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Educational Webinar – USP 800: Road Map for Mitigating Risk

Transcript:

Good afternoon. Thank you for joining us today. My name is Brandon Martin here at mckesson Medical Surgical and I'm so excited to welcome you to today's presentation us P 800 roadmap for mitigating risk presented by med trainer. Before we get started, I'd like to direct your attention to our disclaimer while you're reviewing that information. I will remind you that today's presentation is being recorded and within a day or two, you can expect to receive a link to download a copy of the presentation. You can also download the slides by following the link under presentation materials to the left of your screen. If you have a question, feel free to enter into the Q and A panel at the bottom left corner of your webinar window at any time and we will do our best to answer at the end of the presentation. Our speaker today is Brian Williams Vice President of compliance with med trainer for nearly a decade. Brian has been keeping his finger on the ever evolving regulatory and accreditation standards and sharing that information with med trainer and customers. He has 20 plus years of executive level experience managing as many as 350 health care employees with direct responsibility for infection control, performance improvement and overall staff development. It's Brian's love for learning that fuels his passion for simplifying health care compliance. Brian can answer pretty much any health care compliance question, but if he's stumped, he will not stop until he gets an answer. Brian. Thank you so much for being here today. I'm excited to hand the floor over to you. Well, thank you very much. What a lovely introduction as well in this webinar today, which I'm very excited to present is what is required and how to prepare for USP 800. That's uh coming soon. If you're not prepared uh assessment of risk best practices, we give some examples and some tips for administration disposal and more should be an exciting uh time here. At least for me. I love this topic. Next. Let's start with a, a poll question and I want, I want to make sure that your answer is confidential. It will not be shared stored or distributed. All responses are aggregated and shown in summary form during this presentation. And if you could just take a moment to answer when your facility, when does your facility conduct an assessment of risk for hazardous drug? If you could pick the one that is most applicable, we'll give you a few moments to do that. That should be good. And uh if everyone's had a chance to answer, we can share the results here. I'm gonna write down, you can move on next slide and we can uh share those results with as soon as they're available. Starting our journey uh was gonna sound a lot like a car ride. So uh kind of put it in that context uh because it's a race to get ready. And um if we start with the next slide, um we want to um identify your destination, um you know, without a map uh without a real good plan. Uh We, we're more like tourists, uh maybe getting lost in some of the detail. Us P 800 is a very long and lengthy uh uh script of things that you're supposed to do and have to do. And without a plan, you won't have a starting point without a map, you'll have no final destination and you might find your self spending hundreds of dollars, thousands of dollars um in the name of operator safety. And without a driver, someone who really knows where you're going and how to get there, uh You won't know uh how uh any way to find your final destination and we're gonna get through this presentation and at the end, you'll see how to clearly create a plan. Our next slide um first to consider, uh you know, why US P 800 it was uh supposed to be uh uh an enforceable standard uh back in 2019 and uh went out for appeal due to other US p standards that needed to be. Um, uh, let's just say updated and, but let's look at the exposure risk. Why, why is it, why is US P eight hunt not only enforceable, but why is it, uh, risky for our, our staff and those around us? Um, it can happen just about anywhere from, uh, disposing receiving, cleaning, transporting, uh, storing, dispensing, administering during patient care if there's a spill or an accident, uh, if there's any waste. And, uh, certainly at the compounding facilities, healthcare workers from housekeepers to physicians, especially nurses, um, are, uh, at, at, at risk for exposures. Uh, and those exposures can occur, uh by in uh, inhalation of vapors. Uh, it can be aerosolized depending on the type of compound, uh, droplets, dust, um, residues are probably a very high point of contact that where it's, um, absorbed through the skin, uh, spills, sharps, injuries, surface contamination and all of these things should be considered, uh, a and as you'll see, there are uh, particular ways in which to do that go to the next line. The first thing you want to think about is how does hazardous drugs travel through your facility? Where do they arrive? Are they, do you have a loading dock, uh, receiving area, uh, maybe you're a smaller uh, facility, um, and you just have a front office but, or a designated entry, but start thinking about before they get to your facility um where are they coming in because you have to have a designated place. And then how do you, how do you segregate them? How