The Compliance Divas Podcast
Our podcast covers current topics such as infection prevention and control, OSHA and HIPAA compliance for dentistry. We discuss the latest regulatory information, answer frequently asked questions and give suggestions for dental practices to make compliance easy and sustainable. The Compliance Divas are a trusted source for consistent, accurate information based upon current guidelines, standards, science, and recommendations.
The Compliance Divas Podcast
#167 Sterilization Monitoring Failures - Tips for Successful Remediation
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Sterilization monitoring, known as spore testing, is a key element in quality assurance for instrument sterilization. Join the Divas for a lively discussion about protocols to follow if a spore test fails, comparison of in-office vs. mail testing, developing a mediation plan and much more.
Resources:
- CDC Best Practices for Sterilization Monitoring in Dental Settings https://bit.ly/3L6HzXh
- CDC Breach response process document: https://bit.ly/3znzLxT
- CDC Patient Notification Toolkit: https://bit.ly/3XLbU5i
- HuFriedy Group Sterilization Solutions: https://bit.ly/3VQZ1nR
- Outbreaks and Infection Control Breaches in Health Care Settings: Considerations for Patient Notification https://pubmed.ncbi.nlm.nih.gov/32284161/
Welcome. I'm Leslie Cannum. I'm Mary Gavoni.
SPEAKER_01I'm Linda Harvey. I'm Olivia Wan, and together we are the Compliance Divas.
SPEAKER_03Welcome to this special edition of the Compliance Divas Podcast. Our topic today is sterilization monitoring failures and how to remediate them. The Compliance Divas bring clarity and simplicity by navigating the regulatory world to keep you on course. You can subscribe to our podcast on your favorite podcast app or on our website, thecompliancedivas.com. Any questions that you may have from this edition can be sent to us via email at support at thecompliancedivas.com. All the resources we discuss in this episode can be found in the show notes in your podcast app. And we'd love it if you would leave us a review and or some feedback on your podcast app. As I mentioned earlier, this is a special episode because it's brought to you by the Hugh Friday Group, who is one of our sustaining sponsors. Hugh Friday Group is a global leader in instrumentation, infection prevention, and instrument reprocessing workflows. They help dental professionals be the best in practice with the highest quality of products. With Hugh Friday Group, clinicians can reduce risk, improve efficiencies, drive compliance, enhance patient safety, and achieve superior clinical performance to continue to be the best in practice. And with us today from Hugh Friday Group is Nancy Kane, who is product manager for sterilization. So welcome, Nancy. We're happy to have you with us today.
SPEAKER_04Thank you for having me. Looking forward to it. You bet.
SPEAKER_03All right. So we are going to start out with our Diva Leslie to just review a couple of things with us so we everybody knows they're on the same page. And Leslie, can you talk to us about give us the CDC's definition of sterilization monitoring? And also what exactly is a spore test failure? Because there may be some newer employees out there who have no idea what a spore test failure is.
SPEAKER_02Yeah, Mary, you know, spore testing or sterilization monitoring is often called biological monitoring. And biological monitoring, again, also called a spore test, assesses the sterilization process directly by killing known highly resistant microorganisms. And because spores used in biological indicators are more resistant than common microbial contaminants found on patient care equipment, a negative spore test indicates that other potential microorganisms in the load have been killed. There are certain steps that one would take if they were to conduct the spore testing following the manufacturer's directions. And CDC recommends performing that on a weekly basis. And some demo boards require it on a weekly basis.
SPEAKER_03Thank you, Leslie. And one of the most important parts of that, of course, is that if you have a spore test failure, your sterilizer that failed must be taken out of service. You can't continue to use it. You need to run another spore test, but in the meantime, you can't sterilize instruments because you don't exactly know why that spore test failed. So the first thing is to take it out of service, conduct another spore test, and then if it passes the second time, it's okay to put it back into service. If it fails a second time, then according to the CDC, it must be serviced. So, Linda, let's go to you now and talk to us about the concept of a hybrid approach to spore testing, especially when we're looking at the need to perhaps do an additional spore test while that sterilizer is out of service.
