Educational Webinar: USP Standards & Maintaining a State of Control

Good afternoon. Thank you for joining us today. My name is Brandon Martin here at McKesson Medical-Surgical and I am so excited to welcome you to today's presentation USP standards and maintaining a state of control. Before we get started, I'd like to direct your attention to our disclaimer while you're reviewing the 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 always download the slides in PDF format by following the link under the files panel 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, we will do our best to answer at the end of the presentation. But if we do not get to your question, we definitely will reach out to you in the coming days. Our speaker today is Derek Burns. Derek Burns is the Director of Clinical Services and a subject matter expert for the McKesson Advisory Services team within his current role. He provides clinical and operational insight and supports strategic initiatives for oncology and multi-specialty practices within the western region. Prior to joining McKesson, Derek served as the Director of Pharmacy and admixture Services for Rocky Mountain Cancer Centers, which is a large multisite outpatient oncology center in Colorado and part of the US Oncology Network. He has also worked as an Ivy room supervisor and trainer for two hospital institutions. He has a passion for sterile compounding and is dedicated to streamlining processes for maximized patient safety workflow efficiencies and practice standardization. Derek has expanded his familiarity of USP standards by completing on site education directly from USP received compounded sterile preparation certification from A SHP and is board certified and sterile compounding and pharmacotherapy. He earned his PHD from Butler University in 2006 and currently resides in Southwest Montana Derek. Thank you so much for being here today. I will turn it over to you, Brandon. Thank you so very much for that introduction and thanks to everybody for joining today. I know how busy schedules are in both pharmacies on the inpatient side and outpatient side. So thank you for your interest today. As Brandon mentioned, I'm from the great state of Montana. One thing we are not known for is great internet connection. So I did want to be on video here at the beginning during that introduction just to say hello and thank you but I am gonna come off video as I present these slides just to ensure I maintain a good internet connection. So with those housekeeping items, you can see here right underneath my video, you can download this slide deck that you can use internally. Each of the slides are meant to be a one pager around certain topics that I intended for them to be available to you that you can give presentations internally for your employees. Also, as mentioned, please submit your questions. If we have time today, we will go through some of those. And if I don't get to all of them, Brandon's gonna make sure that those questions make it to me and I'll be able to address those hopefully in a very timely fashion for each of you. So again, thank you all so very much, I'm gonna come off a video and we're gonna get started. So, today's topic, we are talking about maintaining a state of control within each of your pharmacies. Again, whether it's on the inpatient side, outpatient side, whether you're dealing with nonhazardous, compounded sterile products or with hazardous products. So many times I get asked what is required and in a big focus on the what now while that's important and every state is different and depending on who your regulator is, those requirements may be slightly different. My challenge to everyone is to start with why. So considering everything with USP standards with state and federal requirements, everything revolves around the patient and the employee. So as we start thinking about protecting the safety and upholding the safety of the patient and the employee, we're gonna first look at microbial and hazardous drug contamination through that we accomplish it by focusing on the physical plant. So the environment, whether that is the rooms or the areas where these preparations are created, the hardware that you're using and the ventilation. Next, we focus on the people, the processes and the workflows used within your environment. And all of that together encompasses how we maintain a state of control. So the goal here is reducing, not eliminating I feel very strongly that it's impossible to fully eliminate contamination. But the goal is to reduce both microbial and hazardous contamination. Now, to do this most, every single one of these fall into four separate buckets. We look at ventilation and air quality that includes dedicated air supply, HEPA filtration, your pressures within your spaces. So those clean rooms, whether it's a negative or a positive pressure, your air changes per hour having low air returns and whether or not your spaces have iso classification. Now that's gonna be separate if you have an area just for immediate use preparations, if you have a full clean room or if you have that middle of the road, segregated compounding area or containment segregated compounding area. Next, we have hardware. So that might be your room configuration, the hoods that you are using if they're laminar airflow versus uh some sort of biological safety cabinet, supplemental engineering controls which we call C STD S or closed system transfer devices and then also pass throughs. So moving product in and out of those classified spaces, so you