Testing PPE | Early Sepsis Recognition and Treatment | Evolution of Care from Inpatient to Ambulatory Settings

Paul Anderson: Hello, and welcome to ECRI Now, a show about healthcare insights from the experts. I'm your host, Paul Anderson. Today, we'll talk about challenges to the ambulatory surgery supply chain and the importance of early sepsis recognition and treatment. To get us started. though, we'll head to the ECRI Lab to talk to Chris Lavanchy, Engineering Director with our Device Evaluation Team, about the importance of testing personal protective equipment that's been stockpiled to prepare for a future outbreak. Chris, when we're talking about testing and evaluating personal protective equipment, what types of PPE are we talking about?

Chris Lavanchy: Well, it covers quite a range, Paul, certainly things like gowns, isolation gowns, masks, N95- style respirators, and even gloves. These are things that we saw shortages of early in the pandemic.

Paul Anderson: I know one of the issues early in the pandemic was that organizations because of those shortages were getting supplies from nontraditional suppliers or maybe unfamiliar suppliers. Is that what first led us to do some of this testing?

Chris Lavanchy: Yes. Yeah, we were getting some questions early on from hospitals that had been found that they were unable to get the supplies they were looking for. They did find out about opportunities to buy, usually under a lot of duress. They were told that they only had a day or so to make a decision because it would go to someone else if they didn't buy. They had to buy a whole container, for example, shipping container of PPE and wanted to know whether or not what they were going to buy was useful.

Paul Anderson: We went through that process and things have largely, not a hundred percent, but largely self- corrected in terms of the supply chain. Where are we at now in terms of needing to do that testing here in early 2023?

Chris Lavanchy: Well, I think the key here, Paul, is who are you buying from? If you're buying this from the trusted suppliers that you've been using for years, it's probably not so much of an issue. On the other hand, if you are importing these products or getting them from an importing company that you've never worked with before or you're not familiar with the manufacturer, there might be some benefit to doing some testing just to make sure that you're not throwing your money away.

Paul Anderson: What does that testing look like? I mean, I'm guessing we're looking for things that I'm not going to see with the naked eye.

Chris Lavanchy: That's true. I mean, certainly there are things you might notice when you pick up a product. You might see it's pretty shabby the way it's been put together, but generally that's not going to be the first thing that you're going to see. What we recommend, depending upon the device or the product, a gown, for example, the quality of construction's certainly important. You might be able to look at that by inspection and be able to tell whether or not it looks like it's going to hold up, but then there's issues, for example, with an isolation gown about them being impermeable to fluids. In order to be able to assess that, you actually have to do specific tests to target that. Similar with masks, the problem is you can look at a mask and say, " Aah, it seems to fit my face pretty well, it looks like it ought to work," but you don't know anything about its filtration performance until you actually test. Those are the kind of things we have been able to do when hospitals have been faced with these situations.

Paul Anderson: Chris, what types of issues do we see? What I mean by that, are they questions of manufacturing? Are they poor storage? Wear and tear? What types of things start to be shown through some of the testing?

Chris Lavanchy: Well, our testing doesn't necessarily identify the reason the product is not performing well, but we do often recommend people look at their situation. If you're buying, again, from a source that you're not confident in, you don't know much about them and their history, it might be good to do the testing just to verify that you're getting quality products. On the other hand, if you have a stockpile of products that you maybe did buy from a trusted source, but it's been stockpiled for two or three years, you don't know the storage conditions, you can't really vouch for whether or not they've been tightly controlled. That might be a situation where it would pay to go ahead and do some spot testing just to find out whether or not the products have degraded from the storage.

Paul Anderson: I'm imagining that this... You mentioned the storage conditions, right? I'm guessing there's a big gap between sort of a dark mildewy basement versus a well- controlled storage area.

Chris Lavanchy: If you've ever been to a warehouse where these products are stored by the manufacturer, you'll find generally that they have very tightly controlled environmental conditions, humidity, temperature, things like that, dust. These are things that you generally want to avoid in a storage environment and, unfortunately, while hospitals or other facilities may try to do a good job of controlling environmental conditions, the degree to which they control them may impact just how well these products hold up over time.

Paul Anderson: Chris, anybody who's purchasing PPE, because it's obviously not just provider organizations, even as a patient, as a consumer, people were looking for masks and gloves and things like that. Are we looking for sort of similar hallmarks of the manufacturer that'll give me more confidence?

