SENATE BILL REPORT

HB 1177

As Reported by Senate Committee On:

Health & Long Term Care, March 20, 2019

Title: An act relating to creating the dental laboratory registry within the department of health and establishing minimum standards for dental laboratories serving dentists in Washington state.

Brief Description: Creating the dental laboratory registry within the department of health and establishing minimum standards for dental laboratories serving dentists in Washington state.

Sponsors: Representatives Stonier, Caldier, Cody and Schmick.

Brief History: Passed House: 3/07/19, 97-0.

Committee Activity: Health & Long Term Care: 3/18/19, 3/20/19 [DP, w/oRec].

Majority Report: Do pass.

Signed by Senators Cleveland, Chair; Randall, Vice Chair; O'Ban, Ranking Member; Bailey, Conway, Frockt, Keiser and Van De Wege.

Minority Report: That it be referred without recommendation.

Signed by Senator Becker.

Staff: Evan Klein (786-7483)

Background: Dentists are licensed and disciplined by the Dental Quality Assurance Commission (DQAC). In order to be licensed, a dentist must:

• submit proof of graduation from a dental college, school, or dental department of an institution approved by the DQAC;

• submit a recent picture; and

• pass an examination.

A licensed dentist may perform a variety of services, including diagnosing, treating, removing stains or concentrations from the teeth; operating or prescribing for any oral disease, pain, injury, deficiency, deformity, or physical condition; and furnishing, supplying, constructing, reproducing, or repairing any prosthetic denture, bridge, appliance, or other structure to be worn in the human mouth.

A dental laboratory is a facility that manufactures dental care products. Products typically produced by dental laboratories include bridges, crowns, and dentures.

Summary of Bill: Dental laboratories are any facility that engages in making, repairing, altering, or supplying artificial restorations, substitutions, appliances, or materials for the correction of disease, loss, deformity, malposition, dislocation, fracture, or injury to the jaws, teeth, lips, gums, cheeks, palate, or associated tissues or parts.

All dental laboratories operating, doing business, or intending to operate or do business in Washington must register with the Department of Health (DOH). A dental laboratory is considered to be doing business in Washington if its work products are prepared pursuant to a work order or work authorization originating in Washington. A dental laboratory is not required to register if it operates under the supervision of a dentist licensed in Washington, as part of a dental practice, or in an educational institution so long as the laboratory does not perform work originating outside of the dentist's office, dental practice, or institution.

To be registered, a dental laboratory must pay an annual registration fee and submit an application to DOH that includes:

• the name, mailing address, physical address—if different, phone number, and e-mail address of the laboratory;

• the name, mailing address, phone number, and e-mail address of the responsible person or supervising licensed dentist;

• a statement that the laboratory meets the infectious control requirements under the federal Occupational Safety and Health Administration and the Centers for Disease Control and Prevention; and

• an acknowledgement by the responsible person or supervising dentist that:

  1. the laboratory will provide material disclosure to the prescribing dentist that contains the manufacturer and brand name or United States Food and Drug Administration registration number of all patient contact materials contained in the prescribed restoration to include in the patient's record; and

  2. they will disclose to the prescribing dentist the point of origin of the manufacture of the prescribed restoration. If the restoration was partially or entirely manufactured by a third-party provider, the point-of-origin disclosure must identify the portion manufactured by the third-party provider and the city, state, and country of the provider.

DOH must assign each registered dental laboratory a registration number, which must appear on all laboratory invoices and dentist work orders.

Beginning January 31, 2021, the applicant for registration must maintain an employee who works at least 30 hours per week who is either certified in good standing as a dental technician by the National Board for Certification in Dental Laboratory Technology or has successfully completed at least 12 hours of continuing education in dental laboratory technology approved by the National Board for Certification in Dental Laboratory Technology during the 12 months prior to the application.

Beginning January 31, 2025, a laboratory that has not been owned and operated by the same individual since January 1, 1996, must maintain a certified dental technician in good standing with the National Board for Certification in Dental Laboratory Technology who works at least 30 hours per week or demonstrate it is operated under the supervision of a licensed dentist.

Dental laboratories must renew their registrations every year before July 31st.

DOH may maintain an action, in the manner provided by law, against a dental laboratory that violates the registration requirements for an injunction or other process to restrain or prevent the operation of the establishment without a registration. The attorney general must advise DOH and represent the agency in the proceedings.

The registration requirements do not apply to the authorized activities of licensed denturists.

Appropriation: None.

Fiscal Note: Available.

Creates Committee/Commission/Task Force that includes Legislative members: No.

Effective Date: Ninety days after adjournment of session in which bill is passed.

Staff Summary of Public Testimony: PRO: This is not the first time this bill has been before the Legislature, but this bill comes to the Senate with broad support this year. This provides for patient safety by allowing patients to know where their products came from and what materials are in the products they are receiving. This bill incorporates amendments that were incorporated into the bill last year. This is an attempt to provide a clear line of responsibility for those individuals who are creating devices to be placed into the human body. The registration of dental laboratories will enhance patient health and safety and will ensure that laboratories are operating under high standards.

Persons Testifying: PRO: Representative Monica Jurado Stonier, Prime Sponsor; Brad Tower, Washington Dental Laboratory Association; Matt Chapman, Chapman Dental Laboratory; Emily Lovell, Washington State Dental Association.

Persons Signed In To Testify But Not Testifying: No one.