Chapters Transcript Video Time Outs and Closed Loop Communication Anisa Tatini, M.D. and Ryan Masterson, D.O. present at the Johns Hopkins Department of PM&R’s Grand Rounds on June 15, 2021. All right, welcome everyone. Good afternoon. My name is Anti. I'm one of the PGY 3 p.m. and R residents. I'm joined by Ryan Masterson, who is one of the PGY 2 p.m. and R residents. And Doctor Hoyer advised us on this presentation. Uh This is a morbidity and mortality that concerns timeouts and closely communication. So in terms of financial disclosures, uh Ryan and I have no financial disclosures. Uh Doctor Hoyer has a consultancy relationship with State Farm uh related to the evaluation of quality and clinical practices and it's not relevant to the topic of this presentation. So, in terms of our objectives, we're gonna discuss outpatient, the outpatient procedure, adverse event that occurred. We're gonna investigate why the event occurred. And then we're gonna review the universal protocol for outpatient procedures and this is regarding timeouts. Uh We're also gonna discuss the importance of closing communication in the health care setting. And lastly, we're gonna outline a plan to reduce the risk of the adverse event happening again and we're gonna talk about how we're gonna monitor that our inter inter intervention is working. All right. So let's start with the patient case. So, patient is a 67 year old female with a prior medical history of obstructive lung disease, hyperlipemia, substance abuse and CRPS after a car accident who is being treated by Doctor Mayer for chronic pain and bilateral anova foot deformity uh with Botox every three months. The pain medication she's on uh is 60 mg of MS tat and B ID, under 100 mg of Gama and C ID and 10 mg of oxyCODONE every four hours as needed. So I realize that not everyone in our group is a physician or someone uh very familiar with Botox and a kind of their foot deformity. So we're gonna go, we're gonna break that down. So Aquino virus uh come, it can be broken down from its Latin roots. So Aquino comes from equine meaning horse like and if you ever look at the hubs of a horse, they're kind of the hob is in plant reflection, meaning that the heel is up as you can see from the picture that I have down here. And then various refers to inverted and abducted. So I included a picture of anova foot deformity as you can see this patient up here on the top, right? Has that. Uh generally, it's something you see for patients who've had brain injuries, you can also see it a lot with Children with CP. Um And the more common phrase for it is actually club foot. And then in the case of our patient, she has a dystonia. So dystonia basically means involuntary contraction of muscles, which can result in repetitive movements. As you can see if your foot is in this positioning, it's very hard to walk, it can get in the weight of your A BS. So that's one of the reasons that we try to treat this. Uh Botox is a way to treat it if it's due to increased tone and the tibialis posterior muscle as it is for our patient. Uh there are some surgical interventions if it's due to a mechanical reason and then to go into what Botox does. So uh to talk about the mechanism of action of both botulin and toxin. All seven stereotypes affect the neuromuscular junction where they produce denervation by blocking the presynaptic release, but not the production of ace colline. Primarily at the terminal portion of the motor nerve Botox usually lasts about 2 to 4 months for our patients. Sorry. And um the contraindications are, I'm not sure what happened here. Sorry about that. Yeah, contraindications to Botox are generally if someone has a known sensitivity to Botox and if uh they are in the they have currently have an infection. So um generally, we don't want to get Botox when someone is being treated for an infection because there is a thought that the patient can create antibodies to the Botox and it's not gonna work as well. And then the black box warning that we tell every patient when we get Botox is that there is risk of distant spread of the toxin. Uh And the biggest risk would be if the toxin were to spread to the uh muscles for respiration because that would obviously lead to respiratory depression and many other problems. But this is extremely rare. All right. And because I personally am a visual person, I included a picture from the Braham Physical Medicine Rehabilitation textbook. So, going back to your biology 101. If you're looking at the neuromuscular junction, you see that in the axon terminal, there are synaptic vesicles that are filled with acetycholine. You have your sy, you have your snap and your snare proteins, your snare proteins attached to your snap, you have the vesicle attaching to the presynaptic uh axon terminal membrane. It will rece release acetycholine when you have Botox involved, uh the Botox will cleave the snare protein. So therefore, your synaptic vesicle is not gonna attach to the membrane and therefore cannot release the Aceto Cole and therefore the muscle will not contract. All right. So going back to our patient, she presented for repeat uh 50 unit Botox injections to each tibialis, poster muscle. So, prior to the procedure, uh doctor and Mayor and I obtained consent from the patient. She was not new to this procedure. She's been getting it done since 2017. And we independently reviewed dosing of the