Educational Webinar: Are you ready for USP General Chapter 800?

Good day and welcome to the McKesson Medical-Surgical Webinar Wednesday presentation. Today's conference is being recorded toe. Ask a question over the Web during today's program. Please locate the Q and A panel on the floating toolbar at the bottom of your screen. Once opened, type in your question and clicks in tow. All Panelists now I would like to turn the call over to Lauryn Williams. Please go ahead. Thank you, operator. And good afternoon, everyone. My name is Lauren Williams. I'm a marketing manager of customer programs at McKesson Medical-Surgical. I am pleased to welcome you to Webinar Wednesday, our monthly educational webinar events. Today's presentation is titled Are You Ready for USP General Chapter 800? Our speaker for today is Julie Catherine – Julie Catherine is a pharmacist and clinical specialist with the McKesson Provider Advisory services team for McKesson Pharmaceutical Solutions and Services. She began her career as a retail pharmacists and followed that with several years as director of pharmacy operations for a large cancer center. In her current role of McKesson, she worked to support clinics and health care systems with educational support and regulatory guidance and preparation. Before we begin the presentation a few quick notes. Following the webinar, you'll be directed to a brief survey. Please take a moment to complete the survey and help us continue to provide topics that matter to you. Also, we will follow up for a few questions at the end of the webinar. Thank you very much. And please welcome Julie. Catherine. Thank you, Lawrence. Good afternoon. And welcome to today's Webinar Wednesday, where we will spend the next 45 minutes or so discussing USP 800. USP 800 is the general chapter that addresses the safe handling of hazardous drug in the workplace. Um, get my slides advancing it, um, I didn't include an agenda slide, but today I want to review the chapter, cover a few updates and discuss some reading this step during the time that we do have. And I'll also leave sometime at the end in case there any questions in case you aren't familiar with what USPS let's start there. So the United States Farmers Appeal Convention is a scientific, nonprofit organization that sets the standards for the safety and purity of medicine, food and dietary supplements. They use expert committees, the author chapters, which then service standards to improve quality and impact health outcomes. If a chapter is numbered above 1000, then it offers general guidance. If a chapter is numbered below 1000, then it can be enforced by a regulatory body. Um, the U. S P is an advisory body and does not have any enforcement power. The three USP chapters that probably most impact our health care system or USP 795 USP 797 and now USP 800. USP 795 gives guidance for the compounding of non sterile product's USP 7 97 gives guidance for the compounding of sterile products, and US 800 give guidance for the safe handling of hazardous drugs. If you look at the timeline here, you'll see that USP 800 was actually published in February of 2016. The original implementation date was supposed to be July 1st of 2018 but then the USP expert committee made the decision to delay the USP 800 implementation date. The coincide with the official implementation date of USP 795 and USP 797. as you see, both USP 795 and 797 were published in their revised visions in their revised versions in June of this year. So now the intended official date for all three is the December 1st of this year, and I don't expect we'll see any further delays in that, Um, I do want to point out some of the revisions that air now part of USP 797 these again, some revisions that that tend to be important to our health care systems and clinics. The definition of calm pounding has been changed to more closely aligned with the FDA. Definition of calm pounding. I want you to look at these two statements that I have here out of the USP 797 1st of all, that preparation of a conventionally manufactured sterile product in accordance to the manufacturers package inserts for a single patient is no longer considered com pounding. And then, secondly, that preparation of a non hazardous CSP, or compound, is sterile preparation for a single patient using only sterile starting ingredients with administration, we'll begin within one hour of beginning the preparation, which also means within one hour of initial entry into the single dose container is not required to meet the standards in this chapter. In my role with McKesson, I primarily work with physician owned clinics and the majority of which are Community Oncology clinic. So I want to touch briefly on something that's making waves in in this space. Recently, the American Society of Clinical Oncology, or ASCO, sent out of communications, saying that these revisions in U. S. C 797 will exempt many community oncology clinics from the requirements of 797 due to the majority of preparations meeting the above criteria and also being administered immediately. Um, I believe that a group from neurology did the same thing. But Esco when a step further and said that if the oncology clinics are exempt from the requirements done in 797 then they will also be exempt from USP 800 Now. The important thing