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HEALTH LICENSING OFFICE

 

DIVISION 660

STANDARD OF PRACTICE AND PROFESSIONAL CONDUCT

331-660-0000

Standards of Practice

In addition to the standards prescribed under ORS 694.142, the Council adopts the following standards of practice to establish and maintain a high standard of integrity and dignity in the profession of hearing aid specialists. A licensee must:

(1) Maintain a clean and safe environment to ensure the health, safety, and welfare of clients and staff in the licensee's facility;

(2) Ensure consistent and high quality services and devices that meets the needs of the hearing aid clients;

(3) Participate, as appropriate, with the ownership, management, or governing body to plan, implement, and evaluate written policies and procedures to allow that provision of hearing aid services are in compliance with all local, state, and federal laws and regulations;

(4) Communicate and problem solve regularly with the staff, co-workers and governing body to allocate resources properly. The hearing aid specialist must foster effective communication and problem solving between staff, co-workers, governing body and clients; and

(5) Plan, implement, and evaluate an integrated financial program to ensure compliance with all local, state, and federal laws and regulations; quality devices and services; and appropriate and accurate billing for devices and services.

Stat. Auth.: ORS 376.615, 694.115, 694.170, 694.185
Stats. Implemented: ORS 694.025, 694.125, 694.185
Hist.: HLA 13-2012, f. 8-16-12, cert. ef. 8-17-12

331-660-0010

Standards of Professional Conduct

The Council adopts the following standards of professional conduct to protect the public against unprofessional conduct on the part of hearing aid specialists. A licensee must:

(1) Comply with all local, state, and federal laws and regulations concerning the provision of hearing aids. The licensed hearing aid specialist shall cooperate with any investigation of the regulatory bodies;

(2) Exercise appropriate supervision and responsibility over the activities of staff;

(3) Protect client’s rights as required by state and federal laws;

(4) Take appropriate steps to avoid discrimination against residents on basis of race, color, sex, religion, age, national origin, disability, marital status, ancestry, sexual orientation or any other factor that may be discriminatory or not related to bona fide requirements of quality service; and

(5) Possess and maintain the competencies necessary to effectively perform the responsibilities as a hearing aid specialist, including but not limited to:

(a) Exercising ethical and professional decision-making and judgment;

(b) Exemplifying a philosophy focused on the provision of accurate and high-quality services and devices, as well as on generally accepted standards;

(c) Abiding by and keeping confidential client information; and

(d) Keeping current with standards of practice.

Stat. Auth.: ORS 376.615, 694.115, 694.170, 694.185
Stats. Implemented: ORS 694.025, 694.125, 694.185
Hist.: HLA 13-2012, f. 8-16-12, cert. ef. 8-17-12

331-660-0020

Safety and Infection Control Requirements

(1) Each licensee shall keep areas of their facility for otoscopic examination, earmold impression taking, and audiometric examination clean and sanitary.

(2) Impression tools, otoscopic examination equipment and other devices that come in direct contact with the client must be disinfected prior to use. Licensees shall use an EPA registered high-level disinfectant, following the manufacturer's directions, to disinfect nondisposable equipment and tools.

(3) Disposable or disinfected otoscopic specula must be used when examining each ear.

(4) Licensees must wash or sanitize hands prior to taking an earmold impression.

(5) Licensees must observe the Universal Precautions as defined in Oregon Administrative Rule 437-002-0360(26), and 29 CFR 1910.1030 bloodborne pathogen standards, when providing services to consumers. Precautions to reduce the likelihood of exposure include hand washing, gloving, using personal protective equipment, preventing injury, ensuring proper handling and disposal of needles and other sharp instruments and of products or equipment contaminated with blood and body fluids.

Stat. Auth.: ORS 376.615, 694.115, 694.170, 694.185
Stats. Implemented: ORS 694.025, 694.125, 694.185
Hist.: HLA 13-2012, f. 8-16-12, cert. ef. 8-17-12

331-660-0030

Audiometric Testing Equipment

Licensed hearing aid specialists shall maintain audiometric testing equipment, currently used in the practice of administering evaluations, in proper working order at all times and shall be prepared to provide their record of at least annual calibration to a representative of the agency when so requested, upon inspection, or during an investigation conducted by the agency.

