And now, I would like to introduce our speaker to get us started today. Ms. Laura Dixon most recently served as a Director of Risk Management and Patient Safety for the Colorado region of Kaiser Permanente. Prior to joining Kaiser, she served as a Director of Facility, Patient Safety, and Risk Management and Operations for COPEC from 2014 to 2020. In her role, Ms. Dixon provided patient safety and risk management consultation and training to facilities, practitioners, and staff in multiple states. Ms. Dixon has more than 20 years of clinical experience in acute care facilities, including critical care, coronary care, perioperative services, and pain management. Prior to joining COPEC, she served as a Director, 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. She is licensed to practice law in Colorado and in California. Thank you for being here with us today, Laura. We invite you to go ahead and kick us off this morning. Okay. Thank you very much, Lindsay, and welcome everyone. As Lindsay mentioned, our topic today is on something that's been around for a very long time. And, you know, we've done it for that long of time, and you think it's just rote. But now CMS has started to add a few more things in there because of situations that we have probably done for years and not realized, well, wait a minute, we can't take care of them if we don't do that. But then recognizing patients have a right to be informed of what's going to happen to them and know what the good and the bad, maybe I should do it, maybe I shouldn't do it. And that's why we need to bring informed consent back to the forefront. And I'm going to talk about a case very briefly, of course, but it had to do with why informed consent is very important. I always include my disclaimer in here in that the information today is just that. It's informational only. It is not meant to serve as legal advice or establish an attorney-client relationship. Please reach out to your legal counsel, in-house counsel, or representative, whoever that happens to be, for any specific issue as it relates to your situation. Well, just a brief introduction for those of you who may have not had an opportunity to listen through Georgia Hospital Association, the reason they put these on is so you don't get one of these. And that's the wonderful statement of deficiencies where you have to do a plan of correction when CMS comes out and does a survey. And no provider, whether you're a large hospital, small hospital, an acute care, whatever it happens to be, you don't want to get that notice you've been involuntarily terminated from the Medicare agreement. And that's because if there was a survey and they found deficiencies, how many were they? How bad were they? What was your plan of correction? Was there a plan of correction? And did it meet those needs? How does this all work? The regulation itself starts in the Federal Register. Then CMS has a couple responsibilities. One, they have to put out notice to their surveyors and everybody else that it's out there and it's in a transmittal. And they also have to develop the rationales, also known as the interpretive guidelines and the survey procedures for their personnel. Now, you get access to that, which is nice because then we have an understanding, okay, where is CMS coming from on this? And of course, they're to update the manual. For acute hospitals, your last update was in July of this year, April, excuse me, April of this year. Critical access, yours hasn't been updated since 2020. Now, I've reached out to CMS because there are changes that have occurred as a result of everything going on, and they just haven't done a new manual. But their email to me last week said, we anticipated being out in 2025. So hopefully, things I'm talking about today and things that have gone on over the past four, almost now five years, will be in that new manual for you. Three types of surveys, certification, right at the beginning, validation, they want to come back and see how things are going, and then a complaint, which of course, that's usually generated by an event that does happen. CMS comes out, they do quite a deep dive, and they may actually find some other issues, hopefully not. And keeping up with the changes, if you're in compliance, I would suggest you do subscribe to the Federal Register. You will get emails when new events, new rules have come out. Confirm the most recent manual, and if there is a new manual, again, check that transmittal page. I'm going to show you what these things look like as we go through the program. And then it's called the Survey and Certification website. This is where they put out notices of changes to the conditions of participation, what they expect from their hospitals. So for CMS, there is one called the State Operations Manual. The appendix lists out every hospital or every service provider they have responsibility over. So we're going to be talking about Appendix A, and then briefly Appendix W for critical access hospitals. For Appendix A, you will see on here, those transmittals that I mentioned, when you open up the manual online, you'll see that blue lettering. And that will take you right to the transmittals. Of course, W has one of their own also. But that's what it will look like when you click that blue page. Go to the top of the page, and it will tell you what is the most recent one, and that's an example of what it looks like. Again, tells you what's revised, what's new, what's been deleted. So it's a quick way to get there versus going through a 500-page almost for acute and 350 for a critical. Try and find out what did they change. So this is a much easier way to do it. The survey memo site, again, this will tell you what the policy and memos that they shoot out to their surveyors, and just an example of what one looks like. And I'm going to be touching on one today, and it does have to do with our topic on informed consent. I do want to cover just some of the deficiencies, some of the more often seen deficiencies with informed consent. By the way, you have access to those reports. When CMS has gone out and done a survey, they come back and upload their findings into this database sheet. Now, it's a very large database sheet, and it's for hospitals. It's every hospital, by the way. And so the link here is on slide number 18. Scroll to the bottom of the page where you see full-text statements, and take a deep breath because you will get two Excel formats. Go to the one that's most recent. I think it's 2017 to second quarter of 2024, but just an example of what you get when you open up just one of those. It'll have the hospital name, the address, the date of the survey. What did they find? The deficiency tag number. And usually it's a brief description of what the deficiency was. How many records did they look at? And again, a brief description. If you're going to filter and sort by tag number, have your manual, which is Appendix A for Qs, W for criticals, and the four-digit number. If you only put in three digits, you're going to get the wrong number. So here's just some of the informed consent deficiencies that were pretty constant within what I had seen. The form was not on a chart prior to surgery. The surgeon didn't get consent form signed, said, yes, I did it. But there was no signature, nothing with that form. They didn't use an interpreter when you have a non-English speaking patient. No consent forms for endoscopies. That's an invasive procedure. It does involve some of that tissue that could cause damage. Again, we know there are some risk and complications that go with it. Hospital didn't follow its own policy and procedures on consent. This was an often cited deficiency. They didn't make sure the patient's legal representative signed the consent form. That is in the section on patient rights. Consent forms didn't indicate the site or site for a procedure. Again, another one of those more frequently cited deficiencies. Hospital didn't make sure the physician had discussed the risk and benefits of that surgery. When you go in and they were talking, and they do this because they go in and talk to patients, did your surgeon explain what was going to happen? Did they tell you what the risk and benefits were? No, I don't recall ever having that discussion. They did surgery different than what's on the consent form. The form did not include all of the state law requirements. That's why you need to check with your in-house counsel to find out what does our state, if anything, require it be on that consent form. There was no date and time on the consent forms. The human research study consent forms didn't have all of the requirements of federal law that had to be in there. No list of procedures indicating which ones had to have a consent. By the way, it's up to the medical staff to make that determination. No documentation that the bilateral TL, tubal ligation, was permanent form of birth control. No witness on the consent forms. This is for a critical access hospital and their policy said, yes, you shall have a witness signature. And no QAPI in consent forms. It never was done. I want to talk about a couple cases regarding proper informed consent. But let's talk about the problem. Back in 2013, John Hopkins did a study and they found consent forms missing in 66 percent of surgeries. Well, the problem here is when you've got to do pre-op antibiotics, they had already been started. So who knows, maybe the patient said, I'm not doing this surgery, forget it. Then you've got this antibiotic that was delivered and you didn't need it. And by the way, you see that asterisk, I have those references in the appendix for you. That delayed 10 percent of the procedures. Those of you who work in surgery, you know, that's big. When you have a delay in your surgery, then everything gets off kilter. The cost of lost or misplaced consent are almost 600,000 per year because, again, delays. And that was a study done by John Hopkins again back in 2013. So here's one of the cases. This one happened in Denver. We have a 60-year-old female. She came in for spinal cord injections. Well, the physician was using Kenalog and it was an off-label use of corticosteroids. The manufacturer, though, that was great, but this was in 2013. In 2011, two years prior, Kenalog changed its label on the black box, on the insert, and said do not use for epidurals. That's what this was used for. She ended up getting a spinal cord infarction and she is paralyzed now from the waist down as a result of that use. In this situation, absolutely no consent of those risks given, such as vision loss, paralysis, stroke, and death. It resulted in a $14 million verdict against that physician, with that