don't have to walk through a door. Next, we have people and those are going to be the traffic, the workflows, the PPUP pe used by those employees as well as the hand hygiene. Our hands are the dirtiest things that enter into the clean rooms. And then lastly looking at processes, cleaning and decontamination, and not just looking at disinfection. So many entities that I work with uh the only product that they have in their clean room is going to be Isopropyl alcohol. Well, that's only used for disinfection, not for cleaning or decontamination. It includes standard operating procedures, making sure proper training and competencies take place with your employees, the certifications of both your hoods and your rooms and environmental monitoring. So you can see here on the slide three different areas that are circled and, and that's the hope of today's uh webinar. We're not going to do a general overview of USP now that it's past November 1st 2023 both USP 797 and Chapter 800 are enforceable by entities. So what we wanted to do today is go through a deeper dot into closed system transfer devices into PPE and the environmental monitoring to give you the tools necessary to either validate what you're doing in practice or to help you get started on that road to compliance. So we're gonna first off start with personal protective equipment. You'll see a bunch of numbers at the very top at the end of this presentation, I had a long list of references and resources that if any of you desire to dig in further, please feel free to do so. Now we'll start by saying if you haven't already, please make sure that you have downloaded and have accessible both chapter 797 and 800 from USP so that you know what those standards are. I would also urge you to look at your individual states requirements around compliance with these chapters just to ensure that you are following those requirements. So let's first start with activities. So what are the types of activities you should be worried about that require some level of PPE and keep in mind that those may be slightly different whether you're dealing with a hazardous drug versus a non hazardous drug. So start to finish when those drugs are received. If any of those products are hazardous, PPE is going to be required now for a CS P preparation or a compounded sterile preparation that level of PPE is going to be slightly different if you're gonna be making something that is immediate use. You're likely gonna be following aseptic technique practices and likely one pair of nonhazardous exam gloves, likely going to have a face mask and possibly additional PPE depends on the space and room where those activities are being completed, cleaning duties. Obviously needing PPE when you were in those IV rooms conducting cleaning duties. Uh just like normal, you would wear the exact same P pe in those environments. Now, if you are doing um cleaning within a hazardous preparation area or using uh certain decontaminating agents that might have a very strong scent, um You might be looking further at goggles uh in additional respiratory protection drug administration. Absolutely. Uh P pe required um when you are administering those products to a patient, again, whether it is hazardous or nonhazardous in the event of a hazardous drug spill, there are requirements uh for additional layers of P pe and how all of that waste is disposed of and each of those P pe items, uh how you would re or how you would waste those within those environments and then lastly conducting inventory to go in a little bit further with this. Uh if you are conducting an inventory of hazardous drugs, obviously using um chemo rated gloves in those environments. But then also if you are conducting an inventory of drugs that exist uh, or are being housed in those classified spaces. You would wanna have P pe, uh, dawned as well. So now looking at the supply list, what types of P pe, um, will you need to have on hand? So first we're gonna talk about gloves, uh, in the event that you need a hazardous drug, uh, protective glove, please make sure that the back of that box, uh, has a testing, uh, validation of a STM 6978. I will see the need. Majority of all chemo rated gloves will have this on the back. However, uh given the supply shortages during COVID, uh we've seen supplies coming from a multitude of new entities and some of those boxes may be around still and, and I would still urge you make sure that it says a STM 6978 on the back of those gloves, um exam gloves uh for your nurses, for your um technicians in those environments. If they are non hazardous drugs being prepared, you'll also wanna make sure that you follow requirements for sterile gloves uh that in those biological safety cabinets, in those laminar airflow hoods, what we call the ISO five environment. So in that primary engineering control, making sure that you have sterile gloves available. And I would say just as important, making sure your employees are well versed on how to appropriately don sterile gloves so that they maintain sterility. Uh once applied protective gowns, uh you're gonna have gowns that are for hazardous and for nonhazardous use, uh hazardous gowns are going to cost more money. Uh But you might find depending on your workflow and the products that you are preparing, uh you might stick with one gown rather than having both on hand do covers in those environments are very important. Uh That is preventing the transfer of contamination of particulates in and out of those spaces. Uh Coming in is what's important uh to prevent microbial