Stat. Auth.: ORS 376.615, 694.115, 694.170, 694.185
Stats. Implemented: ORS 694.025, 694.125, 694.185
Hist.: HLA 13-2012, f. 8-16-12, cert. ef. 8-17-12

331-660-0040

Statement to Prospective Purchaser

(1) The term "purchaser" as used in ORS chapter 694 and OAR chapter 331, division 660, means any person who purchases or proposes to purchase hearing aid(s) and any person on whose behalf hearing aid(s) are purchased or proposed to be purchased. In the case of a client who is a minor child or other person without legal capacity to contract, the person's parent, legal guardian, or legal representative is the "purchaser.”

(2) To assist prospective purchasers in making an informed decision regarding the sale of hearing aid(s), licensees must provide prospective purchasers with complete and accurate disclosure of facts regarding licensee services, the hearing aid(s) purchase price, delivery and consummation of sale defined in OAR 331-620-0005, and information about the purchaser’s right to rescind or cancel a sale and the procedures for rescinding the sale and returning the hearing aid(s) according to the provisions of ORS 694.042.

(3) The Statement to Prospective Purchaser (Statement) is a contract prepared and signed by the licensee and agreed to by the purchaser. This Statement contains required information listed in ORS 694.036 regarding licensee and purchaser information, medical observation criteria and referral to physician if medical conditions are present, specifications and conditions of the hearing aid(s), terms of any warranty or expressed guarantee, and how to file a complaint with the agency.

(4) Licensees are required to provide all information and facts specified in this rule before the consummation of the sale, which is the delivery of the hearing aid(s) to the purchaser and the date that starts the 30-day rescission period.

(5) Statement Content. In addition to the information prescribed by ORS 694.036, the Statement must include the following information and facts about the purchase of hearing aid(s):

(a) Date of sale;

(b) Purchaser name, address and signature;

(c) Licensee name, address, telephone number, license number and signature;

(d) The purchase price, which includes the cost of the hearing aid(s) and all related fees;

(e) An accurate description of the hearing aid as new, demonstration instrument, reconditioned, or used;

(f) Delivery date of hearing aid(s);

(g) Date the 30-day rescission period ends;

(h) The portion of the total purchase price that will be retained by the licensee, not to exceed 10% of the contract purchase amount or $250 per hearing aid, whichever amount is less, if the purchaser rescinds the sale under provisions of ORS 694.042 within the 30-day rescission period;

(i) Date and place of post-delivery follow-up session agreed upon by the licensee and hearing aid user as stated in subsection (9) of this rule;

(j) A printed or reproduced copy of ORS 694.042 Right to Rescind A Hearing Aid Purchase in its entirety, which includes the procedures for returning the hearing aid(s) to the licensee;

(k) The following statement, initialed by the purchaser: “Copies of my audiogram and the results of tests or verification procedures were offered to me by the licensee, and I hereby acknowledge receipt of the records or that I declined the offer.”;

(l) The following statement about filing complaints: “Complaints regarding the sale, lease, or attempted sale or lease of hearing aids should be directed in writing to: Oregon Health Licensing Agency, 700 Summer Street NE, Suite 320, Salem, OR 97301-1287. Complaint forms may be obtained by calling 503-378-8667 or at the Agency’s Web site: http://www.oregon.gov/OHLA/Consumer_help_complaint.shtml”; and

(m) A statement acknowledging that the purchaser has read and understands the information contained in the Statement, signed by the purchaser and dated;

(6) Statement Format. The Statement must be printed on forms measuring no less than 8 ? inches wide by 11 inches long, with a minimum 10-point typeset, and be legibly written.

(7) Licensees must provide the purchaser a new Statement for each hearing aid or set of hearing aids, unless the hearing aid(s) is an exact replacement of the device listed in a previous Statement provided to the purchaser.

(8) Refund. Any monies paid by or on behalf of the purchaser toward the hearing aid must be refunded to the payer if the delivery of the hearing aid to the purchaser is cancelled. The purchaser shall incur no additional liability for the cancellation.

(9) Post Delivery Follow-Up. Licensees will conduct and document a minimum of one post-delivery follow-up session with the hearing aid user before the expiration of the 30-day rescission period. The follow-up session will take place at the original place of the sale or at a predetermined location agreed upon at the time of initial delivery, or at a time and place agreed to within the 30-day rescission period.

