What Is the Value of Joining a PSO?

Paul Anderson: Welcome to Smart Healthcare Safety from ECRI, the most trusted voice in healthcare. Committed to advancing effective evidence- based care. I'm your host, Paul Anderson. And for more than 10 years, I've overseen our Patient Safety, Risk and Quality membership programs here at ECRI. Tens of thousands of healthcare leaders rely on us as an independent, trusted authority to improve the safety, quality, and cost- effectiveness of care across all healthcare settings worldwide. You can learn more about our unique capabilities to improve outcomes at www. ecri. org. We're recording this podcast from our respective home offices as we practice, and encourage all of you to practice, good social distancing to help limit the spread of COVID. Today, we're talking about Patient Safety Organizations or PSOs, a federal designation rooted in the Patient Safety and Quality Improvement Act of 2005. We'll explore what it means to be and participate in a PSO, the evidence for how participation can benefit patient safety, and briefly review some of the legal challenges to PSO protections. To get us started, I'll ask our guest to introduce herself.

Brigitta Mueller: Hi, Paul. Thank you for having me here. I'm Brigitta Mueller. I'm a physician by background and I currently serve as the Executive Director of Patient Safety, Risk and Quality here at ECRI, which includes our large PSO.

Paul Anderson: And that's a good place to start I think actually is the PSO. And, can you briefly just define what a PSO is? And, why PSOs were a key feature of the Patient Safety Act back in'05?

Brigitta Mueller: So, PSOs were initially created to give a safe environment to protect information from discovery. There was a worry that a problem that happened, for example, in a hospital would not be discussed and therefore people would not learn from it and prevent it from happening again if they're worried that the malpractice lawyers could get a hold of it. So the Patient Safety Act was created to protect that information, to give a forum where people can discuss, evaluate, investigate, and then also draw conclusions from any event that has happened.

Paul Anderson: That benefit seems like it has sort of a dual benefit, right? We can learn sort of the big picture in the aggregate. But are there also benefits, if I'm an individual provider, are there benefits to me individually to participating in one?

Brigitta Mueller: Sure. Just in general, collecting the data and looking across more than one organization over several years gives a lot of information that we can learn from. For example, our own PSO has over 4 million events that we have collected over time. But a PSO is not just a collection and protection of data. Behind the PSO is a whole group of experts, often very experienced nurses, or risk managers, physicians, or other experts that can help any client with problems that they encountered. So for example, somebody in the hospital might have a big problem with falls. We then can look at what other people have done and discuss with the client some interventions that could be done or ways of better capturing what actually happens and what the situations are where these falls occur. And then, we can help them improve their rates. So as an individual provider, I definitely will have the benefit of the accumulated experience that we have at ECRI.

Paul Anderson: And the idea, just to sort of reiterate what you said earlier, is without those protections that come from the Patient Safety Act, we wouldn't be able to aggregate all that information. We couldn't learn from each other because we have this concern that it would then end up in litigation.

Brigitta Mueller: Correct, yes.

Paul Anderson: Are PSOs just for hospitals?

Brigitta Mueller: No. That's a good question. They definitely are mainly used in acute care, so in hospitals. But ambulatory care can be protected as well. Dental clinics, ambulatory surgery centers, long- term care facilities, they're not quite as commonly used in these settings, but they certainly are protected under the Patient Safety Act.

Paul Anderson: Good. Okay. So, very broad applicability. You mentioned that we have, gosh, more than 4 million events that we just did on our PSO and we're proud of our PSO, but there are other PSOs that have other events. Are there other types of information that can be submitted and protected under the PSO for learning and for protection? Because I'm assuming it's not just events.

Brigitta Mueller: That's correct, yes. So for example, let's say I'm in a hospital and something bad happens. Usually the local people will do an investigation what we call a root cause analysis. They go really into the details of why does this happen, what were the circumstances, because usually it's not a person that on purpose did something wrong, but it's the situation that led that person do something that wasn't correct or it was a whole cascade of events that led to the final outcome. So these root cause analysis, they are also protected. But there are many other things as well. It depends on the organization what they decide they want to protect. Some organizations protect their peer review, meaning that the review of quality performance of individuals like individual physicians, that can be protected. They can also protect other information deliberations, for example, in a infection prevention control committee can be protected. What cannot be protected, and I know this is probably your next question, is material or information that has to be reported to the state or to the some other agency by law. So for example, every hospital is required to report how many catheter- associated bloodstream infections they have. So the number of these, that's a mandatory reporting to the state health agency. However, when a hospital tries to figure out why do we have all these infections and what happened in them, that you can protect under the PSO.

