Kathleen Wessel (Host): Patient safety is top of mind for providers and healthcare leaders. Healthcare organizations can fill critical safety gaps and turn compliance into a competitive advantage by re-imagining safety, quality, and clinical efficiency through the lens of the Patient Safety Initiative and advanced clinical surveillance.

Welcome to AHA Associates Bringing Value, a podcast from the American Hospital Association. In this series of podcasts, we speak to AHA Associate Program business partners, check in on their efforts, and learn how they support AHA Hospital and Health System members. I'm Kathleen Wessel, Vice President of Business Management and Operations at the AHA. And today, I'm joined by two esteemed pharmacists, Chris Emerson, VP of Clinical Quality, Training, Oversight and Innovation at Inovalon; and Martha Tran, Director of Application Support at Inovalon. Chris and Martha, welcome to the podcast.

Chris Emerson: Thanks. Really excited to be here today.

Martha Tran: Yeah, thanks so much for having us.

Host: I want to jump right in. I'm excited about this conversation. We all know EHRs serve as a primary infrastructure for communication and coordination across healthcare teams, yet they tend to fall short when it comes to filling critical safety gaps. Can you share with listeners why the EHR isn't enough when it comes to preventing harm?

Chris Emerson: Yeah. So, I'll jump in first. Kathleen, I couldn't agree more that the EHRs are really just not enough when it comes to patient safety. We look no further than a study published in the New England Journal of Medicine in 2023 by Dr. David Bates and colleagues that highlighted that adverse events are still occurring in nearly one in four admissions with a quarter of those adverse events being preventable. And we still have a really long way to go here to get to a state of safe care for our patients in the hospital environment specifically.

In the last six years here, working at Inovalon, which was formerly called VigiLanz, I've been heavily focused on the safety event reporting space. And I think that having a strong culture of safety that really promotes voluntary event reporting and embraces technology to augment that voluntary reporting is a cornerstone to an effective safety program.

Through event reporting, data organizations can truly understand the areas of risks so that they can implement quality improvement initiatives to address those risks. And we know from the literature that safety events are dramatically under-reported with more than 50%, in some cases, all the way up to 80% estimated of safety and incidents that go unreported.

You know, EHRs are very, very focused on clinician workflows, documentation related to patient care, billing for those services that clinicians are rendering. But, you know, EHRs also, they contribute to clinician burnout through information overload, excessive documentation requirements, cumbersome system navigation as a few examples, and really also take clinicians away from being at the bedside where they provide direct patient care, which really can also be detrimental to providing safe care for our patients.

I really also think EHRs are not focused on providing a mechanism for staff to report safety events, near-misses, and safety concerns that they come across day to day. And it's that rich safety event reporting data that can provide organizations with insights into their areas of risk and drive performance improvement initiatives to fill critical safety gaps.

The EHR alone can't solve the problems we're facing. And we need to be able to recognize that there are other tools out there that can help identify and address issues related to safe quality care for our patients.

Martha Tran: I want to add onto that a little bit. Chris touched on just slightly talking about how much data is in the EHR. So, sometimes when talking about EHR is not enough, I almost think it's too much. There's too much data. A patient might come into your system with a history of-- maybe they've been with you for 10 years, there could be over a hundred thousand data points in there for the clinician to review. If the patient comes into maybe critical care, they might be getting 1000 new data points in just a single day. And that's going to lead to just a lot of manual work, a lot of time is spent just sifting through that medical record, pertinent information could get missed. And so, you really need something that can help you make sure that you're getting the right data to make the best decisions, and that those decisions or responses are not delayed. And so, that's where clinical decisions tools can be used. They're going to pull key data points together in near real-time. And then, you're going to have those faster responses. So, the clinical decision tool or alerts, they pull that data in, they make sure that the data's in the right place at the right time, and that's what we're looking for and that's what's going to make a difference.

