Hello, and welcome to Preventing Medical Errors in Your Practice. This content was originally created by Cindy Byer, AUD, and Suzanne Junker, AUD. It is presented by the International Hearing Society with permission from the authors. Agenda, Error and Liability Overview, Administrative and Documentation Errors, Clinical Errors in Hearing Aid Dispensing, Summary, and Closing. Let's begin by considering why should hearing health care professionals be concerned with an errors course? We know that some states require this course for the purposes of state audiology or hearing aid dispensing licensure. Some of you may have experienced an adverse incident, so you know firsthand how upsetting these situations can be. Maybe a patient made claims or brought suit against you, or if nothing else, you felt the regret and discomfort that comes from a bleeding ear or a crying child. Comparatively speaking, hearing health care is low-risk for both the frequency and severity of clinical errors, yet we still have the responsibility of protecting our patients and ourselves against adverse incidents. The cost of providing and receiving health care continues to rise each year, partly because of the risks and liability associated with delivery of care. As health care advances, the complexities of diagnosing and treating medical problems increase. Billions of dollars are spent in resolving cases of medical liability. Regulatory agencies continue to impose more and more responsibility on the licensed provider, and so it is in our best interest, and that of our patients, to take reasonable precautions. To ensure our livelihoods as licensed health care providers, we need to be aware of areas within our practices that may leave us subject to loss of license or disciplinary action. The objectives for today's course are to identify the highest probable origins of adverse hearing care outcomes, to discuss steps that will minimize errors in hearing care practice, and to discuss the rationale and benefits of a risk management program. Let's lay it on the line. If we practice long enough, see enough patients, and especially if we see a diverse caseload that includes very old and very young patients, chances are pretty good that at some point we will face an unexpected and undesirable patient outcome. The material in this course will share with you some of our insights into clinical errors, some experience that we have observed over the past few decades at HearUSA, and some lessons learned along the way. Here are some numbers to frame the discussion. In general, medical error is an issue of importance and contributes not only to the unfortunate death and injury of hundreds of thousands, if not millions of people, but adds another layer of expense to already inflated health care cost structure. The cost of retreating and rehabilitating due to medically induced problems, in addition to the legal burden of protecting the provider and compensating the patient and legal teams, is staggering. Some facts to consider. Ten percent of all U.S. deaths are now due to medical error. It's the third highest cause of death in the United States, and medical errors are an underrecognized cause of death. The first rule in medicine is to do the patient no harm. One of the best ways to minimize risk to our patients and ourselves is to follow established clinical guidelines that assist us in delivering conscientious and appropriate care. Scope of practice documents are available from the American Academy of Audiology at www.audiology.org and the American Speech-Language Hearing Association, www.asha.org. We encourage you to be familiar with and to follow established protocol. Additionally, your practice or organization may wish to detail procedures that facilitate the needs of your practice or patient base. The important thing is that a disciplined process should be in place where all parties involved in the delivery of care are fully aware, trained, and held accountable for their actions. Cultivating an environment of care and consideration is important in minimizing clinical errors. Standards of care establish uniformity across individuals in an organization and sets expectations for acceptable performance. With the privilege of being a health care provider, we assume the responsibility of delivering care in a competent and disciplined manner consistent with the rules of medicine. Some providers may question how greatly medical malpractice concerns should impact their day-to-day practices. Injuries that occur during the delivery of hearing care are typically minor when compared to those in other medical specialties, particularly surgical. Malpractice can be either a deliberate or negligent act committed by a health care provider resulting in injury or other adverse outcome to the patient. As will be discussed today, such injuries may encompass a broad spectrum of incidences from actual physical injury to the unintentional mismanagement of a patient's hearing loss. What are the types of errors that we see in audiology practices, administrative, and clinical? There are diagnostic errors, such as error or delay in diagnosis, failure to employ indicated tests, use of outmoded tests or therapy, failure to act on the results of monitoring or testing. Treatment errors, such as error in the performance of an operation, procedure, or test, error in administering the treatment, avoidable delay in treatment or in responding to an abnormal test, preventive errors, such as failure to provide prophylactic treatment, inadequate monitoring or follow-up of treatment, and other errors, like failure of communication or equipment failure. So let's start by talking about administrative errors. In the delivery of any health care service, it is the provider's responsibility to ensure