The Need for Standards in Audiology

Opinion | March 2019 Hearing Review

Why up-to-date practice standards for the profession of audiology are necessary

By John A. Coverstone

In creating and adopting standards of practice for audiology, we provide a shield for ourselves and our patients that will demonstrate the high level of care audiologists are capable of providing, improve confidence in audiology care, deter others from infringing on the audiology scope of practice, and protect each other from legal threats which may arise in the future. 

Perhaps the most fundamental aspect of training and clinical practice in any area of modern healthcare is standardization. While experimental treatments and poorly understood diseases exist, you would not expect to encounter dramatically different approaches to treating a broken bone, a case of the measles, diabetes, a heart condition, a rotator cuff injury, or astigmatism. Closer to our profession, we expect pediatricians and family practice physicians to adopt the American Academy of Pediatrics  (AAP) guidelines for ear infection management, we expect ENT surgeons to follow established procedures for surgical methods, and we expect our colleague’s hearing exam to be consistent with ours. Most important is that patients expect to be faced with similar options, receive similar guidance, and achieve similar outcomes regardless of the individual practitioner they visit.

The standardization of a profession arises from a general agreement among members of the profession to follow the published evidence and to update their practices when indicated. This often happens when a representative population of experts in a subject area agree that practices should change and update the published standards for that area. It is incumbent upon training programs to teach the same current methods to students, and it is vital among practitioners to update their methods and tools to achieve better outcomes as additional information becomes available from research.

Moreover, members of a profession should adhere to the same standards of practice. If different “standards” exist, then it could easily be argued that no standard of practice exists. Imagine yourself interpreting an audiogram where the audiometer was calibrated to one of several different standards. The time we would all spend converting data would be immeasurable! Similarly, all members of a profession must be involved, through direct or indirect representation, in standards development. Otherwise, there is a very real risk that any published standards will be severely weakened by low acceptance and possibly even by the standard itself being weak due to exclusion of knowledgeable experts.

There are many terms which are used to describe the way in which a healthcare provider practices. It is important to establish a common definition for what it is we should achieve in creating practice standards.

Scope of Practice

A 2005 report by the Federation of State Medical Boards¹ defined scope of practice as the:

“…definition of the rules, the regulations, and the boundaries within which a fully qualified practitioner with substantial and appropriate training, knowledge, and experience may practice in a field of medicine or surgery, or other specifically defined field. Such practice is also governed by requirements for continuing education and professional accountability.”¹

Scope of practice is typically defined by state licensure laws and represents a minimum standard of practice. It does not indicate what methodologies are appropriate or “how” one should practice; it simply outlines the procedures that a practicing provider should be able to perform adequately if they have completed training at an accredited program and passed the practical and knowledge-based examinations accepted for their profession.

Scope of practice is defined in state law, due to the authority of the states to define practices within their boundaries. However, scope of practice is typically very homogenous throughout the United States, as professions in the past 50 years have worked to define an appropriate scope for their practitioners and then write these into law in each state. In the period between 2003 and 2007, US audiologists worked to update state laws so that a more universal scope of practice was adopted. As a result, current laws governing audiology practice are very similar, with minor differences noted for procedures that are not universally part of audiology training programs, such as cerumen management.

Standard of Practice

While scope of practice primarily describes the “what,” other standards describe the “how.” Perhaps the best definition of a standard of practice comes from the definition of standards of nursing practice by the Mosby’s Medical Dictionary.² Adapted for audiology, this would read, “a set of guidelines for providing high-quality audiology care and criteria for evaluating care. Such guidelines help assure patients that they are receiving high-quality care. The standards are important if a legal dispute arises over the quality of care provided a patient.”³

It is important to note that standards of practice are developed and maintained by the profession. In a moment, we will discuss standards that are adopted by the legal system and sometimes taken out of the hands of professionals—sometimes even adopted against common practice of professionals. However, it is vital for a profession to have standards developed internally so there is a reference for those outside the profession to judge the decisions of those practicing within the profession.

Clinical Protocols/Clinical Practice Guidelines

The terms clinical protocols and clinical practice guidelines are often used to describe the same idea. According to the US Department of Health and Human Services,⁴ “Clinical Protocols and/or Clinical Practice Guidelines are systematically developed statements that help physicians, other practitioners, case managers, and clients make decisions about appropriate health care for specific clinical circumstances.”