do you prevent exposure? How do you eliminate residue? Um And make sure also that you're storing them in a manner consistent with the regulations and then it's time to dispense and administer. How are you preventing contact uh with, with the H DS? Uh How are you avoiding absorption insulation? And one thing to take in particular um uh to consider is a cumulative effect. And so exposures can be uh daily, weekly, monthly and ongoing and have a cumulative effect on the staff. And then uh one thing to not forget about is if it's disposed of and not consumed, you know, the difference between bulk versus trace. What are the EPA rules? What are the dot Rules? What are your state regulations? A whole lot of things to consider about your travel route that uh as you plan I would start here because um knowing these things are gonna be helpful in creating that navigation. It's fine. Uh some landmarks to look for along the way. Uh Key provisions of us P 800 is making sure you have a qualified person to provide oversight uh that person. Uh while there's not a specific recommendation, uh is somebody that can uh reference the the standards, understand their applicability and also provide assistance with interpreting standard operating procedures and facility engineering controls. Uh there also might be key in helping put together HD inventory, an assessment of risk if necessary training um personnel to make sure they're competent for their role. Because remember, their role may not be receiving, it may be administering, it may be clean up. It may be a number of things in having operating procedures to, to mitigate risk through facility engineering controls, safe work practices, environmental monitoring and if needed medical surveillance. And also keep in mind that enforcement agencies are starting to um look at us P 800 as a as an enforceable standard. Now, of course, some of these standards were enforceable already. So many of you might be already prepared, but you may not be prepared for questions from OSHA or the joint commission about your plan and about how you fulfill those key provisions. And so look for those things as enforceable standards. You can wind up with a um of an issue with your, your joint commission or related accreditation uh for, you know, getting cited for not having those things in control or not having a person that's competent to provide oversight next flight gps. Uh You know, there's certain areas of the country where um you know, God may have given me many gifts. The gift of, of uh sense of direction is not one of them. And so I count on GPS a lot, but when GPS isn't working for us, P um we need to look what other uh assets. What other recommendations can we follow? And uh the CDC and NIOSH put out managing um hazardous drug disclosures information for healthcare settings, which I think is an excellent publication because we've gone beyond just looking at the no list because there's new drugs and there's drugs that are patient specific. There are drug toxicity and formulations that we may need to understand. At least somebody uh before those uh H DS come into our facilities, really understanding routes of exposure in the work environment in which they're used. Um probability of exposure and the severity of that exposure. Um More depth on the administrate administrative and engineering controls. Certainly for a uh hazarding uh a uh pharmaceutical compounding facility. Those a engineering controls are quite vast expensive. But for the average um health care organization, uh they're, they're not as complex, but these are very important to have in place and understanding where and when and how um is not only about the engineering controls but understanding what the manufacturer um use uh uh information for use in the drug package insert. And if anyone's ever read those, uh they're quite long in tiny print. And it's important that uh you really get to the bottom of what they're telling you about um how to handle that drug and we'll talk a little bit more about that on another slide. But just as important, you know, once it gets used, uh if there's residues or if there is bulk waste. How is that handled? How is it segregated? Because the person who might be taken away, taking it from where you've left, it may not have the information and may not handle it as safely as somebody who's fully educated about it. So, consider downstream exposure and uh there's a link to this at the end of the uh webinar. Uh And I think it's very helpful, excellent as we navigate those hazards. Here we go. So things to consider uh for an assessment of risk is whether or not you have a compounding pharmacy on site. Um Do you uh work, do you compound active pharmaceutical ingredients? API S do you work with drugs where the final dosage requires further manipulation of breaking up or um you know, cutting pills in half et cetera, um generate solutions via reconstitution, breaching that container. Um working with drugs where manufacture instructions includes use of engineered controls and external uh ventilation. And we have an example, uh an older example of where the manufacturer provided two different ways to handle it and how we look at that and where you can find information to help mitigate the risk between what could be confusing information. And if you're deviating from the US P 800 containment strategies, you must conduct an assessment