get us started with part four today. Ms. Laura Dixon most recently served as the Director of Risk Management and Patient Safety for the Colorado region of Kaiser Permanente. Prior to joining Kaiser, she served as the Director of Facility Patient Safety and Risk Management and Operations for COPEC from 2014 to 2020. In her role, Ms. Dixon provided patient safety and risk management consultation and training to facilities, practitioners, and staff in multiple states. Ms. Dixon has more than 20 years of clinical experience in acute care facilities, including critical care, coronary care, perioperative services, and pain management. Prior to joining COPEC, she served as a Director of Western Region Patient Safety and Risk Management for the Doctors' Company in Napa, California. In this capacity, she provided patient safety and risk management consultation to the physicians and staff for the Western United States. As a registered nurse and attorney, Laura holds a Bachelor of Science from Regis University, a Doctor of Jurisprudence from Drake University College of Law, and a registered nurse diploma from St. Luke's School of Professional Nursing. And she is licensed to practice law in Colorado and in California. Thank you for being back here with us this morning, Laura, and we invite you to get us started with part four. Okay, thank you, Lindsay. And we have quite a full agenda for today. We're covering everything from medical staff to emergency preparedness. And I combined all of these because I tried to fit them in together as much as possible. Some of them are a little bit different than the others, but they do overlap. For example, lab and dietary, radiology, these are all part of medical staff components and what has to be done and orders, et cetera. And so that's why I wanted to combine so many of these variable topics. I always include my disclaimer that the program today is informational only. It is not meant to provide legal advice nor establish an attorney-client relationship. Please reach out to your in-house counsel or your professional legal representative for any advice. Well, let's go and get started. Most of you who've had the opportunity to listen to these previous programs know this is why Georgia Hospital Association puts these on for you. So you don't get one of these, and that is the statement of deficiencies. And no provider wants to be notified that because of not meeting the conditions or not even allowing them access to their facility, anyway, it can lead to a termination of the Medicare and Medicaid agreement, which we know can be a huge impact. Everything that I'm covering over this five-part series starts in the federal register. That's where the regulations begin. Then CMS has the responsibility to put together information out to their surveyors in what's called a transmittal. They also have to develop interpretive guidelines and survey procedures. Some of the topics we're touching on today may not have all of the interpretive guidelines. In fact, QAPI is one of the bigger ones. They did update some of them, but not quite all of them. And so we always mention that when those have not been updated. Those of you who've gone through surveys know that there's three types, certification, validation, and then finally, hopefully never a complaint. The areas we're talking about are going to be in Appendix A, and specifically these items, QAPI, quality assessment, also known as quality assurance, performance improvement, medical staff. We're going to talk radiology, lab, diet, utilization review, even physical environment. And then one that's also here is emergency preparedness. Five or six years ago, CMS did a major overhaul of the manual. And it used to be emergency preparedness was in your manual. Well, it's not there anymore. They put it in Appendix Z because pretty much every facility had the same requirements. And so they wanted to put it together so it'd be more efficient. Well, I'm starting right off the bat with QAPI. What you have to do through this program is look at the quality of the services you are providing, and then see if there's any projects that you can do on an ongoing basis to improve the delivery of that care. In doing so, you take quality indicator data, including patient care data, that you have either received to or from quality reporting and performance programs, but also what's going on in your hospital. Maybe you've got some hacks, hospital acquired conditions. Maybe you have surgical site infections, those items that you want to look at. But don't forget there's also maybe adverse event that you want to look at because you are required to track them. We know that nurses and physicians and some other providers, they're not always wanting to report or do report an adverse event. So we know that that doesn't get into your system. In fact, 86% of the time. Office of Inspector General. They work closely with CMS. When things happen, it doesn't quite turn out the way we want, and then maybe we have to pay them back. Well, they recommend using what's called AHRQ, Association for Healthcare Research and Quality. They have called with common formats. And these are formats that help us track issues that could come up. The asterisks on any of my slides and this one, for example, means I have a resource in the appendix for you. Using these common formats could maybe help you improve that reporting process. But there's another method, and that's called triggers. They can help you find the errors. They are on the Institute for Healthcare Improvement, that their website, I have the link there at the bottom of slide 11. Well, overall, CMS is also going to look at what you submit to your quality improvement organization. Every state has one. And they will look at that to see, is there an issue here that the hospital has or has not addressed? And then finally, just as one quick resource for you, QAPI worksheet. CMS years and years ago did this when they were getting ready to update the manual. Now, they're no longer using these worksheets, but it's a huge benefit because it shows and has a great gap analysis for you. They took the information that they obtained after using those worksheets in your hospital, and that's how they developed the new regulation. So it's a good way to find out. And what they did was they put together what's called a massive document called the Hospital Improvement Rule. It applies to all hospitals that take Medicare and or Medicaid reimbursement. And the idea was we're going to improve the quality of care that we provide to patients. It's 680 pages long. And so what they did at that time, they put out the regulation, but they didn't update the guidelines until about a year or so ago. Two years ago, it's actually March of 2023. Right now, it's only for acute hospitals. It's not for your critical access, not for your rural hospitals. It's only for acute hospitals. It didn't include a couple of things. One I mentioned, no critical access hospitals, but also if you participate in a system-wide integrated program. Those interpretive guidelines don't apply to that. They are still some of those that are pending, and hopefully CMS will have an opportunity to get to that. But overall on QAPI, it's a third most cited deficiency. And they found that when you are a hospital that has a great program, it's well-designed, it's well-maintained, where everybody is fully engaged in this continual ongoing assessment and improvement effort, well, that really decreases the incidence of error and adverse events, and really helps improve the quality of care and safe care that is being provided. So for your program, by the way, the numbers in the upper right-hand corner, those are the tag numbers. And it will always start with the letter A. What you have to do is develop, implement, and keep going an effective ongoing hospital-wide data-driven quality assessment performance improvement program. That's pretty much it in a nutshell. What you also have to, though, is remember the governing body is responsible here because they have to make sure that not only does it reflect how big you are and what services you provide, but that all department and services are involved. That includes your contracted services. What this program wants to do and what the governing body needs to make sure of is that it's looking at those indicators that we can use to improve our health outcomes and prevent or at least reduce our medical errors. For example, let's say you have an indicator that all children who come in with fever of unknown origin are going to be evaluated by a physician within a certain amount of time. That, by doing that, by finding, okay, where are we slowing down? What are the gaps or what are the barriers to getting these kids evaluated and treated in a timely manner? That's the indicators. That's what you want to do because we're trying to get these children in a safe spot and get them treated quickly and efficiently. Now, the program has to have a way, a mechanism to really examine the quality of care that's being provided. Why do we do that? Well, we look at our projects and we do that ongoing. Always look at the complexity of your hospital and those projects to determine the parameters. How much do you want to be involved? How many do you want to do? You have the flexibility to put together your own program based upon your needs, your priorities, your population, your size, everything. That's what you have the opportunity to do. The expectations are it is continual study and improving the delivery of care. It's a proactive approach as opposed to a reactive approach that was prior to this, and of course, prevent errors. It doesn't have any particular program that you must use. You have the flexibility to develop your own. I mentioned that already, but really there needs to be a way that you continually identify opportunities for quality and safety improvement. Put those changes into effect. And those changes, are those outcomes, are the changes even sustainable over time? And you have to determine what that time is. Are you seeing a surge in, say, a particular illness? What improvement can you do to make sure that that is sustainable? Bring those incidences down. And you are expected to also have evidence of your data that you are collecting, analyzing, and the changes that you're putting into place. And that means ongoing monitoring of those changes to determine, are they working? And can you keep them going? The surveyor, when they're on site, they want to see evidence that the governing body's engaged in the oversight. They want to see something through the board minutes. That's one way to do. Now, I want to show something on here. They updated some of the language. So if you happen to have worked in this area for many, many years in quality, they did update the language. And right now, it had been, by the way, it had been governing body must do this. Now they are saying should do it. They will look closely to see, are they actually involved? And that's what they want to see. Again, they changed from must to should. The surveyor wants to see your documents. They're not going to judge how good you're doing or how well you're doing or what measures you're using, but they want to see that you're doing something to get this going. And again, this is where they said the governing body, this is where they do say must. This is where they didn't change the language. Here, the governing body has to make sure contractors are doing it and providing services so you comply with the conditions of participation. And I just want to point out, this might be an entity where you're using telemedicine services from that entity. They have to make sure that contractors are doing it so you are complying with the conditions of participation. You have to show how you included services, contracted services into your program, that you're evaluating those contracted services and performance improvement activities related to those contracted services. I'm only using telemedicine through an entity as an example only. So example, are they responding quickly? Are you having incidents, events, adverse events as a result of that? So that's some of the activities and other departments can help with this like medical staff, nursing. That doesn't have to just be the governing body. They just have to show that they're aware of it and that this is occurring. Briefly on QAPI, because we know sometimes they'll come in and the surveyor may want to say, okay, what's