(b) The licensee must document in the hearing aid user’s record any change to the agreed-upon location or date of the post-delivery follow-up session, and, if the licensee is unable to contact the hearing aid user or to provide the follow-up session, the reason(s) why.

(10) In Home Sales. Sales of hearing aids made at the purchaser’s residence and not at the licensee’s place of business, require disclosure of federal guidelines related to “in home sales” and the purchaser’s right to cancel the transaction and receive a full refund of monies paid to the licensee. The following federal disclosure statement must be completed and affixed to the Statement to Prospective Purchaser when a licensee sells a hearing aid(s) at the purchaser’s home.

[ED. NOTE: Forms referenced are available from the agency.]

Stat. Auth.: ORS 376.615, 694.115, 694.170, 694.185
Stats. Implemented: ORS 694.025, 694.125, 694.185
Hist.: HLA 13-2012, f. 8-16-12, cert. ef. 8-17-12

331-660-0050

Additional Conditions for Referral

(1) In addition to the conditions listed in ORS 694.142 a hearing aid specialist shall not fit or dispense a hearing aid for use without first determining if the following conditions exist and, if so, referring the prospective purchaser to a physician:

(a) Evidence of significant cerumen accumulation in the auditory canal preventing visual inspection of the external auditory canal or external auditory meatus and tympanic membrane or foreign body in the ear canal; or

(b) Pain or discomfort in the ear.

(2) A Waiver of Medical Opinion form as required by ORS 694.142(6) must include the hearing aid specialist’s name and license number, the purchaser’s name, address and signature with date as well as the following statement: “I do not desire to have a medical evaluation before purchasing a hearing aid.”

Stat. Auth.: ORS 376.615, 694.115, 694.170, 694.185
Stats. Implemented: ORS 694.025, 694.125, 694.185
Hist.: HLA 13-2012, f. 8-16-12, cert. ef. 8-17-12

331-660-0060

Standards of Conduct

(1) Licensees must comply with the requirements of ORS 694.142, and all other applicable statutes and rules.

(2) Licensees must conform to state or federal laws regulating retail contracts or to any affirmation of fact or promise made in writing by the licensee which relates to the hearing aid or fitting and dispensing services and which becomes a part of the basis of the transaction when the purchaser relies on it or is, in part, induced into making purchase by it.

(3) Licensees must not make inaccurate or misleading representations or statements as to the efficacy of a hearing aid(s) for improving hearing.

(4) Licensees may not use a title or abbreviation that is misleading or may convey that the licensee holds a credential that is not related to hearing instrument sciences, without designating the professional field for which the credential was issued. Hearing instrument sciences includes, but is not limited to, core competencies identified in ORS 694.075.

(5) The Council recognizes and adopts the revised International Hearing Society’s Code of Ethics, as adopted October 1983 and revised March 2009, as its professional standards model. A copy of the document is on file at the agency for review, and may be accessed at the following Web site: http://insinfo.org/lhsV2/Resources/020_Code_Of_Ethics.cfm

(6) During the hearing test or evaluation for fitting a client with a hearing aid(s), the following items must be completed. If the case history and tests were completed within the previous six months and there has been no substantial change in the client’s hearing, the following tests may be performed at the discretion of the licensee:

(a) Confidential client case history;

(b) Puretone Air Conduction Threshold testing (should include at a minimum, the following frequencies - 250, 500, 1000, 2000, 3000, 4000, and 6000 or 8000 Hz);

(c) Puretone Bone Conduction Threshold testing (should include at a minimum, the following frequencies - 500, 1000, 2000, and 4000 Hz);

(d) Speech Recognition Threshold testing (SRT);

(e) Word Recognition Score (WRS) also known as speech discrimination testing;

(f) Most Comfortable Listening Level (MCL); and

(g) Uncomfortable Listening Level (UCL).

(7) For children who are unable to perform the tests listed in subsection (6) of this rule, an objective measure that meets prevailing professional standards can be used to assess auditory function. The test must be completed by a licensed audiologist or physician.

(8) Licensees must perform one or more of the following verification procedures, within the 30-day rescission period.

(a) Soundfield testing for speech discrimination;

(b) Soundfield testing for puretone thresholds;

(c) Real-ear probe microphone measurements;

(d) Speech mapping; and

(e) Other industry accepted objective measures.