contamination. Uh But then also coming out is important not to spread unwanted hazardous contamination out of those environments. Hair covers are very important. Hair covers could be a surgical cap. Uh That kind of ties in the back that keeps everything very tight and very close to the head. Um You also have the buffon like you see in the photo here. Uh those are a little bit easier to apply but sometimes are in the way you're also gonna wanna factor in uh facial covers. Uh So if any of your employees have a beard mustache, uh sort of thing, uh those need to be covered as well. Now, one area that I have had that's kind of a, a bit open to interpretation is the the hair cover uh of when it comes off versus when it has to be redone. Uh If you are coming out of a classified space, um All the P pe needs to be red dawned. Uh Once you leave that classified area. But if you are coming out uh of an actual buffer room into an anteroom, uh My belief is always uh that hair cover can stay on. Um If, if you ever take it on and off from those environments, uh it increases the risk of hair uh to be um removed from the scalp uh to, to maintain in those environments. So again, just be mindful of your movement in and out of these spaces. And when you are dawning and doffing uh just to uh maintain that environment from a mask perspective, we have pleated masks and N 90 fives in 95 masks are now a bit tricky. So all of the statements within us p uh where they talk about a respirator type device, you have to be fit tested, these come in different sizes and they are not universal that testing is required. However, during COVID, anybody and everybody was wearing it in 95 I think the cat is out of the bag there, it's hard to put that back in. Um But now that the supply chain has improved, uh I would urge you that if you are using a respirator, whether it's a full face, half face respirator such as a three M or using an N95 mask, that you go through the steps required for fit testing. And if anybody's writing this down, uh that is an OSHA requirement and that is CFR 1910.134. Again, CFR 1910.134 that sells out all of the requirements from OSHA on how to properly fit test respirators for your employees. So here are some reminders P pe is the last line of defense and that is for protecting the employee from HD exposure or protecting the patient from microbial contamination. Everything else before the P pe are your primary ways of reducing contamination. The hoods, the environment, the processes, the procedures P pe is the last line of defense. So just please do keep that in mind. One thing I will mention P pe is meant to be disposable. One new requirement within these US P chapters. And I think this has come from uh the post COVID environment is that if there are any types of P pe that are intended to be reused in your environments, you must have a standard operating procedure that spells that out what item is considered to be reusable and how you will maintain its decontamination and its lifespan for the employee. Now let's move on to closed system transfer devices, closed system transfer devices um are going to be spelled out and within section 5.4 within us P chapter 800 coy transfer devices are not mentioned in chapter 797. Uh and that is because their primary role is to be used to prevent hazardous drug contamination when you are preparing hazardous drugs have here on the screen. Usage variations and considerations um from a usage standpoint, uh these are used during the preparation of hazardous drugs during the transport. So when items are being moved throughout your facilities, whether it's from the uh compounding room out to the nurse's station to the patient's room in the hospital, or if it is from the pharmacy clean room uh to the infusion suite in an outpatient environment. During transport, you wanna make sure that these items are not leaking and that they are contained. So these devices fit on the ends of syringes on the ends of vials, on the ends of tubing and bags. And they help contain that uh contamination to that environment during transport and then also during administration. So one thing to note is that within chapter 800 the use of C STD S is required for administration but still remains a suggestion during preparation. Now that may seem odd, but let me let me dig into that a little bit further. Keep in mind that during administration, there is less protection for the nurse or the employee administering that infusion that injection. While on the preparation side, you have way more safeguards including uh a negative pressure room and also including that negative pressure hood. So that is why it remains a suggestion. Now, every hospital that I've worked in every outpatient environment that I've worked in and been overseeing both preparation and administration. We have used closed system transfer devices for both, both the preparation and the administration of hazardous drugs. And one thing additional to note is that within chapter 800 it does have the phrase when dosage form allows that leaves it open to interpretation, uh, for the practice for the employee, uh, based on the drug. So some of these medications are not compatible with A C STD other times depending on the route of administration. So for instance, if you have an intrathecal administration of a drug that may not be feasible to add on what looks like a javelin um to be connected to that device for administration in the intrathecal space, also subcutaneous and intramuscular uh as well as ambulatory infusion pumps. So you have to look