I'd like to introduce our speaker to get us started with Part 2 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 Director of Facility, Patient Safety, and Risk Management and Operations for COPIC 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 COPIC, she served as a Director, 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 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 Jewish Prudence 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. We thank you so much for being back here with us this morning, Laura, and we invite you to get us started with Part 2. Okay. Thank you, Lindsay, and welcome, everyone. Well, it's been an interesting couple days, and now with the changes coming down, or those that are starting to go into effect, we may see some more changes within CMS and Health and Human Services. What those changes will be, I have no idea. Right now, I'm just hoping to get an updated manual for your hospitals, for your critical access hospitals. What we're talking about today is a variety of areas within the current manual, and that includes everything from are your walls clean, or how do you respond to an emergency, and then dietary and nutrition. So it's a vast array of items that I'm going to be talking about today. I always include my disclaimer that my program today is informational only. It is not meant to serve as providing legal advice nor establishing an attorney-client relationship. You'll have to reach out to your in-house counsel, legal representative for advice as it relates to any particular situation or an upcoming survey with the questions or response to a survey. Those of you who've had the opportunity to participate in these programs, you know that this is why we're here, why Georgia Hospital Association puts those on, so that you have the opportunity to not receive one of these. That's that statement of deficiencies. And I always mention that no provider ever wants to get notice, involuntary termination from the Medicare and Medicaid agreement. That's when the response is insufficient, didn't address the issues, or there simply wasn't one. By the way, you can also be terminated if you don't allow access to the surveyors when they show up on site. And that hasn't happened very often. I do see it now and then when I'm looking at the deficiencies. They do sometimes happen. So again, we're talking Appendix W, and the areas that we're addressing, by the way, your last manual was updated in 2020. They are due to release one this year. But here's the areas we're talking about today. Now that red, that's because when the manuals last updated, this was new, what they did with them. anywhere within your hospital, something that falls under your CCM. That's all locations, satellites. If you have inpatient, outpatients, that's going to apply to you. The services that are responsible for the building, for the equipment, for the maintenance of each, well, they have to be incorporated into quality assurance performance improvement. Now, as I go through these programs, I shorten that phrase to QAPI, that's your performance improvement plan, because they want to make sure everything is being done. Again, we talk QAPI in a coming up program. So let's talk about how you're built, your construction. It has to be built, arranged, and maintained. So first off, we have access, easy and safe access, and that there's enough space so you can do your job. You can provide care to the patients. We always have to follow any state and federal laws and that construction and in the maintenance. Think ADA, American with Disabilities Act. They will look, the surveyors are going to walk around to make sure that yes, indeed, it is maintained so as for the safety of patients. How are the ceilings, the walls, the floors? There is what's called a Facility Guidance Institute. I have the resource in the appendix for you. Perhaps your plant manager already has this. If not, you may want to access that and give it to them. Now, maintenance includes a couple of things. It's not just simply cleaning the floors. It is housekeeping, that's not to be ignored, but it also includes your preventing maintenance program for your equipment. And that's everything that's essential, whether it's electrical, your patient care equipment, everything has to be maintained in a safe operating condition. And that includes the equipment. Again, whether it's an OR bed, is it going up and down safely? Your thermometers, your wheelchairs, your beds, everything. And equipment includes not just patient care, but the facility, the plant equipment, the boilers, the elevators, the X-ray equipment, all of that has to be maintained. And what we need to do is identify that equipment to meet needs in case there is an emergency. And that can be everything from a mass trauma, the house burning down around you, or a disease outbreak. All equipment has to be tested and inspected before you use it the first time, but also after major repairs and upgrades. And again, there's some resources in the appendix for you on that. The interpretive guidelines for these two tag numbers, they talk about that all equipment has to be inspected, tested, and maintained so it's safe. It's also available and it's reliable. Now, I don't know how many of you have run across the piece of equipment where it worked Monday and by Tuesday, not working again, but then it's back working Wednesday. How you do that, who's going to do this, it's up to you. Whether you're going to have contract services out, employees, or combination. You know, you may have your own plant manager who's very skilled at taking care of the physical stuff, you know, the boilers, the elevators, even the lighting, but perhaps you contract out your biomedical equipment. That's fine with CMS, they don't care. Whoever is over the program, because yes, you do have to have someone who's over this maintenance program. They have to be qualified. And they're also responsible to make sure records are kept in case CMS wants to see them, or heaven forbid there's a patient injury as a result. Overall, what this person and the hospital, what you have to demonstrate is you have qualified people doing these risk assessment maintenance performance, excuse me, preventing maintenance, or you have what's called an alternative equipment maintenance program. I'm going to talk about that here in a minute. You do have to have policy and procedures. You can't get away from that, even in plant. You have to have policies, procedures, and a program that keeps track of your inventory. Who's going to do that? How's it going to be maintained? Are you going to use paper form, or do you want to do electronic? What's the activity for that maintenance? Is it going to be monthly, weekly, yearly? And what's the schedule? Again, that's what they want to see, the policies on how this occurs. Of course, we always follow manufacturer recommended activities and schedules. That doesn't mean you're prohibited from doing them more frequently, but definitely on that recommended basis, keep the documentation so you can show you were compliant with those schedules and what the manufacturer recommended. And it's not just from keeping CMS happy, but also if there is an event that occurs, you want to be able to show you did what was expected, and nothing else would have changed that. Now, Lindsey mentioned we have some questions, so I'm going to start off with this one. Lindsey. Okay, you should now see this question on your screen that says, our facility has an established alternate equipment management program. And then your options here, yes, no, or not sure. And I know we've had quite a few folks join after we did our initial introductions this morning. So again, if you have any questions for Laura as we go throughout the presentation today, please go ahead and type those into that Q&A box down there at the bottom of your Zoom window. Or if you don't see that option, you can of course type your questions into the chat as we go throughout the presentation this morning. Just a couple seconds here. Okay, all right, got some mixed responses here. Oh, good. Okay, and it's okay. Again, you're not quizzed on these, you're not graded on them. So what is an AEM? Well, this is one that's different from what the manufacturer has recommended. That's called the alternative equipment management program. What you need to do if you want to do this is you have to develop, put into place and maintain documentation on what you did. How does your program work to minimize risk to patients and others in the use of that equipment? Now, again, that could be something as simple as a surgical bed where you've decided you're going to check that surgical bed to make sure it goes up and down correctly and safely because anyone who's ever seen that happen or just automatically just drops, your staff could also be injured in the use of that equipment. Overall, we have to follow generally accepted standards of practice when we're doing this. You just don't want to make this up. You need to have some basis for that alternative program. CMS did include in the interpretive guidelines some examples where you could find it, National Standards Institute for the Advance of Medical Equipment Handbook. That's just one example. Which equipment you're going to put in there and who's going to do this is up to you, but you have to make sure they're qualified to do that, whether it's an employee or a contracted service, but you decide on what equipment goes in there. Also, who performs those risk-based assessments and what are the requirements of the program? And of course, managing that program. Make sure everything's done according to that alternative maintenance policy and procedure. Now, who qualifies to make that decision? Normally, in addition to maybe the medical staff because they know what equipment's out there also and what's used for and the board, but really it boils down to what piece of equipment do you have? Medical equipment, yes, usually your biomed technician or engineer. Maybe you have some very complex equipment. That usually requires someone who's specially trained. Lasers, for example, maybe you're very lucky and have, I don't know, hypobaric. If you had equipment, that requires special training. Facility equipment, you can have a little bit broader person on that, like the healthcare facility maintenance management professional, your facility manager, plant manager, director, however they are termed. Overall, you have to keep documentation of those qualifications. You have to be able to show they are qualified and that includes the contractors. If you want those contractors licensed following national standards, great, do it. That's what you can. And really it's to your benefit to have such a requirement. What about the equipment? Well, of course you need to point out what is the critical equipment, whether it's physical plant or biomedical. And this is that equipment, that critical equipment is that somebody is gonna get hurt or maybe die if it fails, like a ventilator. Another example, say it happens to be the x-ray equipment where it's given off too much radiation and we harm a patient of that. They list out several factors that you wanna take into account when you're considering what piece of equipment to throw into this program. Seriousness of harm if it fails, how widespread? Do you have just the one or is it throughout your hospital? What do you have on that equipment and what recommendations come along with that information? What are the requirements? Is it something very simple or very complex? What do you do if it goes down and you need a backup? How quickly can you get that backup? And is there any history with this piece of equipment where it makes you nervous to utilize it? And that situation, is that really one you want in this alternative program or is it better to follow what the manufacturer recommends? Yes, there is certain equipment that CMS, federal and state laws says can't go in there because they have testing and inspection that say you have to follow manufacturer's recommendations. Other requirements such as your National Fire