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Hearing Journal:
doi: 10.1097/01.HJ.0000452244.07451.64
Cover Story

Preventing Medical Errors: How to Proceed with Caution

Shaw, Gina

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Medical errors are an enormous source of liability for healthcare providers. A 2012 article in the Journal of Health Care Finance reported that the direct additional medical costs of medical errors, including ancillary services, prescription drugs, and inpatient and outpatient care, amounted to about $17 billion annually (39[1]:39-50 http://www.ncbi.nlm.nih.gov/pubmed/23155743).

Figure.  Lael Hender...
Figure. Lael Hender...
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The good news for audiologists and hearing instrument specialists is that they are not among the healthcare providers most vulnerable to medical errors that can lead to lawsuits for malpractice or other claims.

“For the most part, we don't provide invasive services, dispense medications, or perform surgery,” said James W. Hall III, PhD, a member of The Hearing Journal Editorial Advisory Board and adjunct professor of audiology at Nova Southeastern University and Salus University. “As a profession, we're way down on the risk list—certainly below medicine and dentistry, for sure.”

It's hard to determine exactly how common claims against hearing healthcare providers are. In the 1970s and 1980s, many audiologists belonged to the American Speech–Language–Hearing Association (ASHA) and used the same insurance carrier, so it was easier to track these numbers. (A 1993 ASHA Technical Report http://depts.washington.edu/swl/sphsc523/liability.pdf on liability and risk management found a total of 129 claims against audiologists and speech pathologists from 1982 to 1993; 58% of those claims involved audiologists.)

“But today, fewer audiologists belong to ASHA, and more of them are covered by a wider range of carriers, so there's no one place you can go to find out how many claims there are,” Dr. Hall said.

Nonetheless, it's possible to get a snapshot. HearUSA operates a network of about 2,000 independently practicing audiologists and hearing care professionals, along with about 180 company-owned hearing centers, and tracks adverse events among these providers.

“We measure adverse incidents at .0003, or three incidents for every 10,000 patient encounters, which is very infrequent,” said Cindy Beyer, AuD, HearUSA's vice president of professional services. That level has stayed unchanged for several years and is stable across volume and experience level, and state and region.

Not only are claims infrequent, but they are usually much less significant than what an ENT physician might see, for example, and they often resolve without medical intervention.

But less vulnerable doesn't mean invulnerable. “In this day and age, any audiologist anywhere will at some point in his or her career either face legal action or have to defend himself or herself against it, at least initially,” Dr. Hall said.

What are the areas of practice most likely to leave an audiologist open to litigation?

Figure. James W. Hal...
Figure. James W. Hal...
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1. EARMOLD IMPRESSIONS

This is perhaps the riskiest area of practice for audiologists, experts agree.

“The impression procedure is potentially invasive to the middle ear, and, if the proper precautions are not observed, there is danger to the middle and inner ear structures,” Dr. Beyer said.

HearUSA has seen a handful of cases of serious and permanent damage related to ear impressions in the past 20 years, including traumatic perforation, inner ear injury, and impression material entering the middle ear cavity and becoming embedded in the ossicles, Dr. Beyer noted.

In an August 2013 e-seminar on medical errors, she described one case in which blow-by of the impression material could not be removed in the office by any of the medical professionals consulted, including an ENT physician.

When the impression material was removed under sedation, it had already obliterated the tympanic membrane, surrounded the ossicles, and entered the Eustachian tube. The patient ultimately underwent surgery to repair the tympanic membrane and remove and replace one ossicle, but the damage to her hearing could not be repaired. There was a malpractice settlement of more than $500,000.

Figure. Cindy Beyer,...
Figure. Cindy Beyer,...
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“Cases like these are very rare, but it is wise to take heed and observe a very cautious pre- and post-impression procedure that involves close scrutiny of block placement,” Dr. Beyer said.

Even if there is no problem with the impression material, the wall of the ear canal is highly vascular and easily scratched.

“When making an earmold impression, it's not uncommon to brush up against the wall, and the patient will start bleeding,” Dr. Hall said.

This means that particular caution should be employed during the impression process. Dr. Beyer advises using appropriate bracing to avoid injury of the canal wall or tympanic membrane, and carefully examining the ear canal before and after placing the otoblock to ensure that impression material cannot travel past it.

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2. CERUMEN REMOVAL

About 200,000 ears are cleaned of cerumen each week in the United States. While cerumen removal is now a prerequisite to comprehensive patient care, this process can leave hearing healthcare professionals open to claims of medical errors when sufficient caution isn't exercised.

First, it's important to ensure that there are no contraindications, such as active ear disease, hematoma in the ear canal, unidentifiable foreign objects, suppressed immune system, or bleeding disorder.

In addition to missed contraindications, other errors in this process can include canal abrasions and failure to clean and disinfect cerumen tools.

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3. FAILURE TO DIAGNOSE

In terms of a large claim or settlement, a major risk to the audiologist is the failure to diagnose hearing loss in infants or young children.

“If an audiologist misses signs of hearing loss in an infant—usually because of failure to complete the most thorough assessment needed, or to refer to someone who could—this can have significant implications,” Dr. Hall said.

“By the time the child is diagnosed, language and speech is delayed, and that may be very difficult to overcome.”

Other failure-to-diagnose errors in hearing healthcare include missed vestibular schwannomas (also called acoustic neuromas).

These rare, slow-growing, benign tumors can sometimes be managed with watchful waiting, but that decision can't be made unless the tumor is identified in the first place, which means referring a patient with suspicious audiologic signs or symptoms to an ENT physician. (The American Academy of Otolaryngology–Head and Neck Surgery [AAO–HNS] has criteria for identifying candidates for evaluation.)