at what you're preparing the devices that you're using and the workflows necessary to see if using A C STD is appropriate tons of variations. Some of them are through a barrier device. Some use filtration is some kind of like um a middle of the road. So not necessarily a lure lock connection, but it's considered a drip free where it uses a spring loaded plunger uh to prevent drips, you might have a droplet on the end. Uh but it is still better than a lure lock connection. There's lots of studies out there, lots of manufacturers that will say that their product is superior to others based on how it maintains a closed system. You should be reading those studies, you should be doing your own research and making sure that the product that you are using uh is the best for your environment. Now, some, some considerations here cost, these are not free, uh they're expensive and depending on the volume of products that you are preparing, uh this cost uh can really, really escalate. So, in some environments, depending on that and since that it is not a reimbursable uh product institutions may look at cutting back and not using them on the preparation side. Now, that's OK because that fits the, the requirements within the chapter. Um But again, do your due diligence, make sure you do your own research to see what creates the safest environment for you and your employees from a component standpoint, you're gonna look at the number of items necessary to do uh close system transfer devices for your setup. Some of these will come with a connection attached to a syringe that is bonded or welded to where it cannot be removed and you cannot add your own syringes. So that is gonna take up more space. Others will have universal vial toppers. Some will be for the small vials, medium vile, large vials. You just need to do your research to determine the number of components necessary that you'll have to have on hand. Here's one that I can't emphasize enough and that is training, making sure that everyone is trained frequently and on an ongoing basis, you have staffing turnover in all of these environments, both from a technician standpoint, as well as a nursing standpoint. And all of these individuals need to know how these items work. I'll give you one story from my hospital days. When we started taking back a lot from our urology clinics and preparing these in our uh biological safety cabinet, we would dispense them out and we found that there were some nurses that were not properly trained on what these devices were and how to properly hook them up to the patient. Uh So in those instances, we needed to have additional components um that would attach to the patient that we would either dispense with those preparations from pharmacy or make sure that they had their own stock on hand in their administration suites. So these are made by tons of companies. Uh I would say the ones that are most familiar uh BD offers, uh three different devices they offer for seal. Uh a newer product called Optima and Texi M which kind of fits that drip free uh definition. Another company IC U Medical makes a chemo lock and a chemo clave product line. We have Siel as well as on guard from B Bron and Halo is another product uh that you'll see a quite a bit out in the marketing side of things. So one thing I do want to mention is there are a lot of discussions that take place around extending beyond use date with the used of closed system transfer devices. So going even beyond the use of this in a hazardous drug situation and going beyond to nonhazardous drugs, that is completely out of the scope of this webinar. Uh That is something that you would need to do research on, on your own. Uh There are many papers out there that exist that will show uh that can inhibit or reduce the chances of introducing microbial contamination into those environments. However, one thing that I would caution everyone with is that is completely dependent on your environment. So during that time, that place where those preparations are made um could be completely different than any study uh that was set up in a controlled laboratory type environment. So it all is dependent on the hygiene. Uh the hand hygiene of the employee. Uh the P pe used the environment how it's free of contamination, uh swabbing with alcohol uh around every vial top, et cetera. So again, really what I want to focus on is consistency here that if you are using C STD S or thinking about using C STD S that you are using them across all hazardous drugs when you can uh consistently uh in both the uh preparation and administration side of things. If possible. Next, we're gonna move into viable air sampling. So viable, meaning a particulate that has growth, air sampling. We are testing the air. One thing I will note is within 797 and, and we're talking section six. So viable air sampling is within 797. Specifically section six, there are differences in requirements based on the category or the bud that you are assigning to your products. So with the new 797 you have immediate use, you have category one, category two and category three, we're gonna say for today's um webinar category three is out of scope. I highly doubt many on the call are looking at category three. That's when you're having to do your own testing, uh own validation and giving that beyond use date. That is past a category two, most of the time that is gonna be from um manufacturing facilities and pharmacies that are doing that on a large large scale. So we're going to focus on immediate use. Category one, category two from a