to note is that both U. S P and Asko our advisory bodies and much of what is written in the USP 800 standard, has already been incorporated into some state OSHA plans or state Board of Pharmacy regulations. Uh, some potential enforcing bodies include OSHA. Uh, state boards of pharmacy could even even the CMS, FDA and, of course, joint commission. So you need to check with your state regulatory bodies to see if and how they plan to enforce is this will vary by state. And that's really all the guidance that I could give on that. And then the third revision that I want to mention, um, is that the old, low, medium and high risk categories have now been revised in the category one category to, um, your category one preparations have a maximum beyond you, stating of 12 hours at room temperature and 24 hours refrigerated with your category of are, Let me say this U. S C 797 also says that, your hood does not is not required to be located in a classified area, and we'll go through that in some, uh, flies on them in through the webinar. And then the last thing about Kevin 97 is that administration remains outside the scope of 797 When we think about the objectives of USP 800 US 800 is the new chapter, but the guidance is not made. We have authoritative guidelines that have been developed by professional practice organizations and federal agencies for the safe handling of these hazardous drug that have been available for nearly three decades. The main objective of ESPN 100 is to protect personnel that handle the hazardous drugs in the workplace. Since 1994 there have been over 100 studies documenting evidence of contamination of work environments with hazardous drug. And they're over 50 studies that have demonstrated the presence of hazardous drugs in the urine of health care workers, which would indicate exposure. The chapter covers all aspects of handling hazardous drugs, from the state of the product in the clinic to the disposal. This insurance that there are standards for all personnel who handle the hazardous drugs and in all areas of the clinic or health system where they may be found. And you'll probably get tired of hearing may say that today because I think I'll probably say it five or six times. Um, while aimed primarily at protecting the health care workers, um, it also does protect patients and the general public who have who have access to facilities where the HDs air being prepared has. The drugs are administered in many non acute care settings outside of the hospital and typical pharmacy com pounding centers. Our data shows that physician offices, men's and women's health clinics, ambulatory surgery centers, cancer centers, labs, home helping home infusion uh, may also require hazardous drugs for patient treatment. It's important to be familiar with which drugs are considered hazardous and trace the life cycle of that hazardous drugs. Um, throughout your facility, I'm gonna give you just a little history on chemotherapy during World War Two is discovered that people exposed to nitrogen mustard developed significantly reduced white blood cell count. This finding led researchers to investigate whether mustard agents could be used to halt the growth of rapidly dividing cells such as cancer cells. And by 1946 the use of nitrogen mustard for lymphoma is going to popularity in the United States. After the publication of these studies, um, the advancements continues for each decade that followed. But by the late seventies and early eighties, there were reports of some adverse effects in the nursing and pharmacy staff that were handling some of these agents today. There are numerous studies, as I mentioned, which have shown that over time has the drugs can accumulate within the body and caused clinicians and other handlers to become stick. As you see here, from the left side of the slide, the risk aren't just for nurses and pharmacy staff, but for anyone who regularly regularly handled hazardous drugs or ways. And then on the right side, we think about some of the risk that have been documented in the studies. We see hair loss, allergic type reactions, skin rashes and then some more serious things, like chromosomal damage, cancer, miscarriage or birth defects and infertility In 19 eighties. In the early 19 eighties, the American Society of Health System Pharmacists, or a Sht published the first standard on the safe handling of hazardous drugs. So again, the recommendations in the chapter are certainly not new. Uh, the CDC estimates that there approximately eight million U. S. Workers here it's suppose the headrest drugs in the workplace. There are many employees within the health system that can potentially come in contact with these has struck this part of their job. We're going to talk through some of these areas, a zoo. We go through the webinar, but these were just some of the different, um, areas, Uh, that where you have personnel that probably are or could be coming in contact with hazardous drugs. So let's start talking about the chapter. Let's look at several of the sections from the chapter itself. There are 18 sections of U. S. T. 800. These air, the 18 sections, Um, the chapters actually only 13 pages long. It's about 20. With the glossary in dependencies, I strongly encourage you to read through the chapter. If you haven't already, you