And now, I would like to introduce our speaker to kick us off with Part 1 today. Ms. Laura Dixon-Most recently served as the Director of Risk Management and Patient Safety for the Colorado region of Kaiser Permanente. Prior to joining Kaiser, she served as the Director of Facility, Patient Safety, and Risk Management and Operations for COPEC from 2014 to 2020. In her role, Ms. Dixon provided patient safety and risk management consultation and training to facilities, practitioners, and staff in multiple states. Ms. Dixon has more than 20 years of clinical experience in acute care facilities, including critical care, coronary care, perioperative services, and pain management. Prior to joining COPEC, she served as the Director of Western Region, Patient Safety, and Risk Management for the Doctors' Company in Napa, California. In this capacity, she provided patient safety and risk management consultation to the physicians and staff for the Western United States. As a registered nurse and attorney, Laura holds a Bachelor of Science from Regis University, a Doctor of 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. Thank you for being here with us this morning, Laura, and we invite you to go ahead and get us started with Part 1. Okay. Thank you very much, Lindsay, and welcome, everyone. As Lindsay mentioned, this is a five-part series, and it's great that Georgia Hospital Association is providing that because some of you may be very new to your role, and so this series of webinars will give you a good basis for what is required from CMS. I always include in here this disclaimer. This disclaimer is just that the information I'm providing today is just that. It's informational only. I don't mean for it to be legal advice or to establish an attorney-client relationship. Please reach out to your own counsel, legal representative, whoever that happens to be for your facility, because there may be a specific state law that would impact, add to, or even limit some of the requirements that CMS does, meaning there's a shorter time frame or a little bit tighter control. I'm going to start with just an introduction to the conditions of participation and why this series is coming around, not so you don't get one of these. Those of you who may have a little more experience, have gone through a survey, know that if CMS finds anywhere where we didn't meet the condition, that you would get this notice, this statement of deficiency, where you have to prepare and submit your plan of correction, and no facility wants to be notified that they have been involuntarily terminated from the Medicare and Medicaid agreement. That can be a huge financial impact to a facility. Late last year, there was a hospital in the North U.S. that they got notice and they were terminated. An entire hospital had to shut, pretty much eventually shut down, because they couldn't continue to operate with that loss. How does this work? How do the regulations start? Well, it all starts in the Federal Register. That's where the loss starts. Then CMS, as a Division of Health and Human Services, they have certain responsibilities where they have to put out the regulation in that transmittal. And a transmittal is the information provided to their surveyors. They also have to develop interpretive guidelines and survey procedures. Now survey procedures are self-explanatory, but the interpretive guidelines give you the rationales behind it. And those are very important because sometimes there's more information on what's expected of us than what's in the actual regulation. And of course, they have to update the manual. For acute hospitals, your manual was last updated in July of last year. If you are a critical listening to this or you have a critical access within your system, their last one was in 2020. By law, they have to update that manual every five years. So for criticals, you can anticipate a new manual coming out. Three types of surveys, certification, where you'll be getting started. Maybe it's a validation survey, where they're coming back or they're following up on one of the deemed status societies, such as Joint Commission. And then you have the complaint survey, which that can be very focused or they can decide to stretch that survey. If you are new to your role, you might want to consider subscribing to the Federal Register. They'll get notice of when there's something new out there. You also want to make sure, please have the most current manual. As I mentioned, acute here was just last July. If there is a new manual, you want to look at the transmittal page. I'm going to show you how to find these things, by the way. And the survey and certification site, at least monthly. That way you can keep an update on, okay, what's changed? What's new? What did they send out to their surveyors? It happens to be just the appendix for the entire operations manual. It will cover everything that CMS has the responsibility over as far as providers. Hospitals, you are combined with psychiatric hospitals. They found there was so much overlap, why make it redundant? For critical access, you are W. Now, there's some other manuals I want you to keep an eye out here. And you can download these, of course, free from the internet. But look at Q. That happens to be immediate jeopardy. That's when CMS would get a complaint or they get notice of an event that's happened at a hospital that jeopardizes the health, safety, and well-being of patients to such a degree that they're going to be out in two days to visit you. Another one is Appendix Z. That is the emergency preparedness manual. They had originally had it in each individual facility type manual, but they realized, again, so much overlap that they put it into its individual manual. So for your Qs, I mentioned the transmittals. When you get into your own appendix, Appendix A, you'll see that blue lettering that says transmittals. When you click on it, and by the way, W for criticals, they have their own too. This is where it will take you. It takes you to the most recent change that came out. It may not apply to your hospital if you're a critical, but this one in particular was for Appendix A, and they did several updates. They were talking QAPI, infection prevention and control. We don't have those yet for critical access. We're hoping, again, with this new manual that they are to put out, it will be there. When that occurs, I can't say. It may be February. It may be later in the year. But that's an example of what the transmittal page will look like, essentially. It will tell you what's revised, what's new, what's been deleted, so it's a quick way rather than going to the seven, sometimes 800 pages in order to find what's new. The memos. This is, again, what CMS sends out to their surveyors to say, hey, this is new, you need to check it out. So, I have the link there. You have to copy-paste these links to your surf engine. They won't automatically connect for us, unfortunately. And that's just an example of what one looks like. For you, this was your updates to your QAPI program. That will tell you the date it came out. And then they attach all of the manual pages to where it is affected. Now, some of these aren't necessarily the manual, but it affects you. For example, and I'm going to talk about a few of these, something to do with care of the maternal patient. Maybe it's texting. Though it's not in the manual yet, you need to know it on what's there. Briefly, again, if you're new or just want to get some extra training, CMS has surveyor training that you can access. It's on their website. The nice thing is, what you would do is you would log in, say, yes, I'm a provider, and then you will go to the alphabetical listing for what is there. And there's a host of information in here, whether it's Alzheimer's or just simple basic life safety code. They give you how long it takes, and you can take them in any order that you want. And again, they're all free. So it might be a good way to, if you're, again, new or you have staff that you want to start training. I mentioned the deficiencies. We don't ever want to get that notice of deficiencies. I just want to point out, you can access them, that CMS updates. It includes acute, critical access, rural health hospitals. If it's a hospital, it's going to be in there. It has the tag numbers, the address, the name of the facility, date it was done. No plan of correction, but you can ask for it. And it is updated quarterly. So again, I have the link here. This is on slide number 21. Scroll to the bottom where it says hospital surveys. And then once you click that, you get this monstrous Excel document, but you can filter and sort. Whatever you want to do. Do you want to do it by tag number? Do you want to do it by description? What is it that you want to look at? They do give a brief description of what they found during that survey. This is a monstrous document. So you might want to think about what you want to look for. If you're going by tag number, you will have to use the letter for the manual and the four-digit number for the tag number. They usually will start with a zero until you start getting up to around the 1,000. That's around surgery. But otherwise, you'll get into the wrong one if you don't put the letter and the four-digit number. Some quick memos of interest. These are recent ones. The ones that are highlighted here are the ones I'm going to chat about. Again, multiple ones have come out over the last couple of years. QAPI, Quality Assurance Performance Improvement. Last, in 2019, CMS did a major overhaul of both manuals. And in that rule, they put out the rule, but they didn't put out the interpretive guidelines, which really doesn't help too much. But nonetheless, that's what they did. They didn't do that until 23. And right now, we only have it for your type of hospitals, acute. They did not include in this, in this update, if you're a system-wide integrated program, that wasn't included. Criticals also was not included. They didn't have those updates. Both of those remain pending. I have a feeling once that new manual finally comes out for criticals, they will make them accessible. So overall, it is the third most frequently cited deficiency. They found that when you have this well-defined, well-maintained program that is fully engaged hospital-wide for continuous improvement, it really does enhance quality of care. And it reduces those errors or those adverse events that can lead to patient injury. The basic requirements is it is ongoing. It's not usually want it done. You want to keep it going. Show measurable improvement. You know, we reduced our readmissions from last year to this year by 25%. When you identify, reduce these errors, whether diagnostic or medication, blood transfusion, it doesn't matter. That's really what they want us to do is provide very much safer care. I cover QAPI further in part four of this series. Texting. We're all doing it now. Back in the old days when I was in nursing, we didn't do texting. We didn't even have cell phones, for heaven's sakes. What we did was we picked up the phone and tried to track down the physician. Maybe we paged him. Or we had an overhead request for them to call us. Back in 2018, they had a memo that talked about texting and mainly of orders. But they realized at that point we didn't have that secure platform back in 2018. In 24, last year, they did update it and they said, okay, now you can do it. You can text orders and PHI if you have a HIPAA-compliant secure texting platform. You can do it. And, of course, that by doing so, you're compliant with the conditions. In other words, that information is getting into the record once it happens. CPOE, we know that's the best way to do orders, but they will allow texting of orders now. Ligatures and risk assessment. That memo came out in 23. They talked about three main elements that do have patient safety, patient assessment, staffing and monitoring, and environmental risk. These are the three areas they would like us to assess. They do understand that not every hospital is going to have the same configuration throughout its facility. Of course, if you have behavioral health or if you're a psychiatric hospital, you're going to have tighter controls. If you have a very busy ER that has a lot of behavioral health patients who are coming in, you're going to have a lot of different measures in place than, say, what you do on your med-surg unit. Look at the needs of your patient and your clinical psychiatric assessment. If they come in and they have had an incomplete suicide attempt, whether it's an overdose of pills or an actual hanging, a strangulation, you're going to have a lot of different devices in place or measures in place than you would for a patient who's coming in for, say, a bowel resection. Look at your actions. Make sure that they're putting in response to whatever that assessment says you have a gap, your deficiencies, or maybe you, unfortunately, did have an adverse event. Focus on those appropriate measures rather than an overall universal approach because you may be making more work for yourself than you actually need to. And then the next one was discharge planning. Yes, it came out in 23, but there's still some issues coming around with discharge planning. They talk about that requirement to have a good effective process that focuses on where does the patient want to be in their treatment and include their caregivers, their support people because sometimes they go home with them and they need that information. One of my sisters just had a shoulder surgery the other day. Her husband is 15 years older than her. And we made sure there was a lot of discharge planning that