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FDA Red Flags
FDA Red Flags Webinar
FDA Red Flags Webinar
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I encourage you to be here today to learn more about the importance of red flag roles and how these roles affect your businesses. Your moderators for today are me, Keri Peterson, Project Supervisor, and me, Pran Vincent, IHS Marketing and Membership Manager. Our expert presenter today is Chris Gustafson, ACA, ECHIS. Chris is the owner of Evergreen Hearing Center in McMinnville, Oregon, and has long remained an active member of the hearing health care community. He has served as a board member and past president of the Oregon Hearing Society and is a former member of the board of directors for the National Board for Certification in Hearing Instruments Sciences. Additionally, Chris was also on the Governor's Advisory Council on Hearing Aids for the Oregon Hearing Licensing Agency. In addition to being a graduate of the IHS American Conference of Audiopathology Program, he also holds an Associate of Applied Sciences from Spokane Falls Community College and a Bachelor of Science in Psychology from Western Oregon University. Please note this presentation highlights recognized principles commonly found in the legal arena, but in no way connotes or should be considered as legal advice. It is recommended you consult your legal counsel for specific advice regarding legal matters that may be pertinent to you. No relationship exists that represents a potential conflict of interest or special business relationship between the International Hearing Society and Chris Gustafson or Evergreen Hearing, nor any of its principals or employees. We're very excited to have Chris as our presenter today, but before we get started, we have a few housekeeping items. Please note that we are recording today's presentation so that we may offer it on demand through the IHS website in the future. This webinar is available for one continuing education credit through the International Hearing Society. You can find out more about receiving continuing education credit at our website, IHSinfo.org. Click on the webinar banner on the home page or choose webinars from the professional development menu on the left side of the page. There you'll find the CE quiz and information on how to submit it to IHS for credit. Also on the webinar page at the IHS site, you'll find the slides from this presentation to help you gather the information you'll need for the CE quiz. If you haven't already downloaded it, feel free to do so now. Tomorrow you will receive an email with a link to a survey on this webinar. It is brief and your feedback will help us create valuable content for you moving forward. She emailed me or texted me last night and said they were not available. Today we'll be covering the following topics along with Q&A within a 60-minute presentation. Learn the importance of the FDA and STC red flags. Discover how FDA red flags relate to a series of medical conditions. Explain STC red flags and how they relate to marketing and policy. At the end we'll move on to a Q&A session. You can send us a question for Chris at any time by entering your question in the question box on your webinar dashboard, usually located to the right of your webinar screen. We'll take as many as we can in the time we have available. Now I'm going to turn it over to Chris who will guide you through today's presentation. Chris? Welcome everyone. I'm glad to see you are here that you're signed on and listening to this. Today we're going to cover the FDA red flags and why they are so important. I have sat in many meetings and brought up the question of what are the eight specific red flags, only to find that we can name off six or seven and there's always one or two missing. So we're going to go through them one by one and in detail. The first one is a visible, congenital, or traumatic deformity of the ear. The second one is active drainage from the ear within the past 90 days. The third one, sudden loss within the past 90 days. The fourth one, reported acute or chronic dizziness. Number five is unilateral hearing loss of sudden or recent onset within 90 days. Next one is an ear bone gap not greater than 15 decimals. Next one is reported ear discomfort. So let's go through each one of these in detail. Okay, number eight, excessive cerumen or foreign body within the ear canal. Whenever we see an ear that is deformed, whether it is congenital, meaning from birth or acquired, which is since birth, or from trauma, we can identify this through observation, questioning our patient, the patient intake form, and their health history, and then we need to refer them on to a physician for medical clearance. A congenital deformity means that this is a condition that has existed since birth, can be from development, deprivation, or from some disease process. A couple of forms of congenital deformities, the first one is microtia, which is abnormally small ear canals or ears, and atresia, which is a congenital absence or complete closure of the ear canal or an absence of the external auditory meatus. This may be accompanied by underdeveloped or undeveloped metal ear ossicles. Acquired deformities would include exitosis. This is a bony growth arising from the surface of the bone within the bony