your documents here? Well, we have protected records. That's peer review. We have our root cause analysis documents. Technically, they are to avoid making copies unless it's absolutely necessary to support a citation. Also making notes that could identify that particular event that they want to find out about. They will also make sure that whatever you have done, let's say you're giving them alternative records to a peer review. They want to make sure that any recommendations from your project or your area that you're working on did improve it. You're working on your processes. Things are improving through that outcome. Overall, the surveyor wants a copy of your documents. They'll look at to verify it reflects what you are, your complex organization, the services you provided, that it's hospital-wide, whether it's by your employees or through contractors. It is data-driven. You can able to show we had this many surgical site infections. We've implemented this program. We now have decreased those infections to zero per month. And it's really those who improve our outcomes and prevent or reduce our errors. While the surveyor's on site, they want access to the staff because they're trying to assess your compliance. And again, I mentioned documentation. If they do request that protected information, you can give alternative non-protected evidence, but it is in that surveyor's sole discretion to determine if that is sufficient. If there is no alternative evidence that you have present or it's insufficient to determine it, you will be cited. Now, I urge you here to, if they are absolutely demanding, let's say it's an RCA, work with your counsel on how best to address that with the surveyor. There may be a state law that might help you in that respect. Speaking of which, not only just RCAs, but patient safety organizations and that work product. Memo of 23 that came out that CMS did recognize you voluntarily submit this work product to the organizations. That work product is confidential. It's privileged. A surveyor cannot demand disclosure. So if it is involved in this and you say, well, that was part of our work product that we submitted, then you have to give alternative documentation to show you're in compliance because this act came out way back in 2005 to put together these organizations. And at that time, 20 years ago, they still had outlined privileged and confidential status. And that could be statements from nurses, doctors, others. It could be medical records. It could be an analysis that you did internally of that event to show, okay, this is where we didn't meet expectations and what we had to do. But there's other information that might be in there that is not protected. That you have to submit to those external reporting agencies. National Practitioner Data Bank is a great example. Sending off the adverse drug event information to the FDA, that's not protected. State incident reporting that you may have to do, not protected. That information falls outside of this protected PSO work product. Overall, what you do have to show is your program is maintained and it's effective. You have to provide surveyors access to your program information without disclosing all that protected information and be prepared to provide evidence that you are in fact involved in a patient safety organization. They will verify that yes, indeed, that relationship does exist. Back to the program scope itself. Well, we know it needs to be ongoing and show measurable improvements to improve our outcomes. So what do we do? We measure, we look at the data, we track, and then we come up and do our quality indicators. Then we track those indicators. Are they working? That's patient care data. And again, what you may have submitted to Medicare or the QIO. How often and the detail of that data collection, the board makes that determination. How often are you going to be out there evaluating, say hand-washing techniques? How much data are you going to collect? Is it going to be month to month, every other month? Are you going to go to every unit? That's up to the board to make that determination. The program should include continuous collection and corrective actions so that we can improve our outcomes. Use that data to determine, are our services effective to give safe care? Analysis of the data. Okay, here's our quality indicators to improve it. And that, yes, indeed, we did meet that specific indicator. You can develop your own measures as indicators. That's up to you, given what services you provide, what scope. The governing board, again, specifies the frequency and detail, what to be collected, what are you trying to measure, what areas of the hospital are you going to look at, and a descriptive information so that you can determine the requirements so that they can approve it. What are they going to say, yes, we're signing off on this? But again, there has to be evidence the board's been involved. And the development, the planning, the frequency, et cetera, and that's why, again, the board minutes are your best avenue in order to get that accomplished. On activities, you have to collect data so you know, okay, where do we want to look? And then how are we going to change this so we can improve our care? You set the priorities, high risk, high volume, problem-prone areas. Look at how often it's occurring, how widespread is it occurring? How bad is it when it does occur? And again, these are some things going to affect our quality of care and patient safety. Take actions to really aim at that performance improvement. So now you've got this action in place, great. Is it working? We have to measure that success, track our performance. Yes, we've had a decrease in surgical site infections over the past six months by doing ABCD, but they have to be sustainable. If you've worked in quality, sometimes it can be a little onerous, some of the steps we have to do, and then we skip a step or we don't, we just kind of completely bypass a portion of that step or steps. And here's an example, one that we've got at hospital. They put together a very detailed process for administration of IV meds. This was the one where there were multiple steps that were missed and then errors started to increase. And in looking at it, they went back and said, that's not working. Scrapped it and started over. Areas, the high-risk areas, you know them, L&D, ICU, emergency department. Maybe you have immunocompromised patients, high volume where not only patients, but potential patients could be infected. Food preparation. Are we doing our food and keeping our food at the correct temperature and storing it correctly? I always mentioned hand hygiene, that comes up frequently. Another one is medication administration, because that's everything from the emergency department to hospice, where you can have or would have medication administration. Problem-prone, that's where you really have to look at your own data. Where do you see the history of issues? Or maybe you want to look at your community. Is there something going on in your community that keeps cropping up, whether it's your hospital or another one down the street? Is it a CLABSI? Maybe it's handoff communications between hospitals. Incidents, that's how often it occurs, prevalence, how widespread, and then severity, the degree or seriousness or significance of that event. On the scope of your program, it must include, again, indicators so that we can identify and reduce errors. And again, to measure, analyze, and track them. They must track errors and adverse events, analyze the cause, and then put preventive actions into place. How you do that, that's up to you. Whether it's root cause analysis, RCA squared, pheromones effects analysis, whatever you're going to do to try and prevent it from happening. The governing body, medical staff, C-suite, they're all accountable to make sure there are clear expectations established. They include definitions in the interpretive guidelines. So if you are looking to reevaluate, redesign your program, I would take these definitions, just slap them right in there. Error, we know that's a failure of a planned action or we used the wrong plan to get the same aim. A near miss, we got it, before harm can occur. You need to analyze and determine the causes with that systemic approach and then strategies to improvement. But don't stop there, then you have to evaluate those changes. Are they sustainable? You have to do also performance improvement projects. The number, that depends on your size and what you offer. You may want to use IT to help you with this, to help gather that data, analyze it. Where did you fall outside of what your expected indicators were? Document the projects and why are you doing it? That's where your errors, your events can help you out. And then if you participate in a quality improvement organization project, you can do that. Or one of comparable error, but if you've got one that you know your local QIO is doing, maybe that's something that could help you. They give us definitions, a difference between a project and an activity. And a project, that's really, that's what takes up a lot of the time, where it's upfront planning, objectives, et cetera. Activities, okay, that's what you're going to do to make this thing work. Those ongoing functions of the program, tracking errors, analyzing the data, putting changes into place, monitoring in all those affected departments. I always compare it to, maybe I want to redo my kitchen. Well, my project is, I'm going to redesign my kitchen so it's more efficient. Activities are what I do. I hire a contractor, hire a designer, we get the plans into place, we make sure funding is there. And then we start demolition, we're tracking the contractor to make sure they're up to date, everything's getting done in a timely manner, and no bad things are happening. And otherwise, this time for me to start and end is working. And my kitchen will be done in six months. I did mention QIOs, Quality Improvement Organization, they are there to really help our Medicare patients advance the quality. Every state has one. There is a website on these QIOs, I've listed them here for Georgia, you're in area three, and so you're a key pro, my state happens to be in the same area. And these are contractors that work again with CMS, and they take care of many issues that might come up with our Medicare patients. That's what they're there for. And so they are really looking at some of those projects and maybe a good resource for you. I've touched on that the program must reflect the complexity of what your hospital is, all departments, all services, whether it's contracted or employed. And you have to show evidence that you've reviewed your QAPI program. They've really started to bring in, especially with the last changes, the executive, the board's responsibility. These folks have legal authority and responsibility of what goes on in your hospital. And the medical staff, your C-suite, they have to make sure that your program is ongoing. It includes patient safety. It's hospital wide. And how many, they help determine how many projects you're going to do annually. You know, can you do 17 different projects in a year? Probably a little overwhelming. But you know, when you're a large, maybe 800 bed teaching hospital, that may not be unusual. Where you're a hospital, say two to 300 beds, doing eight projects is more than enough to keep you involved. And some of these projects can overlap other departments. It doesn't have to be department by department, but every department has to participate in something somewhere along the line. Leadership has to establish those expectations. And that's for safety. There has to be communication across the hospital. And what are the roles of the staff? What's their responsibility in this program? What are those under contract? Put that in your contract, so they know you're expected to do this. And if you fail to do it, that could be a basis for reevaluating the contract. Speaking of contracted services, again, governing body, they have to make sure it's done safe and effective. And that what they provide is part of your QAPI. You will have to show that you have somehow demonstrated there's been periodic assessment of this contractor. Also, what resources have that contractor themselves allocated to do QAPI activities? How have they actively participated? This can be something, periodic reports, going to meetings, doing their own projects, for example. But the