the safety of all patients served. To this end, audiologists and hearing aid dispensers must provide their patients with testing and treatment environments that control for the transmission of disease from provider to patient, patient to provider, and patient to patient. Elderly patients especially may present with compromised immune systems, placing them at particular risk of contracting infections while visiting a health facility. Direct contact occurs not only between provider and patient, but also between the patient and the equipment and tools that in turn come into contact with other patients. Adherence to established infection control protocol is especially important when potential for contact with bodily fluids exists. There are several published sources on infection control, including Kemp and Bankitis and course work on Audiology Online and resources on IHSinfo.org. If you don't have an active program for controlling infection in your practice, you should take a closer look at that. In addition to lack of hand washing, here are some common workplace scenarios that you and your colleagues or support staff might need to work on. Handling unclean hearing aids. The patient hands us over a dirty hearing aid and we instinctively receive it. The hearing aid should be delivered into a container or a sanitizing wipe to ensure there is no transmission of bacteria. Failure to disinfect patient contact areas, counters, chairs, any surface touched by the patient. Infrequent changing of ultrasonic solution. This should be changed after every cleaning. Failing to clean and disinfect tools, again, anything that has touched a patient or bodily fluid. Reusing foam earphone inserts, tympanometry tips, and real ear measurement tubing without proper disinfecting. Not washing hands after handling used tools and equipment. Improper storage of clean and dirty tympanometry tips. They need to be in a covered container. Here's a tip. Consider some posters or signs around the office to remind coworkers of this responsibility. If you see non-compliance, offer a friendly reminder. Policing the environment and helping each other to stay diligent is helpful. In my experience in over 30 years of quality and clinical oversight, the maintenance of adequate clinical record documentation is a primary area where there is ample room for performance improvement. It is impossible to develop an effective plan of care for any patient without first evaluating each patient's medical and audiologic history. By asking the right questions, we are in a position to determine the most appropriate of care, whether that may be hearing aids, an assistive listening device, cochlear implant, and or medical or surgical intervention. That's why it's important that we explore every question in a case history and document the answers into the record accordingly. Here USA has experienced many audits from insurance and state medical investigators and the extent and quality of documentation plays an important role in assessing the delivery of care. Good record keeping helps us stay focused and develop logical plans for patient care. Although time-consuming, there are good reasons for taking the time to record the results of each visit and contact with the patient. Primarily, it's important to have patient information available when reviewing the file. Secondly, patient files are legal documents and subject to subpoena, audit, and other types of regulatory review. Our professional name and license number is attached to the patient's record, and judgments and opinions are rendered according to the extent and quality of supporting documentation. Here's another tip. Keep records of the exact hearing aid make, model, circuitry, features, and experiences of the previous hearing aid user. Appropriate recommendations for improvement should incorporate past experience as well as current and future expectations. We gain insight from knowing the details of the previous fitting when we develop our Go Forward plan. If medical clearance is so indicated by the results of the test, it is important that we make reasonable effort to obtain it. Although the patient may sign the medical clearance waiver, we should take steps to bring a medical opinion into the case as indicated. A detailed review of the history and current experiences, along with a carefully formulated plan to meet the patient's expectations, guides us in the right direction. Note, if you have reason to believe that you have a challenging patient, repeat visits, or unsuccessful history with treatment, consider asking for assistance from another colleague. Unresolved problems lead to frustration and failure for the patient and the provider. Remember to document difficult cases extensively. Here are the AMA guidelines for medical records. Each visit should include the reason for the encounter, relevant history, physical examination findings, prior diagnostic test results, assessment, clinical impression or diagnosis, rationale for ordering medically necessary tests or services, the patient's progress, response to changes in the treatment and revision in diagnosis as necessary, care plan, and date and legible identity of the provider, signature, initials, electronic signature, and authentication. Here are the most common deficiencies in record keeping. Incomplete notes, encounter forms or flow sheets, illegible notes, missing or illegible signature, alterations or changes made to the original medical record, use of non-standard medical abbreviations, biased or non-professional remarks, disorganized or misfiled patient records, repetitive non-individualized notes, especially with electronic medical records, and misuse of rubber-stamped or electronic signatures. Additional documentation issues are failure to document all