WSR 98-06-079

PERMANENT RULES

DEPARTMENT OF HEALTH

[Filed March 3, 1998, 4:59 p.m.]

Date of Adoption: November 17, 1997.

Purpose: Amendments to incorporate 1996 legislative changes to chapter 18.35 RCW. Add the terms "certificate holder" and "certification" where appropriate and change the word "aid" to "instrument," other housekeeping changes as necessary.

Citation of Existing Rules Affected by this Order: Amending WAC 246-828-005, 246-828-030, 246-828-075, 246-828-080, 246-828-090, 246-828-100, 246-828-270, 246-828-280, 246-828-320, 246-828-330, 246-828-340, and 246-828-350. WAC 246-828-295, 246-828-300 and 246-828-370 were withdrawn. See WSR 98-05-058.

Statutory Authority for Adoption: RCW 18.35.161.

Adopted under notice filed as WSR 97-19-099 on September 17, 1997.

Number of Sections Adopted in Order to Comply with Federal Statute: New 0, amended 0, repealed 0; Federal Rules or Standards: New 0, amended 0, repealed 0; or Recently Enacted State Statutes: New 0, amended 15, repealed 0.

Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, amended 0, repealed 0.

Number of Sections Adopted on the Agency's own Initiative: New 0, amended 0, repealed 0.

Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, amended 0, repealed 0.

Number of Sections Adopted using Negotiated Rule Making: New 0, amended 0, repealed 0; Pilot Rule Making: New 0, amended 0, repealed 0; or Other Alternative Rule Making: New 0, amended 15, repealed 0.

Effective Date of Rule: Thirty-one days after filing.

February 10, 1998

Delores E. Spice

Executive Director

AMENDATORY SECTION (Amending Order 339B, filed 3/5/93, effective 4/5/93)

WAC 246-828-005 Fitting and dispensing activities requiring license defined. Fitting and dispensing activities requiring licensing include the following:

(1) The sale, lease, or rental or attempted sale, lease, or rental of a hearing ((aid)) instrument; and

(2) The selection or adaptation of a hearing ((aid)) instrument in connection with the sale, lease, or rental of a hearing ((aid)) instrument; and

(3) The taking of an ear mold impression to be used in connection with the sale, lease, or rental of a hearing ((aid)) instrument except when taking an ear mold impression for the purpose of replacing a current ear mold with one of the same type.

Activities exempt from the provisions of chapter 18.35 RCW: The sale, lease, or rental of assistive listening devices which are described as personal or group listening systems, telephone listening devices, or altering devices are exempt from provisions of chapter 18.35 RCW. Assistive listening devices are designed to solve specific listening problems and are generally worn on a temporary basis. Hearing ((aids)) instruments are designed for a wide range of listening situations and are generally worn on a full time basis.

[Statutory Authority: RCW 18.35.161(1). 93-07-009 (Order 339B), 246-828-005, filed 3/5/93, effective 4/5/93.]

AMENDATORY SECTION (Amending Order 165B, filed 5/8/91, effective 6/8/91)

WAC 246-828-030 Reexaminations. (1) Should an applicant fail any part of the hearing instrument fitter/dispenser examination, he/she may apply to the department to retake the failed part of the examination.

(2) All reexaminations shall be conducted at the next regularly scheduled examination.

(3) Any person who fails to qualify for licensure after three consecutive regularly scheduled examinations shall be required to take the entire examination. A waiver may be granted upon a showing of emergency circumstances.

[Statutory Authority: RCW 18.35.161. 91-11-031 (Order 165B), recodified as 246-828-030, filed 5/8/91, effective 6/8/91; 89-04-017 (Order PM 818), 308-50-020, filed 1/23/89. Statutory Authority: RCW 18.35.161(3). 87-14-030 (Order PM 654), 308-50-020, filed 6/26/87. Statutory Authority: RCW 18.35.161. 84-19-019 (Order PL 479), 308-50-020, filed 9/12/84; Order PL 222, 308-50-020, filed 11/5/75; Order PL 159, 308-50-020, filed 2/8/74.]