Host: It's just an overwhelming amount of information coming at various clinicians who end up interacting with patients. So, I appreciate your raising all of those issues. Before we dive a little further, can you share a bit more about both your professional journeys and what experiences brought you both to Inovalon? And Chris, why don't we start with you?

Chris Emerson: Yeah, sure. So, as already mentioned, I'm a pharmacist by education. I graduated from the University of Michigan, completed a PGY1 pharmacy practice residency at the VA in New York City. After that, I spent some time as a faculty member at the Arnold & Marie Schwartz College of Pharmacy and Health Sciences at Long Island University. And it was really during that time, precepting students out of Lenox Hill Hospital in Manhattan, which is now part of Northwell Health. I became very interested in technology and how technology and healthcare can improve patient care. And I ended up taking a full-time position at the hospital there in pharmacy informatics. I did that role for about five years before our family relocated to Chicago where I found this job that I'm doing now for the last 12 years in healthcare software and supporting and implementing the VigiLanz Pharmacy Surveillance Solution for a long time.

But since then, I've taken on a broader role and support all of our clinical surveillance solutions, our infection prevention pharmacy safety and quality products. And I have a wonderful team of 17 dedicated healthcare professionals who support all of our solutions, and Martha is one of them. And I'll let her give us her background here as well.

Martha Tran: Thanks, Chris. So, I'm also a clinical pharmacist by training. And I would say I'm a true Midwest girl. I went to Purdue University to get my degree. And then, I continued on to La Crosse, Wisconsin, where I was at Gundersen Lutheran for my pharmacy practice residency.

Then, I took on my first job at a large teaching hospital in Chicago. I started with inpatient oncology. And I would say that's where I got my first taste of how technology could really improve the patient care and make it safer. One of the pharmacists I worked with there was really savvy and started creating templates for us to use for the common chemotherapy regimens. And these not only calculated or double checked our calculations on doses, but also made sure the other important pieces of the protocol were there. So, making sure there were pre-meds, or making sure that the patient was getting the right fluids, all those little things that could easily be missed if there wasn't a checkpoint.

So then, I really started thinking about, you know, technology and kind of, you know, where I wanted to go. And I moved on from there to be a clinical manager. And I started working for an organization that was very, I would say, forward thinking at the time, definitely very data-driven. They used data, and then patient safety to be the things that really set the roadmap to what they're doing.

So while I was there, I worked closely with clinical informatics and I was involved in three big technology initiatives. One was bedside barcode scanning. One was implementation of smart pumps. And then, finally was the implementation of a clinical surveillance tool. So, all of these improved patient safety. We caught near-misses, wrong dose, wrong drug, even wrong patient with the bedside barcode scanning. And then, the smart pumps really played a major role with helping those nurses, especially if they're titrating a medication or we had a nurse-led heparin protocol. It helped ensure the safety of that. And then, of course, where I started with chemotherapy, the administration of that was also made safer.

But what really stuck with me was the response of the pharmacy team when I implemented the clinical surveillance tool. You know, we had a really nice EHR. They got alerts at order entry. They had a task list and they got reports for their daily work and prioritizing it. So when I was tasked with implementing this, I was a little bit nervous to roll out a new tool. I had probably half or maybe a little bit more of our team. They were the biggest fans of new technology. And then, in particular, I had one pharmacist who just was adverse to change in general. So, I kind of was really worried about the acceptance.

And I transitioned them over to the tool. When it first went out, I punched a lot of questions. And the questions kind of slowed a bit, so I kind of thought, "Oh, maybe they're really starting to like this." And then, I found out, oh, actually, they're still using those paper reports. So, immediately, those reports, they were no longer printed and really had to kind of force them into using the tool, take away the crutch. And the pharmacist came up to me and actually thanked me for adding this tool to their workflow. So, I was shocked. You know, there was no more manual hunting. We were getting more work done. Interventions were definitely getting made sooner. And one big thing is that important handoffs weren't being missed anymore. And so, my little "aha" when the pharmacist came up to me, the one that I mentioned earlier who was really adverse to change, and she said, you know, "You usually just add more and more work to our plate. But this has truly helped us with our daily work. Thank you."

