.

[00:20:57] Harry Litman: And Robert, anything to add to this? Cause you’ve now been through the creation of an agency. Maybe it could have been slightly tweaked or maybe you think the motto is perfectly adaptable, but what about how it would actually work day-to-day?

[00:21:16] Robert Sumwalt: Well, I think there are certainly elements from the NTSB, as well as the rest of the airline industry to put together something like this. I don’t think the NTSB model alone is what you’re looking for because that the NTSB historically is an accident investigation. But I think that you could have a freestanding agency that would look at all things, healthcare, whether it’s investigating sentinel events, whether it’s collecting data, sharing data whatever it happens to be. And I think Karen told me once that there’s like 36 organizations involved in some element of, of healthcare. And is that necessarily the best answer? I don’t know. Karen, Harry, you’re the moderator, but Karen, what are your thoughts on that?

[00:22:00] Karen Wolk Feinstein: Well, you know, we do have a bit of confusion out there with all the different organizations, but the saddest thing is many of them come up with individual solutions, problem solving. They do a little root cause analysis at a small unit level and they don’t do it at large scale national level. As a consequence, we very seldom think about preventing errors before they occur. We look back and we say, oh, what went wrong? But it may only be, it never gets out of that hospital unit where they did the root cause analysis it’s frankly kind of crazy.

[00:22:45] Harry Litman: All right. In the little bit of time we have left let’s talk political brass tacks a bit. Karen, it will literally take an act of Congress to establish a National Patient Safety Board. So actually for both of you, the 117th Congress has got a few things on its plate right now. What needs to happen in order for this, your vision, Karen, to become a reality and a priority? And I want to ask in particular, if this is the sort of thing that a legislative strategy would be to kind of be front and center, or sort of, you know, as some big developments in Congress are sort of slipped in through a side door.

[00:23:29] Karen Wolk Feinstein: I’d say A or B! Yes, obviously for us, in some ways the gold standard is an act of Congress that creates an independent. And let me underline that the NTSB is independent of…

[00:23:46] Harry Litman: Robert, you’re shaking your head! Do you think the independence, which I gather has meant that the president can only fire for cause, has been an important part of the success here?

[00:23:55] Robert Sumwalt: Yeah, I’m certainly nodding my head at that. The NTSB is in fact, an independent agency. They are not a part of the Department of Transportation. And I think that gives them the freedom to call it the way that they see it, to say that the FAA or the DOT did not do this or that. I think that’s a critical part of whatever organization would be set up for healthcare because that’s a critical element of the NTSB.

[00:24:27] Harry Litman: And it is a big kind of controversy now in the law, but I’ll leave that to the side. Karen, I interrupted you because that kind of sparked my interest. Sorry, going back to you…

[00:24:37] Karen Wolk Feinstein: No, no, it’s so important to both Robert in terms of the success of the NTSB and my perspective on what would make a successful and NPSB. So, obviously an act of Congress. We are encouraged by the speed with which the Consumer Financial Protection Bureau was created, responding to a crisis at that point financial, but we do have a pandemic, which unfortunately is entering, I guess you call it the fourth wave. We do have a pandemic and I think it is also a crisis situation. I don’t want to separate responding better in the future to a pandemic, the problems with our public health system, and why we can’t make any dent in medical error, they’re all related. I honestly believe that an NPSB could protect patients and workers better in all three situations.

So, what do we need? We need what the Consumer Financial Protection Bureau had, I mean, no mystery, a passionate Senator (Elizabeth Warren) and a responsive president. So yeah, I get up every day and wish for two passionate senators. One is R one is D and a white house that says, darn we better get on this, it makes good sense.

[00:26:02] Harry Litman: First director in Richard Cordray! All right, Karen and Robert, thank you so much for taking the time to explain this. Huge and largely preventable crisis in our healthcare system. It really does seem astonishing that something like medical error, which can be sharply reduced as the third leading cause of death in this country.

Let me just ask you a final question. Is there anything that listeners out there can do to play a role either in addressing the problem or bringing the NPSB into life?

[00:26:39] Karen Wolk Feinstein: Oh yes! Thank you so much for asking. We’ve put a broad coalition together, which I do think is very impressive as all the key stakeholders: hospitals, insurers, consumer advocates, thought leaders, quality improvement groups, all of them… we have over 50 major U.S. organizations from health systems to national Blue Cross Blue Shield, FamiliesUSA, and more.

We also have a website, and I really would ask our viewers, our listeners to visit it at npsb.org, sign a petition, register your interests, get informed. And I’d say if you know anyone on either the Senate HELP – the Health Education, Labor, and Pensions – committee, or the House Energy & Commerce committee. If that’s your Senator give us a call. We want to talk to you. We definitely know what makes the difference, what sinks the pot, and we need that passionate representation.

[00:27:41] Robert Sumwalt: You know, you asked earlier what does it take to get something like this going? And let me just say that it usually takes blood. It takes blood spilled. That’s what gets people’s attention. Back in the early thirties, a loved and beloved football coach at Notre Dame was killed in an aviation accident and that got something formed to start investigating aviation accidents. June 30th, 1956 was the Grand Canyon midair, two airliners came together over the Grand Canyon, 128 people died that day. That led to the formation of the FAA. And so, it usually takes a very serious event to get change. Well, unfortunately, we’re having very serious events every day, every hour in the healthcare system, but there’s not that crisis mentality that we’ve got to do something. So let’s go ahead and stop these – prevent these – medical errors before they lead to 250,000 deaths each year.

[00:28:47] Harry Litman: It’s a great point. It’s like a rolling serious event. All right, well, that’ll do it for the first episode of Up Next for Patient Safety, stay tuned for subsequent ones and for the general, and heavy lifting and blood as Bob puts it to really try to launch some at the kind of agency that could have such a huge impact on such a tragically preventable source of death in this country.

Thanks very much Robert and Karen for being here. Bye-bye everyone.

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