went on in there because not only is he older, he also has some heart issues. So we had to make sure they were planning PT to be available. She had resources if there was something she fell and he needed help. What we're trying to do here is really reduce our readmission. That's the purpose, one of the goals behind it. Of course, we know we send them where it's applicable and all medical information goes along with them. Sometimes folks were getting sent back to their nursing home and that information wasn't available. With medication reconciliation, they found that patients were being double ordered in the same classification. The memo identified areas where it was missing. Again, to try and reduce these readmissions. If you even have an accrediting organization, CMS has sent this to them to remind them, be alert for that. You have the discretion to develop your own policy and procedures to meet those requirements. Six areas of concern were noted. Meds, durable medical equipment, skin conditions, did they have tears or were they starting to get maybe a little breakdown in that skin? Communication, what is needed at home or maybe at the nursing home? Those who happen to have behavioral health, substance use disorders, or other behavioral needs, those were areas we needed to make sure we're communicating. And then again, the preferences for care. The final memo, this came out late last year. That had to do with respiratory infection data. They actually went back and renewed the reporting data. When we hit COVID, we know we had massive reporting we had to do. Once COVID got under control, 22, 23, they started to ease back off of those reporting requirements. Way on 24, it started to uptick again. And now we also have RSV that's really making its appearance known. So now they renewed and revised those requirements that we have to report. Because the reason was, CMS wants hospitals to be ready for these things as they come along. Back in November 1 of last year, you had to report weekly, electronically, information on those three respiratory issues, influenza, RSV, and COVID-19. That's the memo I just wanted to show you again. That's what it would look like. There is the links so you can go get it. They provided a fact sheet for us. And that fact sheet spelled out the information and how often you have to report. All hospitals, unless you are strictly a psychiatric or a rehab hospital, or you are critical access with those distinct units, you must submit frequently. Otherwise, these two types, psychiatric and rehab, only do it annually and in January. You have to submit daily data values on a weekly basis. And you have to do it by Tuesday at 1159 p.m. And that is daily data for each of the previous week. Yes, you're doing a look back, but that's how maybe you can anticipate, is this a search? Are we facing a search? In this memo, CMS recognized, you know, that's a lot to put on somebody, especially when you're, A, overwhelmed, or maybe a smaller facility. So they came up with a second process that you could do. New admissions that have confirmed respiratory illness. They want it reported by age group. You can do data on a weekly totals instead of daily data. Now, I added that emphasis, that is not in the memo, but now you can do a weekly as opposed to what happened Monday, what happened Tuesday, what happened Wednesday. And they also want your staff bed capacity and occupancy. What's the prevalence of hospitalization ICU patients? And there you can do one day a week snapshot. If you have, you're just overwhelmed, they realize it's better to take care of patients and try and get this stuff reported. So that's why they gave us the second option. Now, I want to point out one thing. This does say admissions, because I had an excellent question earlier this week. Does that apply to ER patients who we send home? I have sent off that information to CMS to ask them just to clarify that. I can't see they would want that as a reported when patient comes into ER and then is discharged. They're not admitted. So the memo specifically says admitted patients. The benefits here that one day a week, new pathway for weekly reporting, good balance between value and against the burden that was being put on hospitals to do that. And the 25 for 2025, this is the information of what you want to collect. Again, if you're doing that one day a week, staff bed capacity and your occupancy between adult and pediatrics. And then the new weekly, new hospital admissions for adult and peds by age range over a defined weekly period. So again, they gave us a little bit of breather here on what we had to do. Okay. I thought I was done, but I have one more. One more memo. It talked about informed consent. Right now, informed consent itself is in three sections of the acute manual. Patient rights, we're talking about that next week. Clinical records and surgical services. There are two sections in the critical, you're in clinical records and surgical services. And what happened here is that, well, we know patients have a right to know what's going to happen to them. Not only informed of their care, but who's going to do it. And they have a right to say yes or no. In doing so, we know we have to give them enough information so it's an informed decision. It's not a way for them to request or demand inappropriate or unnecessary care. And the reason this came out is that some of you may have heard about this. This event happened a couple years ago. She was going in for surgery. She's a nurse of all people. She's a nurse in a hospital. And she checked in for a stomach surgery back in 2017. So before the procedure, she specifically told her surgeon, I don't want any medical students to be directly involved. She spelled that out. After the operation and the anesthesia wore off, the resident came in and told her, oh, by the way, you got your period. And the only way he would have noticed that is if he had done a pelvic exam. Even though she said absolutely nobody could do it. Now this is not new, unfortunately. Because back in 2011, ACOG put out through their ethics paper that pelvic exams on an anesthetized woman, she doesn't have that opportunity to be involved. And in fact, it really shouldn't be occurring. As of June 2019, we have now some states that have outlawed it without specific consent. Those are the list of the states that I could find at this point back in 2019. So any exams, it is now talked about in the surgical section. It is not medical records. It is not yet in patient rights. Will they update it? Perhaps. But for now, it is only in the surgical section. And this did talk about those concerns where we don't have patient consent to do this. So here is how the tag number is identified. The red lettering is what is new. And it is only in A. It is not in W. And essentially in criticals. But if you're doing surgery, you're having students, residents coming and doing these things under the supervision of a physician, maybe you want to have that discussion and add that to your informed consent if that is occurring. So this is when you have medical APPs, et cetera, who are doing these exams as part of an educational and training purposes. And that's not just VAJ exams. These are rectal exams, prostate exams, breast exams. They're really starting to say, we need to get patients' consent. Now, these are just some of my suggestions, not in the regular journal. Make sure your medical staff knows this, that this is their responsibility, especially your surgeon and your surgical staff. Look at your policy and procedures. Do they need to be updated to include that language? Your consent form, same thing. The memo has the language that you might want to include in there. And of course, train your staff. Because if the nurses are starting to see this, your surgical team is seeing this. They have a duty to speak up and say, this wasn't consented, you can't do that. And then I want to talk just briefly on CDC, the vaccine storage, because we're still having some issues on that. There is a toolkit, very basically, no dorm-like fridges, use a medical biological refrigerator. I have the toolkit in the appendix for you. Educate your staff. What is the temperature it has to be? Make sure this is done on orientation and annually, especially as our new vaccines are coming out. We're updating the COVID, Impox is now coming around. I wish they had a vaccine for norovirus, but we don't at this point in time. Keep this information close to the refrigerator so staff doesn't have to fumble around or try and guess or hunt it down where that manual is. You can refer specific questions directly to CDC. I have that link for you. But otherwise, anytime you see an asterisk on my slide, I have a resource in the appendix for you. And this is the most current manual that I was able to find and it did update COVID and Impox vaccine storage. All right, we're gonna go ahead and start now. I wanna begin with non-discrimination, but that's been kind of a hot topic lately. Lindsay mentioned we have a few polling questions. And so I'm gonna start with the first one. Lindsay, would you put that up please? Sure, well, I'm actually gonna read this first part and then I'll put the question up there for you all. This is that Mercy Hospital is a 200-bed level four trauma facility that received a five-month pregnant patient who was involved in a rollover motor vehicle accident. She presented with extensive internal and vaginal bleeding. Termination of the pregnancy is recommended to preserve the patient's life. Patient consented to the surgery. Dr. M, who is an OB surgeon, is on duty for ER call and refuses to do the surgery for a religious basis. Next available surgeon is in another procedure at another facility and not available for at least two hours. Mercy was in the process of transferring the patient to a level one trauma center when the patient's condition deteriorated. And then I'll post this question up here that says, under the circumstances, can Mercy force Dr. M to do the surgery? And your options here, yes or no. We'll give you just a second to put that in. And for those of us who joined us a few minutes after we opened this morning, if you do have questions for Laura as we go throughout the presentation, we'll have several of these polling questions that'll come up on the screen. You can go ahead and type in your questions in the Q&A option found at the bottom of your Zoom window, or of course in the chat, and we'll make sure to go ahead and address those questions as we go throughout the presentation this morning. And I take it there's no questions at this time, Lindsay. Is that correct? I do not see any at this point. That's correct, yep. Okay, it looks like we're getting some good responses. Good, good. This is a tough one with some of the new state laws. Okay, so I'm not gonna say anything, so we're gonna talk about this as I proceed, okay? But I first wanna start off with just OCR section 1557. This is from the Affordable Care Act. There are some provisions that they found overlapped with the conditions of participation. They're pretty much saying the same thing. Now, CMS said, hey, we're happy to add this to our rules, but then they realized this is not going to be answered or finalized with just the publishing. So they said, yeah, we're not gonna do that because it could change. And with those changes, they would have to change the manual. However, if you have a surveyor on site and they see an issue directly related to section 1557, they will send it over to the Office of Civil Rights for investigation. Right now, and these are the main ones that affect hospitals. There are two separate signs you have to have posted. And these are in common places where patients are coming in, whether it's emergency or admitting. One, translation service is available at no charge. That's not new, that's been around for forever. Secondly, you have to have a notice about if a patient has a complaint, how do they get ahold of them or a concern that they want a voice? They have to have a policy on it, educate your staff so they know, hey, who do we get ahold of? And staff can direct them. EMTALA is a separate required sign. For right now, OCR 1557, there's two signs. Your EMTALA would really rank it up to three. As far as non-discrimination, this part is again in the Affordable Care Act that prohibits discrimination on those protected classes, race, color, national origin, sex, age or disability. And these are in the program. These are in the health programs and activities of which Medicare is one of them. And really, it just meant to build on that longstanding non-discrimination rights. There were some final changes that happened a couple of years ago. This was a judge, it was an appeals judge, and he said, hey, we can't force hospitals to perform abortions. It's against their religious beliefs. So OCR went back and said, okay, we'll return to our position of, quote, just sex in the federal law. Nothing on gender identity because OCR kind of slipped that in there that said sex and or gender identity. And they took away the gender identity. The provision on termination conflicted with that. And so based upon it, they went back and rewrote the rule based upon the ruling. So that's where we are right now. We also talk in non-discrimination about our enhanced language assistance that we have to provide interpreters who are qualified, not certified, qualified. We also have to make sure if that's necessary, patients have auxiliary aids, whether it's braille, large print, TDD phones, closed caption, whatever it is. We have to make sure those are available. On qualified interpreters, if the patient wants them in front of them, we