So, that was just a great feeling. I was so excited. I was really adding a complementary tool for them. And since I had spent a lot of time deciding how to do it, it really felt good. And so, that's kind of what got me more interested in this clinical surveillance. And I ended up leaving that role and moving on to VigiLanz, which is an Inovalon solution. I've been able to share that tool with so many more pharmacists. And I've been with actually VigiLanz for 11 years, so I've seen it grow so much. I'm just as passionate now, 11 years later, on improving patient care and seeing what we can do with the tool. And I have an amazing team that also share this passion. And we really just challenge each other every day-- what more could we do?

Host: I love that, both of you. Such rich histories that you're able to bring into your current practice. And thank you for sharing that story, Martha. That was wonderful.

Moving on, AHA's Patient Safety Initiative is a national effort aimed at improving patient safety across U.S. hospitals and health systems. Its goals are centered around three foundational pillars, fostering a culture of safety, addressing disparities in safety, enhancing workforce safety. Can you share with listeners how leading organizations are implementing advanced clinical surveillance to support the goals of the patient safety initiative and often turning compliance into a competitive advantage, Chris?

Chris Emerson: I'll get started with a little story about a customer of ours that's utilizing what we call autodetection here at Inovalon, and that really is focused around creating that culture of safety. Specifically, we have a safety event reporting platform that we call safety management. And that solution is utilized by several leading healthcare organizations across the country. And I have the esteemed privilege of being able to connect with those organizations on a regular basis. And we work very closely with them to identify new and innovative ways to use the products to improve patient safety and outcomes.

I mentioned this autodetection piece, and that's really one of the most exciting things that we've worked on here in the last several years. And I have a good example of a customer of ours who has a large hospital system, and they were the first to implement our rules-based AI solution that leverages a rules engine to automatically detect when safety incidents have occurred based on data that we're receiving from the electronic health record. They implemented 21 different rules-based AI scenarios that they were looking for across 19 of their hospitals. And they were focused specifically on medication safety. And after 18 months, they did a comparison of their event reporting rates, where they compared voluntary reporting to voluntary reporting that was augmented with autodetection, so kind of like a before and an after comparison.

And the results were quite staggering. They observed a 400% increase in their medication event reporting rates compared to voluntary reporting alone. So, adding those additional electronic mechanisms to identify when safety events are happening led to a substantial increase in the number of events that they had getting reported in that medication event space. Seventy-seven percent of those events that the rules-based AI identified were investigated and categorized as safety incidents. The remaining 23% were either closed as duplicate because someone manually or voluntarily reported that same event or the event was reviewed and deemed to not actually be a safety event. So, the rules-based AI was very effective in being able to identify actual safety events based on the criteria that we built into those rules. Since that information was shared at a national conference, we've seen a significant increase in interest in utilizing this technology to augment organizations' voluntary event reporting at several other large health systems.

And later this year, to kind of take this to the next level, we're planning to roll out a natural language processing model that will consume documentation from the EHR and identify adverse drug events and report those, consume that documentation, run the model, identify adverse drug events or medication errors, and report them as safety events in our safety management products.

So, really exciting stuff, the way that we can leverage technology to really support that culture of safety by increasing event reporting rates, taking humans out of the equation, you know, making it so that individuals don't have to take that initiative to report everything. Like, we can rely on technology to do some of this work. And the documentation is going to be more accurate, more complete. All of those things really will help foster a safer environment because organizations will be able to better understand all of the things that are going on in that particular area where we're able to leverage this technology.

So, one of the parts of my job that I really enjoy the most is working on this kind of stuff and this technology to really automate workflows and take humans out of the equation for some of these processes that don't necessarily get the attention that they need. And, Martha, I don't know if maybe you have an example as well of something in this space.