of risk. I think you'll find here that an assessment of risk is prudent regardless, but it's only required if you deviate from that standard, like Uh And when we talk about manipulation, um manipulation is not just done in the pharmacy. Uh sometimes uh uh H DS are ground up. So the the contents are ground up to assist with patients taking medications. Very common in long term care facilities. Uh splitting doses by breaking pills in half. Um many like assisted living facilities, for example, uh the pills will come in a card and they're taken off the card and given to the patient. And if they're in their final form and they're not manipulated, uh US P does not apply but safety does. Uh because as you're breaking those pills in half, you're creating uh potential exposure, increasing the risk and it deviates from Osha's rule on it being in its final form. So prevention of, of uh that if you are manipulated from the final form, which could be and you know, spend another moment on this, it could be uh due to uh a, you know, it's not a usual thing you do, but you wind up with a patient that needs it done that way. Make sure that you know how to protect yourself, the patient and others, you know, provide staff with directions on the US P 800 requirements, check that product insert and most importantly encourage using good judgment if you are splitting, you know, tabs. Are you doing it on a on a table? Are you doing it, you know, in the patient room, where are you doing it? And how are you cleaning up afterwards? And how are you also preventing that exposure to yourself? Um, thank you. Uh, why update? Uh, so if, um, if you've update, updated your assessments, which is a requirement every year, if that's what you do it do, um, ne O changes, there's been H DS added and removed from the list. Um, Botox, for example, was added, taken away and then taken away again. Uh There's contradictions between manufacturers and instructions for use. Um that uh might say you have to use a uh containment area and others where it's simply um using the right P pe. And so making sure you've assessed what's going on with those drugs and other hazards such as passive inhalation and service contamination, which all continue to uh kind of dwell on because it's a very common way that others get exposed to um H DS that have been prepared or uh administered by others. Uh fentaNYL is an example. BC G is a good example of the manufacturer's instructions uh being a little bit um uh vague in terms of exactly what you're supposed to do. Um a septic technique if you're um simply uh adding uh uh adding fluid to it uh to um mix it up. But if you're preparing it, it must be under, under a hood. And so because of that conflict prepare versus um we um uh sorry for the, the word I'm looking for. Um that conflict needs to be addressed. And how do you address that? You work with the pharmacist? And if you don't have a pharmacist, you work with the pharmacy that it came from. And if, if that doesn't work, you can also look at the FDA and there's other resources at the end. Uh that gives you some areas where you can go look at these and make some good judgments and you want to look at employee safety long term exposures if you had chronic illnesses. Um Is there, is there any opportunity for the clothing uh to get uh residues on it and uh wind up with contamination in the home? And these are all things that are very well documented that have happened and is a good reason why to check and do an assessment every year to see where things are at and see where you're at as an organization. It's fine. All roads lead back to an assessment of risk. This is my own rendition. Uh So this is uh you know, my interpretation and II I say my interpretation because in, in, in uh US P 800 the assessment of risk is only if you deviate from US P 800. But there has to be a mechanism of knowing whether or not you're deviating. And probably most important is to compile and review your drug inventory and drugs that may be used may not be in your inventory. So identifying those are H DS and their potential for exposure. Um Is it in its final form? Yes, then you can follow the OSHA rule. But I still still believe you need a creative written assessment and train staff. But if it needs further manipulation, does it need a uh C STD A uh a containment device? Um Again, written assessment, analyzing all points of contact alternative containment strategies. Um All of these lead back to this written assessment, which I think is pretty simple and straightforward. You can have a form for each and uh update those on manual basis and use those to train and educate staff, make them available to staff so that they understand what those risks are. And so because there is a potential conflict of, you know, an OSHA rule versus A US P 800 rule. Um It's your rules that will apply and by having a written assessment and direction, it will be easier to train staff and provide consistency next. Uh setting the guard rails, um standard operating procedures. Uh Now go into a little bit more about what's required. So the, the things that you must the must haves are facility engineering controls. Uh You have to have some type of occupational safety program or safety plan. You've got to designate um areas where H DS are um uh stored and where they are disposed of how they're received against storage, um how they're compounded