have to find it some way unless it's an emergency and we need to do it. Otherwise you can use video remote interpreting. That's totally fine. Just has to be good quality. So it's not stopping, starting fuzzy or anything like that. I already mentioned braille. Health and Human Services mentioned several others, video-based telecommunication. Those are great. I worked in a system where we had, we called it the green monster. And it was that video remote teleinterpreting where we could get the person on the line right there and they would do the sign language interpreting. Computerized assisted transcription, that's where it's just like what our cell phones are doing. Now you hit the little microphone and it's there. But otherwise we post a sign where patients come in, in the emergency room. This is their OCR rights. OCR has a sample. We have to train all staff. Put it in 15 languages about interpretive services being available. Four states and DC have 17 languages, which my state Colorado is one of them. And we have to have someone in charge to handle grievances. When this person for grievances, we're gonna talk about that in the next couple of sessions. I believe it's next week. You do have to get the name and phone number on this person. I reached out to CMS asking, do we have to provide their name? Can we just get the phone number or the department? And they said, no, that is not adequate notice. And mentioning even in this time of some patients not being too cheerful, I guess is a good word, where there are threats. And they said, we understand that, but they still have to give the name. So I'm sorry, I wish that was a better response from CMS. All right, I'm gonna move on now to the conditions. We have to comply with them. And that's for all patients, Medicare, Medicaid, a state plan or Cigna, whoever it happens to be. We know if you have deemed status, you're accredited by that organization and you can get reimbursed without going through a state survey. Not that it won't happen, but they can do that. And CMS has been following a few of them around. They found some discrepancies in what the accrediting organizations were saying as far as meeting the expectations of CMS. Joint Commission was one, Joint Commission resolved that and they're good with it. Now they're doing some follow-arounds for DMV, that's Del Norte Veritas. There aren't very many hospitals that are accredited through them in the US, but they were starting to follow them around. The interpretive guidelines, the ones that you wanna keep handy, maybe download into your library. Of course, A, criticals if they're in a system. I mentioned EMTALA, emergency preparedness and emergency, determining immediate jeopardy. But also keep life safety code because there were several violations, exit routes being blocked, lighting being insufficient. And also labs. Now I don't cover labs, that's CLIA and very CMS and very specific oriented, but you wanna keep that handy for you. By the way, there are certain education that is required that we have to provide to our staff. I wanna mention restraint and seclusion. Restraint and seclusion is the one topic, the one topic in that entire manual where it has to occur before application or removal of restraints is done. So if you have a new person on, they have to be trained on the safe application and removal. That must occur annually. So have that in their personnel folders to show that yes, indeed, you did have it. Abuse and neglect, those are also annual. Pretty much if you're doing a skills lab, these are areas you might wanna think about adding, depending on what their level or their requirements for their job is. Emergency department, what common emergencies would you see coming in? You might have at some point required education for the staff with the restraint and seclusion being the only one prior to a staff member touching a patient. The key areas within the manual, and we're gonna talk about these over the next four weeks after this one, life safety, patient rights, EMTALA, records, medications, QAPI. We're even gonna do dietary and emergency preparedness. Other key areas, infection prevention, anesthesia and surgery, standing orders. Pretty much the whole manual are some of the key areas that we're gonna be hitting upon. On the survey procedure, this is before they even come into your door. They all get together. The surveyors will get together and they determine, okay, how large is our group gonna be? Who's gonna be in charge? What are we going to look at? And then they're going to probably meet with you and they will tell you this is what we need to see and who we wanna talk to, areas we wanna explore. They will also pull records. They will look at your policy and procedures and take that. By the way, if they want a copy of something, ask them to make you a copy because then you can correlate what they're looking at at the same time. Federal law says you must allow them access or you risk losing your Medicare and Medicaid reimbursement. The whole survey is done by observation, interviews and document review. If you are a critical access hospital and you have a 10-bed dedicated behavioral health or rehab, that's distinct, they're separate part, you're under A, you're not under W. And again, they can either find condition, which are the biggies, or standard level deficiencies. Overall, we have to comply with all federal, state and local laws. They're going to talk to your CEO or another designated person who have that information and can't provide it. I already mentioned they can refer certain noncompliance to agencies who have oversight, Office of Civil Rights, but it could also be EPA, Hazardous Waste Disposal, OSHA, if there is some universal precaution issues with your staff. They will also ask, have you been cited for any violation in the past? Because what they're looking for, did you rectify it? And did you fix it so it didn't come back? The hospital has to be licensed or approved along with your personnel. If you are using telemedicine, in other words, they're coming from another state or they're from another hospital, you want to make sure they're licensed in your state. Same with your docs. If they are doing telemedicine in another state, they need to just make sure they are licensed in that state. They'll verify your staff and personnel, they meet all the requirements, in other words, what's the education requirements. You can add to that, by the way. Most states don't require critical care individuals to have PALS, NELS, ATLS, et cetera. But you can, if you wish. They'll also look at a sample of your personnel folders. They want to make sure all that information is in there and it's up to date. Moving on to the board, the medical staff. I combined these because there is so much overlap. Starting with your governing body, you have to have an effective one because they are legally responsible for what happens in your hospital. If you're an assistant, you can share a board, that's fine. Otherwise, you have to have some written documentation that spells out who is responsible for that hospital. The board has the responsibility to make sure medical staff requirements are met. In short, who are they going to allow to be eligible for appointment to the staff? Of course, what is state law? Because that could be an advanced practice provider. That could be a registered dietician. They also have a lot of responsibility in QAPI and antibiotic stewardship. And this is from that 2019 rule where they really started to say, board, you need to know what's going on here. You may want to include adding those lists to your board book when they're having their meeting. This is what we're working on and this is the status of them. So that's what we need to do is make sure that the board's aware what their responsibilities are. Integrated systems. This is when there's a lot of you together. There's no survey of a system. They go to each and every one of them. You can't have one policy for the system with the exception of two of them, system-wide QAPI and system-wide infection prevention and control. And they did that because they felt there was so much information that perhaps one hospital could share with another to improve service and to improve care. An individual hospital can use the policy that's within the whole system, but they have to individually adopt it. And it must be clear somewhere, minutes of the board that spell out, we adopt this policy to be implemented in our hospital. If you're an integrated, each hospital has to have their own chief nursing officer, but you can't have an integrated nursing service. You can have one CNO to run a couple hospitals, but they have to be identified at each hospital as the chief nursing officer. You can operate a QAPI program at the system level. Each hospital has to be certified. It has to have its own data, adverse events, and what are the indicators that they're going to do? I think part of the reason behind this, I believe, was to share that knowledge base that, hey, this is what we're working on and it's working. Maybe hospital B could use it too. Then the overlap, the board determines who the categories can be appointed, whether it's a physician, optometrist, PA, dietician, whoever it is. That's according though to what the state law says they can also do. You may have in your state law where registered dieticians are not allowed to be appointed to the board. That is actually those numbers that did prohibit it are really coming down. There are really just a few states now that prohibit that. And then they grant privileges to be appointed to the medical staff. They appoint individuals on the advice and recommendations of the medical staff because the medical staff has to make sure that this person is up to snuff and the medical staff is the best individual, the best department to know that. They make sure the bylaws for medical staff, the rules and regulations are any changes because they have to approve them. And they also have to make sure there's some accountability by the medical staff to them as the board on the quality of care. All care that is given has to be, of course, by an order of a practitioner. You notice it doesn't say physician, it says practitioners because they broaden the scope on that. Operating within the privileges granted. And of course, we need to document that order. Even if it's a protocol, we still have to have that order. The medical staff criteria, they expanded this several years ago. They have to make sure that it is based upon what the medical staff privileges describe, that there is written criteria for appointment. It's character, competence, training, experience, and judgment. Years and years ago, we said, oh, you're board certified, that's good enough. Not anymore. No, they need to have a little bit more meat behind it to make sure that that practitioner is really practicing safely and up to snuff. Medical staff. Well, we can use other practitioners. Again, nurse practitioner, maybe a PharmD, if you want to. Credentialing, privileging, they have to follow the bylaws according to medical staff rules and regulations. And the criterias in the medical staff. That means, are you going to have full-time, part-time, consultative? However you're going to do it. So that's the categories within the medical staff. So we're already up to question number two. Lindsay. Okay, and again, I'm gonna read this first part and then I'll post the question here. This says that Bennett Hospital is a 120 bed facility with a limited number of physicians, especially in obstetrics. One of the OBGYNs, Dr. Z, is 89 years old who continues to have privileges for deliveries only. There have been no bad outcomes with his deliveries in the past two years. Dr. Z's privileges are up for review and the two physicians doing the review are in direct competition with him and have on more than one occasion voiced concerns with his abilities. Then the question here is, what would you recommend the board do to address the conflict? And I'll post this up here on the screen. So your options here are to move forward with the review and await results, place Dr. Z on probation pending the results of the review, contract with two outside physicians for the review, or make an executive decision to withdraw Dr. Z's privileges but grant consultative privileges. And I do want to back up while the folks are thinking about this one, Lindsay. On that previous question, because we're kind of stuck here, what they did, they did have to work with the physician. He ended up stabilizing that patient. That's all he did. Once the other physician was in surgery and they could get to a point where that physician could step out, they scrubbed in again and took over the surgery. It was a really fine line because do they violate the doctor's religious beliefs, which they can't do, or do they save the patient? So it was a really touch and go with that patient and they lucked out. She did survive. The other physician was able to finish in time, scrub in and do the final procedure. But at least the one surgeon was in, he started it, but he said, I'm not doing the abortion, I won't do it. So they got to that point. It was really touch and go. So that's just something, keep in the back of your mind, what are we going to do if this occurs? Do we try and contact the docs, the other, another partner to maybe come in and help us out? Now that could be another option. That one surgeon didn't have a partner. He pretty much worked alone. So just kind of keep that in the back of your mind. Could it happen? Yeah, it could happen. I did want to follow up with that. Perfect. Okay, you've gotten some good results here. I'll go ahead