Protection Agency, that's like radiology and imaging, medical laser, anything that's brand new. Maybe you've purchased it from another facility and you just don't have enough on the maintenance history. Those are ones you really wanna be cautious with in your alternative maintenance program. Not that you can't get them, it's just be very careful. Follow what the manufacturer says and do your best to try and find that equipment. We had a patient, excuse me, a physician who had used a heating blanket. You may have heard this case before where they were using a heating blanket, it was stored in the back room under a dust cover and the only one or the two they had in the surgery area at that time were already in use and this patient needed it. So the charge nurse goes in, pulls out, dust it off and plugs it in, it seems to be running. Well, after two hours or so of the surgery, they shut it off because her temp's back up and when they take the heating blanket off, she is blistered from the waist down. It hadn't been properly maintained and that's why they put it into the back room and it hadn't worked. Unfortunately, they didn't tag it for do not use, they didn't have the history on it and that was a very sad outcome. The frequency that you're doing this, that of course, what kind of equipment do you have and the risk with use of that equipment? Can you follow recommendations from the manufacturer and nationally recognized expert associations? But also what's your experience? Even though the manufacturer says, every other month you can test it, maybe you wanna do it every month. Again, that's your decision on the frequency. Otherwise, strictly adhere to your activities that you have or what you have developed. Moving on to inventory, you are expected to have that list of facility and medical equipment, that's essential. If you have those low cost items like mops, vacuums, you can just keep the number that you have, but they wanna know how many ventilators do you have? How many C-arms do you have? Otherwise, your alternative equipment must be readily separate and identified as such. That's the equipment you put in your alternate program. And the same with critical equipment, it has to be identified as such. The surveyor will talk to those who are in charge of that maintenance. Again, plant manager, maybe head of your biomed, whoever that happens to be. Do they have enough provisions for availability? What equipment is essential? What do you have as essential just on a day-to-day basis or in an emergency? And they'll also work to determine if that complete inventory is there to meet the patient's needs. Are you constantly running out of a piece of equipment? If so, why? Why is that? They look at your documentation on your personnel qualifications. In other words, they'll look in their HR folder. They wanna make sure or find out how you assure contractors use qualified persons. If you're following manufacturer-recommended activities and frequency, great. They wanna see documentation on that. If you're using an alternative maintenance program, they want that sample equipment and how you do it. What are the strategies to make sure that's done, including certain critical equipment that maybe you put into your alternative maintenance program and there's some you can't, like lasers, you can't put those in there. Moving from equipment on to disposal of trash. We know we have to have routine storage and prompt disposal. This is one where they're still waiting interpretive guidelines. It really didn't change that much back in 2020, but I don't know if they haven't provided interpretive guidelines because, well, you think this was simple? Do we really need to put a rationale out there or what you expect? I'm providing here just the previous guidelines. This is just for reference only. Because right now we're talking biohazard waste. In addition to your radioactive equipment and maybe just routine trash, cups and bowls, we have to dispose according to those standards, whether it's EPA or CDC, whatever happens to be. And likewise, their survey procedures are pending. One thing I have noticed is that they will go around, they'll check in the hallways to see is their trash lined up. If it's outside, is it secured? So let's say you have biohazard and you're using this to use needles. Have you secured those needles from unauthorized access so that no one can get to them? They'll walk around and they look in the rooms to see how full are those needle disposals? What type of needle disposals do you have? Now, yes, we know we have those that have the open at the top, but are things sticking out of it that makes it dangerous? Are we past the fill line on it? Or are you using the ones where you drop it in and it locks, you can't get back into it? So they do go around and they look at that in the individual rooms, in the surgery suites, wherever it happens to be. They're going to be observing those. Speaking of medications, they also look to see how are you storing these things? How are you storing your drugs and biologicals? Are they in a properly locked area? So again, prevent unauthorized access. Are medication carts in your C-section room? Is that locked when it's not in use? You don't have meds sitting out either in your dumbwaiter or your tube system that are just waiting. The surveyor will ask what standards and guidelines and laws you are using. You know, as far as standards and guidelines and laws, that could be something as simple for, are narcotics we're following DEA recommendations and requirements? That could be as easy as that. For the physical environment, I mentioned they're going to look at your walls, your floors, your ceilings. Is it clean? How about an uncluttered environment? Now, you're looking at a picture, one that was taken during the COVID pandemic when yes, it was okay. They were giving us some leniency in keeping those hallways clear because it was safer and more efficient to keep some of this equipment in the hallway, rather than, you know, taking the moment to gown, glove and get in there when the patient's alarms are going off and the patient's having a problem. Otherwise, they want to make sure equipment is properly stored. It's not lined up in the hallway. I had a hospital once where they were getting ready for absolute full survey. And they had beds lined up in the hallway. Oh, we're just doing some remodeling. Those were extra beds. And it's like, y'all need to get these out of here because you're clogging up your hallway. And they did. They moved a lot of their ancillary equipment stuff that wasn't being used to a close secure area so that the hallways were clear. They also look for spills, any other obstructions on the floors, but they also look for visible water leaks, plumbing problems. They'll look at your ceilings. Do you have water that's leaked in through the roof that could contribute to some pretty bad mold or other allergens or infectious material that could affect the health and safety of a patient? They also look at your ventilation. Is it proper lighting and temperature also? And they're really concerned in food preparation and storage and pharmaceutical areas because some of those meds do need to be maintained at a certain temperature and humidity. Patient care, same thing. Do we have sufficient lighting to do our job? And ventilation, especially in the OR to help ventilate those gases out and keep our staff also safe. Again, guidelines, survey procedures are pending in this area. Now, just briefly, I know it's somewhat of an old memo, but it still is very relevant. This is from 2013. 2013, excuse me, 2013. If you don't have any state law, you can write your own policy on talking about a waiver for humidity. And this is relative humidity. It allows it between 20 and 60. It used to be between 20 and 40, but now they kind of expanded that knowing there's areas of the United States they simply cannot adhere to those other levels. My area is very dry. Other areas, you may be very humid, where again, you have that waiver that you can allow for. Anesthetizing locations, it is very long. In the interest of time, I don't cover it. You might want to look in that memo. The link is in the appendix on slide 161 for you. So what happens when we lower humidity? Well, it affects everything, not just our hair and our skin and our nails, but it affects the equipment and supplies. Shelf life of our EKG electrodes can really go down. Multiple times we had to throw out electrodes because they were dry. And no good adhesion to the skin, you're not getting a good reading. Equipment, it can be affected by static charge, especially our older equipment. Our software can either really behave strangely or have premature failure, like calibration of the equipment. Always follow the manufacturer's instructions for what are the relative humidity requirements for that piece of equipment. And again, that can be something as simple as an electrode, EKG electrode. Still in the plant environment is our life safety. We always follow our provisions, and that includes with the National Fire Protection Agency. What they have, they have what's called tentative interim amendments. And they talk about, okay, this is what you need to have. Positive latching, that is where it locks. Not quite a deadbolt, but it definitely closes. And that you want on the stuff you don't want others to gain access. Flammables, combustibles, medications. You do not have roller latches on those doors. Same with, again, I've already talked about some of the waivers. Now, there is one waiver that if you can't comply with what is required, you can get a waiver under life safety code. And that's for those that cause unreasonable hardship, but it can affect the health and safety of your patients. You keep evidence of what you've done on regular inspections by the state fire control agency. And they also mention another waiver. We used to not be able to install our alcohol-based hand rub dispensers, but now you can. Let's put them in a smart area where we don't have inappropriate access. Now, most of these, again, interpretive guidelines survey procedures are pending on a lot of these. Sprinklers. What if it goes down? Maybe you're doing maintenance, you've had a cold snap, and heaven forbid your pipes froze. Okay. If it's down for more than 10 hours, you have two options. You can put up a fire watch where somebody is there all the time and keeping an eye on things. The nice thing is you don't have to evacuate and keep people there. On the flip side, yes, you evacuate that part. But you can't evacuate the entire building or the portion until it is repaired. And in fact, I worked at a company where there was a water main break. And we had to evacuate and leave. We couldn't go back in until it was repaired because our fire suppression system was down. Sleeping rooms and windows. They didn't talk about the windows. Every sleeping room. Has to have an outside window or door. So, if you're going to have a fire, you're going to have to have a window or door. The sill height. Can be higher than three feet. Off the floor. You know, above the floor. Now this doesn't apply to your nurseries where you've really got short occupancy. Also special care nursing where new occupancies, there you five feet. That's what they're looking at. Guidelines again, and surveys are pending. So, if you're going to have a fire, you're going to have to meet certain codes. You still have to meet certain codes. If you're maintaining organization, if your joint commission deemed status, for example. On a waiver. Again, for an undue hardship. You still have to meet certain codes. And they can grant the waiver. Again, if it's an unreasonable hardship and what they're looking at is how long would it take to repair? What is the cost? To repair, make that repair that alteration. So, if you're going to have a fire, you're going to have to meet certain codes. And they're going to have to make regular reports on how are you doing to maintain the safety? So again, they're really looking at that. Hardship. Reasonable hardship. Now, just because it costs money. Doesn't mean that's