(9) Licensees must post the following statement in public view on the business premises or provide the purchaser with a written notice stating: “Individuals are entitled to a copy of the audiogram used to conduct hearing evaluations and any test results.” If copies of the audiogram specified in OAR 331-660-0070, or results of tests or verification procedures conducted under subsections (6) and (8) of this rule are requested, they must be provided to the purchaser.

(10) Licensees who are unable to complete testing for reasons such as a client’s medical condition or inability to perform tests or verification procedures are excused from compliance with the relevant parts of subsections (6) and (8) but must document the reasons in the client’s record.

(11) Tests listed in subsection (8) of this rule will be used to determine the fitted hearing aid(s) ability to meet current industry standards in reference to ORS 694.042(1)(c), during investigation of complaints filed with the agency.

(12) Licensees must maintain a record of the technical specifications issued by a manufacturer for the hearing aid(s) that have been delivered to or purchased by their clients. The specifications must be available for inspection by the agency’s representatives upon request.

Stat. Auth.: ORS 376.615, 694.115, 694.170, 694.185
Stats. Implemented: ORS 694.025, 694.125, 694.185
Hist.: HLA 13-2012, f. 8-16-12, cert. ef. 8-17-12

331-660-0070

Uniform Measurement Standards

(1) The Council recognizes and adopts the following uniform set of hearing loss measurement standards required for use when interpreting audiograms using 0 — 110 for degrees of decibel hearing loss (dB HL) and 125 — 8000 Hz for frequency. This set of uniform measurement standards must be used for advising consumers on peripheral or cochlear hearing loss: [Table not included. See ED. NOTE.]

(2) Hearing loss may have a greater effect on children than adults. The degree of hearing loss does not necessarily reflect the degree of impairment.

[ED. NOTE: Tables referenced are available from the agency.]

Stat. Auth.: ORS 376.615, 694.115, 694.170, 694.185
Stats. Implemented: ORS 694.025, 694.125, 694.185
Hist.: HLA 13-2012, f. 8-16-12, cert. ef. 8-17-12

331-660-0080

Client Record Requirements

(1) For the purpose of clarifying record keeping requirements, the term “client” as used in this rule, means the individual who is a consumer, purchaser, potential purchaser or hearing-aid wearer.

(2) Required Records. Licensees must record, update and maintain documentation for each client relevant to health history, clinical examinations and treatment, and financial data. Documentation shall be written or computerized. Records must include the following information:

(a) Basic client information, including name, address, telephone number and dates of service;

(b) Health history relevant to hearing evaluation or fitting of a hearing aid(s), including referral to a physician or a Waiver of Medical Opinion form required by ORS 694.142(6);

(c) Identification of any conditions that would require referral to a physician licensed under ORS chapter 677, as required in ORS 694.142(1) and OAR 331-660-0050, and a notation that the client was referred;

(d) Audiograms as specified in OAR 331-660-0070 and results of tests or verification procedures as specified in OAR 331-660-0060;

(e) A copy of the Statement to Prospective Purchaser required by ORS 694.036 and OAR 331-660-0040, including client’s signature and date acknowledging that the client has read and understands the information contained in the purchase agreement;

(f) A copy of the Right to Rescind a Hearing Aid Purchase giving notice of rights under ORS 694.042; and

(g) Date and description of services rendered in the form of “chart notes”, including any complications. Chart notes must include the recorder’s initials, license number and professional title if multiple practitioners provide service to the client.

(3) Record Format. Records and documentation must be accurate, complete, and legible, typed or recorded using ink. Legible hand-written or electronic records are acceptable.

(4) Record Identifiers. Client records listed in subsection (1) of the rule, must include the licensee’s name, license number, professional title or abbreviation, and signature or initials somewhere on the documentation as a means of identifying the person who is providing service to the client. This information may be affixed to the record(s) in the form of a professional stamp or handwritten entry.

(5) Record Retention. All client records and documentation, written or archived electronically by computer, must be stored and maintained for a minimum of seven years after the licensee has last seen the client or past the age of minority, so that the records are safeguarded, readily retrievable, and available for inspection by the Oregon Health Licensing Agency’s representative.

Stat. Auth.: ORS 376.615, 694.115, 694.170, 694.185
Stats. Implemented: ORS 694.025, 694.125, 694.185
Hist.: HLA 13-2012, f. 8-16-12, cert. ef. 8-17-12

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