AMENDATORY SECTION (Amending WSR 95-19-017, filed 9/7/95, effective 10/8/95)

WAC 246-828-075 Student supervisors--Scope and definitions. (1) Students enrolled in an accredited education or training program may perform the duties of a hearing ((aid)) instrument fitter/dispenser in the course of their training if under the supervision of a Washington state licensed hearing ((aid)) instrument fitter/dispenser or certified audiologist. Supervision shall mean that the licensee/certificate holder is physically present on the premises at all times.

(2) An accredited education or training program shall be defined as any course of study in the field of fitting and dispensing hearing ((aids)) instruments that is offered by a school or program recognized by the state of Washington.

(3) The student shall at all times wear an identification badge readily visible to the public which identifies him or her as a student.

(4) The licensed/certified supervisor shall be responsible for all acts of the student.

[Statutory Authority: RCW 18.35.161 (1) and (3). 95-19-017 246-828-075, filed 9/7/95, effective 10/8/95.]

AMENDATORY SECTION (Amending WSR 95-19-017, filed 9/7/95, effective 10/8/95)

WAC 246-828-080 Minimum standards of equipment. Minimum equipment in the fitting and dispensing of hearing ((aids)) instruments shall include:

(1) Access to a selection of hearing ((aid)) instrument models, and hearing ((aid)) instrument supplies and services sufficiently complete to accommodate the various user needs.

(2) Facilities for the personal comfort of customers.

(3) A test environment with background noise no greater than current American National Standards Institute specifications (S3.1-1960 (R-1971)) plus 15 dB. When nonstandard environments must be used, appropriate procedures shall be employed and documented.

(4) Pure tone audiometer calibrated in accordance with WAC 246-828-090.

(5) Equipment appropriate for conducting speech audiometry (testing).

[Statutory Authority: RCW 18.35.161 (1) and (3). 95-19-017 246-828-080, filed 9/7/95, effective 10/8/95. Statutory Authority: RCW 18.35.161. 91-11-031 (Order 165B), recodified as 246-828-080, filed 5/8/91, effective 6/8/91; 84-19-019 (Order PL 479), 308-50-110, filed 9/12/84; Order PL 159, 308-50-110, filed 2/8/74.]

AMENDATORY SECTION (Amending WSR 95-19-017, filed 9/7/95, effective 10/8/95)

WAC 246-828-090 Standards for equipment calibration. (1) All electronic equipment utilized by licensees/certificate holders for the determination of audiometric thresholds for pure tones and for speech shall conform to all current standards of the American National Standards Institute. Licensees/certificate holders shall insure that all such audiometric equipment has been evaluated electrically and acoustically at least once each year, adjusted or repaired if necessary, and that conformity with such standards was determined at that time. Records of such calibration shall be permanently maintained by licensees/certificate holders and shall be available for inspection at any time by the department. No licensee/certificate holder shall be permitted to certify as to the calibration of his own equipment unless authorized to do so by the department. In addition, all licensees/certificate holders shall utilize routine procedures for the daily inspection of audiometric equipment, or prior to use if used less often than on a daily basis, to generally determine that it is in normal working order.

(2) Hearing instruments, assistive listening devices, and electronic equipment used for assessment and/or monitoring of auditory and vestibular function shall be maintained according to manufacturer's specifications.

(3) All instrumental technology used to diagnose and/or treat disorders of communication, swallowing and hearing shall be maintained in proper working order and be properly calibrated according to accepted standards.

[Statutory Authority: RCW 18.35.161 (1) and (3). 95-19-017 246-828-090, filed 9/7/95, effective 10/8/95. Statutory Authority: RCW 18.35.161. 91-11-031 (Order 165B), recodified as 246-828-090, filed 5/8/91, effective 6/8/91; 84-08-062 (Order PL 463), 308-50-120, filed 4/4/84; Order PL 159, 308-50-120, filed 2/8/74.]

