#100 Biological Monitoring-Confirming Instrument Sterility

How do you know if your instruments are really sterile? What if your sterilizer is not performing its job? In this special episode, the Compliance Divas cover best practices for sterilization monitoring  and how to handle a failed sterilizer test.

• Best Practice for Routine Sterilizer Efficacy Monitoring: https://bit.ly/44fngiZf
• CDC Sterilization Monitoring:  https://bit.ly/44xvOBY

Videos from the HuFriedyGroup

• Step-by-Step Video for Spore Check 24 hour: https://youtu.be/2K8GJ0QjkKM
• Step-by-Step video for HuFriedyGroup Type 5 Steam Sterilization Integrators: https://www.youtube.com/watch?v=ZTCqm5Z4u-o
• HuFriedyGroup Blog Post:  How to Approach Biological Monitoring: https://www.hufriedygroup.com/blog/approach-biological-monitoring
• In-Office Biological Monitoring of Table-top Steam Sterilizers: https://bit.ly/3HypjVof
• Mail In Biological Monitoring Support: https://bit.ly/3ne99Kc

                                                 https://www.thecompliancedivas.com

Transcript

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SPEAKER_02 0:04

Welcome.

SPEAKER_01 0:05

I'm Leslie Cannon. I'm Mary Gavoni.

SPEAKER_02 0:09

I'm Linda Harvey. I'm Olivia Wan. And together we are the Compliance Divas.

SPEAKER_00 0:18

Hello, I'm Leslie Cannum, and I'll be the moderator for this podcast episode on biological indicators and best practices in monitoring sterilizers. Welcome to the Compliance Divas podcast. We have a special episode planned for you today, and we're going to talk about a key component of instrument processing, confirming that your sterilizer provides sterility using biological indicators. Thanks to support from our sustaining sponsor, the Hue Freedy Group. The Hue Freedy Group is a company with over 200 years of collective experience in the dental industry. It's a global leader in instrument manufacturing, infection prevention, and instrument processing, reprocessing workflows. The Hue Freedy Group helps dental professionals be best in practice by providing a complete circle of protection in the dental suite, bringing together world-class products, services, education, and communities that result in superior clinician performance, clinical outcome, and safety for clinical clinicians and patients. In 2021, the Hugh Freedy Group was acquired by STERAS, a leading provider for infection prevention and other procedural products and services. And now is the dental business segment of SERAS. The Compliance Divas bring clarity and simplicity to compliance by navigating regulatory compliance to keep you on course. We'd love for you to subscribe to the Compliance Divas podcast through your favorite podcast channel or on our website, thecompliancedeevas.com. The resources that we mentioned during our podcast can be found on the compliancedeivas.com website and also in the podcast show notes. Please submit any questions you have to support at the compliancedeevas.com. So how do you know if your instruments are really sterile? You place your instruments in the sterilizer, you turn on the cycle. At the end of the cycle, you verify that the chemical indicator on the poucher cassette has changed color. But how do you really know if your sterilizer performed sterility? There are a combination of process parameters: mechanical, chemical, and biological. In this podcast, we're going to focus on biological indicators. And there's several reasons why sterilization monitoring is important for dental instruments. First, there's patient safety. Second, regulatory compliance. Third, liability protection. And then fourth is instrument longevity. I'm going to call on our diva, Mary, to tell us a little bit more about biological indicators, including mail-in versus on-site biological indicators. And tell us a little bit about a hybrid approach and a third-party verification. Mary?

