Title of Regulation: 18VAC30-20. Regulations Governing the Practice of Audiology and Speech-Language Pathology (amending 18VAC30-20-10; adding 18VAC30-20-241).

Statutory Authority: § 54.1-2400 of the Code of Virginia.

Public Hearing Information:

December 11, 2015 - 8:45 a.m. - Department of Health Professions, Perimeter Center, 9960 Mayland Drive, Conference Center, 2nd Floor, Richmond, VA

Public Comment Deadline: January 29, 2016.

Agency Contact: Leslie L. Knachel, Executive Director, Board of Audiology and Speech-Language Pathology, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463, telephone (804) 367-4630, FAX (804) 527-4413, or email leslie.knachel@dhp.virginia.gov.

Basis: Regulations Governing the Practice of Audiology and Speech-Language Pathology (18VAC30-20) are promulgated under the general authority of subdivision 6 of § 54.1-2400 of the Code of Virginia, which provides the Board of Audiology and Speech-Language Pathology the authority to promulgate regulations to administer the regulatory system.

Authority for the board to adopt regulations for limited cerumen management in the practice of audiology is pursuant to Chapter 327 of the 2014 Acts of Assembly.

Purpose: Since cerumen management is a more advanced skill in the practice of audiology, requiring additional knowledge and training, regulations specify the education and specific training necessary to perform it on patients. Additionally, audiologists must know the contraindications for performance by an audiologist and the conditions that require referral to a medical doctor. The goal of the amended regulation is to provide a framework for safe practice in an advanced procedure that prior to 2014 was not recognized in Virginia as being within the scope of practice of an audiologist. By the change in law and regulation, the practice is expanded to include limited cerumen management, but the qualifications for such practice and the limitations of practice by an audiologist are essential to protect patients.

If an audiologist does not have the clinical knowledge and skills or if he attempts to perform cerumen management on a patient beyond his scope of practice or in spite of contraindications, he can do serious damage to a patient's ear. If an audiologist is adequately trained and practices according to the standard of care and the board's regulation, the public's health and safety should be protected.

Substance: 18VAC30-20-10 is amended to include a definition for "limited cerumen management."

18VAC30-20-241 is a new section, in which subsection A sets out the basic educational qualification for performance of cerumen management, subsection B sets out the training an audiologist must satisfactorily complete to perform cerumen management and specifies that documentation of such training must be maintained, subsection C sets out the contraindications for performance of cerumen management, and subsection D provides that an audiologist performing cerumen management shall obtain informed written consent of the patient or legally responsible adult and maintain documentation of such consent and the procedure performed in the patient record. It also specifies that the audiologist shall refer patients to a physician if they exhibit contraindications or experience any complication, such as dizziness, during the procedure.

Issues: There are no disadvantages to the public. With the passage of Chapter 327 of the 2014 Acts of Assembly, it is clear that cerumen management of a limited nature is within the scope of practice of audiologists who have been specially trained in the procedure. Proposed regulations protect patients by specifying the necessary training and the medical conditions and situations in which it is not appropriate for a patient to have cerumen removed by an audiologist. There are no particular advantages or disadvantages to the agency or the Commonwealth.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The proposed regulation provides a regulatory framework for practice in cerumen management, which was not recognized in Virginia as being within the scope of practice of an audiologist before 2014.

Result of Analysis. The benefits likely exceed the costs for all proposed changes.

Estimated Economic Impact. Prior to 2014, Virginia law and regulations did not address cerumen (commonly known as ear wax) management within the scope of practice of an audiologist though various forms of it were practiced by some audiologists to various extents. Cerumen management involves identification and removal of cerumen from the ear canal. According to the Board of Audiology and Speech-Language Pathology (Board), if an audiologist does not have the clinical knowledge and skills or if he attempts to perform cerumen management on a patient beyond his or her scope of practice or in spite of contraindications, he or she can do serious damage to a patient's ear.