sampling perspective. So viable air sampling. What is the purpose? The purpose is to check for unacceptable levels and confirming the effectiveness of how you are cleaning and all the personnel practices, whether or not they are being followed within your environment. So microbial air sampling must include a volumetric, airborne particulate sampling. I highly doubt anybody on this call ha has a machine that is capable of doing this. Some hospitals do. Uh but these machines are roughly 3 to $8000. Uh They're not the easiest to use. Uh And I would say most institutions are electing to have their certifiers that come in and certify their rooms and certify their hoods to do this on their behalf. That's what I've done in the past. Um And this is a requirement of viable air sampling within each of these spaces. So this is gonna take place within your classified spaces. So if you have a room or a hood that has an iso classification, we're gonna say that is a classified space. So if you have an ante room, if you have a hazardous drug room, if you have a non hazardous drug room and the environment within each of those hoods, those are classified spaces. So you have your certifier come in. They are testing for particulates in general, but then they send that those samples off for viable sampling. This has to be done every six months and the selection of the area that is tested truly matters. You want to provide an accurate representation of compounding conditions. So I would urge that any time a certifier comes in, you have them test during dynamic conditions. So when you are working, uh maybe you're not in there performing a preparation of a CS P but maybe you're in the room doing an inventory, maybe you're in the room stocking your supplies. Uh I think that is safe. I think having that movement in and out, it is more indicative of the day to day. However, I usually see certifiers scheduled and coming in at the end of the day or at the beginning of the day when no one else is in the IV room again, I I know everybody's workflow is a bit different. Scheduling is very tough. Sometimes the space within these rooms are very tight. But if you can create a dynamic condition, that is the best scenario, air sampling commonly completed like I have at the bottom by an outside certifier doesn't mean that has to be the case. Uh Some institutions will choose to do it themselves. But I think just from a feasibility and an efficiency standpoint, this is something you can give to your certifier. Now, if you are gonna ask a question, you have to be prepared to respond to the answer. So if you have this tested and you have a sample that comes back and it is outside or exceeds allowable levels, you have to have a response. You can't just let that sit in documentation and do nothing about it. So it is very, very important that you create an action plan. And when these samples come back, these reports come back from a certifier, you know exactly how to respond. Your employees, know how to respond and you do it consistently and you do it timely. So here are your isoc classification levels. You have 57 and 85 is gonna be within your primary engineering control or your hood seven is going to be for your buffer room. So the room where the hood is located as well as could be for your ante room. If it is adjacent to a hazardous stroke room, if it's only adjacent to a nonhazardous buffer room, then that ISOC classification would be eight and that may seem odd for some on the call. Um but an iso eight room is dirtier. And if it is adjacent to a negative pressure hazardous room, you have a higher propensity of those particulates flowing into that space, uh potentially jeopardizing uh microbial contamination containment. So you have here the action levels that if exceeded, you have to do something about it, that's greater than one CFU or colony forming unit in an IO five environment, greater than 10 for seven and greater than 100 for eight. So you need to know how your certifier reports are received. Who receives them? Where are they documenting this information? And is it easily, um, determined if you've exceeded a level? Usually these certifiers will never call. Um Usually you have to hunt through multiple pages just to find this information. So be familiar with those reports, nowhere to look for this information. So in the event, if you have ac fu that exceeds allowable levels and just know that you will, you will eventually have one that exceeds. Hopefully, it's not the hood. Hopefully it's within uh your ante room or so forth. But you have options, you have options on how to respond. So here are some of those responses, investigate, ask the question as to why do you potentially have an excursion? Maybe you include retraining, maybe you do a rele and re disinfection, but I would say go further and look at your cleaning processes, make sure that those individuals that are responsible for, that are doing it appropriately and doing it when they should be doing it. You might find you need to suspend operations to do some of this. You might have the ability to lower your beyond you state temporarily. So if you are doing a category two beyond you state, maybe you back down to a category one beyond you state. If it is the room where those are being prepared, now you might back down even further to an immediate use beyond use date if you are having a potential issue within your hood. Keep in mind that uh an immediate use beyond use date for a non hazardous product can be done outside of that hood. So you would be kind of replicating