Bill Text: MN SF288 | 2011-2012 | 87th Legislature | Introduced
NOTE: There are more recent revisions of this legislation. Read Latest Draft
Bill Title: Dental laboratories regulations
Spectrum: Bipartisan Bill
Status: (Passed) 2012-05-07 - Secretary of State Chapter 269 05/02/12 [SF288 Detail]
Download: Minnesota-2011-SF288-Introduced.html
Bill Title: Dental laboratories regulations
Spectrum: Bipartisan Bill
Status: (Passed) 2012-05-07 - Secretary of State Chapter 269 05/02/12 [SF288 Detail]
Download: Minnesota-2011-SF288-Introduced.html
1.2relating to health; regulating dental laboratories;proposing coding for new law
1.3as Minnesota Statutes, chapter 150B.
1.4BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
1.5 Section 1. [150B.01] SCOPE.
1.6To promote the health, safety, and welfare of citizens of this state, dental laboratories
1.7conducting business in this state must adhere to the regulatory procedures in sections
1.8150B.02 to 150B.05.
1.9 Sec. 2. [150B.02] DEFINITIONS.
1.10 Subdivision 1. Dental laboratory. "Dental laboratory" means a corporation,
1.11partnership, or sole proprietor engaged in the manufacture or repair of dental prosthetic
1.12appliances on the prescription of and for a licensed dentist or the work authorized by
1.13another commercial dental laboratory.
1.14 Subd. 2. Dental technician. "Dental technician" has the meaning given in section
1.15150A.10, subdivision 3.
1.16 Subd. 3. Certified dental technician. "Certified dental technician" means a dental
1.17technician who has met the standards set by the National Board for Certification in Dental
1.18Laboratory Technology or its equivalent as established by the Board of Dentistry.
1.19 Subd. 4. Licensed dentist. "Licensed dentist" has the meaning given in section
1.20150A.01, subdivision 6.
1.21 Subd. 5. Work order. "Work order" means a written instrument by a licensed
1.22dentist directing a registered dental laboratory to manufacture or repair a dental prosthetic
2.1appliance for an individual patient. The work order may be handwritten. It may be faxed
2.2or sent electronically using an electronic signature.
2.3 Subd. 6. Work authorization. "Work authorization" means a written instrument
2.4by a registered dental laboratory authorized by prescription by which a registered dental
2.5laboratory subcontracts all or part of the fabrication or repair of a dental prosthetic
2.6appliance authorized by prescription to another regulated dental laboratory. The work
2.7authorization may be handwritten. It may be faxed or sent electronically using an
2.8electronic signature.
2.9 Sec. 3. [150B.03] REGISTRATION REQUIRED.
2.10 Subdivision 1. Registered dental laboratory. (a) An individual dental laboratory
2.11operating, doing business, or intending to operate or do business in this state must register
2.12with the Board of Dentistry every two years and receive a unique registration number
2.13identifying the registered dental laboratory.
2.14(b) In order to be regulated under this section, a dental laboratory must practice
2.15infectious disease control criteria as required by OSHA and the Centers for Disease
2.16Control and Prevention (CDC) of the United States Public Health Service.
2.17(c) A dental laboratory in another state or country that provides service to a dentist
2.18licensed in this state is required to be registered with the state.
2.19(d) Dental laboratories registered in this state are subject to inspections as directed
2.20by the Board of Dentistry.
2.21 Subd. 2. Prescription required. (a) The dental technological work must be based
2.22on a prescription issued by a licensed dentist. Prescriptions may be handwritten. They
2.23may be faxed or sent electronically using an electronic signature.
2.24(b) The laboratory shall not diagnose or issue a treatment plan with a patient for or in
2.25place of the prescribing dentist.
2.26 Subd. 3. Outside dental laboratory work. A dentist practicing dentistry in this
2.27state must us a dental laboratory registered with the state of Minnesota and displaying
2.28a state registration number for any dental laboratory work that is performed outside of
2.29the office of a licensed dentist.
2.30 Subd. 4. Material content notice. (a) A dental laboratory shall disclose to the
2.31dentist, within seven days of written request, the complete material content of a prescribed
2.32restoration in a manner in which it can be easily included in the patient record. The
2.33material content notice must be included in the patient record.
2.34(b) The laboratory shall return to the dentist who issued the prescription certification
2.35of:
3.1(1) the country of origin where the dental technological work was performed,
3.2in whole or in part;
3.3(2) the name, physical address, and registration number of the laboratory authorized
3.4to manufacture the dental device.
3.5 Subd. 5. Biennial fee. In order to obtain registration, dental laboratories doing
3.6business in this state must pay a $300 registration fee every two years in addition to
3.7meeting the requirements in this chapter.