Botox. Uh Doctor Mayer and I didn't really talk too much about too much about the Botox injections prior to that happening. However, during the procedure, I misheard Doctor Mayer telling me to give only half of the surge to Botox and I gave 100 units instead of 50 units to left tibialis posterior. So we immediately told the patient that this happened and we were able to obtain more Botox to give to the other leg. So to break it down even more simply who was involved in this, I was involved in this and then doctor Mayer was my attending. So what actions occurred? I administered the wrong dose of Botox after mishearing my attending. And what were the care teams? What was the care team members thinking or feeling? So I will say in this situation, we were not rushed to do this procedure. I will say uh I am someone who is deaf in my right ear and it has been hard for me to hear in the setting of masks and face shield. Currently, it was also a bit loud in the room at the time. So what was the patient thinking or feeling? The patient was calm throughout the entire procedure? She'd had this procedure done many times before and she didn't have any concerns. All right, and what was happening at the same time, there are other people waiting to be seen in the clinic, but we weren't rushed in this situation and I will say that something good that happened. This situation was we told the patient immediately about the error. It's important to tell the patient what happened and not just beat around the bush with this. And the patient herself was not upset about what happened. She had mentioned that she felt like Botox recently was not lasting as long for her. So she was kind of interested to see if a higher dose would last longer for her. And then what happened had a bad outcome. Obviously, the bad outcome here was that a patient was given too much Botox, uh which they might not need. So in the case of Botox, it, the way we put it to patients is that can make the muscles weaker. So obviously, this could lead to falls, this could lead to impaired mobility, it can lead to difficulty with their AD LS. So we did tell the patient before she left that, please reach out to us if she's having worsening ability to emulate, um we could fit her for an ankle for Ortho A fo All right. And in terms of patient outcome, I'm sure you guys are all wondering about this. I was too, I recently looked in her chart. She was actually admitted in the last week to an outside hospital uh for a, a rheumatologic work up for her lung disease. She was there for about three or four days. Uh She was not seen by PT or OT during her time there. I reviewed as many notes as I could and I came across a case manager note that said the patient was ambulatory prior to admission and that she was able to drive herself to the EP she is due for her follow up in about a month. So I'll have more information from there. So from this point, I'm gonna turn it over to Ryan to talk more. All right. So a little bit more about why this happened. Um Task factors involved, there's actually a universal protocol for procedures which was mentioned earlier and that was not followed in this case. Um And I'll get into that a little bit more specifically in a moment. Um Team factors involved, you know, the resident and attending to not properly communicate clearly during this procedure, there was a miscommunication about uh the number of units given and also there was not a review of the dilution of the Botox. Typically. Um residents like to do a 1 to 1 ratio and in this case, it was a 2 to 1 ratio. So just a change in the concentration that you're giving. So knowledge factors, as I mentioned, the resident was unfamiliar with this particular dilution of the Botox that was in the vial. Um And there were no patient caregiver or technology factors that were identified. So how can we reduce this risk in the future? Um Well, the first thing we're doing now is to educating the the residency attendees regarding this uh universal protocol for procedures through the Eminem uh presentation today. And then also emphasizing the importance of closed loop communication. So this universal protocol is in place um to describe a specific process has to be used by every participating organization prior to any surgery or invasive procedure. And this doesn't matter where this takes place, it could be in the or could be at the bedside, it could be in a uh procedural suite. And that's just to ensure that uh we are working on the correct patient and typically we identify them by name and date of birth that this is the correct plan procedure and then it's done on the correct anatomical side and site. So this policy applies to pretty much every organization within the Johns Hopkins um system. So for a time out, which should be done um prior to every surgical procedure. Um And, you know, like I said, the location doesn't matter if it was in the clinic or at the bedside, it should be performed immediately to the start of the procedure. And it must include the person performing the procedure and at least one other individual. And uh typically with residents of attending, the two of those are fine if you're by yourself with a nurse or a technician. And the time out should be uh completed, like I said before, each one. And then I already mentioned that it's the correct patient, the plan procedure in the site and the site. So one way that we