going to qualify. It has to be something that would so alter it. That you would almost end up tearing down the building. To start over, to make that modification, to meet that code. I'm unaware right now. I don't know. I don't have that opportunity. They've just decided our building is so old. It's just safer and more efficient. To build a new building. And start over. Then they just didn't have to keep pouring money into that. Repair, whatever they had to do. And they didn't have to completely close. They were able to continue. All right. Now we're on to emergency preparedness. The second topic. Okay, I'm actually going to read this top part to you all. And then I'll post the question up here for you. So this says that Prairie Hospital experienced a storm with hurricane force winds. Resulting in a partial loss of the roof. Patients were moved from the involved area. And Prairie activated its emergency preparedness plan. After six months, Prairie reopened. And evaluated its response to the event. Identifying two areas for improvement. And Prairie was due for its annual full testing exercise. Can Prairie use the event as part of its testing requirements? And let's post those options up here for you. So yes or no, are your options here? Okay. We had one question come in, Laura, while we wait for those responses. And this asks, if you have any recommendations for disposing of illicit drugs. That are surrendered by the patient to hospital staff. If law enforcement. If law enforcement is not available. And take back bins are limited to legal substances. Do you have recommendations or best practices for disposal? Yeah, that's a tough one. Because that comes up so much. I know DEA is part of law enforcement. And I think that's going to be your best shot on how to dispose. Pharmacy won't take it. They don't want a thing to do with it. And I don't blame them. But that's the best that I could offer is check again. Just keep law enforcement or DEA saying, hey, we got that. Don't know where it came from. I'm not saying where it came from, but how do we get rid of it? Where can we take it? To properly dispose. You can't put it in your sewer system. Down the drain because then it contaminates that water. So that's, unfortunately, that's the best. That's the only recommendation I've been able to come up with this. Just keep contacting either other law enforcement. Say, what can we do with this? And be careful if they say, well, bring it into us. It's like, yeah, we don't want to do that. And then whoever brings it in. We don't want to put them under any unnecessary undue scrutiny. Well, where is it? How much to have? How much to take? You know, stuff like that. Unfortunately, I can only recommend just keep looking for law enforcement, DEA, someone like that. Sorry, that's about as much as, that's the only reference that I could come up with. Okay, I'm gonna go ahead in this poll and share those results. Okay, yes, all right. And I would agree, I think you can. You can just, and we're gonna talk about this testing here in just a minute. So as far as emergency preparedness, we know it's anything and everything. And unfortunately, my slides are out, my pictures are a little out of order. What you're looking at, and probably, sadly, what Los Angeles area went through was a wildfire. And you can see it engulfed buildings. This was in our neighbor, it's called Marshall. It's between Boulder and Denver. And this was back in, I wanna say 2022, the December of 2022. This raging fire stoked by what we call Chinooks, the winds just tore through and just decimated pretty much everything in its area. Now, this particular hospital was a little bit away from all of these other buildings. And the way the winds were going, it took the fire away, but it didn't take the smoke away. And in fact, what you're looking at is how the smoke engulfed the hospital and the ventilation system. The slide on the lower right corner, because by the way, they had to evaluate this hospital. The ventilation system couldn't handle it. And this, you can see, is what happened. All of that smoke, debris, dust entered into there, and it wasn't safe to keep patients or staff. And that was the mess they found after the fires were out and they could return to the hospital. They were closed for well over a month while they went in and did everything. They had to clean out all the vents, they had to clean out all the ventilation system and do it again. Because we know it's not just big hospitals, it's each and every hospital that can be impacted, large or small. Oklahoma, this was in 2024. They were hit, patients were moved before the storm, and they ended up being eventually transferred to another hospital. Now, this next slide I'm gonna show you, it's a very short video. But this happened, it was a 10 alarm fire, 26 trucks responded, 300 emergency personnel, 90 ambulances. This was the largest public service emergency in the hospitals. This was in Boston, by the way, this hospital. And what you're gonna see, again, it's a very, very short video, but what you'll see is, you'll be able to start to run more. And, excuse me, that worked in rehearsal, didn't it, Lindsey? But what we're hoping is. Yeah, okay. So let me see if it's gonna run here. Yeah, see, this was their electrical system. And I understand that you can hear the video that they're recording. I cannot. I'm gonna shut up for a minute. Inside Brockton Hospital's electrical room. One of the greatest things I love about the fire service, the fire service. And essentially what. And we can hear it, Laura. Okay, good. So essentially what happened is, this happened within the hospital. It was an older setup. And it caused, it was electrical fire. Of course, everything was shut down. All of the patients had to be shuttled out and taken into other locations. Again, largest fire within that hospital's history. And within that area's history also. They finally did reopen. It took about a year or so before they were finally able to redevelop and then get back up and running. So again, it can happen internally. On emergency preparedness, this is one. You still have the luxury of having the regulations in your manual. All the other manuals don't. They were moved to Appendix Z. All the requirements, the interpretive guidelines, the survey procedures are in Appendix Z. But I wanted to cover it since it is part of your manual. Anytime something comes up, you're having either a certification or a validation survey, they're going to check this out. Because you have to, of course, comply with all laws, whether it's federal, state, or local emergency preparedness. You have to have and maintain a comprehensive program that utilizes what they call an all-hazard approach. That means if it's possible, it could happen in your area. You have to take it into account. And that includes infections. It must include a plan. A communication plan, which I don't know why they separated it, but they did. Policy and procedures. How you're going to train and test. Emergency and standby power. Again, if it's possible to occur, it will. Now, granted, this was back in 2020, a derecho, but these things have been coming more and more across the United States. There were a couple of them just last year, where for some reason in the Midwest, these hurricane-force winds hit. And that picture at the bottom, sad to say that's my old nursing school dormitory, where it was wiped out and ended up being destroyed. We also have man-made emergencies, where we have active shooters. I don't touch on active shooters. That's a separate program. But we still have to take that into account when we're looking at our program. So what do we have to have? This is the first part of the plan. It has to be reviewed and updated every two years based upon an assessment, a risk-based assessment, whether it's your facility or within your community. Again, using that all hats approach. You have to look at ways to address those events that you've come up with in your assessment. Look at your patient population. Who's at risk? What services do you provide? And a succession plan. What if your leadership is impacted by this emergency? You also have to include how you are going to cooperate and collaborate with outside officials. Your policy and procedures are based upon the plan and the assessment, and that includes your communication plan. Again, reviewed and updated every two years. Now, you may not have too many updates, but you at least have to look at them every two years. What you want to include are simple things like food, water, but also medicine and pharmaceutical supplies. Your alternate sources of power. Are you going to keep running if you're going to stay there? How do you track your off-duty staff or those who are sheltered in place with the patients? How are you going to evacuate? What's the method to get this thing rolling? Shelter in place. What do you tell them to do? Because if you have a patient in ICU on multiple equipment, they're not going to be easy to move. How do you keep them safe? How are you going to document so you continue with confidentiality? Are you going to use volunteers or not? Maybe other staffing strategies, like say, for example, it is such a community-wide event that the National Guard is called out, and perhaps the National Guard has medics and other healthcare professionals. How are you going to utilize them? That's why you need to cooperate with those other officials. And then making arrangements with other hospitals and providers. Can your physicians help take care of triage? Maybe just do basic care for some of these patients in their clinic if they happen to come in. Are you going to open up those clinics for that triage care? Communication plan. That's one that includes the name and contact information of your staff, whether it's your employed staff or contracted physicians. Also contact information for those who are specifically identified as your emergency preparedness staff. Primary alternate means of communication with your staff and agencies. Are you going to use two-way radios? Are you cell phones? Is that a possibility? Were the cell phone towers wiped out in, say, such a hurricane or tornado? Also, how are you going to share information on patients? Are you going to send paper or are you going to call that next provider of care? Likewise, if you evacuate, how do you release information as permitted? How do you provide information on where the patients went and their conditions? Because we know their loved ones are going to be running around trying to find them. And then how do you provide information on what you have? What's your occupancy? Are you going to stay there? If so, what are your needs? Or can you provide assistance if it's another hospital or facility that is impacted? So moving on to training and testing, and this kind of comes with that question that I had. Of course, we have to have and maintain a program for testing and training. We know that's based upon the plan, the assessment, your policy and procedures, and likewise, it's reviewed and updated every two years. So for testing, what you have to do, you have to do two exercises a year. You're required to do that. One, full-scale. You can do it within your own hospital or within your community. What works best for you? If you have an actual disaster, as our hospital did, you have an exemption for that next full-scale requirement. Full-scale. The other one you can do, or you have to do, is you have an option here. You can do a tabletop, you can do a mock trial, you can do full-scale. If you're that ambitious, you want to do it, go for it. But what you want to do with that is really analyze and document what you found. Maybe you need to revise your policy and your plan. Maybe you're going to do an active shooter and you do do a simulation. You do a mock active shooter within your emergency department and you send out the notice and nobody hears it. Okay, you have to go back and evaluate. Why didn't anybody hear that alarm? Or did we freak out the staff and patients so much that maybe we need to revisit how we're going to do it again? So those are