if they are and using the and maintenance of proper engineering controls like C PAC E and uh C uh C STD S and a little bit more about that in just a moment, safe work practices such as hand hygiene and P pe labeling, packaging and transport disposal. Uh for my many years in health care management, you know, something that happened often that there's a spill or there's a, you know, something that happened, they call housekeeping, housekeeping comes over and they don't know, they don't know what it is and you know, training them to ask what a spill is prior to picking it up. And then having the right training is super important. It should be in your hazardous communication program. And if warranted, you should be doing medical surveillance. It's not a requirement, but it's certainly an advantage, especially in larger facilities where you have that type of resource. Uh You want them, you want staff to know how to deactivate, decontaminate, clean and disinfect how it's dispensed how it's handled and administered. And if there's any environmental monitoring and, and again, it spill control, it is extremely important. Like I want to apologize for the uh uh surgical attire here. Not, not intended to be the P pe that you must wear, but you do need to consider um its receipt. You know, what are you using when you receive them? Uh If uh you know, you have to train whoever is receiving it because it could be um a, a front desk person, uh, a jack of all trades person in your organization. And if they notice that a package is damaged or that it has, uh, a residue, you know, liquid stain or it's somehow been compromised to not open that box just without P pe and not without, uh, telling who brought it that it's damaged and making sure it's documented because it may need to be sent back and contained. Um, where is it being stored? You know, the front desk area, um, may not be the proper storage place and it certainly, if it's a designated storage, do you have a way of segregating? Uh, and then as you're doing that, are you using, uh, you know, gloves and, and whatever is needed depending on that, that compound, um, compounding sterile and non sterile. Again, there are very specific rules. Now, um, the administration deactivating, cleaning and disinfecting. We're gonna talk about how to build a spill kit here in just a moment and waste disposal, which really, um, is driven by the EPA, but it's administered by the States. So no matter what the EPA says, you also need to follow your state, uh, guidelines for hazardous, um, pharmaceutical disposal. Uh, let's see, um, provide a warning. So what's included in a spill kit? Um, sufficient supplies to absorb a spill of about, you know, 1000 mL. Um, maybe less. Uh, there are specific, um, supplies for things, you know, that, uh, like mercury in the past that we don't see much of in healthcare anymore. Appropriate p uh P pe to protect workers during clean up use of double gloves, um absorbent plastic uh back seats, built pads, disposable tiling, at least two sealable thick plastic hazardous waste disposal bags and a disposal scoop for collecting glass fragments and a puncture resistant container uh as well. Uh These um guidelines are available at A SHP and uh make sense. So if, if, um, if something is in a glass container, uh certainly when you're looking at how it's handled to begin with preventing breakage and making sure if it is broken, uh it may be a substantial size, you may need to have a uh hazardous uh drug company, hazardous waste disposal company come and clean that spill. You've got to, you know, make sure that the place is cordoned off or the spot is cordoned off that people can't track through it that there's some kind of warning. Um, and also having them available uh in a sufficient quantity based on the uh experience that you're having. Um, some places experience these more than others with the turnover of staff, uh having a spill kit handy is uh just a, a risk reduction activity that I think you'll find uh very important as you look closer at uh these types of risks. Um, next to the sl um, and then is the material waste, you know, is it horrible or scrap as uh the EPA would say, is it characteristic of a hazardous waste? Is it listed as a, as a hazardous waste from the EPA? Um Is it characterized listed or both? It must be handled as a hazardous waste and the labels required on the mixtures and the original project products that become waste? Really take some expertise to make sure how that was determined. This is especially important for those types of mixtures that are patient specific or new um and innovative drugs that maybe there's not um a sufficient amount of background on that. You have to look at the original um uh active ingredients. Um Next slide, avoiding hazards. And uh this next slide here is from my good friend and uh pharmacy uh compounder uh uh uh Seth uh de Pascual. He said the value of education, not learning of many facts, but the training of the mind to think by Albert Einstein, think for yourself or others will think without thinking of you. Uh Is there a coincidence here that this would be representative of what we need to do with hazardous drugs? I think so because teaching people to be a bit apprehensive if something does not feel right, look right or smell right for that matter. Um If some, if they see something, you know, if they're not thinking about