can go to the U. S T website and download a free copy. I'm not going to read through all of these, but this list shows the Brits of USP 800. I know a lot of times, especially in the clinic space, is actively working. We, uh, send the focus a lot on engineering control, structure, clinic structure, things like that. But as you see, there's so much more than that. Um, the majority of the sections feature mandatory guidance to be followed, but there are a couple of sections in here. Um, specifically, section six, which is environmental quality and control and section 18 around medical surveillance that are actually discretionary sections. Um, I'm sorry, advanced too quickly. Okay, let's talk about the first requirement of the chapter that each facility maintains a list of the hazardous drugs that he uses. NIOSH is the National Institute of Safety and Health, and it is a division of the C. D. C. Several years ago, NIOSH began publishing a list of hazardous drugs. The list is updated every two years, although the latest list was due to be published in 2018 and it's still not been published You to some ongoing debate about some of the drugs proposed to be added. So the last published list that we have is dated 2016. When you're making the list for your facility, you want to refer to this list. The list is divided into three different tables. They have the anti me a plastic drugs, the non antonia plastic drugs and the reproductive risk only drugs. You may be asking what determines why a drug is classified as hazardous For this, we also go back to NIOSH and the NIOSH definition. Um, NIOSH actually defines the hazardous drug as a drug that has one of the following characteristics. Um, it's carcinogenic or a drug known to cause cancer. It's Terata genic or a drug known to cause damage to developing embryo or fetus. It could be a drug shown to cause reproductive toxicity. Um, such as miscarriages or infertility. It could be a drug that demonstrates organ toxicity at low doses. Um, it could be something that has been deemed as Jenna toxics. This is something that has a drug that has a destructive effect on a sales genetic material that can lead to mutations which can then lead to cancer. And lastly, it could be a new drug to structure or toxicity. Profile mimics drugs are already on the list. Um, remember again, this list is only published every two years. So as new drugs come out, you need to look back and say, You know what classes this drug in and does that match drugs? They're already on the NIOSH list. These were some of the drugs listed on table one of the NIOSH hazardous Strug list. Um, these the Antonio Plastics, your facility probably administer some or maybe even many of the drugs on this list, depending on what type of health care facility you were in. Now, if a drug is on this list and requires any type of manipulation, then it must be treated as hazardous and with all the containment strategies from the chapter. If a drug is on table two or three, those can potentially be treated differently, and we will discuss that more in depth in a couple of minutes. This is a list of the proposed additions to the 2018 NIOSH list of hazardous drug. Again, I've not seen the finalized list, so we'll have to wait and see if these are added. The last thing I saw was that the list is will potentially be out around December of this year, but I haven't seen a final release state. You probably noticed, um, from this slide that, as well as the previous slide, that several of the drugs rent Orel formulations. And there's a reason that I wanted to point that out because that's important. Um, there are some dosage forms of drugs that are defined as hazardous that don't pose a significant risk of exposure because of their dosage form. So the drug itself is hazardous, but the dosage form limits the exposure because of you know it's in its final form. Think about it this way. So if you're counting or dispensing Capeside, Urbina's a loaded tablet that's not going to pose the same risk to your nurse or technician as drawing up in administering five f you or you have drugs like a war friend or paroxetine on Table three that posed a specific risk for your pregnant workers. So for these dosage forms, the clinic can do an assessment of risk to determine alternative containment strategies. Once you do this assessment of risk, you could then store these take side of being tablets in the oil pharmacy rather than in your negative pressure rooms that is required for the I V formulation of five F You, um, if you do these this success assessment of risk, um, you'll see here on the slide. These are the things that you must include. You know what type of HD is that is an anti neo plastic? Is it not anti neo plastic? Is that reproductive risk? Only what dosage form is it in? What's the risk of exposure to the employees that are gonna be handling it? How's it package, and how's it going to be manipulated? If you don't perform an assessment of risk, then all of your hazardous drugs must be handled with all of the containment strategies, um, to find in the chapter this light is just a kind of a same thing with what we just said. Um, and it's It's a drug who is in its final dosage forms that you need to do that assessment of risk, and you can come up with some different containment