the things you want to learn from these exercises. In May of 22, they did send out a clarification because there was a lot of back and forth. When do we have to do this? And a lot of this had to do with COVID because they did recognize some of you were still under that emergency plan. By the way, yes, we are seeing an uptick in some of our respiratory illnesses. I believe we talked about it last week, how many, what you have to report on how many, whether it's RSV, influenza, or COVID. So right now, if you're still under your activated emergency plan, for whatever reason, during your 12-month cycle, your year cycle, if it's currently activated, then you get to use that as meeting your full-scale requirement during that cycle. If you've gone back, you had your exemption, let's say in March, and we've got some examples, I think, to show how it looks. So you claimed that exemption in March. And now you're coming around and six months later, you're doing your tabletop. You still have to do that. You have to do your exercise of choice. But now you're coming around next year. It's 2025, you're due for a full-scale. If you went back to normal operations in, say, December, you're due to do that testing. You have to do the full-scale. With the only exception, you're reactivated. So I've just got some quick examples in here. In the interest of time, I'm gonna go through some of these. So you did your full-scale in January, tabletop in November, another full-scale in the following year, and then March, sure enough, you had to activate your plan for whatever reason. But then in December, you went back to business. You still have to do your workshop, your exercise of choice in that second round. But you do get an exemption when you had to reactivate your plan. Your next full exercise would be the following January, if you went back to normal operations. If you did, here's number two, you did a tabletop in January. You were scheduled for a full-scale in November, but you activated your plan in, say, March or April for whatever reason. The year later, you went back to normal operations. So again, you have an exemption because you activated the plan before your full-scale was due. But now you're back in business shortly after that. Now you're back on track. You do your tabletop, and you do your full-scale when it's due. Number three, you did your tabletop. You got an exemption because you activated your plan for your full-scale, and you're still under that plan. Well, you still get the exemption from the full-scale exercises, but not your exercise of choice. You still have to do that. And then finally, you did a tabletop in January. You got your exemption in November, and then you went back to normal the following year. So here's how this plays out. You did your exercise of choice, activated your plan in March, you're exempt in November, but now you're back to business. Again, you have to go back and do your full-scale as required. In determining the exemption, CMS is going to first off, what's your cycle? Do you do January to December like a business year, a calendar year, or do you do a business year? Maybe you're July, June to July, whatever it happens to be. They'll verify you've done two of the required exercises within a 12-month period, and they want you to describe your exemption. Why did you get that exemption? What was the basis for that exemption? They just want to make sure those who asked for it understood what it was. And again, next full-scale, not exercise of choice. The surveyor will look for documentation that you first activated your plan, and what did it include? Did you activate your staff? Did you send out an alert whether it was a page or an overhead page where you had to activate your plan? Did you transfer patients? Something that changed your daily operations. What was the initiation of more protocols? Maybe you got more face masks or maybe you shut down an entire wing for a certain amount of time. Maybe you had to stop surgical procedures because of the issues. Maybe there was a gas leak or something. Coordination with the local officials, fire department. Maybe you did have to call out more troops to help you with this event. They will also look for minutes of board meetings. They want to see what's discussed during the board meeting or other facility meetings. Maybe you have your emergency preparedness committee meeting and they're working hard on this. They want those minutes, what was discussed. Whether or not you did get a waiver. LA has this waiver, this you can kind of call it an individual waiver for LA because of the damage from the fires. And any incident command reports, they'll want to see those. They want to make sure that you are compliant and that you conducted the appropriate exercises when you were due. In other words, the tabletop could be sitting around the room talking about it. With the tabletop, you usually have a facilitator who describes the situation and really helps the discussion keep moving. That's why you want to make sure notes are taken during those so you can show, yes, indeed, you did do your tabletop. Moving over to power systems, this is the last one within emergency preparedness. We have to have something so we can keep the place running. An emergency generator. Where are you located? You follow healthcare facilities code, your tentative amendments. But you had to make sure you are inspecting your generator. You're testing it. Are you using fuel? If so, where is it located? And make sure, of course, the fuel probably best offsite so that's not impacted should you happen to, like the hospital in Boston where they had a fire. If you're part of an integrated system, you have to show each separately certified hospital participates. They participate in the risk assessment. They participate in the planning and testing and training because we have to train our staff on this. That they're integrated into those policy and procedures for an integrated program. Again, if you are participating in that. All right. I'm moving on to board of directors, governing body. I will pause for a moment to see, Lindsay, are there any questions you would like me to address? I don't see any pending right now. If anybody has any questions, you can, of course, type those in. But I think we're good for now. Great. Okay. Now we're moving on to the safety governing body. In your case, for critical access, it could be a person that has been delegated or designated in writing as, say, the CEO. Somebody who is responsible. You have to have a governing body and I'm using that to include an individual. They assume legal responsibility for this hospital. They assume responsibility to make sure policy and procedures are implemented and monitored. Because they have to make sure they're approved. They approve them all. They have to make sure we're giving good quality care in a safe environment. They determine who practices at the hospital. Each practitioner with written criteria. And written criteria for appointment. Board appoints based upon the advice of your medical staff. And they also have to make sure, if that's the case, that the medical staff is following their own bylaws. And that the medical staff is accountable to the governing body for what happens in that hospital. For the care that is provided in the hospital. There's five characteristics that on criteria that they want for appointment, a selection of staff. Character, competence, training, judgment, experience. No more is it simply, oh, I'm board certified. That's not going to fly. They want more meat to this. And the surveyors will either look for or ask on documentation of the categories of staff. And yes, indeed, they want to verify appointment. Telemedicine, a lot of you are probably using this mainly in maybe your emergency department. But the board has to make sure there's a written agreement for the such services. This inside hospital, they must be a Medicare participating hospital. An entity, we know that's usually a group of physicians or providers who work maybe off site. But it can also be a non-Medicare participating hospital. So, it could be either of those two. But they have to make sure they're giving services to your patients that enables you to comply with the conditions. The practitioners, and I'm going to use that jointly with physicians and practitioners, they have to be, of course, privileged and credentialed at the other site or entity. But they have to be licensed in your state. Privileges, credentials, review services that are provided by these practitioners, you have to make sure those are done. And that includes when you have to send that notice to the hospital or entity, we've had a complaint about that provider, or there's a bad outcome from the care provided by that practitioner. So, you still have to keep an eye on these folks. You still have to, you know, make sure there's some review of their credentials and services they are providing. First off, the surveyor is going to make sure you have an organized body. They want documentation. They will verify that there are stated categories of candidates that are eligible. Then we'll look at your policies. When were they last updated? Does it reflect their governing body's responsibilities? They want evidence showing that this person is involved in the day-to-day operations. Now, if they want, this person can go down and walk around and see how things are going. But they need to know what happens on a day-to-day basis. How's our census doing? How many, have we had many car accidents? How are we doing on staff? Those operations. And they will also look for records of anybody that's appointed to the staff. Was the board involved in that appointment? Were they aware of the advice or recommendations of the medical staff in making that appointment? They will confirm the board uses policies with those appointments. Like, what are they doing? What's your scope of expertise? Are they this wonderful, great surgeon and they can do anything and everything? Or are they one that is limited to non-surgical privileges? Also federal and state law, what can they do and can't they do? They'll verify written criteria, the minimum criteria used for appointment. And again, they verify that the medical staff is operating under their own bylaws. Usually what they'll do is sit down and talk with the CMO. They want to find out, how do you make sure staff is operating as they're supposed to? Next thing we have to do by a governing body is disclosure. We have to tell people, our patients, our community, who is responsible for the operation and medical direction within this hospital. That's why you have to have some mess fit, a policy and procedure to report changes, operating officials to the state agency. They have put in here the CEO or medical director or CMO, whoever that happens to be. And again, survey wants to see the policy and that you're implementing. When did the last time your CEO changed? How did you notify him? Did you keep a copy of the letter or the email? However you did it to notify the state agency, we now have a new CEO. I'm going to include contracts and agreements here because that's so much a part of the governing body on what they have to do. Because we know you have multiple agreements out there. And that's usually with suppliers who participate in Medicare, like outside lab tests, for example, distance site entity or hospital. Now they're not required to be a provider under the Medicare, but your hospitals are. So they just want to make sure that there's some agreement with them. For physicians, they want to make sure the agreements include one or more doctors. And if it's not in writing, well, you better be able to show that they are taking patients and treating them, like have an appointment and they're seen after the fact. That's your agreement. So if they're going to come in and have admitting privileges and do A, B, C, D, okay, great. Do you see the patient afterwards or have arrangements been made? Let's say it's in the ED. You wouldn't expect your ED physician to see a patient after discharge, but it's those other physicians. And that's why