portion of the ear canal, resulting from prolonged exposure to cold water. This can result in a narrowing closure of the ear canal near the tympanic membrane. Osteoma is a single benign tumor resembling cortical bone occurring at the tympanomassoid structure line, and tends to have a narrow base. Often this can result in the narrowing or closure of the canal near the tympanic membrane. Acquired deformities, including traumatic deformity, we're more apt to see this coming into our office as the veterans coming in have been exposed to violent explosions, extreme noise, or an embedment of a foreign object. Other trauma-induced conditions may result from a blow to the head or result from cauliflower ear. Disease-induced deformities may include benign or malignant tumors, metal ear or external ear questiatoma, melanoma, and mastoiditis or mastoidectomy. These deformities may result from previous surgeries such as a mastoidectomy. Oftentimes this may be overlooked with a handheld otoscope, where a video otoscope may be more revealing. Your patient history questionnaire should be revealing this fact. We need to ask the questions. The second item is active drainage from the ear within the past 90 days. Supertivotitis media, that is an acute or chronic otitis media with infected fluid or separation and inflammation of the metal ear with infected fluid. This is usually most evident to the dispenser from the odor at the ear or on the ear mold. Another cause would be staphylococcus. These bacteria are one of the most common forms of acute or chronic external otitis. With extreme cases of a staphylococcus, the external meatus may be entirely closed. There may be edema, which is swelling due to abnormal accumulation of fluids, exudates, which is an infected fluid substance discharged from the cells of the blood vessels. It's basically pus. After staphylococcus, the patient will report having pain at or near the ear. Staphylococcus usually responds well to antibiotics. Now this may be more prevalent with swimmers, and it's more common in hot and humid climates. Staphylococcus bacteria is one of the most common forms of acute or chronic external lenticulitis. Another cause would be otomycosis. This is an infection due to a fungus in the external auditory canal. Most common complaint is of itching. This infection has a pH of 4 to 5, and so it suppresses both bacterial and fungal growth. Aquatic sports, including swimming and surfing, are particularly associated because of the repeated exposure to water, which results in the removal of cerumen and drying of the external auditory canal. This bit of information should be helpful to us in counseling our patients in not using the Q-tips and trying to remove all wax from their ear canals. The wax does have a purpose. The third red flag is sudden loss of hearing within the past 90 days. Any reported sudden or rapidly progressive hearing loss should set a little red flag waving in the back of our minds and saying, hey, we need to refer. The causes of a sudden loss may be from trauma, infection, disease, cochlear stroke, acoustic neuroma, ototoxicity, or allergies. In some cases, with prompt medical attention, the loss may be reversed. So refer these patients immediately. Sudden loss due to trauma will result from head injuries, can be causing a mechanical bone fracture, concussion, direct injuries to the middle or inner ear, barotrauma, which is a drastic air pressure changes. These are common with water skiing and scuba diving accidents. Sudden loss due to a disease would include influenza, scarlet fever, whooping cough, meningal encephalitis, viral cochleitis, the mumps, measles, chicken pox, diphtheria, and herpes zoster otitis. Several disease may be from meningitis or bacterial albinitis. A story that I want to share with you is a patient came into my office many years ago. She had a profound hearing loss, and she walked up to the desk and said, my hearing aid has died. But as she's handing me her hearing aid, it is squealing with feedback. I listened to it, I analyzed it, and I came back and said, when did your hearing aid die? She came back and said, yesterday. Well, I got on the phone at that point in time, called a friend who is a doctor, asked him what he would like me to do with this. He said he wanted her checked into the hospital in Portland, which is an hour away, by 4 o'clock that afternoon. Now, in this case, it happened to be the last working day before Christmas. I got off the phone, told her she had to go to the hospital and check in by 4 o'clock. She said, no, Christmas. I'm not going to the hospital. Her husband said, she will be there. And they left. Now, in this case, they put her on a regimen of various medications, trying to save the hearing. Unfortunately, it was beyond saving. They ended up saving her life. If not her life, her mental faculties. She was diagnosed with having had congenital syphilis. She had no idea that she had the disease. She had been born with it. Her mother had had it. We weren't able to save the hearing. We saved her life. And she became a candidate for a cochlear implant, which she is wearing today. Sudden loss due to medications, aminoglycosides, are a class of antibiotics used in treating infections caused by gram-negative aerobic bacteria. All of these are ototoxic, and to some degree, most of