and share those. Yeah. I think C is the best one. I agree with that. I think get an outside review. So you have the potential for that conflict of interest to be gone. Okay, this guy's 89. Maybe he should have retired a while ago, but he was still adept. And of course the patient loved him. Just, oh, he birthed me. Why can't he birth my kids? That's what they have to look at. What's in the best interest of this patient? And then the physician did, they did go ahead and do the two physician oversight, overview. And they said, I wouldn't want him operating on my mom or my wife. And once they were able to sit down with him, they had that coffee cup discussion. I believe it's sometimes what happens with, between colleagues. And it wasn't the two other physicians. One of those reviewers offered to sit down and talk with him. And he did agree to finally step back from surgery and just act in the consultative role. Cause he was a really good doctor. Trained some of them as it was. Okay, medical staff, they have to do appraisals every, at least every 24 months. Look at their qualifications. Are they so competent to do each task activity for which they have privileges? And that includes anything specialized they have. How are their outcomes? Have they had a lot of bad outcomes? Are they compliant with their licensure and perhaps continuing education requirements? There also has to be some communication between the medical staff and the governing body. The board has to consult directly with either whoever's assigned, whether it's a CMO, president, whoever it happens to be. Somebody who's there to talk about the conduct of the medical staff. It occurs periodically throughout the year. Again, CMS does recommend twice a year. Given your size, you may want that more frequently or changes that are occurring. Include those issues on quality of care that's provided. If you're in a multi-hospital system, then the board has to directly consult with each of that facility's CMO. It can't just, oh, you just do it for all of us. No, each CMO. If you have a unified, integrated medical staff, in other words, you've got four hospitals, the medical staff for all four have come together and you are now one body. You have to make sure it's allowed by state law. You have to have policy and procedure spelled out and it's consistent with the bylaws of those hospitals. Each hospital's medical staff has to vote on it, pass by a maturity vote. And if, again, you're part of a system, each hospital has to be separately certified. There has to be, if you're going to do this, some method for governance, peer review, appointment, privileging, and credentialing. There has to be some method for that to occur. Moving on to telemedicine. Medical staff, they decide, or the hospital decides, we need to have this specialty. So the medical staff will make a recommendation to the board that we want to use the privileging and credentialing of the physicians at the other hospital to do our privileging and credentialing to help us with that. In that situation, the board said, cool, we're going to allow that. There has to be an agreement between that hospital or entity. The providers have to be licensed in your state and there must be evidence of privileging credentialing along with a copy of their privileges at that other facility. I wanna point out one thing, an entity is that group of physicians who are not in a hospital or they're not working under the auspices of a hospital. It's an entity. And previously, CMS did not recognize them. They didn't allow for that or wouldn't pay for it. Well, now they're realizing, yeah, that's a huge benefit, let's have it. And so they are now allowing that to happen. And it does give a little oversight to it also. So for telemedicine, if you're going to do that, you as your hospital can rely on the privileging and credentialing of the other hospital or entity when granting privileges at your facility. If you have an issue that comes up, you have to report it back to that distance site on any complaints or adverse events. They recommend having one file with all of those telemedicine outside providers. You can also do separate files if that works for you, but the surveyor wants to see it. They want to see that documentation, that yes, indeed, you granted privileges to each provider and you relied on the entity or the hospital in the privileging and credentialing. So you can do that. Again, a hospital has to be CMS certified. If they are not, they fall under the entity component. So even though it's a hospital, if they're not CMS certified, that would be now an entity. Our CEO, the board has to appoint this person because they are responsible to manage the hospital. The surveyor is going to verify that yes, indeed, they are managing the higher hospital and they have been appointed by the board. If you're joint commission, I don't touch on joint commission, but if you are, that is in the leadership standard. I pointed out because there's more detailed information than in the CMS manual on what is the role of that CEO. So it is there if you happen to be a member of joint commission. Care of patients and the board. The board has to make sure every patient is under the care of a physician, dentist, podiatrist, chiropractor, psychologist. They have to be licensed and member of the medical staff. Licensed practitioners. They used to be licensed independent practitioners, but they took out independent and now it's just licensed practitioners. They can admit if your state law permits them to do so. They still want evidence that that patient is under the care of a physician. So you need your policy and procedures to spell that out. Now the exception here, MO back in 2023 for acute hospitals. Yes, I have it in the appendix. Federal law nor CMS requires a Medicaid or non-Medicare patient admitted by midwives to be under the care of a physician. That's acute hospitals. If you are critical access hospital, you still have to have a physician under their care. They made that delineation. So for acutes, yes, they can admit without being under the care of a physician. Otherwise you have to have evidence they are under the care of physician in the medical record. The board medical staff, they have those policy and procedures to make sure yes, indeed that does happen. The board has to ensure the physician is on duty or at least on call because they are responsible for monitoring the care of that Medicare and Medicaid patient. To do so, the surveyor is going to talk to your nurses. Can they get that physician if they need it? And do they come to the hospital when they are needed or requested? Yeah, that's why you have to have those policies to make sure this is current, that they are monitored by the physician. Especially if it's outside the scope of practice for that admitting practitioner. And this is the list of those admitting practitioners where the physician and MD or DO must monitor the care if it's outside the scope of a dentist, podiatrist, optometrist, psychologist, chiropractor. And of course they're usually limited to manipulation. Again, if it's allowed by state law. So if you have a patient who's admitted by a dental surgeon, say for example, and they wanna do oral extractions, but this patient also has underlying cardiac issues, then the physician and MD or DO needs to be involved in that patient's care. Then we get to the good stuff with what the board needs to do. That's the plan and budget. The board is responsible to make sure there is an operating budget with all anticipated income and expenses. They have to provide for capital expenditures for years going forward. How are you going to finance it? They need to identify those sources, whether it's acquisition or improvements. And these actually have to be submitted to CMS for review. You include acquisition of land to buildings, also update it, review it annually. Have you changed your mind? Maybe we can't update the surgical suites because we've had an event that happened maybe over in med-surg and we need to update our building in that respect. You need to have a committee of representatives from the board, your C-suite, your medical staff, because it is prepared under the direction of the board, but still you have to have that committee. And you have to be able to show all three participated in that plan and the budget. Contracted services, what does the board have to do? Well, they can allow it, can be in care through employees or contracts, they do have to act under the QAPI program. We need to assess them to make sure that they're providing care and services up to the standard of care. You also have to make sure if there's any quality issues that we're monitoring and correcting those problems. And then finally, we want to make sure they're performed safely. There is been some increased scrutiny by CMS on contracted services a little bit. I believe that perhaps some of the deficiencies they were noting, there was very little to any oversight. And that's why you want to look at your QAPI program, make sure every contracted service is evaluated, whether it's cleaning the snow off of your parking lot, maintaining your parking ramp or structure, if that's what it is, or if it's contracted emergency services, hospital of service, whatever it happens to be, because they are responsible to still comply with the conditions. So you may want to add that to your contract, you may want to think about having your counsel add that to the contract, that's their responsibility. Failure to do so could result in immediate termination of the contract. We're done with the board. Now I'm going to move on to emergency services. This is emergency services within your facility. EMTALA is a separate one. We do that at the end of the year through Georgia Hospital Association. It's a two-part series because EMTALA is very involved. And over the past two years, it has undergone so many changes in respect to reproductive care. If you have an emergency department, this is where you comply. If you don't have a dedicated emergency department, your governing body has to make sure there is something, some policy and procedures on providing emergency services, because you may have visitor that walks through and drops over in your lobby. Okay, what are you gonna do? How is that going to be handled? You can have a qualified RN assess a patient as long as it's within their scope of practice and the board of nursing doesn't have an issue with it. Usually your medical staff policy and procedures will tell you how you're going to address these emergency procedures. Maybe they also need to address if that patient's need exceed what you could do. So we then have to arrange for appropriate transport. So again, we have that visitor, they've come in, they've keeled over and they're having maybe a dissecting aortic aneurysm. How are you gonna handle that? Are they stable enough that you can transport them? Make sure staff know what to do in that emergency. Don't rely on 911. This again, those are for the ones that don't have a dedicated emergency department. How do they respond to a code? How do they respond to that emergency? But if you do, you do have them provided, but not at your off-campus. So maybe you have an offsite physical therapy department or radiology. How are they gonna handle those emergencies? Cause you know, they're gonna crop up. Stabilize and treat. That's pretty much what you do. Call 911, this is off campus only because you don't want them to try and do a full code if it's beyond what they should be doing. Have it within their ability, whether it's staff, your staff could pass out having a medical emergency, visitors and patients. Make sure staff know what that is. I've been in a clinic and it was affiliated with the hospital and they would have a full crash cart and run a full code rather than call 911 because they wanted to do that. They wanted the experience, not the best for the patient care. And so it took a little bit of education and they finally realized 911 by the time they called it, they were there before they could even get an IV line established. So that's the other reason. Have those who know how to handle them. All right, this is a new rule that I wanna talk about. It's part of the 25 outpatient PPS. Talked about several goals of the previous administration, how we respond to maternal health crisis. It also talked about health disparities and really giving safe, effective care. It does not modify or change EMTALA. It is a new condition of participation. I don't have any tag numbers yet and there is no memo on it yet, but really it's to meet the maternal health conditions to avoid termination from the program. So these were the areas that were addressed in that memo, especially emergency services readiness. What they're talking about here is in the final conditions. What they're trying to do is make sure hospitals are ready to care for these patients who present with maternal issues, pregnancy, birthing, postpartum even. And it applies to anyone who offers emergency services, whether or not you have OB, whether or not you have a NICU. So it still applies if you're providing these emergency services. You have to have adequate provisions and protocols following nationally recognized guidelines. It applies to all staff. They have to be trained on the protocols and the provisions annually. You have to have documentation to show they've successfully completed and can do a return demo. So you have to set aside provisions for these emergencies, equipment, supplies, medications. Those you normally use in a life-saving procedure, whether it's blood, blood products, equipment, supplies. Now I wanna point out one thing. This is not applicable. The critical access hospital are rural emergency hospitals because they found they already have these in their condition of participation requirements. This is added only to appendix A. Which tag numbers where, I can't tell you because they haven't put those out yet. So hopefully we'll get those soon. Now I'm moving on to medical records, patient rights and access. I wanna start there. This is the last portion of our program today. First off with patient rights. 