Proposed Amendment: N.J.A.C. 13:44C-7.1
Authorized By: David M. Szuchman, Director, Division of Consumer Affairs.
Proposal Number: PRN 2009-145.
Renee Clark, Executive Director
The agency proposal follows:
N.J.S.A. 45:3B-2 defines the practice of audiology as practices related to "hearing, its disorders and related communication impairments." N.J.A.C. 13:44C-7.1 sets forth the scope of practice for licensed audiologists. This rule includes the measurement and interpretation of sensory and motor evoked potentials, electronystagmography and other electrodiagnostic tests for purposes of neurophysiologic intraoperative monitoring and cranial nerve assessment. The Director has become aware that licensed audiologists are performing such tests for purposes that are unrelated to hearing, its disorders and related communication impairments. The performance of tests for non-hearing related purposes is outside of the statutory scope of practice for licensed audiologists and the Director proposes to amend N.J.A.C. 13:44C-7.1 to clarify that any of the functions listed in the rule shall only be performed when they are [page=2083] related to hearing, its disorders and related communication impairments.
The Director proposes new rule N.J.A.C. 13:44C-7.1A in order to allow licensed audiologists to perform cerumen management, the removal of wax like secretions from the cartilaginous portion of the external ear. The Director consulted with the Board of Medical Examiners to discuss this issue and it was determined that cerumen management is not exclusively within the practice of medicine. With proper training, a licensed audiologist can safely undertake this activity.
The proposed new rule limits the performance of cerumen management to licensed audiologists who complete specific education in cerumen management. This education must include recognizing contraindications to performing cerumen management, actions to take if complications occur during cerumen management, infection control precautions and methods for removal of cerumen. A licensed audiologist is also required to observe 30 cerumen management procedures and to perform 30 cerumen management procedures under supervision. A licensed audiologist may only perform cerumen management in a licensed healthcare facility or in his or her office and must refer a patient to a physician if there are contraindications to performing cerumen management or a complication arises during cerumen management. A licensed audiologist may not perform cerumen management on a child six years or younger and shall cease cerumen management if the patient experiences tenderness in the ear or dizziness. Licensed audiologists who perform cerumen management must maintain a case history and informed consent for every patient.
The Director has determined that the comment period for this notice of proposal shall be 60 days; therefore, pursuant to N.J.A.C. 1:30-3.3(a)5, this notice is excepted from the rulemaking calendar requirement.
The proposed amendment will protect licensed audiologists and patients by clearly identifying those procedures that are outside of the professional scope of practice for audiology. The proposed new rule will benefit patients in that they will be able to obtain cerumen management from licensed audiologists who are properly prepared to perform these procedures.
The proposed new rule will impose costs on licensed audiologists who wish to perform cerumen management. These individuals will bear the cost of completing the required education prior to performing these procedures. The Director does not believe that the proposed new rule or amendment will have any other economic impact.
Federal Standards Statement
A Federal standards statement is not required because there are no Federal standards or requirements applicable to the subject matters of the proposed amendment or new rule.
The Director does not believe that the proposed amendment or new rule will result in an increase or decrease of jobs in this State.
Agriculture Industry Impact
The Director does not believe that the proposed amendment or new rule will have any impact on the agriculture industry of this State.
Regulatory Flexibility Analysis
Since the holders of audiology licenses are individually licensed by the Committee, under the Regulatory Flexibility Act (the Act), N.J.S.A. 52:14B-16 et seq., they may be considered "small businesses" for the purposes of the Act.
The proposed amendment and new rule will have the same economic impact on small businesses as it has on all businesses as detailed in the Economic Impact above. The Director does not believe that licensees will need to employ professional services in order to comply with the proposed amendment or new rule. The proposed amendment and new rule do not impose any reporting requirements, but do impose compliance and recordkeeping requirements as detailed in the Summary above.
The Director believes that since the proposed amendment and new rule establish a procedure within the scope of practice of licensed audiologists and protects the health, safety and welfare of patients, therefore, the rule should be applied uniformly to all licensees regardless of the size of the business.
Smart Growth Impact
The Director does not anticipate that the proposed amendment and new rule will have any impact on the achievement of smart growth and implementation of the State Development and Redevelopment Plan, otherwise known as the State Plan.