strategies for those drugs. Section three gives a look at several potential opportunities for exposure throughout your facility, depending on what type of health care empty you work in. There may be multiple areas and job duties where exposure is possible. For example, there's the potential for has this drug residue to be present in receiving areas for your boxes were impact. There's several opportunities. Breaks, exposure, uh, to your nurse, pharmacist or technician in your mixing room, whether through the reconstitution of the has just a vile cleaning the hood or simply from contact with contaminated PPE, nurses face potential exposure when administering the hazardous drugs when handling contaminated body fluids, or even just when transporting the has just drugs within the clinic or health care settings, such as from the mixing room to the chair cider bedside. Section four requires that you have a designated compound ING supervisor toe oversee that the chapter is being followed. It also requires that again, this is the sentence I said. You'll hear over and over. It requires that all personnel throughout the clinic that handle the hazardous drug are properly trained and following also state and federal standards. There's no requirement on who the designated person has to be. It just needs to be someone with a thorough understanding of the standard and someone that can implement the appropriate procedures. Um, your facility will actually need to decide if this person should be a nurse, a technician, uh, pharmacist or practice administrator or someone different. The designated compound ING supervisor will be responsible for developing and implementing your policies and procedures, overseeing the your facilities, compliance with it yesterday 800 the other appropriate standards in laws. This person must also ensure competency of the personnel and ensure environmental controls. Um, this person can be responsible for more than one side of your health care system with multiple sites. I think the main take away is that the designated person must thoroughly understand the rationale for the risk prevention policies on and know how to act on act on those. Section five gives guidance around facility that design and engineering controls. You do need to have a designated area for receiving your drug orders. You aren't required to have a separate room for receiving, but you do need to have a designated area you wanna have Some PPE available here is well, is the spill kit. Those drugs that are on your hazardous drug lists that are on table one of the NIOSH lists and that require manipulation will also need to be stored in a negative pressure room. Uh, they need to be stored separately from your nonhazardous drug stocks. You're has just drugs must be stored in a manner that prevents village or breakage of the container fall, and you certainly don't want to store. Those has just drugs on the floor. If a drug is on your hazardous list from Table two or three of the NIOSH um, list and it is or isn't a final dosage form of any of Antonio plastics from table one and you perform that assessment of risk that I just spoke about. Then you may store those drugs with your other inventory as long as your clinic policy allows it. When it comes, you're mixing room. You now have two options. You can have an ISO classified clean room, or you can have a containment segregated compounding area or C S. C A. Um, and I'm sorry. There are a lot of acronym through this section. Um, but both of these rooms must be a four walled negative pressure rooms, and your hood must be vented to the outside. Your has just drove can be mixed in a class, too. Type A to B one or B two B SC, which is biological safety cabinets, a class three D SC or a calm, pounding aseptic containment isolator. That's a CHC odd. Um, the room should be negative pressure between point no. 1.3 inches of water column relative to the adjacent area, and you'll need a gauge outside of your mixing room to monitor the pressure on. I think the reason that we have ah, an actual range here is because if your air pressure is too negative exception will actually pull air in through unfiltered areas and possibly contaminate your room. The ice of seven clean room must have a minimum of 30 air changes per hour and your CSE a must have a minimum of 12 air changes per hour. If you go the clean room route, you're beyond you stating or follow the U. S. P 797 recommendation. Um, if you decide to go with CSE a everything that's mixed, then it must be hung within 12 hours. With both, you are required to have a sink and I wash. If you have a nice 0/7 space, the sink will need to be located in the anteroom. Uh, things are actually allowed in the same area as the CSE A. As long as the sink is located at least 1 m or 3 ft away from your hood. These air some example configurations actually straight from the appendix of USPS hundreds. The first picture there shows a CSE a. So your CSE A does not need to have HEPA filtered air because it does not need to be isil. Classified Onley category ones can be mixed in this unclassified area. though, and these preparations must be administered within 12 hours. Um, there must be a perimeter around the VSC or hood in the CSC A. To design the area where the compound ing occurs. The second two are examples