The State Board of Dental Examiners (SBDE) adopts a new Chapter 110 without changes to the proposed text as published in the December 17, 2010, issue of the Texas Register (35 TexReg 11155) and will not be republished.

These individual sections are as follows: §110.1, relating to Definitions; §110.2, relating to Sedation/Anesthesia Permit; §110.3, relating to Nitrous Oxide/Oxygen Inhalation Sedation; §110.4, relating to Minimal Sedation; §110.5, relating to Moderate Sedation; §110.6, relating to Deep Sedation or General Anesthesia; §110.7, relating to Portability; §110.8, relating to Provisional Anesthesia and Portability Permits; and §110.9, relating to Anesthesia Permit Renewal. Concurrent with this adoption is the repeal of the existing anesthesia rules contained in 22 TAC §§108.30 - 108.35 and §§110.1 - 110.4.

The SBDE's Anesthesia Rules Ad-Hoc Committee was convened to update the agency's sedation and anesthesia rules based on sedation guidelines adopted by the American Dental Association (ADA) House of Delegates in 2007. The committee met on August 27, 2009, November 19, 2009, April 15, 2010, and August 19, 2010. The committee was chaired by Tamela L. Gough, DDS, and its members included William L. Purifoy, DDS; James W. Chancellor, DDS; William Birdwell, DDS; Maxwell Finn, DDS, MD; and Arthur Troilo, JD.

The new sections developed by the committee (new Chapter 110, Sedation and Anesthesia) consolidate sedation and anesthesia rules previously found in §§108.30 - 108.35 and Chapter 110, Enteral Sedation. The most significant change in the revisions is to the levels of anesthesia and sedation permitting. The permitting process emphasizes the level of sedation of the patient rather than the route of administration of the medication. The new sections establish five levels of anesthesia and sedation permits beyond the standard dental license: Nitrous Oxide/Oxygen Inhalation Sedation; Level 1: Minimal Sedation; Level 2: Moderate Sedation (enteral sedation); Level 3: Moderate Sedation (parenteral sedation); and Level 4: Deep Sedation or General Anesthesia.

Most levels of permitting will change in name only. Licensed dentists who lack sedation permits may continue to utilize local anesthetic and prescribe minor tranquilizers for anxiolysis. A licensed dentist who holds an active Nitrous Oxide/Oxygen Inhalation Conscious Sedation permit, Parenteral Sedation permit, or Deep Sedation or General Anesthesia permit on or before the effective date of the new sections will have his or her permit automatically reclassified as a Nitrous Oxide/Oxygen Inhalation Sedation permit, Level 3 permit, and Level 4 permit respectively on the effective date.

Comments were received from the Texas Dental Association (TDA), the Texas Society of Oral and Maxillofacial Surgeons (TSOMS), Texas Association of Nurse Anesthetists (TANA), Texas Academy of Pediatric Dentistry (TAPD), Texas Society of Periodontists (TSP), American Dental Association (ADA), and Texas Academy of General Dentistry (TAGD). In addition, twenty-four (24) individuals also submitted comments.

Comment: The term "titration" throughout the rules should be replaced with "incremental dosing" and "supplemental dosing" as they are more scientifically accurate and are used in the ADA Guidelines.

Response: The term "titration" is used in the ADA Guidelines for Teaching Pain Control and Sedations to Dentists and Dental Students, Section II, Definitions, Page 4, Subsection moderate sedation, Line 11. It reads, "{t}he following definition applies to administration of moderate and deep levels of sedation: titration - administration of incremental doses of a drug until a desired effect is reached." The Board makes no changes.

Comment: The ten (10) demonstrations of case management required in 22 TAC §110.5 (Moderate Sedation) should include appropriate documentation of various processes, i.e. management of informed consent process, specific anesthetic agent selected and prescribed, etc.

Response: The ADA Guidelines for Teaching Pain Control and Sedation to Dentists and Dental Students, Section V, Page 14, Teaching Administration of Moderate Sedation addresses the above concerns. The Board makes no changes.

Comment: Portability should be limited to licensed dental anesthesiologists who have completed an accredited post-doctoral residency-based program in anesthesiology/dental anesthesiology. Individuals who are currently holding a portability permit should be required to meet these requirements before they are "grandfathered."

Response: The Dentists licensed by the SBDE with Anesthesia Permits and Portability Permits have an excellent track record for patient safety. To limit the Portability Permits to dental anesthesiologists would not be in the best interest of Texas dental patients in need of sedation/anesthesia services and would limit access to care. The Board makes no changes.

