1. (a) A commercial dental laboratory and an in-house dental laboratory with more than two dental technicians shall be registered according to the provisions of Texas Civil Statutes, Article 4551f(6)(a)-(c), if it is a place where a person undertakes to perform or accomplish any act or service listed in Texas Civil Statutes, Article 4551f(1). Permitted services to be performed under a written prescription from a licensed dentist in addition to those described in Article 4551f(1), include:

   1. (1) Shade taking. Dental laboratories providing this service shall institute and maintain infection control procedures for in-laboratory shade verification to protect the patient and laboratory staff from infectious contamination. Each laboratory shall:

      1. (A) Dedicate a specific area of the laboratory for performance of shade verification procedures.
      2. (B) Maintain the area used for shade verification in a neat, clean, and clutter free state at all times.
      3. (C) Disinfect areas of patient contact both before and after each patient.
      4. (D) Provide a dedicated set of shade guides to be used only for patient shade verification. Disinfect shade guides before and after each use.
      5. (E) Provide a patient hand mirror for extraoral use. Disinfect mirror before and after each patient use.
      6. (F) Use a disinfecting agent for cleaning shade guides that are accidentally dropped.
      7. (G) Require that the technicians taking the shade wear protective clothing, including gloves.
   2. (2) Computer imaging as pertaining to the oral cavity by a registered laboratory. Computer imaging may be accomplished only when authorized by a written prescription from a licensed dentist. The result should be furnished to that dentist accompanied by a disclaimer to the patient that computer imaging is an artistic interpretation and does not guarantee exact results.
2. (b) A dental laboratory shall furnish each licensed dentist from whom prescriptions are accepted with its permanent registration number and expiration date of such registration, and shall maintain for a period of two years any work orders of any laboratory with which it contracts services. The work order shall reflect the Texas registration number and registration expiration date of the contracted laboratory. No work may be farmed out except to a Texas registered dental laboratory.
3. (c) All dental laboratories first registered after September 1, 1987, must have a certified dental technician on premises a minimum of 30 hours per week. The certified dental technician may be the designated CDT of record for only one laboratory per registration period.

4. (d) The Dental Laboratory Certification Council shall ensure that the following criteria are met for each new laboratory registration application and each renewal of any registration.

   1. (1) Application/renewal is complete and all required information is provided.
   2. (2) Current and active CDT certification for designated CDT, or for grandfathered laboratories, proof of continuing education hours as outlined in §116.4 of this title (relating to Continuing Education) is attached and current.
   3. (3) Appropriate fee is attached.
5. (e) Any laboratory owner applying for a new laboratory registration who has pending fees and/or penalties due from a previous laboratory registration when such laboratory was closed for noncompliance with subsection (f) of this section must first remit to the SBDE the registration fee and penalties for each year such fees were not paid before the registration is approved and processed.
6. (f) It shall be the duty of each laboratory owner to notify the SBDE in writing within 60 days of a change in: ownership of a laboratory, location of laboratory, closure of laboratory, the designated CDT or, in the case of a grandfathered lab, the designated employee. Changes of CDTs will require that proof of current CDT certification for the replacement CDT accompany said notification. Changes of designated employees for a grandfathered lab will require proof within six months of the change that the designated employee meets continuing education requirements.
7. (g) A person owning or operating a laboratory in the State of Texas must maintain the entire laboratory in a clean and sanitary condition without any accumulation of trash, debris, or filth, and such premises shall be maintained in full compliance with all health requirements of the city or county, or both, in which such a laboratory is located and in conformity with the health laws of the State of Texas.

Source Note:The provisions of this §116.3 adopted to be effective June 8, 1988, 13 TexReg 2613; amended to be effective August 21, 1991, 16 TexReg 4283; amended to be effective March 18, 1997, 22 TexReg 2496; amended to be effective December 3, 1997, 22 TexReg 11679.