SPEAKER_01 3:23

Thanks, Leslie. Many practices use the most common type of spore testing system, which is a mail-in service. So you have a strip impregnated with spore-forming bacteria and a control, and you run the spore strip through the sterilizer, put it in the envelope with the control, and then mail it or ship it overnight, however you do it, to your spore testing service. And then they will process it. They either send you back the results, email them, or you may get a phone call in some cases if there's been a failure. The popularity of the in-office testing systems has grown recently primarily because of the time saving. There are many practices that have complained, especially during the pandemic, when things were so slow that it took a very long time to get their results back from the spore testing service. And so these in-office kits, in some cases, can give you results in as few as 15 to 20 minutes, but it depends on the type of system that you purchase. So when you purchase an in-office system, you get an incubator that you use to process or incubate the vials. One is a control that's not run through the sterilizer, the other, of course, is the one that you do run through the sterilizer, and then you follow the directions what to do with the vials, put them in the incubator for the designated amount of time, and then you record the results in a logbook that comes with the system. This provides faster results, and especially if you've had a failed spore test, this is a very convenient method of determining whether or not you can put that sterilizer back into service sooner rather than later. The issue that comes up sometimes is that of third-party verification, and so having an expert outside analyzing the results of your tests. So what we see now are many practices developing or implementing a hybrid type system where three weeks out of the month they do their in-office test, and then one week out of the month they do a mail-in test. So they've really got kind of the best of both worlds. They've got the convenience and timeliness of an in-office test, and then the third-party verification of the mail-in service test. Either is acceptable, but I recommend this hybrid method to a lot of the practices that I work with again because I like that third-party verification, that expert interpretation of the results, if you will, and also the support that you get if you do have a failed test. They will walk you through all your troubleshooting. But certainly, if you purchase an in-office system, the manufacturers of those systems will also provide you with information, but you have to go and get it other rather than the third-party verification outside service calling you to do the troubleshooting. So either way is good. Just make sure that you are following the manufacturer's instructions for where to load and what cycle to load it in and all those types of things that Linda and Leslie and Olivia are talking about. But either system is a good one. Hybrid, in my opinion, I think is the best.

SPEAKER_00 7:37

How it would be such a disruption to the practice if you had a positive spore test and you didn't have an alternate sterilizer to use if you had to take your sterilizer out of service for any length of time. I also like the thought of uh having my results instantly, as opposed to having to wait on mail. And I know that sometimes mail services have been delayed. Uh, it could be that uh sometimes the person who is doing the spore testing may not be working that week. And so it gets uh conducted either later in the day or later in the week. And your results could be delayed uh as long as 10 days, I think, if you're not watching carefully. So, Linda, could you give us some idea of where to place a biological indicator spore test, what load you might use, and uh also would you give us some idea of what a type 5 integrator is?

SPEAKER_03 8:34

Sure, Leslie. These are some important aspects of the whole sterilization process for all of our dental listeners. So after you decide which product product you're using, whether you're using a hybrid approach or a MLAN or on-site, it's important that you place it properly inside your sterilizer. And the first thing to consider is that you place it in a fully loaded chamber. That means that you actually have instruments in the sterilizer that you're getting ready to run. And it should be positioned in a location in that chamber that's least favorable for sterilization. And this is typically known as the cold point, Leslie. So that would normally be in the center of the load towards the front of the chamber. So start there and get those test results first and be sure that you do not use the first load of the day. It's better to use another load and get on a schedule in the practice so you're doing it roughly the same time every week or every day, however often you're running your biological indicators. And then also bear in mind that it's important to check the sterilizers operating manual for the details on where to place this test as well. Sometimes they have specific directions. And if not, then defer to any other directions on the biological indicator company, the strips or the vials that you're using. Look for those two resources to be sure there's not additional directions that you should be following. Leslie, I'd like to share an additional safety tip for our listeners. Um you mentioned it when you talked about the type five integrator strips. And if an office is not already using that, I highly recommend they begin implementing that uh immediately if possible, because it's such an important step. And I'm going to explain why in just a moment. First, I want to mention that adding a type 5 integrator strip is not the same thing as using an indicator monitor or indicator strip. You mentioned earlier about chemical monitoring and biological monitoring. And while these are both different forms of chemical monitoring, they're not the same as biological indicators that Mary spoke about. But the type five has a specific purpose for us to help us to have another additional layer of safety and validity that each time that we run that sterilizer, that the instruments are actually coming out sterile. And while the type five, Leslie, doesn't tell us that the spores were killed, that's what the biological indicator does. It does tell us that the parameters of sterilization were met. So it's very important to begin to add this step type five into our steps, our process for sterilization monitoring as well. And like the biological indicator, I would recommend that you put it in the cold point at first. And then after you get that established, you know, that area is working, then move it around in the sterilizer. I always tell my teams, Leslie, to do it this roughly the same load of the day. So you become consistent. That way you have a habit and a standard so that if everybody knows that we usually test whether it's our biological test or our type 5, that we're doing it before lunch or after lunch, whatever that time frame is to be convenient. It's important that they add this into their setup, Leslie, so that way they can have additional assurances that the parameters of sterilization have been met. And it really, really adds another layer of patient safety.