patient. And so, again, here we have a person who's permanently damaged because we weren't made aware of these risk and complications. Would it have changed her mind? Maybe. Maybe. But it also would have put that physician on alert that, oh, by the way, using this medication is off-label. Maybe I better look at it, make sure it's not a black box warning. Here's a second one. Patient gets a perforation of the carotid artery. They're doing a total resection of a recurrent tumor that shows up, craniofaryngioma. Well, the allegation was not properly or appropriately informed of the possibility of doing something that's much lower risk, such as a subtotal resection instead of a total resection. Here, this is where we have that disconnect between, did the physician say yes? Because he said, yes, I did talk about it. We talked about having a subtotal over a total. The patient said, no, no. If I had known the lower risk, that's the one I would have done. And the consent form only said alternatives have been discussed. That's all it said. The PA did do the final consent, did not specify subtotal versus total. And the Supreme Court here said that the intermediary wasn't supposed to be doing this informed consent. That's up to the physician. The surgery was performed in 08. Case was decided several years later after that. It was published in the New England Journal of Medicine. And this really helped also support where they mentioned the physician has that responsibility for informed consent. And that's why this case kind of highlights it that, hey, you are the physician. You are the ultimate person to do that discussion. And document it, please. Lindsay mentioned we have a few questions. And I'm going to start off pretty early. And I'll have her go ahead and put that up. Perfect. Okay, let's get this first one up here on your screen. So you should now see this one that says our policy and procedure requires only the physician or practitioner doing the procedure to obtain the patient consent. Your options here are yes, no, or prefer not to answer. And then for those of you who may have joined just a few minutes after we got started this morning, there will be several of these polling questions that we'll post up on the screen for you. The questions are always, the responses are always anonymous. And your questions are voluntary to answer, of course. Excuse me. And during the time of these polling questions, we're also going to pause to address any questions that you have for Laura up to this point in the presentation. So if you do have any questions at this time, please feel free to type those into the Q&A option found there at the bottom of your Zoom window. Or if for some reason you don't see that as an option, you can, of course, utilize the chat feature to type in your questions there as well. And we'll have multiple opportunities to address your questions throughout the presentation. And I know some of you who work in large hospitals, especially if you're in a teaching hospital or if you have a lot of advanced practice provider, you may get some pushback on this. I remember when I was having my total hip replaced, the PA came in and did the informed consent discussion. She did. But then the surgeon, wisely, came in and said, so-and-so talked to you. Do you have any questions for me or you want to go over anything? So he did know that he had that ultimate responsibility. But the PA did a lot of that discussion, I must admit. We didn't go into risk and benefits. Now, whether that's because I'm in medicine or had worked in health care and was familiar with what was going to happen, I don't know. But hopefully none of the physicians are making that assumption. Well, they're a nurse. They know. They know I don't have to have that discussion. They're a doctor or PA. I don't have to. Yes, you do. Regardless, you have that responsibility and you must do it. Okay. Perfect. Great. I like it. Looks like we had just one question come in, Laura, and you may be addressing this later on in the presentation. But the question asks, what QAPI is required for informed consent? Really, there is no absolute quote requirement. Just look at your informed consent. Look at those issues surrounding informed consent. For example, let's say pre-op, that all of a sudden it's coming to the attention that the informed consent form is not signed by the surgeon before the procedure. Or there's no witness on it. They're not following their own policy and procedure. So first off, look at what issues are coming up with your informed consent process. Does it need a revisit? Are you finding, again, more advanced practice providers are doing it and not the surgeon who is doing it? Are you starting to get complaints? That was never discussed with me on the risk and complications. I didn't know that. We have to go back and look at it. So that's what you want to do. Look at those processes. That's one of those processes that's very widespread. And with QAPI, that's what you want to look at. Look at those widespread processes that could result in harm to a patient. Otherwise, no specific requirement. Just, you know, their policy said we'll look at these every so often, and they didn't. So that was part of the reason that their QAPI hadn't been done. All right. So here's the information I mentioned about that patient who happened to have it. Here's where the surgeon did not do the consent. And that's why they are saying, you know, it's really up to the physician to make that one. And there's been a few others that have mentioned it and the role of the treating physician. I've listed that reference. This is from the New England Journal of Medicine. Even the National Institute of Health said, you know, really, physician, it's you. Because they have questions that you're really the expert in it. Yes, your advanced practice provider has worked with you forever. But you're the expert. And that's why they need to hear it from you. Even the AMA Ethics Statement say, yeah, this is up to the physician to make that decision and that discussion. Okay. Conditions of participation starting with the acute hospitals. Again, if you accept Medicare and Medicaid, you have to follow these rules. It's in Appendix A for you, Appendix W for criticals. Again, your state may have specific laws. And there's a separate consent for human research. Those of you who have done it know it is very extensive consent forms. I participated in one for a medication for hot flashes. Boy, that thing went on forever on how long it was. And I really learned a lot by reading through that consent form on what's involved with human research. So on Appendix A, there are three sections in consent. They do not always mimic each other. Informed decisions, that's in the patient rights section. Medical records. That includes what has to be in the minimum. And we're covering these. By the way, these tag numbers, we will cover them. And finally, surgical services. That makes sense. People go to surgery. Criticals, you have two sections. If you have a separate rehab or behavioral health distinct unit, you follow Appendix A, not Appendix W. So if you happen to have a patient in rehab who has to go to surgery, you must follow Appendix A. Same if you have a behavioral health patient who maybe harmed themselves and they have to go under reparative surgery, same thing. You follow Appendix A requirements. Again, they follow closely. They really, really do. With the exception of just one, which I'll cover. There is actually a website. They updated it to talk about informed consent. There's also frequently asked questions on it. And it covers the multiple and common issues that come up. What do you do if you have a 17-and-a-half-year-old and mom and dad are there? Who do you get consent from? Or the 17-year-old-and-a-half comes in and mom and dad aren't around. How do you get consent? Maybe can we take an electronic signature? Answer is yes. When and why and how you have to get consent. So there's a lot of good frequently asked questions that they bring up on informed consent. Well, let's start with the patient rights section. That's in Section A0131, where a patient or their representatives can decide whether or not they want consent. Of course, they have to have informed decisions in order to do that. And they can request, they can refuse treatment. And that means we give them enough information so they know what's going to happen or have a good idea, and they can decide an informed decision based upon that. Now, that does lead to the expectation the patient has that competency to make that request. Now, as far as requesting treatment, that doesn't mean that they can request or demand care that is not necessary and is not appropriate. Also, they can delegate that decision making to someone else, to the degree your state law does permit that. Most DPOAs, durable power of attorney for health care, they don't become effective until the patient is incompetent. But nonetheless, that competent patient can still say, I want this decision maker to make my decisions. Get it in writing so you have that backup. So if anything does come out of it, you've got that in writing. And of course, they're competent at the time they make that decision. So if that's going to happen, again, they can do it orally or in writing. But again, I stress writing. Your counsel will probably say the same thing. But still give them enough information so they know what's going on with them and they can make a decision. If there is a personal representative, give it to that information to the patient, the competent patient, and the representative. Now, however you call it in your hospital, are they going to be an advocate, support person, care partner, whoever it is, make sure they have that same information. And that means they also get consent from that designee, that representative, when it is required, such as a patient advocate. Briefly on your incompetent, incapacitated patient, they're two different. They're similar because they can't give consent. Incompetent are those usually with advanced dementia. Incapacitated, they can't talk. They just can't. If they cannot and you don't have an advanced directive, which nine times out of ten you probably will not have one, anyone who comes forward and says they're the representative, they can provide consent. In that situation, you cannot demand something in writing unless there is more than one person who steps forward and says they are the representative also. Now, you can demand, if you have reasonable cause to believe they're not truthful about making that claim, you know, they just show up, absolutely no relationship, no, I don't know who they are, but you can go