Chris Lavanchy: Yes, I think you would be. A healthcare facility buying large quantities might want to do a little bit more due diligence, but the consumer that's buying these products also, I would recommend that they do some investigating to make sure the product they're buying is going to meet their expectations.

Paul Anderson: Chris, thanks so much for joining us today.

Chris Lavanchy: Thank you.

Paul Anderson: To learn more about the work our Device Evaluation Team is doing, check out our ECRI Lab tour webcasts. Anyone can get an infection and any infection can lead to sepsis, an overwhelming response that can lead to tissue damage, organ failure, even death. Each year, at least 1. 7 million adult Americans develop sepsis and about a third don't survive, making it the leading cause of death in U. S. hospitals. I sat down with Shannon Davila, the Patient Safety Leader here at ECRI, to talk about what can make sepsis so hard to recognize and steps organizations can take to move towards more rapid treatment. Shannon, this year's Sepsis Survivor Week is being celebrated starting February 12th, and we named early recognition and treatment of sepsis one of our top 10 patient safety concerns for 2023 at ECRI. Can you maybe describe a little bit about what a patient experiences when they survive a bout with sepsis?

Shannon Davila: Sure, so sepsis is a really complicated illness and it has a lot of impacts on both the body and the mind. Now, we could start with when a patient's in the hospital and they're being treated for sepsis. Many patients experience a prolonged stay in the hospital, which if you're staying longer in the hospital, that increases your risk of a whole host of different things, including higher mortality rates and higher risk of developing things like pressure injuries, falls, medication safety events. Now, when these patients are recovered and they get discharged, it's not that they're healed and they're all better. Many times, sepsis survivors actually have prolonged physical and cognitive effects. In fact, there is a syndrome called post- sepsis syndrome, which characterizes the struggles that many sepsis survivors deal with long after they've been discharged from the hospital. It can include fatigue, insomnia, even depression, and so it is a real thing and it's really important for healthcare providers to have those conversations with patients that survive sepsis because they do have a long road to recovery.

Paul Anderson: We talk about in our top 10 the importance of the early recognition of sepsis. What makes it hard to recognize sepsis?

Shannon Davila: Like I said, sepsis is a really complex condition to deal with, and sometimes patients don't present with the textbook or classic symptoms. Now, when you're working in a busy environment like an emergency department where typically a lot of patients will present, it's really important that the clinicians are really thinking through asking the question, could this be sepsis? Now, of course, there's a lot of distractions, a lot of other things, factors that clinicians are working through which can make it even more challenging. In fact, when COVID was at its height, one of the things that we recognized, and we actually talked about this in our top 10 from last year, was cognitive bias, particularly around COVID. Anchoring bias is when patients present and people are really looking for COVID symptoms and thinking this patient might have COVID. In fact, when the patient could in fact have sepsis. Again, a lot of different factors, complicated environments, and different patients present atypically sometimes.

Paul Anderson: Early recognition is really important, and then that leads to rapid treatment. We know that the patient's survival decreases with every hour that treatment is delayed. Besides recognition, what are some other barriers to rapid treatment?

Shannon Davila: Right, so because it is such a complicated condition and there's a lot of technology involved in diagnosing and treating sepsis, we really recommend that clinicians and safety and sepsis team take what we call a total systems approach to addressing this. When you think about sepsis, it's really important to understand, are we following the steps that are recommended by the guidelines that are out there? Are we ensuring that we have the right tools for our clinicians to work through those process to help them do what's right? Then, the third part is understanding the outcomes, and leaders really need to make sepsis outcomes, including both leading and lagging indicators, an organizational priority. You can use that data to help provide feedback to the clinicians on their performance around identifying sepsis and treating it rapidly, but also to really learn lessons about those cases that don't go as well as they should so that you can really develop action plans and help improve at an organizational level.

Paul Anderson: Shannon, thanks so much for joining us today.

Shannon Davila: Thank you for having me.