SPEAKER_00 11:46

Linda, that is very important information for each and every dental team member who is responsible for sterilizing instruments and testing the sterilizer to know. And uh just to recap, you said that we're going to use our spore testing in a fully loaded sterilizer. So it's more reflective of a typical load. Uh, it's going to be in the least favorable spot placed in the sterilizer according to the manufacturer's directions, one of the hardest, most challenging places in your sterilizer, and uh that many times that's located in the front near the bottom. However, always defer to the manufacturer's instructions of the sterilizer. And also, if there are no instructions on the manufacturer of the sterilizer, you know, I've never been shy about calling and asking the manufacturer where the best spot would be to place a spore test. And then you can defer to the manufacturer's directions of the spore testing kit that you're using. You also mentioned to use a warm sterilizer, which is like the second load of the day or be consistent, whatever load it is, just not the first one of the day, because it may take a while for that sterilizer to really fully warm up. And then you told us about the difference between indicator strips, which just measures a few parameters versus integrator strips, which are very highly reliable, but do not replace spore testing itself. So I'd like to call on Ardiva Olivia to give us some more perspective on ownership, training, education of entry-level people, and accountability. Olivia, can you give us your insights?

SPEAKER_02 13:27

Sure, Leslie. Uh, first of all, I love this topic because I feel that it is a critical aspect of managing risk in a dental office. And so, first off, someone needs to specifically be assigned this role of biological monitoring. It can't be just whoever has time takes it on. Someone is specifically delegated to manage this area of monitoring the sterilizers. And I would even suggest adding it to their job description so they know, just have a bullet point on the job description that that's part of their primary role. And then making sure they've been properly trained, that it's not just recycled information that came from a previous job or workplace setting, because it may be a different sterilizer, different processes. So, for example, they can look at the uh the operating procedures or the owner's manual, or even tap into the videos that are available. I know that there's great videos that Hugh Freedy offers, as well as other manufacturers, at looking at the how-tos to make sure it's being done correctly. And also keep in mind that we are working with people of all different educational backgrounds and training. In some states, Leslie, it is not required that the dental assistant be formally trained and tested. And so we there may be a state where if this training is not required, we cannot assume that they know how to do it. So we want to be proactive in our managerial roles and helping them and removing any challenges or barriers that they face. Because we may have someone right out of high school that takes this position, or someone that previously worked maybe in the food industry. But accountability is important, Leslie, because when we know that that's our job, it may be more successful to know that we've got that person. And not only that one person, but who's the backup person? So if that individual's on pregnancy leave or they're sick that day of the week that it's ordinarily done, who jumps in their place to take care of it? And I bring this up, Leslie, because I've seen in offices where there's been citations. For example, Leslie, I've seen where OSHA cited dental offices for not doing the weekly score testing. And we probably think of score testing as a patient safety issue, but guess what? It's also an employee safety issue because if those instruments are not validated as being sterilized, they're handling those instruments with the false illusion that they're sterile. And so we want to avoid any upset in our practices with something like this to happen. And Leslie, I encourage the safety managers or the dentists, or however, you know, if it's a large DSO, whatever their model is, or if it's small practice, I encourage them to look at the logs because there's this legal concept called let the master answer. So even though someone may have made an error or they were sick that week, or they went on pregnancy leave, didn't realize that it wasn't being done. The owner of that practice is still responsible. And keep in mind this is also required by the state dental boards. So put your eyes on that log to make sure it's being completed and that it's being completed properly. I've looked at logs as a consultant where the dates were incorrect, they didn't have the year listed, there was no initials of the person handling it. So it's important to follow CDC's guidelines that this must take place weekly to verify the performance of our sterilizers. And also, let's not forget implantable devices. We always foretest before placing an implantable device. And so this needs to be built into our policies and our procedures. Um, a good place to put it is also in your infection control plan. And as a lawyer, I see this as liability protection. And I love the hybrid approach that you all have discussed. I think that's a great idea. But whether you're doing all mail out or all self-testing or the hybrid approach, which is a blend, we have to make sure that it's being done in order to protect our practices from any patient safety issue or fines or discipline from the dental boards. And Leslie, one final comment. I think this is a great topic to discuss during our morning team meetings, as well as our regular staff meetings, whether they're monthly or quarterly, to have people to chime in on safety issues, such as the biological monitoring, just to make sure this important process is being handled correctly. So that would be a little bit of my insight, Leslie.