Paul Anderson: So it's sort of the distinction between the fact that something happened versus the investigation into the particular circumstances and the root causes, as you said. And I'm guessing, and maybe I'm wrong about this, but also any quality improvement plan that might flow out of or corrective actions that might flow out of that investigation.

Brigitta Mueller: You can protect that, although you might not want to, because you want to use that widely. Let's say you want to retrain all your nurses in how to handle central lines to make sure everybody has the same process. That's not something that needs to be protected. That's something you want to distribute to everybody. But there is other information that you might want to protect of that. So you can be very granular to, yes, I want to protect this, and know this part does not need to be protected. Also, what cannot be protected is anything that is used for other purposes like business purposes. Let's say, for example, how many patients need to be readmitted for something? That's a business information that everybody has to report to CMS. So it's not just reportable, but it's also used for business purposes. For example, any investigation what we call a root cause analysis, when you go into the details of why something happened, what were the circumstances, who was involved, and all that, that you can protect. Some organizations also want to protect their peer reviews, meaning that if you want to look at the quality of care between different providers, for example, you can protect that. What you cannot protect, and I know you will want to ask that, is anything that is mandatory to be reported to some agency either the state health departments, CMS, or some other agency, like for example, the number of catheter- associated bloodstream infections. That's a number that every hospital has to report. However, if the hospital does an investigation on why this happened, and why do we have more infections than somebody else or than we expect, that investigation part does not have to be reported to the state, but can be protected under the PSO.

Paul Anderson: So it's kind of the distinction between the absolute number is one piece of information and all that investigation and research and root cause analysis, as you described, that separate and that is okay to be protected, so to speak.

Brigitta Mueller: That's correct, yes.

Paul Anderson: And then, how about what comes out of that investigation? A quality improvement action or a corrective action that we want to take. Is that eligible for protection?

Brigitta Mueller: You potentially could protect it, but the question is whether you really want to do that. Because again, the reason for the investigation is to learn and to get better and to prevent the next event. So let's say you want to standard that making sure that all nurses use the same standardized approach to handling these catheters, hand- washing, the same kind of dressings, and all that. That part, that plan to do some more training to make sure everybody is consistent, I don't see a big reason to protect that because that's a good thing. You want to share that with everybody. However, if you have some detailed information about, let's say, it's this ward that had a lot of problems and we're focusing on this area now, that might be something you want to protect. So, you can be very granular on what you want to protect and what you want to share.

Paul Anderson: And I see your distraught, you're drawing a distinction between protecting and sharing. And I guess sort of my question would be, is there ever a reason... My instinct as an outsider and a non- attorney would be just protect everything. I want protection. It sounds great. I want everything protected. Are there limitations once information is protected in how you can use it within your own institution?

Brigitta Mueller: The challenge is that patients have a right to the information, so there is always some tension. You don't want to hide things. You want to protect people who innocently did something wrong. If they on purpose did something wrong, you clearly want to pursue that and take action and that should not be hidden. And some lawyer actually may use this in a case. There are some other protections around that. But in general, if something was done on purpose, that's a different story. However, most of the case what we see, most of the time what we see is that somebody just innocently did something wrong or the situation didn't let them do the right thing, so they took a shortcut and that ended up the wrong way. So, there it is a system's problem that we need to address. And so that one, the organization needs to learn and get better at improving the situation for the people.

Paul Anderson: So I mentioned, the Patient Safety Act was passed in 2005. The first PSOs were designated in 2008. ECRI was among that first round. So gosh, that's well over 10 years now. Have we seen anything in that time to suggest that having PSOs is having its intended effect, that we are starting to make meaningful improvements in patient safety, either locally at one organization, or I don't know if we can say anything big picture nationwide, if these are having the effect we hoped for?