leadership, there has to be evidence of leadership oversight. One way to do that is the budget. How are resources allocated to this program? I've already mentioned minutes that QAPI really should be part of the standing agenda. Where are we? What's going on? How many projects? And the executive leadership, your board, they should make, and they must really, make program decisions on planning, projects, review of the performance. They make the decision based on the review for overall direction and ongoing maintenance of that program. Sure, they need to know what's going on. Maybe they need to allocate more resources to another project and then say, okay, this is sustainable. Let's just monitor it for a while. Speaking of resources, they have to make sure there's enough out there so you can do the job. You can meet these programs. You can measure, assess, make sure you're improving. It's sustainable while we're reducing risk and that the processes are there so that the improvements continue. Now, CMS won't tell you what is considered adequate resources. That again, what is the project? How involved is it? Is it one unit? Is it the entire hospital? Who's all going to be involved in this? Just some examples of some process improvement, blood cultures done timely, that you've got your MI patients getting your thrombolytics timely. Those are just some examples that have been thrown out there in the past on projects that hospitals have worked up. I'm going to talk about a unified and integrated. This is again the one where we don't have interpretive guidelines on it, but if you are part of a system where you have two or more hospitals under one board, you can share your QAPI program. It's called unified and integrated. It does not yet apply to critical access hospitals. When I had reached out to CMS about that, it says, well, not yet, but we're considering it. That was a couple of years ago, so I think they're still considering it. If you're going to do this, it has to be okay with your state laws. The board is responsible and to make sure each separately certified hospital meets each and every requirement of a QAPI program. It has to take into consideration your unique circumstances. What is the difference in your population? What are your different services that you are offering? Is one a pediatrics? Is one a behavioral health? Policies and procedures, they have to decide if you're going to do this in a unified program, then they have to make sure each hospital's needs are met. Doesn't matter what the practice or the location, but they have to be given due consideration and make sure if it's specific to that hospital, it's considered and addressed. As a result, and again, we're still in unified, each hospital has to show that the program's set up in such a way that it takes into account what they are and who their population is. What services are they providing? Each hospital has to have policy and procedures to make sure those needs and concerns are addressed. Again, doesn't matter where are they located. This process, this model incorporates each hospital's program to improve efficiencies, maybe innovations, flexibility. You can disseminate best practices. That's why I'm really hoping they do this for critical access hospitals. They could benefit from what the acute hospitals can do and what they know, what they've seen. Here's something that's new. I just want to point out something. When going through my notes yesterday, reviewing my slides, I realized I had uploaded this twice. I think I was a little overprepared for today's program. This is new. This is from a new rule that went into effect just last November. It's a new addition. It started January 1. If you provide OB services, you have to include in your QAPI program or have a program for them to assess and improve outcomes for these patients and including disparities on an ongoing basis. This is new. This is the first time where CMS has said hospitals have to use QAPI program to address health disparities. This must be implemented by July of 27. They are giving us some time to put this into place. For this QAPI, there are four minimum requirements. What you're probably already doing, analyzing your data and your indicators, but look at your diverse subpopulation that you've identified in your facility among your OB patients. Then take that information, measure it, analyze, track it on outcomes and especially disparities. That's when you are providing care, services for those obstetrical patients. Number three, you have to analyze and prioritize outcomes and disparities and then put actions into place to improve them. Measure those results and again, continually track your performance. Number four, do at least one performance improvement project focused on improving outcomes and disparities among your OB patients annually. They really wanted to bring this home that we need to really look at our OB patients. Again, first time they've done this for a particular specialty and especially disparities. They still tap leadership to be involved in these activities. One thing that's different here, if you have in your state, your jurisdiction, wherever you are, a maternal mortality review committee and if you offer OB services at your hospital, you have to have a way to incorporate information from that mortality committee into your program so that you're aware of what's going on within your jurisdiction. Again, that's if you have one in your area. That's new. They did, again, give us time, July of 27, to get this program up and running and make sure it's running. Okay, we're done with QAPI. I'm going to move on to medical staff and that brings me to the first question. Lindsay, would you take care of that, please? Sure will. I'm going to read this top part to you and then I'll post your options there up on the screen. It says that Cooper Hospital utilizes physicians, advanced practice providers, and registered dietitians. The medical staff bylaws, rules, and regulations apply to all, but state law is silent on such privileges. Dr. M, who is a bariatric surgeon, wants to use her employed RD to write nutrition orders for her patients and has petitioned the medical staff and board to allow such. And then the question here is, how would you advise Cooper? And here are your options. Allow limited privileges, write orders with co-sign by the MD, not allow pending clarification from the state dietary board, or possibly other. If you have other comments, you can, of course, type those into the chat. I'll give you a couple seconds here. And if you have questions for Laura, I know this is our next to last session in the series, so if you have any questions, make sure that you are typing those in. So I know today is a full two hours, I believe, Laura, but if you do have any questions, make sure that you type those in so we can get those addressed as well. Okay. Okay. Go ahead and share those results there. Yeah. You see, this is where we don't have clarity from the state. It's very, very silent. What would you do in this situation? You know, you could have absolutely all of them because with the MD signing off on those orders, essentially the MD needs to know what it is. Not allow it. That could be okay. That could be fine until we do get clarity from the state. By the way, I do touch on this on registered dietitians where they are allowed to write orders. Some states still do not permit it. But starting overall with your medical staff, you have to have one that's organized. Of course, it operates under your bylaws that the board has approved. That means you have to have those bylaws and they apply equally across the board to all practitioners, whether that's an MD or an advanced practice provider or whoever. Overall, the medical staff is responsible for the quality of care that is provided in the hospital and they're responsible to the board on that. We know that they could include physicians, other categories, maybe it's a non-physician. But whoever is allowed to be on the staff has to have privileges. They are evaluated under that system. They function and have to operate under the bylaws, the rules and regulations, and those have to be consistent with state law and what the scope of practice says this person can do. That means somebody has to be looking at their credentials, medical staff, whoever that happens to be. Appraisals, they have to evaluate each person to determine, are we going to continue to keep them on staff? Are we going to revise their privileges? Are we going to terminate them? How often? Well, CMS recommends at least every 24 months for each practitioner. If CMS recommends at least, in other words, every two years, that's where I'd go. Now, you may want to shorten that. That's totally your decision. It's time consuming, by all means, but if you have a practitioner who may want to look at something else or start a new practice, start a new service, then you'd have to reevaluate it. Because in looking at those evaluations, you look at their qualifications and their competencies, and that's each and every task or activity within that scope, whether the scope of practice or their privileges that you have granted them. Again, if they request privileges beyond what's already on the list, then the medical staff needs to appraise it and the board needs to approve it. Credentialing files, keep them separate for every member. If you're going to limit them, don't forget about National Practitioner Data Bank. Bylaws need to have that process for those periodic appraisals and who is going to be doing them. Credential, we look at what their credential are. Excuse me, make recommendations to the board. Yeah, this is a great person, let's keep them on. Yes, we want to appoint this candidate according to our state law, scope of practice, rules, and regulations. They also then recommend the candidate. They know that they are subject to the bylaws, rules, and regulations, and that's why the medical staff really needs to delve into this. Look at their credentials. What are they requesting? Are they currently licensed? Now, that's pretty easily done. The medical board, they are usually the primary source for verification on that. Training, professional education, same thing, but then you want to look at their experience. Is there any evidence or references that you can have there to support their competency? And any of you who've done any medical staff privileging knows that's a very involved process, getting those references tracked down and getting the information back, but somebody needs to look at it to evaluate it. How old is it? How relevant is to what they want to do now? We also, the medical staff can't make a recommendation to the board for appointment because one provider is board certified. You can require it, that's up to you, but that's just not the basis because both the medical staff and the board have to enforce all of the requirements and then step up and take action when they're not adhering to the bylaws, the rules, and regulations. I'm going to touch on telemedicine real quick. First is the hospital. This is where you and another hospital agree to provide telemedicine services. So when you want to reach out to another hospital and have them help you, excuse me, or provide this telemedicine, you have to have an agreement. And in doing so, this is the distant site hospital, you're the originating site. The governing board can say, you know what, medical staff, you can rely on what that other hospital has done to privilege and credential this individual when you're making a recommendation to us to grant privileges. The only thing is the hospital has to be Medicare participating. That practitioner at the other site has to have privileges over there. They have to be licensed in the state where your patient's located. And then anything that comes up, adverse events, complaints, they have to make sure it gets back to that hospital where that provider is actually located. An entity, now this can be either a group of physicians, providers that go to a separate office and work and they're a separate entity. They're not associated with the hospital. Or it can be a non-Medicare participating hospital. They put them under entity. And it's the same rules. You know, you can rely on what that entity has done to privilege and credential their own providers. They have to make sure that the services permit you as a hospital to comply with the conditions of participation. That's one difference between a hospital and an