patient visits, failure to initial or sign and date all patient visits, failure to include subjective and objective data at each visit, failure to document actions and follow-up, failure to evaluate and document previous hearing aid experiences, and insufficient amplification history and documentation of needs and expectations. Here are a few more areas specific to our day-to-day practice. Neglecting to print slash save programming and real ear sheets for future reference, missing physician scripts and signed clearance forms as indicated, failure to ensure hearing aid make, model, and style match billing invoice, required language, documentation fails to follow patient care adequately, and failure to effectively address unresolved problems. Over the years, we have seen several cases in civil court pertaining to hearing aid sales. In these scenarios, there is often an arbitrator or court representative, and the provider must be present with the plaintiff in order to try to achieve an acceptable outcome. Be forewarned that the court does not want to go through a protracted battle of details and he said, she said. Professional documentation that completely covers the situation can make or break the outcome. Sometimes you are called to court long after the incident occurs, months or even a year. Inventory won't serve you well, but good documentation will. Similarly, we have seen cases where the unsatisfied consumer files action with the state licensing board. The process entails first a written response from the licensee with supporting documentation. Again, if it isn't written down, it didn't happen. So the time to incorporate a disciplined record-keeping system is before the problem occurs, not after. Protected health information, PHI, is highly valuable on the black market because it can be used to obtain pharmaceuticals, commit insurance fraud, or obtain medical care through channels such as Medicaid and Medicare. In fact, according to the FBI, stolen health information currently fetches $60 to $70 on the black market, while a social security number goes for less than a dollar. The fiscal impact of medical identity theft is considerable, generating losses to the health industry of more than $30 billion each year. However, patients also sustain financial consequences of fraud, having to pay an average of $13,500 to resolve these issues. In 2016, one in three medical records are compromised. Now some examples. Housekeeping is important. In one example, a patient enthusiastically sat in a chair and knocked off accessories which hit the patient in the head. They claimed pain and suffering and brought a lawsuit against the hospital and provider. It's important to be aware of booth hazards as well. From the incident report, the patient returned to our center today, August 4th, with an emergency room medical report which states she had no broken bones, but she has a foot contusion which requires ice and elevation for three to five days. Although the patient did not request reimbursement, she did state to the audiologist that she had a $65 copay for her emergency room visit. The patient was not upset, however, she did recommend that we place something over the entranceway of the testing booth to prevent further incidents. I also would like to state that the patient was wearing a leg brace before this incident occurred. The division manager then added, I called the center to get details on the booth design. I spoke with PCC. She said that the booth is low profile with a low edge that people need to step over. This is typical of most booths. There are no sharp edges or protrusions. All of us are in the habit of telling patients to watch their step as we assist them into the booth, and this provider gave the warning to this particular patient. From the report and the injury, it appears that the patient did not lift her foot high enough to clear the entrance, and she essentially kicked the booth while stepping in. Her toe struck the edge of the booth, resulting in the contusion. The audiologist reported that the patient was wearing a brace of some sort on her other leg. This may have impaired her ability to bear weight on that leg while stepping into the booth. The audiologist indicated that the other test room booth has some bright tape along the edge of the booth, which makes the threshold more visible. She will purchase some brightly colored duct tape this weekend and will install it on the booth next week. The outcome? The patient contacted S.Y. Toe sticks out of shoe typically, and they're wearing a boot from the podiatrist and has to have special shoes made. We have discussed administrative errors, so now let's discuss clinical errors. This course has been developed to help identify some of the potential areas in hearing care practice that could lead to clinical errors. Hopefully, by bringing these areas into focus, the probability of these errors occurring in a hearing health care practice will decrease. The areas covered in this presentation include infection control, history and documentation, cerumen removal, evaluation and testing, ear mold impressions, circuit selection of programming errors, verification errors. Let's move on to cerumen removal. This is an area of practice which presents the possibility of clinical error with subsequent malpractice litigation due to the fact that it is invasive to the ear. Approximately 200,000 ears are cleaned of cerumen each week in the United States. In most cases, earwax removal is a prerequisite in hearing care practices unless prohibited by state licensing laws. In a rehabilitative hearing aid practice, excess cerumen can interfere with hearing assessment, ear mold impressions, probe microphone hearing aid measures, and hearing aid function. In most states, only