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
#235 Can Your Patients See What You are Saying"
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In this episode, we’re joined by a special guest, Dr. Anne McIntosh—CEO of the Safe ‘N’ Clear Communicator mask. Have you ever treated a patient with a hearing impairment, a patient who’s anxious, or someone with special needs? The Safe ‘N’ Clear mask is a powerful way to enhance communication and connection with every patient. Even better, it’s an ASTM Level 3 mask and FDA‑cleared for use in healthcare.
Safe’N’Clear, Inc. Changing the face of healthcare https://safenclear.com/healthcare-compliant-mask-protection/
Welcome. I'm Leslie Kenneth. I'm Mary Gavoni. I'm Linda Harvey.
SPEAKER_01I'm Olivia Long, and together we are the Compliance Divas.
SPEAKER_03Welcome to the Compliance Divas Podcast. I'm Mary Gavoni and I'm the moderator for this episode. We have a very special guest with us today, Dr. Ann McIntosh, who is the CEO of Safe and Clear, a manufacturer of a special face mask for allowing patients that are hearing impaired to read lips but keeping the user safe. Dr. McIntosh, as I said, who is the president of Safe and Clear, serves the community, teaching communication courses at the college and university level. Safe and Clear's current goal is marketing the world's first FDA-cleared transparent surgical face mask. The communicator enhances communication by allowing the user's face to be visible around the mouth. Dr. McIntosh holds a bachelor's degree in speech communication from the University of North Carolina at Chapel Hill, and a master's degree in interpersonal communication from the University of Montana at Missoula, and a PhD in communication sciences and disorders from the University of Texas at Austin. She is the author of three books, and Dr. Macintosh enjoys spending time with her spouse and children in their communication-friendly design home and gardens. Welcome, Dr. Anne. We're so thrilled to have you here today.
SPEAKER_04Thank you. It's wonderful to be here.
SPEAKER_03And Linda, we're going to have you start us off with a question for Anne.
SPEAKER_02Happy to do so, Mary. Dr. McIntosh, welcome. I'm looking forward to learning more about your mask today. And we know that your mission is to change the face of healthcare by providing clear communication for everyone. So we'd ask you to elaborate on that and also tell us your story along the way, if you don't mind.
SPEAKER_04Yes, well, my story is that I'm a college professor, as Mary has already shared, and in teaching communication classes, we have a sub-specialty called conflict resolution, where we solve problems. For any of us who have um experienced a communication breakdown or been in a relationship and someone said you said something, and we get have all these misunderstandings, right? So communication is very, very complex and we can have communication breakdowns. So we go in and try to solve some of those problems. So one of the things I do as a college professor is once we've identified that we've had a problem, we try to go back and figure out how to make the repairs on that so that we can then get it flowing again, and also to learn from that so that we can head off any potential problem from that as we go in and improve our communication competence and get better with our communication skills. So the story here is that after my husband and I got married and we started our family, it was time to go to the hospital and deliver the baby. And after 25 hours of labor, we still had not gotten the bundle of joy quite into our arms. And so the um doctor on call at that time said, I think we need to go ahead and do a C-section. So that was all well and good that we needed to do the C-section, but I had not prepared for the C-section, meaning I didn't know exactly what I was involved. I mean, I kind of knew a little bit, but I really didn't have the details. Um, and as a person who uh is profoundly deaf in both of my ears, one of the things I do to solve communication problems before they happen is I try to get all the scoop on it that I possibly can. What are the vocabulary words that I'm gonna be listening out for? What are the kinds of questions that might be asked of me? What are the kinds of um uh actions that they need, commands that they need me to do? So, what do I need to listen to so that I am a good and compliant patient with them? Um, and so I hadn't done any of that for the uh the C section. So I was kind of going in um and I felt like I was a student getting ready to get tested, and I hadn't studied, I hadn't done my homework yet. And so that is when you're the labor and delivery room, we can see everybody. The nurses will come in, the doctors, the CNA, and you can lip read, um, and you're very comfortable in the labor and delivery room. But when I go from there over into the OR, the operating room, where the procedure is done, now the environment is different. Everybody is garbed up from head to toe, surgical scrubbed all the way down to the booties on the feet, and of course the covered mas. So I was not able to follow anything. So here I am, college professor. My daytime job is to teach communication, got three degrees in communication, and now I can't communicate. Let's just say that was not good for business like that. Um, it was like, what do I do? If I hadn't changed, the environment changed on me. So now I was not able to function in this particular environment. And so that's where the idea of um the mask comes in here is to to develop that so that I can be able to see. Um, so important. 93% of the meaning of communication is derived from the nonverbal. 93%. So your mind was right, it's not what you say, but how you say it that matters. And so for people who are deaf or hard appearance or have other issues, they're not able to pull that in. So that became the mission of changing the face of health care. I knew that I was not the only person. Um, I was very fortunate, very lucky, everything went well. Um, the baby was delivered, um, everything was fine. But how many people did not have my experience in terms of outcome? How many people did not get good care or did not understand post op or something like that, and that impeded that? So that is why I said, you know, this isn't just about me. This is a larger issue. So we need to change the phase of healthcare so that we can improve that for everyone.