these are vestibular toxic. Now, aminoglycosides, I'm not going to go through each and every one of these, but I can talk a little bit about some of them. Neomyosin is used quite heavily still today. Neomyosin is used. Tereptomyosin is not used as often today. Couple that aren't on here, erythromyosin, is not ototoxic in itself, but when mixed with aspirin or with ibuprofen, can cause a temporary shift. And if the person is on that combination for any length of time, that temporary shift may become permanent. So basically, any of the myosin family drugs, we should look at as being suspect. We can check with a PDR, a physician's desk reference, we can check with a pharmacist, a doctor, find out if these drugs are being used, and if that is causing changes in their hearing. If so, we need to be monitoring the hearing and keep up with it and keep in touch with the doctor. Other ototoxic drugs, salicylates, which is aspirin, iodine, sulfa drugs, and quinine. Again, quinine is used for treating malaria. Hearing losses due to tumors in the middle and inner ear include comus tumor, osteoma, middle inner carcinoma, a cholecytoma, and an acoustic neuroma. The fourth red flag is reported acute or chronic dizziness. First we must understand the difference between dizziness and vertigo. In either case, these patients should be referred to a physician for immediate investigation. Dizziness is a general term referring to the inability to maintain normal balance, and it can be described as nausea, hyperventilation, asphyxia, or faintness, a lightheadedness due to circulatory problems, or the sensation of spinning. Vertigo is a vestibular symptom affecting the spatial nystagmus. A nystagma is an uncontrollable, rapid fluttering of the eye. The patient will report to having a spinning sensation or senses that the environment is spinning around. The causes of this may be from medication, a serious auto-pathological illness, vestibular dysfunction, acoustic neuroma, viral colitis, or cochlear stroke, or from a near syndrome or disease. Meniere's disease is also known as endolymphatic hydrops. This is pathology affecting the inner ear and results in a sensory neural hearing loss, tinnitus, and vertigo, and a sensation of ear fullness. These symptoms may appear separately or simultaneously. Now with Meniere's, the hearing loss can fluctuate, usually affecting the lower frequencies at first and spreading to all frequencies as time elapses. That fluctuating hearing loss resulting from this makes it difficult to fit a hearing aid, one that needs a wide range of adjustability for the patient to have control of that during those fluctuations. The fifth red flag is a unilateral hearing loss of sudden or recent onset within the past 90 days. Trauma and disease are generally unilateral in nature and should be referred to a physician prior to proceeding with the auditory rehabilitation. Some of the causes of a unilateral hearing loss may be from Meniere's disease, acoustic neuroma, interlymphatic fistula, trauma, autoimmune disease, perforation of the tympanic membrane, cholesteatoma, and otitis media. The sixth red flag is an air bone gap 15 decibels at 500, 1,000, and 2,000 hertz. When an air bone gap of 15 decibel or greater occurs at 5, 1, and 2, it indicates that there is a potentially significant medical treatable condition. Some of the causes of an air bone gap would include at the outer ear and canal, a closure of the tragus, a collapsed canal, atresia of the external ear, obstructions in the external auditory canal, accumulated cerumen or other debris before an object, external otitis, fungus, tree, and cancerous growths. At the tympanic membrane, an air bone gap may result from a perforation, post-infection or surgical scar tissues, a thickening of the tympanic membrane from tympanosclerosis, extreme flaccidness of the tympanic membrane, fluid, a cholesteatoma, or glomus tumor. Within the middle ear, there may be otosclerosis, a disarticulation of the acicular chain, otitis media, mastoiditis, a cholesteatoma, or again, a glomus tumor. Reported pain or discomfort is the seventh red flag. The patient may report to having pain in or around the ear, which may be, indeed, from, related to the ear, or may be a result of men having their joint syndrome, the ITMJ, or orthodontic abnormalities, such as a dental oversensitivity or sinus problems. These should be reported unless they are under the current care of a physician or a dentist. With visual assessment, we should be able to determine the presence of swelling, the absence of a cone of light on the tympanic membrane, redness or drainage in the ear canal. Serious ear disease, trauma, or acquired abnormalities may also be the cause. All of which should raise that red flag waving again and refer to a physician for immediate treatment. The eighth red flag is the excessive pseudorumen of a foreign body within the ear canal. Impact of pseudorumen may cause a conductive hearing loss, increased incidence of tinnitus, a chronic cough, jeering eyes, interaural attenuation, and complaints of occlusion. Depending on the sensory neural hearing loss, the audiometric pattern may be worse in the low frequencies with someone with normal sensory neural hearing to a flat loss configuration with one with a high frequency hearing loss. What's gonna happen with impacted