entity. Their privileging and credentialing process, they have to meet the conditions of participation. Then again, the practitioner's licensed where your patient's located and you report back any issues, complaints, adverse events that happens. So that's what the governing body can do. They can say you can accept it if you're good with it. But then overall, the medical staff, you're accountable to the board for quality of care. So it has to be organized in a manner approved by the board. In other words, the board has to spell out what are we going to do for our organization? How many directors? How many leaders? Is there going to be one CMO? How would they want to set it up? Are you going to have a medical executive committee? If so, the majority must be physicians. And the responsibility for the medical staff is assigned to an MD, a DO, a dentist, podiatrist, whoever it happens to be. The guidelines say that our conditions create those checks and balances with that overall framework between the board and the medical staff because each person, each entity, so to speak, has their own area of authority. Now, medical staff, you're going to provide oversight through peer review. That's how you're going to do it. Governing body, you say who gets to practice at your hospital and who are we going to appoint? Medical staff, they take all the criteria for appointment and then they make the recommendation. They review it and then make the recommendation to the board. This person we'd like to have come on board as far as our appointment. The surveyor will make sure it is well organized, it's formalized structure. There are delineated lines between the medical staff and board. If you have an executive committee, again, they will make sure the majority are physicians and that someone or some individual is responsible for the conduct and organization of that medical staff. That's usually your CMO. They will also talk to the CEO. They will talk to medical staff leadership. What do you have? What mechanisms do you have in place to make sure you can do your duties? Back to our unified and integrated, you can do this if you want. It's similar, separate, distinct, medical staff reach hospital in a system or you can have one that all works together. State law has to permit that and you have to have policy and procedures. The care provided and how this is set up must be consistent with your bylaws. The medical staff has to have voted and passed by a majority vote because the medical staff is still responsible for the quality of care. So if you want to do this, you can do this, a unified staff. If you're part of a system where you're separately certified, same thing, you can agree to have this. You can use one staff organization and structure for many hospitals, but you have to meet all of the requirements of that section if you're going to do that. And you have to share a governing body. So what are the benefits? Why would we want to do this? Well, that's great, because then each hospital doesn't have to have its own distinct organization and structure. It doesn't have to come up with its own bylaws, rules, requirements, credentialing, peer review, leadership, et cetera. You can share it amongst yourself. And the way this works is that if you're going to do it, you have to be able to describe the process for self-governance, peer review, appointment, due process when, say, peer review is involved. And, again, pass by a majority. You have to be part of the system, not just a multi-campus hospital. This is a multi where you've got several hospitals that are coming together to do this. The medical staff, if you're going to be unified, is organized and integrated as just one body. It operates under one set of bylaws that the governing body is signed off on. They must apply. The bylaws apply equally across the board at all locations and all care. If you have had a shared staff before 2014, they want evidence the board elected to do it and consistent with any state law. And the staff, medical staff, we still have to inform them. You can change your mind and come out of this shared staff. You don't have to do it continually, but that does have to be. Now, these are very extensive guidelines. And in the interest of time, it's just best to read it closely, especially with your medical staff. If you're part of a system, again, you can share the medical staff. State law says it all. Those who hold privileges vote by a majority to have it or to opt out. And if the physicians only have telemedicine privileges, they are not eligible to vote. Then the board approves it. And you may need to amend your bylaws rules and regulations. The system has to demonstrate that the bylaws have been revised. There is a process again for self-governance. How you do peer review and they want documentation. There are some unique circumstances. You have to be part of a system. Consider each hospital circumstance. Patient populations. Services offered. And during the survey, the leadership and medical staff have to explain. That decision to do so, which means yes, you have to have policy and procedures. And they need to make sure that anything that's a concern. From any of the medical staff at each hospital has been given consideration. That, hey, we're running short on funds. We've got a huge upsurge in our population of this particular service, say pediatrics. And we need to figure out a way, how are we going to take care of them? The surveyor want to see, for example, standing orders. And this is again, you're unified. How did each hospital make sure that they were approved by nursing and pharmacy? Do you have policies to minimize drug errors? Your formulary system. How did that come about? That were there any consent requirements that you had to take into consideration? Infection prevention and control. How do you identify and control them? So that's what the surveyor may ask at that during the survey. And then just back to the routine bylaws, the medical staff adopts them and enforce them. The board approves them. And then we have to make sure that there are no changes. Any changes. To those bylaws that may occur. Overall, the bylaws have to have a statement of duties and privileges for each particular category. They have to participate, make sure that there was participation in performance improvement. That the bylaws make sure that there's an evaluation of practitioners on objective. Criteria. We have to have privileges for each category, whether it's active or only consulting. We can't assume that just because I'm signed up and I'm a surgeon, I can do each and every surgery. We have to make sure they can do every task activity. That they are specified in their privileges. Individual ability to perform must be individually assess in short. Or privileging. The bylaws have to have organizational structure. We have to make sure that the bylaws. Lay out the rules and regulations. And for the medical staff. Lay out the rules and regulation. What's acceptable standards of care for diagnosis. Rehab surgical care. And the surveyor wants to have you describe that formation of the leadership. They'll verify bylaws also describe who is responsible. To review and evaluate. The PR the care that's provided by the medical staff. Qualifications for appointment. We have to make sure that the bylaws. Lay out the rules and regulations. We have to make sure that the bylaws. Lay out the rules and regulation. was look at those other five components. Qualifications, do they provide acceptable care? How often are there medical records? Are they done timely? Are they participating in quality improvement? Currently licensed, that should be a basic one. The surveyor, they want the bylaws to describe the qualifications and the criteria in writing. So we're coming off the medical staff and now we're going to go into things the medical staff would do. And that includes history and physical. The bylaws have to include the requirement that an HNP be done. It's no older than 30 days prior to admission or it's done within 24 hours after admission. It has to be of course done before surgery or procedure that requires anesthesia and completed by either a physician or a maxillofacial surgeon or other qualified provider. Unless, and here's the exception to this full history and physical. Perhaps you only have those patients that need an update to history and physical. Either way, it has to be on the chart before surgery and before a pre-procedure assessment that's documented in the chart with allergies and medication. This is what they're talking about, a healthy outpatients where you don't need to have a full history and physical. You can do an assessment and just a quick update to say this person is still fine. And as far as the history and physical, if there are no changes in the patient's condition found on examination, then the provider needs to document that. I looked at the history and physical, I re-examined the patient, no changes. But any changes have to be documented. And that surgeon sees, oh, no, this isn't right. The history and physical is incomplete. They can disregard it, then they have to do another one. So that's the updated exam. And again, in lieu of that history and physical, these again for outpatients, you can do an assessment in lieu of a history and physical. The bylaws have to allow this and also spell out when history and physical is not required. But that assessment has to be documented after registration before the procedure occurs. It can be done by a physician or someone else who's qualified according to state law and your policy and procedures. But that assessment has to be done and documented before the procedure occurs. The policy, the medical staff spells out and maintains and develops this policy on which patients the assessment applies. It's not required, but it is an option. And you may still say, forget it, we're not going down that road. The medical staff can still require history and physical. But the policy, if you're going to do the assessment, what is the age diagnosis? What are you doing? Comorbidities? Any standards or guidelines from national societies and any state laws. So again, what is the level of anesthesia? What are you doing? And are there anything else that maybe we need to take into account? Excuse me. No, this is in your policy. That's what has to go in there. Radiology. There's not too many tag numbers. I'm going to pause briefly and see, are there any questions, Lindsay, you would like me to address? It looks like there are a couple that have come in. Okay. So this first question asks, so what guidance is there on the structure of MS governing documents? What things have to be in the bylaws versus in the R&R? For example, anything that could cause a loss or limitation of privileges that should be in the bylaws? I can't get into that during this program today. If you're a member of joint commission, joint commission sometimes has some really good guidelines on what really should be going in there, where CMS is going to leave it pretty broad and let the hospital make that determination on what needs to be, what's in a bylaw, what's in a rules and regulation. And also sometimes in-house counsel, those who've done healthcare, they can help with that delineation with what's in a bylaw, what's in our rules and regulations. So I'm sorry, I really can't answer that during the program. Perfect. And I do see this question came in anonymously, so if you have further questions, you can always reach out to us at education.gha.org. And there's another question asking, if you know of any consideration of CMS establishing a national clearinghouse for credentialing to help ease the burden of this process? Oh, wouldn't that be wonderful? No, at this time, they do not. I know there are organizations that do it for a fee, but CMS has not done that right now. Okay, and then do you happen to know why H&P is specifically required to be in the bylaws? If it's a basic element of patient care, why would it specifically need to be outlined in the bylaws? I'm sorry, would you repeat that for me, Lindsay? Asking if you know why the H&P specifically would be required to be in the bylaws since it's a basic element of patient care, wondering why it specifically has to be outlined in the bylaws. That's a very good question. I really don't know why they would. You'd think it was common sense. Yeah, why is this person coming in? What do we need to know about them? But that's one of them, they said, yeah, they need to be in