2019 was a busy year, as you can tell. And they even showed in there, patients aren't getting access to their information in a timely manner. OCR finds them. In fact, they just sent out another one yesterday. This started back in 2020, this particular citation where a patient said, hey, I need this information. I'm moving out of state and I have to have this records. 2020, they wouldn't give him access. He kept asking, sending letters, asking, sending letters. So now OCR has found out about this. He finally did get them three or four years after the fact. But they did find this facility for not giving access to the records. Now you don't think 30,000 is much. But when you think of the impact on the patient, that probably wasn't enough, to be honest with you. This talks about in this particular, when a patient wants a copy of the records and they have to have that authorization as opposed to I want access to my information. We know patients who don't get those records timely can file a complaint. Back then, one in every 10 was not getting the records. That's the most recent data I can find on it. I have a feeling it's more. Now it's like one in five would be, they're not getting records. We know they will find you. That includes providers, doesn't have to be a hospital. As of March 23, there were over 325,000 complaints regarding that. This is the 14th find back in 21, where this was, again, a right of access. Number 46, they didn't give the records where they were required to. And it didn't matter what type of provider. Here was a dental office that they said, you didn't give them access to these records. Some of these are pretty significant finds in the hundreds of thousands because we just simply didn't give them access. Okay, on to medical records. I have the tag numbers here for you that we're gonna be addressing. We know we have to have a service for medical records and someone has to be responsible for that. Records have to be maintained for each and every person who is either treated or at least evaluated. In other words, in the emergency department. You have one unified service. It's responsible for everything within your hospital, both inpatient and outpatient. And the surveyor, once they're there, they're going to ask for 10% of your daily census, at least 30 records. So you can imagine if you're a 400-bed hospital and you're full, that's gonna be a lot of records they're gonna be reviewing. You have to have a record for every patient, even if it's no bill or leaves AMA or leaves without being seen. You still have to have something on them that said they were there, this is what we did do, and the patient, whatever their disposition was. And that applies across the board, whether it's a pathology film or a radiology film. Your health information department, they have to be set up in a way to meet the needs of your hospital and your patients. That's why you have to have an organized staffing according to your size. You have to have enough personnel there so it's completed, filed, and can get to it when the docs need it. They have to have enough education, skill, qualifications to meet those needs, but they also have to have education on federal and state law requirements. I have to make sure enough coding and indexing, that is crucial when you're doing QAPI because if you wanna pull data on say, how many surgical site infections have we had, that's what you have to go for. Surveyor wants to see the job descriptions for your medical record department staffing and also the schedules that are occurring. Excuse me. Record retention, this isn't new. We've had this around for decades. We have to keep a record for each patient. It has to be complete and retained and accessible 24 seven. A way to identify the author and protect the security of those records and also from damage. Other threats, think cyber phishing. Records completed within 30 days, kept at least five years. Now your state may be longer. That's why you wanna reach out to your council to find out what is our requirements. Critical access is a little bit longer at six years, but otherwise, whether it's a radiology film or documentation doesn't matter. It's five years at least by CMS. Again, other records may be longer. OSHA, EPA, they may be longer. The surveyor wants records from the past 48 to 60 months. Five years, that's what they're looking at. Are we keeping them? On retrieval, that's why you want that system of coding and indexing so you can get that record when you need it. And also by diagnosis, it has to be accessible for those departments when they need it. Does ED need it? CCU need it? Who needs it? Of course, measures and procedures to ensure confidentiality and that unauthorized folks don't get access, whether it's electronically or the old school paper form. Copies, only released when you have a proper authorization. DPOA, Durable Power of Attorney can authorize it. On the original, only released per court order or a valid subpoena. And usually the court will take a certified copy. They understand the sensitivity and the need to protect that original copy, the original form. That's why you have to have that policy to ensure confidentiality. And yes, the surveyor wants to see your policy. We know there are certain times you can disclose information. Payment to healthcare operations where you don't have to get the patients okay. Bill paid. Maybe you need to have medical record reviews, fraud and abuse detection. That again, OIG can come in and say, we wanna see your records. Policies to address to limit disclosure and the surveyor, they're going to watch and walk around and observe to make sure yes, indeed records are protected. Which now we're at question number three, Lindsay. Okay, let's go ahead and get that one up here on your screen. So you should see this one now that says, carry on hospital has one provider who insists on using a signature stamp for her signature. She has MS and extreme hand tremors. Is this permissible? Yes, no, or possibly not sure here. And it looks like Laura, we have a couple of questions that have come in to the Q&A. If you wanna take a second to- Yes, please. So this first one says, if a hospital has a disc with x-ray films but refuses to give it to a patient and tells them they have to come back the next day to go through the health information, is that permissible? Or let's see, department to sign for the disc, could that be considered information blocking? That was a follow-up question. Okay, so, okay. First off, the patient wants the disc. My question, could they make a copy of the disc? I don't know. I don't know the technology behind that, but they have to make it accessible. If that's the, cause that could be it. So, hey, this is the only thing we have and we can't let it go. Then maybe they can have some way to have the patient and or another provider come in and review it. It's like when an attorney wants to see the records and the patient signed off on it, they can do that. But just so there's documentation why they are refusing to let it go. It's the only one, we can't reproduce it. And yes, we talked blocking later. We can't reproduce it. If we do reproduce it, it will be incomprehensible, so to speak. So something that said, that's it. That's the only thing we have. What was the second part of that question? So an answer possibly, yes, you could say, we can't release it. That's all we have. What was the second part of that question, Lindsay? I'm not sure if this was follow-up to that first one or if this is separate and it did come in anonymously. So if you would like to clarify here, it says department to sign for the disk. Is that information blocking? Yeah, I guess I'm not clear. I think what they're saying is department has to sign off on release of the disk or access to the disk. I think they'd be very careful with that one. I can see why. As far as release, probably it's like, yeah, we know where it's going, but you just, you cannot delay patient access. You just can't. It has to be a reasonable request. This is it, come on in and we'll let you see it, but that's all we can do. Okay, and then another question that came in asking if annual employee evaluations are mandatory. Evaluation, no. Well, they don't talk about it. I mean, it's your responsibility when you hire an individual that if there's something going on, that's your job to really follow up with them. The HR director will probably say yes. And so CMS, they don't touch on that minutiae of employee evaluation only to the extent of that required education, restraint and seclusion, abuse and neglect. There, yes, you have to have annual education, which means, okay, you've got to find out, are these folks going to be competent to do that? Are they still safe to make those changes? It might behoove you to do those annual evaluations because sometimes you get a less than optimal actor that might slip through initially and you want to find out quickly before there's patient injury. And of course you're responsible for that employee. So an answer is CMS won't go to that. They won't go to that level of annual reviews of the employee, only education. Right. Okay, I think that was the last question. I'll go ahead and share those results of the polling question. So yeah, we're kind of all over the place. That's okay. This is a new one because CMS, and I'm going to say it right now, CMS kind of contradicts themselves on this one. So first off, the content of records. We know it has to have everything that you have done for that patient from the minute they hit your door until they leave. That means supporting the diagnosis. How did they progress? How did they respond to meds and intervention? We know they have to be promptly filed within the record. They must be legible, complete, dated and timed, authenticated by that person who's responsible to do it. In other words, the RN or the physician. They must specify in the medical staff or bylaws and policy who can make the entry. And just have a way to identify that author and have a list of those written signatures available. You know, it used to be you did your full signature print, cursive, professional signature, and then of course your initials. Now with electronic, I don't know to the extent that they go, just enough that we know those written signatures if that occurs. We know it has to be legible. That's the nice thing about electronic records. We can read the handwriting, but does it make sense? Medical staff rules. They address the counter signature when it is required, like your advanced practice providers. There is a section on standing orders. If you have those, you want to make sure it is signed, dated on the last page or the final page. How many pages are involved? Is it just one? Or is it one of three, two of three, et cetera? Any changes, additions, deletions need to be initialed by the person who's making that change. So the rubber stamp, our poor doctor. If you're going to do that, CMS has in their separate program integrity manual that says stamps are not allowed. However, they also say, if you allow them, there must be a signed statement by that person that they are the only ones to use it. They won't give it to their nurse to sign off on the prescription nor the advanced practice provider. It has to be only them. Now, this can be used when it is in such a situation where the physician has a clinical condition that they cannot accurately sign a legible signature. That's the only time. It just otherwise can't be for convenience. Electronic records, how are you preventing alterations and no auto-authentication, i.e. not able to review is not yet transcribed. They say that is a direct violation of the conditions. Verbal orders. If they've got partners or others they work with, they can sign off a verbal order. If their state law and their scope of practice says they can't do it because it could be a PA. Those who take it need to do a readback, write it down, date and time it, and then get that person who ordered it to authenticate it right away and date and time. You determine within your policy and procedures what's that timeframe going to be. Again, state law sign, if they have an addressment in there in the state law, the timeframe to sign it off and who. If not, following our policy and procedures. We had it in hours that usually would get verbal orders at two in the morning when the physician was on call. The next morning when their partner or then came in to do rounds, they had to sign off. There was a 24-hour limit on that time. Otherwise, no more than 48 hours. Usually you have to have that whole record signed off within 30 days. And again, date and time the entry. Standing orders, we've all used them. We can have those, they're pre-printed. And they come by many, many rules. They can be order sets, protocols, that's if you want to call them that. But there's a couple of requirements for them. One, they have to be reviewed and approved by the medical staff, nursing and pharmacy leadership. And they have to be on the phone. It's before they can be used. Your policies have to address how they're going to be put together. Are they approved and monitored? Who can initiate them? And then when are they signed off? These