SPEAKER_02I just love that story. I mean, not that it happened, but I mean, the sh the the change that that drove you to is just really um it's super, it's very inspiring. And on top of that, I know our listeners haven't seen this yet, but they will. Your mask is clear. So people you can read somebody's lips. And in addition to your experience, Dr. McIntosh, everybody was experiencing that during COVID. So I think to some level, most dental professionals can't identify with what your experience was, even though we weren't in a labor delivery room OR. Um, and I know everybody was struggling with um meeting new patients, even and having a mask. I I saw some of my clients take a hand mirror that they might give their patient to look at their teeth and on the back of it put their picture so they could see who they were talking to. So this is beautiful that you have developed a mask that's clear in the front so you can easily read lips and understand. Because what our our offices and team members have done is they've gone back to their pre-COVID habits in order to talk speak effectively to their patients, they're taking their hand and pulling down a contaminated mask and then forgetting to take it off and wearing it around under their chin. So you've solved a multitude of problems. Thank you for joining us today. Mary, back to you.
SPEAKER_03Thanks, Linda, and thanks, Dr. Ann. Um, Leslie, our um Diva has shared with us in the past, shared with our listeners, that she is hearing impaired. So, Leslie, this of course is a a very um special topic near and dear to you. And talk about your own experience a little bit and and can you and Ann have a conversation about how patients really can benefit from this?
SPEAKER_00Well, Mary and uh Dr. McIntosh, I I think everyone would understand that when you uh wear a mask, you eliminate that visual for being able to read lips for people who are hearing impaired. And so many people in the United States are hearing impaired. It's like one in seven uh individuals has hearing loss. So I don't feel so much alone and isolated, although, in my situation, working as a dental assistant in the 80s and 90s, I um stopped working when masks became required in dentistry because I couldn't read my doctor's lips anymore. So I had no way of knowing what they were asking me for. And so uh today I I embrace my hearing impairments and I let people know in advance and and uh being up front about that really helps. So people turn toward me and speak to me so I can see them. And uh the other thing I I experienced myself as a hearing impaired person is that um in as a patient, when I was either in a dental office or in a medical office, uh, I always nodded my head to say I understood what was being said. And that was mostly because I was embarrassed to let them know that I really didn't understand what they were saying to me. And I really didn't want to take up their valuable time by asking them over and over again, what I didn't understand. Can you repeat that? Could you write that down for me? I wasn't really willing to advocate for myself as a patient, and I think that we must find that our patients, there's got to be the patient population that has lived in my shoes, has walked in my shoes and has lived my experience. So, really, how are we making sure as dental professionals that we've communicated the patient's health needs effectively to how they understand it? And you, as a communications expert, certainly would be the key person to go to for training on communication skills, asking the patient maybe to repeat back what they heard or what they thought they heard, or or uh maybe having some kind of a visual writing down or having a um something, a written sheet, a quick tip sheet on what you're explaining. But a lot of dental offices don't do that. So patients leave, they they may not understand valuable um instructions or tips that will help them to sustain their dental care, so home care instructions. They may not understand financial arrangements. Um, I remember one experience I had at a dental office. Um, the patient thought that I had said free when I said fee. And so I got in a little bit of trouble with the dental office with a patient that left thinking that that I said that the treatment was free when it was actually there was a fee for that. So um, if we can put ourselves in the patient's shoes, make sure we understand that not everybody is willing to admit that they're hearing impaired. And having a mask where you can bring that what you said, 93% of communication is seeing and how it's said, and reading lips and body language, all of that, we have to make sure that we tie that in together effectively so that we are delivering safe dental care to our patients.