what these standards are, they're not going to be able to protect themselves or others. And so, you know, getting um the training to get people to think through what hazardous drugs are and what you must do to protect each other, I think is very important in that. There's a dialogue and an open uh open communication for it. It's like uh closed system transfer devices. There is not one standard. Uh There are several selections available. Uh The design, a chamber of air cleansing system, types of membranes between the syringe and medication container. Certainly you'll, you'll need some consult from uh, a pharmacist. Um, and looking at what the manufacturers offer. Uh So there is not one that is, um, uh recommended or required by the standards. Um, there are some that have metal or needle free connection systems. There are, I think eight or so that are FDA approved. Uh But you know, one of the things with us P 800 regarding uh CC STD S is, um, it just allows the use of primary engineering control hood in a positive pressure environment. Medications must be compatible with the, um, CST materials they found with uh Benda Mustang that uh it does break down the plastics and so it can be compromised over time. Um It just allows preparation of some nonhazardous medications in primary injury control, but that are cleaned after preparation of HH DS. So this is probably a little deeper than, um, is intended for this, uh, this discussion, but certainly things to keep in mind, you know, do you need AC TSDAC STD and would it be helpful? And if it's helpful, making sure you understand its limitations, its uses and how to clean it and uh that it um it meets your needs, you know, as a uh defined, it's a drug transfer device and mechanically prohibits the transfer of environmental contaminants in the system or an escape that has this drug and vapor concentrations outside the system. Uh That's how NASH uh explains it. Like uh medical surveillance is recommended but not required. Uh Some uh some organizations have a baseline uh assessment of their staff, their health status and medical history. Uh It's an organized approach to identify staff that can be potentially exposed to H DS. Certainly pharmacists and, and uh nurses uh and anyone um administering H DS uh would fit this category. Uh There would be follow up for changes, uh health changes suggesting toxicity or acute exposure. Um The some of these have a long term risks uh for uh being uh fertile. And uh you know, if you have staff that um are pregnant that are wanting to get preg pregnant or wanting to get pregnant, uh both male and female of that potential exposure, you need to even think of a little a little more during that time and they need to know that they should be um followed up for any health changes, suggesting toxicity and acute exposure of any kind. And then uh some also conduct an exit examination um when a worker's employment ends again, not a requirement but a recommendation. Uh, certainly if you're, if you're finding that, uh, there is a, um, uh, a number of incidents or reports or exposures, rashes, uh, breathing difficulties, things that might be related to, uh H DS, uh, exposures, you're gonna want to take a closer look and you may even want to look a lot closer and be pre preventative as suggests. Uh, and a way to me uh assess that exposure history. Um you know, estimated number of H DS handled per hour per week or per month. You know, because some handle it very frequently, others, not so much the quantities and dosage forms, whether there's any biological monitoring that would be helpful, their medical record, um external medical surveillance reports, and probably most importantly, just collaboration with staff and peers, you know, letting, letting them know that, hey, we care about um how these drugs can help our, help our patients, but we also care that you're not exposed to them and have long term health effects. Uh Next slide uh we sample in validation um with us P 800. It's uh recommended every six months. Uh My friend Seth would say this is too limited, especially if you're compounding with powders. Um You may also look at other types of testing, but just for a moment, let's talk about white sampling. Um It can, it can indicate whether or not the surfaces in which you're um preparing H DS, um, are, are free from those uh residues. And so if you're not sure you, there's nothing that says you can't sample more often. It's a very inexpensive uh test, it's readily available, I guess, an ASM, um, and it's something that can help you kind of calibrate, uh what you're doing where you're doing it and how effective you are at maintaining the area without hazardous drug residues, um, and validate the personnel. Um If what you're doing is not meeting, to define goals, you can either change the process and procedures or change the threshold goals, which is a little misleading. And let me tell you why, if the, my, my experience is that the, um, the staff will find a way to get something done no matter what it is. And if they don't have the right tools, they don't have the right PP, they will work around it because their goal is to provide for the patient or finish their job. And when we look at processes and procedures are they actually meeting to define threshold of goals? I'll share one quick story. You know, I, in my early management days, I was told to go down to a, um, uh