are usually where you have a specific criteria in the protocol where the nurse or other staff can initiate it before the physician is actually physically on site. It must include how it's your policy. How are you going to authenticate it? Number two, you must document the standing order is consistent with nationally recognized guidelines. And it's on you as the hospital to show good basis for this standing order. American College of Radiology said this is how many x-rays this person can have or how long that that film will take. Number three, they are subject to periodic and regular review. Again, medical staff, nursing, pharmacy. The reason is, is this still a good order? Is it working for us? You know, pharmacy may say that takes too long. And also, if we put this medication together and have it ready to go, and then it expires, we gotta toss it. At a minimum, CMS recommends annual. And then your policies, how do you address it? How do you correct it? Revise or modify those standing orders. And then number four, that standing order has to be included in the record at the time of initiation or ASAP, after the fact. Make sure they are dated, timed, and authenticated by the ordering provider. If it is a non-physician, they have to make sure state law permits it within their scope of practice. The bylaws allow it, the rules, regulations, the policy allows it. So that's when it is a non-physician. We do know, and CMS recognized, there's no standard definition how you wanna call it, whether it's order set, protocols, whatever. And they know that that can result in a lot of confusion. So they did give us some definitions, menu options, because they know not all electronic order sets are considered a standing order. Here, if you simply have a list of opportunities, a menu, staff can't do anything until it is completed. And the options don't create that set. So the provider has to come in and decide, I want this, I don't want that, and then sign off on it. Staff can't do anything until that occurs. A standing order is, yes, a nurse can initiate without a specific order, but the policy has to make sure you meet those regulations. Doesn't matter what you call it, we don't care. But meet that predefined clinical situations. Perhaps you have a patient who comes in through the CCU, or they're admitted to CCU, and I use that because that's where I used to work, and we had standing orders that, okay, we're gonna start this, we're gonna put them on nitro drip, we're gonna do this. If the patient's heart rate drops before this, do that. If they have VTAC, do this and that. I can initiate that without having to stop, get the physician on the phone, get the order, et cetera. I could initiate it. If you have a hybrid, they still have to meet the compliance. And that's what you have to be careful of. These are the hybrids. Other requirements, I mentioned the well-defined clinical situations, so we support it. Initiated usually as an emergency response. Evidence-based treatment regime and medically appropriate. Now, this could be your rapid response team. Other examples, triage to stabilize ED patients, post-op recovery, like PACU, when they're shivering and you give them the medication to stop the shivering. Provision of immunizations. The only thing it can't do is when it's prohibited by law, there is no such thing as a standing order for restraints and seclusion. They spell that one out. Other examples and menus, it's where the practitioner picks from the set. Again, they can't be initiated until somebody else works on them and they signs on. Options don't create the order and the physician has a choice whether or not to use it or start over. So that's orders. Let's go to history and physicals. There were some changes. Again, medical records, surgery, and medical staff section. Now we have the option of doing an assessment if we have an outpatient and within the hospital. This is not yet in the critical access, only in your QA manual. The reason they did this, it gives us some flexibility for these assessments rather than a full-blown H&P in those selected surgeries or procedures. Now, they said, CMS says, they're gonna amend the medical record chapter, add interpretive guidelines and survey procedures. Hasn't happened yet. So again, you have to have a medical staff policy. It's outpatient only and you're doing an assessment rather than a history and physical. Still has to be documented in the record. You don't have to do this. It is an option. Those minor things, maybe you're doing a lumbar epidural steroid injection or maybe you're doing cataracts where you don't have to have that full assessment for the patient because what they found is it really didn't change things. New England Journal of Medicine did a study, found it didn't change anything, the outcome, whether they did an assessment for outpatient or the full-blown H&P. But your policy, here's just some things that you wanna consider. Who do you have? What's your patient age and what's the diagnosis? How many comorbidities do they have underlying there? What are you doing for this patient? Are you doing a cataract or are you doing a total shoulder surgery? Level of anesthesia, national guidelines. Maybe they spell out, yeah, this person needs to be had the head-to-toe check and any applicable state laws. The assessment, if you are doing this, has to be complete and documented after they're on site, but before you do anything to them. The procedures are those, the medical staff has decided don't need it. So you, again, have to have a policy on that and it needs to indicate that in consideration of age, comorbidities, et cetera. But even if that's on the list, the physician still has the option of doing the full H&P. But you still have to document in that record any preexisting conditions, appropriate tests. I don't know, maybe they're on Lasix. You wanna make sure their potassium's okay. Allergies and current meds. And I did mention, again, the New England Journal study that said, you know, they don't add anything doing all that CBC and UA. They don't add anything to their outcome. History and physicals, same provisions between what's in the medical staff. I have the tag numbers for the medical staff there. It must be done within 24 hours and no older than 30 days. It has to be on the record before they go to surgery. If the state law allows and your policy within your hospital allows, your advanced practice providers can do those. Just the physician have to review and sign off. They have to authenticate it. As far as the admission H&P, updated entry into the record to reflect any changes. And the person who does it has to be licensed and qualified. So if my family practice does my H&P two weeks prior to my hip or my cabbage, whatever it happens to be, then the surgeon has to review, make any updates, determine are there any changes since that was done and then authenticate it. You can include that in the progress notes. You can do a sticker, a checkbox, whatever you need to do or write it right on the history and physical form. This is some possible wording that was added for those of listening that's on site 146 that the history and physical was reviewed, patient examined and no change since it was completed. Overall complete H&P on every patient unless it's an emergency and then they're going to look at your notes in progress notes in the emergency department. So that's why the new regulation expanded not only the categories of who can do it, but as long as it's allowed by state law. So that was an expansion. You might want to consider PI performance improvement. Are they on the chart before they go to surgery? And if not, why not? What's the gap? On your assessment documented in the record after registration, according to what the medical staff bylaws say has to be done as part of that assessment. They repeated this requirement in all five sections, records, medical staff and surgery. And then here's just what the medical record has to include just everything that occurs on the patient. Why are they there? Any consultations or findings, make sure it's promptly filed, complications, hospital associated infections, anything that's an unfavorable reaction, whether it's drugs or anesthesia or the surgical procedure and make sure that practitioners are comfortable documenting complications. This is where your medical staff or a leader can help you. Some document very well, very objectively. Some could use a little help. And now I have question four. I think this is the last of our questions. Lindsay. I believe so. I'm gonna read this top part for you to give you a little bit of a break here, Laura, and then I'll post the question up here. And then as I'm doing so, if you have any questions for Laura, I'll go ahead and be typing those in as we are getting closer to the end of the presentation this morning. So this question says state surveyors presented to hospital L following a complaint based on lack of informed consent for an invasive radiology procedure. During the record review, three different consent forms for the same procedure were found, two of which were from physician offices. Review of the forms found some mandatory elements were missing, name of the person doing the procedure and signature of the provider doing the procedure. And the question here is, will the hospital be cited? And I'll go ahead and post that up here for you on the screen and your options here. Yes, no, or possibly. And then we do have just a couple of questions. Laura, while you all are putting in your responses and this one says, for standing orders, what is the requirement for medical assistance? Well, can medical assistance initiate orders? Is the question. It depends on what the order is. Usually what happens, I'm not familiar that medical assistants can initiate orders in a hospital. Usually it's the nurse can delegate it down to the medical assistant or CNA, whoever that happens to be. So I'm not familiar that a medical assistant can do that. It's generally a delegation to the next level up, the nurse, the PA, whoever happens to be. They delegate it down to that. So I'd be really curious to see an example of one of those. I haven't seen one. And I see a follow-up here or it's from another comment or possibly it says that that is their understanding as well. Yeah. Okay, and this other question says, if it has been longer than 30 days, so 45 days as an example, does the provider have to complete a new H&P or is it acceptable to update and verify the previous H&P? That's a good question. Right now CMS hasn't touched on that, but if they see something older than 30 days, they've usually kicked it back and said, that's not okay. You have to do a new H&P. And yeah, I don't, I have not, I'm not aware that they would accept that an update, no updates noted for anything over 30 days. It can be a pain I know, but it's better to err on the side of caution. Absolutely. Okay, one more question has come in here and then I'll conclude that polling question that asks, if a patient is in the emergency room and they request a copy of their record or a disc with copies of the radiology images, but the staff refuses to give them a copy of the record or the disc with the copies of their images, telling them that they have to go through the health information department and sign a release, would that be considered information blocking? It could. It could. We have to give them access to that information and we don't wanna make, okay, so they wanna copy, they want the physical copy of that information. If it's electronic, it should be fairly simple, but if they want an actual hard copy, that's usually a request for their records, then yes, you can say, we don't have the capability, we have to file our own bylaws and that means going through HIM. Sign the release, give them a copy of that release and then say, how do you want it sent to you? Mailed or whatever. And then you have to have time to get it there. And by the way, they're shortening those timeframes. They wanna shorten them from 30 down to 15, period. But if they just wanna look at the record, see what's in there, okay. They can do that. It's getting the copy, you can say, we don't have that ability, please sign a release and we'll get someone to take care of it. Otherwise, yeah, I would have them go and they want the physical copy. That's a request for authorization for release. You don't have to, you don't have to do that. They can walk up to HIM and get a copy of what they need. Okay, perfect. I'm gonna go ahead and end this poll and show those results there. Yes, they will. And possibly, because I get it. It can be challenging. As far as having three different consents, it's up to the medical staff, what you want to allow and the board. You need to make the determinant. Are we gonna allow these outside consent forms to be used? That's fine. Some of them say, that's great, but you also have to use ours. So it's double. All right, I'm gonna move on to the form consent. Again, it's in three sections, rights, medical record and surgical services. Properly executed for treatments that the medical staff say we have to have. But also the AMA, American College of Surgeons, they have that list. I could not get that list because that is a members only, but here's some of the mandatory elements. Of course, where is this happening? What's happening? Who's going to do it? The person who's responsible. What are the benefits, material risk and alternatives were explained. Now, some hospitals, they will also list them out such as not to be exclusive or including but not omitting, blah, blah, blah, blah, blah. Signature of the patient. The date and time it was signed, excuse me. And then