AMENDATORY SECTION (Amending WSR 95-19-017, filed 9/7/95, effective 10/8/95)

WAC 246-828-100 Hearing instrument fitting dispensing--Minimal standards of practice. Minimum procedures in the fitting and dispensing of hearing ((aids)) instruments shall include:

(1) Obtain case history to include the following:

(a) As required by WAC 246-828-280, documentation of referrals, or as otherwise required by this chapter.

(b) Historical evaluation to include inquiry regarding hearing loss, onset of loss, and any associated symptoms including significant noise in the ears, vertigo, acute or chronic dizziness, nausea, earaches, or other such discomfort which may indicate the presence of medical illness. Specific inquiry should be made to determine if hearing loss has been sudden or rapidly progressive in the past ninety days, if there has been any active drainage or infection in ears during the past ninety days, and if there are any specific physical problems which may relate to the use of a hearing ((aid)) instrument.

(2) Examination of the ears should be done to reasonably determine if any of the following conditions exist:

(a) Impacted ear wax.

(b) Foreign body within the ear canal.

(c) Discharge in the ear canal.

(d) Presence of inflammation or irritation of the ear canal.

(e) Perforation of the ear drum.

(f) Any other abnormality.

(3) Hearing testing shall be performed to include the following:

(a) Hearing loss, or residual hearing, shall be established for each ear using ((puretone)) pure tone threshold audiometry by air and bone conduction with effective masking as required.

(b) Appropriate live voice or recorded speech audiometry by ear phones to determine the following: Speech reception threshold, most comfortable level, uncomfortable level, and the speech discrimination percent.

(c) Hearing testing shall be conducted in the appropriate environment as required by WAC 246-828-080, minimum standards of equipment, or as otherwise required by this chapter.

(d) When ((puretone)) pure tone audiometry indicates an air-bone gap of 15db or more, 500, 1000, and 2000 Hz, the presence of unilateral hearing loss, or any inconsistent audiometric findings, the client shall be advised of the potential help available through medical treatment. Should the client decline to consider such methods, or if the client has previously been appropriately treated or has been advised against such procedures, an appropriate notation shall be made in the client's record.

(e) In the event a client is referred to a licensee by an M.A. audiologist, otologist, otolaryngologist, or by a fitter/dispenser duly licensed under chapter 18.35 RCW, and the audiometric results obtained within the previous six months are provided to the licensee as a part of this referral, the applicable provisions of WAC 246-828-100 shall not be required. However, a confirmatory audiometric examination is recommended.

(4) Medical evaluation requirements:

(a) If the prospective hearing ((aid)) instrument user is eighteen years of age or older, the hearing ((aid)) instrument dispenser may afford the prospective user an opportunity to waive the medical evaluation requirements of (b) of this subsection provided that the hearing ((aid)) instrument dispenser:

(i) Informs the prospective user that the exercise of the waiver is not in the user's best health interest;

(ii) Does not in any way actively encourage the prospective user to waive such a medical evaluation;

(iii) Affords the prospective user the opportunity to sign the following statement:

I have been advised by (hearing ((aid)) instrument fitter/dispenser name) that the Food and Drug Administration has determined that my best health interest would be served if I had a medical evaluation before purchasing a hearing ((aid)) instrument; and

(iv) Provides the prospective user with a copy of the signed waiver statement.

(b) Except as provided in (a) of this subsection, a hearing ((aid)) instrument dispenser shall not sell a hearing ((aid)) instrument unless the prospective user has presented to the hearing ((aid)) instrument dispenser a written statement signed by a licensed physician that states that the patient's hearing loss has been medically evaluated and the patient may be considered a candidate for a hearing ((aid)) instrument. The medical evaluation must have taken place within the preceding six months.

(5) Selection and fitting of the hearing ((aid)) instrument shall include the following:

(a) Provide information regarding the selection of the most appropriate method and model for amplification for the needs of the client.

(b) Provide the user with the cost of the recommended ((aids)) instruments and services.

(c) Provide for or have available an appropriate custom made ear mold.

(d) Provide final fitting of the hearing ((aid)) instrument to ensure physical and operational comfort.