can really ensure this takes place is a closed loop communication. Um And since the room was loud, there was a lot going on, that could have been a time just to verbalize that what you heard was correct, even if uh you assume that it was. Um So the closed loop, uh closed loop communication model actually originated from the military and radio transmissions that was based on verbal feedback to ensure that the proper team understood a message and it has three steps. The first one is the transmitter communicated a message to the intended receiver. Secondly, the receiver accepts the message with acknowledgement of receipt via verbal confirmation and seeks clarification if required. And the original transmitter then verifies that the message has been received and correctly interpreted and thus we have the closed loop. So how often do these type of communication related errors occur? Well, um my search, there's a number of different uh values that I found but um according to the Joint Commission of Accreditation of Health Care Organizations, which is commonly cited, um this is approximately 70% of medical errors are caused by problems with communication. Um miscommunication uh is to blame for up to 30% of malpractice lawsuits. And closed loop communication has been shown to reduce the risk of some preventable errors and medicine by making sure that we're all on the same page. Um And that uh we can kind of mitigate any risks or errors through communication. So there was actually a recent publication in 2019 and it was titled Debunking the Myth that the majority of errors are attributed to communication. And this reviewed 42 articles of different attributions to heirs. And it found uh it kind of broke it down between three types of main errors. Uh The most common being errors of commission at 47.6%. And this was when the wrong action was taken, for example, it could be uh prescribed in the wrong medication. Um Errors of the mission are 14.2% and this was due to failure to take a correct action and then errors through communication. Um And then the last one being kind of a a combination of everything that they found a significant contribution between the, the three above and that was at 28.5%. Um And this study actually reached out to the joint Commission for clarification on the 70% just because it is very commonly cited uh in different literature and it was um the author did get back to them and it was a little bit vague. They just said that communication errors were a contribution. So we're not really sure if it was a little bit of, of everything or what that was, it wasn't broken down more clearly. So communication errors, we know that they occur for a variety of reasons, uh ensuring a proper time out can help mitigate one of those risk factors and the closed loop communication um can catch these errors before they occur. So, moving forward, how um can we reduce this risk? Well, we found out that the PM R department performs approximately 3000 injections annually and of those injections, Botox uh was 1170 injections. So we know it is Botox injections are something that we commonly perform and we reached out to our fellow cores just to get a better sense of if it was frequent or infrequent, um that timeouts were performed and we found that they were not consistently performed prior to the Botox injections. And typically the procedure was discussed as in this case with the patient during the, the consent. And uh we plan to do a monthly survey um regarding the use of timeouts and procedures in all the clinics. And if we happen to identify uh certain sites that are, are not as hearing as closely to the, the time out policy, then we would contact that site and make sure that we're reviewing it with the attendant and the and the residents involved. So, in conclusion, our goal is to ensure compliance with the universal um policy for procedures and to help prevent errors, we want to encourage closed loop communication and we really, if an error does occur because no matter how hard we try, they're gonna happen at some point. Um is that we, we do inform the patient immediately and take any necessary steps to correct that mistake their references. And um I'm happy to take any questions. Hi, this is Julie. I just had a couple of questions or points. Um The policy has some procedure workflow related to documentation of that time out. Right. Yes. Ok. And just, you know, since you're using us for education, I guess, you know, to kind of also maybe explain where that happens in the EMR and just the value of maybe doing an audit versus a survey. Um when you're trying to follow up on compliance with these monthly checks that I do think sometimes providers have documented, they've done a time out in the EMR just when they've done the consent form. So I did not. So I, I thought about that as well, but uh I'm not sure if people are documenting, they're doing a time out when they don't do them. If I, I can actually, in this case, I think we more or less did a time out, maybe not as formally as we should have. But what is missing from the universal precautions? And I think this is a really critical point is there's nothing written in the universal precautions about dose and four injections, both Botox and the other places could be a huge issue also is with back off and pump refills. It's important that we confirm the dose and the concentration because that