of classified clean rooms. Um, these examples or isis seventh they do requiring a piss illustration. Particle counts, um, a minimum of 30 air changes per hour. Now you can mix either category one or two in these rooms and beyond. You stating then would be longer than 12 hours. Just these were just some pictures, um, to give you some other considerations when you're designing your your hazardous drug mixing room. I mentioned the gauge outside to monitor the air pressure. Those first two pictures. That's what those were picturing. You want signage in the area to alert, um, others that there are hazardous drugs being stored in mix in those areas? Uh, many clinics and facilities to used to used past three windows, uh, to get the drugs, the preparations out of the hazards, mixing room into the, you know, into the nurse's hands before hanging on, then the floors. Let's just talk a little bit about some of the other things like you want the surface of your ceilings, walls, floors. Fix your shelving, counters, cabinets, Anything that's gonna be in the room. You want to be smooth, impervious, free from cracks and crevices, non shedding and clean nable. You want your floors to the shameless material. Um, either reported two part epoxy resins or a sheet good. Something like a seamless final or seamless rubber, which is what you see in this picture here. That's code up the side of the wall. Um, if you're facility, uh, follows 797 There are also some temperature and humidity requirements with your walls. You wanna use either a sheet vinyl, a fiberglass reinforced plastic or a wall board that has the coding of a two part epoxy paint. If you do use wallboard, I would recommend an antimicrobial or anti mold type, and then with your doors, you probably want to use the same list still, or fiberglass reinforced plastic door that has the half glass vision panels or even glass doors. A lot of my clinics prefer to you to use the glass doors. Um, one other word of advice. If you're starting to do some construction renovation or changes. He's the contractor or designer that's actually worked with medical facilities before. That has knowledge in this space. So there are three types of engineering controls within the chapter with the see what's called the C Peck. The CPC. This is your containment primary engine engineering control or your hood, the C sec, the containment secondary engineering control or the room that your heads in your mixing room, your negative pressure room. And then thirdly, there's now the supplemental engineering control, which is the closest, um, transfer device. The closest, um, transfer devices designed to keep the environmental contaminants contaminants out while keeping the has just drug and any harmful vapors. In, um, it's recommended that the closest, um, transfer devices be used in calm pounding, but it's actually required that they be used during administration. They're currently six, um, close to some transfer devices on the market. Cause can be a factor when budgeting in the use of the closest transfer devices. Um, I hate to throw out numbers because another, a lot of different contract different facility types, But, um, just from some independent data with some of our groups, we estimate that a facility that mixes 20 has just drugs the day to potentially expect to spend about 45,000 a year on the closest, um, transfer devices. All of the closed system transfer devices currently comply with US 800. So here's some things to consider when deciding which one to use. In your practice, I would review all the products are available on the market. Look at the papers and articles that have been published. Um, solicit input from your clinical team. Um, have the manufacturers come in and let you do a test run. Uh, they'll let you demo them, get input from your clinical team after they've done that, so that you can assess the integration of the device within your current work flow of your clinic or health care facility. There are a lot of different pieces parts. They work differently. So, um, find the one that works best for you and, of course, certainly review your vendor contract. Um, compare pricing as well. I'm sorry. I think I skipped again. Okay, No, but Section six recommends that you do white testing for HD residue every six months. Again. This is the one we talked about being one of the discretionary chapters. So it is a recommendation and is not required. Um, if you wanted to be white testing you could request it from your hood certification company. I've heard that it could be quite a offenses. Maybe around $500 per area. Tests did, um there are also a couple of options that air just hitting the med surge space for do it yourself. Testing proper personal protective equipment is a very important step in your worker protection. You will need to have s o ps in place that establish what PTE is to be worn during the different job functions in areas of the clinic where the HDs air handled. There is some specific guidance in certain areas in the chapter, but some will be in accordance to your specific policies. Um, US 1000 does require chemo downs, hair covering double she covering double chemo gloves in the mixing room. It also requires that nurses where a chemo gown and double double gloves put administering a hazardous drugs. Now your gowns