Clinical practice guidelines may be one of the most important tools of a healthcare profession. They provide the “how” that scope of practice and standards of practice do not, and they may provide specialty-level detail that expand on Standards of Practice statements. These are commonly referenced by courts and others outside the profession when seeking guidance on standard practices of a profession.^5,6

Some organizations have even eschewed the term “practice guidelines.” The American Academy of Opthalmology publishes “Preferred Practice Pattern Guidelines,” which is intended to recognize that no two patients’ needs are the same and a single approach cannot ensure quality of care. The American Medical Association uses the term “Practice Parameters” to promote the idea that guidelines should be flexible and allow for individualized treatment plans.⁷

Clinical practice guidelines provide details about the recommended procedures for completing diagnostic, evaluative, and therapeutic tasks. They address appropriate procedures for patients with specific conditions and often guide clinicians in the decision-making process during these encounters. As with standards, practice guidelines have a sound scientific basis and should be based on expert consensus. They should not be exclusionary due to membership, employment affiliations, or other factors, and should be widely available to members of the profession.

Standard of Care

Multiple legal sources provide essentially the same definition for standard of care: “The only degree of prudence and caution required of an individual who is under a duty of care.”^8-11 More commonly, standard of care is described as what a similarly qualified provider would do, given the same patient with the same condition, under the same set of circumstances. Various publications in the legal field have debated whether this is what a “reasonable provider” would do, whether this is what a “similarly qualified provider” would do, or whether this is what the “average provider” would do, given a set of circumstances.

Thus, standard of care is a legal term and not a medical one. This standard arises from legal precedent as courts determine whether a provider accused of malpractice acted appropriately or not. However, courts are governed by people, and therefore differing opinions exist regarding how to use published guidelines, whether they automatically protect individuals following them, whether they have significant bearing on what a “reasonable” person would do in their circumstance, and so on.

However, the most dangerous course of all would be to find yourself a defendant in a lawsuit where no standards exist and have the court unilaterally decide what the standards for your profession should be.

Best Practices

All the preceding standards describe a common minimal or acceptable standard for a profession. Best Practices go beyond what the minimum or average practitioner would do and describe those methods believed to achieve the best possible results with patients. Merriam-Webster defines best practices as, “a procedure which has been shown by research and experience to produce optimal results and that is established or proposed as a standard suitable for widespread adoption.”¹²

In other words, best practices should result in best outcomes. They are not necessarily the most common practices, although are frequently promoted as those which should be adopted as standards. Many times, best practices will gain adoption in a profession and become the standard of practice. It should be the goal of any profession that best practices become universal practices so that every patient receives the best possible care and outcomes.

The Need for Practice Standards

Practice Standards serve many important functions for a profession. When standards are established for a healthcare profession, training programs may teach to those standards. This both provides a guideline for faculty curriculum development and helps to ensure that students completing training at institutions across the country are similarly prepared to enter practice. The presence and widespread adoption of practice standards provide a framework to design curriculum, develop advancement criteria and assessment tools, and produce examination material to appropriately assess a candidate’s readiness to begin independent practice. Without standards, all these aspects of training are weakened when considered on a national scale.

Standards also help to ensure similar practices among providers. While it may be true that all members of a profession do not adhere to the same standards, this is generally the goal of the profession so that patients will receive a similar—and hopefully high-quality—level of care by visiting any practitioner. If this expectation is not met, it is feasible to assume that patients will be reluctant to seek the services of that profession due to the uncertainty introduced by the adoption of differing methodologies and the likely difference in outcomes that will result.

It is therefore incumbent upon members of the profession to seek continuing education in their area of practice and stay current with emerging methods. In failing to do so, practitioners will necessarily create for themselves a disparate set of knowledge and skills. This will likely result in varying outcomes, depending on how old the methodology is which they continue to utilize.

There may also be ethical implications for having standards in a profession. In fact, it could be argued that adoption of standards (or not) have ethical ramifications and that ethics depend on standardization. Many people may consider it self-evident that adhering to standards is the most ethical way to practice any profession. Some may consider it arguable whether the reverse is also true. However, this question bears consideration: Is it possible to have ethical standards without having practice standards?