you need that policy on referring patients that you do discharge who may need one or more visits or whatever has to be done. Lab and diagnostic, if you don't have them, you have to have an agreement with at least one or more providers. You want to make sure again, these folks are getting the testing that they need done and that for basic lab, yes, they are available in your hospital. Staff can do it. You can have a contracted service that comes in and provides basic lab services. You have to have an arrangement so that if you have that outside lab, maybe it's a reference lab, that they are doing those testings, again, policy and procedures on those. And if there's additional diagnosis, you know, like again, that outside lab, they have to have that CLIA certificate. That's what you want a copy of that. Make sure you get a copy of their CLIA. And because they're surveyed separately, they don't come under the regular hospital, they're surveyed outside of there. Evidence that the lab again has that or waiver and same for radiology. If you're sending them outside, make sure you get a copy of the report at least. You can ask for more. We'd like to have a copy of your maintenance equipment to make sure that what you're doing to our patients is done safely, that we're not getting patients in with radiation burns. Food service is another area we can contract. You can provide it or you can contract it out. We just have to meet the nutritional needs of our patients. If you contract, make sure they're aware of those CMS requirements. We want to look at these folks we're contracting out through QAPI so that they are compliant with the contract. Now, in other words, you're getting nutritional needs met, that those who need special diets are getting them and they're compliant with what those needs are, and that they're giving them when you need them. And what about outside normal meals? How are you going to provide for them? Whether you're going to use that contracted service or just keep things handy within your hospital. You don't have to have a food service within it, but you do have to be able to provide food. Overall, keep a list of all your services under contract. One location, if possible. You don't have to, but if possible, then you're not running around to five departments to try and find it. However, if you are providing contracted pharmacy, contracted radiology, whatever it is, maybe the head of that department wants to have that contract. They will know what needs to be done. But at least keep a list of the services that you do have and who's responsible. For each service, that contract must include what service is being offered, who's doing it, who's providing it. Are they onsite or offsite? Limit on volume, frequency of the services. Again, I mentioned with food services, are they going to provide those in-meal between snacks that folks need? When are they available? Is it 24-7? And that the contractor meets the requirements and performance indicators. Because yes, they go through QAPI. Who's responsible? Again, who's ever responsible for that service can participate. They have to take action when the contractor doesn't meet the requirements, the conditions. And it includes not only what you provide directly, but indirectly. Laundry. Are you getting your laundry back in time? Is it clean? How about housekeeping? Instrument cleaning and sterilization, is that done in-house initially and then sent out for reprocessing? Interpreters, we can't forget them. Your security, how are you going to provide security to your facility and your patients? Others, dialysis, if that's what you're going to provide. So sometimes it's not always related to patient care, but we have to make sure that we have those contracts available and we know what their requirements are. All right, staffing. Now, these are the folks who work in your hospital. You have to have a staff that includes at least one or more physician, but you can have those advanced practice providers. You do have to have an organizational chart with names of all providers. And the surveyor will look at that. They want to see that organization chart and your work schedules. Any ancillary staff, they are, of course, supervised by your professional staff. That's why they want to see that organizational chart. They want to see that chain of command flow. You have to have enough staff to give services, emergency services, nursing services, lab, whatever it happens to be. And again, they look at schedules and they compare it to your daily census. Do you have enough staff and supervision? If you have a four-bed ICU combined CCU, do you have enough qualified staff to take care of all of them? You do have to have a provider available. It doesn't have to be a physician, a provider, always available to give services. And of course, we know in dormitory they have to show up when needed, but also when patients are in your hospital. Not 24 seven, if you don't want them there, that's your decision. They provide diagnostic services, therapeutic. Otherwise you provide services and supplies, which you normally see in a physician's office. Not that you can't add to that, but at least that was minimum. You must have a nurse on duty whenever you have at least one patient, one inpatient, whether it's an RN, LPN, whoever. The surveyor again looks at your staffing schedules. The physician, they have to provide medical direction and supervision, and they will verify they are available for consultation. Maybe it's by phone. That's fine. An advanced practice provider, they not only provide care, but they have to participate in development of your written policy and procedures. They want evidence also that the physician participated in that, and that they're reviewing those policies periodically. They don't say how often, but normally we're looking at our policies, our patient care policies, about every two years, sometimes one year. You decide the frequency. If you want to do them every one year to make sure, yeah, we're up to snuff, great. Supervision, usually they sign off on the orders of the PA nurse practitioner. It's what your state law says you have to do, and that's what they're looking for. Surveyors will look in the chart for that sign off by the physician, and they do say also sign off on a sample of outpatient. CMS does give us some guidance. 25% of all outpatient encounters where your advanced practice providers or non-physician practitioners are providing care, so about a quarter of them is what they would recommend. There's no time frame on that periodic review. Put it in your policy and procedures. Maximum interval, that's the maximum between those inpatient reviews. Is it one day, 24 hours, 48 hours? Look at what you do. How busy are you when you're looking at them? Because if you've got four to six beds, very different than a full 25-bed critical access. If you have electronic records, do you allow them to review them remotely? Can your security systems ensure that confidentiality and inappropriate access is maintained? Medical direction, we have to have a physician present for enough time to provide direction and consultation. Again, it can be in person or by radio, telephone, whatever it is. Amount of time present, they don't say. You determine that based upon the acuity of your patient, what's needed. Other requirements, they may find that coming in twice a week is just too much, especially if you're a very small hospital in a very remote area, where maybe you have six patients. Just don't forget EMTALA, that is separate. The providers have to be on-call and available to provide emergency care. By the way, you have to have a list of your on-call physicians available. Your advanced practice providers, they don't just take care of patients, they have a lot else to do. They have to participate in development of the policies, and that includes execution and review. They have to be a member of the staff, and the surveyor will talk to at least one of them. How do you participate? What do you know about the policies? Do you know when this was last reviewed? Were you involved in that review? How much involvement did you have? They also have to work with the physicians in the review of the patient's records. They want that back and forth dialogue, working to make sure that if there's any concerns, those are addressed promptly. Advanced practice, they perform functions that the docs don't perform, and if necessary, they can refer a patient out if you can't provide it there. Just, of course, we have to make sure records are maintained. They notify the patient when they're admitted. Document that the patient is under the care of that physician. Here's just my note. These aren't in the manual. I'm just putting out some notes. We know we have to send a copy of the records with the patient if you're transferring. Now, if you have the luxury of electronic records that you share and you can send them electronically safely according to a secure platform, great. CMS doesn't care. Have a transfer policy consistent with EMTALA, and again, make sure training is done on our staff when EMTALA does come into play. And here's our third question. Lindsay, would you put that up, please? Absolutely. I'll get this up on your screen. Okay, you should all see this one that says, our hospital policy allows for a non-physician provider to admit patients. Looks like we've had just a couple of questions, Laura, and this one asks if you can clarify, the governing board, are they required to approve all policies or just clinical policies? The way it reads is they review policies. They do not delineate between clinical or other policies. They don't delineate. So my reading is it would be all policies. They just have to make sure somebody's reviewing them and looking at them, and if the medical staff has approved a medical care policy, now they seem to want to see, yeah, that's okay, we're in agreement with that. Again, they did not delineate between clinical and non-clinical policies. Okay. I wish they did, but they didn't. And then this last question I see says, one more came in, but okay, is there a timeline for a patient that a dietician consult order is in that the patient has to be seen? A dietician consult order that they're seen by a dietician? Is that what, I think that's what the question is asking. That's how I read it. No, they don't say anything in there about how soon does that dietician get in to see the patient. They don't mention that. I think they're going to follow national standards, and if the American Nutrition and Dietetics say, hey, you're in there within, you know, a couple hours, then yeah, you would want to make sure that patient gets food, and it's meeting with that dietitian, good food that the dietitian recommends. So no, CMS does not make that delineation. And you said one more? Yep, and actually this, another question came in. The person who asked the question about the policies asked if you could just quickly repeat that answer. And I think that you said that there is no delineation between the two policies, yeah. Correct, by the governing body, correct. There is no delineation in the CMS regulations for the policies that the governing board has to review and approve. They do not separate, they say governing body reviews policy and procedures and approves them, or at least approves policy and procedures. That's the way the code's written. Perfect, okay, and then this other question says, for mid-level providers, should they be members of the medical staff with voting rights if elected by the medical staff? I guess that's what your bylaws allow. What do your bylaws allow them to do? As long as it's not against the state scope of practice, then it's up to you if you want them to be voting members. You can have different levels of members of the medical staff. Perfect, okay, I don't see any other questions. I'll go ahead and end this and share those results. Okay, so yeah, a little bit delineate, different ones, and I bring this up because CMS requires a Medicare and Medicaid patients be under the care of a physician if they have an issue, whether it's behavioral