must be impervious and intended for use with hazardous drugs. They need to be disposable, seamless clothes in the back and have long sleeves and cuffs. Um, I believe the standard also recommends that you change those often, um, maybe every 2 to 3 hours. Um, if you leave the space you're supposed to dispose off and then using new And when you come back in, you want your gloves that have been tested for permeability by specific chemotherapy drug? There is a standard for the gloves called a S t m. 6978 on. Do you want your gloves to meet those standards? Um, way. Talk about respirators. The NIOSH in 95 respirator is appropriate for most activities, but ESPN 100 actually does recommend a full face piece chemical cartridge type respirator. Um, if your employees are at risk of respiratory exposure to that has this drug, um such as doing a deep the contaminating in your hood or cleaning? Ah, large film. When it's larger than what a spill kit to clean up. The chapter requires that you have a hazardous communication program in place. This will include the appropriate signage in areas where there has just drugs or stored or mix, Um, similar to the yellow sign that I showed you in a couple of slides back as well as proper labeling on the I V bag, your employees will have to be trained with regard to their individual job function in handling the hazardous drugs. Um, employees also need to know how to assess the safety data shoots for the hazardous drugs that air handled in your facility. Um, and again, I know gonna say just 100 times to that, each clinic will need to have policies and procedures in place. One other thing I wanna point out about this is that if an employee is of reproductive age, he or she will need to sign a form acknowledging that they are aware of the potential risk with handling the hazardous drugs. This is just a template that I downloaded. Um, I believe from PPT mag. There are other templates out there. I think O N s has one, but this is just wanted to show you an example of something like this. But your employees of reproductive age will need to sign briefly. Um, I'm from the Section nine covers the types of things that need to be covered when training your employees, uh, one more reminder that everyone in the facility who handles your HD need to be trained according to the job functions. So this is just the list of the type of things you would want to train your staff on? Uh, definitely. You would want them to be familiar with what? Those What's on your list of HDs? What their risk are your s o ps? How to use the, you know, the proper use of PPE Um, the proper use of equipment and devices You want your technicians, nurses, whoever mixing those drugs to understand how the hoods work. Um, you want them to know how to respond? Thio, known or suspected to have this drug exposure, you want them to be familiar with what you're still management plan is and then also just how to properly dispose of these has just drug and trace contaminated materials. Last time. Well, maybe not the last time, but just to driving home one more time. This is just all aspect. Um, all employees that come in contact with these has just drugs within your facility are at risk. So make sure that when you're doing your training program that it's personalized thio each of the different types of jobs that are within your facility where they might be coming in contact with these hazardous drugs. I already talked briefly about receiving, so I'm not gonna read every one of these. But section pin goes a little more in depth, and it also includes additional guidance on how to handle a damaged product. Um, just know that once you're having a struggle to receive, there should be moved immediately in their protective outer bag to the HD storage area. Remember that that HD storage area has to be also that negative pressure room with the minimum number of air changes you will be unpacking in that designated area and you'll be wearing PPE according to your clinic or facility policy. Um, you'll also want to spill kit in this area. Some clinics transport drugs between sites. Section 11 give some guidance on the proper labeling, transport and disposal of has just drug. If you are transporting drug between sites, you would want a designated container that we're protecting integrity and surreality of that has just drug, while also protecting the transporting personnel from accidental exposure. If you're a clinic that has a facilities person or if you contract out the waste disposal or custodial duties thin. Those people need to be trained in the proper handling of the hazardous drugs as well. We talked a little earlier about dispensing the final dosage forms like tablets or capsules. The aural hazardous drugs should not be cut or crushed or placed in automatic counting machines. It is recommended that any equipment used be decontaminated after every use. This would be like you're counting trays and spatulas. Um, it would also be a great idea to have a separate counting Trey, um, and spatula for your hazardous tablets and capsules. Section 13 says that any calm pounding must be compliant with U. S P 797 standards. We already discussed any language and U. S P 797 as it pertains to calm pounding so I won't go through that again. Um, if your facility is engaged in sterile compounding, you