the bylaws. Great, I think those are the only questions. Great, okay. All right, radiology. We know patients have x-rays and exposure to ionizing radiation has doubled, if not tripled in the last 20 to 30 years. And this is mainly due because we now have these great tools, CT, fluoroscopy, medicine, we have these great imaging, but we're starting to use them and they're very, very beneficial. And now they've noticed that the ionizing radiation from a CT is greater and patients can get these quite a few over time. How many have they had? 80 million done in one year. You know, it's a lot. FDA, they've developed an issue to help reduce unnecessary radiation. They wanna make sure that it's justified to use. And what we're doing is the lowest dose reasonably achievable. In other words, how low can you go to still get that really good bill? And so FDA talked about changes in their safety precautions to decrease radiation. You know, those high risk patients where maybe it's just contraindicated, shielding the patients and staff, looking at the equipment, making sure it's calibrated appropriately and that staff are trained. When do you wear your shield? When do you not? Where does your dosimeter badge go? Et cetera. So we can also monitor our staff. Joint commission, they talk about radiation risk of imaging. They update it in 19. The higher dose we know the delivery, then the higher the greater for damages and especially repeated. I remember working in our ICUs and our CCUs, patients grading chest x-rays every day. And you know, we had to evaluate, okay, this person's been in for two weeks and they've gotten two weeks of daily radiation. So that's what we had to start looking at is that really absolutely necessary? Because it can cause cancer, burns, other injuries, cataracts. It is a carcinogen according to the World Health Organization. So how can we reduce them? A program so that we can provide education on managing exposures, maybe keeping in mind the dangers of excessive radiation. Again, have that radiation safety officer if you can. And what are the typical doses and ranges? Have clear protocols. What is the maximum dose for each study? Work with a physicist, a medical physicist. When you're looking at altering your protocols, work with your clinicians. Make sure that there's good communication of why are we doing these x-rays. That picture happens to be a radiation burn from getting too many x-rays. All right, radiology. You have to have diagnostic radiology services to meet standards for safety and staff qualifications. Also, that if you provide therapeutic services, meet those like stenting an artery, lithotripsy of a kidney stone. Guidelines say we have to have policy and procedures on safety, including making sure all staff are qualified, that maybe you want one service, regardless of where it's performed. This has to be under the direction of a radiologist. Now, that doesn't mean that the radiologist has to go down and peek over the shoulder when you're doing x-rays in ER. It's just they're responsible and under the direction of that service. The guidelines, they talk about the difference in the test. Now, I know we're getting a little short on time, but if you would like me to do the question, that's fine, Lindsey. I'll leave it to your discretion. We just answered those other questions. I don't see any other pending questions at this time. So if you want to maybe skip this one and we can move on, then that's perfectly fine with me. Great, okay. You have to have service to meet needs of patients. In other words, what kind of patients are you getting in and can we take their x-rays? Diagnostic services on site, and that's based upon, again, your patients and your type, available at all times, either on campus, or if you have an offsite location, and you can use staff, you can use contracted services, such as interpretation of your films. The scope and complexity, they have to be in writing. Therapeutic radiology, that's optional, but diagnostic must be present. Interpretation, you can use teleradiology, but just remember that's still telemedicine and they have to meet all of those requirements. Emergency department, make sure it's available 24-7, whether it's a CRM, portable, whatever it happens to be. Surveyor will ask, how did you determine the needs of your patients? How did you make sure diagnostic services are there promptly when you need them? For therapeutic, again, meet the standards of safety. That can include ionizing radiology. We have to make sure it's free from hazards to patient and staff. That's why our policies have to ensure that safety. MRIs, they can cause burns, adverse events, risk of flying magnetic items. We've heard those stories where an oxygen tank got brought into the MRI, magnets fired up and the tank gets sucked into the magnet. All services provided according to standards of practice. ACR, they talk about MRI safety and CMS does mention others, FDA, AMA, but then we also have to comply with any state laws or other federal laws. Our policies have to include the principles of as low as reasonably achievable. Now they put in here as defined by the EPA. I don't know why, but they did. Protocols used or approved by the radiologists, make sure we're doing them right. That is safe and according to specifications. What patients are at risk? That's what our policies have to be able to identify. Maybe they're allergic to the contrast. They have an implantable device. And how do we mitigate our hazards? Policies, yes, there's several of them. They have to include procedures to arrest risk with an MRI. How are we gonna train our staff? Those who come in and help with that. That they're competent, including training on policy and procedures, running the equipment. How do they respond to an emergency? Where's the crash cart? Who's going to respond? What are you expected to know? And observe the patient. The surveyor will verify you have such policy and procedures. And do the staff know where they are? Are they familiar? And then they're going to observe staff providing care to see are they following those policy and procedures? You have to monitor quality and safety of the services, patients properly prepped, properly placed, IV access is in place and done correctly. If you're having to do repeat studies on the same patient, why? Is it poor quality? Can I not see what's going on in there? Some of you, those of you have listened, I've mentioned the blue boxes. These are advisories, recommendations only. You're not cited if you don't do it. But again, they talk about absolute dose limits, not discouraging from having diagnostic reference levels, again, really good information in these. And they've recognized that they can't cite you on them if you're not following them. Safety precautions, well, we have to have signage that's clear and recognizable, adequate shielding for patients and staff, labeling, storage, disposal of our radioactive material and keeping it safe during that transport. We have to do periodic inspections of our equipment. So if we do have any hazards, we've identified it and corrected it. Policy has to address periodic assessment and calibration of our equipment. Always follow manufacturer's recommendations, have a way to track modifications because that could affect the dose delivered and any adverse events are addressed that we're looking at them, we're evaluating and taking action. Worker safety is also addressed because we have to watch our staff for the amount of exposure they're getting and have a policy, who's required to wear it, where are they to be located? And that could be nursing, where is nursing going to be placed if they have to be down there with that patient who comes from ICU to help them? They have to be trained on the use of brass jets, believe it or not, yes, we have to train them. And policies are approved by the radiologist in this area. The surveyor may ask, what do you do if a decimeter comes back high? What's your steps in taking care of them? Other provisions, of course, we have to have an order for our services. The medical staff and board decide who can write that order. Qualified radiologists to supervise this service. If you have a consultant, same thing, they have to be privileged, same for teleradiology. And only interpret those tests determined to require a radiologist specialized knowledge. You probably have your radiologist do all over reads. That's just an example. Which ones do they absolutely positively have to overread? On personnel, you only want qualified staff in there using the equipment, whether it's a tech or a radiologist. They have to also know how do you respond to adverse events. Reassess their competency, document their training, the dates, and satisfactory competence. And then finally, records. Our radiologist records our reports, the films, that's all part of the record. We keep them at least five years. But again, watch your state law, it may be longer. Records kept for all procedures you do. And the surveyor is going to ask, who's using this piece of equipment and how are they qualified? They'll probably gonna look in their HR folder to make sure that, yes, indeed, they're qualified. So moving on from radiology, let's go to laboratory. And part of what's called the look back program. Like radiology, we have to have services, lab services to meet the needs. Here, the services are performed in a CLIA certified facility, meaning you have to have a current certificate to the level of your lab. Services in any department outside of the lab have to meet those guidelines. They can be, again, direct or by contract, but regardless, they have to be incorporated into your QAPI program. Labs results, they're part of the record, and so they have to meet those conditions of participation for medical records. Complete, signed off, timely, et cetera. Now, lab conditions are in Appendix C. I don't cover them. They have made some updates late to this appendix in 2024, and some of them were grammar, punctuation, et cetera, but they did make some changes to Appendix C. Adequacy, you must have enough, either direct or by contract, with a CLIA-certified lab, and they'll determine what services are you doing in-house and which ones are out-house, which ones are you taking by contract. They will verify if you're using a reference lab, it is CLIA-certified for that specialty. It could be a very complex one. If your hospital isn't that big enough to do certain testing, like genetic testing, maybe you're in blood and alcohol testing, the reference lab has to be CLIA-certified to perform those tests. You have to have emergency services for lab, 24-7. If you have multiple campuses, same thing, available 24-7. The medical staff will determine what is going to be immediately available, but generally it should reflect the scope and complexity of your operations. Written description of what are those emergency labs. You know, is it gonna be your CHEM-6? Is it going to be your INRs? Is it going to be your cardiac enzymes? Which ones are going to be available through the emergency processes? And what are provided, a written description that are provided to the medical staff on routine and stat basis, what is considered stat, like potassium. Then you have to have a written description of all your services, and that has to be available to the medical staff. So the staff needs to know, okay, what does this hospital provide? And the surveyor wants to see that written description. And that it's accurate and it's current when was it last reviewed. On tissue specimens, the lab has to have a way so that they can receive and report on tissue samples. You know, written instructions on how do you collect it, preserve it, get it down from surgery maybe to you. Sending back the report on that tissue. The medical staff and pathologists, they determine when those specimens need to be either gross or micro examinations and a written policy on it. On potentially infectious blood, this is HIV, hep C. Prior collections from a donor. Here, this is where they tested negative when they donated, but then testing comes back positive later at a later donation. So I donated January, I was negative. I came back in November, donated again, but now I'm positive. Test positive on supplemental, how much are you going to do for follow-up testing? That's required by the FDA. And as far as timing of seroconversion, we understand that may not be accurately estimated, but I wasn't and now I am. On blood and blood products, if your