ahead and do the surgery. Let's see what happens. You can demand writing. If you've, you know, your spidey senses are kicking in and saying something's not right here, you can demand something in writing. That's why your policy and procedures are so helpful because we know these things happen on a weekend, a holiday, two in the morning. That's why having those policies help your staff know what to do. If you don't think they don't look at them, they do. Working in risk management, I was so impressed with how many times the staff would come, says, I looked at our policy and I'm just not clear on something. They do look at them, that's why it's crucial to have them. How do we make sure the patient can exercise their rights? They delegate it. What if I have concerns about that delegation? How are they going to be involved in their care and treatment? When they want treatment and under what circumstances, can you deny it? Can you say, no, I'm not going to do that? State laws on patient rights have those handy or reference them in your policy and procedure. I mentioned the survey or what they do when they come around. Well, first off, they want to see your policy, naturally. Does it provide for when there's a representative? How do you identify that representative? Is there a way to assure patients have information on what's going on with them? Their status, their prognosis. How do you involve the patient in that care planning? Now, that can be something as simple as, I'll sit down and talk with the patient. Patient is to be informed of their care status on a mission, every day the physician is in and at discharge, etc. Something not too elaborate because then they understand it and can follow it. They're also going to look at medical records. They want to find out, are these consents in there? When were they signed off, i.e. date and time? Who signed off? Is there a witness? Did the physician sign off on it? They want to also interview your staff to find out about their knowledge on informed consent and patients. Tell me about your informed consent process that you had done. What were you told about your procedure? Were you told about any risk or what risk and benefits or complications were disclosed to you? Did you understand what was being told to you? That's where your health literacy will come into play. Along the same line of consent, like for surgeries, is advanced directives. We know patients have that right to formulate and have them followed and that they can delegate that to someone else. They can delegate to a support person who's maybe exercised their visitation rights. They're very sick and they just don't want to hassle us. Maybe they don't want to see a particular family member and they can turf that to someone else. That's fine. They can do that. The designation, though, if there is an advanced directive, that takes precedent over anything in writing. I'm sorry, let me rephrase that, anything verbal. If they have an advanced directive, that takes precedent over anybody who comes forward and says, I'm their representative, verbal. I mentioned low health literacy. Again, 90 million Americans, they have it. Fifty-two percent of patients didn't understand the consent form. And that's why we have to put it in plain language. There was some research a couple of years ago regarding plain language and the information we provide to patients. CDC, they even mention even people who read well and are comfortable with those numbers and everything, they can still have health literacy issues because that could be outside their real health. They don't know those medical terms. They're scared. They're confused. They could be very critically ill. And you're throwing information at them that, whoa, that's way above my knowledge level here. So that's why we need to put it in that common language. I have that information from the CDC in the appendix for you. So interpreters, again, we have a large mass of people who don't have English as their primary language. So we make sure we have a qualified interpreter. Document it when you are using it. This is required by federal law, CMS conditions of participation, and Office of Civil Rights. Again, Office of Civil Rights, Section 1557, even though it's not put into the conditions of participation, it is referenced, and that's why we have to follow it also. So you may want to include on your consent form if you did use an interpreter. You know, check it, put their initials, whatever you happen to do to have that available for you. So moving on to medical records section. This is where the bulk of what goes into a consent form, what has to be in there, is in. So, of course, properly executed form for any procedures or staff that the medical treatments and procedures, the medical staff has said, yep, you need to have this one. And again, any federal or state law that might chime in. And, of course, the record has to have that consent for those specified. Bylaws, your medical staff bylaws need to address that. Look at also what your state laws say. Say maybe there's a certain invasive procedure. Perhaps they require your state has a very healthy or robust behavioral health unit and consent forms, for example, whether it's involuntary committal, perhaps it's involuntary medication, ECTs, whatever it happens to be. Federal laws, that usually relates to human research. And those should, these procedures, they need to go on. The physicians, of course, have privileges to actually do. And you may need to add to that list if physicians want to start doing new procedures as the time goes along and the research is starting to advance and we're updating our procedures. And those who have a risk really need to have some kind of a consent form. Here's just a sample of some of those procedures you may want. You'll see here a simple aspiration. You don't, maybe they have decided, no, it's not, the risk aren't that big. But if you're going deep, like into a joint, you might want to be able to get a consent on that because they need to be aware of what those risks are. Otherwise, all surgeries, unless it's an emergency, this applies to inpatient and outpatient, the specified procedures. We know it is a process and we have to follow our policies on it. The form has to follow those policies. Include in there, this is a federal or state requirement, and there are six minimum, also known as mandatory elements, that must be in any consent form. So I've got them listed here on these next few slides. One, where is this happening? The name of the hospital, the procedure where it's going to take place, the name of the procedure or treatment, the patient's giving consent. Remember, one of them, one of those often cited deficiencies was it wasn't on there. It was left blank. Who is doing this procedure or the treatment, the name of that practitioner? Some statement that this procedure had these anticipated benefits, material risk, alternative therapies, and maybe the likelihood and severity that they could occur. These have been explained to the patient and their legal representative. Then, of course, the signature of the patient representative, date and time it was signed, and any other applicable state law requirements. Now, you notice one thing that's not on here is the signature of the physician is not on here. These are the minimum that should be on there. What they're looking for is, yes, we did explain it to the patient and their representative. That's the key, that this conversation did occur. You can have optional elements, CMS calls them those well-designed, and your practitioners need to know what those are. They need to be aware of what's in your policy for your hospital, and especially if it's in the bylaws, rules, and regulations. One of the optional elements is, who did this discussion? Who had that conversation with the patient representative? The date, time, and signature of the person who witnessed it. I know sometimes I get pushback from nurses on it, who said, I didn't give consent. No, you're witnessing the signature. That's what you're witnessing, that, yes, that patient signed it. What are the material risk of that procedure that you discussed? The listing of them. These can be brief. I've seen those in the past, where it's an infection, further surgery, extended stay, et cetera, et cetera, whatever it happens to be. Statement that maybe someone other than the operating surgeon is going to be working on the patient. Such as residents, they'll be doing important tasks on that surgery, according to what the policy of your hospital is. And in the case of the residents, there's usually a statement in there that says, residents may be participating in your care to the level of their skill set. And they will be under the supervision of that responsible practitioner. They're not in there operating on you alone. Also, other qualified professionals who are not physicians may do parts of the surgery or anesthesia. And again, only within their scope of practice, their skill, what the state law says they can do. And those have been granted privileges to do. Now, these are not your residents. These are like your RN versus CIS. Maybe it's a physician assistant or a nurse practitioner who's in there with that surgeon. They're doing important parts. The survey will make sure that you have, that the medical staff has that list of procedures and treatments, where the consent is needed or required. The forms have those elements, the mandatory elements. And they're going to look at least six records. Those of you who've gone through surveys know they tend to pull a lot more. And then they will compare your standards for your policy. Are they consistent? Does this form match up and follow what the policy says? And of course, any state laws that happen to be required. So the bulk of what needs to be in the consent form is in the medical records section. I want to talk about the surgery section. This is a third within the acute manual. Here, you have a properly executed consent form for that procedure in the chart before surgery, except in emergencies. Now, in the event of emergencies, and I wanted to mention this before, but I'll put it right here now. So a patient comes in through the ER. And, okay, it's get them in here, evaluate them right after surgery. You can document, the physician's documentation can help support that consent, because they understand, hey, this is what's going on with the patient. And there wasn't time to sit down and really have a long in heart that conversation when that patient is an extremist. That somebody, we have to get them in there and take care of it. So usually the ER note, the physician's note will help support that yes, this informed