again, I just wanna point out again that additional requirement in the surgical section of those who are maybe doing something during the surgery as a learning experience. There are optional elements. You don't have to do this. You don't want to, these are optional. Who did the informed consent discussion? Who witnessed it, date, time and signature? Who witnessed that form? A listing again of those material risk you did cover. That's an optional. Who other than practitioners are going to be doing important tasks? Now, this is not those for training, but maybe opening, closing, suturing, et cetera. That qualified practitioners who do perform may also do not only surgery, but anesthesia. The record, medical records has to have that informed consent for any procedure or treatment. That the medical staff says they need to have one. But look at your state laws. They may have a listing of those that require consent for invasive procedures. Of course, we know we have to have it for research. Those are very specified informed consent forms. Just a quick listing, an example that you may wanna have. Maybe you don't want a simple assist, have a consent form for that. If you're going to do something a little bit more involved, like say, oh, I don't know, amniocentesis, yeah, you want a consent form for that. These are just a list of them. But they are required for all surgeries unless it's an emergency. Inpatients, outpatients. Any procedures your medical staff has said you have to have it. We've heard it repeatedly. It is a process. That's what it's to show. The form has to follow the policies and include state and federal law. And again, all of those minimum are also known as mandatory requirements. I wanna repeat, this is to tag 8A0955. This is whether that's the part in the surgical section. That was the new updated memo. It's not in W, but again, if you're doing this, you might wanna consider for your critical access. The surveyor will verify that the medical staff has that list of procedures or treatments that require consent. They wanna look at least some of the forms. They wanna make sure they contain the mandatory elements. They will compare your form to your policy and procedures. Is it consistent? And are there any state laws that are requirements that are included? They will know those when they show up. Your record has to otherwise have all orders, notes, reports, vital signs, and orders that are authenticated and signed off. Anything where there's a complication and anything you did to monitor the patient's condition. Think about your OB monitoring, your fetal heart monitoring strips, how are you maintaining those? And of course, a discharge summary. What are we gonna do with this patient? The outcome of their hospitalization, where did the patient go? And what's the provision for follow-up care? That includes post-hospital appointments. How are you gonna meet them? Or if they're going to go maybe to long-term, maybe home health is going to come around. You can't delegate it if state law permits this to your advanced practice provider. But again, the physician has to authenticate it, in other words, sign off on it. And then we need our final diagnosis in the record as to the best of their ability. Completed within 30 days and also includes inpatient and outpatient. I wanna mention something here on final diagnosis because it came up in a previous question. What if the patient leaves before we have that final diagnosis? They document the best you can on the information you have. Based upon the information that I have as a physician and all the test results, this is what I believe to be the final diagnosis. I cannot conclusively say that's what it is because the patient left without being seen, left AMA, blah, blah, blah, before testing was completed. Interoperability, I'm gonna go through this fairly quickly because it is not in the current memo. Thank you very much. Three years ago, four years ago now, almost they put this memo out. And really they're talking about our electronic medical records system that we have a way to send out notice when a patient is admitted, discharged, or came in and then left. That we send notification on at least who it is, the practitioner's name, and who is sending it. Because what they're trying to do is that your system has to have the capacity where it's fully operational according to state and federal statutes so that we can exchange this patient information when we need to. Do what you can, that's a permissible under law, not inconsistent with what the patient says you can't share of registration in the emergency department or admission to an inpatient service. That we send notification immediately prior to or at the time also of discharge or transfer. And we also include in there, if the patient said, don't send it, I don't want anybody to know I'm there. You may be sending multiple notifications by the way, whether, by the way, your patient's here in ED, your patient's here in ED. Oh, by the way, we're admitting your patient. Again, could be noticed because they found a lot of physicians who weren't aware the patients were in. If you're using that form, that EHR that is conformant with exchange standards, you have to show you had a reasonable effort to make sure the system sent that notice to those who need to know. Whether it's their current provider or a post-acute care provider. Maybe it's their PCP or to their group. Information blocking, I'm glad somebody brought that up. So unless it's required by law or meets an exception, if you have a practice that interferes with access, exchange or use of that information that you know is unreasonable, interferes with or prevents or discourages exchange or access of that information. Okay, again, access to their information. Couple of things that this rule doesn't even apply to. These are not new ones, psychotherapy notes. These are ones that are separated from the rest of the record. It has to be those notes recorded by someone who is a mental health professional that they put these notes down while they're analyzing either during private or group sessions. Secondly, when it's used in anticipation of a lawsuit or an administrative action. Again, this rule does not apply to it, period. But there are three exceptions where it is not considered blocking. In other words, you can block a patient's access to this information, but you have to meet each and every one of these conditions at all times. One, you're preventing harm. There are two requirements. It is a reasonable belief that you're reducing harm to the patient, and it is no broader than necessary. Number two, the type of risk. It must be determined on a case-by-case basis. And that harm comes from that data that you believe is misidentified, corrupt because of technical failure, or it's wrong for whatever other reason. The harm is likely or will interfere, excuse me, the blocking will interfere with their access. And you have made this determination on a case-by-case basis, it references someone else, and it interferes with legally permissible access. Now, again, it has to be an unreasonable restriction. And again, it's consistent with the determination by that professional, or it's just simply wrong information. So there's the harm. Number two, privacy. You put this blocking into place, it's nondiscriminatory, and it's consistent. It complies with your policy and procedures. It must be in writing, and you have to have training on it with policy and procedures. And also, you've documented case-by-case criteria when that precondition does exist. The precondition is relied upon, it's on a consent or an authorization. So in other words, if your providers, you get a release of information that doesn't satisfy all the elements of that precondition, that you get the person a consent form that is consistent with releasing the information, that you have not been properly encouraged to withhold that, excuse me, you do not improperly bribe, essentially, the patient to withhold their consent. It says, you don't need your consent if you give me a whole bunch of money, and then I'll give you the papers. And there's a uniform policy and procedures. As far as denial of access, when the right of access, again, I wanna see my medical records, okay? You cannot deny access to that record unless, again, it's psychotherapy notes. Request not to share unless it's required by law. You can elect not to provide access if the patient requested and there's no improper encouragement. Don't share it with my soon-to-be ex's attorney, and I'll give you this money not to do that. That your provider, you're documenting that request within timeframe, and it's consistent and non-discriminatory. So again, request not to share it because sometimes patients don't want their employers to know what's going on with them. They can ask that you not share that information. And as far as not sharing it, but you may decide, I'm gonna terminate the request for restriction. As long as the patient agrees, if it's in writing or if it's orally, you document that. I'm gonna terminate this request not to share. And they tell the patient, I'm terminating it because I have to turn it over. Finally, the security, I'm sorry, there's a fourth one, security exception. Practice to interfere with access is not blocking if it's directly related to safeguarding confidentiality, what's in there. And it's specific to a security risk being addressed. It's consistent, non-discriminatory, and you have a policy on it. And then finally, it's infeasible. You can't do it because a disaster. We're very familiar with what's going on in California. They have loosened those rules and restrictions on that because there's no information available. We can't get it to you, or you cannot segment the requested information from what's there. And then again, it's infeasible under the circumstances. Other ones, type and purpose for which you can't do it, the cost to comply, financial resources that you have available. It is non-discriminatory. And the provider owns or has control over the platform. So that the physician owns that or the other person owns a platform. And then in determining it, if it's because you wanna prohibit competition, that's not gonna fly. You have to turn it over. And maybe turning it over, I'm not gonna get paid. That's not gonna be allowed. You have to turn it over. For example, in some states, there are certain records when a patient has an administrative action going on that you have to turn them over for free. You can't charge for them and you can't deny access. Responding, if the provider does not fulfill a request, they have to give a written reason and you have 10 business days to do that, to turn it over. So before I go on, are there any questions on what we've covered so far? We're still okay on time. Yeah, there are a few questions if you'd like to go ahead and cover those. Perfect. So this first one asks if a patient specifically requests access to the psychotherapy notes, are they required to be unblocked and released to the patient at that point or does information blocking exception still hold true? Yes, that doesn't, not even under information blocking. Psychotherapy notes have still that special, I don't wanna say protection because the, again, the healthcare provider who does provide that psychotherapy care can make the determination, oh, there's no way I want that to get out to her or him, that could cause more harm than good by giving them access. So blocking doesn't even come into it. The provider can say, no, they don't get access to that. That's okay. Get psychotherapy notes are the one and only where that is allowed to be blocked. Perfect. Okay, and then this next question says we received consent from outside facilities for blood transfusions and the outside facility obtains telephone consent from the patient and then the consent is faxed to the facility where the blood is administered. Is that permissible? Yeah, yeah. And by the way, on those telephone consents, I've always recommended getting two people on the line, two staff members to hear it and tell the patient, I have nurse Betty, I have nurse John here. We are needing to get your consent for this. That's a good way to protect yourself when you've got that backup to hear it. Okay, another question just came in asking, what are the CMS rules regarding information blocking for proxies, specifically in a parent to child relationship? For example, the parent requests information of the child, but the child does not want it released to the parent. Yeah, and that's where you have to work with your counsel because there may be a certain state law. What records does the child want blocked? Is it drug and alcohol treatment? Is it mental health care? Is it reproductive care? Now those protected classes where a child can say, nope, sorry, mom and dad, you don't get it. And there are even age limits in there where like a child, a female who's maybe 15 under certain state laws, that's protected under reproductive health. And they can say, nope, they don't get access to it. It could be 16 in your state. So that's where, that's a state, that may be a state specific age requirement. If it's anything other than that, most courts are gonna say, sorry, kiddo, we gotta get mom and dad have access. Unless there is a court order to the opposite that says they have lost their parental rights and they don't get that information that the kid or whatever can say, no, I don't want, I don't want my abusive father or parent or whatever it is to have access to that. Then they can say no. Okay, and then I think the last question here says, can you have just the title of the person or do you have to ask the