(a) Definitions.
  (1) "Local infiltration anesthesia" means the deposition of a local anesthetic solution meant for the elimination of the sensation of pain by local injection of a drug near the terminal nerve endings of teeth and supporting tissues.
  (2) "Direct supervision" means the delegating dentist is physically present in the facility where the procedure is occurring and is continuously aware of the patient's physical status and well-being.
(b) General Provisions.
  (1) A Texas-licensed dentist may delegate the administration of local infiltration anesthesia to a licensed dental hygienist, if the dental hygienist works under the direct supervision of the licensed dentist.
  (2) The dental hygienist must hold a current local infiltration anesthesia certificate in accordance with the requirements of this section.
(c) Standard of Care Requirements.
  (1) Administration of local infiltration anesthesia must be in accordance with the minimum standard of care and limited to a procedure the dental hygienist is authorized to perform on a patient who must be:
    (A) at least 18 years of age; and
    (B) not sedated, or is sedated using only nitrous oxide-oxygen inhalation.
  (2) Informed consent must be obtained in accordance with §108.7 and §108.8 of this title (relating to Minimum Standard of Care, General; and Records of the Dentist respectively). In addition, the informed consent must include the risks and complications with the administration of local anesthesia and vasoconstrictors, and the delegating dentist and provider of local infiltration anesthesia must be clearly disclosed.
(d) Requirements for Initial Certification. To receive a dental hygiene local infiltration anesthesia certificate from the Board, a dental hygienist must:
  (1) apply on an application form approved by the Board;
  (2) pay an application fee set by Board rule;
  (3) submit proof to the Board of the successful completion of a current course in Basic Life Support (BLS) for Healthcare Providers;
  (4) submit proof to the Board that he or she has fulfilled at least one of the following qualifications:
    (A) completed a minimum of 12 hours of clinical and 20 hours of didactic education in the administration of local infiltration anesthesia taken in a classroom setting at an educational institution accredited by the Commission on Dental Accreditation of the American Dental Association (CODA). The education must fulfill the requirements in subsection (e) of this section;
    (B) during the preceding year of initial application, was authorized to administer a local anesthetic agent by:
      (i) a branch of the United States armed forces; or
      (ii) another state with clinical and didactic requirements substantially equivalent to the requirements of a course as described under subparagraph (A) of this paragraph, and have practiced for a minimum of three out of five years immediately preceding application to the Board; or
    (C) successful completion of a CODA-accredited dental hygiene program that fulfills the requirements of subparagraph (A) of this paragraph.
  (5) have passed a Board-approved certification examination relating to the administration of a local anesthetic agent as described in subsection (e)(4) of this section. A "Board-approved certification examination" means an examination provided by a CODA-accredited course.
(e) Education and Examination Requirements.
  (1) The education program must be overseen by a Texas-licensed dentist who is a member of the CODA-accredited education institution and who has experience teaching the administration of local infiltration anesthesia.
  (2) Didactic component. The program must include at least 20 hours of didactic instruction relating to the administration of local infiltration anesthesia in the practice of dental hygiene. Such education may be completed using an on-demand video course and must include:
    (A) Texas State Board of Dental Examiners laws and regulations;
    (B) physiology and neurophysiology;
    (C) head, neck, and oral anatomy;
    (D) adult respiratory and circulatory physiology and related anatomy;
    (E) emergency procedures;
    (F) recognition and management of local complications associated with local anesthetic injections;
    (G) recognition and management of systemic local anesthetic toxicity related to the administration of local anesthetics;
    (H) medical history and evaluation procedures;
    (I) considerations for medically complex patients;
    (J) behavior context and dental patient management;
    (K) definitions and descriptions of physiological and psychological aspects of anxiety and pain;
    (L) pharmacology of agents used in local anesthetics and vasoconstrictors, including drug interactions and incompatibilities;
    (M) indications and contraindications for use of local anesthetic and vasoconstrictors;
    (N) recommended dosages of local anesthetic and vasoconstrictors;
    (O) patient monitoring through observation, with particular attention to vital signs and reflexes related to consciousness;
    (P) selection and preparation of the armamentaria and record keeping for administrating local anesthetic agents via infiltration;
    (Q) safety and infection control procedures with regard to local infiltration anesthetic techniques and proper disposal of sharps; and
    (R) post-operative care and instructions to patients.
  (3) Clinical component. The program must include at least 12 hours of clinical instruction relating to the administration of local infiltration anesthesia in the practice of dental hygiene. Such education must include:
    (A) selection and preparation of the armamentaria for administering local anesthetic agents;
    (B) demonstration of proper infection control techniques regarding local anesthetic agents and proper disposal of sharps;
    (C) demonstration of proper evaluation of the patient's health status, taking and assessing vital signs and monitoring the patient's physical status while under the effects of local anesthetic;
    (D) demonstration of the proper techniques for the administration of local infiltration anesthesia on a live patient or hands-on simulation:
      (i) basic technique;
      (ii) aspiration;
      (iii) slow rate of injection; and
      (iv) minimum effective dosage; and
    (E) clinical experience demonstrating the successful use of local infiltration anesthesia on a minimum of 5 live patient experiences appropriate for dental hygiene treatment. At a minimum, each student must demonstrate clinical competency in 4 different quadrants that includes at least 3 teeth. A hands-on simulation competency component must be demonstrated prior to treating the live patients. The live patient or hands-on simulation clinical experiences required must be performed under the direct supervision of a Texas-licensed dentist associated with the course.
  (4) Examination.
    (A) Each student must pass a competency examination on the material covered in the didactic section of the training course with a minimum passing score of 75% before continuing to the clinical section of the course. Students who do not pass the didactic competency examination may be offered remediation before the start of the clinical experience.
    (B) Each student must pass a clinical competency examination including a demonstration of satisfactorily performing local anesthetic infiltration injections.
(f) Continuing Education.
  (1) A dental hygienist with a local infiltration anesthesia certificate must complete no less than 2 hours of continuing education every two years in the administration of, or medical emergencies associated with, local anesthesia specific to the procedures to be performed by the dental hygienist administering the local anesthesia. The continuing education requirement under this subsection shall be in addition to any additional courses required for licensure.
  (2) The continuing education must be provided by an educational course provider recognized by the Board.
  (3) Dental hygienists must maintain documentation of the satisfactory completion of the required continuing education courses.
(g) Ineligibility. Applicants of an administration of local infiltration certificate are ineligible if they are in violation of a Board order at the time of application.
(h) A dental hygienist must submit a written report to the Board as provided below:
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