will need to comply with U. S P 797 as well as USP 800. We also have already talked some about administering Chap Section 14 addresses. Administering the chapter does say that nurses must wear a chemo gown and two pairs of gloves when administering. That has just drug to a patient. Um, the tubing must be fitted with the closest, um, transfer device, and you want to make sure that the PPE and equipment are properly disposed of. There are now four steps required in the daily hood cleaning process, and you must have a policy in place to include your procedures. The agents you used, the delusions, your frequency and documentation requirements. Um, again, if you are doing sterile, compounding the cleaning of those drill calm pounding areas need to comply with U. S. P 797 I'm sure you probably know this, but it's a reminder you don't want to spray anything in the h has a drug areas, um, or in your hood. This can aerosolize the hazard of drug. Canarsie allies the residue. It can also do damage to your HEPA filter within your hood. Um, you do want to think about what PPE needs to be worn. Probably a gown, double gloves, head hair and shoe covers. Um, I protection. It's splashing. Is possible potentially respiratory protection if necessary. So these are the four steps we now have the activation, decontamination, cleaning and disinfection. The first two steps, the activation and decontamination step can typically be achieved using era peroxide formulation or bleach. Um, if you do use a 2% bleach bleach solution, it will do both the deactivation decontamination. You would probably want to follow that with sodium sulfate to remove it from the same list steel. Because it's left, it's left on there. The bleach can definitely cause pitting, uh, in the stainless steel. You would immediately follow that with a German Seidel detergent, which is your cleaning step. And then, finally, the disinfection step is typically going to be your sterile 70% isopropyl alcohol. Uh, now there are commercial products available for these steps as well, but I just wanted you to be familiar with what the steps are. Your hood needs to be decontaminated, cleaned and disinfected, at least daily when it's used. Any time of spill occurs before and after after it's certified and after any voluntary interruption occurs, the work trey under the hood or the BSC needs to be decontaminated, cleaned and disinfected. Um, at least monthly. And just one more reminder that all personnel performing these activities must be trained in these procedures and must where the appropriate PPE there is now a great UST 800 product catalog that's available on the med search site. This is a great resource with USD 800 compliant items. Um, it makes the process much easier than scouring for the entire catalog, trying to distinguish which products or compliance. So I think this is a great addition to the to the med search site for Section 16 addresses. Still, control spill kits will need to be available in the areas for your HDs air handled. You'll need to have a policy in place that explains your clinics process for handling the spill. You should document your stills, and the personnel that are exposed must have an immediate evaluation. Your S A T S must address the location of your skill kits and you're clean up materials. Your personnel need to be trained in using the skill kids. Um, it's also recommended, as I mentioned before, that your staff members where a fit tested in 95 respirator when cleaning up a spill, you are required to have s o ps for all sites and this is a list of the policies and procedures that should be included and that your personnel will be trained on your designated person will need to review these s O PS at least every 12 months. That review must be documented. Um, and the training on these s O PS will also need to be documented. The last section of USDA hundreds is on medical surveillance. This is a discretionary section. Um, there's really no, I don't know why. It looks like I have a blank. I hope you're seeing some key elements. It looks like they're blanked out. Um, it doesn't make specific recommendations as to what should be assessed, but, uh, key elements that you would want to consider is that you get baseline lab work on your employees that handle hazardous drug that you monitor those employees on a yearly basis. Um, it's also recommended that you continue to monitor the health of your employees. Um, even after they terminate employment with your clinic, if you are interested in starting medical surveillance programs, there's a very helpful publication that NIOSH has put out called medical surveillance for health care workers exposed the hazardous drug. You can look that up online, but again, this is a discretionary sections. Um, it's not currently required so that it's up to your facility to decide how to proceed with this recommendation. So what are some steps that you should be taking to be ready for the December 1st 2019 implementation date? Um, I would definitely recommend, um, that used familiar. You have familiarized yourself with the chapter. Um, I would recommend that You certainly know the hazardous drugs they're being handled in your clinic that you do a readiness assessing readiness assessment. Not the same as the assessing the risk. This is a readiness