that type of environment. You might find that your HEPA filter needs to be replaced. Keep in mind that recertification needs to occur to confirm corrective action has been effective. Now, that is going to be a hard one to accomplish if you only have one hood. So back up to the top of where some of these might be a temporary beyond used adjustment. Um You might have that a little bit longer that takes a while for a rec certifier to come back out and retest your environment to confirm that the CF US are below those action levels. And then lastly, this is a should, this is not a requirement but an attempt to identify the micro organism with a microbiologist. So now let's move on to the last area that I wanted to focus on today. And that is surface sampling and HD wipe sampling. OK. So if you have the chapters and you want to reference reference back to that surface sampling is going to be in section six of chapter 797. And coincidentally HD wipe sampling is gonna be also in chapter or I'm sorry in section six, but of chapter 800. So the purpose here we're gonna start with surface sampling, you are sampling the surface. So what what surfaces am I talking about? Anything that could hold microbial contamination that comes into contact with A CS P? So keep in mind these are gonna be surfaces within a controlled environment that is iso classified. So you would not be conducting a surface sampling of a countertop out in the nurses station. I mean you could, but we know it is going to come back absolutely positive for growth. So that includes past the chambers. It includes equipment within your primary engineering control staging areas, work areas within your ante room and within your buffer room I have here on the screen, those break points. So within your hood, if you have greater than C three CF US. That is an actual level within that iso seven environment for your buffer room greater than five. And then anything within your ante room if it is an iso eight, so be mindful if your room is, if your ante room is an ISO seven, that's probably where most excursions are going to occur within that anti room environment because you are greatly limited um at only being at or below five CF US. But for is 08, that is greater than 50. Highly doubt someone is gonna be able to accomplish that, but possible greater than 50 is quite hard to hard to obtain. How often does this need to be done? That is monthly. So here's where the challenging piece comes in your certifiers that come in to do your hoods in your rooms. They're only coming in in every six months, they're not coming in every month. So most practices are having to do this type of surface sampling in house, meaning one of their employees has to conduct um these samples, they have to store these samples, they have to document these samples. Uh And they also have to bring about change anytime there is an excursion. So the first step that I would start looking at if you're not doing this already is how are you? And this is beyond today's call but around globe fingertip sampling and media fills, most institutions are already doing that in house. So So knowing your labs, your environments where your incubators are um adding this onto that process. Uh Granted, this is more frequent than those every three months for media fills and every six months for everything else. Um But that is the easiest way to accomplish this. If you're in an outpatient environment with no lab and you don't have an incubator, that's going to be a little bit more challenging. Uh But it doesn't mean it's impossible. So a couple of notes here within that section six, it completely spells out the entire process for collecting these samples where to collect them in the entire process for incubation and reading. But a couple things to note these are, these are plates, OK? They're like a convex plate that you would a plastic plate with a growth medium on it and you would turn it upside down and touch it to your surface, take it off, put the cap back on it and incubate those things have to be turned upside down within the incubator. Second. When they are incubated, you have to read them twice. First, it's incubated between 3035 °C for at least 48 hours. And then someone within your facility has to examine that. So if you're not open on weekends, just keep in mind um when those days would fall, then second, you would incubate it for an additional five days at 20 to 25 °C and, and do a reading. So anytime you do that, you're gonna want to document, uh, when it was done, who did it? Where was the area? And a yes or no, whether it was beyond the, um, recommended level. And if it was beyond or exceeded that level, uh, you need to document what you did and usually that's going to be cleaning an environment retraining, looking at your policies and procedures to ensure, uh, everything is documented correctly. Now, moving on to HD wipe sampling. So surface sampling is looking at microbial contamination. HD residue wipe sampling is looking at hazardous drug contamination. Ok. So that purpose is to identify hazardous drug residue, making sure it is contained and verifying decontamination procedures, material handling and competencies for your personnel. So where are you gonna test wherever a hazardous drug residue may show up and they show up everywhere. They show up on pumps, they show up on the deck of a hood, uh the floor underneath the hood, they show up in bins and shelves where drugs are stored uh outside of boxes, they show up on infusion pumps, countertops where preparations are stored. Uh I've even