pseudorumen is we're gonna have obstructed ectoscopy at the canal and the tympanic membrane. The inability to perform impedance audiometry and acoustic reflexes, inaccurate audiometric test results, an inability to perform probe mic measurements, taking an ear impression, we cannot get a good, accurate ear impression, and the use of a hearing aid may cause excessive feedback or reduce hearing. Significant but not impacted pseudorumen may result in the loss of natural ear or canal resonance, inaccurate probe microphone, inaccurate tympanometry, obstructed view of the canal and the tympanic membrane landmarks, a pseudorumen adhering to the tympanic membrane may cause the interaural attenuation and elevated hearing thresholds. Taking an impression of an ear with impacted or significant but not impacted wax may cause that pseudorumen to become impacted. So, having completed the eight red flags for the FDA, I'd like to move on to the FTC red flags and what that means to the dispenser. According to the Federal Trade Commission, their mission is to prevent business practices that are anti-competitive, deceptive, or unfair to the consumers. The Federal Trade Commission works for the consumers to prevent fraudulent, deceptive, and unfair business practices and to provide information to help spot, stop, and avoid them. In our advertising, if we use expert endorsements, if the ad claims the endorser is an expert, the endorsement must be qualified as that expert. Endorsements must be supported by actual exercise of that expertise in evaluating the product. Comparison claims must be based on the expert's evaluation. With endorsements, the focus is on the consumer's perception of whether the message is an endorsement. The fundamental question here is whether the relationship between the advertising and the speaker is objectively such that the speaker's statement can be considered sponsored by the advertiser. If it is, then this is an endorsement. Examples of expert endorsements. If a hearing aid ad where the endorser is referred to as doctor implies that the endorsement implies that she is a medical doctor, the ad must make it clear the nature and limits of the endorser's expertise. General considerations in our advertising, false and misleading. If a doctor claims a product is clinically proven to work, even though she knows a clinical study has serious flaws, then it would be false and misleading. If a company pays a blogger to try a new product and write a review, the company becomes liable for claims the blogger makes about the product. And the blogger is liable for misleading or unsubstantiated claims and is liable if she fails to disclose clearly and conspicuously that she is being paid. In our advertising, if we take a manufacturer's ad and change it, we need to send it back to the manufacturer for approval before we print and publish the ad. You may be liable as well as the manufacturer if the ad is not accurate. Unsubstantiated and false claims, a couple of examples came to light. With Dahlberg in 1995, the hearing aid manufacturer claimed the product would enable persons to distinguish and understand speech sounds in group or noisy situations. That it would restore the natural hearing and could reverse, halt, or delay hearing loss progression. The FTC concluded that the claims were unsubstantiated and false. Failure to disclose the material fact that a person may not receive any significant benefit from any hearing aid was a violation of the 1996 FTC order and their settlement was 2.75 million. In another case, a marketer of a metal bracelet that was allegedly electropolarized claimed the product really paid. The product was promoted in 30-minute infomercials and on the internet. The FTC concluded that the claims were unsubstantiated and false. Clinical testing showed the product was no better than a placebo. The settlement here was 400,000. Providers who allow deferred payments must comply with the FTC ruling by August 1st of 2012. The interim final rule narrows the circumstances under which creditors are allowed or covered. It went for release and became effective November 30th of 2012. Under the FTC rule, the Red Flags program must have four parts. As a business owner, I think each and every one of us need to be paying close attention to this. First, the program must include reasonable policies and procedures to identify signs or red flags of identity theft in the day-to-day operations of the business. Again, that first program, reasonable policies and procedures to identify the red flags of identity theft. The second, the program must be designed to detect the red flags of identity theft identified by the business. Third, the program must set out the actions the business will take upon detecting the red flags. And finally, the fourth one, because identity theft is ever-changing, a business must re-evaluate its program periodically to reflect the new risks of this crime. A story I'd like to share with you involves a customer coming in to buy a hearing aid. John Doe walks into your office, says, I'm having trouble hearing. You have John fill out the patient's history questionnaire. And when completed, you take him into your test suite and you sit down and discuss his hearing, where he's having trouble, how long he's at it, has he seen a doctor? You're going through