consent is necessary. It's always good to have that conversation, but an actual signed consent form, if you don't have that opportunity, get them into surgery, take care of them and just document that you talked to them about it. Benefits to the proposed intervention. Why do we want to do this surgery? What's the likelihood of each based upon what is the clinical evidence and that practitioner's judgment? They've done this. They know how well this is going to happen. These are in the surgery section. It must be in the record before surgery again, unless it's an emergency. And those are the ones that the medical staff has decided, yep, you need to have a consent form. But don't forget your ambulatory surgery center, because that could be a branch of your hospital. And you want to make sure that those are also in the bylaws. They need to have them and it's the same surgeons doing them. Now, usually these three sections will overlap. That yes, we have to do that. Yes, we have to talk about the risk benefits and alternative and who has to do it. But there's a couple additions here for surgery. So just bear with me when I start to get to them. Otherwise, you assure that the practitioner who's doing the surgery has obtained the consent and consistent with your policy and procedures. Anesthesia consent forms has raised some questions for 20 some odd years now. It went from a requirement with CMS or a separate consent form to a recommendation. The American Society of Anesthesiologists, they do also recommend a separate consent for anesthesia. It may be a legal recommendation that somewhere along the line, having anesthesia involves quite a bit of risk to a patient. So that's why we have to tell them what we're going to do, what are the risk and the complications and get their approval, get their okay on it. You could mandate consent for anesthesia, maybe other invasive procedures. Let's say they're doing blocks for the surgery. They can have some consequences. Like let's say they're doing maybe a block for a hip surgery. And you can kind of hit a nerve in there and cause some screen pain. You can also cause death of that nerve. So that's what they're talking about when you're doing, especially surgeries where you're doing a pre-anesthesia treatment or procedure to add to that surgery. Those happen to be the guidelines. ASA is wonderful. They do give us access to their guidelines and you don't have to be a member. So that's really nice. Your policies include who may obtain consent. Again, who can. What procedures do require it? You have to have that list. They want to see that list. When it's considered an emergency and you don't have to get the patient's consent. And when the representative can also give consent. Now, again, the patient has final say. And if the patient's competent and says, no, I don't want it, you're done. The representative cannot override that. Also, including your policies, what goes into that form and how do you complete it? How do you get that informed consent and that it's in the record? And make sure it's properly executed prior to surgery. Again, unless it's an emergency. Used to be that nurses had a checklist and they still do. Going into surgery. And one of the first things right at the top of the list was signed consent form. That's the first thing you always check to make sure. Yes, indeed, it was. And it took a while when I was first starting out risk management to convince that you have to keep that checklist because we have to be able to prove. Yes, indeed, we did our processes. That's what our policy said. And so it was really quite easy. They actually incorporated it in to their pre-op checklist. What they had to do. And it was a form that they now keep within the record. If you get consent from outside the hospital, the surgeon's got it in the office. How do you make sure it gets into the record prior to surgery? Are you going to allow it to be emailed in? Are you going to allow it to be faxed in? Who can bring it in? The physician? The patient? We know the patient will probably forget it, most likely. So how are you going to get that into the record? And again, any other state laws, they still have to abide by it in that consent form. They list in here, again, optional elements for a well-designed form. Again, anesthesia, what type of anesthesia are you using? Indications for that surgery. I'm having a right total hip because of advanced osteoarthritis and to reduce pain and increase mobility. Material risk and benefits and the likelihood of each. Again, these are optional ones. Material risk, they define in the guidelines at those high degree of likelihood, maybe low severity. Others, low likelihood, but it's bad. High degree of severity. And that's usually when you get to the permanent loss of function, coma, death. Treatment alternatives. And again, what are the material risk and benefits to each? Usually we'll see do nothing. That's about it. That's all you'll see. Okay. What are the benefits of doing that? If I decide not to go forward with this procedure? And again, those consequences, who will do the interventions? Who will administer anesthesia? These are optional. You don't have to have them. They're optional. And if anyone other than the operating practitioner will be doing important parts of the surgery. And here in surgery is where they spell out, great. What are those important surgical tasks? These include, it's not necessarily limited, but it's include these at a minimum. Opening, closing, dissecting and removing tissue, harvesting a graft, transplanting tissue, administering anesthesia, and then putting in devices or invasive lines. But those are what they consider important surgical tasks. You may have more based upon surgery and the invasiveness of the process. Residents. It's always helpful to have that discussion when you have residents within your facility. What are they going to do? We'll make sure it's based upon their availability and yes, their level of competence. Unless that resident is separately moonlighting, that needs to be stressed. That if they're moonlighting, they're not acting under your control. If it's decided at the time of surgery, who can participate? That's wonderful. That's great. Because then you can put in there who it is and what are they going to do? It may be nothing more than holding retractors. That could be the extent of their participation. Is that an important task? Not necessarily. Helpful, but not important. So they may not be opening or closing. Again, it's based upon what does that surgeon know that resident can do? And how sick is the patient? What is their condition? They may not want to have that person who has multiple traumas and a very invasive, maybe they've got a dissecting aortic aneurysm and really need to have that skill set in there to manage and get the best optimum outcome. If you have a qualified medical provider, make sure that they're also included in what parts of the surgery or anesthesia they're going to be taking. And that has to go with their scope of practice. CRNAs, yes, they can intubate. Anesthesia assistance, what is their scope of practice? Can they intubate or not? If you have a resident or somebody doing that, you still have to tell the patient, I've got residents, they're going to be in the room. They may assist by opening, closing, et cetera. And again, put it in writing, that is optional, but it helps to at least have that patient a good, thorough, informed consent. So here's the case I want to talk about. And some of you may have heard about this case. It started back a couple of years ago. In April of this year, CMS sent out a memo. I have it in the appendix for you. And it talked about increasing concerns where there was no informed consent when supervised personnel were doing training and education related exams that were outside what was medically necessary during that procedure. It talked about the articles and the annals of surgery, and it talked about a growing number of states that now have statutes that regulate this performance. We're talking those sensitive exams on anesthetized patients. Breast exam, prostate exams, vaginal exams, those type of sensitive exams. And it resulted because of a case of a nurse, no less, who happened to go in for surgery. And she told him flat out, this nurse was in Arizona. She checked into her own hospital. She was having stomach surgery back in 2017. Before the surgery, she told her physician, at no time is any medical student to be directly involved in her care. No medical student, not residents, medical students. Well, after the operation, she was in recovery, anesthesia wore off, and a resident comes in to do it. And a resident comes in to see her, how she's doing, said, oh, by the way, you've got your period. Well, this particular resident happened to note and do the pelvic exam during her surgery, even though she said no medical student. Now, the out here was, oh, it was a medical student. It wasn't a resident. No, no, no, no, I said nothing. You don't do anything, and you did it. She considered a resident to be part of the medical student staff. And so that's why she was saying, I don't want anybody touching me. You're doing stomach, not down below. This case ended up actually going to court. And it was a very highly publicized because it's like, where is that line between teaching, that's what we are, and giving the students that opportunity and patient rights? And the court sided with the nurse saying, you know what, you didn't have a right to do that. She said no, and it still did it. That accounts for almost criminal action. And so as a result, CMS really took action. I must have, I gotta hand it to them. They really, really got on this one. It is now only in the surgical section. This is the only place you will find it. It is only right now in appendix A. It may, I have a feeling, when the new manual comes out for critical access, this will be in there. And I'm feeling they'll just copy paste the language, to be honest with you. But right now, they have added, the red lettering is what's new to the previous section. So if you have medical events, practice providers, whoever it is, other applicable students who are doing important tasks or examinations and basic procedures for educational training, you must include that in your consent form. You must tell the patient, and the patient has a right to opt out of it. And they list here, breast, pelvic, prostate, rectals, and others that your state says you have to get consent in order to do that. So this is new. It is in effect. You might want to go back and check out your policy or even your consent form for, and especially if you have been in teaching hospitals. I