health or medical, outside the scope of their practice. In other words, you have, let's say you have an advanced practice nurse who their ballot, their focus is maternal health, but you have a patient who's admitted under that nurse. And then while they're in there, maybe they go septic, you need to get a physician involved. They have to be admitted under the care of that physician if it's outside that scope of practice. Privileges consistent with state law, what does the state law permit them to do? And the surveyor will make sure that physician is monitoring the care when it's outside the scope of that advanced practice provider. That means we notify the physician when they're admitted by a mid-level and especially when it's an issue that either comes up during the stay or simply outside their scope and document they're there under the care of a physician. If policies allow mid-levels to admit, and we follow state law and scope of practice and our policies are really there to ensure patient safety, that's what we're trying to do. And then there has to be a periodic review of clinical privileges and performance. Doesn't matter if it's a physician or advanced practice. Our advanced practice, that's usually by our physicians. An MD, you have a couple options. If you're the member of a network and another hospital, great. Your quality improvement organizations, they can do it. Maybe you are in a state rural healthcare plan, they can do it. Telemedicine, maybe again, if you're in a network, great, have them review the care. Guidance is pending on this. And the reason they've given you a couple options on the review of physician, because they know you may not have that many physicians or maybe there's a little conflict going on between those physicians. And you wanna have a fair and impartial review of the care that they provide. Under provision of services, this section really talks about our patient care policies, what is required and what you have by an arrangement or an agreement. Now, these are the ones I'm gonna touch on for this round. As we go through the next two sessions, we'll be finishing up the others, but these are not very big areas that we're covering. You can see some of them are only one or two tag numbers. So it's very short. First off on our patient care policies, what we know we provided according to what those policies say in the state law. The surveyor, they wanna see these policies on your healthcare services. They'll watch staff as they're delivering care to make sure they're following. They're doing what they're supposed to, washing their hands, identifying the patient, making sure it's the right medicine. They wanna see if there's anything inconsistent with not only state law. And if so, they refer to the state authorities. So for example, you've got, say you have a nurse or maybe an aide who is most likely working way beyond what their scope says. They will send that off to the state nursing board and give them the heads up on, this is what we observed during our survey of this hospital. Where the board takes it or the governing body takes it from there at the state level, I can't say. On development of policies, they're done with the advice of our staff, at least a physician and a mid-level. They're looked at every two years. And the reason they wanna do it, is are there any changes? These again are patient care policies. The final decision on content is made by the governing body. So if the governing body, nurse patient care policy or care policy, governing body comes back and says, we don't agree with that. They have to give the reasons. Why did you reject this policy? And they must include the rationale behind it. Why are you saying, no, we're not going to allow that or we're not going to agree to that policy? On scope of services, what do you do either directly or by contract? And what they're looking at is something with Samia. So let's take a physician. Taking complete medical history, providing complete HMP, laboratory testing, radiology testing, and you're going to make arrangements with the hospital down across the county to provide such services. Okay, that's what your policies can include as far as our written description of care. Emergency medical services. Now, this is different than EMTALA. These are the folks who are in your hospital or a visitor, whoever it happens to be. You have to have something that you're going to take care of these conditions when they pop up. And that's what the surveyor wants to see in your policy. How do you provide 24 seven emergency care to patients? What equipment, medications, blood or blood products do you have on site? How do you coordinate also with your local emergency medical service? What staff do you have available to provide such a service? Are you going to require all RNs in your emergency department, the ACLS, PALS, NELS, et cetera? Are you going to require those who work in critical care to provide emergency service? Do you have a rapid response team? How do you provide these emergency medical services to your patients? On medical management, this is when you have to have a consultation or referral. They want to know how are you going to do that? Of course, we keep our records and we review them. What we, again, periodic review and evaluation of what you provide at your hospital. Protocols to manage these problems you commonly see. Advanced practice and medical management, as we know, mid-levels, and I should correct myself, it's now to be considered advanced practice providers. Protocols at mid-levels. They play a large role. They are providing a lot of care in our criticals. What you need to do is determine in your policies, what can they do? When do they have to get ahold of the physician? When do they need to refer the physician, the patient to another physician or even outside your hospital because something's come up and it cannot be handled? So in September, they did put out a memo and it talks about midwives and it reinforced that CMS is good. They know that these midwives are excellent at giving good care to mothers and babies. And by the way, I have it in slide 165 on this memo. Critical access hospitals still have to provide oversight of physician's due for all inpatient. That includes non-Medicare. And they have to periodically review and sign off on records cared for by advanced practice. This is CMS. This is not a state. This is a CMS. So for supervision, this is a clarification. They recognize that for critical access hospital, CMS had absolutely no authority to remove that physician oversight for inpatients. It is a statutory requirement, federal statutory requirement and that's why it has to be followed. It is required for outpatients only if the state law says so, but for inpatients, yes indeed, there has to be physician oversight. Let's move on to drugs and biological. Still all part of the provision of services. Policies include how we get them, how we keep them, how we maintain them, how we dispense them, how we administer them. We keep them stored according to standards of practice and rules, we have to make sure they're current and accurate records are kept for our scheduled drugs. From the minute you get them until the minute they're, wherever they end up, either administered or disposed of. Outdated, mislabeled, unusable drugs, you cannot keep those for patient use. You have to, that means you go to the floors and pull them out, that's what that means. Otherwise, our storage is consistent with standards or guidelines for pharmaceutical services, whether that's USP, Institute of Safe Medication Practices, whatever it happens to be. And of course, following any state and federal laws. Now they list out others. I'm not gonna name them all there. This is on slide 114. CMS actually listed these resources for us, including American Pharmacy Association. One thing you do is say policies have to identify the qualification for your pharmacy director. They have to make sure state laws are being adhered to. Who can do these services? They're also responsible to make sure that the staff is supervised, the pharmacy staff is supervised. They're following standards of practice in developing your policy and procedures. And you can cite the references in your policy and procedures, rather than spelling them all out. You can cite where you got that reference. On storage, we have to make sure our storage areas are secured, but that includes your carts and your dispensing machines. Make sure we have our environmental conditions based upon manufacturer's recommendations. Does it have to be refrigerated? How about keeping it out of light? I went to pick up a prescription at our local grocery, and I know she went into the refrigerator and pulled it out of there. I went, oh, I didn't know that was supposed to be refrigerated. So asking the pharmacist, does that have to be refrigerated? And she said, not for you, but for us, yes. Because we have to make sure it's at the optimal light once we release it to the patient. So again, make sure you're following manufacturer's recommendations on that. Of course, security, always make sure we're following any state and federal laws. Who has access to the pharmacy or your drug area? Housekeeping, security, usually they're not unsupervised access. Somebody needs to be in there with them. If you have offices associated with your hospital, make sure patients and visitors, they're not in there without supervision because you'd be surprised what some of the physicians have in their office. Sometimes it's a little scary, but it's in there. Just make sure the patients aren't alone. Actually, if they're in a locked cabinet, that's probably the safest. It's not required, but look at what you've got in those offices. And a secure area means it's restricted to authorized personnel. In non-controlled drugs, you have some flexibility. It doesn't have to be locked. Say you're setting up for a procedure or somebody's sitting at the nurse's station and you have to have the units there within it, like this described, what's shown here on this picture. But otherwise, if no one's around, it needs to be locked. Evenings, weekends. And this is controlled and non-controlled substances. For your carts, secured when not in use, whether it's an epidural cart or a medication cart. Non-automated ADUs have policies on whether or not they're locked or unlocked. And if unlocked, that staff is close by and monitoring the area. So if they're passing medications, is that drawer shut or is it left open for passerbys in the hallway? As far as handling drugs, handling, that's reconstituting, mixing them up. We follow manufacturer's recommendation and that includes sterile IVs. Now they say here only pharmacy can reconstitute or compound a drug unless it's an emergency or it's not feasible because their product life is so short. That may occur in ER. That may occur in OR. Let's say you're in a unit and you happen to have some of the toxolytics handy that they need to be reconstituted. Staff just have to do it right, that they don't destroy the medication in the process of reconstituting it. Compounded drugs, these are ones that are prepared in a manner according to principle. These are ones that we bringing things together as sterile or non-sterile because we're trying to prevent that contamination and toxins where they're intended to be sterile. If you're doing your pharmacy and you're doing the compounding yourself, you have to show how you make sure everything is sterile and non-sterile are prepared according to the standards of care because all compounded forms must be sterile. That is everything from an eyedrop to an injection to a nasal inhalation. There is the drug quality and security. You think, why are we bringing this up? Well, this talks about an outsourcing facility. When you're getting your compounded meds from another, getting them offsite, your pharmacy isn't doing it. An outsourcing facility, these are the ones you wanna look for because they register and comply with the entire section, a part of this FDA, the Food and Drug Compounding Act to make sure it's safe. And it's called 503B. There's