makes a huge difference. And that's where I think we fell apart is that, um, you know, I kind of instructed the medical assistant to drop the Botox, you know, 2 to 1. I don't think Anita heard that. Um, and we really didn't discuss before going into the room again, that how the medicine was mixed and how many CCS told she actually had the needle in place and then, you know, I told her half AC C and then she did the full CC. But, um, uh, you know, I think that's where it's, it's critical is that, that we also include in the universal precautions when we're injecting the medication to verify the medication and the dosing and uh concentration. But I, so, yeah, I was just, but, but I think to Julie's point and, and actually, I mean, I'm just looking at sort of who's participating on the call. We've got, you know, some providers here that do injections, um uh and procedures I, I'd be interested to hear from, from a, you know, how, how are folks do documenting that? Um Currently, what, what is their practice? And Eric, there's a check box on the procedure of notes that you do for that. So that's what we usually use. I don't know about others. But, um, but it, again, I think defining what exactly is a time out is important here. So it's not just that, oh, we confirmed that we're injecting the tibial post here on the left. I will say I was surprised when I was reviewing the universal protocol that there was actually nothing about dosing because, uh, that was something that I thought would be include, included. Um, I wanna add that at Bayview because we are a regulated clinic. The, um, medical assistants or nurses who are with us are actually required to do the time out with us in the room and they are the ones who document it. So it's a little bit more like an or setting. Um I think that's different than some of the unregulated spaces that we have. So I just wanted to throw that Anisa. Was there any contact with the um patient prior? You, you said there's a three month follow up but was there any sort of phone call a week after two days after to just check in with her to my knowledge? Now, do you know we had instructed her to contact us? But we didn't reach out to her? Yeah, just, you know, from a safety perspective and um you know, patient relations, maybe a little bit of a missed opportunity. I know none of us were there to kind of hear how the interaction went, but it's kind of nice from a service recovery to make sure that she heard. Right. And we're not just putting it all on the patient to contact us. And um I also have another question. Sorry, I'm a little riled up. Obviously the I don't understand the medication enough. But when you said there were, um, no factors, you know, other than it seems like, you know, human at this point, I was just wondering the whole procedure for this delusion. Is that something that could be changed with the pharmacy and how you're getting the meds so that there isn't this dilute Ryan's shaking his head? No. Ok. I didn't know it just, it enters another thing to have to try and dilute the medicine versus maybe ordering it in the correct. So we have, we have to dilute it right before the procedure and then we instruct uh either doing it ourselves or one of the ma s like what uh dilution we'd like. So they inject a certain amount of um uh sailing and some, some numbing in there to get the, the proper dilution um, per our request. But there's a whole variety of dilution. There's a whole delusion table. It's kind of your preference, how much you're doing, where you're doing it. So there's unfortunately not necessarily a standard that we can, uh do for that other than if we just want to make it standard for like, always doing a 1 to 1. But it's kind of uh provider specific. Typically, the residents all like to do a 1 to 1 just because it's a little bit easier. Ok. I just didn't know if there were other, uh, providers in the health system that use this. And is it something that pharmacy, you know, when you're looking at a system fix, is that something that there's routine dilutions that are used? And maybe those can be like assembled or something that would help eliminate it comes in a powder form and we dilute it in the clinic. So pharmacy is not involved in that at all. Um And in terms of the delusions, it depends on the procedure. So um certain procedures are supposed to be done with 2 to 1 delusion like for migraine, call it 2 to 10, so we usually use 2 to 1 for larger muscles as well. But um uh so there's a rationale for when we use 2 to 1 versus 1 to 1 or some other delusion, but um everybody needs to know what dilution we're using. Um And like I said, the same thing applies to back of them pumps. In fact, the outcomes much worse. If you do it in the back of pump, it can kill somebody with the back of them pump by giving them their own concentration. So, um I think we need to be much more careful about that. Do you um Eric and, and um sorry, Sam and, and Eric also mentioned, I because um when you do epidurals or other forms of injections, um there may be also the similar concern that you are bringing up um some on understanding concentrations or delusions and doses and how are the er so it would be nice to know if these forms can be standardized and to include those sediments or this is something beyond our, um, scope and, uh, maybe if they have any of the pain providers in the zoo, um, uh, or, or, uh, I