do want to stress this is not just limited to acutes, because criticals you may have those who are in the residence and they're trying to learn, but we still have to get patient consent. That's just going across the line for not getting the patient consent. Surveyor, they want to make sure the medical staff knows what needs a consent form and that your policy and procedures address when it is an emergency. They'll again look at six records of surgicals and especially those about to go to surgery. I've seen this where they're standing in the pre-op area and they say, I want to see that chart. They're looking in there to see, is the informed consent in there? Is it signed by the patient? Is it dated? Preferably the surgeon. Then they're going to go talk to post-surgical patients. It's mainly how satisfied were you with that discussion you had about your surgery? Hopefully, they are talking to patients who are not immediately out of stop. Usually they don't. They don't go in to pack you. They'll look in there, but they're not supposed to really take care of patients because they understand. They'll go to talk to them on the floor if they're still around. That's why you'll probably see these on inpatient versus your outpatient procedures just with the timing and the anesthetic wearing off. Before I move on, Lindsay, are there any questions you want me to address? Yes, ma'am. It looks like there is one that's pending here that says, is a health literacy policy a regulatory requirement? Health literacy policy, it's more under the section 1557 that you have to have some way, some method in order to communicate effectively with patients. That's why they're saying, how are you going to account for health literacy if you can't communicate effectively with them if they don't understand? Usually, it's best to say, tell me what we talked about. You get a good basis at least, did that patient understand? It's easy. You just say, okay, now repeat back to me what's going to happen during the surgery and what you're concerned about or risk. That's why sometimes your advanced practice can help with the consent discussion, but the ultimate still lies with the physician. That's why I had to hand it to my surgeon. He did come and say, any questions? Do you understand what's going to happen? Can you recite to me what's going to happen? Or tell me what you expect from this surgery to occur? As far as any regulation, again, we have to make sure they understand it and they list in the interpretive guideline health literacy. When I said, yeah. Perfect. She said, thank you. That was very helpful. Another question I see here asks, is a separate consent required for each acute dialysis admission if the patient is on chronic dialysis? That's a good question. We see that a lot, especially when patients keep coming back in for all of these. That issue has gone back and forth for a long time. We also see it with cosmetic surgeries or those who come in for repeated infusion therapy. Do I have to have a consent form for each and every time? The last I heard it was split between which attorney they're talking to. I've had one attorney say, absolutely, cover yourself, make sure that they understand, you're undergoing this, make sure you get a new consent for every time. I've also seen it where it's one consent and it's dated and signed for every time the patient comes in. It's the same form. It's just date, time, patient signature. I've seen it that directional. We still have to tell them, hey, this is what's going to go and they still have to consent to that form of treatment, that episode of treatment. If you can use the one slide, your counsel is fine with the one form, patient signs it every time they come in. That's going to be beneficial as opposed to not having something because you know that's the time something's going to go south on you. I think that was the last question. Okay, great. Again, critical access, you follow pretty closely what ACUTE says. It's in a separate manual. Only two sections talk about it, clinical records and surgical services. During the entrance, the survey entrance, they will ask to talk to a surgery patient about what they knew on their surgery and the consent that was provided. During the document review, again, this is the entry part, they'll look at your records to make sure it's actually on the chart. With your clinical records, I guess we have a question here. Lindsay, I'll have you put that up. Perfect. Okay. All right, this one should now be on your screen. This question asks, our admitting staff obtain patient consent to treat is signed by the patient representative before services are provided. Yes, no, or not sure. I know we just covered some questions. If you have an additional question, type those in. We're happy to address those as well. I put this in because I had one critical access. I said, no, our admitting staff gets all the consent forms signed. They're like, well, that doesn't work. Nice try. That's where we had to start working with them to start delineating who has the responsibility on which consent. Now, this is simply a consent to treat when they walk in the door. Okay, so let's talk about consent. Now, we know we have to have evidence of those consent forms, and they're signed by the patient. They've given information on everything. For a basic consent to treat, you're walking in our door, you're consenting for us to give you treatment. That you're admitting people can sign, but when you have a specific treatment or procedure that the medical staff has said, you have to have a separate consent form. Those are the ones that the physician has to do. And these are also that your state federal law may say you have to have. So very similarly to what's in the acute, the name of the patient, legal guardian, guardian, the name of your hospital, what are you doing, who is doing it, and the signature of the patient. So that's what they must contain. Also date and time the consent's obtained, that we explained this procedure to the patient or guardian representative who witnessed the consent and the person who explained it to either the patient or their guardian. Now why they chose to say guardian over representative, I can't answer that. And maybe they'll change that when the new manual comes out, but that's how it is in the interpretive guidelines. Surveyor will verify again you have your list of procedures that you have to have that consent, that there's a form on each chart according to what your policy said, that these are properly completed, that's what they mean by executed, they're properly done, and they're signed, dated, and timed. One of the issues that they're trying to make sure does not occur is post-surgery consent forms being signed by the patient, because that's when red flags start to go up. Like, wait a minute, when did you do this? We've had to cancel procedures and surgeries because we accidentally pre-sedated the patient before the consent form was signed, and that's where you can lose some money and kind of irritate some people when you say, I'm sorry, you've gotten your sedation, we can't give informed consent from you in that situation. Surgical services includes, again, inpatients, outpatients, they have to know who actually does the surgery. Here they do specifically mention ghost surgery, and ghost surgery is, that's usually one where the surgeon says, okay, I'm going to be doing this and this and this on you. Patient sedated, surgeon leaves the room, someone comes in and does it. That's ghost surgery. We have to tell them, again, if someone other than the primary surgeon is going to do important parts. And this is even if they're under the primary surgeon's supervision. What tasks are they going to be carried out? They acquired elements are just like it is, the name of the patient is an acute name of the patient, hospital, procedure, practitioners doing the procedure, other parts. That's when the primary surgeon is not doing it. Those significant tasks are the same as they are in the acute manual, opening, closing, harvesting, dissecting, removing, implantation, altering tissue. That's what they consider important parts. Other elements, you have to have the signature of the patient, time and date you got that consent, the procedure was explained, the signature and the person of the witness, and then who is explaining. They pretty well copied, again, what was in the acute manual and what's in clinical records. They go as far as saying, what is the minimum explanation that needs to be given to a patient? Why are we doing this treatment? What are the risk and consequences? What are the risk and prognosis if we don't do anything? Probability, it will be successful. And then alternative methods and their associated risk and benefits. You may also want to take into account, now they don't have that same language on non-related exam during surgery yet. Right now, they don't, but perhaps they will include that for your manual. That's the one where the residents and medical students are doing those sensitive exams. But again, we have to give enough information so the patient understands what's going on. Authorization form signed by the patient who simply doesn't understand it, that's not informed consent. So, get a look at your languages, low health literacy, and use that interpreter with documentation that yes, indeed, you did use it. Some of you may have already gone now to putting English and their primary language on the other side. The question comes up, which side do they sign? Well, of course, their primary language, because that's how they understood it. So, that's the key one. If you can get them to sign the other side, okay. But the key is, what one did they understand? And that's in their primary language. Okay, let's move on to out of the conditions. Let's go on to some of our accrediting organization, joint commission. That tends to be the big one. There's a standard on informed consent, two sections again, patient rights, and here record of care. In the record of care, it has all the information that talks about their care, their treatment, their services, and that it must have, the record needs to have, that informed consent per your policy. Great. Previously, Joint Commission didn't have this language in their standards, but they added it at the request of CMS, especially if they wanted deemed status. So properly executed consent has to be there before surgery, unless an emergency. It documents the mutual understanding and agreement for care and treatment. This is a little bit more, how do I say, more interactive than how CMS puts it, but essentially that's what it is. We talked about it, we agreed, and this is where we're going