So, you've heard about the institutional review board and our case study with the Michigan project and I would now wanted to talk just about some other things that we really need to be aware of when we're doing quality improvement in patient safety work. I'm going to call this risk and rights and we're going to talk a little bit about what risk management can do for you and also what the Institutional Review Board does for any contracts that you have and including any grants that you may receive to support your work. Okay, so our objectives for today are to understand the role of risk management and quality improvement. There are lots of different departments in litigation and legal work at each hospital that I've ever been to. So to make sure you know what you need to seek their approval for and you need to get consent as well, but also an opportunity to look at some of the opportunities that you have as a quality improvement or patient safety expert as you move forward to see what we need to do before we make sure that the information that we're putting out there does not put us or the hospitals' intellectual property at risk. We'll get started with in the US health care, I think many of you already know this about from the Harvard study about the number of deaths per year. And actually, as you probably also know, many people believe that this is a significant low ball figure compared to what we actually see. And as long as I've been working in patient safety and quality, we've seen preventable harm which when I first began working in this area wasn't even something that was really talked about or recognized, but it is the third leading cause of death in the United States. Meaning that all of those infections that we can prevent, those falls, those decubitus, and all the things that our patients have that we used to just consider hospital sequelae, most of them are preventable. And in the US, three in 10 patients suffer a preventable harm, which is quite significant if you're looking at 30 percent of the patients, and the more things that you have done to you, like if you're an ICU patient or you're having an operation, the more procedures that you have, the more likely it is that you have an adverse event. The same with length of stay, the longer that you stay in the hospital, the greater your risk for an adverse event. I think that what is also important is that up to six of 10 patients report that they were not respected or heard. And I think that this is a different kind of patient harm. We're moving towards patient-centered care meaning that we want to know the patient's opinion and we respect and we include them as one of the health care team members. Further, we're talking about not only the physical harm but a lot of the cost that's associated with this so nearly $1 million or $9,000 per United States household are spent annually on mistakes that we've made that are preventable. So, very significant especially as we look to reduce costs of health care. And we're looking to not only optimize health care but being able to provide it to as many people as we can. So as I said, when we started off, every hospital legal department usually has multiple different groups of providers. And I think that the list that I put here is pretty much standard and the whole goal is to make sure that we are supportive, our work is supported, that we have strategic priorities that we're able to meet. But also, that we are covered when we're out there doing our works, and not only do we worry about litigation and we have a general counsel and claims in litigation, but we also have business transactions and those are often with either contractual, whether it's somebody that we're hiring or when we hire our services. And at the Armstrong Institute, we have participated as an outside vendor numerous times in both primary and secondary contractors for both statewide and federal work. And there's many, many pages of reading that need to go into that. There is also many opportunities for you to miss very important things. The things that I worry about not only the scope of work but, do they estimate the number of FTEs to do the work at an appropriate level? Is there adequate compensation? And is any of the work already out there that may put you at risk where your program at risk? And who is actually attending in the transaction? Who are you training to make sure that you really understand your audience? So, those are things that are very important. Things that also can fall into that area are how slides have to be labeled or how online education needs to be labeled. So, just about anything that can happen when you're a contractor really needs to be evaluated. And we send everything to not only our business transactions but also our institutional review board who looks at it to make sure that it falls in line with the requirement for the work that's being done. There's also labor and employment for disputes with employees whether they be unionized or non-unionized, working hours for instance, vacation time, time off, and then technology for commercial transaction I think is also very important because a lot of what you develop as a quality improvement or patient safety expert or even if you are primarily a clinical researcher, if you develop something that has the potential to improve patient care or diagnose something faster, these are things that the hospital legal department can actually assist you in making sure that it's copyrighted appropriately and then put out there on the market and even offered for purchase sometimes by the second and third party vendors. So, our focus today though is more about risk management and what we expect from risk management in quality and safety. So, risk management in general provides us legal advice for how we manage our patients, on how we manage our medical staff. If there are ethical issues, oftentimes, we feel that there are things that we do that might not be necessary but we're doing them because maybe there is an opportunity for a better diagnosis or maybe it's because the provider is also afraid that if he doesn't order a significant tests, it will open them up to litigation. So, there are lots of different issues that we have risk management participate. The other thing is, as I mentioned, was the IRB attorney that looks over the contract that we're working with. And they pretty much, just like the business attorneys, when they look at that, they look at the contractual work that we're set to do and make sure that it's in our scope of work. They also provide advice as to whether or not it should be submitted to the IRB and almost always, we take the opportunity that if we think that there's going to be a publication out of it, we do send it to the IRB. And we submit it as either quality improvement or non-human subjects which you would have heard Dr. La Marche talking about. And depending on your quality improvement project, it's a good idea to consult with your IRB especially if there is a grant funded and you know that there's going to be publications, if you lose copyright when the research is over, and I think that what's important to know is that even though it's quality improvement, sometimes we do call that quality improvement research because we do have baselines and we have our baseline numbers and then we have our metrics that we follow after the implementation. And we look to see whether or not we made a significant change either in a patient outcome such as length of stay, mortality, and/or cost of care. So, all of those things are really important. In quality improvement, I think that because we've always been taught that we shouldn't be competing on patient safety, there's a lot of opportunity for sharing. So I just wanted to go through some of the things that have been pointed out to us in the many years that we've been doing quality improvement for the last 15-20 years that I think were really important to share with you so that you're making sure that you're on the same page with risk management, you have their support when you do share something, and that there are some things that the hospital will limit your ability to share. So, those stories that we tell to engage patients, we have to also make sure that it's a story that's ready to be told and won't put us at additional risk.