SPEAKER_00Sure, Mary. In order to discuss the concept of a hybrid approach for biological monitoring, let's look at each one of the components first. Basically, a hybrid approach consists of using a combination of the mail-in service along with an in-office testing. So that way the office doesn't choose one or the other with a hybrid approach. It's rather it's a combination of both. So the mail-in service, to start with that one, consists of using the strips that are impregnated with four-forming bacteria that you run in the sterilizer. Most all of us are familiar with that technique. Then you place that strip along with the control strip in the mailback envelope and send it back to the company to run the test. If you pass, then the typically the written report just shows up, it seems magically, if you will, in your portal. They're very confident and confident about getting that to you. If you fail, all companies are also very conscientious about calling and or emailing you right away. So they give you the results as soon as they get the test, pretty much. It's very quick. But the downfall is you do have to wait for that service to be mailed across the country sometimes. It just depends on where you're located in the country and where you're actually mailing the test to as far as some time delay. But one of the benefits, as we all know, of using a third-party mailback service is just that it's that third-party verification of the sport testing and the results that are given. So that's in a nutshell how the mailback services run and one advantage of them. But Mary, we're seeing that a lot of offices are opting more now to use the in-office testing for the shorter turnaround time. Some of the in-office systems that are on the market now can give you the results in as little as 24 minutes. It seems when we think about how technology has revolutionized patient care per se, it's also revolutionized our world of infection control. So this in-office method consists of an incubator where you actually process the vials. And one vial is the test vial, and that's what's running the sterilizer, much like the impregnated strip that I just mentioned. And then you place that along with the control vial into the incubator for the amount of time according to the manufacturer's instructions for use. Now, Mary, one advantage of the in-office testing is that you, if you get a failed test rather, you get it sooner than later. So that enables you to implement your protocol for breach or failed test sooner than later. And then you can again, as you're testing in the office, you can get the next test back in 24 minutes again. So you can really conduct your testing pretty quickly if you should get a failed result. But the value, Mary, of using both of these techniques that we've been calling the hybrid approach is that now you have the best of both worlds. You can choose to use the in-office test protocol for three weeks out of the month, and then one week, that fourth week, do the mail back to the third-party company. So you have that third-party verification. So, Mary, again, I think the hybrid approach really gives a practice the best of both worlds and gives them a 360-degree view of how their sterilizers are working.
SPEAKER_03Thank you, Linda, for that great explanation. And I think all of us agree with you. And it's especially helpful, again, if it would take a really long time for a mail-in test to get to the processor. And although they would get the information back as quickly as they can, we may still have several days at least before that sterilizer could be used again if there was a failure. So I think that's a great approach. Get the third-party expertise, but also have a more timely test. And these new ones that are coming out with such short timelines are amazing for us to be a little bit more efficient, but make sure our patients are safe. So, Nancy, we're going to make you an honorary diva for today for joining us. And as the Hufridi Group is a provider of both types of systems, and of course has the ability then to supply a practice with a hybrid system. Can you share some insights and statistics with us regarding sterilizer failure?
SPEAKER_05Sure. And thank you so much for having me join you today. I'm really excited to talk about this topic. While in-office systems are growing in popularity, mail-in biological testing is still very popular. And it's estimated that over 60% of facilities perform their testing via a mail-in system. On average, about 2% of mail-in biological monitor tests that are submitted into Hugh Freedis Cross-Text Labs are considered failures. And there are over 3 million tests processed a year throughout our labs, which I always find just an incredible number, just shows how many people are out there testing their sterilizers. So that means about 60,000 failed tests a year are processed through our labs. And as you mentioned, all those failures are remediated with a trained customer care team. And many of the tools that you're going to be discussing today will help alleviate some of the potential stress that facilities might feel when they get a biological failure.
SPEAKER_03Well, I think that's really important that if somebody, especially, is maybe new to a practice or unsure of what the appropriate procedure is, that they have that support to walk them through what to do. What are some of the causes of sterilizer failures that you all have noted?
SPEAKER_05So it's difficult to determine exactly just based on running the test what the actual results of the failure would be. But the vast majority of failures are individual people mistakes. Either you're using the wrong type of test in the sterilizer, knowing what type of sterilizer you have and the and the process that it runs is very important to ensure that you're using the right type of test, possibly contaminating the test during the mailing process or during just the handling process.
SPEAKER_03So those are some reasons of for some failures. So it sounds like a lot of them are what we typically refer to as operator error. Leslie, did you have anything that you wanted to add to that?
SPEAKER_02Yes, Mary. And you know, I had not even considered Nancy's point about contaminating the medium in the process of removing it and mailing it. That's something that's new to me after all these years of conducting spore testing. And operator error, of course, is usually the first thing or wrong type of test, as she mentioned, but it can also be in operation of the sterilizer, improper loading or overloading of the sterilizer. And I think the divas all see this every day when we go into dental offices. Improper packaging.
SPEAKER_03Thank you, Leslie, for that additional information. Now we're going to call on our legal diva, Olivia, to talk about any potential legal ramifications of sterilization failures.