to go. They talk about electronic signature, and for Joint Commission, yes, you can use electronic signature. CMS is okay also on it, as long as it can be authenticated. And then, again, if the patient can't consent, they can do a verbal consent, the surrogate decision maker can also give that consent. That we honor under rights now, we're in the rights section, we honor the patient's right to give her whole consent. That has a good long rationale to it, because by obtaining consent, it's really an opportunity to have that understanding between the patient and the provider. What's going on with me? Why do we have to do this, and what do you want to do? What's the benefit to me of having that procedure? It considers what are their needs and their preferences, while abiding with all of our laws, and it's education. It is really patient education, so they understand and can participate in those decisions about their care. They have to have a written policy on consent. This is into Joint Commission that describes all of these elements, a specific care that has to have consent, how you're going to do it, how they're documented into the record, when you can use a surrogate decision maker, parents for minors, or maybe it's a guardian when you have an incapacitated patient, or someone else, maybe another DPOA, like advanced directives. That includes a discussion about what is the proposed plan of care, and the potential benefits, risk, and side effects. For example, I've got a patient who needs to have a mastectomy. She has breast cancer. This conversation needs to include, these are the complications that could occur, infection, pain, swelling, lymphedema, scars. I've known some really good doctors who are very good at explaining, I can't control how your body heals. These scars may end up being larger than what we had hoped, but just be aware that there may be a scar that's beyond our control. Then, what's the opportunity the patient's going to get that goal? I like that one where they include, patient has an ACL, wants to go back to playing soccer. Great. Can they? What are the risks and complications? Potential problems that could occur during recuperation. This is something CMS doesn't touch on, during recuperation. When you have that older patient who maybe is a little bit more mobile, that we really need to get you moving and rehab so you can go back home. What problems could occur? Clots, pneumonia, sepsis, that could occur. Alternatives, along with those benefits and side effects. When you're going in for a mastectomy, and they do the surgery, then are we also looking at radiation, chemo? No treatment. The surgery is going to be the end of it. Perhaps there happens to be some treatment that occurs during the surgical procedure. I have a brother-in-law who he's had a few hip replacements. At one point, they had to go in and actually use radiation to break up the cement in one of those prosthesis because it was so hard packed in there that they couldn't get the old broken prosthesis out to replace it. That's one thing that you would want to include in there. Or if they're going in, and maybe it's an extended period of time for radiation, they're doing it under floral, and complications happen. It's always beneficial to let the patient know that could occur. We want you to be fully aware, fully informed, so that if you come out and maybe something's happened, we can explain it. It was all part of the treatment. Otherwise, consent for blood transfusions. Yep, we have to have that. Non-English speaking patients, how do we use that? Interpreter, document it. Consent form dated and time. Maybe someone other than the patient is going to sign if their hands are immobile or incapacitated, they're all wrapped up and can't use it. How are we going to get that signature to confirm, yes, indeed, the patient signed it or somebody signed on their behalf? And do not leave the name of the procedure blank. They actually had to list that out. There is a quick safety. Some of you may have seen these. It's kind of like their alert bulletin, their fact sheet. And we know that there's challenges to getting informed consent and helping them understand it. And we know communication is by far the most common root cause when there's been a serious adverse event. They talk in this quick safety about 49 reports of informed consent-related sentinel events. 36 of them are wrong-sided surgeries. Yes, they still occur for some reason. 20%, 26%, a quarter of them didn't have enough information, no risk benefits or alternatives. They weren't in there. Nothing on health literacy. And, in fact, this quick safety point did mention formal training for physicians on getting informed consent. I haven't had an opportunity to speak with some med students lately or residents. I would be very interested in what kind of training do you get on getting informed consent from your patients? What do they teach you? How much in-depth do they go? Do they do simulation with you? There are some schools that are starting to do simulation with med students, so they have a little bit better feel for it. Another area I want to talk about is what's called DNV. DNV stands for Norte Que Veritas. It is one of the accrediting organizations, and they really follow CMS almost to the letter. And they are available on their website. You don't have to be a member like you do a joint commission. You can download them. Same thing with CMS. It's in surgery, patient rights, and medical records. Now, I'm going to go through these not so much in depth because, again, they pretty much dovetail off of what CMS has said. We have to have a properly executed form in the record before surgery unless it's an emergency and signed by the patient. Your policies have to, again, stress how do you do it if it's from an outside source. Same mandatory elements, name of the patient, hospital, proposed procedure, and practitioner. The statement that the risk benefits alternatives have been discussed and they've been explained. Not just discussed, but explained. And material risk. What are those materials? This is part of the mandatory ones that you have to list out. Also, high degree of likelihood, low severity. Low degree of likelihood, high severity. They do spell that out a little bit more in depth. That you can delegate responsible practitioners to those necessary practitioners. Then the signature of the patient and date and time that it was signed by the patient. Your policy has to describe, must describe, who can get the consent, what procedures required, again, like the medical staff, what's considered an emergency. And that can be pretty broad, by the way. It can be very, very broad. When the representative can provide consent, what's in that consent form and the instructions to complete it, that's in your policy. How you document in the record and how you make sure it's properly executed and incorporated into the record. I like D&V. They did mention residents, just like CMS did. Those where residents are doing those important parts, what's their availability and level of competency. If you know at the time of surgery, great. Include it. That they'll be under the supervision of the operating practitioner. If the practitioner will not be physically present for some or all of those tasks the resident is performing, because we know that happens. They're at closing and the supervising physician says, okay, resident, you go ahead and close. They break scrub and go into the next room. So we have to make sure the patient's aware of that. And if state law, if you've got a qualified medical provider, not a physician, what are they going to be doing within their scope of practice? Under patient rights, same thing. You must obtain informed consent for each patient for procedures that the medical staff has said you must do this or state law says you must do. The staff has to specify which ones have to have it and they define it when it's an emergency and signed conformed sent is not required. Which brings me to my third question, Lindsay. I guess it would be helpful if I can unmute. Okay. I'm going to read this top part and then I'm actually going to post the question up here for you. So this is, AD is scheduled for a right total knee, a consent for a left total knee replacement was pulled and signed by the patient, signed after discussion with the surgeon. Neither the surgeon nor the patient noted the error and it was not until the patient had received pre-sedation that the incorrect side was noted. What would you recommend to the surgical staff here? And let's go ahead and get those options there up on your screen. The first one is pause the surgery and obtain the spouse's consent, proceed with surgery on the correct side and discuss with the patient after the fact to obtain a signature or cancel the surgery and reschedule when the correct form can be signed by the patient. And as you are putting in your responses here, Laura, there are a couple of questions that have come in. Okay. So this first one says in the case of provider groups, if one provider in that group signs the consent and on the day of surgery, another provider in that group performs the procedure, are they covered under the original consent or do they need to get a new consent for the performing provider? That's a really good question because yeah, that sometimes comes up and that's where you have to have that discussion ahead of time. And I've heard that discussion happen when you have those large groups like orthopedics. I've heard that discussion or even the cardiovascular surgeons where it's like, you know, I'm planning to do your surgery. That's what's going to happen. But understand that events come up and sometimes I physically can't be there. My partner, so-and-so may have to step in for me. I would put that as part of my discussion with the patient. And to the best of your knowledge, I would include that name in there. Do you know who that's going to be? By all accounts, it's probably this. If you can't do that, I would get another consent form signed just to be on the safe side. Just again, because then the patient can't say, oh, I didn't know Dr. Benz was going to do it and not Dr. Mercedes was going to do it. So that's always benefit to you. We know again, it's a process. That's why they have to be fully aware this could happen. Absolutely, and this follow-up comment here just says, the verbiage on the consent does state that the provider and or associates may perform the procedure. So maybe that would cover that. Yeah, maybe that would help. And I have seen that happen actually, yes. Because there are some of the associates, maybe your patients don't want to have to do that. We all know