3.8 Sec. 4. [150B.04] DENTAL LABORATORY CERTIFICATION.
3.9By ......., in addition to obtaining registration in this state, a dental laboratory doing
3.10business in Minnesota must do one of the following:
3.11(1) obtain certification from the National Association of Dental Laboratories
3.12(NADL);
3.13(2) employ a certified dental technician (CDT) to work in the laboratory;
3.14(3) obtain ISO certification; or
3.15(4) obtain Dental Appliance Manufactures Audit System (DAMAS) certification.
3.16 Sec. 5. [150B.05] PROHIBITION AGAINST USE OF A NONREGISTERED
3.17DENTAL LABORATORY.
3.18A dentist licensed in this state must not have a dental prosthetic appliance
3.19manufactured in a dental laboratory that does not meet the regulatory requirements
3.20of this section.
3.21 Sec. 6. [150B.06] CONTINUING EDUCATION REQUIREMENTS.
3.22(a) Each dental laboratory renewing registration on or after ................ shall be
3.23required to have documentation on file certifying that each of their dental technicians
3.24has completed eight hours of continuing education biennially. Programs of continuing
3.25education shall be programs of learning that contribute directly to the education of the
3.26dental technician and may include, but shall not be limited to, attendance at lectures, study
3.27clubs, college courses, or scientific sessions of conventions; and research.
3.28(b) The aim of continuing education for dental technicians is to improve dental
3.29health care delivery to the public as such is impacted through the design, manufacture, and
3.30use of artificial human oral prosthetics and related restorative appliances.
3.31(c) Continuing education courses shall address one or more of the following areas
3.32of professional development including, but not limited to:
4.1(1) laboratory and technological subjects including, but not limited to, laboratory
4.2techniques and procedures, materials, and equipment; and
4.3(2) subjects pertinent to oral health, infection control, and safety.
4.4(d) Programs meeting the general requirements of continuing education as
4.5recognized by the National Association of Dental Laboratories (NADL). Other
4.6organizations, schools, or agencies may also be approved to develop and offer continuing
4.7education in accordance with specific criteria established by the Board of Dentistry.
4.8(e) Any dental laboratory renewing a registration on or after ................. shall
4.9submit a sworn affidavit, on a form acceptable to the Board of Dentistry, attesting that
4.10each of their dental technicians has completed the continuing education required in this
4.11section according to the guidelines and provisions of this section and listing the date,
4.12location, sponsor, subject matter, and hours of completed continuing education courses.
4.13The dental laboratory shall retain in its records any receipts, vouchers, or certificates as
4.14may be necessary to document completion of the continuing education courses for two
4.15registration cycles. With cause, the Board of Dentistry may request that the documentation
4.16be provided by the applicant. The Board of Dentistry may also request the documentation
4.17from applicants selected at random without cause.
4.18 Sec. 7. [150B.07] IN-OFFICE DENTAL LABORATORIES.
4.19Sections 150B.01 to 150B.06 apply to a dental laboratory that is located within a
4.20dental practice and the dental technicians employed by that dental practice.
1.3as Minnesota Statutes, chapter 150B.
1.4BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
1.5 Section 1. [150B.01] SCOPE.
1.6To promote the health, safety, and welfare of citizens of this state, dental laboratories
1.7conducting business in this state must adhere to the regulatory procedures in sections
1.8150B.02 to 150B.05.
1.9 Sec. 2. [150B.02] DEFINITIONS.
1.10 Subdivision 1. Dental laboratory. "Dental laboratory" means a corporation,
1.11partnership, or sole proprietor engaged in the manufacture or repair of dental prosthetic
1.12appliances on the prescription of and for a licensed dentist or the work authorized by
1.13another commercial dental laboratory.
1.14 Subd. 2. Dental technician. "Dental technician" has the meaning given in section
1.15150A.10, subdivision 3.
1.16 Subd. 3. Certified dental technician. "Certified dental technician" means a dental
1.17technician who has met the standards set by the National Board for Certification in Dental
1.18Laboratory Technology or its equivalent as established by the Board of Dentistry.
1.19 Subd. 4. Licensed dentist. "Licensed dentist" has the meaning given in section
1.20150A.01, subdivision 6.
1.21 Subd. 5. Work order. "Work order" means a written instrument by a licensed
1.22dentist directing a registered dental laboratory to manufacture or repair a dental prosthetic
2.1appliance for an individual patient. The work order may be handwritten. It may be faxed
2.2or sent electronically using an electronic signature.
2.3 Subd. 6. Work authorization. "Work authorization" means a written instrument
2.4by a registered dental laboratory authorized by prescription by which a registered dental
2.5laboratory subcontracts all or part of the fabrication or repair of a dental prosthetic
2.6appliance authorized by prescription to another regulated dental laboratory. The work
2.7authorization may be handwritten. It may be faxed or sent electronically using an
2.8electronic signature.
2.9 Sec. 3. [150B.03] REGISTRATION REQUIRED.
2.10 Subdivision 1. Registered dental laboratory. (a) An individual dental laboratory
2.11operating, doing business, or intending to operate or do business in this state must register
2.12with the Board of Dentistry every two years and receive a unique registration number
2.13identifying the registered dental laboratory.