seen them on elevator buttons and yes, I have tested that uh also on keyboards within the nurses station uh because it is easy uh for gloves to stay on and not always be doffed. Uh After an administration takes place, this is a little different, this takes place every six months. However, here's the difference. This is still a suggestion. So a couple things to note, there are currently no studies demonstrating the effectiveness of a specific number or size of wipe samples to look for hazardous contamination. There's also no certifying agency that validates vendors and the wipe sample kits they provide and lastly no standard exists for an acceptable limit of a hazardous surface contamination that results as positive. So because of all of that, it sits right now within Chapter 800 as a suggestion, it's still a good thing to do, but they are very costly. And right now, if your state does not have a requirement or your accreditation organization doesn't have a requirement. Sometimes that's a hard sell. Um These kits could cost anywhere from 2000 to 3000 $4000. Uh They come with 6 to 12 wipe sampling um wipes for each of these areas. Uh I've, I've done this in an outpatient environment. I've done it in an inpatient environment. There's a few um companies out there now, uh that makes these uh wipes uh within a kit that can even give you an answer uh within a few moments if it is positive or negative. Um I would suggest looking at this if you haven't already. Um sometimes you can reach out to the company that you purchase your C STD S from and get them to partner with you to offer these wipe sampling kits um at either a reduced or no charge to validate what is being done in house and how effective those C STD S are at containing hazardous contamination. Again, no guarantee there, but it's always worth an ask. Um But that frequency recommendation for hazardous white sampling is every six months. I would say common markers that they're looking for cyclophosphamide I phosphide, uh methotrexate five fu and especially platinum containing drugs that are super, super difficult uh to get off of surfaces. So one last slide I want to leave everyone with is around preparing for enforcement. Uh So the I said at the very beginning of today's webinar, the first question I'm always asked is what is required. And the second question is, well, who's gonna require it? So there's two different sides of this picture. We have a regulatory side and an advisory side and sometimes it's very hard to discern who you are hearing from what you are reading, who wrote it and what is floating around. So I really want to clear this up. Every state, he's gonna be re uh be slightly different regarding what is required. Um But every requirement has to be enforced by someone. So everything on the left side here is a regulatory. So we have the FDA State Boards of Pharmacy, state Medical Boards. This sometimes could come into play if you're a non licensed pharmacy uh working under the physician's license, we have OSHA, that's huge, especially for compliance around us. P 800 making sure that those uh employees no matter where they work have the same level of protection and safeguards. We have C MS, we have ACH C and joint commission. Both of those are accreditation organizations. Uh This is not an exhaustive list. These are just some examples. Um but I did sit through a presentation at a SHP mid year last year, uh where I got to hear directly from one of the inspector educators for the joint commission and what they are requiring uh from a US P compliance perspective ach C a little bit different depending on which environment you have accredited and how far they are going into looking at either the oral environment versus the infusion environment. Now, why this is important to discuss is we also have advisory organizations, advisory organizations do not enforce, they only interpret nobody from us P is ever going to walk in your door to see if you are upholding the standards that they've pushed out. Same with NIOSH. NIOSH only creates a list of hazardous drugs. Um It is up to another entity to enforce what you are doing with those hazardous drugs and how you handle them. A SHP is a wonderful resource uh for gathering guides or best practices, but A SHP does not create standards. Nothing that they push out is enforceable unless a state uh wants to add something like that to their list of regulations. And then we have a lot of entities um as OCAONS uh or Oncology Nurses Society. Uh they, they produce directives, white papers, best practices around whether it's hazardous drugs or compounding in general. Uh Just keep in mind that they are interpreting standards just like you should interpret the standards. Um It's not always best to just take everything they say is gold, question them uh and make sure that you are doing your own research to determine who is your regulator, who you should be following and what those requirements are within your individual states. So I know that was a lot, but hopefully, I was able to provide a bit of a deeper dive for each of you uh around close system transfer devices around P pe and environmental monitoring. So as I mentioned a little bit ago at the start of this, these slides are available for you. Uh I created them as one pagers that you can use internally to educate nurses, to educate um technicians uh and even to have higher level conversations and discussions with senior leadership. Uh If one of these areas is on your radar uh for expanding compliance, there's three different pages at the end here