don't know, I don't know who's in the list here. But, uh, but it, it will be no good to know, um, from those folks who are in pain. If they have anything that is in the time out, that is uh include those and concentration. I, I just, yeah, to your point, I, I think just the couple of people that I see, I think maybe Alexis and, and, and do uh Danny Sova may be uh sort of maybe more, a little bit more interventional than others. I don't know if you guys wanna a way in here. Uh Hello, this is Alex. Uh Sorry, I I logged on a bit late. Um So I mainly do Botox. So two things. One is um there is a, there is a dropbox in Epic where you have to record a time out. It asks for a time, a date and time when you, when you did the time out. So it's always there for you to document. I don't think it stops you from signing your note if you fail to click those boxes, but I always, you know, try to click those boxes every time you do a procedure. And uh the second thing is like Um So for Botox, um the dilution is done in the clinic and, you know, ideally, right, just right before you do the injection. Um So it's not something that you can ask the pharmacy to dilute ahead of time. Um And once you dilute it, uh correct me, Sam, there's a shelf life where you have to use it. I think you can store it for a little while in the refrigerator, but it has to be consumed once you've diluted it. So you can't really like dilute it ahead of time. Um So, so those are the main things about the and then the, the time out really, it's usually you mainly ask uh laterality of extremity or which extremity you're injecting. I don't think you ask the patient specific muscles, but, you know, try to ask, ok, we're injecting the left left arm today. It's a left arm. Um But I don't think you can go and ask the patient specific muscles that um that you want to inject and that may be an opportunity for us to um provide input with revisions of that policy. It might just be that in the past, um you know, they're looking at it from your scope of practice. And so that's something we can um definitely reach out to have additional clarification for that for dosing if there's not a different hospital policy that also talks about kind of read back or kind uh labeling of syringes or something like that. I didn't check into that. Hi, this is Daniel Sova. I would just add that. I do most of my work at Green Spring Station and they do a lot of steroid injections and at least at Greens Spring Station in the clinic. Uh, C MA S are not allowed to fill the syringes with steroid themselves. Um, the physician is, physician is expected to do that. Uh, so I guess that takes care of one closed loop or potential issue where there's a miscommunication um between the provider and nursing staff. So I just have to ensure that I'm filling up the correct amount of steroid and the correct steroid, which there is potential there as well as issues. But that is what happens at uh Greens Spring Station Danny just to add to that in terms of just your, your documentation. What, what is, what is your kind of practice right now? Uh Same thing, you know, you have that check box and also it's always, um in my, in my note, always making sure to document time that was performed. So I have a question of, of other providers. What what do people do when you don't have a resident with you? So I frequently have clinic alone. Um and I'm doing injections, um and I mark them doing a time out, but technically, I don't have the second person in the room frequently. Um You know, they, I may, I may have checked the dose and, and so forth ahead of time. But they're, they're not in room. I'm just curious what other people's practices are in that situation and whether we're in compliance then. So, uh, this is Alex again. So Sam, uh similar to you, I don't have an assistant when I do a Botox most of the time. So the only way I can really do a, I guess a time out is I talk to the patient. II, I don't know if that is officially counting as a time out again. We're injecting the left arm today and then the patient will say yes, OK. We uh but there's no second person in the room with me most of the time. Um Also uh in Green Spring Station, the MA S are allowed to mix and dilute the Botox. Um So if, if I have the time II, I try to sort of just verify what they're doing sometimes. Uh there was a time when they were training new MA S. So um it just had to take extra time to make sure that they were mixing the right um solutions that I wanted. Sorry, just to clarify. I was, I was not referring to the Botox, which I think they do do. I was, yeah, specifically regards the steroids, uh they do not mix. Uh That's, yeah, that's correct. And in, I think in Colombia and in Green Spring Station, the ma do not mix um steroids. That's an interesting policy because I would think the Botox is a more serious medication in terms of. So I'm not sure why that would be. That is a good question. It is interesting. Uh Maybe we can hear from some other attendings just about kind of their practice. I think that's Sam. I think you bring up a good point. Um Marle story, I see you guys. I know, I know you guys do Botox as well. I know I'm not in attending. But one thing that I find useful in particular with return patients is printing out the old Botox note because it shows the laterality, the dose and the concentration. Now that doesn't help if you have a first