other requirements such as good manufacturing practice that they have to comply with. They're inspected by the FDA, not according to how bad is that drug? What's the risk to the person? And they meet other conditions like reporting adverse events to the FDA. So these folks have really a lot of work they do to meet that higher level. But then we have compounding pharmacies. Now, these aren't bad. These are good. You can use these. If you are doing this, as opposed to a manufacturer or that outsourcing facility, what you and what they have to do especially is make sure they have to demonstrate that the medication that you got was prepared according to those principles. If you're contracting with a vendor, get access to their quality data because you wanna make sure they're compliant with USP standards. That's the United States Pharmacia. Document when you obtain and look at that data. Who's looking at it? That's your decision. Usually a pharmacist is the best person to look at. They know what they're to look at, but ask for that data. The Institute of Safe Medication Practices and the American Society of Hospital Pharmacists, they talk about sterile compounding. There are guidelines, 2013, but they're still applicable. And it talks about safe preparation of our compounded sterile preparations so that they are safe. We don't have these errors. It talks about drug storage, compounding, and even labeling. The Society for Hospital Pharmacists, they also have guidelines on contracting, absolutely contracting with the services and some suggested language. Again, I have those in the appendix for you. Back to our hospital on dispensing, we comply with all laws. What staff can dispense this medication? Of course, it's done timely. You have enough staff to do it. And we have a system to ensure orders get to you in time for pharmacy and they're available when needed. And that any concerns or questions are clarified with the prescriber before they go out the door. And here's our question number four. I think we're good on time, Lindsay. So I'll go ahead and have you put that up. Absolutely, we're doing great. Okay, so this question should now be on your screen and it asks, our facility utilizes a unit dose system with strict access limitations. Okay, let me scroll back up here. Okay, Laura, this question asks, is there a requirement to how often a scope of service is written or is it just when there is a change? I'm sorry, would you repeat that? I missed the first part. Is there a requirement for how often a scope of service is written or is it just when there is a change? Scope of service, I take it you're talking about when a provider is changing the scope of service or are we talking the entire hospital? Mainly when you're really changing that scope of service. Because if you have, say, I'm just gonna take a physician, for example, who wants to come in and now do certain surgeries that with their initial appointment, that wasn't part of the list. Then yeah, you definitely wanna look at that again. Same with any advanced practice provider. Maybe you have a general nurse practitioner who now wants to provide OB care. Then you definitely need to look at that. Or you are now going to provide OB care in your hospital. That's when you really wanna look at it. But don't forget, you still have to look at these patient care policies throughout the year. Make sure, hey, are they still up to snuff? Are we still meeting what's expected? And yeah, if there's any standard change in the standard of care and what we deliver, we definitely need to look at it. Even if we looked at it last October and now in January it's changed, then we need to look at it again. Sorry, I know that can be somewhat overwhelming when sometimes medicine is changing faster than we can keep up. Okay, and then let's see. Okay, is monitoring temperature and humidity of medications that are stored in locations other than the pharmacy or medication dispensing rooms required? For example, intravenous fluids stored in central supply or medications in a locked crash cart in a trauma room in the emergency department? It's not required. It is not, I have not found anywhere. You just have to make sure the medications you do are stored appropriately. So let's say it is in the crash cart. That's a great example. And those crash cart, who's watching those medicines to make sure A, they're not expired and B, they're maintained the way they're supposed to be. In our crash carts, in my hospital, we used to have pharmacy refill that, that was their responsibility. And once a month, they came around and checked on it and made sure that everything was still okay with the crash carts. We checked it daily to be locked, but they checked the medications monthly for any expiration out, et cetera. At that time, they went and see, okay, how are we storing this thing? And in central supply, we still have to maintain, you know, the supplies have to be maintained at that right temperature. If that's your IV solutions, then that's part of your supplies. Yes, you do have to keep that. They didn't break it down in the requirement. You just have to make sure medications are appropriately stored and biologicals are appropriately stored. So in a roundabout way, yes, you have to make sure humidity and temperature are properly maintained for those biologicals. Perfect. And then one more question that just came in to ask if there is, excuse me, if there is a requirement in the regulations for review policies and procedures on a certain time period? Yeah, for policy, they want every two years. They do. They want them looked at every two years so it's still valid. And the other thing you want to look at is, are we adhering to that policy? Because if there's a workaround and we're not, maybe we need to review the policy. That's not that the policy is bad or what we're doing is bad. Just maybe we need to look at it again. What are we doing that we can maybe do better by this workaround? Maybe the workaround is fine. It's adequate and it meets the standard. But at least every two years, we look at our policies. And having gone through that with a healthcare system, I know that's an arduous task. I understand that. Absolutely. And then finally, is there a requirement in these regulations to have a list of contracts as there is in the hospital COPs? Would you repeat that? Is there a requirement in these regulations to have a list of contracts? Yes, yeah, that was at the beginning of the... I'm sorry, I'm blanking the tag number. It's in the governing body and contracts, the contract management and agreement. And I will send you that tag number. I'll send that to you, Lindsay. Okay, perfect. Okay, I'm gonna end this poll and share that result there. Okay, great. All right, good, yes. We had a situation where we had these wonderful ADUs, I call them automated dispensing units, cabinets. They're a great secure option, they really are. Problem was, somebody was going in and helping themselves with the medication. And we didn't have, there wasn't a security camera that we eventually did install to watch, to see, okay, where are these things kept and who's gaining access? And sadly, it was one of the staff who was accessing it, taking the medication and delivering it to themselves. So you can still use the unit dose, that's fine. Or floor stock, that's fine. Automated cabinets, they're great. It's a secure option that you can do. You just have to have in the policies who get access. And including, even if it's after hours, like a night cabinet. Policies, they have in the blue box, it talks about other things you wanna include, like do not use abbreviations, a high alert list. What do you have, how much are you gonna dispense to minimize that diversion? Limiting overrides. We know they happen, but why? Why are the overrides continuing? So these, you can't be cited on, you can't. And it's like 129. Just really good examples. For schedule medication, yes, we have to keep records from beginning to end. They have five schedules and controls, one to five. And it has to be locked when it's not in use. Any discrepancy, reconcile as soon as possible. Make sure outdated, unusable medications aren't used, they're retrieved. And pharmacy, they have to have labeling, inspection, and an inventory management system. Don't, of course, we don't use PASSTAR beyond use date and policies. How do we determine that if it's not marked? Now, I just put in here joint commissions because if they do not use abbreviation list, it's not new. It's been around forever, but that is available. And I haven't found an updated list yet. ISMP, there's certain abbreviations that they say do not use, this was my most recent find for them. That's pretty broad on what we don't like. Injection could be misinterpreted for intraocular. Big difference. And then labeling. Every medication has to be labeled. What is it? The strength, Latin control number, expiration date. If you're using multi-dose files, okay. Expiration, 28 days on the label, unless the manufacturer says shorter. I wouldn't take it past 28 days. And put the date. It expires if they look at it, they know, oh, can't use it now. They also talk in here about reporting errors, adverse drug events, and educate the staff on doing that. We know we have to do that. Pharmacy, they can help assess these errors. Is it something down in pharmacy that either caused or contributed to it? Was it a mislabeled drug for whatever reason? And take action through your QAPI. Why are these events happening? The surveyor is going to first talk to nursing. How do you get your meds? Are you getting them in a timely manner? If late, that surveyor is gonna dig deeper. Why are they late? Especially if it's a consistent issue. Pharmacy, they are going to ask professional principals what ones you're using in your pharmacy. They'll walk around. Are medications secured? Or are they sitting out on a counter for anybody to pick up? And they'll verify only the pharmacist or someone who's authorized can compound, label, and dispense. Because some states do prohibit techs from doing any of those three tasks. They'll make sure you have a way to follow up on adverse drug events and errors. And they will determine if you get compounded drugs from an external source that is not FDA registered. If so, how do you monitor adherence to safe principles? And they want an example of when you had to determine a beyond-use date for compounded sterile medications. It is a very, very long survey procedure for that particular tag number. I hit the highlights on those. And then reporting errors and adverse events. We have to do that. We have to have a procedure to do that. Staff have to do that. They must report them. Of course, we take care of the patient, but then a system that it gets reported to QAPI, whether that's through your incident reporting system, however it handles. Make sure staff know what their expectations are, what they need to do. There is a definition for each. They do mention the National Coordinated Council Medication Error Reporting Prevention. They do mention that. So an error that's preventable, that can harm a person, it's while it's under our control, but it could also be the patient. It's related to professional practice and products and healthcare, our procedures, and systems including any one of those three. An adverse reaction, that's not how we wanted them to respond, whether it's undesired or excessive. What do we do? Of course, we stop it. Maybe we have to modify the dose, just bring it down a bit. Could result in a prolonged stay. Maybe we have to support them because it was such a reaction. Could impact their prognosis and could either be temporary harm or up to death, an allergic reaction. Adverse events, errors, responses. If they reach the patient, we have to tell the practitioner. Immediately, of course, if the patient's harmed. Maybe we gave them the wrong medicine and they dropped their blood pressure or their heart rate. If you don't know the harm, still report it. Be on the safe side. If no harm, you know there's no harm. Maybe you gave Tylenol instead of aspirin for a headache. Okay, and