2.14(b) In order to be regulated under this section, a dental laboratory must practice
2.15infectious disease control criteria as required by OSHA and the Centers for Disease
2.16Control and Prevention (CDC) of the United States Public Health Service.
2.17(c) A dental laboratory in another state or country that provides service to a dentist
2.18licensed in this state is required to be registered with the state.
2.19(d) Dental laboratories registered in this state are subject to inspections as directed
2.20by the Board of Dentistry.
2.21 Subd. 2. Prescription required. (a) The dental technological work must be based
2.22on a prescription issued by a licensed dentist. Prescriptions may be handwritten. They
2.23may be faxed or sent electronically using an electronic signature.
2.24(b) The laboratory shall not diagnose or issue a treatment plan with a patient for or in
2.25place of the prescribing dentist.
2.26 Subd. 3. Outside dental laboratory work. A dentist practicing dentistry in this
2.27state must us a dental laboratory registered with the state of Minnesota and displaying
2.28a state registration number for any dental laboratory work that is performed outside of
2.29the office of a licensed dentist.
2.30 Subd. 4. Material content notice. (a) A dental laboratory shall disclose to the
2.31dentist, within seven days of written request, the complete material content of a prescribed
2.32restoration in a manner in which it can be easily included in the patient record. The
2.33material content notice must be included in the patient record.
2.34(b) The laboratory shall return to the dentist who issued the prescription certification
2.35of:
3.1(1) the country of origin where the dental technological work was performed,
3.2in whole or in part;
3.3(2) the name, physical address, and registration number of the laboratory authorized
3.4to manufacture the dental device.
3.5 Subd. 5. Biennial fee. In order to obtain registration, dental laboratories doing
3.6business in this state must pay a $300 registration fee every two years in addition to
3.7meeting the requirements in this chapter.
3.8 Sec. 4. [150B.04] DENTAL LABORATORY CERTIFICATION.
3.9By ......., in addition to obtaining registration in this state, a dental laboratory doing
3.10business in Minnesota must do one of the following:
3.11(1) obtain certification from the National Association of Dental Laboratories
3.12(NADL);
3.13(2) employ a certified dental technician (CDT) to work in the laboratory;
3.14(3) obtain ISO certification; or
3.15(4) obtain Dental Appliance Manufactures Audit System (DAMAS) certification.
3.16 Sec. 5. [150B.05] PROHIBITION AGAINST USE OF A NONREGISTERED
3.17DENTAL LABORATORY.
3.18A dentist licensed in this state must not have a dental prosthetic appliance
3.19manufactured in a dental laboratory that does not meet the regulatory requirements
3.20of this section.
3.21 Sec. 6. [150B.06] CONTINUING EDUCATION REQUIREMENTS.
3.22(a) Each dental laboratory renewing registration on or after ................ shall be
3.23required to have documentation on file certifying that each of their dental technicians
3.24has completed eight hours of continuing education biennially. Programs of continuing
3.25education shall be programs of learning that contribute directly to the education of the
3.26dental technician and may include, but shall not be limited to, attendance at lectures, study
3.27clubs, college courses, or scientific sessions of conventions; and research.
3.28(b) The aim of continuing education for dental technicians is to improve dental
3.29health care delivery to the public as such is impacted through the design, manufacture, and
3.30use of artificial human oral prosthetics and related restorative appliances.
3.31(c) Continuing education courses shall address one or more of the following areas
3.32of professional development including, but not limited to:
4.1(1) laboratory and technological subjects including, but not limited to, laboratory
4.2techniques and procedures, materials, and equipment; and
4.3(2) subjects pertinent to oral health, infection control, and safety.
4.4(d) Programs meeting the general requirements of continuing education as
4.5recognized by the National Association of Dental Laboratories (NADL). Other
4.6organizations, schools, or agencies may also be approved to develop and offer continuing
4.7education in accordance with specific criteria established by the Board of Dentistry.
4.8(e) Any dental laboratory renewing a registration on or after ................. shall
4.9submit a sworn affidavit, on a form acceptable to the Board of Dentistry, attesting that
4.10each of their dental technicians has completed the continuing education required in this
4.11section according to the guidelines and provisions of this section and listing the date,
4.12location, sponsor, subject matter, and hours of completed continuing education courses.
4.13The dental laboratory shall retain in its records any receipts, vouchers, or certificates as
4.14may be necessary to document completion of the continuing education courses for two
4.15registration cycles. With cause, the Board of Dentistry may request that the documentation
4.16be provided by the applicant. The Board of Dentistry may also request the documentation
4.17from applicants selected at random without cause.
4.18 Sec. 7. [150B.07] IN-OFFICE DENTAL LABORATORIES.
4.19Sections 150B.01 to 150B.06 apply to a dental laboratory that is located within a
4.20dental practice and the dental technicians employed by that dental practice.