everything, doing everything right. You move to the next step, you take the otoscope, take a look in his ears, everything's clear. You put him in the booth to do the hearing test, and sure enough, John has a moderate sensory neural hearing loss. He comes out, you sit down and discuss with him the various options, how a hearing aid can help him, the benefits of the hearing aid. You discuss the different levels of technology. And John asks a few questions, he's talking with you, he's a friendly guy. At which point he decides he would like to get the best. So top line, hearing aids for him. And he asks you if he can have this on a trial basis. And you explain, sure, we have a 30 day trial. He says, if I like them and I think I will, I'll be happy to write you a check in full at the end of the 30 days. So the hearing aids are ordered, you set up his appointment to come back 10 days or two weeks later to get his hearing aids. And very promptly, John comes back two weeks later, in fact he comes in early, and he sits there chatting with the receptionist. You bring him back into the fitting room and you get him all fit up, you do everything right, you're doing the real ear measurements, speech mapping, whichever, and everything looks good. He says, oh, these sound great. So you set up the appointment for him to come back a week later for his follow up. A week later, he shows up early again, he sits there and chats with you and the staff. Friendly guy. You get him into the programming area and he says, but in this situation, it's too loud. And it still sounds a little tinny to me. So you make adjustments to the instrument. Counsel him on usage and make sure that he's learning to adjust to the new instruments. At the end of the appointment, you set up another appointment for his follow-up a week later. The next week comes around and John doesn't come in. A little bit of concern, you instruct your office staff to call John and see him, you know, remind him he missed his appointment. The receptionist makes a phone call only to come back and say, John's number's been disconnected. Okay, let's send him a postcard or a letter saying, hey, we missed you on your appointment. We need to get you back in here. And include the bill. So the billing goes out with the notice to give us a call, come on in. Three days later, a gentleman walks into the office, throws a letter down on the table and says, what is this? I didn't buy any hearing aids. You are the victim of identity theft. The patient or the gentleman standing there at your desk with the letter is a victim of identity theft. What we need to do is educate our staff, keep our programs current. Now, one of the things that I've been really aware of every time I go into a dentist's office or a doctor's office, the first thing they ask for is a copy of your driver's license. Get the photo ID of anybody that you are putting on a time payment plan or putting out on trial of a hearing aid that you haven't received to check up front. Cover yourself, protect yourself, but get the photo ID. Make sure the person that you're talking to is the person he says or she says they are. One more story that I'd like to share with you, it was in yesterday's news here in Oregon. The Attorney General has filed suit against the five-hour energy company for misleading advertising. So it's not just the FTC that can file suit against you. Other people are watching your advertising. For references on the FDA, I use the Singular Illustrated Dictionary of Audiology, a website called patient.co.uk had excellent information, comes out of England. Use the WebMD Health Search. An article written for the hearing professional four or five years ago was the FDA Red Flags Video Otoscopy Observation and Referral, written by Matt Chartrand. I would highly recommend reading through that. It is an excellent article. It is available through IHS website. And if you type in the FDA, I started my search with the FDA Red Flags. Max's article popped up there as well, but excellent article. I'd highly recommend reading through that one. And from the help of my wife, and making sure that what I was writing and what I'm saying is accurate. On the FTC, in FTC Red Flags, it's going to pop up there. The biggest thing that comes up is identity theft. I'd also like to thank Jeffrey Gibbs and the Hearing Industries Association for his presentation at their meeting four years ago. Jeffrey is an attorney with a firm specializing in FDA and FTC. So at this time, I'd like you to enter your questions into the test box, and I'll be happy to answer your questions. Thank you, Chris. We're so excited that 160 of your fellow colleagues have joined us today on the webinar. We do have some time for your questions. If you have a question, please enter it in the question box on the webinar dashboard. Our first question is, if this was a life-threatening condition, and the patient refuses to seek medical care, do you have a responsibility to report this? If a situation like that came up, you will definitely want to encourage the patient to see a physician. And if the family members are present, encourage them. But there are some religions that say, hey, I'm not going to go see a doctor. So we can't force them to do that. If they refuse to do that, the best thing that we can do is, certainly we can help them with fitting