physicians, nurses, or audiologists who have been trained in cerumen removal can perform this. Some states prohibit audiologists from removing wax or simply remain silent on the issue, so you may want to check with your state licensing agency. If it's not recognized in your scope of practice, your liability insurance may not cover it, so check this out. Make sure that anyone performing cerumen removal has proper training and skills. Even with training, there are personal limitations that should be recognized. These include vision and dexterity, so these need to be considered. It's critical to have the right tools and equipment, and by all means, a stable and very effective light source is required. Here are some good reasons not to perform cerumen removal on a case-by-case basis. Effusion in the ear canal or other active ear disease, hematoma in the ear canal, surgical modification of the canal wall, unidentifiable foreign objects, diabetic patient, pending legal proceedings, suppressed immune systems, bleeding disorders, or required constraint for removal. And here are the most common observed missteps. Ignoring contraindications. Using a cerumen consent form is a good idea to help identify the contraindications and have them on record with the patient's signature. Neglecting to clean and disinfect cerumen tools, canal abrasions, improper storage of tools. Take a moment to notice the above images as well. These are common audiometry errors that we've observed over the years. Incomplete or poor case history, improper supervision of trainees, remember your name, your license, your responsibility. Choosing the wrong test or omitting a test due to time constraints, over or under masking, misinterpretation or under-interpreting results, not making a referral when it is appropriate to do so, when testing children or difficult to test patients, not keeping them on task and getting invalid results. These are some of the most common testing errors that we have observed. Improper placement of headphones, reversal or bone oscillator, poor or unclear test instructions to patient, inappropriate masking over or under, false positive air bone gaps related to insert receiver positioning, speech recognition testing at levels too low to reach maximum performance, failure to perform annual calibration on test equipment, and failure to perform daily slash weekly listening checks. To avoid errors in hearing care, we need to control even the most routine of cases. In truth, the sheer repetitiveness of the procedure can lead to negligence, such as the case with threshold testing. The simple reversal of earphones can alter not only the diagnosis, but lead to erroneous recommendations of medical referral, hearing aid parameters, or surgical intervention. Patient confusion over testing procedures can result in false positive or false negative results. Double-check your results and make sure that everything adds up and that obvious discrepancies are corrected. Likewise, when conflicting data is present, it is our responsibility to attempt to more closely diagnose the condition, not just to report it. For example, if a tight beats and panogram occurs with the present reflexes, there is a problem with some aspect of the test. Similarly, if the speech scores do not support the air conduction thresholds, additional work is necessary to clear up any uncertainties. Rule out air bone gaps that may be associated with improper insertion of insert receivers or collapsed canals. In 2010, the right ear word recognition score was 96% and the left ear word recognition score was 72%. In 2014, the right ear word recognition was 96% and the left ear word recognition was 8%. In this scenario, a hearing aid was recommended for the left ear without medical consult or clearance. The right ear results indicate significant possibility of retrocochlear pathology, such as an acoustic neuroma. Hearing aid dispensing is regulated through state licensing or registration in all states. Testing and prerequisites are typically spelled out in the rules. Required testing usually includes as a minimum, except where certain handicaps or mental or chronological aid precludes, speech audiometrics including word recognition measures, air conduction threshold assessment, tolerance and comfort levels, and a measure of middle ear involvement. Most states require soundproof booths, but some don't. Others have specific testing and text requirements, and a few states even require fittings with real ear measurements as a mandate. Inaccurate tests due to improper masking can lead to inappropriate recommendations, improper referrals, and inadequate hearing aid fittings. It's probably worthwhile to note that masking is typically involved with diagnostic cases, and dispensers by most state law must refer patients with potential medical problems for audiologic assessment when indicated, since their scope of practice is limited to testing for the purposes of fitting hearing aids. This is an example of undermasking at 30 dB EM. Coordination of care between you and the patient's physician ensures that the patient receives the appropriate treatment for the hearing condition. It is important that we refer to established practice guidelines to avoid the over or under referring of medical care. Under referring patients for physician intervention may deny patients the opportunity for the most effective and appropriate resolution to the hearing condition. Over referral of patients for medical care is costly and inconvenient. When we follow practice guidelines that incorporate best practices with subjective and objective data, we provide a good basis for coordination of care. The presence of artificial air bone gaps due to test error is often a primary source of over referral. Referring earlier to our