We would argue that it may not be possible to establish what is or is not ethical behavior if a profession has not established standards that are based in evidence, created and vetted by experts in that area of practice, and widely adopted by those practicing in that area. For instance, if there is no agreed-upon, widely published, and adopted standards for what procedures should be used, then it can only be the personal views of every practitioner that decide what should or should not be done to accomplish that procedure. As a result, instead of an ethical principle calling for practitioners to achieve a minimum standard, it becomes ethical for anyone to achieve any standard of their choosing. An ethics board which would condemn the practices of an individual without referencing an accepted standard is simply holding that person to the arbitrary choices of the board members.

Last, and equally important, is the safeguarding of the profession. Relevant threats to the profession may come in two ways. First is the threat that a profession without widely adopted standards creates a public perception that many—or even any—methods are deemed satisfactory. This may further create a perception that individuals without the same training and investment in the profession are able to do the same work and achieve the same outcomes. When there are no standards, there are probably no well-defined outcomes, and therefore fuzzy outcomes seem much easier to achieve.

The other potential threat to the profession comes from legal action. This has been a much lesser concern for audiologists than for many other healthcare professions, but it is worth some discussion. Audiology is more recognized as a profession than at any time in history, and, recently, audiology practices have been widely questioned in some areas. Particularly in light of current trends, such as less costly instrumentation for patients, it may be reasonable to assume that patients will expect better outcomes from traditional devices. If so, patients may also be more prone to seek legal action if their expectations are not met or if an error in communication results in personal or financial injury. As one explores this topic, it becomes apparent there is no guarantee in legal outcomes (see sidebar below); however, having well-developed standards provides a reference for those outside the profession—including officers of the court—and allows audiologists to have a voice in determining appropriate practices.

As the sidebar about legal precedents demonstrates, consideration is given to the customary practices of a profession; however, the standard of care does not make average practice the definitive factor in determining negligence. What common practices do you employ which omit procedures that are accessible, harmless, inexpensive, and brief—and yet may significantly improve outcomes for your patients?

There are two early legal precedents that helped define “standard of care” as the term is used today, both cited in Peter Moffett and Gregory Moore’s article “The Standard of Care: Legal History and Definitions: the Bad and Good News,”⁹  which was written in 2011 specifically for emergency medicine physicians. The article provides excellent background about the history of standard of care interpretation in the courts.

Tugboat owners and radios. The first precedent Moffett and Moore discuss arose entirely outside medicine. In 1932, a tugboat named the T.J. Hooper had been caught in a storm off the Jersey coast, and the two barges it was transporting sunk. The owner of the tugboat was sued by the owners of the barges, who stated that the T.J. Hooper was not safe to be at sea because it did not have a radio to receive storm warnings. They also asserted that it was “customary” for tugboats to have a radio, technology that would have prevented the T.J. Hooper from towing their barges during a storm. At the time, the customary definition of the legal standard was, essentially, “what is typically done.” The judge in this case—whose real name was Justice Learned Hand—found in favor of the barge owners, but not because of custom. His decision, in fact, stated that it was not customary for tugboats at the time to have a radio receiver. However, he asserted that the practice was “reasonable,” meaning that the owners of the tugboat would have been prudent to have a radio and therefore could be held liable. 

This was an important precedent because it failed to excuse a customary practice. As worded in Justice Hand’s written statement, “…a whole calling may have unduly lagged in the adoption of new and available devices. It never may set its own tests, however persuasive be its usages. Courts must in the end say what is required; there are precautions so imperative that even their universal disregard will not excuse their omission.”¹³ 

Ophthalmologists and a simple test for glaucoma. Importantly, Justice Hand’s statement was quoted in a 1974 decision by the Supreme Court of Washington,¹⁴ which is the second precedent described by Moffett and Moore. In this case, a patient sued her ophthalmologist after going blind from glaucoma. The ophthalmologist won both the initial trial and first appeal based on expert testimony that the patient was under 40 years of age and the incidence of glaucoma in this group was only 1 in 25,000. Therefore, it was not standard to test patients under age 40 with tonometry. The Supreme Court, however, decided that the test was inexpensive and harmless to the patient and should have been offered. This is an important decision because it also held the defendant liable to practices that were not commonly performed at the time. In the end, the court established a bar of reasonable prudence, rather than average practice.