Martha Tran: I want to touch on the culture of safety. I think that's one of the best things about this safety initiatives is that, as part of the culture of safety, we're sharing data, we're sharing outcomes, we're really being transparent, and then that allows us to be able to, you know, solve problems collaboratively. We can share best practices. Before, it's kind of like that saying, "You don't know what you don't know."

So with clinical surveillance tool and the analytics, you can make a change. Then, you can measure the impact, and then you can work on continued process improvement. A really good, I would say, real-world example of that with one of our clients. They were looking at the outcomes for bloodstream infections. This facility, they had a really strong antimicrobial stewardship team that included specific antimicrobial stewardship pharmacists. And what they had done is they had pretty recently started utilizing rapid diagnostic testing, and that just allows for the organism to be identified sooner. And then, when an organism was identified, then it would be the pharmacist's responsibility to make sure that that patient was on the right medication to treat the organism.

And so, the rapid diagnostic testing was very helpful because they did get that organism identified sooner. But where they found a gap was that that information had to get from the lab, that result had to get to the pharmacist. And so, sometimes there was a delay there. So, the institution, what they did is they added real-time alerting. And our clinical surveillance tool was actually able to not just create an alert in the system, but it actually sent a notification directly to the pharmacists that were on the team. And then, they were able to, again, match up the correct treatment for the patient. And they did show in that study that there was an improvement in the outcomes of their bloodstream infections.

Host: Great examples. I appreciate you both walking through those. Martha, what is the impact of having real-time surveillance on pharmacy and medication safety? Digging in a little more, what are some of the proven strategies in detecting and preventing medication errors or misconversions from IV to PO.

Martha Tran: I think when we're talking about real-time surveillance, you're going to see a really big impact on the outcomes because, many times, it's going to allow your clinician to intervene before an event occurs and prevent the harm or else very soon so that the harm would be less severe.

So an example with that real-time surveillance and that type of an impact, one of the things that pharmacists do on a daily basis is adjust medications for a patient's renal function. And so, what we did probably when I first started practicing is we had a report that we manually reviewed. We usually would review it in the morning and make sure that the doses for the medications that the patient was on, making sure that were appropriate for the renal function.

An example where real-time would be much better would be a patient you might come in and review and their serum creatinine, which is the lab we're kind of looking at for renal function is one, which is fairly normal. So, the pharmacist might just kind of pass over it and continue on with their day. They've reviewed that patient. That patient won't get looked at again until the next day. However, with real-time surveillance, we're able to do trending, and you're able to see more information, not just that static one value. And so, if the pharmacist had seen, "Oh, this patients renal function or serum creatinine that I was talking about was only 0.5 the day before, oh my gosh, it doubled. I better take a look and see what's going on with this patient." So without the whole picture, you are not going to make the right response, or that response is definitely going to be delayed in that example.

Very similarly, another test that pharmacists work on is changing intravenous medications to the oral route. There's a few different reasons for doing that around patient safety. Definitely if they have an IV and it's more of a risk for an infection. It might prolong their stay in the hospital. And then, of course, there's always cost involved. And so if the patient can take it orally, typically those pills would be less expensive. And it's certainly less expensive to administer because you wouldn't need a nurse to administer it. So, there's a lot of reasons that pharmacists do focus on switching over to the oral route.

So sometimes, again, this would be an example where you're looking at that patient in the morning and you see they have a test coming up, and so you know they have to be NPO or they can't take anything by mouth until after that test. So again, I would review it and be like, "Check off my list. I'll take a look at it tomorrow." But with the real-time surveillance, as soon as that patient gets put on a regular diet alert can go to the pharmacist, and then they can go ahead and they can make that change. This might result in one, two, three, maybe three less doses for that patient by the IV route. It might even result in that patient getting discharged a full day sooner. So really, there's a big difference between, like, monitoring a patient by a report manually in comparison to that continuous monitoring that is always looking 24/7 at that data.

Host: No, that's great. Thank you for kind of tying those cause and effect examples together. I think that's really helpful. Can you give us some insights into what's working right now with both inpatient and outpatient settings, and how do members extend safety into outpatient settings?