“I regularly see cases from one particular attorney who only handles failure-to-diagnose claims involving these tumors,” said Marc Kramer, PhD, clinical assistant professor of audiology in otolaryngology and former director of audiology at New York–Presbyterian Hospital/Weill Cornell Medical Center, who maintains a private practice in forensic audiology and litigation consulting.

“If they are missed for too long and continue to grow, you miss your window of opportunity for early intervention. If you catch them in time, they can often be managed with Gamma Knife surgery, but when a tumor like this remains unidentified for too long, the patient can lose all hearing on that side as a consequence of more radical surgery.”

More generally, audiologists should be wary of all signs and symptoms of possible cranial nerve VIII involvement, and adhere to the AAO-HNS criteria for audiologist referral to a physician.

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4. INFECTION CONTROL

Errors in infection control can include something as simple as not washing hands between patients, as well as failure to disinfect the patient contact areas, reuse of equipment like foam earphone inserts and tympanometry tubing without proper disinfection, and infrequent changing of ultrasonic solution.

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5. PROGRAMMING, VERIFICATION, AND TESTING

There is a host of possible errors in these areas of a hearing healthcare practice, such as improper placement of headphones, failure to regularly calibrate test equipment, overmasking or undermasking, and failure to take a complete case history.

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6. INFORMED CONSENT

“The first thing you should do—before irrigating the ear for an ENG [electronystagmography], putting on electrodes for any electrophysiologic tests, performing cerumen management, taking an impression, or anything else of that nature—is get signed informed consent from the patient,” Dr. Kramer said.

“You can't go to a physician for almost any procedure without giving informed consent, but this seems to be uncommon in our field. Why that is—it's beyond me.”

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7. DOCUMENTATION

Hearing healthcare professionals are just as vulnerable to documentation errors as any other healthcare provider. Accurate and complete patient records are essential not only to protection against litigation, but also to the provision of quality care.

Your patient record should include the reason for the encounter, relevant history, physical exam findings, diagnostic test results, assessment or diagnosis, rationale for ordering any tests or services, a care plan, notes about the patient's progress, and provider identification information.

All of this information should be legible and individualized to the patient—not just pages of cut-and-paste—and avoid nonstandard abbreviations and subjective, nonmedical comments.

“One way that good audiologists get into trouble is that they follow evidence-based guidelines for patient care, but they don't document it,” Dr. Hall said. “If you didn't write it down, it didn't happen. Document, document, document, even if you're just saying a few words to the patient.”

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PROTECT YOURSELF

To help avoid these—and many other—pitfalls, it's essential to follow established clinical protocols.

“Avoiding the temptation to rush, cut corners, or modify techniques on the fly can help us to prevent the unintended consequences that come about when we are under pressure,” Dr. Beyer said.

“I would also recommend that all audiologists foster a culture of advancement—a clinical setting where each audiologist seeks to learn, improve, and advance the performance of everyone on the team.

“It's important to motivate, share, and be open about performance improvement opportunities, near misses, and ways to achieve better outcomes.” (All of this, she acknowledges, is sometimes easier said than done in a busy practice with many different personalities, but it should certainly be a priority.)

Despite your best efforts, if you're in practice long enough, it's almost inevitable that someone will file a claim against you. What are the keys to limiting your liability in these cases?

Figure. Marc Kramer,...
Figure. Marc Kramer,...
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Evidence shows that saying “I'm sorry” is at the top of the list. It's tempting to circle the wagons and react defensively when accused of an error, but that's almost certainly the wrong way to go.

A pioneer in full disclosure about medical errors is the University of Michigan Health System, which first adopted what has become known as the Michigan Model for handling errors in 2001. A key part of the model is open and honest communication with patients and families, including the offering of apologies when warranted.

Over the course of the next decade, malpractice claims against the health system declined significantly, from 121 in 2001 to 61 in 2006. Claims have remained steady at about that level since then, despite an annual increase in patients of approximately 30 percent. Between 2001 and 2007, costs per claim also decreased by 50 percent.

“Compassion and support go a long way in keeping patients from reacting in a litigious fashion,” Dr. Beyer said. “In my experience, patients who have been on the wrong end of a process or a procedure are seeking some validation of their pain or inconvenience, and it doesn't hurt to say, ‘I'm really sorry this happened to you.’

“Facilitating physician intervention, calling to check on your patient the next day—these are acts of kindness that any of us would appreciate.”

Business issues must also be handled, of course.

* If you have a risk management department, contact it immediately.

* Consult with any supervisors or medical directors to get internal direction.

* Seek legal counsel for your protection when it comes to documentation.

* If the incident is significant, notify your insurance company immediately. If the insurer is not notified in a timely manner and the claim arises in the future, the company may not cover the claim. (Experts recommend that audiologists carry professional and general liability insurance at minimum coverage levels of $1,000,000 per claim and $3,000,000 annual aggregate.)

* Conduct a root cause analysis of the situation. How did it happen? What were the contributing factors? How can you prevent it from happening in future? What types of training and communication are needed to support the corrective actions?

* Add training in medical error prevention and management to your continuing education priority list. “Some states require proof that you've taken a course in medical errors before licensure renewal, but, even if that's not mandated in your state, it's a very good idea,” Dr. Hall said. (Drs. Beyer, Kramer, and Hall have all led such courses; different options are available for review through the American Academy of Audiology and AudiologyOnline.)

“The number one thing to keep you out of trouble is your relationship with patients,” Dr. Kramer said. “If you're on good terms and you don't do anything really, really horrible, they tend to be very forgiving. But if you're not on good terms, something small can get blown out of proportion.”

© 2014 by Lippincott Williams & Wilkins, Inc.

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