SPEAKER_00 18:56

Olivia, excellent point. And of course, our listeners uh benefit greatly from your legal expertise. And what I heard you say is that having someone who is assigned to doing spore testing, so it's role-specific written into their job description, it should be site-specific because sometimes we hire people who have a great deal of experience in dentistry, but they may not have worked with the same sterilizers that we have. So site-specific training, uh, the videos on the Hugh Freedy group site are also going to be in our show notes and on the Compliance Divas website. So that would be, I would say, basic training for any time we have a new team member who joins our practice so that they understand the steps that need to be taken. And again, the educational level, it's uh easier to watch a video for someone who may not have a great deal of formal training in dentistry. And I find that there are a lot of on-the-job trained dental assistants today, especially with the workforce shortage. So you've brought up some very good points. And then finally, let the master speak. Olivia, you and I are well acquainted with a case where uh a dental practice was being investigated for one issue, but yet it came up that they had 13 failed sterilization sport test weeks. And uh that was, I think, the thing that uh made the biggest difference in proving that this practice was not on top of infection control. So we do need to keep records, someone needs to be verifying those records. You're 100% spot on with all of that. What I'd like to do next is talk a little bit about the step-by-step uh practices for loading spore testing into a tabletop sterilizer, whether you have the spore test strip or whether you're using the on-site vial system. And I also want to remind our listeners that we have an expanded podcast, episode number 98, where we go into not only the steps for spore testing, but uh we go we expand on what to do in the event of sterilization failure. So the best practices for routine sterilizer uh monitoring, start out by taking your sterilization packaging material. If you frequently use the self-sealing pouches, that's what you'd want to put your spore test medium in, whether it's the strip or the vial. If you use wraps for cassettes primarily, then you would want to be sure that you package or wrap your biological indicator that way so that you're creating a test pack that is most best represents the routine process. Now, if you're using the vial, you would want to label the vial with the sterilizer number, load number, and processing date. If you're using a self seal pouch, you would place that BI. And we're recommending a type 5 integrator into an empty pouch and seal it with the pouch's instructions. And uh, we also recommend that we place that particular test pack in the spot recommended. By the manufacturer, and make sure that you run your cycle as you normally would, a normal load of instruments, and make sure that if you do include that type 5 integrator strip, you'll have immediate feedback that all critical variables will met when you open up the sterilizer, meaning time, temperature, and saturated steam. So this is really important, as Olivia mentioned, when you have uh implantable devices, that you have immediate feedback before you release that implantable device. So again, use a self-seal pouch if that's what you normally use. Use wrap as cassettes if that's what you normally use. Load your sterilizer the way that you would normally use it and run it in a typical cycle. So that gives you the steps for placement. But again, we have more expanded information on uh the step-by-step process. Also, uh, one quick reminder is that we don't want to run the control strip or the control vial in the sterilizer, because that control is what tells us that we have positive growth and we're comparing negative growth versus positive growth. So, with that being said, we want to also make sure that we're using the same uh control from the same batch. Typically, with a mail-in type of spore test program, the control is already in a sealed part of the mail-back program. With the vials, we want to make sure that we are not using uh the vials control uh vials test uh as an actual test. We want to use that to control from the same batch proving that we have uh killed all microbial life with the vial that has been run through the machine versus the vial that has not been run through the machine. Well, I'd like to call on my fellow divas. Uh Linda, you had a couple of comments you wanted to make um about how many people are not aware of in-office spore testing with using vials.

SPEAKER_03 24:05

Can you talk to us about that a little bit? Sure, Leslie. And all the offices that I've been in over the years, I find that the majority of them are using the mailback. And I think they're not always aware of the in-office options. And I think that's a viable option. And Mary went into that so beautifully and talked about even incorporating the hybrid approach and the different parameters. Just I like to remind offices, Leslie, that technology has really not just touched the exact care that we're providing patients, you know, crown in a day and digital impressions and everything, but it has touched our infection control and sterilization world as well. And so being aware of the changes there is really important to stay on top of. But Leslie, I wanted to also comment on something that Olivia said that really just rang, you know, resonated with me. And that was the whole logs and keeping the logs that that accountability piece. I've been saying for years that I think that we should add infection control or compliance in general and safety to the agenda. So when it comes up, they'll be sure to talk about it at the team meetings, as Olivia recommended. It's just so very important. And that ensures accountability because then the team member or members in charge of different aspects of the quality monitoring and a practice, whether it's the water lines or testing the autoclaves, then they know that they're going to be asked about this and have the data to bring to the meetings. And you and I know that if there's a failed test, they're going to address that right away. You're not going to wait to the next staff meeting to talk about a failed sterilizer test. But it just brings to point and reminds the doctor that these are being done and reminds everybody the accountability is so important. I've just recently worked with an office where the doctor has a board issue going on. And as he's delving into the different components of infection control in his practice, we uncover the fact that some of this poor testing hadn't been done for a couple of weeks. Not the quite the 12 weeks that you and Olivia knew of in that case, but again, it just gets dropped from somebody's radar. And I think it's just a great reminder. So thanks for allowing me to share that, Leslie.