Future decisions by US courts served to further define the standard of care in medicine, including establishing minimal competence as the standard, not average level of skill. As Moffett and Moore⁹ point out, a standard of “average” competence would leave 50% of practitioners below the standard. Courts have also held that poor outcomes are not a measure of competence, as a physician is not an insurer of health or a guarantor of results. Instead, the standard is the level of skill generally possessed by others practicing in the field under similar circumstances.

There are variations as to how courts have used clinical practice guidelines.^5,6,9 Introduction of a document, such as a clinical practice guideline, would typically be considered hearsay in a court because the author is not available to testify or allow cross-examination. However, several cases involving clinical practice guidelines have suggested that guidelines possessing some scientific validity may be used as “learned treatises” and avoid being excluded based on the hearsay rule. Clinical practice guidelines have been used to support an expert witness testimony, impeach an expert witness, defend practitioners who adhere to the guidelines, and suggest that physician deviance from the guideline indicates deviation from the standard of care.

In the end, clinical practice guidelines are strongest when based in evidence, developed by recognized experts in the area of practice, maintained current, and followed by the individual accused of negligence. Practitioners ignoring accepted practice guidelines run the risk of being found negligent by legal proceedings.

Development and Maintenance of Practice Standards

If universal standards are to be developed and maintained for the profession of audiology, this must be done in a systematic and generally accepted fashion so the resulting standards are accepted by the profession and are legally defensible. No standards/guidelines may be created without a thorough practice analysis of the profession. Fortunately, the American Board of Audiology (ABA) developed an outstanding practice analysis, published in 2015, which provides a foundation for many standards and other programs in the profession.

A newly created professional entity, Audiology Practice Standards Organization (APSO, www.audiologystandards.org), proposes the following process for development of national standards in audiology:

• Standards should be based in evidence to the greatest extent possible. When evidence is lacking or conflicting, expert consensus should be reached to establish a standard.
• Standards should represent a high level of care that provides positive outcomes for our patients and that is achievable for all licensed audiologists.
• Subject matter experts involved in initial creation of standards should, to the greatest extent possible, be representative of specialty subgroups, practice settings, length of practice experience, and ideology, as it is recognized that some procedures may include multiple accepted practices.
• Subject matter experts should be largely comprised of audiologists practicing in the subject area. Researchers and other non-practicing colleagues should be welcomed and included but limited appropriately.
• Development of practice standards should be facilitated by an independent individual who is experienced in standards development.
• Notification of standards under development should be available to all members of the profession.
• All developed standards should be published to the entire profession for review, discussion, and comment. This should be regardless of membership or credentials maintained by the practitioner (except state licensure, which is required to practice).
• Feedback received should be duly considered by subject matter experts, even when representing opinions or evidence are provided which were initially rejected.
• Standards should be published so that they are  accessible to all members of the profession.
• Standards should be reviewed and updated in a time frame determined by subject matter experts to be necessary to maintain the standards as current.

Some exemplary standards and guidelines do exist in audiology, most notably those by Valente and colleagues.^15-17 Unfortunately, most of these are now 10-20 years old and current practices are eclipsing the relevance of those standards. Additionally, due to the period in which they were formulated, some were developed in more closed circles with more limited review and comment by the general profession than might be afforded today. It is impossible to understate the importance of reviewing and updating (as necessary) standards at regular intervals. Without doubt, there are significant resources which must be dedicated to both developing and maintaining standards for the profession.

Many audiologists may also wonder what standards they should follow in developing their own clinical guidelines. Ultimately, each practitioner must decide on the integrity and relevance of each standard, should more than one published standard exist. We strongly believe that the preceding ideals of standards development indicate when a strong standard exists that is worthy of adoption by the majority of the profession.

In creating and adopting standards of practice for audiology, we provide ourselves and our patients a shield that will demonstrate the high level of care audiologists are capable of providing, improve confidence in audiology care, deter others from infringing on the audiology scope of practice, and protect each other from legal threats which may arise in the future. This is of paramount importance to the profession at this time and worthy of the time, effort, and expense required to build a solid foundation for the practice of audiology.