discussion about tying together test results, air bone gaps in the presence of contradictory test data requires further investigation to rule out false positive results. In our experience, the taking of ear impressions is by far the riskiest procedure that we perform. With proper training and experience, impressions can be performed safely and this procedure is an integral part of everyday practice. We need to be diligent, however, because this procedure is invasive and there can be unforeseen complications, so we need a conscientious approach to inspecting the ear canal and confirming otoblock placement to avoid creating damage. So here we have a rather aggressive deep canal ear impression. This calls into question the procedure that was used to obtain it. The potential for damage to outer, middle, and even inner ear structures increases when taking deep canal impressions for many CIC and the newer IIC type of hearing aids. Complications include canal abrasions, trauma lesions to the tympanic membrane, and middle ear ossicles, accidental removal of a pressure equalization tube, paralymph fistula with result in fluctuating, progressive or long-standing sensory neural hearing loss, or concussive inner ear trauma accompanied by temporary or permanent threshold shifts. To minimize the risk associated with ear impressions, careful procedure and examination are helpful. When placing the ear light or otoscope within the ear canal, use a bracing technique to avoid potential injury of the canal wall or the tympanic membrane. This is especially important when working with young children, patients who may be frightened by the impression process, or patients with compromised neuromuscular control, which may lead to unexpected movement. It's also very important to visualize the ear canal pre and post block placement, making sure that there are no gaps between the wall of the canal and the block. We encourage the use and familiarity of an impression checklist to be posted in this procedure area for a frequent reminder to be diligent. In this case, a surgical report obtained through the insurance company when the patient filed suit against the company noted the patient was left with numbness in the tongue, loss of taste, additional hearing loss, and dizziness. This case settled for $100,000. Note the pre and post incident impact to the patient's hearing condition. This is an extreme case that happened several years ago involving an audiologist. The patient presented with moderate to severe neural hearing loss in an incident ear and severe sensory neural hearing loss in the other ear. Post impression, neither the audiologist, GP, or ENT could remove the impression, which caused severe pain on each attempt. It was eventually removed under sedation. The material had obliterated the TM, surrounded the ossicles, and then entered the eustachian tube. Note that in the photograph here, the impression material has blown by the cotton block that was intended to protect the middle ear structures. The patient underwent surgery to repair the TM. One ossicle was removed and subsequently replaced to clean out the eustachian tube. The patient demonstrated a significant decrease in ACA thresholds, now presents with severe slash profound mixed loss, and complained of both dizziness and decreased hearing. This case was settled for $560,000. The audiologist was reported to the Healthcare Integrity Data Bank, and here USA developed corrective actions to reinforce the risk and required precautions for preventing these types of errors. This type of large payout contributes to malpractice premiums, so it's not a single cost, but a recurring one. We know of several cases where PE tubes were dislodged during the course of impressions, all which involve children. In these cases, the child experiences significant pain and bleeding. The parent is naturally distressed, and the physician is not pleased that his surgical procedure has now been rendered ineffective, so it's not a good situation. This is the explanation provided by the experienced audiologist. I did not see the gap between the cotton block and canal, which allowed material to blow by the block. The reason I believe the blow by was so serious is because it was a toddler, and the canal is so small that there is little margin for error. I've been doing impressions for 25 years. I should have been even more careful. I just didn't see the gap. In case 4, per the provider, on appointment day, the otoblock was placed in ear to second bend. Inspection of otoblock after placement showed it was placed properly. When taking impression of right ear, patient moved. When taking out impression, patient was having a lot of pain. Upon removing impression, there was a slight amount of material past the otoblock. Otoscopic examination showed an abrasion on the floor of the canal with no blood. Temp revealed normal results. But as you can see in picture 2, the otoscope further out of the ear, the provider indicated it appeared to be skin that had been peeled back from the canal wall. The third photo was taken with the otoscope pointed at the abrasion site. In this case, the ear mold impression was not extracted by the provider because of the amount of pain the patient was in. They headed to urgent care. His mother arrived. She told me he had a graft done a few months ago. However, the patient told me he had surgery a few years ago. In the morning, they were headed to the ENT, and the mother wanted to know the material used for the impression. She told me that she wasn't aware that he had a fistula in the ear after his surgery in 2015. The ENT was able to successfully remove the impression without surgery, but there was a huge amount of pain and bleeding, and the patient is currently on antibiotics. As mentioned