actual name of the person assisting the surgeon? That's a good, cause yeah, that happens a lot when you're in the teaching situation. It helps to have a name, but then you always put that little caveat in there. Resident so-and-so or an alternative who is equally qualified will be assisting in there. It's best to have the name if you can. I understand in some of those teaching situations that may not occur, that just simply, you may not be able to have the benefit of that name. If you can, yes. Or again, the qualified substitute will also be present. Perfect, I think that was the last question. Okay, excellent. So we're doing okay. So this is one, I know we talked Office of Civil Rights, but I wanna talk about the medical record. This is a little bit different and it talks about reproductive records. And then I'm gonna finish up with that security risk assessment. There was a proposed rulemaking that came out January 6th that talked about modifying the standards. What they're trying to do is improve the confidentiality of our PHI, electronic PHI, and also increase cybersecurity for it. Because boy, I'm telling you, there have been so many hackings and phishing expeditions, cyber attacks. Anything more, we just don't know how much more we could take. Well, what happened, again, this was January of this year. Normally, Health and Human Services doesn't like to make any modifications more than once every 12 months. However, and especially with phishing, they have made some modifications to the security risk assessment based upon these updates. But I wanna start with, first off, HIPAA and reproductive health. This went into effect last July, or last June, excuse me. And right now, we now are prohibited from using or disclosing protected health information by a covered entity, plan or clearinghouse in conducting criminal, civil, or administrative investigations or imposing liability on any person for the mere act of seeking, obtaining, providing, or facilitating reproductive health, where it's lawful under the circumstances where it's provided. Also, it prevents disclosure of information of any person who does that, for any person who's conducting an investigation or trying to impose liability. This applies where a covered entity, i.e. a hospital or a physician or a provider, has reasonably determined that one or more of the following conditions exist. And I'm gonna show you this. We had to be compliant as of December 23rd last year. You update your privacy practices as of 2026. So here are the required conditions. This is when you have care, it's being provided in your state, and it's lawful under the circumstances in your state. It is protected or maybe even required. It is provided by someone other than who, it is provided by a person other than the entity that receives the request given under the presumption that it was lawful. Unless you know, you as a provider know, that it was not lawful. In other words, you know that care that was provided to your current patient was given by an unlicensed individual. So here's examples of when you can disclose it. You're defending yourself in a proceeding involving that care, or a criminal action where liability, or civil where liability might be imposed, or the inspector general. They're coming around and they're doing an audit for oversight purposes. So you get a request, say it's from another state, and you have in your possession, protected health information related to reproductive health. In that case, you have to obtain a signed attestation that that use and disclosure of the information is not for a prohibited purpose. It applies when the request is for health oversight, judicial proceedings, law enforcement, disclosures even to coroners and medical examiners. That's an expansion of what you usually had to turn over. And now you have to get an attestation. Here's an example. This is CMS's example of the attestation. I have the link for you. I believe it was on a previous slide where you can pull down this slide. The person requesting it has to fill this out. They must do it. If you don't get it, you don't disclose that information. So again, you have, let's say the person came in and they wanted to your state and it's allowed by your state. I want information on birth control. Maybe the other state prohibits that discussion with it or even providing counseling in that respect. Now you get a request for records, say from the attorney general from that other state saying, I need this person's medical records. Okay, great. I need this attestation filled out before I'm gonna release them. That's what has to be done. And then on the risk assessment, we know that it's happening more and more and more. July of 24, 950,000, almost a million because they did the security risk assessment. 1.9 because they didn't protect the records. In other words, they did not do that security risk assessment. You will now have to implement policy and procedures to prevent, detect, contain and correct violations. You and your business associates must do this assessment. Individually, you have to do that. Make sure it's in compliance with all the safeguards. The analysis is just one of the four required implementation specifications under the security management process standards. This is what you must do. Policy and procedures, as I mentioned, to prevent and contain them. An analysis is one of them. You have to do an accurate and thorough assessment of any potential risk or vulnerabilities to that confidentiality and the record. A necessary tool in reaching substantial compliance with other specifications and the outcome of that analysis, that's really a huge factor in assessing what you're doing. Is it reasonable and appropriate? The scope of the analysis, you wanna look at potential risk to the confidentiality, and that's all forms. I don't care if it's a hard drive, a CD, whatever. And also, where are you storing it, the data? How are you receiving it? How are you maintaining it? How are you transmitting it? You have to identify and document any potential threats and vulnerabilities. Maybe it's unique to your situation. And if those vulnerabilities, if triggered or exploited, would create a risk of inappropriate access. And really, you wanna look at your current security measures. What is the likelihood a threat could occur? What have you reasonably anticipated? And really document what you find of your vulnerabilities. Determine the impact of that occurrence. Is it critical, potential risk of potential EHI? And the output, again, document those risks. Determine your level of risk. And finalize your documentation. There's no specific format, whether you do it in paragraph form, Excel form, just they need documentation. They won't tell you how to do it. Do a periodic review of that assessment. Are we still on track? And make sure that any analysis identifies when updates are needed. Frequency, they don't tell you in the security rule, just if you're getting new technology, maybe you're doing a new business opportunity, maybe there's a change in ownership or turnover in your key staff, like your IT people. And that's another time to do it. Now, OCR recognized, this was last year, about October. Now they did know there's not one single way to do this assessment to guarantee compliance. And the Office of Civil Rights and the Office of National Coordinator, they had a tool, but new caveat, that tool doesn't capture all the technical vulnerabilities. It is only one way to do a gap analysis. I have that tool in here for you. Then limitations, it's a gap analysis that will map what you currently have. But unfortunately, it doesn't have the electronic PHI asset inventory or technical details. So they knew there was a little gap in there. It just simply doesn't capture the entire spectrum that OCR wants to see for that one. So unfortunately, they hoped it would be great, and they recognized there were some gaps. And again, this was just October of last year. Okay, our final one. We have a hospital, 380 beds, teaching hospital. Physician applied for privileges, cardiovascular surgery, heavily involved in research with a synthetic prosthetic valve, low probability of thrombolytic response. It was in the process of getting FDA approval, but the FDA wanted more cases. While physician has privileges, provisional privileges, limited to cardiovascular surgery only, and that stents bypass, et cetera. The IRB, Investigational Review Board, they hadn't approved that research program. After three months, our doctor's complication rate increased for routine valve replacement. In fact, four out of the 10 patients had some type of sequelae, whether it was a stroke or micro-thrombi. One month later, this is, you know, after she's been there a couple months, a 36-year-old comes in and has a CVA codes during this mitral valve replacement. The policy required autopsies on unanticipated deaths because yes, unfortunately he did die. During the post, fragments happened to be of this unapproved synthetic valve was noted in the left carotid artery. No reference in the record of a consent for the unapproved valve or discussion with the patient or their family. What do you think the citations are gonna occur that CMS might impose? So I'll leave that to you, Lindsey, on how you want them to respond. And then we've got about four minutes left for any additional questions. Perfect. I do have those options there for you for this final discussion. Question up there on your screen, so you can go ahead and be putting in your responses there. And then if you have any additional comments for this discussion, you can, of course, type those into the chat as well. And if you have any final questions for Laura, I know we've had several throughout. We so appreciate you putting in your questions. If you have any more, go ahead and be typing those in while we give you a couple of seconds to put in your responses here. And this was a case from the West Coast. I don't like to identify the state, but it was from the West side of the US with the patient. And actually our physician did lose her privileges because of what they found and what the review, the internal investigation found as a result of this care. Yeah, I see a comment here that says that they could be cited under all of those areas. Yeah, yeah, you're absolutely correct. Definitely medical staff, the informed consent. Yes, absolutely. As far as what there were. It was a very sad case in that respect. A young man lost his life because of it. So thank you, Lindsay. Thank you, everyone. I have another 20 some pages of resources, so I'm not gonna go through those in the interest of time. If you go through them and have a question on one of them, I'll have you go through Lindsay. She's great about getting me the questions and then I'll follow up back with Lindsay. Perfect, and there is one final question that just came in Laura that asked, is the reproductive care attestation form required only when a surveyor requests a physical or electronic copy of records, or does it also include in the moment chart reviews? I guess I'm a little, the attestation, I'm not sure what you mean by a copy of the attestation that should have been in the record anyway, when the records were requested by that other entity wanting those records. I guess I need a little clarification on the question. It should be in the record that goes along with the release or the request for that information. Gotcha, and this question did come in anonymously, so if you need further clarification or if you have more information to share, you can certainly do so. And as Laura mentioned, you can, and this goes to everyone, if you have any additional questions, please don't hesitate to send those over to education at gha.org. And I'm happy to get those over to Laura and she goes above and beyond in her response and we're just so thankful. She doesn't have to do that, we're just so thankful that she does. And you are also fortunate to have her and I know that I'm so thankful as well. I did post just some final wrap-up information there for you all in the chat. Just note that you're gonna receive an email tomorrow morning, but it does come from education, noreply at zoom.us. So because it's coming from Zoom, it very well may get caught up in your spam, quarantine, your junk folders. If you don't see that in your inbox in the morning, I would first just encourage you to check those additional folders and then maybe mark that email address as a safe sender so that you continue to get those emails in the future. And included in that email will be a link to the recording of today's session. And you can just also use that same Zoom link that you used to join us for the live presentation to also access the recording as well. And just note that it will be available for 60 days from today's date. And then also included in the email tomorrow will be a link to the slides that Laura did present for us today, but you do have that link in the chat now as well. And again, if you have any questions, don't hesitate to reach us at education at gha.org. Thank you so much for joining us today. I hope you found value in the presentation and we look forward to having you back with us for the remainder of the series, part two next week. Thank you all so much. Thank you, Laura, as always. We look forward to having you back with us next week. Have a wonderful afternoon. Thank you. Thank you. Thanks everyone. Thank you, Lindsay. Bye-bye.

Laura Dixon

risk management

patient safety

CMS compliance

healthcare facilities

Medicare Medicaid

Federal Register

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acute hospitals

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