services, if you regularly use services by an outside blood bank, make sure that agreement governs procurement, transfer and availability of that blood product. How do you get it? And how soon can it be at your front door? It must require that blood bank to notify you of any infections, HIV and hep C infections. If you tested negative when you donated, but then came back positive, we know that's an increased risk. So as far as notification, the blood bank has to notify that hospital within three calendar days. 45 days of the test results of more testing or follow-up testing that the FDA may require. Three calendar days after they gave you the blood or the components from an infected donor, whenever that becomes available. Oops, excuse me. So if you get notice that you've got, somebody came back positive, you determine where it went and quarantine it. If they notify you results of additional testing is now negative, you can release the blood. If it's positive or indeterminate, toss it, throw out the blood. Notify the recipients of that blood. If again, they said that additional testing is indeterminate, I'd do the same thing. Destroy, label prior collections held in quarantine. That's what CMS is saying. On record keeping, you keep records of anything, any disposition of all units for 10 years. You have to make reasonable attempts to notify the person who received it, document the record. If you know the attending, the attending who ordered the blood can notify the patient also. On that notification, there's three things you have to include. You have to get tested and have counseling. There's enough information so the patient can make that informed decision. Do I wanna be tested? Do I wanna get counseling? And then number three, locate the programs where they can get both counseling and testing. You document three attempts within 12 weeks to notify the patient. If you're unable to locate them, document it extenuating circumstances that you've tried to reach them that go on past the 12 weeks. You may need to notify a representative or relative if they're judged incompetent. If they're competent and your state law allows a representative or relative, then do that. You can do the patient and then that other person. If they're deceased, it goes to the representative or relative. If it's a minor, parent or legal guardian. Have these policies for notification, documentation, keeping in mind confidentiality and other patient information. Have policies on notification that conforms to your state local laws and to make sure again, we're keeping confidential records that we've notified the minimum necessary. Look back activities. This only related to new blood that they identified after 07. And here you have to comply with FDA regulations on blood safety, appropriate testing, quarantining of infected blood, notification and counseling those who might've received it. So again, that's it for lab. Any questions, Lindsey, you'd like me to address? I don't see anything at this time. Okay. Food and diet. Well, CMS, this is where that initial question on the dietician came into place. CMS recognized their conditions were too restrictive. They didn't allow hospitals to privilege registered dieticians according to state law because they felt these are the best qualified persons to assess a patient's nutritional needs, their plan. And they come up with a plan to treat those needs. They use registered dieticians, but your state could call them something else, licensed, qualified nutritional specialist, whatever it is. So CMS said, okay, now we understand that this dieticians such as registered dieticians can be privileged to order them, to order diets. That can include your enteral feedings, your supplemental feedings, therapeutic diet. They can order lab tests that are necessary. They are granted privileges by the medical staff to make these orders. And that can be with or without appointment to the medical staff. In other words, they have privileges, they're just not appointed to the staff. So now registered dieticians can order diets independently without requiring the approval of a physician or other practitioner, but they have to be credentialed. They have to be privileged. And this includes your swing bets. There is the American Nutritional Association. They will identify any restrictions on licensure. I have the link there for you so you can identify it according to your state. So your services overall, you have to have organized services that are directed and staffed by qualified personnel. And you have to have enough to do that. If you contract, the company has to have a dietician. They serve, it can be full-time, part-time, consultant, whatever it is. They maintain the minimum standards of the conditions of participation. And there has to be a liaison between that contracted company and the medical staff on any recommendations on dietary policies. Otherwise, your service has to be organized, directed, and staffed to make sure our nutritional needs of the patient are met following any physician orders and of course, standards of practice. There are seven dietary policies that are required. I'm gonna go through these fairly quickly here. A diet manual has to be available, whether it's therapeutic, how often meals are going to be served, what do you do for diet ordering and tray delivery, accommodations when it's non-routine, like TPN, or changes in the order, early or late trays, that this integration of the service is into QAPI and infection prevention and control. There's guidelines on acceptable hygiene of the personnel, hygiene practices, and sanitation, because we're not only preventing germs, but also rodents, we're keeping infestations out. You have to have one full-time employee who is the director. They are really the managers of the service. Here, the medical staff and board gives them the authority and delegates them to run the dietary service. And that's what the job description has to spell out. It is physician-specific. Here's their lines of authority for directing the services. And training programs for staff to make sure policy and procedures are followed. There are five policies the director has to put into place. Safe practice for food handling, emergency supplies, orientation, work assignments, supervision, you know, what a manager normally would do, menu planning, including purchasing food, retention of records, and this includes menus QAPI. There are no policies on the QAPI for the food service. Dietitian is different. This is someone who's qualified. They are the part-time, full-time consultant. Here, they supervise the nutritional aspects of care. They can provide counseling to the patient family on a particular diet. And they also perform and document nutritional assessments. They evaluate how is the patient tolerating this diet. They work with other services, whether it's nursing, pharmacy, social work, going home. Maybe they have a food issue. They can't afford the right types of food or even food. They keep data to recommend and add to therapeutic diets. If it's not full-time, there has to be some kind of provision when a physician or someone needs to consult with that dietitian. Otherwise, you have to have enough personnel and who is competent in their duty to make sure this thing operates. Menus have to be nutritional, balanced, and meet the needs. And effective patients is everybody, all inpatients, outpatients. If they're an observation, you got to feed them. You got to provide something for them. Patients have to be assessed for any deficiencies or a need for diet, a therapeutic diet and supplements. Again, in the interest of time, I'm going to pass on the third question also. So for dietary services, the Institute of Medicine, they have food and nutrition boards, dietary reference, DRI, dietary reference intake. Four values that they reference. One, the recommended daily allowance. That's the average intake of a nutrient for healthy people. Then there's adequate intake. It's similar and this is determined when a recommended dietary allowance can be determined. This is the safe and effective adequate dietary intake. This is based on observed intakes of a nutrient in a healthy person. Number three, tolerable upper intake. This is where it won't pose a toxicity list for those who are at risk. So let's say you have someone who has an issue with kidney issues. There's certain nutrients that we have to be very careful that we're not going above that nutrient so that their kidneys can continue to function and we're not making a toxic level. And then the estimated average requirement. That meets the requirement for half of the healthy people. And here's just for an example what that DRI happens to look like. Ages, genders, any other specific condition. Therapeutic diet, here's where we meet the nutritional needs. We have to assess it if there's a deficiency. Diet ordered, that must be part of their treatment for a disease or a condition. We maybe wanna eliminate, decrease certain substances and mechanically altered food, they don't have any dentures or they've had oral surgery and they can't chew. That's why the patient assess, we have to assess them for any needs that they might need or deficiencies. That would go into their care plan so that we have to monitor their intake, whether it's weights, INO, a lab value. Nursing always does that assessment on a mission and that includes, is there a nutritional screening? Maybe somebody at risk, then maybe we need to get dieticians involved. That assessment, that comprehensive, any surgical conditions, something that interferes with their ability to either digest or absorb nutrition. And then watch those for signs and symptoms and malnutrition, bulimia, imbalances, any condition affected by an uptake, I already mentioned renal disease and those who get artificial nutrition. TPN is one example. We have to have substitutes if they refuse food, something of equal nutritional value, meet those basic needs. And that's what the care plan has to include. Include the INOs and their weights. The surveyor wants to talk to the dietician. How did you determine the menus and the needs of the patient? How are patients so identified as meeting special needs? They'll look at an order for a therapeutic and then they'll look at the sample records of those who are identified. Of course, we need an order for any diet, including therapeutic, somebody who's responsible for the care of the patient. Qualified dietician, of course, consistent with state law. And again, some prohibit a dietician from ordering it. Diets are based on the assessment and it must be documented in that record, that assessment, including how are they tolerating that diet? If anybody's been on a no-salt diet, it's like eating cardboard. It is not flavorful at all. And they may not eat it. And the board, again, they can permit staff to grant privileges to dieticians to make these orders. Most states will have a statute that will determine what is a qualified dietician or professional. A hospital has to make sure this person is qualified before they appoint them. And other terms, again, nutritional, certified clinical nutritionists. If they are not privileged or credentialed, they decide, even if state law says it's okay, then the practitioner has to write that order. And the person can still do the assessment, make recommendations, but the physician, that practitioner needs to write the order. The surveyor makes sure the diet is ordered and that they will ask the hospital, what standards are you using to make sure this is occurring? They'll look at records to verify orders are there that prescribed. What is the nutritional needs they've been met? And how is dietary intake and nutritional status being monitored? And then the therapeutic manual. Something has to be there, approved by the dietician and the medical staff. So personnel, medical, nursing, food service, they know what can this person have or not have. And the various diets. It cannot be older than five years. Utilization review is pretty short. There's very few. Only eight pages long. What they're looking at are those services to Medicare and Medicaid patients. You have to have a utilization review plan where you're looking at services provided by your hospital and by the medical staff to these Medicare and Medicaid beneficiaries. It should state what is the responsibility and authority of those who are involved in this process. Now, there are exceptions when you don't need a plan. There's two of