Chris Emerson: Yeah. So specifically, on the safety event reporting side, there's been a substantial increase in interest from outpatient settings to embrace electronic event reporting platforms to more efficiently capture, investigate, track, trend, analyze the safety events that are occurring in those care settings. One outpatient setting in particular we've seen a lot of interest from is in the ambulatory surgery center space. In the past couple of years, we've implemented the safety event reporting solution in more than 175 ambulatory surgery centers in the U.S., so quite a substantial increase in interest, specifically on safety event reporting.

What we're finding is that many outpatient areas don't have robust safety event reporting platforms that can integrate with an EHR or registration system, which really helps automate aspects of the event reporting process and optimize workflows and investigation processes. So, one of the things that we do is we take that registration information into our environment, and then when a reporter is reporting a safety incident, they can use a patient search functionality. And that will automatically populate up to 30 different aspects of a safety event reporting form, whereas normally, a reporter would have to sit there and type out all of those data points. So, that's a big barrier to event reporting in general, is that time commitment to actually sit down and fill out the form and write out the patient's medical record number and their patient ID number and make sure you don't type it wrong. But when you can integrate with a registration system or an EHR and be able to just execute a patient search and automatically populate all of that information, it not only it saves time, but it increases the reliability of the information that's being put into the form.

Really, what we're hearing from the sites, these ambulatory surgery centers who have gone through this implementation process with us is that their event reporting rates have increased dramatically because of ease of use of the system, less cumbersome to report the events. And not only that, they're getting more events reported, so then the administrators of the system or, you know, the patient safety managers or quality managers of these organizations are now able to more effectively understand what's going on within their care environments when it comes to patient safety and they can, you know, identify gaps in care or gaps that need to be addressed through some process or procedure change, and to help ultimately improve patient care and prevent future events from occurring.

You know, one recommendation if you're in an outpatient environment would be to really assess your current event reporting process in that area and ensure that your staff have an intuitive, easy-to-use process for reporting safety events. And that system provides the ability for the administrators to usually track and trend data with reports and analytics. It's always those things you don't know are going on at your facilities or those near-misses that are not getting reported that kind of keep you up at night worrying like, "What do I not know about what's going on, you know, that could harm a patient tomorrow?" I always think the more you know, the better chance you have of being able to do something about it before a patient is harmed.

So, my big takeaway I think in the last couple of years in working with these outpatient care environments is they haven't historically had the tools available to them to really do this effectively. And now, there's a big push or an interest in getting those tools. So, you know, take a look at your processes and what solutions you have available for reporting and evaluate what's out there in the market and see if there's something that's better.

Martha Tran: Yeah. Back when I was in the hospital, it was the same thing that we were pushing for is to get more and more reporting done so that we could really see what was going on and make a difference.

But I'm going to take this question just a little different angle here and talk a little bit about how I think the pharmacists are having the impact both inpatient and outpatient. And the main setting where I'm seeing that is really through transitions of care. That's whenever the patient is changing in level of care, so whenever the patient is admitted and when they're discharged, or it could be when they come in the critical care unit and then they get switched to a lower level of care, like a med-surg unit.

The example with when the patient is first coming into the hospital, a lot of pharmacists are involved with medication reconciliation. So, what they're doing is they're looking at the home medication list that the patient is on, and then comparing it to whatever the physician has already ordered to continue in the hospital. And they want to make sure that, you know, medications aren't being missed that should be continued, and medications aren't continued that should be held.

An example where clinical surveillance tool could really be of use is when maybe a new medication is being started. One big topic right now that a lot of people are interested in is opioid stewardship. An example of an alert might be a patient is started on a fentanyl patch, which is a very long-acting medication. The pharmacist could get alerted because they haven't had anything on their home medication. They've had no exposure to an opioid on that home medication list. So, that's a really great example because it's hard to always have the manpower to take a look and review those lists. So by adding the clinical surveillance, you'll make sure that really important things like that aren't missed.