them. Okay, let's see. And this one says, if you don't have a consent in their primary language, can you write on the consent that a translator was used and patients sign the consent, but it was written in English? Yeah, most likely, as long as you've got some documentation. Yes, there was an interpreter here because you may have one of those really off non-common languages that come across and you can't account for that. It just, you're gonna have a whole stack of papers if that's the case. If it's helpful and you can have printed off, it's awesome. But yeah, in those events that you get one of those, you just simply don't have it handy, get the interpreter, have them go through it line by line, by line, by line, by line. And then put it, this is what I signed. If the interpreter can write it in their language that I explained this procedure in their language and put their signature there, the patient signs, and they get a witness to that, that you probably will be okay in that respect. But otherwise we are expected to have those in common languages. Now in Colorado, we have 17 of them that we're supposed to have handy. And I know we have our top five languages. Our consent forms are in our top five. They're printed in that top five. Otherwise, yeah, they have been using the interpreters and signing off that way. Okay. Go ahead and share the results. Okay. Okay, so good. We're kind of off and, oh, thank you. Nobody said proceed. Yeah, after the fact, I've seen that happen. I was like, and of course that's the one where complications occur. So in this situation, what they did was they paused it and they paused the spouse's consent. It was a piece of paper that did make the difference. And what happened was that they explained our process and the patient understood it was supposed to be on the right. He understood that. And it's like, well, I don't care about the piece of paper. What'd you do? And they did it on the right side. It was just the consent didn't match what was done. So that's what they did. They paused it, went out and talked to the wife and she said, oh yeah, sure, I'll sign it off. I was in the conversation and I heard it. So they were okay in that respect. You could cancel. If you're much more comfortable canceling, that's fine. That would be okay too. Okay, optional content. Again, we're still in DMV, same thing. Who did the discussion? The date, time and signature of witness. Now they said those are optional. I would make those mandatory because then someone else hasn't been involved so much in the discussion. The nurses, they're the ones who can sign that witness. An indication or a list of the material risks that you discussed it. Again, someone other than the practitioner will be into important task and that qualified practitioners who are not physicians will be doing anesthesia or parts of the procedure. The surveyor will verify again that your medical staff has listed out what treatments will require it, that the form complies with the policy. And again, six records. They wanna go back and look at all of those. In the medical record section, same thing. There's a properly executed form according to what procedures are listed and what the state or federal law requires. So now I'm gonna wrap up with just some of the standards from your professional organizations. I wanna reiterate CMS does not establish the standard of care that leaves it to you folks or to your organizations because that's where the expertise lies. I wanna start with the leapfrog group just as a little background here. 2020, they looked at consent forms. Very few had that more information that was critical so the patient could understand what was going on. And a lot of it was, it was just too much medical ease. They couldn't understand, they didn't understand what are you gonna be doing? And a lot of the other items, clinic clinicians level of experience with the procedure. Now that's not a mandatory requirement, but sometimes we need to have that discussion. Trainees involved, alternatives of, and risk and benefits of each expected difficulties. Recovery time, those were not mandatory except for people who are going to be doing important parts of that task. Six informed consent standards. Training programs on informed consent, they tailor to the different topics and what's the role of the staff. The process and the coding, again, how the clinician explain it, what are the difficulties, recovery time, how are we going to manage your pain? That's really come a little bit more forward since we've had so many issues with opioid addiction, et cetera, how are we gonna manage your pain? And the expectations, especially with managing that pain. Restrictions after a procedure. Okay, I've come in, I've had my colonoscopy, I've gotten some really good, maybe fentanyl versed or propofol, whatever happens to be, no, I am not driving home. This is your restriction. As far as the documents, what's included on their clinician, whether that clinician will be absent during part of it, assistants, trainees who will be involved, and that it's written at a sixth grade level or below. That's what the lead for our group is recommending. Also, how do you make sure you're having that discussion? And in the language they understand. So if your surgeons are doing this outside of your hospital, are we confident or comfortable that an interpreter was used when it's a non-English speaking patient? And they do encourage us to use that teach back method. There are also samples from your professional organizations. I mentioned the ASA, American College of Surgeons, you have to be a member in that spec. Hopefully some of your surgeons would be able to get you access to that or provide some samples to help you if you're looking to redesign your consent form. AORN, Association of Operating Room Nurses, they have some really good things, but unfortunately lately now they have required you to be a member of that. Hopefully your head of your surgery, your chief nursing officer is a member of that. So I mentioned that the ASA can love them because they do provide a lot of good stuff for you. And at no charge, you don't have to be a member. Nurses Association, they happen to have an example of what one looks like for that consent for anesthesia services, whether it's general spinal, maybe a nerve block. And then the AMA, they talk about what needs to be in that consent form. Same with the College of Surgeons. They really hone it down. Hey, this is what you need to be having that conversation. On a risk calculator, okay, how do I know which ones are gonna be important for this patient to know? There's actually a surgical risk calculator. American College of Surgeons, they have one. It helps a surgeon get good information before they schedule elective surgeries. What are the chances of a bad outcome like death? And the risk percentages, they are only estimates, but they're pretty close. They're a pretty good one. 22 pre-op factors, and the outcomes for almost 1,500 procedures. And what it does, it takes into account, first off, the patient. What do you have? And what's their history? What are their comorbidities? They've used it a lot with the heart surgeons. That's who started this risk calculator. And now they're looking at other surgical specialties to add to it, like colon, pancreas, maybe even the joints, because how many more now are we doing even outpatient surgery to determine, is it better to have this done inpatient? And then like gastric bypass, hernia repairs, prostate surgery. And I just wanted to put in here, this is the Journal of American College Surgeons, back in 23, but I looked, and it hasn't been updated recently. So that's an example of what that calculator looks like. It's a plug it in and click it to get your determination. So we're back up now to our final one. And I'll go ahead and read this, and then I'll load up the options for you. We have an 87-year-old admitted for an L4-5-S1 fusion. He is alert, oriented, very competent. Informed consent was signed. It references L3 through five, nothing else. No discussion with the patient, no reference in the record. Why did we change the location of the surgery? Before the incision, surgeon marks the site, asks for the plate to be available. Surgery goes along, no complications, does the plate. Post-op, however, the patient has excruciating pain. Now this is different than what he had pre-op. Now he's thinking, okay, I'm gonna get rid of a lot of my low back pain, my leg pain, my leg numbness, et cetera. But now he's got really bad pain, not what he would have expected from having the surgery. Well, post-op radiology and review of the record shows these aren't matching up. The discrepancy, that's when they find it, the discrepancy of the planned surgery and where the plate is actually inserted. So what issues do you think have been present at this care? Is it none? Hey, might've been warranted once we got the surgery started Not enough consent, nothing on a plate. Consent, okay, but the location should have been confirmed with the record and the consent. None, patient may have understood he's old man, maybe he just didn't understand it. Improper, incomplete, informed consent, anything else? So whichever ones you want, and maybe they can add also into the chat box if you want, Lindsay, anything else they might wanna suggest here for, what are the concerns here with this patient? And so while they are considering that, if it's okay with you, Lindsay, I think I'll scroll down just to a few of them so you can start seeing. I'd like to put the articles, the information from the CDC on health literacy. A couple of these consent forms, I don't promote any one of them. It's there for information only, this one happens to be from health and human services on sterilization. We also have, this is the memo on updating the consent and in reference to that surgical training module. They have talked about doing training on informed consent, especially for the physician, so they know what's expected, but also other providers like nurses, they could help with that informed consent discussion and why you wanna approve consent. That's the leapfrog resources and that's it. So again, I tried to put as many of the free resources in the appendix for you if you wanted to pull them up. So with that, I'll turn it back to you for any additional questions. Wonderful, thank you so much, Laura. I do see just one question here and if you do have, like Laura mentioned, any additional comments regarding this final discussion question, you can go ahead and type those into the chat. So one question asks, if you could discuss any best practices or pitfalls that you may have seen or experienced with