them. When your utilization quality control, quality improvement organization has assumed that binding review of your hospital. That means you have to have an agreement that the QIO will come in to look at your utilization review. Number two, CMS has determined that the procedures established by the state under your Medicaid program are superior to anything in the Medicare program. And you are going to meet those requirements. Now, right now there's none approved by CMS for number two. QIO, yes. So that's when you don't need a plan. Otherwise you have to have a plan. That you do have one, the surveyor will make sure it meets the requirements or if you have that agreement with the QIO. If so, the surveyor will not assess it because they know it meets the standards. If you don't have a contract with that QIO, you're not following the standards you are cited at a condition level. So for this, you have to have a committee. Two or more practitioners must carry out this function. Two members must be physicians. The committee is either by somebody at your hospital. You can use an outside group. Maybe your local medical society has that. If you're small and it's not practicable to have your own functioning committee, then you have to have an outside group that CMS has approved. There are limitations. A committee may not be conducted by someone who has a direct financial or ownership interest in the hospital, 5% or more, or who is professionally involved in the care of the patient that's being reviewed. The surveyor will want to see who's on your committee and they will look to see if the governing board has delegated this function to an outside group. If it's just, you just can't do it internally. As far as Medicare and Medicaid necessity for admission, duration of stay and services, the review of admissions is done before or at admissions and a sample basis, unless of course you've got an outlier, like an extended stay or why are all these costs high for the person? The surveyor wants to see your plan. Is medical necessity reviewed for all the time the patient's there? Your inpatient prospective payment system, you look at the review of duration of stay and services provided. Those reasonably considered to be outliers, look at those or high costs are involved. On admissions and continued stay, that decision not medically necessary is determined on a couple of ways. One by a committee member if the practitioner concurs or if the practitioner doesn't come up with their own views when given the opportunity. Otherwise that determination that it was not medically necessary has to be made by two members. And before determining non-medical necessity, the committee has to talk to the physician and give an opportunity to present their side. If it is decided, no, it was not medically necessary, you give written notice no later than two days after the determination to the hospital, the patient and the practitioner. The key here is document medical necessity that yes, they have to stay. And that two midnight rule, they must stay in the hospital. That's why documentation is so appropriate. And that's why when looking at medical necessity for the setting, extended stays, what services, maybe they were there because of fall at the home and all of a sudden they develop chest pain. Okay, they have to stay, we have to do cardiac cath, et cetera. And this is huge if you've ever undergone a wreck that recovery audit contractor, they identify improper payments, including overpayments and underpayments. And I believe there might be an increase in some of these audits with just some of the environment that's going on now. Extended stay, committee has to look at periodic review for each inpatient. If they're paid under your inpatient stay, they look at all cases and do this no later than seven days after the date set in the plan. The committee must review services also provided. Are they medically necessary? Are they available? And timeliness of scheduling these items such as surgery and therapeutic procedures. That's what the review must include. I'm gonna briefly touch on the MOON Act, the Notice Act, the MOON form. It's a Medicare outpatient observation. We give written notice to outpatient observation patients for explanation. They're outpatient. They're in there for no more than 24 hours and use the revised form. The only change was the expiration date. You have to give it before discharge, no later than 36 hours after observation began. And it tells patients you're outpatient, you're not inpatient. And because this has implications in swing bed availability and eligibility and cost sharing post-hospital eligibility for SNF. If the patient refuses to sign, just the staff signs a certification, I gave it to the patient, the date and time. Use plain language and the form determined by the secretary. It should be in the appendix for you. There are several documents, it's in English and Spanish, PDF, Word. And again, the reason they did this was because they had a Medicare patient observation for one day, then they went to inpatient for two, then they were transferred to a SNF. 46,000 weren't covered because they didn't have the qualifying three-day stay. Now this is traditional Medicare, not Medicare Advantage. Okay, we're moving along well. Physical environment, we're coming down to the last two. And maintenance. This is our hospital. We have to be constructed, set up and maintained so it's safe for everybody so that we can provide safe diagnosis and treatment. The conditions apply to all locations, all campuses, all satellites. For your maintenance, your maintenance hospital department, those responsible for the building and equipment, that has to be incorporated into QAPI and comply with those requirements. A survey of your environment is usually done by one surveyor. They may include a life safety code surveyor, someone who is specially trained to do that. And that's good for you because they're really tuned in to what's required and can help you meet those requirements. They're going to look at the physical plant, the condition of it. Is it clean? Can we provide care and activities safely? Is there something that maybe a manufacturer would recommend? They wanna make sure there's ongoing maintenance inspections, routine and preventive. Testing activities. Again, these are all incorporated in QAPI. Is our EKG machine working? Is our X-ray machine not giving out too much radiation? So this is the entire building and the entire processes. Accessible, we have to make sure we can get them in, that it's constructed and maintained for risk to patients, employees, and visitors, that we're following ADA standards. Also with any OCR requirements that I'm returning patients away based upon those OCR requirements. Also that we can meet their needs for translation, that it is accessible. Is braille on the outside of something if you happen to have patients? This is some of the items that they'll look at under OCR. Age-related. In other words, if you have pediatrics and neonate, maybe you have elderly patients, are we looking at standards so risk are reduced for that special populations? Like access to cleaners, hazardous material, our furniture. Do we have those beds for those kiddos so they're not having to hop up and down as safe? Medical equipment is adjusted for those elderly or the pediatric patients. Don't forget security. We have to have enough to prevent elopement or unauthorized access to units. And there is the International Association for Healthcare Safety and Security Guidelines, I listed that here, that they can provide you some guidance on it. So again, unfortunately in the interest of time, I'm sorry we can't get to these questions, but before I go into the last segment, I will stop and see if there are any questions. But as far as security, look at areas that are really at risk. Newborns, peds, behavioral health patients from elopement or self-harm. Those with diminished capacity that maybe just get up and wander around. Are we keeping an eye on them and keeping them safe? But then non-clinical rooms, HVAC, gas storage, ventilation rooms, electrical rooms. Well, those are areas you don't want unauthorized folks getting into. Ligature risk, same with security, preventing that inpatient suicide. And also strangling staff and others. Presence of unmitigated risk. If you're a psych hospital or a dedicated psych unit, that's considered immediate jeopardy. This is unmitigated risk. Ligature risk findings, they are referred to your health and safety surveyors. They will evaluate further. And does this come under another tag number called patient rights? Weather-related issues. Have something to address the interior and exterior of your hospital so that it's safe. Driveways, garages, sidewalks. If you're in an area that gets flooding or ice storms, here in Colorado, we get ice, flooding, snow, whatever it happens to be, that we have to make sure our sidewalks are safe, our garages are relatively safe. If you use power strips, any deficiencies, those again, those go to the life safety code surveyors for citation. Very long description in Tag 701, by the way, on power strips. And when can you use them inside and outside patient care areas? Emergency systems, power, lighting. What do you require in those crucial areas like OR, ICU and ER? Stairwells. Those are considered areas that must have backup power lighting. Other areas you can use flashlights, just have them available. Facilities for emergency gas and water supplies. These are things you sometimes don't think about until it happens. Positive latching on doors. This is where you've got something, you don't want people in there, like combustible materials. You cannot have a roller latch. You have to meet the needs of life safety code. CMS, they may waive them if it's unreasonable hardship and there's no danger or effect to health or safety of patients. Outpatient surgery, you meet the same provisions as ambulatory healthcare occupancies. Trash, that's part of the physical environment. You have to have storage and disposal of trash. That includes biohazard and according to what your state and federal law, EPA, OSHA, any state environmental regulation. Here's one where they still haven't gotten around to updating the guidelines on it. How do you dispose and store your trash pending pickup? And this includes again, biohazard. Have a written fire control plan to report extinguish, keep patients safe, a fire control plan on evacuation, working with authorities. And we're gonna go into this just briefly with the next session. Evidence of regular inspections from your state and local fire agencies. They added alcohol-based hand rubs years and years ago. We couldn't have these. But now they realized that that's crucial to preventing transmission of infection. You can now put them in. You can put the dispensers in place as long as it's not inappropriate access. They amended it, the guidelines for alcohol-based hand dispensers, but the guidelines are still pending. You have to have a sprinkler system. If so, if it shut down for more than 10 hours, you have two choices. Evacuate that part of the building until it's backed up or put up a fire watch. And a fire watch means somebody's there 24 seven. They're not leaving, somebody's guarding it to keep an eye on it. Outside window, every sleeping room has to have an outside window or door. They talk about the sill height, not over three feet. If you're in a special care area, yeah, like a neonatal nursery, they can't go over five feet. And now this doesn't mention if the window can open or should not open, probably a good idea not open, just for safety of the patients. You follow your health safety code. CMS, again, can grant a waiver if it's unreasonable and it's no safety issue for patients. And then your facility, keep them so that it's well-designed according to your laws. It reflects your scope and complexity. That includes toilets, sinks, equipment being accessible, water for its intended use, whether it's drinking or irrigation. That's why look at your water quality management program because Legionella is still around. It's in water heaters, eyewash stations, everywhere. And that's why do that facility risk assessment, determine if it can spread within your system. For your diagnostic and therapeutic guard, they're set up for the safety of patients. So you have supplies and equipment, they're maintained. So we get that level of safety and care. It is a condition that you have to meet safety