SPEAKER_04And you're correct. One in seven people with hearing loss. Um, and it takes, on average, about seven years before someone realizes that they have a hearing problem that they can't hide anymore, that they can't fake till they make it. Um, and but that's just the hearing loss people. You have people on the autism spectrum that can benefit. We have neurodivergent people. We also have people where the ear works just fine, but they have central auditory processing issues at the level of the brain. And it mimics a lot of hearing loss. So while one in seven is affected, when you start adding some of the other disabilities, I think we can safely say that that number is probably more like one in five. But my number is 100% of people are affected by hearing loss. So I'm the one who has the hearing loss, but now my dental hygienist and my dentist is affected by my hearing loss. My husband, my children, my student, the person bagging my groceries, the person who is assisting me at the post office. Everybody is affected by the hearing loss. And so again, going back into that environment, I'm still that same person with the three degrees with the PhD, but can I communicate in those areas or not? Um, and so that that there is really vitally important. Um, now in terms of the dental assistants and the offices and so forth, helping them with the the clear mask, many times they're just not aware. And I'm actually working right now with a team of all-deaf dentists and all-deaf dental hygienists, and we are creating a curriculum for the American Academy of Developmental Medicine and Dentistry. And so we are very, very hopeful that we can put these tips that you're talking about, you know, where can people go, in language that they can understand because it is from the dental perspective. Now, one population that we haven't talked about here, which is near and dear to most dental offices, is no shows and late cancellation. Why do people just not show up for a dental appointment? Or why do they lose their nerve right before and do a late cancellation? My hunch is that these are what we call high dental chair anxiety. And so if you had that face mask, then you can see that warm, reassuring smile, and you're not looking like you're from outer space and Mars, and you've got these drills and these long needles, and you're gonna stick these things in my mouth, but then it can address the late cancellations, it can address the no-show, that affects their profitability. That affects their bottom line. In addition to you can't treat a patient who doesn't come to your office. So, again, this goes back to improving the quality of dental care because now you can reach more people. And Mary looks so nice and warm and friendly wearing her mask. And if she talks, I bet you can see that it doesn't fog. Because a lot, that's a one of the number one questions we get. Does this fog? Or we'll get questions where people call and say the mask is fogging. When it's really, I think they're glasses that are fogging. Um, because the film here itself does not fog.
SPEAKER_03And you're right, it does not, and it doesn't fog my glasses either because it's got a good um seal over the bridge of my nose. And contrary to the belief, as Linda um kind of alluded to earlier, that practitioners have to take their mask off in order to be heard. They don't have to with this mask because I'm guessing my voice is coming through very clear on the audio recording, even though I have this mask on. We can hear, but someone can read my lips and know what I'm saying. I love this mask, it's very, very comfortable to wear. And that leads us to our next topic, which is how does this measure up? Is it I alluded to before that it's FDA cleared, but what about ASTM rating and so forth? So, Olivia, take it away.
SPEAKER_01Dr. Macintosh, we are really impressed with your safe and clear mask. Uh amazing. But dental office environments are unique, especially compared to our medical colleagues. And what would you say the mask in detail about the ASTM rating? Because that would be important for us in dentistry and whether it's FDA cleared for use in healthcare settings.
SPEAKER_04So I'm gonna call this the more supreme of the mask because it does have FDA, uh it is FDA registered and cleared and approved. And there are masks out there that are not. And we saw that unfortunately during COVID when we were just rampant trying to grab a mask, any mask. Grandma was crocheting masks and giving those to people. I'm sure it was made with lots of love, but in terms of infection, disease, and control, you know, we were just all kind of freaking out about that. So uh it did get received FDA approval, the level one, um, back in 2016, and then in 2022 we had the level three. Um, so the AFTM standards are there, and the communicator level one and level three exceed the standard, the AFTM. So it actually performed um at that level or above. So that that is the good thing on that. Um, as Mary was talking about, these are earloops, they're not tie backs. Um, some people request tie back because I think they're used to tie back, but over time the tie backs loosen. So if you're in a procedure, you really can't go back and contaminate to retie. Well, as the earloop, the flexibility will hold and stay. Um, and you can twist that earloop if you need to. If someone has a smaller face, because this is kind of like a one-size-fit-aw mask, right? But people's faces um are all different sizes on that. Um, we also, in addition to FDA, in case you have any listeners on your podcast who are in Canada, this has the Health Canada approval. And if you have any um listeners from Europe, we also have the Europe CE mark of approval. So we have gone through and really filled out the paperwork and written the check to get these uh approvals for all these countries. So it really is um a really good mask. Uh, we just really want people to understand that it will solve so many problems for you that I think that people don't even realize that they have once you start using this mask.