a hearing aid, but we definitely want to make sure that it's well-charted in our chart notes, or having them sign a form that says, hey, I definitely refuse to go see a physician. We can't make them do it. You know, they may say, no, I'm not going to go. We have a choice. We can say, well, no, I'm not going to fit you. But if we do decide to go ahead and help them with hearing aids, definitely make sure it's well-charted. That seems fair enough. Our next question is, what do you need to do as a business owner if a laptop containing protected patient information has been misplaced, leaving these patients open to identity theft? We need to make sure that our office policies are, you know, the files are put away. The computers are such that, you know, you don't want to have one patient's records up on the screen of your fitting computer while another patient comes in. We need to close those operations out. And we certainly need to be sure that we've got the firewalls in place on our computers to protect us against anybody coming in and accessing our computers. Basically, it's the same requirements here as it would be for the HIPAA requirements. So hopefully everybody is following those rules and making sure that one patient doesn't see information from another patient or have access to the information. So keep our policies in place and evaluate them on a regular basis. Take a look around the office. Make sure that we've got things put away. Perfect. Speaking of keeping policies in place, our next question is, in order to be compliant with the FTC, should your compliance plan be available in writing? I would encourage you to sit down and fill out your policy. Have everybody in the office aware of what the policy is. If you suspect some form of identity theft, how are we going to notify the patient should be on that policy? What steps are we going to do to make sure that it doesn't happen again if it has happened? But protect yourselves. And the policy, having it a written policy, is definitely one that I would do. Thanks. And our next question is, should you proceed with a hearing aid sale if the patient presents an expired or out-of-state license or ID? If it's expired, the photo ID is going to say who it is. I would ask for other forms of ID. How do they get there if their driver's license is expired? I think we could ask them to bring in some other form of identification, something with another photo on it. Or provide two. I know dealing with various insurance companies and companies, finance companies, they're asking for the forms of identification be photocopied and in your file. And they're requesting two forms of identity protection there, whether it's a driver's license or a military card. Even a Costco card has a picture on it. So whatever it takes, you want to get the copy. And you want an accurate one. Fair enough. The next question deals with a patient that you may suspect of having pre-dementia, but they've come to your office a month. Could you go that extra step to try and find a contact person for them? I would highly recommend that. I've seen more cases of sales being made to somebody with dementia, only to find out that the family says, no, the person has dementia. They don't have that capability of making that decision. So it's always wise to have family members attend, if at all possible. But in a case of dementia, make it mandatory. Keep the family in there with you. Sure. Thanks, Chris. Our next question is, and it's more of a statement that somebody uses, it sounds like at the end of their telephone call, they say, make your appointment in here better soon. Is that an overstatement of advertising and possibly subject to liability fees? No, I don't think so. In my advertising, I say, hey, better hearing begins at Evergreen Hearing Center. That's what we're about, is, you know, if a person puts in there, make your appointment here better soon, I don't think that's inaccurate or misleading in any way, shape, or form. I think that's perfectly acceptable. Okay. Our next question is, you have an experienced user of 20 years who has an ear bone gap that they have had for a long time. Do you refer the patient or fit with new hearing aids? If it's been medically cleared. If they've seen a physician about that in the past and you've gotten medical clearance in the past, I would encourage them to see the physician, but if they say, no, I don't want to, I'm not going to push it. Now, a situation that came up for myself here recently where a doctor's office called and said, send us a copy of the audiogram for this individual. And I opened up the test file, and here's a beautiful 40 decibel ear bone gap. And I was like, oh, my God, I fit a hearing aid on this person with that much of an ear bone gap? Couldn't believe I would do such a thing. Well, digging a little deeper into the file, here's a referral from the physician saying fit this person with a hearing aid, so I was like, wow. But, yeah, in his case, he had medical referral. He had seen the physician. Several of these have popped up here recently where I've run into that. And you want to encourage them to see the doctor, we should be encouraging everybody to see the doctor. But if they say, no, I've already been that route, I would proceed. So, hope that answers your question. Thanks, Chris. Our next question, we