assessment, uh, to see what sections you're currently compliant with, and then which ones you still need to work on. I put a couple of websites fair that have some templates that you can go to to download a readiness assessment. You need to decide now if you're gonna have to make any structural changes to your mixing area. Um, remember that you have to have that negative separate negative pressure rooms with the proper air changes within externally vented BSC or hood. You might need order a new hood. Um, look now and see if your staff is already using the proper PPE or if you're changes that need to be, you know, need to take place in that area. Start training your staff now on the chapter. And if there will be any changes in your processes that will have to take place, Um, also definitely start working on those policies and procedure at the bottom of the slide. Um, this is a link back to that USP 800. Um, section of the med surge website, which has a lot of resource, is as well. All right, we're gonna do something fun. Now, we're gonna have a polling question, so I'm going to go ahead and open the pole. The question is, how prepared is your facility today for us? Be 800. We're fully compliant. We're making strides, but still have a lot to do. Or we have not yet started to prepare and would like a sales trip to reach out to us. So I'll give you a few seconds toe. Think through that and give us your answer. All right. I think the answer is air slowing down another five seconds. Just another couple of seconds. It is telling your responses, all right? I'm not saying how you answer, I think from what I could tell as it was uh, going up. I thought it was gonna pop up on the screen. I'm sorry, but it looks like the majority or our number two, which is what I would expect. I'm sure many of you have have started. Um, but you're not there yet and that that's that's what we typically are seeing across the country. So finally, McKesson Med Surge is super excited to be partnering with med trainer to provide the USPS 100 toolkit as an additional resource for our customers. All the requirements that I mentioned in the presentation will be simplified using the tool kit. It includes the assessment of risks that we discussed earlier, as well as a module to identify the hazardous drugs. There s a P templates, which I'm sure what makes their job much easier. Their training modules, Um, just a tracking feature to document training. So I certainly expect this tool kit to be a great resource. Um, if you have any questions about how to get access to the mid trainer tool kit, reach out to your MedStar drip or account executive. Well, I believe that my time is up. Thank you for joining this webinar. I hope that you found it helpful. I'm going to leave the remaining minutes that we have left to see if we have any audience questions that I will do my best answer. Hi, Julie. We dio I have a question. And it iss Do you know if McKesson can assist the contacting reps for different C S t d to evaluate or demo them on which works best and what parts are needed for our particular needs, I would say yes. I don't know what division I assumed that med surge can do that. I know that several of my clinics have had, um, different manufacturers come in and do, uh, demos with them. So if you you may, uh, if you have a med surge rep now, I would send something to that rep. Um, if not, uh, Christians or a web address or something email address that we could give them to follow up after the call. Okay, Another question we have is we administer Antonio plastic and non Antonio plastics in our office. We're not accredited by any by any bodies. What organization would be able to enforce U. S P 800 regulations in our position, offices and then she followed up with what oh should be able to enforce. And that's one that I really can't answer definitively because it's going to be based on your state. Um, it is, I mean, because it deals with workers safety. I would think OSHA will be involved, but it will be. It will be dependent on the your in your state as the whether or not. And I don't know. I know some state OSHA plans have adopted parts of US 800 but I can't. I'm sorry. I can't answer that for sure, because I don't know. Okay. And one last question. Where can we get a template for the reproductive risk risk Acknowledgement That one I believe I downloaded off P p p mag p p p m A g uh dot com O. N s, um, oncology nursing societies I believe they have. One is Well, um, if you want Teoh, I don't know if my email was on the slide, but if you want to reach out to me, I'll be glad to send it to you. Um, after the webinar as well. Okay, her julie dot Katherine and the kitchen dot com. I think that's always have for Q and A thank you. Thank you, Julie. Thank you, everyone, for attending today's webinar. Please join us next month for a presentation titled Tell a Retinal Imaging for a Diabetic Retinopathy and Primary Care. It is scheduled for Wednesday, September 18th at 2:30 p.m. Eastern Standard Time. You can find a list of upcoming Webinars on our website, and then that's stop McKesson dot com, and you can register their as well in closing. I'd like to thank Julie for sharing her expertise with us and all of you for attending Thank you, and this does conclude today's webinar You may now disconnect.