Acknowledgements

This article was submitted on behalf of the Audiology Practice Standards Organization (APSO) Board of Directors. For more information about APSO, visit: www.audiologystandards.org.

John Coverstone, AuD, is President and CEO of Sentient Healthcare, which includes his private practice, Audiology Ear Care in New Brighton, Minn, and is Past-president and a current Board Member of the Audiology Practice Standards Organization (APSO). As part of his business, he also works as an educational audiologist for more than 65 schools in Minnesota. Dr Coverstone co-hosts the Audiology Talk and the American Tinnitus Association’s (ATA) Conversations in Tinnitus podcasts, and writes for ATA. He previously worked in hearing instrument and medical equipment manufacturing, and served as the 2015 Chair of the Board of Governors for the American Board of Audiology (ABA). Dr Coverstone has been involved in numerous audiology organizations, including serving on the Board of Directors of the Minnesota Academy of Audiology and as that organization’s President in 2012. 

Correspondence can be addressed to Dr Coverstone at: [email protected]

Citation for this article: Coverstone JA. The need for standards in audiology. Hearing Review. 2019;26(3)[Mar]:24-29.

Image: © Tzogia Kappatou | Dreamstime.com

References

1. Federation of State Medical Boards. Assessing scope of practice in health care delivery: Critical questions in assuring public access and safety. http://www.fsmb.org/siteassets/advocacy/policies/assessing-scope-of-practice-in-health-care-delivery.pdf. Published 2005.

2. Mosby Elsevier. Mosby’s Medical Dictionary. 8th ed. Maryland Heights, MO: Elsevier Health Sciences; 2008.

3. American Nurses Association. Nursing: Scope and standards of practice. 2nd ed. Silver Spring, MD: American Nurses Association;2010.

4. Institute of Medicine, Lohr KN, Field MJ. Clinical practice guidelines: Directions for a new program. Washington, DC: National Academies Press; 1990.

5. Mello MM. Of swords and shields: The role of clinical practice guidelines in medical malpractice litigation. University of Pennsylvania Law Review. 2001;149(3):645-710;2001.

6. Mackey TK, Liang BA. The role of practice guidelines in medical malpractice litigation. AMA Journal of Ethics. 2011;13(1):36-41.

7. Walker RD, Howard MO, Lambert MD, Suchinsky R. Medical practice guidelines. Western J Med.1994;161(1):39-44.

8. Strauss DC, Thomas JM. What does the medical profession mean by “standard of care?” J Clin Oncol.2009;27(32):e192–e193.

9. Moffett P, Moore G. The standard of care: Legal history and definitions: The bad and good news. Western J Emergency Med.2011;12(1):109-112.

10. MedicineNet.com. MedTerms Medical Dictionary. https://www.medicinenet.com/script/main/art.asp?articlekey=33263. Accessed February 26, 2018.

11. Wikipedia. Standard of Care [definition]. https://en.wikipedia.org/wiki/Standard_of_care. Accessed February 26, 2018.

12. Merriam Webster Dictionary. Best Practice [definition]. https://www.merriam-webster.com/dictionary/best%20practice.

13.  TJ Hooper v. Northern Barge Corporation HN Hartwell & Son, Inc, v. Same. 60 F.2d 737 (2d Cir. 1932). https://law.justia.com/cases/federal/appellate-courts/F2/60/737/1542549/

14. Helling v. Carey. 83 Wn. 2d 514 (1974). https://law.justia.com/cases/washington/supreme-court/1974/42775-1.html

15. Valente M, Bentler R, Kaplan HS, et al. Guidelines for hearing aid fittings for adults. Am J Audiol.1998;7(1):5-13.

16. Valente M, Abrams H, Benson D, et al. American Academy of Audiology (AAA). Guidelines for the audiologic management of adult hearing impairment. https://audiology-web.s3.amazonaws.com/migrated/haguidelines.pdf_53994876e92e42.70908344.pdf. Published 2006.

17. Valente M, Barninger KH, Oeding K, et al. American Academy of Audiology clinical practice guidelines: Adult patients with severe-to-profound unilateral sensorineural hearing loss. https://www.audiology.org/sites/default/files/PractGuidelineAdultsPatientsWithSNHL.pdf. Published June 2015.