before, it's imperative to use the proper bridge and brace technique when taking an ear impression. Some additional impression notes. Block materials include the traditional cotton and the newer polyfoam. Because of its compressibility, the latter ear dam material is often a poor choice for use with viscous, high-density silicone impression materials. Material mix consistency and injection force are also critical variables in the impression process. Friable and monomerically scarred tympanic membranes and surgically altered ears are at particular risk. The use of lubricant such as mineral oil will prevent material from adhering to the canal wall. Technology and programming errors. Digital hearing aids offer an ever improving world of flexibility and possibilities. With these benefits come the added complexity of multiple memories and continuously evolving features and algorithms. Undeniably, digital hearing aids are a tremendous advantage for a number of very good reasons. That's not to say, however, that the implementation of digital amplification will automatically result in an improved patient outcome. It is incumbent upon us to employ the skills and techniques that will result in the patient realizing the many benefits. One of the most common mistakes made in hearing aid dispensing is the over reliance on first fit algorithms. An online survey showed that 70% of responding audiologists program their patients hearing aids using the manufacturer's first fit settings. Also, according to the literature, less than 12% of targets on the manufacturer's fitting software screen match what is actually measured in the patient's ear. Software is very considerably among manufacturers and we can't assume that the norms done in research facilities are going to apply to each individual patient in real-life situations. We have to verify the fitting objectively with probe mic measurements, assess the patient's results subjectively, and use the data that we have to make knowledgeable decisions on the patient's behalf. Using first fits as a routine procedure leads to repeat visits, unrealized expectations, and anxiety. It's also a waste of provider time to keep adjusting and counseling in the absence of good clinical data to guide the process. Take into consideration previous amplification experiences and the identification of primary needs and expectations. Both of these areas have a significant influence on the type of technology that we select as well as the ways in which we apply it. The best way to make the most of the technological advancements of the day is through adherence to a disciplined process of evaluating pre- and post-hearing aid fittings, careful observation and analysis of both subjective and objective data, and an appropriate investment in patient education and counseling. Here are, in our experiences, some of the most common hearing aid dispensing errors. Not saving program into the aid, too much compression slash inappropriate compression strategy, not ordering appropriate options, not activating or programming additional memories, not incorporating past history into programming logic, over-reliance on first fit, not entering UCL slash LDL data for two frequencies so that first fit will calculate accurate output levels, not entering bone conduction scores on manufacturer order form when an air bone gap is present. Here's an example of a hearing aid programming error. In February 2014, outside dispenser fit mid-level Starkey 3-series reg BTE at $5,000. This is the REM of the exchanged upgrade at the time of delivery. The right ear at 500 Hz, 1000 Hz, and 2000 Hz. At 50 dB input, under target 12 dB, at target, over target 6 dB. 65 dB input, under target 12 dB, at target, at target. 80 dB input, under target 12 dB, under target 4 dB, over target 6 dB. Since all responses at 0.5 K are under target, it appears she was under fit at 0.5 K. For the left ear at 500 Hz, 1000 Hz, and 2000 Hz, with 50 dB input, under target 12 dB, under target 2 dB, at target. 65 dB input had under target 20 dB, under target 6 dB, and under target 3 dB. At 80 dB input, it was under target 12 dB, under target 4 dB, still acceptable, over target 6 dB. Since all responses at 0.5 Hz are under target outside of tolerance, it appears she was under fit at 0.5 K. And here's the real ear measurement of the other facility hearing aids. Years ago, there was a case where an experienced audiologist fit CIC hearing aids on a patient with longstanding perforation and diabetes in the left ear. The patient wanted CIC hearing aids, and in an effort to accommodate the patient, the hearing aids were dispensed. Within 90 days, the patient had a raging fungus in the left ear. The closing of the ear canal with no venting and with a diabetic predisposition for fungus meant the case turned very badly for this patient. It took dozens of doctor visits and a refitting to BTE hearing aids over an eight-month period to resolve this issue, plus around $10,000 in medical expenses. How could this, of course, have been altered? At the very least, the patient should have had rigorous training about the importance of ventilating the ear and cleaning the hearing aid. This did not occur, according to the patient, and there was no documentation to this extent. A quick tip. If you're pursuing a risky fit, take care to implement and document precautionary measures. Verification and validation are clinical tools to ensure functionality of hearing aids as well as individual patient benefit. Verification techniques are primarily used to determine if the hearing aids meet a particular standard and are performing appropriately. Validation techniques use functional gains, speech perception, questionnaires, or interviewing to determine how much benefit one is receiving from the