Comment: For all individuals providing parenteral anesthesia, the Board should impose a new requirement for office based anesthesia evaluations. At the least, anesthesia equipment/monitors must be fixed, calibrated and inspected annually.

Response: §108.31(10), Facility Inspections, is determined on a case-by-case basis. Budgetary and manpower requirements to inspect every office are not feasible at the present time. The Board makes no changes.

Comment: A mechanism should be in place to assure that all office locations where drugs are administered are registered with the DEA as required by their rules and regulations.

Response: §108.8(10) requires compliance with the Texas Controlled Substance Act. The Board makes no changes.

Comment: If the Board is going to allow sedation permits other than through approved residency programs in medicine or dentistry, the Board should require several months (4-6) for permitting and not a 60 hour course.

Response: SBDE proposed anesthesia rules are based on sedation guidelines adopted by the American Dental Association House of Delegates in 2007. The guidelines for moderate parenteral sedation require a minimum of 60 hours of instructions, plus management of at least 20 patients by the intravenous route per participant. The Board makes no changes.

Comment: The language throughout the rules that states a dentist cannot supervise a Certified Registered Nurse Anesthetist (CRNA) unless the dentist holds a permit for the level of sedation procedure being performed by the CRNA should be changed. A dentist should not be required to possess a permit for the level of sedation that a CRNA is performing. A CRNA practices under his/her own license and scope of practice and does not require supervision by a dentist.

Response: SBDE has jurisdiction over the practice of dentistry and the authority to adopt rules regulating the practice of dentistry. The Board holds to the doctrine that the dentist is "captain of the ship" in that the provider dentist is responsible for his dental patient and the care provided. When the dental services are provided in the dental office the patient is a dental patient; therefore, the SBDE rules apply. The rule does not limit a CRNA from providing anesthesia services in other settings where dental services can be provided such as hospitals and outpatient surgery centers. The Board makes no changes.

Comment: Dental anesthesiologists who are currently enrolled or about to graduate from a Commission on Dental Accreditation (CODA) accredited residency in anesthesiology and, therefore, have a minimum of two full years of general anesthesia training, could be added to those eligible for a provisional general anesthesia permit under SBDE Proposed §110.8 and for a provisional portability permit.

Response: SBDE proposed §110.8(b)(2)(A) - (D) provides for Provisional and Portability Permit for an applicant who would apply for a deep sedation/general anesthesia permit. The Board makes no changes.

Comment: The board should clearly distinguish the definitions of "anxiolysis" and "minimal sedation." A licensed dentist without a sedation permit may continue to prescribe minor tranquilizers for anxyiolysis, while minimal sedation requires a permit.

Response: The Board recognizes the confusion between the anxiolysis and minimal sedation; however, anxiolysis should minimize the anxiety of a patient but not alter the cognitive function and or the coordination function of a patient. The Board makes no changes.

Comment: The board should either require a dentist to document pulse oximetry, heart rate, respiratory rate and blood pressure for patients under minimal sedation in SBDE Proposed §110.4(c)(5)(C) or remove the language. The permissive language does not make it clear whether it is a dentist's duty to document these items. Another commenter adds to this suggestion by stating that if the documentation is discretionary, then should not the time interval also be at the discretion of the dentist.

Response: SBDE proposed §110.4(c)(5)(B) states that a time-oriented sedation record may be considered for documentation of all monitored parameters. While the rule reads "may" be considered for documentation and indicates volunteer compliance, rules §108.7 and §108.8 state that the dentist "shall" make, maintain, and keep adequate records of the diagnosis made and treatment performed for and upon each dental patient for reference, identification, and protection of the patient and dentist in a manner consistent with that of a reasonable and prudent dentist in a like or similar situation. Most dentists would document the monitored parameters; however, the ADA Guidelines do not require documentation. The Board makes no changes.

Comment: The board should place all continuing education (CE) requirements regarding level 2 and 3 permit holders for treating different patient groups in one location; otherwise, it creates confusion. Another commenter states that SBDE Proposed §110.5(a)(3)(A) and (B) and SBDE Proposed §110.9(c) do not clearly state the CE requirements.

Response: SBDE Proposed §110.9(c)(1)(A) - (C) states the required continuing educational hours for each level of permit. SBDE Proposed §110.5(a) outlines the educational and professional requirements that apply to a Level 2 and 3 Moderate Sedation Permit. The Board makes no changes.