Paul Anderson: Be sure to check out ecri. org for the release of our annual Top 10 Patient Safety Concerns list coming during Patient Safety Week, beginning March 12th. Healthcare providers have known for years that care is moving away from the hospital and into outpatient settings, and surgery is no exception. I spoke with Andy Poole, a leader in our ambulatory care work, who spent the five years before he came to ECRI as CEO of an ambulatory surgery center, about some of the implications of that shift. Care has been moving from the acute to the ambulatory setting for years, and that pace has only been accelerated during the COVID-19 pandemic. We're here at a gathering of ECRI business and sales leaders to talk to Andy Poole, a leader in our Ambulatory Care Business Development area, to talk about some of the strategies that ambulatory care providers can undertake to help keep their costs in check while they're promoting patient safety. Andy, what do you we mean when we say that care is moving away from the acute to the ambulatory care setting? What does that look like and what kinds of care?

Andy Poole: Sure, Paul. It's multifaceted. It's really when you think about the traditional model, you go to your physician, that's ambulatory care. You walk in, you walk out, that's ambulatory, that's walking, but then when you got really sick, you would end up institutionalized. You would end up into a facility like a hospital where kind of the serious care was managed. More and more things were there traditionally, and what we've seen is that it's when you move into the hospital, it becomes expensive, it becomes complex. There's also a big chance that you could catch something that you didn't have when you came in. All these things have driven care to be more in a setting that's easier to access, but what's happened is it didn't just happen overnight. It had to establish that it's safe to do these things that were once done in the hospital. Some of the biggest differences over the last few years has been around total joints, which has always been an inpatient procedure. When I started my physical therapy career, it was people were in the hospital for days and went to a facility afterwards. Now, it could be same- day procedures and people are going home. Cardiac procedures, the same, so there's an establishment of once things are safe, they're moved to a location that's easier to access. It's more affordable and prevents that inpatients then.

Paul Anderson: How's the pandemic changed that? We're like three years in now. Has that accelerated things, changed things?

Andy Poole: It wasn't... We had a trickle at the faucet and it wasn't like we cranked it open. It's somebody came and knocked it off with a sledgehammer because it has just truly flooded the patient visits, and in many cases, it's created its own problems because people weren't ready for that level of care. It was one of these things where we had to respond quickly. As I mentioned I think earlier, you've got the rise of telehealth, you've got the rise of care at home, and ASCs have seen a huge increase in the number of cases they're doing. I say ASCs, I should say ambulatory surgery centers. That's really accelerated a lot of the volumes that have moved out of the hospital, and it allows the more complex procedures into kind of backfill and so that everybody's receiving care where it's best and safest.

Paul Anderson: With those folks wearing a lot of hats, being pulled into a lot of different directions, what kind of strategies and support do they need to manage that just to get through the day every day?

Andy Poole: Yeah. The hard thing about healthcare operations right now is you can walk in the morning and everything looks great on paper from a staffing perspective, and you get there and there's two people who are now in isolation or unable to come in or you had a turnover issue. They need to jump right into the staffing model, and unfortunately, and we've seen this all across healthcare, it's one of those universal challenges right now is the other... the safety programs, the quality tracking, things like that get left behind, and so a lot of times they do need a group like ECRI that can come and provide some support in that area.

Paul Anderson: What kind of strategies and support do those ambulatory care providers need to be thinking about to react to just the realities of the world that's happening around them?

Andy Poole: Yeah, it's a big challenge and like I said earlier, there's a lot of times where you don't have the same infrastructure to really help you manage those, but it used to be a big focus, and it still is to an extent, but the focus has been about just- in- time inventory management, not having too much. Now, we've had to balance that against the reality that what you don't stock up on today could be shortage tomorrow and they can really cripple your operations. You have to establish relationships with multiple vendors to be able to make sure that you're going to be able to get what you need when you need it. Where we really have been helping a lot of the organizations that we work with is identifying. Because ECRI has an independent lab and testing these materials, we can help provide knowledge around what is truly like and like. It's a safety risk when you are used to delivering one product and then all of a sudden the next one, next day it's gone and you've got a substitute in there. Is it exactly the same? What are the differences? One, do I know what I should be paying for these? Two, what is the difference so that I can make sure when I put a different product in my team's hand, they're going to be able to deliver it safely? It's a big issue.

Paul Anderson: Andy, thanks so much for joining us today.

Andy Poole: Oh, it's my pleasure, Paul.

Paul Anderson: To learn more about how ECRI can help your organization plan for its supply chain challenges, visit us at ecri. org. Thanks for watching ECRI Now. To find future episodes, visit us at ecri. org. Until next time, I've been your host, Paul Anderson.