In order to address potential health and safety concerns, Chapter 327 of the 2014 Acts of the Assembly (HB500) added "limited cerumen management" to the scope of audiology practice and directed the Board to establish criteria for its practice. Pursuant to the legislative mandate, the Board promulgated emergency regulations, which became effective on December 29, 2014. The proposed regulation will replace the emergency regulation permanently.

With this action, the Board proposes to define "limited cerumen management" as the identification and removal of cerumen from the cartilaginous outer one-third portion of the external auditory canal. The Board also proposes to allow the practice of limited cerumen management by only those audiologists i) who are a graduate of an accredited doctoral program in audiology that included didactic education and supervised clinical experience in cerumen management, or ii) who completed an approved course or workshop in cerumen management. Furthermore, the Board sets out the contraindications to identify cases when the procedure shall not be performed, but the patient be referred to a physician; requires audiologists to obtain written consent of the patient or legally responsible adult; and maintain documentation. The proposed rules do not require audiologists to submit evidence of training and education, or consent documents to the Board, but instead require the evidence be available when and if the Department of Health Professions investigates a complaint.

The proposed training and education could occur within a practice under direct supervision. Training courses are also being developed by the state and national professional associations specifically for cerumen management. Parts of the training may be done online, but certain parts of the training must be done in-person with an audiologist who is already qualified or with a physician. The cost of the training and education may vary. The Speech-Language Hearing Association of Virginia is currently offering a one-day training in September 2015 at a cost of $230 for members and $300 for non-members. However, since the proposed regulation applies only if an audiologist wishes to perform limited cerumen management and if an audiologist chooses to obtain education and training to perform it, we can reliably infer that the anticipated benefits likely exceed compliance costs to him or her in terms of time, travel, and training fees.

Other benefits of the proposed regulation include: explicitly allowing qualified audiologists to perform cerumen management on a limited basis and possibly avoiding an extra visit to a physician’s office for limited cerumen management, establishing what the allowed scope of cerumen management by an audiologist is, establishing under what circumstances it may or may not be performed, and consequently providing a greater degree of patient health and safety compared to its practice without any standards.

While the proposed regulation is expected to be beneficial, the magnitude of benefits may be relatively small. As mentioned above, prior to 2014, various forms of cerumen management had been performed by some audiologist to various extents. The Board is unaware of any complaints or investigations related to practice of cerumen management when there was no regulatory framework on cerumen management by audiologists.

Businesses and Entities Affected. The proposed rules affect audiologists who want to include limited cerumen management in their practice. Currently, there are 517 licensed audiologists in Virginia, but the Board does not know how many of them are currently practicing cerumen management and how many may choose to perform this procedure in the future.

Localities Particularly Affected. The proposed changes apply throughout the Commonwealth.

Projected Impact on Employment. The proposed amendments are unlikely to affect employment.

Effects on the Use and Value of Private Property. The proposed rules are not anticipated to affect the use and value of private property.

Real Estate Development Costs. The proposed amendments are unlikely to affect real estate development costs.

Small Businesses:

Definition. Pursuant to § 2.2-4007.04 of the Code of Virginia, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

Costs and Other Effects. The proposed rules introduce compliance costs to audiologists in terms of time, travel, and course fees to obtain training and education only if the audiologist does not have the appropriate training and education and he or she chooses to perform limited cerumen management and he or she would have performed it without obtaining the appropriate training and education if there were no regulations. However, it is highly unlikely that an audiologist would have performed a procedure that he or she is not trained and educated in for liability reasons. Thus, the compliance costs are likely negligible.

Alternative Method that Minimizes Adverse Impact. The adverse impact on audiologists is likely negligible as discussed above.

Adverse Impacts:

Businesses: The proposed regulation is not anticipated to adversely impact non-small businesses.

Localities: The proposed amendments will not adversely affect localities.

Other Entities: No other entities are anticipated to be adversely affected.