hearing aids. However, neither validation nor verification are always employed by providers, even though they have been found to be correlated with user satisfaction. The utilization of verification and validation during the hearing aid fitting process was shown to significantly reduce patient visits, 1.2 fewer visits, with evidence that utilizing both verification and validation may compound to yield the best results. According to patients, one third of hearing care professionals in the United States utilize both verification and validation during hearing aid fitting. Mark Track 8 data suggested that wide-scale adoption of verification and validation in the US hearing care market will increase patient satisfaction and reduce patient visits. The biggest mistake, according to the reports available in industry publications, is the failure of most audiologists and hearing aid dispensers to verify hearing aid fittings, period. Up to 80% of the providers, according to the articles, don't perform objective verification of fittings and rely on patient feedback to make adjustments. In the opinion of many, this is a gross negligence and contributes to the lack of professionalism perceived by the consumer. Without belaboring that, let's just go on to state that when it is done, it needs to be done in a manner that achieves the goal of an adequate fitting, not as a matter of routine charting. Lack of objective data to verify the fitting throws into question the validity, efficacy, and legitimacy of the hearing aid fitting process, and it can be said that it reassigns the responsibility for guiding the patient's course of care to the patient. In the practice of healthcare, pre- and post-measurement of conditions is universally accepted. The probe mic measurement needs to be held to a standard, ensuring that soft, medium, and loud inputs yield acceptable outputs that meet within the dynamic range of the patient. Our goal is to provide adequate audibility, maximize speech intelligibility, and maintain a zone of comfort within the patient's dynamic range. Restricted dynamic ranges result in distortion and under-amplification. Likewise, patients purchase multi-memory products with the expectation that a specific functionality is present. When a secondary program is activated, the user is looking for a hearing aid response that matches the expectations and counseling provided at the delivery. When this does not occur, it could be that the program is defective, the program was not saved into the hearing aid memory, or possibly the program isn't functioning as it is intended. In any event, it is our obligation to demonstrate that the hearing aids are functioning well in all settings. This also provides an opportunity to give additional training or instruction as indicated. This would be particularly true with directional microphones. We need to make sure that they work like we think they do. This is an example of satisfactory real-ear measurement output responses. Here's an example of unsatisfactory real-ear measurement output responses. Common clinical errors in verification include failure to verify settings, failure to verify multiple programs, failure to interpret output appropriately, failure to include bone conduction in real-ear measurements, failure to include bone conduction in real-ear targets when a conductive component exists, and not using speech stimulus for digital products. With reference to validation, a common deficiency is the failure to employ standardized measures for patient feedback, to routinely collect written data as opposed to offhand remarks provided informally during the patient visit. Further, to analyze patient feedback and incorporate it into management of care via adjustments and counseling. There is a wealth of information when data is collected and shared on a one-to-one basis, and then further when aggregated and used organization-wide. Key findings can be used to improve clinical performance and elevate the overall standard of care, a very valuable process. Okay, so let's recap some of the factors and areas where we will find that our risk for errors increases. This includes wrong treatment or hearing aid recommended slash therapy provided, wrong site treatments, such as what happened with earphone reversal. Working with age extremes requires additional care and expertise. Inexperienced providers and unsupervised externs are more likely to experience a higher degree of clinical error. For those of us that have been in the field, a lack of continuing education and quality learning experiences may leave us with an inadequate fund of knowledge and outdated information. Unfamiliarity with state-of-the-art equipment might be a factor. And finally, fatigue, distraction, and poor record-keeping can lead to misdiagnosis or error in a clinical situation. Here, USA has a systematic process of collecting and reviewing data. In the past 30 years, we have seen well over 2 million patients and dispensed hundreds of thousands of hearing aids. We centralize reporting of adverse incidents, which are unexpected outcomes of the patient. We also centralize complaints and track them by frequency and type of complaint. As a result, we have thousands of clinical and peer-reviewed records, and we aggregate that data, analyze it, report it, and look for ways to improve our performance. During 2016, we recorded 39 patient care-related incidents. When compared to almost 250,000 patient visits, that was less than one incident for every 10,000 patient encounters. In total, seven of the 39 were related to ear impressions. We performed in excess of 80,000 ear impressions that year. Most of the impression incidents were abrasions to the canal where the wall was scraped or irritated by the block or impression removal. We reported