And then, as the patients transition to outpatient, the pharmacists really need to make sure that the patients understand their medication. They need to make sure that their patients are able to get their medication. Beyond just alerts, we also have what we call a transitions of care list, where we set rules that run 24/7, just like our alerts, in the background to populate the list so that it can identify the patients that are going to benefit the most from the pharmacists, spending a little extra time educating them, or perhaps we even might need to get the care management team involved before that patient goes home.

So, examples of things that could run in the background might be looking for social determinants of health. That's a big one that now there's codes available, so it's easier to capture that information, but you need to make sure that that patient can afford that medication when they go home. If that patients more worried about getting food, they're not going to get their medication filled.

Other types of things, if they're going home on medications that are really more high-risk of having an adverse event. And those patients, we need to make sure that they understand what to look for. So if they're going home on a new anticoagulant, they need to know the signs of potential bleeding or bruising, and they need to know what to do when these things occur. So, having that patient well educated is really going to help-- not just their patient outcome, but then also it's going to help the hospital because it's going to help with decreasing readmissions as well. You can see how the tool can monitor both inpatient and outpatient.

And also, when you get into the outpatient setting, alerts could even be added around followup and making sure that the labs that they need on a regular basis are done, because those are things when the patient leaves the hospital, that can be really hard to keep track of. So, you can use a tool like this across inpatient and outpatient.

Host: Perfect examples and really illustrative of kind of the power of the system when it's set up to help support those goals. You know, I want to try to squeeze in one more question at the end, and that is, really, what does the future of patient safety look like for you both? And what is some practical guidance that you have for AHA members as they look to implement advanced clinical surveillance? Chris, why don't we start with you?

Chris Emerson: I'm very optimistic about the future of safety in healthcare. I mean, we're on the frontier of the AI revolution. And while I certainly don't think AI's going to solve all of our problems, I think the potential that AI could have a substantial impact on safety in healthcare is tremendous.

In terms of a practical guidance, I guess I would comment specifically on those organizations that might be thinking about utilizing rules-based AI or electronic triggers, other technologies really to kind of augment their voluntary safety event reporting. So in partnering with organizations on this initiative, I can say that if you go down this route, that you will undoubtedly have an increase in the number of events being identified, and you may uncover areas of risk at your organization that you were never aware of, which is really what the goal of this whole process would be.

You know, you have to use this new information to build that foundation of continuous learning and improvement. And I think that's critical. If you want to have a strong culture of safety, you first need to have a culture of learning. And my suggestion would be to start building the framework for how these technologies would be utilized and get alignment from the highest levels of your organization. Many leaders, they struggle to embrace the idea that having more safety events being reported is actually a good thing. So, I think having that culture of learning mentality really needs to be pervasive throughout an organization for something like this to lead to meaningful change and improvements in the safety and quality of care that we're providing.

Martha Tran: We're just going to continue to see increased advances in technology. We're going to see it being utilized more. And what it's going to allow is for practitioners to really practice more at the top of their scope. Of course, AI is going to be the biggest player making changes right now. But with AI, I think there needs to be a little caution utilized. I think it's important that everyone understands the technology that they're using. And also, what the limitations are of that technology. So, clinicians still need to do their own critical thinking and not rely solely on technology. It's really meant to be a complement and not a substitute.

Host: Yeah. I love the comment that you made, Chris, around, you know, culture of safety, culture of learning. I would also add culture of trust that also fits in there as well, and really instilling the trust from both sides and both roles.

This has been a great conversation. And I love kind of the alignment of what you and your organization are doing with members and what AHA is really focused on on improving patient safety across the board. And I want to thank you both, Chris, Martha, so much for joining the podcast and sharing your takeaways with AHA members.

For our listeners, if you'd like to learn more about the AHA Associate Program or anything that you've heard on today's podcast, please visit us at sponsor.aha.org. And this has been an AHA Associate Bringing Value Podcast, brought to you by the American Hospital Association. Thanks for listening.