Agency's Response to Economic Impact Analysis: The Board of Audiology and Speech-Language Pathology concurs with the economic impact analysis of the Department of Planning and Budget.

Summary:

Pursuant to Chapter 327 of the 2014 Acts of Assembly, the proposed action provides a framework for safe practice of limited cerumen management by an audiologist including (i) a definition of "limited cerumen management," (ii) the education and specific training necessary to perform limited cerumen management on patients, (iii) the contraindications for performance by an audiologist of limited cerumen management on patients, and (iv) the conditions that require referral to a medical doctor.

Part I
General Provisions

18VAC30-20-10. Definitions.

A. The words and terms "audiologist," "board," "practice of audiology," "practice of speech-language pathology," "speech-language disorders," and "speech-language pathologist" when used in this chapter shall have the meanings ascribed to them in § 54.1-2600 of the Code of Virginia.

B. The following words when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Contact hour" means 60 minutes of time spent in continuing learning activities.

"Limited cerumen management" means the identification and removal of cerumen from the cartilaginous outer one-third portion of the external auditory canal in accordance with minimum standards and procedures set forth in this chapter.

"School speech-language pathologist" means a person licensed pursuant to § 54.1-2603 of the Code of Virginia to provide speech-language pathology services solely in public school divisions.

"Supervision" means that the audiologist or speech-language pathologist is responsible for the entire service being rendered or activity being performed, is available for consultation, and is providing regular monitoring and documentation of clinical activities and competencies of the person being supervised.

"Type 1" means continuing learning activities that must be offered by an accredited sponsor or organization as specified in 18VAC30-20-300.

"Type 2" means continuing learning activities that may or may not be approved by an accredited sponsor or organization but shall be activities considered by the learner to be beneficial to practice or to continuing learning. In Type 2 activities, licensees document their own participation on the Continued Competency Activity and Assessment Form and are considered self-learning activities.

18VAC30-20-241. Limited cerumen management.

A. In order for an audiologist to perform limited cerumen management, he shall:

1. Be a graduate of a doctoral program in audiology that is accredited by the Council on Academic Accreditation of the American Speech-Language-Hearing Association or other accrediting body recognized by the board and that included didactic education and supervised clinical experience in cerumen management as specified in subsection B of this section; or

2. Complete a course or workshop in cerumen management that provides training as specified in subsection B of this section and that is approved by the American Speech-Language Hearing Association or the American Academy of Audiology.

B. An audiologist shall maintain documentation evidencing satisfactory completion of training in cerumen management to include the following:

1. Recognizing the presence of preexisting contraindications that necessitate referral to a physician;

2. Recognizing patient distress and appropriate action to take if complications are encountered;

3. Use of infection control precautions;

4. Procedures for removal of cerumen, including cerumen loop, gentle water irrigation, suction, and the use of material for softening;

5. Observation of each type of cerumen management procedure performed by a qualified audiologist or physician; and

6. Successful performance, under direct supervision by an audiologist qualified to perform cerumen management or a physician, of each type of cerumen management procedure.

C. An audiologist shall not perform cerumen management on a patient who has any of the following preexisting contraindications:

1. A perforated tympanic membrane;

2. Inflammation, tenderness, drainage, or open wounds or traces of blood in the external ear canal;

3. History of ear surgery that results in distortion of the external ear canal;

4. HIV infection or bleeding disorders;

5. Actual or suspected foreign body in the ear, excluding hearing aid components that are located in the lateral one-third portion of the ear canal;

6. Stenosis or bony exostosis of the ear canal; or

7. Cerumen impaction that totally occludes the visualization of the tympanic membrane.

D. An audiologist performing cerumen management shall:

1. Obtain informed written consent of the patient or legally responsible adult and maintain documentation of such consent and the procedure performed in the patient record.

2. Refer patients to a physician if they exhibit contraindications or experience any complication, such as dizziness, during the procedure.