(e) Provide adequate instructions and appropriate post-fitting adjustments to ensure the most successful use of the hearing ((aid)) instrument.

(6) Keeping records on every client to whom the licensee/certificate holder renders service in connection with the dispensing of a hearing ((aid)) instrument. Such records shall be preserved for at least three years after the dispensing of the first hearing ((aid)) instrument to the client. If other hearing ((aids)) instruments are subsequently dispensed to that client, cumulative records must be maintained for at least three years after the latest dispensing of an ((aid)) instrument to that client. The records must be available for the department inspection and will include:

(a) Client's case history.

(b) Source of referral and appropriate documents.

(c) Medical clearance for the hearing ((aid)) instrument user or the waiver set forth in subsection (4)(a)(iii) of this section which has been signed after being fully informed that it is in the best health interest to seek medical evaluation.

(d) Copies of any contracts and receipts executed in connection with the fitting and dispensing of each hearing ((aid)) instrument provided.

(e) A complete record of tests, test results, and services provided except for minor services.

(f) All correspondence specifically related to the service given the client or the hearing ((aid)) instrument or ((aids)) instruments dispensed to the client.

[Statutory Authority: RCW 18.35.161 (1) and (3). 95-19-017 246-828-100, filed 9/7/95, effective 10/8/95. Statutory Authority: RCW 18.35.161. 91-11-031 (Order 165B), recodified as 246-828-100, filed 5/8/91, effective 6/8/91; 89-04-017 (Order PM 818), 308-50-130, filed 1/23/89; 84-19-018 (Order PL 478), 308-50-130, filed 9/12/84; Order PL 159, 308-50-130, filed 2/8/74.]

AMENDATORY SECTION (Amending Order 166B, filed 5/8/91, effective 6/8/91)

WAC 246-828-270 Personal disclosure. A licensee/certificate holder who contacts a prospective purchaser away from the licensee's/certificate holder's place of business must:

(1) When the contact is in person, present the prospective purchaser with written notice of:

(a) His or her name, the name of his or her business firm, his or her business address and telephone number;

(b) The number of his or her license/certificate.

(2) Telephone contact with prospective purchasers must disclose the name of the licensee/certificate holder, name and location of his or her principal establishment and purpose of call.

(3) When the contact is through a direct mail piece or other advertising initiated by the licensee/certificate holder, clearly show on all promotional items the business/establishment name, the principal establishment address and telephone number, not just the address or telephone number where he/she will be on given days.

(4) A principal establishment is one which is bonded pursuant to RCW 18.35.240.

[Statutory Authority: RCW 18.35.161. 91-11-032 (Order 166B), 246-828-270, filed 5/8/91, effective 6/8/91; 91-11-031 (Order 165B), recodified as 246-828-270, filed 5/8/91, effective 6/8/91; 85-23-065 (Order PL 563), 308-50-310, filed 11/19/85; Order PL 159, 308-50-310, filed 2/8/74.]

AMENDATORY SECTION (Amending Order 165B, filed 5/8/91, effective 6/8/91)

WAC 246-828-280 Documentation of referrals. A licensee ((or trainee))/certificate holder or apprentice shall document the name of the referral source for all persons who are fit with a hearing ((aid)) instrument. Documentation shall consist of a name and address of the referral source and the date of such referral. Should the referral source be the person being fit with the hearing ((aid)) instrument, this information shall also be recorded as the referral source.

[Statutory Authority: RCW 18.35.161. 91-11-031 (Order 165B), recodified as 246-828-280, filed 5/8/91, effective 6/8/91; 85-10-024 (Order PL 526), 308-50-320, filed 4/24/85; Order PL 159, 308-50-320, filed 2/8/74.]

AMENDATORY SECTION (Amending WSR 95-19-017, filed 9/7/95, effective 10/8/95)

WAC 246-828-320 Minimum standards for fitting and dispensing locations. (1) The hours of business of each hearing ((aid)) instrument establishment shall be prominently and continuously displayed and visible to the public at each regular place or places of business owned or operated by that establishment.