time person who you're trying to distribute to. But I do think bringing that in with the consent and having it on right next to you is very helpful so that you're confirming Audi auditory and visually seeing the number. This uh I'm sorry, piping in again, this is Julie, I have the policy pulled up and it says here um time out process immediately before starting and you know, time out must involve C for ambulatory outpatient settings and clinics for nerve block, time out the person performing the block and a nurse. So that's this time out must involve so that one of the statements and then it says preprocedure, the person performing the procedure and at least one other individual educated in the time out process. If no other person trained in the time out process is available. The second person may be the patient with capacity prior to sedation. So this falls into this nerve block, time out right where it has to be. It does not, uh Botox is not a nerve block. Thank you. Ok. So it looks like uh Alex, I guess, you know, the second person may be the patient. So you're in compliance for that, but just nerve block needs the nurse. Ju Julie when you say preprocedure, what, what exactly does that mean? Um And I can um I'm not smart enough to put a link. I don't know in the chat, I can send this. Um they, they go on to define terms and things like that as well. Um But it just, this just said for ambulatory outpatient settings like dermatology, ophthalmology, pain and it just said preprocedure. So I guess if you're doing this Botox, that's like before you do the procedure then, so if it's not a nerve block, then it sounds like it falls into this preprocedure or pre incision if you're in an operating room um for procedures performed outside the operating slash procedure room, nerve block and prep area, bedside procedures. So that doesn't sound like you're setting. So um it sounds like you're in this ambulatory outpatient setting clinic and that's all, they just have two categories for nerve block time out and then preprocedure probably because they weren't defining every single type of procedure that you might need a time out for. So the one question I did have when we were talking about using the patient as someone, uh, to be part of our time out, what makes someone knowledgeable about the time out was what I was wondering, do they need like the formal time out training or is it just talk the physician talking to the patient about what a time out is good enough to be considered educated in the subject? Right? I'm looking, I'm trying to scroll and read as fast as you're talking to. Um They didn't include that in a definition. Um You know, it doesn't say like time out or second observer there. Um The the policy is 10 pages. Sorry. So I'm trying to see if it's got it somewhere else. I mean, it talks about the responsibilities for the attending physician procedural provider, surgical team, the verification and I don't know that might be more than us getting in the meeting right now, but it's definitely worth um the team for follow up with this as you continue to educate, look and see if it's got more of the definitions in there for you. Doctor. May you had your hand up for a while? Were you trying to say something? Oh, I had left it up from before. Sorry. So the only limitation we have is in like in most of our cli my clinics, at least I don't have an assistant and there's no nurse or ma with me in the room. So it would be just between me and the patient or if the patient is not knowledgeable, usually they come with a caregiver who can also verify at least the laterality or which extremity. But, um, I, I usually don't have an assistant so there's no second nurse or, or ma in the room. Yeah. And we can definitely look into this. I, I guess my thought was, you know, obviously the patient needs to understand what procedure they're undergoing. You know, if it's a steroid injection, what's the purpose and that, you know, should be done in the consent as well. So I, I think if there's an understanding what the procedure is and to your point about the laterality, I think that's uh to me that sounds like a I, I think I, I think we should be good with that, but I, I can definitely, you know, we, I think we should, you know, just double check on that. Thank you Julia for sharing the policy. I hope the link works guys. It's in HPO um there's lots of information in it. Gosh, one of the pages talks about the documentation procedure then. So definitely worth it because they're trying to cover all the different scenarios, you know, or settings where timeouts are done. Great job guys. Sorry, I asked a lot of questions. They were all really good questions. So do you have any more slides. I don't wanna like, cut you off in case there's anything else to present. You know, this was a pretty, uh, a short case. Very good. Well, if you know what I mean, we had a great discussion. I think I really a you guys for putting yourselves out there and, um, and talking about a challenging case for yourselves. It, does anyone else have any more comments? Otherwise we can defer it a little early for your presentation? Thank you, everyone. Have a great day and, uh, we'll see you next week. Yeah. Thank you so much guys for that. It was great. Thank you. Nice work. Thank you. Great. Well, David with this discussion. Created by Related Presenters Anisa Tatini, M.D. Ryan Masterson, D.O.