two incidents related to cerumen removal, both of which were minor. Over 70% of the incidents were related to dislodged domes getting stuck in the ear. Many of these required medical intervention to retrieve them. In this example, during an annual evaluation, otoscopic examination revealed a dome dislodged in a patient's left ear. A dome was also on the left hearing aid. This patient was referred to urgent care for removal. Advised the patient to not wear the left hearing aid until the dome had been removed. The patient was unable to recall the last time someone looked inside of his ear canals or when a dome had been missing from his aid. The patient informed the provider that in the past, domes and filters were given to him for him to change by staff members. Several things are concerning with this case. First, the patient had a dome in his left ear and was wearing a hearing aid with a dome attached also in his left ear. He did not report pain or discomfort. He was in for a routine annual checkup. Second, patient claims staff provides him with domes and filters for self-changing. This incident happened on March 28th, 2017. And the last visit was on October 24th, 2016 with a technician. Domes should be professionally changed by staff every three to six months. Assure the receiver is clear of wax debris. Remnants may prevent a secure attachment. Assure the click sound is heard to confirm secure attachment and assure correct size and style. Potential errors and mishaps are possible during administration of a variety of hearing care services. Most of these are avoidable by the conscientious provider and quickly corrected when they do occur. It's the responsibility of providers to provide the most efficacious services to patients within a clean and safe environment. So even in the best of practices and despite our best efforts to the contrary, it's possible to have an unfortunate patient outcome. What do we do when we encounter an unexpected adverse patient outcome? Here are some steps to follow in the event of an unexpected event. If indicated at the time of incident or follow-up, call the patient's physician and explain the situation and ask if the physician would see the patient or if there is an ENT that should be contacted. Consider a third party to do the follow-up inquiry, but touch base with the patient to determine the status and to convey concern about the situation. Document the event and the situation and to convey concern about the situation. Document the appointment date and time. Demonstrate compassion, concern and verbalize blameless apology. I'm sorry this happened to you. I'm sorry that you're feeling uncomfortable. These are good things to say when our patients are upset. Do a root cause analysis and implement corrective action, which we will look at next. Root cause analysis is a class of problem-solving methods aimed at identifying the root causes of problems or events. The practice of RCA is predicated on the belief that problems are best solved by attempting to correct or eliminate root causes, as opposed to merely addressing the immediately obvious symptoms. Our advice, don't include the details of the incident in the patient's medical records. If it's included in the medical record, it can be accidentally transferred to another party. If it's part of an operational internal file, the information is better protected. But do keep track of the event and the details and ensure that there are steps taken to close the loop. This would include provider or designee follow-ups with the patient and or physician following the medical consultation. The provider or designee should follow up with the patient and or physician following the medical consultation. The provider supervisor should be kept apprised of all developments and take care to communicate and follow the patient through the incidents. Through care and concern, we're best able to control the outcome and minimize further adversity. You should also communicate with the resources you have, such as a risk management team, insurance carrier, there's 30 days notice to an insurance company, or an in-house legal department. Here's a few reminders on improving patient safety. Find out why it happened. Strategize about new methodologies. Foster a culture where people are interested in quality of care and discuss near misses, risks and problems. Patient education is an important part of this process. Quality oversight is necessary and staff training is paramount. And in closing, we remind you that routine visits and procedures are not always routine. Take good care. Use a disciplined process to ensure minimal risk to the patient and the provider. Handle adverse incidents with concern and professionalism. Manage the incident to the best probable end. Train and retrain to foster a culture of excellence. Some resources for good practice are your state or provincial licensing laws, your code of ethics, the patient bill of rights, policies and procedures of your company or institution, and maintaining your professional credentials. A state license with required continuing education, board certification with required continuing education, or a state license with required continuing education. A state license with required continuing education or any specialty certifications. Here is the list of works cited in the creation of this presentation. Thank you for taking the time to listen to this presentation on Preventing Medical Errors by Cindy Beyer, AUD, and Suzanne Junker, AUD. It was presented by the International Hearing Society with permission from the authors and read to you by Michelle Weiss.

prevention

medical errors

hearing health care

patient safety

clinical guidelines

administrative errors

clinical errors

technology errors

patient harm