SPEAKER_01And it seems like compliance would be achieved because I've been in some dental offices where as the other divas said, they would take their mask down to communicate, causing cross-contamination problems. And then also I've noticed that some that were not wearing masks because they had their lipstick and makeup all pretty, and they and then the last thing they want to do is cover their face completely. So you could still see their smile through the mask. And I think seeing that smile is so reassuring in in itself. So really a clever design, Dr. McIntosh.
SPEAKER_04And you know, dental hygienists have pearly white teeth and they whiten them and then claw cleaned up, and then you just go to your daytime job and just cover it all up. I mean, that's a real opportunity there to to role model and to show. And it can stimulate conversations. Maybe a patient will see something with the dental hygiene. What do you do for and it starts that oral health literacy? It it's that education. Well, I do this. Are you using fluoride or fluoride-free toothpaste and things like that? And those conversations maybe wouldn't have come up had they not been able to see the dental provider's face and and their mind.
SPEAKER_01That's a good point. Thank you.
SPEAKER_03Absolutely. Thank you for that great, great explanation. Um, and all the efforts that you've gone to to make sure that this mask is not only effective, but safe as well. Um, one of the things I'm sure that our listeners may be thinking about is, and we always have to deal with this is okay, how much more would this cost than a typical face mask? So let's talk about um, again, maybe select patients that we could use it with to introduce it into a practice. And I know that you have developed a statement of medical necessity that could be used. We don't, we can't guarantee effectiveness, but could be used to document for insurance companies. Let's talk about that a little bit.
SPEAKER_04So to be clear, let's give credit where credit is due. Those two wonderful women um out in Colorado, um, Kelly Watson and Terry Summer, who created the universal medical necessity statement. I just simply made the contact. So that's that was not me that did that. Um, but yeah, so this mask is 100% sourced and made in the United States. So we don't have to worry about uh supply chain interruption from overseas. We don't have to worry about TER or any of those kinds of things. So it is sourced and made here. Because of that, we will need to talk about the cost factor. So if you just look at our mask against another mask, our mask looks a little bit more expensive. But then I'm like, but this covered mask over here might be causing you cancellation, late show, lack of all the help. So this mask could end up costing you more and more and more money or to the patient later on. So long term, I'm To say that our math probably is a cheaper math, but back to your point, we are very sensitive to our customers and we listen to them and we're like, let's see if we can get some reimbursement value for them. So from both the dental and the medical, we're looking at that the CPT code 99070. And for those people who are really um tuned into this, that would be supplies and materials. And during COVID, I do believe that the people were able to get reimbursed because they were using so much in terms of sanitation, disinfectant, and those kind of things. Um if you can uh put that in and um and write a medical necessity of why this is important, rather than just assuming that this is going to be denied or something like that. Really, really push for this. Um CDT code 1999, that's unspecified preventive procedure. Take the time, if you take a few minutes and really talk and share this with someone, what they're doing, then they can make informed decisions about their dental care. So um there was a deaf woman out in Washington state who went in for what she thought was a dental cleaning. She came out and they had removed seven of her teeth. Seven. She said she did not know that, she was not anticipating that, and she said she did not agree to that. And they're like, oh, but you did, you signed this form. She did not know what she was signing because she was deaf. She had requested an interpreter, that request was denied, or the interpreter didn't come, so they proceeded with the procedure. So that's very, very unfortunate. Um, and that's all preventable. Going back to the communication thing, how can we prevent them? There's also CDT code D9999, which is unspecified adjunctive procedure. And a part of the uh CMS, your patient's rights, and your CMS infection control standard, this is really, really important. Pulling that mask down is such a big, big no-no. We shouldn't be doing it. And though they think that they're helping the other person, but in this day and age, when we now have the clear mask, it's unnecessary. You don't have to do that. We don't need to do that. Let's block germs and not block communication. Let's not put ourselves at risk or our patient. Um, so anyway, we have those codes, and actually I'm working with the two women that I was talking about that if there is a dental practice out there that is struggling to get insurance carriers to cover this, they would like to hear from them. What is the verbiage on the denial and the appeal? And they'd like to help them out with that. Um, I'm hopeful that the day will come that this becomes standard level of care and that everybody will be using this because we don't know what issues someone might be having that may or may not be diagnosed, may or may not be documented, but this can still help. And so we get the get that reimbursement in there. The dental providers will see that their patients are coming in. They will see that the patients are hearing them and complying with them. You know what your patients are doing in between those six-month checkups. Are they flushing? You can tell. You you'll ask them, are you flushing? But you're asking a question that you already know the answer to, right? You can see these kind of things. And so, are their patients complying with you? Well, they need to understand what you're asking of them so that they can take care of their teeth in between those appointments.