SPEAKER_00 26:07

Linda, that's great information. And on the topic of dental boards, I know here in California, another dentist who was uh facing allegations with the dental board uh had issues where he had not printed out his spore test. In other words, um, the dental board wanted to see that these results were looked at by somebody. So there needs to be some kind of a system or a log where, as Olivia mentioned, maybe somebody's initials go through to identify that the spore test was viewed by someone. It isn't just relying on uh the mail-in company to contact you when you have a failed spore test, but you've actually validated the results yourself. And I know that Hugh Friday has a great program called Greenlight, where someone could actually be identified as the person who enters the data into the program to show that these are the results of our weekly spore testing. Now, I want to call on our diva Mary to tell us what to do if we have a failed spore test, in other words, positive growth. Should we panic, Mary?

SPEAKER_01 27:07

No, Leslie, you do not need to panic. But there are some specific steps that need to be followed if you had positive growth or failed spore test. The first thing is that you need to take that sterilizer out of service, you need to put a note on it, do not use, and you need to run another spore test. Before you do that, you may want to do some troubleshooting to see what might have caused that positive growth or the failure on the previous spore test. Most of the time, it's some type of operator error. The sterilizer is overloaded or the monitor is placed in an in a the wrong place in the load. There are many things. The other thing I would do is check the controls on the sterilizer, and especially if you have a newer sterilizer that has a printout, you can actually look and and make sure that your sterilizer met the parameters for sterilization, but something happened in the chamber with that particular spore test. So this is important in needing to know whether or not you need to recall some instruments as a result of that positive growth on a spore test. So we take it out of service, we run another spore test, and this is where having an in-office system would be very, very convenient because you could get the results of that second spore test in as few as maybe 20 minutes, depending on the type of in-office test that you're using, so that you could immediately put that sterilizer back into service after that spore test is run. Otherwise, if you have to send it out, wait for it to be analyzed, wait for the results to get back to you, it could be several days or longer, and you can't use that sterilizer in the meantime. So having a backup sterilizer certainly is important. I think in these cases, having that in-office system to get almost immediate results. Um, again, within 20 minutes, perhaps, depending on your system, would be very, very helpful. But make sure that you troubleshoot to make sure or to find out why that might have happened.

SPEAKER_00 29:32

Perhaps that are newer with their practice might have been told that usually spore test failure is not necessarily the machine, but it's operator error. We want to make sure that our listeners convey to their newer team members not to be afraid to report a failed spore test, that this is something that needs to be brought to the attention of, as you have mentioned, either the supervisor or the owner of the practice, so that the steps can be taken to make sure that it is something that is operator error. I mean, we do make mistakes, we're humans, and it's not a mechanical error of the machine. So immediate action should be taken, but not necessarily uh cause for alarm, for panic, or for embarrassment as a team member who's responsible for operating that sterilizer and running that spore test. So, Olivia, can you briefly tell us the steps to put a sterilizer back into service if we do have one that let's say does have a mechanical problem and has to go off to the repair shop?

SPEAKER_02 30:32

Sure, Leslie, it's important that we have a successful spore test before putting that sterilizer back into use. Simply because it was repaired or maintained by a service repair person doesn't mean that we can omit or skip that step. And Leslie, I would encourage our listeners to add that to their log. So think of your log as a running summary. So if there was a failed test, you make note of it, that you retested it. Maybe it's like Mary said, there's operator error. Or if you had to remove the sterilizer from use, put that in the log as well. And then when it returned, that it was spore tested to assure that it is operating properly and efficiently. So once again, just stressing the value of those logs or summary sheets. And this can be done with a live Google sheet, or you can use even a paper document and then scan it in, whatever your comfort level is on dealing with paper or electronic records, it's the important thing that we retain those records.

SPEAKER_00 31:44

Overall, in closing, sterilization monitoring is a critical part of maintaining a safe and effective dental practice, and it helps to ensure that patients receive the highest quality of care possible. A positive spore test should be taken seriously and investigated promptly. In closing, I'd like to thank the Hugh Friedi Group for being a sustaining sponsor of the Compliance Divas podcast. And remember, we bring clarity and simplicity to compliance by navigating regulatory compliance to keep you on course. Please submit your questions to support at the compliancedevas.com. I want to remind everyone that the resources that we mentioned today will be in the show notes of this podcast, as well as on the Compliance Divas website. You can submit your questions to support at compliancedeevas.com. Thank you, everyone, for joining us for this very special episode on sterilization monitoring.