(2) All such regular place or places of business or any activities emanating therefrom shall meet the minimum standards for facilities and equipment essential for the testing of hearing and the fitting and dispensing of hearing ((aids)) instruments as set forth in WAC 246-828-080.

(3) The term "place or places of business" means a location where a licensee/certificate holder engages or intends to engage in the fitting and dispensing of hearing ((aids)) instruments at a permanent address(es) open to the public on a regular basis.

[Statutory Authority: RCW 18.35.161 (1) and (3). 95-19-017 246-828-320, filed 9/7/95, effective 10/8/95. Statutory Authority: RCW 18.35.161. 91-11-031 (Order 165B), recodified as 246-828-320, filed 5/8/91, effective 6/8/91; 85-10-024 (Order PL 526), 308-50-390, filed 4/24/85.]

AMENDATORY SECTION (Amending Order 165B, filed 5/8/91, effective 6/8/91)

WAC 246-828-330 Notice of availability and location of follow-up services. Every licensee/certificate holder shall provide to a hearing ((aid)) instrument purchaser, in writing prior to the signing of the contract, notice of availability of services. The notice shall include the specific location of the follow-up service, including date and time if applicable.

[Statutory Authority: RCW 18.35.161. 91-11-031 (Order 165B), recodified as 246-828-330, filed 5/8/91, effective 6/8/91; 85-10-024 (Order PL 526), 308-50-400, filed 4/24/85.]

AMENDATORY SECTION (Amending Order 340B, filed 3/5/93, effective 4/5/93)

WAC 246-828-340 Surety bonding--Security in lieu of bonding. Every establishment shall file a bond or security in lieu of a bond as required by RCW 18.35.240. An establishment means any facility engaged in the fitting and dispensing of hearing ((aids)) instruments.

In addition to the primary establishment, a branch facility requires separate bonding if that facility is open to the public at a permanent location for twenty or more hours a week or one thousand hours a year. ((Fitter-dispensers)) Fitter/dispensers or audiologists who rent or lease office space in a facility whose primary function is other than the fitting and dispensing of hearing ((aids)) instruments do not require separate bonding for that facility unless the ((fitter-dispenser)) fitter/dispenser or audiologist or his/her representative is present at that location twenty or more hours a week.

[Statutory Authority: RCW 18.35.161(1). 93-07-010 (Order 340B), 246-828-340, filed 3/5/93, effective 4/5/93. Statutory Authority: RCW 18.35.161. 91-11-031 (Order 165B), recodified as 246-828-340, filed 5/8/91, effective 6/8/91; 85-10-024 (Order PL 526), 308-50-410, filed 4/24/85.]

AMENDATORY SECTION (Amending Order 165B, filed 5/8/91, effective 6/8/91)

WAC 246-828-350 Reasonable cause for recision. The purchaser of the hearing ((aid(s))) instrument(s) may rescind the purchase and recover moneys in accordance with RCW 18.35.190(2) for reasonable cause. The term "reasonable cause" is defined to include the following:

(1) Any material misstatement of fact or misrepresentation by the licensee/certificate holder regarding the hearing ((aid(s))) instrument(s) or fitting and dispensing services to be provided which the purchaser relied on or which induced the purchaser into making the agreement;

(2) Failure by the licensee/certificate holder to provide the purchaser with the hearing ((aid(s))) instrument(s) and fitting and dispensing services which conform to those specified in the purchase agreement between the parties;

(3) Diagnosis of a medical condition unknown to the purchaser at the time of purchase, which precludes the purchaser from using the hearing ((aid(s))) instrument(s);

(4) Failure by the licensee/certificate holder to remedy a significant material defect of the hearing ((aid(s))) instrument(s) within a reasonable period of time in accordance with RCW 18.35.190 (2)(c);

(5) The hearing ((aid(s))) instrument(s) and/or fitting and dispensing services would not be in accordance with accepted practices of the industry; and

(6) The licensee/certificate holder fails to meet any standard of conduct prescribed in the laws regarding the fitting and dispensing of hearing ((aids)) instruments and this failure adversely affects in any way the transaction which the purchaser seeks to rescind.