for patients and visitors, have supplies to meet the needs, secure against theft or contamination, and emergency supplies that if something happens and people can't deliver supplies, do you have backup supplies? As far as complexity, that's determined according to the services that you're offering. Is it large enough and appropriately designed? The survey will verify you're big enough, you have enough equipment that you can have enough patients and staff to provide those services. Ventilation was big a couple of years ago, especially in the surgical areas with the gases. And they wanna make sure there was proper ventilation, temperature controls, not only in surgery, but in pharmacy, food prep. And so look at where oxygen is being transferred, lighting, humidity and temperature. Just briefly on relative humidity, if it gets too low, your supplies can dry out and it won't work, it can increase static and that can affect your equipment if you're getting a lot of static discharged. It can also affect calibration of equipment. They did incorporate references, standards by reference, and they did provide information from the National Fire Protection Agency. There's more information if you need that available. And so now we're down to our last little bit. This is covered extensively in Z. I have it here as an FYI because you have to show compliance. They actually have the standards in the Critical Access Hospital Manual, but here on appendix Z, and I'm gonna run this, it's a very short video. This is the first time the public has heard and seen explosions coming from inside Brockton Hospital's electrical room. One of the greatest things I love about the fire service, the fire service who calls, we're gonna show up and then we're gonna get the cavalry to come in behind us. And they did. Take a look at the numbers. It was a 10 alarm fire. And as you can see from here, this was a huge impact. 10 alarms, 90 ambulances, hundreds of personnel, fire trucks from all over came to help with this one. They had to evacuate the hospital and it ended up being shut down for over a year before they were able to reopen. Not only is it your hospital that could be impacted, but the surrounding community. What you're looking at is a fire that occurred here a couple of years ago in Denver and the Metro Denver area up toward Boulder, where tens of thousands of houses were wiped out by a wildfire. And unfortunately, LA has gone through the same thing. It wasn't that the hospital was impacted by the fire, it was the outcome from the smoke and the debris from the fire. It hit the ventilation system and they ended up having to shut down again, clean it out, clean the rooms, clean the ventilation, everything had to be wiped down. So that's why we have an emergency preparedness plan to plan for these things, whether it's manmade or natural. And we use that all hazards approach. In short, if it's possible, it could occur, plan for it. We have to train our staff and do testing annually. We have to work with local federal state systems, whether it's FEMA or your local fire department. We have to have enough supplies and help provider still meet the needs during that disaster. So again, even if it could occur, we've seen these more than once now, it's a derecho. And these are ones with hurricane force winds on land. So we have to do a risk assessment and develop our plan based upon that. Then we look at the plan every two years. We have to do testing and training and that includes a full scale exercise. Take into account if you have special patient populations, psych patients, neonates, elderly with dementia. What about our fuel? How are we going to keep our generators running? We have to have policy and procedures. We have to develop and maintain testing and training based upon our plan, our risk assessment, our policy and procedures. What are we going to do? And our communication plan. This is reviewed and updated every two years. Testing, we have to do exercises twice a year. One is full scale and one is your exercise of choice. It could be a tabletop, a mock demo or a full one. From that testing, you analyze and document what you have done. And then maybe we need to redevise our plan. 22, they put out a memo clarifying it because this was because of COVID. So many things were going on. Hospitals were still impacted by COVID and they said, yeah, we need to revisit this. How many times is this testing going to occur? And so in a specific 12 month period of time, you may get a pass on doing testing, a certain testing if you still have activated your plan. And if you did claim such a pass or an exemption, then you have to, and you've gone back to normal services, then you have to do your full scale testing. But what they do, the surveyor is going to determine what's your annual cycle. Have you done two of those required exercises within that 12 month period? If you are still under your activated emergency plan or reactivated it, you get an exception. You are expected to explain and describe that exemption because here the exemption is on the full scale exercise. When you're doing this and you're developing your plan, take into account security of your patients and your supplies. How do you obtain pharmaceuticals, food, other equipment? Maybe you need backup equipment or new equipment. What are the staff qualifications? Do you need to train your staff to take other roles? How are you going to notify personnel? Your implementation of your power system, emergency and standby. Where is it going to be located? Where's the generator going to be located? How are you going to supply your fuel for that generator? If you're part of a system, each hospital has to participate and they have to make sure they're involved in that planning of your emergency plan. Your policies, how do you track your off-duty staff? How do you track your sheltered patients and staff? What about transferred patients? Policies address evacuation, documentation and confidentiality of that documentation. Just because you have an emergency, not all of HIPAA. It's voided. How are you going to use volunteers? Are you going to use volunteers? On your communication plan, who's your contact for staff, physicians? How do you share information on patients? And it brings us to the last for the last four minutes. We've got an older hospital, multi-specialty, located in the Midwest. We get our snow and our ice storms. The last update was eight years prior to the emergency plan. That included automatic doors at the entrances. Well, due to the age of these doors, the mechanism, sometimes the outer door got jammed open. So snow, ice, things could come in and that made it slippery. We have a 59-year-old visitor. They had to have a walker. They're entering our hospital and they slip on melted snow, fracturing their upper arm. So they do an RCA and they realize that we have this issue with the doors. It's been reported, especially by volunteers who sat next there. There were several work orders that had been developed by maintenance, but due to the age of the mechanism and the replacement parts, they couldn't get them or it was simply impossible. They took that long to track them down. What should the hospital do? Do they replace the entire door system? Do they put someone there at the entrance to assist and warn visitors, force up warning signs, slippery condition, anything else you can suggest on this hospital? So we've got about several minutes. Lindsay, we can go ahead and talk this one or any other questions. Perfect. I don't see any other pending questions at this time. So if you do have any that maybe you've been sitting on and haven't typed in yet, you can go ahead and put those into the Q&A option, or of course they're in the chat. And then if you have any other suggestions regarding this final discussion question, you can type those into the chat as well. But if you won't tell her, we can go ahead and discuss this one and go over any other resources. Okay. Well, this problem has been going on for some time. Honestly, the volunteers were getting tired of being frozen out once that door got propped open and never closed on them. And so the hospital did decide, you know what? This is not safe. And it's just going to continue to happen. We can't get the parts or the parts didn't fit as far as an accommodation. So they did decide, the governing body decided, we can't have other people injured in doing this. And our staff, our staff comes through the front door too. And so they did bite the bullet and replace the entire system. It did cost, but it was very, very effective. And one other thing they did, yes, they posted up signs, you know, please be aware it's slippery and snowing if this happens. But then they also decided, can we have somehow maintenance housekeeping? Somebody come around and check this mat or whatever it was. They put down this large moisture absorbing mat at the entrance to help with it, didn't stop it. But then they were able to get maintenance out to start cleaning this thing off and groundskeeping to make sure that maybe we put salt, make sure the salt is out there to help not dissolve it. And then keeping it on that mat to keep it clear as much as possible. And the volunteers were more than happy to just go out and peek to see if it were there. And then they would notify that person to come help. It did help. It really, the staff was much happier, especially the volunteers when that door remains shut and it wasn't so cold at all times. So they did, it did cost, no question about it, it did cost, but in the long run, it really improved it, really helped with that hospital. And even the staff and the visitors know, oh, I'm so glad you got rid of those terrible doors. In conclusion, I do want to point out, I have roughly 35 pages of resources. I'm not going to go through it. I see, yep, they've all replaced the doors. That's the best thing to do. And that's what the hospital ended up doing. So with that, again, I have 35 pages of resources for you. If you get to a link that doesn't work, let Lindsay know, she'll let me know, and I'll try to figure out why it's not. I've included that new law in here on reducing maternal morbidity and how you can find that, the new regulations. It's a long one, it's way at the bottom of that new law that did come out. Just put some other information in here on QAPI and maybe what you might want to follow up on. So we have 10 minutes, we can get back to them, Lindsay, and I'll leave it to you for any closing comments. Perfect, thank you so much, Laura. I did just post some reminders there for you in the chat. Hopefully you have been receiving the follow-up emails after each of the sessions in this series. Just note that we'll come tomorrow morning to your inbox from educationnoreplyatzoom.us. So if you don't see an email in your inbox in the morning, just check in your spam quarantine, possibly your junk folders, because if it's coming from that Zoom email, it may very well get caught up in those folders. But included in that email will be a link to the full recording of today's session and a link to Laura's slides. But I did provide that link there for you in the chat now as well. Once you do receive that Zoom link, just as a reminder, we do have an additional security measure in place. So when you click on the link, it will ask you to put in your information. That will prompt the email to come to us for approval. And we just ask you to give us one business day to grant those recording access requests, but we do typically approve those much quicker than one full day. We thank you so much for joining us today. I know that you do see Laura's content information here on the screen, and we have been receiving questions following several of the sessions so far. We encourage you to continue sending those questions in. And you can send those to education at gha.org, and I'm happy to get those over to Laura and then her responses back to you. And we look forward to having you all back with us next week for the final session in the five-part series. Thank you so much, Laura, as always for your time and information. I hope you all have a wonderful afternoon. Thank you so much. Thank you, everyone. Thank you, Lindsay. Thank you, bye-bye.

risk management

patient safety

hospital compliance

CMS regulations

quality improvement

emergency preparedness

federal guidelines

medical staff requirements

peer review

credentialing

safety standards

facility safety

healthcare management

patient care quality