SPEAKER_01Sure, Mary, I'm concerned that there are numerous legal implications. For example, Mary, there could be dental board violations. You know, if we're not in compliance and handling sterilization monitoring correctly or following up on failed tests properly, then it could trigger violations with the state dental board. Let's say there's an allegation from patients that their infection resulted from non-compliance with proper sterilization, that can certainly trigger a malpractice claim from the patient, alleging that there's been negligence, uh malpractice on the part of the dentist or the dental practice. And what if all the patients came together, as we've seen in some other breaches? If those patients came together and hurled a class action lawsuit against the dental office, that's certainly a possibility. And of course, it's always stressful and embarrassing when a dentist faces discipline with the dental board. They could discipline the dentist's license, put the license on probation, or even suspend their license. I've looked at plenty of remediation and consent orders over the last few years. And it's it's painful for dentists. So that's why they have to be proactive in advance in making sure, not just thinking that their staff is taking care of sterilization monitoring, but looking at those logs, making sure there's a plan in place. If a test fails, what would happen next? And although I have personally not handled a case such as this, but have you ever thought about the implication for an auxiliary such as a dental assistant or hygienist even? Would they face disciplinary action if they were negligent in their role that's assigned to them? So these are multiple different scenarios of things that could go wrong and the possible impact it could have on that dental practice or dental facility, Mary.
SPEAKER_03Absolutely, Olivia. And I think as you so eloquently stated, it's pretty broad what could actually happen to a practice. And the other thing that we need to look at is what do we do if we know that there was a sterilization failure and there were a number of instruments used on a patient and or patients, and do we need to follow up with the patients? And that will be a separate podcast, but there's a lot of factors that come into play there. So look for a future episode talking about those potential breaches. So one of the questions I want to ask of the divas, and feel free to chime in, is should a practice have a written remediation policy?
SPEAKER_00Linda. I think that is of utmost importance because I'm all about documentation. And I think some of our key words in a dental practice should be what does our policy say? And that should be across the board, whether it's infection control, OSHAHIPA, or HR. So I think having that written protocol helps to have that. What do we do next when it occurs? We have protocols for fire emergency evacuation, handling a patient emergency. I think offices definitely need a protocol for what happens when there is a failed autoclave test.
SPEAKER_03And one of the greatest preventive measures we have, besides obviously doing those weekly spore tests, and that is the CDC's guideline, is weekly making sure that we check each package also as we take it out of the sterilizer. Check the integrator that's placed in each load, because that could be an early indicator that something may be wrong either with the sterilizer or somebody isn't following protocol for loading and placing that integrator and so forth. Leslie, would you just address? Because I know you mentioned this earlier in the podcast, the differences between a spore test and an indicator and an integrator.
SPEAKER_02Well, Mary, the spore test is looking for organisms that are highly resistant organisms. And then if we're looking at an integrator, an integrator is measuring of all the parameters that are needed to be met within a sterilization system.
SPEAKER_03Leslie, would you like to share with us, because you did mention it earlier in the podcast, I think it's important for our listeners to know the difference between a spore test or a biological indicator, a process indicator, and an integrator.
SPEAKER_02Mary, the spore test is going to be looking for the termination of all of the organisms within the sterilization cycle. And these are highly resistant organisms. So a spore test is your best way and CDC's recommendation to qualify that your sterilizer is doing its job, that it is working. Now, an integrated, if we were to use that, that would be something we would put into a load, and that would help us with a certain degree of accuracy that we have got a good cycle going. But more than that, it would be an early warning system. If something was not right, an integrator system would tell us that rather than a spore test that we might have to wait for, either if we mail away or for incubating on site. And an indicator strip is a strip that could go into each package or into each cassette inside next to where the instruments reside that helps us to determine that certain parameters are being met, not only on the outside of the package, but inside of the package, where the instruments are.
SPEAKER_03That is such a critical issue, Leslie. And you did a fabulous job of differentiating between all of the testing devices that we have. And I've seen those situations as well where people say, Oh, yeah, we we monitor our sterilizer every day. I mean, you seriously do a spore test every day, but it's an integrator, not a biological indicator. So that's very, very important.
SPEAKER_04Um, Divas, any final thoughts as we close out this episode?
unknownLinda.
SPEAKER_00Mary, I'd like to ask Nancy to repeat those statistics about the test. I think that was such an important piece of what all the things we talked about today, just to really help our listeners stay top of their game with the number of sport tests that are run, how many are failed. So they realize this does happen, and it brings back the value of having that protocol that we mentioned earlier.
SPEAKER_05Sure. When it comes to the mail-in tests that our labs process, we process over three million tests a year. Um, so you can imagine that's almost 15,000 tests a day that our labs are processing. And about 2% of those tests that we process are considered failures.
SPEAKER_04That's a big number. Thank you, Nancy.
SPEAKER_00That's really important.
SPEAKER_03Yeah, that is. Well, Nancy, thank you so much for joining us today. And we thank the Hugh Freedy group for their support and for allowing you to be here with us. The Compliance Divas bring clarity and simplicity to compliance by navigating the regulatory world to keep you on course. You can submit any questions about this episode to support at the compliancedivas.com. Resources that will be helpful for this podcast are in the show notes in your podcast app. And we just ask you to leave us a review or give us some feedback in your podcast app. Thanks for listening. We'll see you next time.