have somebody who wants to know if you recommend having a web camera or another type of camera in the office to take a picture of your patient to have in the file along with a copy of the other ID they provide. I think that's an excellent option. The one thing that we don't want to do is be recording a session unless we have the patient's permission to do so. If you're videotaping a session or sound recording it, you need to have signs up saying that you're doing so and have the patient sign a form saying yes, they authorize you to do this, whether it's for training purposes or whatever. But having a photo taken and stored on the computer that says who you're, I mean, that gives you a picture right there. So, nothing wrong with that. Thanks. The next question is, what should you do as a professional if you suspect abuse of any kind? As part of the allied health community, we are required to report abuse, elder abuse or not. It doesn't matter what age the person is. If we suspect it, we should be making a phone call. The phone calls can certainly be unanimous. They're not going to come back and say, oh, he turned you in or he's called that in and reported that. But not only for abuse, but if we see a patient that's driving, 90-some years old, and you look at him as he drives away in a very unsafe manner, almost causing an accident, we should be calling that in as well. But abuse should be reported. If we suspect it, it needs to be investigated. Sure, Chris. That sounds appropriate in that case. Our next question is, does the asymmetry have to be three consecutive frequencies for a medical referral or any asymmetry? X-ray frequencies? If it's a significant asymmetrical loss, we need to find out why. So that should be referred. And is it something that's been there a long time? Have they seen a physician before on this? Anytime that I see an asymmetrical hearing loss, it makes you think, where did that person go that he took one ear and not the other one? What happened to that one ear? Unilateral losses or an asymmetrical loss, there's something that's gone on there that's caused that problem. We need to investigate it and find out why. They should be referred. Okay, Chris. Our next question has to do with the question we talked with before about abuse. And somebody wants to know, if you're going to report abuse, who should you report it to? The police? A doctor? Family? Who would be the most appropriate person for you to do that with? If you have a patient's doctor's name from your patient history questionnaire, you have a person there. It could be the police. It could be the social services, whoever is working with that patient. So, if in doubt, check with the police department. Good advice. The next question asks, should they refer someone who has a significantly different word recognition score between ears? That is another, it becomes asymmetrical in that case. So, speech testing scores, if the hearing loss is similar in both ears, and you have one that's a low score and the other one's a high score, there's something going on there and they need to be referred. Okay, Chris. We have time for one more question. And this deals with credentials that equate expertise. What are some of the more common credentials? What should you do? What type of proof should you keep on file? Should somebody question your credentials or if you're up to date on them? Well, your license should be posted in a conspicuous spot so the patient can see that. It's required, I'm sure, by most states, if not all. So, those are your primary ones, but membership in the society, NBC certified, anything else that you have certifications in, maybe it's a CAOC certification for doing industrial testing, these should be posted so patients can see them and make sure that they are indeed up to date. Okay. Well, we'd like to thank you, Chris, for an excellent presentation and thank you everyone for joining us today on the IHS webinar, FTA and FTC Red Flag Rules. If you'd like to get in contact with Chris, you may email him directly at ihsgus at gmail.com.
Video Summary
In this video, Chris Gustafson discusses the importance of FDA and FTC red flag rules for hearing healthcare professionals. He emphasizes the need to be aware of the eight specific red flags outlined by the FDA, such as visible deformities of the ear, drainage from the ear, sudden hearing loss, and reported dizziness. He also highlights the importance of complying with FTC guidelines for advertising, including avoiding false and misleading claims, ensuring endorsements are qualified as experts, and being transparent about product claims. Chris advises getting a photo ID for patients, having clear policies in place for identity theft prevention, and encouraging patients to see a physician if necessary. He also notes that business owners should regularly review and update their red flag programs to reflect new risks of identity theft. Chris concludes by answering questions from viewers and providing further information on reporting abuse and maintaining credentials.
Keywords
FDA red flag rules
FTC red flag rules
hearing healthcare professionals
visible deformities of the ear
drainage from the ear
sudden hearing loss
reported dizziness
FTC guidelines for advertising
false and misleading claims
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