IC U step down unit and check the, uh, procedures for how we were getting things done in that unit. And I looked at it for a week, I checked all three shifts. I, I saw the interaction between patient care, staff, housekeepers support staff and, and the, um, CS people that would bring up the supplies. And, uh, when I came back, I said, you know, what, what was the person thinking that wrote these procedures? And I noticed that my boss suddenly started looking at the library. Well, it was my boss who wrote us. We did wind up, um, reworking those procedures and processes to make it a safer and more efficient environment. But it really took collaboration. We really had to change the goals for multiple departments. Uh you know, keeping clutter off counters and not having supplies left out in the open and understanding what oversupply looks like. And so when I talk about redefining thresholds and goals, make sure you know what your staff are doing, how they're doing it and what needs to be done to be to be safe. The fine, one of my favorite ones from Seth as well is mitigating risk. And what we have here is a failure to communicate. You can have uh the best sops and training, have your ha this communication standard all worked out, have a good surveillance program and even a continuous quality improvement activity. But if it's not built on a solid foundation where staff and everybody who touches and possibly can be exposed by hazardous drugs, understands how to mitigate risk in their role. This game means this game ends badly because anything moved here can knock down the whole system. And if you think about that? Who have you communicated to? How have you communicated, how often have you? And do they really understand, you know, do they have access to the um manufacturers, uh instructions for use or product inserts? Have they been trained on how to use the CTSD? Uh Do they understand what uh you know what and how residues can form by splitting pills or by working with compounds that are not in their final form. So we want this again to end well and uh be careful because even the best laid plans if not communicated properly will fall down decline. Uh The path to success requires an accurate map and competent drivers back to our, uh kind of racing, you know, racing for success. And just before we move to this next slide, just about racing for success in almost every organization I hear about turnover. And so you're training new staff constantly. It can be, you have turnover from 10, up to 50% in some, uh in some areas. And so it's super important to make sure that the map that you create is easily, um identifiable and uh able and, and, and uh clear enough to create competent drivers, whether they're uh, a front desk person, a nurse housekeeper, um, anyone along those ways so that they, they know where those dangers are. It's just like going into a turn. If you don't know you're going into a turn and it's a dark night, you might crash excitement. The goal here is to arrive safely and comply. You know, number one, do you need to comply with us? P 800. If so, designate a program manager. If you don't have somebody get them trained, uh there's plenty of resources to uh do that as well as if they have AAA background in pharmacy or clinical background. That person can be, become your champion depending on the size of your facility. Uh, and regardless of, of, uh, if you do have, if you must comply, um, I propose that you take a, a list of, make sure, you know what all of your, uh, hazardous drugs are and, um, do it a, a quick assessment of risk, maybe a little deeper for those that you're not sure of. And I think we'll find for some organizations and I don't know if we have the results of that poll left, but I certainly would like to show before we, um, move to the next slide, um, the assessment of risk and then updating those sops, uh, you know, depending on when you wrote them, how you wrote them. Things may have changed as we showed earlier, you know, from BBC G to, um, uh, other, um, uh, compounds. They come on and off the list and just because they come off, the N list does not mean they're not hazardous, they're hazardous properties that you need to consider. You need to train your staff according to those and so that you're ready for anything, however it moves through the facility, you know, from front to end, you have to know. Um Let me ask the marketer if they are able to show the results of our survey earlier. Hi um Brian apologies and apologies to our audience. Uh We had some technical difficulties and we're not able to launch the poll module. Uh But for those of you who did um go ahead and answer the questions in the Q and A uh appreciate that it looked like our most common um response was prior to receipt. OK. And most appropriate. And so, uh again, hopefully these suggestions are helpful. Uh There's a litany of uh resource links available uh at the end of this. And um uh let me show you just one last thing here on the next slide. Uh med trainers certainly can help uh for me, me, trainer learning, including topics on how to do an assessment of risk complying with us P 800 sterile, non sterile compounding, assign courses in bulk automatic reminders, set up time for uh set up real time reports. Uh know that staff are getting trained, you know, with our on boarding uh tool, you can add uh courses and policies and uh