Brigitta Mueller: That's a difficult question. Because it would be very hard to claim that a certain advancement is just due to a PSO because usually there's so many different approaches that are taken at the local level, at the regional level, at the national level with awards, with punishment. For example, CMS now gives out penalties if a certain quality metrics are not reached. So, it would be very hard to say. As a patient safety expert, we're clearly not where we need to be. Too many things are still happening. We saw that just now with COVID, for example. We were very unprepared in many areas and we all know in the nursing home arena especially. Despite theoretically knowing what should be done, but either the funding wasn't there or the focus wasn't there, and all of a sudden we ended up with a big problem. Unfortunately, that still can happen in hospitals, in long- term care, in any setting. So continued vigilance and focus on patient safety, and learning from anything that goes wrong, as well as things that go right is very important.

Paul Anderson: So, I want to touch base one last thing is this idea of legal protections. We've talked a little bit about that's sort of one of the big benefits of PSOs in general. And again, with the caveat that neither of us are attorneys, I assume however that since these protections have been around, they've been challenged by plaintiff attorneys, trying to get this information that's designated as protected. Can you briefly summarize what is the current status? How have courts handled those? And I understand that different appellate level courts may come to different conclusions or state courts. But what sort of the broad scope of the status of those protections? Have they been upheld?

Brigitta Mueller: The Patient Safety Act is a federal law. So theoretically, federal law trumps state laws. However, we know that states often like to do things their own way. So, there is really a difference among the states. Some states have very good protection to the point where some people don't even think we need a PSO because the state protection is so good. Other states, there is continued attempt to undermine the protection and that pull out certain parts that might not be protected. The bottom line is the Patient Safety Act is not an easy law to understand. So unless you really specialized in this area, your hospital council might not know all the details. Your malpractice lawyer may not know all the details. The judges may not understand all the details of the intricacy. So we certainly have seen that it was necessary from lawyers that specialize in this area to write amicus briefs, or support, or not support certain decisions because either they didn't or did agree with the conclusion. So it's not written in stone, it's not settled totally. But as a PSO, we have some access to lawyers with specialized expertise that can help individual hospitals or other clients if they get into trouble with the law in that regard. We are not ourselves lawyers, but we work with organizations that can provide that kind of support.

Paul Anderson: Yeah, highly. I find myself saying more and more, I'm not a lawyer, but. I say that a lot these days. So, I always like to wrap up the podcast by asking folks to describe something listeners can do today to start advancing patient safety in whatever topic we're talking about. And someone might not be able to move this afternoon forward the decision to join a PSO and finalize all of that before supper time. But, where can they start? If they're evaluating whether they want to participate in a PSO, what are some initial steps they might want to take?

Brigitta Mueller: I think the most important part is the culture of safety. If an organization is willing to learn from anything that goes wrong and things will go wrong because we have so complicated situations in healthcare, if you're willing to learn from it, to be open with the patients or family members that have been impacted by it, not to punish automatically any providers that have been involved in it, but learn from, what can we do better? How can we prevent it from happening again? That's the first step. We need an open discussion about these things and sharing of experiences. Because if I by chance do something wrong, it's very likely that somebody else could have done the same thing wrong. So, why not talk about it and then be aware that there is a risk that I do something wrong if I do the same task like this other person.

Paul Anderson: Yeah. That's a great starting point. Dr. Mueller, thank you so much for joining us today.

Brigitta Mueller: You're very welcome.

Paul Anderson: You can learn more about ECRI and the Institute for Safe Medication Practices PSO on the ECRI website at www. ecri. org, where you'll see opportunities to download examples of the types of learning that the PSO can offer for its members, such as through past Deep Dive reports like our 2020 look at Surgical Patient Safety and our annual Top 10 Patient Safety Concerns report, which had its 2021 version released just in March of this year. Be sure to subscribe to Smart Healthcare Safety on Spotify, iTunes, Google Play, or wherever you get your podcast to get our latest episodes. We welcome your feedback. Please visit us at ecri. org or email us at ecri- podcast @ ecri. org.