don't call them at two in the morning to tell them that, unless, of course, your policy says you must. Document it and include that you notified the practitioner. Our QAPI, we know that they help reduce them. It could help reduce if we are effectively reporting them. What are our vulnerabilities? Where are gaps? And how can we correct it so it doesn't happen again? Educate staff, and that includes near misses. Near misses can help because it didn't reach the patient, but boy, something's going on that this occurred. And, of course, we want to make sure that the reports get to where they need to be. And you want to work with your counsel on this one. They may have some recommendations on restricting us to those incident reports, but you might want to think about doing your RCAs that will help identify who needs this information to find out where's the gaps, that we can fill those gaps. Encourage non-punity, please. Don't rely on incidents, on the incident reports. We know some of them, maybe a lot of them don't get done. They don't report them. How do we otherwise identify? Maybe it's a trigger drug analysis. Watch how they're doing passing of medications, and especially the high alert. Keep an eye on those. And encourage reporting to your MedWatch program. They can help. You may be surprised how many other facilities are experiencing the same med issues that you're experiencing, and perhaps they found a solution for it. Again, they always stress that non-punitive environment. They find these are long-term employees who are making some of these. Those who have great records. Oh, I've been around forever, and amen. Never had a problem, and now I do. That's why we need to change our culture, that we don't have that shame and blame process. And balance that, of course, with just culture. If this is someone who these events continue to happen, then maybe, yeah, we need to look at some other measures. If we have somebody who completely disregarded, knowing, hey, this was not what we're supposed to do. We know this causes problems, and you still did it. That's where you take action. That's where you need to step in and really have that this isn't okay. The surveyor wants to make sure staff know what to do if there is an error or a reaction. Who do you contact, and how do you document it? They want an example of what they would do in that event. They'll look at records of when those did occur, were they immediately documented and reported? That's what they're looking at a lot of. What was the gap between that event and this got put into action? They also want to make sure these get into QAPI and that staff are trained on those reporting expectations. So just one or two of these resources, the high alert, how do you guide? That's through the Institute of Healthcare Improvement. I've got this link there for you. ISMP, the list of high alert medications, and the importance of how we do injector IV medicines. CMS requires we follow standards of care. They specifically mentioned ISMP. On safe injections, we have to make sure staff follow them. So we're reducing infections, our healthcare associated infections, and a lot to do with preparation. By the way, you're also assessed under infection control with this one. Compounded sterilized medications, we know those can cause issues, and nurses may do that for immediate use. Are they properly cleaning off everything and using safe technique? So I'm going to wrap up with dietary and nutrition. Dietary needs, nutritional needs of inpatients following our practices. We have to have an order for everything. How will you do that? Now, this is new. Some states now allow registered dieticians or qualified nutrition, however they're called, to make and write those orders. But the medical staff has to say, yes, you can do this following our state law. The survey procedures on here are pending. So as far as how soon that person is seen, what does the national standards say they need to be seen? Doctor orders this low-calorie diet, doctor orders low-sodium diet, whatever it happens to be, how soon are they going to be seen? I've listed the previous guidelines. It's only as a reference only. It's not in the new manual. You won't find them there. You're not required to prepare meals yourself, by the way. You can contract that out. Infection control issues, they still hit them hard. They're walking around to see how they're prepared. Are staff changing their gloves appropriately? Is the food at the proper temperature and maintained there? And that's cold or hot. And staff have to make sure the nutritional needs are met. So in other words, nurses are assessing patients. Does this patient look schizophrenic when they walk in the door? What is it? And then that there's also an order present. Policies looked at every two years. Use that group of people. Use your provider, including in there. And the guidelines, again, are pending. The Institute of Medicine, they have dietary reference intakes for our patients, depending on age, gender. Are they pregnant or lactating? So there are these resources on what should I have in any certain nutritional intake on any given day? Now, I want to point out one thing. It doesn't include your sick patients. Maybe those who have kidney disease, liver disease. That's not in this list. This is for your normal individual who comes in. Here's our last summation, and I'll read through it, and then I'll have Lindsay put up the questions. We contract out with a telemedicine entity for pulmonary support in our ICU. This entity is based in another state, but provides services to all around their area. All physicians on staff, they're at a teaching institute. It's in your home state, and they're granted privileges, and they've done everything they're supposed to. We have a patient who's at the step-down unit, but they have a respiratory arrest. They contact the entity for assistance and support in managing this event. But unfortunately, the patient's pronounced deceased before they get admitted to ICU. Well, the contract between the hospital and the entity is silent on services provided outside the ICU. Well, the state shows up four days later to investigate the event. This was a complaint that was filed by the family. And do you think there's any citations or deficiencies that our hospital might receive as a result of the limitations of that contract? With who are they going to contact in the event that this occurs? None. The entity was just trying to help contract because there wasn't provision for such care. Maybe they should have taken that into account, especially in a step-down unit. Would they be cited for failure to adequately provide telemedicine services or anything else? These are just some of them that had come up, that could they be cited, yes or no? So Lindsay, with that, I'll have you put it up. We've got, oh, good, enough time. I do want to mention that there's about 20-some slides of resources. I'm not going to flip through them. Some of them are actual links. Some are those that I referenced during the program on where you can find them. And again, these are the ones on my internet searches that I find are the most recent additions of those resources. So I'll send it back to you, Lindsay, see if we have any more questions. Perfect. We do have a couple of questions while you all are putting in your responses here. I did put up those questions as a poll there. So, okay. This first question asks, what about procedures? I know you mentioned policies having a timeframe, or do procedures also have a timeframe for when they have to be reviewed? And when you mean procedure, I think you're talking clinical policy and procedure. What do we do and how do we do it? And correct me if I'm wrong. They haven't given us a time. On patient care policies, they want you looking at them as it goes along or as you're providing care. Usually, if you're doing them at least every two years, I think you're going to be okay. I really do. But you may want to see what policies you have. I think that's what you're, as far as you're doing a procedure, like say an epidural steroid injection, are you still consistent with what national standards say? Anytime the national standard change, yeah, that's an automatic. You have to go back over your policy. So I hope that answers it. Yep, she said yes, thank you. Perfect. Okay, so can the governing body delegate the review of the policies to a team or committee? Yes, but the governing body is still responsible for that. So if the governing body, let's say you've got your medical staff, nursing and pharmacy, and they're all going through all the medications that you have on site, they make a recommendation to that board on, we recommend having these three new medications added and these four taken off. The board still has to approve that. They have to do that. And because if they say, keep everything, they have to give a rationale. So again, yes, you can delegate that. The board is simply still responsible for the policy and procedures and they approve them. But yeah, otherwise it's an overwhelming process to do that. Absolutely. Okay, if you have any other questions, go ahead and be typing those in. And then in the meantime, Laura, I will end this polling question and show those results there. Okay, all right. So yeah, contract, yeah. Why didn't we take that into account? What are you gonna do if this patient who was in ICU and I'm trying to think what's, yeah, this patient was tubed as I recall, crashes and burns. Maybe they wanted to extend that contract to help with this one. Yes, they're to identify telemedicine services. There wasn't an adequate scope. It was just that one little itty bitty where really they needed it throughout the hospital to help them. As far as any issue that might come up from a litigation standpoint, that probably say, hey, we were just trying to help. That's all we were trying to do. We weren't required to do it. The board needs to really have good legal counsel to help them when they're developing their policies. They can come up with some questions that we just don't think about because we just do it in our normal day-to-day care. So thank you everyone for participating. There's the start of the appendix and here's that guidelines I had mentioned. I don't, again, don't wanna flip through 20 some odd slide and make you dizzy. So thank you, Lindsay, and thank you everyone. Lindsay, I'll follow up with you on that tag number for the recommended list for contracts. Perfect, and if you all have any other additional questions, you do see Laura's contact information here, but we do encourage you to reach out to us at education at gha.org to submit those questions or if you just need further clarification, I'm happy to get those over to Laura. And then again, she is always wonderful about getting those responses back to us and she doesn't have to do that. We are just so thankful that she does. I know you all appreciate it as well. I did just put a final closing comment there for you all in the chat. Just again, as a reminder, if you joined us last week, hopefully you did receive that email the day after the live presentation. So that same process will apply for tomorrow. That email will come from educationnoreplyatzoom.us and that will include a link to the recording of today's session and again, a link to the slides that Laura presented for us today. But you should see that link there in the chat now for the slides as well. And again, if we can help answer any questions, don't hesitate to reach out to us at education at gha.org. Thank you all so much for joining us today. We look forward to having you all back with us next week for part three. Thank you, Laura, as always for your time and information. Hope you all have a wonderful afternoon. Thank you so much. Thanks, Laura. Thanks, everyone. Thank you, Lindsay. Bye-bye.

risk management

patient safety

CMS changes

Health and Human Services

facility maintenance

emergency preparedness

dietary and nutrition

compliance

performance improvement

quality assurance

staffing requirements

pharmacy management

just culture

healthcare safety