Comment: The terms "anxiolysis" and "minor tranquilizer" should be included in the list of definitions since they appear in the preamble to the rules.

Response: The ADA Guidelines for Teaching Pain Control and Sedations to Dentists and Dental Students do not include these terms in their definitions. SBDE does not require a permit to prescribe anxiolytic and minor tranquilizer drugs. These terms are less common in modern text. The Board makes no changes.

Comment: The board should define exactly which vital signs are required, because different authorities define "vital signs" differently; therefore, the term can be ambiguous.

Response: §108.8(b)(4) states, "{v}ital signs, including but not limited to blood pressure and heart rate..." implying that blood pressure and heart rate would be a minimum. Vital signs include blood pressure, pulse rate, respiratory rate, and body temperature by definition. Dentists are encouraged to do more as the situation requires. The Board makes no changes.

Comment: SBDE Proposed §110.7(d) (Portability) is not necessary, and the rules should just possibly state that wherever the anesthesia services are supplied, the dentist is responsible to maintain the standard of care. He further states that this section is a deviation from the ADA guidelines.

Response: SBDE Proposed §110.7(d) is necessary to safeguard the health and safety of Texans by assuring the anesthesia services provided comply with SBDE Rules. The Board makes no changes.

Comment: SBDE Proposed §110.6(b)(3) and §110.6(c)(3)(A)(i)(II) and §110.6(c)(3)(A)(ii) should be modified to require that anyone performing deep sedation/general anesthesia should have "one other" ACLS provider in the operating room at all times. It would be very difficult to simultaneously prepare for cardioversion or draw up the necessary medications or restart an I.V. line while attempting to place an LAM or endotracheal tube in between your artificial respirations using a BVM with a BLS provider (the Board's standard).

Response: The ADA Guidelines for the Use of Sedation and General Anesthesia by Dentists, Page 11, Section C, Subparagraph 3 (Personnel and Equipment Requirements) requires a minimum of three (3) individuals must be present. A dentist qualified in accordance with Part IIIC of these guidelines to administer the deep sedation or general anesthesia and two additional individuals who have current certification of successfully completing the Basic Life Support (BLS) Course for Healthcare Provider. The Board makes no changes.

Comment: The requirement for emergency drugs and the defibrillator in SBDE Proposed §110.6(c)(3)(B)(vii) to be "immediately available" must be changed to available "in every operating room."

Response: The ADA Guidelines for the Use of Sedation and General Anesthesia by Dentists, Page 11, Section C, Subparagraph 3 (Personnel and Equipment Requirements), Equipment states that an appropriate defibrillator must be immediately available. The Board makes no changes.

Comment: In SBDE Proposed §110.7(d), the second line should be removed and replaced with something like the following: "The dentist shall travel to and from the location with all the anesthesia and emergency equipment necessary to support provision of anesthesia services that meet the standard of care. If the dentist providing portable anesthesia is the operator/anesthetist, then this dentist must have their own assistant who meets the standard of care for the level of anesthesia provided. Oxygen supplies, required of every dentist, shall be evaluated prior to beginning any anesthesia case." In the portable anesthesia practice, the location is unimportant. The location is merely a box, and the most important concerns are the equipment and supplies used by the operator with his/her trained staff. It is the operator and not the location which dictates patient safety.

Response: SBDE Proposed §110.7(d) is as follows: "A dentist providing anesthesia services utilizing a portability permit remains responsible for providing these services in strict compliance with all applicable laws and rules. The dentist shall ascertain that the location is supplied, equipped, staffed, and maintained in a condition to support provision of anesthesia services that meet the standard of care." Application of the SBDE Rules and the Dental Practice Act with the proposed rule answers the above concerns. The Board makes no changes.

Comment: If a dentist is going to practice anesthesia on another doctor's patients, regardless of the level of sedation, the dentist should have an anesthesia residency.

Response: The Proposed SBDE Anesthesia Rules and the ADA Guidelines for Teaching Pain Control and Sedation to Dentists and Dental Students establishes the educational requirements for the different levels of sedation and general anesthesia. The Board makes no changes.

The new sections are adopted under Texas Occupations Code §254.001, which provides the Board with the authority to adopt and enforce rules necessary for it to perform its duties, and §258.153, which provides the Board with the authority to establish by rule the minimum standards for the enteral administration of anesthesia by a dentist.

The adoption affects Texas Occupations Code, Title 3, Subtitle D, Chapter 258, and Texas Administrative Code, Title 22, Part 5.