Housing Affordability Impact
The proposed amendment and new rule will have an insignificant impact on affordable housing in New Jersey and there is an extreme unlikelihood that the rules would evoke a change in the average costs associated with housing because the rules concern the scope of practice of licensed audiologists.
Smart Growth Development Impact
The proposed amendment and new rule will have an insignificant impact on smart growth and there is an extreme unlikelihood that the rules would evoke a change in housing production in Planning Areas 1 or 2 or within designated centers under the State Development and Redevelopment Plan in New Jersey because the rules concern the scope of practice of licensed audiologists.
Full text of the proposal follows (additions indicated in boldface thus; deletions indicated in brackets [thus]):
SUBCHAPTER 7. AUTHORIZED PRACTICE
13:44C-7.1 Scope of practice--audiology
(a) The practice of audiology includes[, but is not restricted to,] the following functions related to hearing, its disorders and related communication impairments:
1.-10. (No change.)
13:44C-7.1A Scope of practice--cerumen management
(a) The purpose of this section is to set forth standards for the performance of cerumen management by a licensed audiologist. Cerumen management is within the scope of practice of an audiologist who meets the requirements of this section.
(b) "Cerumen management," as used in this section, shall mean the removal of wax like secretions from the cartilaginous portion of the external ear in otherwise healthy ears.
(c) A licensed audiologist may perform cerumen management only if he or she:
1. Completed initial education pursuant to N.J.A.C. 13:44C-3.2, 3.3 or 3.4, which included instruction in the topics required by (d) below; or
2. Has successfully completed a 12-hour seminar or workshop in cerumen management, which qualifies for American Speech-Language Hearing Association (ASHA), American Academy of Audiology (AAA) or Academy of Doctors of Audiology (ADA) continuing education credit and which includes instruction in the topics required by (d) below.
(d) Initial education or a course in cerumen management shall include:
1. Recognizing the presence of medical preexisting contraindications that warrant referral to a physician, such as:
i. A patient who has hearing in only one ear;
ii. A perforated tympanic membrane;
iii. Inflammation, tenderness, open wounds or traces of blood in the external ear canal;
iv. Drainage from the external ear canal or middle ear;
v. Ear surgery within the last six months;
vi. A patient who has tympanostomy tubes;
vii. Diabetes mellitus, HIV infection or bleeding disorders;
viii. Actual or suspected foreign body in the ear;
ix. Stenosis or bony exostosis of the ear canal;
[page=2084] x. Cerumen impaction that totally occludes the ear canal;
xi. Cerumen located beyond the isthmus; or
xii. Inability to see the tympanic membrane;
2. Recognizing patient distress and appropriate action to take if complications are encountered;
3. Infection control practices, including:
i. Universal health precautions;
iii. Cleaning, disinfection and sterilization of multiple use equipment; and
iv. Universal precautions for prevention of the transmission of human immunodeficiency virus, hepatits B virus and other blood borne pathogens; and
4. Methods for removal of cerumen, for example, cerumen loop, gentle water irrigation, suction and use of material for softening.
(e) In addition to the education requirements of (c) above, a licensed audiologist shall complete the following prior to performing cerumen management:
1. Observe a minimum of 10 cerumen management procedures using a cerumen loop, 10 cerumen management procedures using gentle water irrigation and 10 cerumen management procedures using suction performed by either a licensed audiologist who has met the requirements of this section or a physician; and
2. Successfully perform, under the supervision of a licensed audiologist who has met the requirements of this section or a physician, a minimum of 10 cerumen management procedures using a cerumen loop, 10 cerumen management procedures using gentle water irrigation and 10 cerumen management procedures using suction.
(f) A licensed audiologist shall perform cerumen management only in a healthcare facility licensed by the Department of Health and Senior Services or in his or her office.
(g) A licensed audiologist shall not perform cerumen management and shall refer a patient to a physician if any of the pre-existing contraindications listed in (d)1 above occur.
(h) A licensed audiologist shall not perform cerumen management on a patient who is six years old or younger.
(i) A licensed audiologist shall not perform, or shall cease performing, cerumen management if patient reports:
1. Tenderness during manipulation of the pinna or at any time during the cerumen removal procedure; or
2. Dizziness occurring during cerumen removal.
(j) A licensed audiologist shall refer a patient for immediate treatment from a physician if a complication arises during the performance of cerumen management.
(k) A licensed audiologist who performs cerumen management shall maintain a case history for every patient and informed consent signed by the patient as part of his or her records.
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