manufacturer's instructions for use and assign them according to their role. Certainly in our document management policy, you can store NIO NIO drug lists, job descriptions, uh create an upload policies, maintain version control and um electronically send for approval, get um employees take technology. But more important than the mechanics of that is if you're being surveyed and if you're being asked by your accreditation organization, and I've had this happen hundreds of times where uh they ask our staff something and I know that staff knows the answer but they're intimidated or they just, they, they're, they're stressed out and uh give them a place to look for it that they can easily access and make sure that they can access it and explain it that will avoid deficiencies and certainly any type of um penalty that you might be up up for. So let us know if we can be of help and we have uh references um and resources from uh doing assessment diverse tools, the blueprint for managing pharmaceuticals um and healthcare facilities waste, uh FDA uh Journal of oncology, nursing, very um uh up to date, schedule white testing, quality improvement product. They did um M manual that analytical methods. Uh A bunch of different things here that I think might be helpful for you on your journey to keep everybody safe and let me reintroduce you back to mckesson. Thank you very much today for joining us. Thank you so much, Brian. Uh We do have a couple of questions that have come in. Uh our first question uh regarding the environmental sampling slide. Uh This question is if that environmental sampling is recommended or required. I believe it is required every six months by USB. Excellent. Our next question, what is the best way to track the complete list of H DS and future changes? Excellent question. Um The, the uh uh book that book, the information at the CD CDC uh put out uh with in conjunction with NASH um really explains a methodology more than a list. So it used to be, if it's on the NIO list, you knew what it was, you knew where it was and it was fairly easy, right? There are three different types. We still have that list, but again, things are coming on it and off of it. And so you may need to use the manufacturer's instructions for use uh product insert. Uh You may need to go a little deeper into the um uh FDA and if it's a new or exploratory drug, uh and you, you uh may need to get on the phone with uh a, a pharmacist that can go a little deeper that has that type of experience. I know that's a very broad answer, but things have changed since the original uh time that uh US P uh was became an enforceable standard. And we can't rely on just one list anymore. Certainly, if it's on the list, you can rely on it. But if it's not, you still need to look at those properties. Excellent. Uh Is there a recommended assessment of risk? There are um there the uh A SHP has some risk tools and you uh basically go through that. Uh There, there's a link here and on the resources. Uh We also offer one in our, in our system. Uh But it's really just taking a closer look at each drug, uh their, their manufacturer's instructions, if there's any black label warnings, et cetera. And at the end of that risk, there is a rationale and that's why you need to have somebody who's knowledgeable about these things. So that, that rationale can be worked out for BC G at the time when we did that a few years ago, uh the aseptic technique was acceptable uh provided it was followed and that there was uh no leaking or spillage. Um So I, I think that's probably the best answer I can give you. Uh our next question is uh if you could share your thoughts on handling arsenic. Um Well, I would handle it as least as possible number one. but it may not be possible depending on what it's being used for. Uh But these, these are fairly universal um uh procedures, right? Um How are you using it? When are you using it? How does it enter your facility? Where is it stored? How is it administered uh or prepared and what happens if there are, you know, leftover quantities? And so that goes back to the assessment of risk. And so I would be um I would be misinforming you, if I said, hey, this is the absolute way unless I actually did an assessment of risk myself. Um US P also has, um, uh, I, I don't think I put it on here but they have a, um, of a, uh, app about hazardous materials that might be helpful to that regard. But again, you've got to look at it from every direction. How's it coming in? How's it going out, what the manufacturers say? And then certainly, if there's any waste, what is your state state say? Thank you so much as we near the end of the hour, I would like to thank you all for taking the time to join us today. Special thanks to Brian Williams with med trainer. Uh Be sure to look for uh links uh in the follow up email. There will be a copy of the presentation materials as well as a link to a recording of today's presentation for a full list of our upcoming events. You can visit us at M MS dot McKesson dot com slash educational dash webinars here. You can register for a future webinar, share with your colleagues or sign up to receive regular updates on our webinar schedule. Once again, Brian, thank you so much for joining us today. Uh uh We really appreciate you sharing your time and expertise uh with our audience and with that, I hope you all have a great day. Thank you.