SPEAKER_03Well said, Anne. And what we will try to do is get permission to link that form um in the show notes so that people can access it and we can make a note that if um folks are having rejection of those getting that information back to those ladies so that we can sort of complete the circle here. Linda, you had something to to add.
SPEAKER_02Yes, Marie, thank you. So, Dr. Dr. McIntosh, I think that's a fabulous way to approach this because even if it's a little more than a typical mass that they're going to buy some discount, you know, dental buyers, it's important that your your not just the the communication with the patient has a cost associated to it, has a cost of non-compliance. And the cost of non-compliance could be a dental board complaint, your reputation, it could be a complaint with the American with Disabilities Association and other regulatory agencies. So why not spend whatever, even just a few pennies more? Or even if it's a few dollars, that's that's negligible considering the cost of and the headache of going down the other route and not having good communication with the patient. So thank you for sharing that story. That's a very powerful story about that dental patient.
SPEAKER_00Leslie, this is so new and unique that I think patients will talk about it and come to a dental office, see their hygienist or their dentist wearing this type of mask, and it might be a good marketing tool. Hey, in my dental office, they do something a little bit different, and boy, do I really like that. And I can understand what they're saying, and I can see their teeth, as Dr. McIntosh said, that that sometimes even the beautiful smile of the hygienist or or the that maybe there's some dental work that has been done on one of the team members that can perpetuate a conversation on how can I get that? How can I get that smile? How can my teeth look like that? They're so white, your teeth look so straight, or et cetera, et cetera. Thank you for that, Dr. Mackosh. I've got a lot to think about and a lot to share with my clients and audiences.
SPEAKER_04Oh, thank you for sharing that because I would work in with a uh dentist in West Virginia who specialized in pediatrics, and he would say that sometimes he would be doing a procedure. He said, really, in actuality, it should take 10 minutes, but it would actually elongate and take maybe 45 minutes because he would have to stop, he would have to uh reassure the pediatric patient, calm them down and all that kind of thing because everything was just so scary. And so he said, you know, with the clear face mask, he had hoped that it would reduce the amount of time for a procedure to be able to do that. And I'm like, it would absolutely save you time on that. And it will also help um in terms of uh, you know, being in compliance. We want to be in compliance, but you're talking about all the liabilities and other kinds of things. You can buy a whole lot of mass for what you pay with an out-of-court settlement. Um and and then uh and then just the pain and the suffering that someone goes through if they lose seven of their teeth or something. Um, you know, so different issues like that do have a cost factor to that. But the side cost of using other masks, I think is huge. We just haven't really connected all the dots for that. But we offer professional development workshops. We can work with dental hygiene programs across the country. We can work with the dental school, with the deans, or the other uh with dental practices. No, no practice is too small if they have questions and to work with them and show them how how this can be be helpful for them. Um, and of course, it is expensive, but if people will buy by the volume, you talk about you know getting started, so people can buy a box, they can buy a case, or they can buy a pallet. And if you're in a city and you are colleagues with your competing dentist in the area, they can all go in together, purchase a pallet, save on shipping and cost, and then they can divvy it up once it's up there. So again, going back to we can be creative about how to get this into the hands of the people who really need this at a price that is cost effective for them.
SPEAKER_03That is awesome. You are such a visionary, Anne. I I love it. Um, and such a powerful tool for um improving the communication with our patients. Thank you for sharing your story. Thank you for sharing your mission with us. And I just want to reiterate that this is a mask that is FDA cleared as a medical device for use in healthcare. It comes in an ASTM level three mask, which is what we recommend for um aerosol generating procedures in dentistry, and we'll make sure that in the show notes we have contact information for your company safe and clear, and we'll link to your website and and we'll try to get that statement of medical necessity linked as well. And just and cannot thank you enough for um, first of all, for reaching out to us and saying, Hey, I have this mask, are you interested? And uh, my immediate reaction was, oh, of course. And this is just this is fabulous. So thank you, thank you, thank you. The compliance divas bring clarity and simplicity to compliance by navigating the regulatory world to keep you on course. You may submit questions by email to support at thecompliancedivas.com. And the resources we mentioned in this episode are listed in the show notes section of your podcast app. We invite you to subscribe to the podcast so that you never miss an episode, and also to leave us some feedback on the podcast app that you use. Thanks for listening.