electronic consents. Okay, older patients, they hate those tablets. I can tell you right now, it's interesting. They're looking like, what am I supposed to do with this? I don't understand this. What am I, how am I supposed to, that's the biggest complaint is who's supposed to do it. From a legal standpoint, as long as everything is explained in there, it's a language I understand and health literacy and the patient has the time to read through that and ask questions. And again, the surgeon does the same thing, has that discussion that doesn't omit the discussion the provider has to have with the patient. That still has to occur. That thing they're signing is just a piece of paper. It's a discussion. That's what they're more interested in. And that's usually why I see, this procedure has been explained to me by my surgeon. I've had an opportunity to ask questions and I wish to proceed. And then the patient could sign off on it, their finger, electronic signature. Either way, the patient has to say, yep, that's my signature. I agree to this and I'm moving on. We really haven't seen it unless there's a question of, nobody told me what they were going to do and I didn't understand the risk complications, et cetera. No one explained it to me. That's where the big thing comes. Otherwise, it's just a matter of keeping those things updated, just like any paper form. The nice thing with electronic is sometimes you can find those apps, I guess is the best way to put it, that will automatically convert it into the actual secondary language for the patient. So you have that benefit that, hey, it's right there and they can read it in their primary language and it's done. That's how they would sign off on it. So that's one benefit to it. I have not seen, I haven't watched or seen any litigation surrounding that electronic consent form. It's only when the patient say, no one explained it to me. Yeah, I signed it, but I was in a, they rushed me. That's mainly the big thing it's a complaint about. They rushed me, I didn't understand it, blah, blah, those type of complaints that I'm hearing. Actual litigation, I have not seen one. Perfect, okay, let's see, as a follow-up to e-consents, is it okay to obtain consent via a telehealth visit where the patient signs electronically? Usually they do because that's how they consent to the telehealth visit. By the way, I'm gonna put a notice out there. Unless Congress acts by December 31st, a lot of the telehealth services are no longer going to be reimbursed. They're gonna go away. They had put them into place with the pandemic. They extended them, but the deadline now is December 31st. So unless they act to extend it, it's gone. And that's payment for telehealth services. Right, okay. Christian, I see your comment here in the chat saying that you were having technical issues earlier and weren't sure if your question was addressed. And Laura, this I believe goes back to the, yeah, okay, in the case of provider groups, if one provider in that group signs a consent on the day of, it was addressed, Christian. And if you need additional clarification on that, we're happy to send that to you after the session. And Laura, you want to give just another quick review of that so we can make sure they can hear that. My 10-second spot? Sure, my 10-second spot. I feel like I'm being interviewed. Yes, if you have, and again, we see this like with the orthopedic groups, the cardiovascular groups, those types where the primary surgeon who was going to do the procedure simply can't be there. There's always a discussion with the patient. Hey, this is what's going on in my group. This is real life. And it may happen that I can't get to you, but my colleague, my partner, who is just as experienced as I am, is going to be able to step in and do your surgery. And that's why some of the consent forms, and I think somebody did mention it, myself or one of my colleagues, my partners, however they want to put it, that word, will be doing this. It helps if you have that name. I would actually, and just in retrospect, I would actually have that secondary physician also sign, if the primary physician signed that consent form, I'd have them sign it underneath on date and time when they did that. So at least the patient understood, oh yeah, so-and-so stepped in. They can also then have the option to say, no, I will wait until you are available to do my surgery. So yes, you can do that. Thank you for doing that. Okay, and then it looks like this may be the last question here is, how long is a signed consent form good for, Tom, from signed to actual surgery? CMS won't address that. Some of you may want 30 days, like with the HMP. After 30 days, you've got to get a new one. Some say six months, some say a year before it's no good. That's why you might want to check with your state law, see if there's any particular, CMS has not addressed that, neither has joint commission nor DNV. How long is that consent valid? So that's, you know, because that could change, the patient's situation could change, provider could change, anything. So that's why you might want to check with your state law and your policy, how long are you comfortable? I think a year is way too long. Six months, you're pushing it. 30 days, okay, I'm comfortable with 30 days, because patients get a flu and have to come back and do it again. Try it again. Okay, perfect. And Christian says thank you, by the way. You're welcome. I'm going to end that poll and show those results. All right. Improper incomplete consent form. No kidding. What happened here is the surgeon wasn't exactly on their game, to be politically correct, I guess is the best way to put it, and he didn't look at the X-ray. He didn't look at the X-ray for what it was supposed to be, and he forgot, oh, yeah, I want to put a plate in the patient, and he forgot to mention that during his discussion. So it was absolutely, as the majority of you have said, improper incomplete consent form, inadequate consent form. You're absolutely right. We omitted some very important points. In fact, it was so bad, they ended up, the patient's pain, they couldn't get out, they had to go back and take the plate out because it was so bad. And they ended up going back and doing the right surgery down below and stabilizing the spine where it was supposed to have been. He didn't do well in recovery, very long, long course of recovery because of the pain, the two surgeries, and he's not a healthy young man. So he had a very long one, extent. And they were, the hospital, there was a citation, a deficiency noted for the informed consent process because he wasn't following the policy and procedure. So, Lindsay, thank you for all your help during the program. If there's questions after, I think Lindsay mentioned, get them to her. She's great about getting them to me, and I'll follow up with Lindsay. Perfect. Thank you so much, Laura. I did just post just some final reminders there for you all in the chat that you should receive an email tomorrow morning, but just note that it does come from education, no reply at zoom.us. And so if you have joined our sessions in the past, you may be very familiar with this process, but those emails coming from Zoom may very well get called in your spam, quarantine, junk folder. So if you don't see that email in your inbox in the morning, I would encourage you to first check those additional folders. And if it's still not there and you'd like to just go back and access the recording, we do record these webinars as on demand, meaning that you can use that same Zoom link that you used to join us for the live presentation today to also go back and access the recording. And just remember that the recording is available for 60 days from today's date. We have a security measure in place so that when you click on that Zoom link, it will ask you to enter your information, and that will prompt an email to come to us for approval of that recording access request. We do approve those very quickly, but we ask that you give us one business day to grant those approvals. And then also included in that email will be a link to the slides that Laura presented for us today. I did go ahead and provide that link there for you in the chat now as well so you can have that as a resource. And then if you're joining us as a member of the Georgia Hospital Association, please pay special attention to the final link that will be included in that email tomorrow morning, and that is a link to the survey. And that is how you will obtain your continuing education credit information. If you're joining us as a member of a partner state hospital association, I do always encourage you to reach out to your contact within your association to obtain any information regarding CEs that your state is offering, as GHA is only able to offer continuing education credit to GHA members. Okay. I do have one question looks like here, Laura, that asks if you can clarify the comment about telehealth services not being paid after 12-31 unless Congress acts on it. Exactly. That was set to expire December 31st, reimbursed from Medicare and Medicaid for telehealth services. Now, your private payers may continue to do so, but that's what's going on right now unless they act to either make a permanent, which I'm really hoping they do, so they don't have to revisit this every couple years, payment for telehealth visits. Visits will no longer be paid under Medicare. So if you have physician offices that are affiliated with your hospital or that you know of them, you might want to let them be aware. Telehealth visits will no longer be reimbursed unless Congress acts, which is too bad because I use them and they're wonderful. I really appreciate using those. Absolutely. Thank you for keeping us informed and up to date with all of the latest information. We so appreciate you, Laura, to see lots of great comments here. Thank you so much. And as Laura did mention, if you do have additional questions, you can always reach out to us at education at gha.org. And I'm happy to get those questions over to Laura and then her responses back to you. You do see her contact information here on the screen as well. Thank you all so much for joining us today and for engaging with us. And I hope you found the information to be valuable. Thank you so much, Laura, as always for your time and information that you shared with us. And I hope you all have a wonderful afternoon. Thank you so much. Thank you.

informed consent

patient rights

medical treatments

risks and benefits

state regulations

federal regulations

CMS guidelines

Joint Commission

patient safety

legal compliance

telehealth consent

healthcare providers

liability issues