of all of my references and resources that I've used uh to help create the content for these slides. So I'm gonna stop there. Uh I know Brandon has been collecting some questions and I know we've got about six more minutes left here. Uh So I'm happy to help address any of those? Excellent. Thank you so much Derek and, and thank you all uh in the audience for your time. If you do have a question for Derek, uh there's a Q and a window in the bottom left corner of your screen, you can enter it into there. Uh We'll do our best to get through some questions. Um If we are not able to um answer your question or um if it's uh something that would require a little bit more uh discussion, then we'll certainly reach out to you uh in the coming days. But uh let's start with uh a question about P pe uh if you could expand a little bit more on uh how best to ensure employees are compliant with P Pe Brandon. That's a great question. Um Obviously, when it comes to P pe, you have to have a standard operating procedure of what is going to be required by your employees. Also, you have to have competencies documenting that your employees have been trained and you've signed off that they meet those requirements. Um However, a lot of individuals will leave it at that and make an assumption that technicians that pharmacists, that nurses are practicing compliant or compliance and consistency and that's not always the case. So I would urge you to constantly be training, constantly, be um providing those competencies that needs, that has to occur yearly for your employees at this and at the start of their employment. But those that are overseeing compliance really need to be looking and watching and monitoring within their environments to ensure compliance. I would not do that on a scheduled basis. I would do it randomly and without notice and never be afraid um to correct someone if they are stepping over a line of demarcation without the right P pe, if they're not donning their P pe in the right order, it's not necessarily calling individuals out. It's maintaining that safety and going back to that why of making sure that that patient is protected and that employee is protected is someone's responsibility within your organization. And usually it's the designated individual overseeing all compliance with both 797 and chapter 800. Thank you so much. Uh Now, in a situation where uh someone would uh may have to change from one type of closed system transfer device to another. Uh can you walk through uh a recommended approach for, for making a change like that? Absolutely. Uh So earlier, uh on one of the slides, uh I mentioned around close system transfer devices that you have a lot of considerations to walk through. How many pieces and parts are required. Uh What type of mechanism does the C STD use to maintain its closed system? But I have been in a situation before where I am asked to switch from one closed system transfer device to another. Sometimes those questions come internally uh within my department So maybe I've got a technician saying this one's not working anymore. Uh It's leaking. We keep having issues, maybe it's a stock problem to where there are shortages and we're not able to get the pieces and parts uh consistently. But other times it ends up being a request from a higher up individual within the organization, whether it's due to cost, uh maybe a cheaper C STD on the market or there have been instances where a manufacturer uh will offer better pricing on other products within their portfolio if you were to use their closed system transfer device. So sometimes these questions come through and in my um my belief has always been use a closed system transfer device, use it consistently use it well, use it across all of your hazardous drugs regardless of what the C STD is. But if you do find that you're moving from one product to another, there has to be extensive in house training both within the pharmacy and within nurses and anybody else involved in the transport of these items to make sure that they are using them appropriately. And a movement from one C STD to another should not occur haphazardly. There has to be lots of planning involved. And if you have multi sites within your institution, I would urge you to make sure that all are using the same C STD rather than each site using something different. Uh The problem can or come up uh where you have employees floating from one organization to another. Uh They may not be familiar with the C STD currently being used. So it looks like we're at time. I want to thank everybody for joining today. Again, if there are questions that we did not get to, which I'm sure uh there are some, uh, Brandon's gonna make sure to get those my way and I will reach out to each of you and help you how I can. So again, thank you all so so very much for your time today. I greatly appreciate it. Thank you so much, Derek and thank you all for joining us today. Um Just wanted to direct your attention to this disclaimer at the end uh and some contact information if you need to reach uh anyone at mckesson Medical Surgical. I also wanted to point out uh that uh you can obtain a full list of our upcoming events and recent events uh by visiting us at M ms.mckesson.com/educational dash webinars. You can register for a future webinar, share with your colleagues or sign up to receive regular updates on our webinar schedule. Derek. Once again, thank you so much for joining us today and sharing your time and expertise. We really appreciate it and I hope everyone has a great day. Thank you.