Section 110.1 - DefinitionsUnless the context clearly indicates otherwise, the following words and terms shall have the following meaning when used in this chapter.
(1) Analgesia--the diminution or elimination of pain.(2) Behavioral management--the use of pharmacological or psychological techniques, singly or in combination, to modify behavior to a level that dental treatment can be performed effectively and efficiently.(3) Board/Agency--the Texas State Board of Dental Examiners, also known as the State Board of Dental Examiners, and, for brevity, the Dental Board, the Agency, or the Board.(4) Child/children--a patient twelve (12) years of age or younger.(5) Competent--displaying special skill or knowledge derived from training and experience.(6) Deep sedation--a drug-induced depression of consciousness during which patients cannot be easily aroused but respond purposefully following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. Patients may require assistance in maintaining a patent airway, and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained.(7) Direct supervision--the dentist responsible for the sedation/anesthesia procedure shall be physically present in the facility and shall be continuously aware of the patient's physical status and well-being.(8) Enteral--any technique of administration of sedation in which the agent is absorbed through the gastrointestinal (GI) tract or oral mucosa (i.e., oral, rectal, sublingual).(9) Facility--the location where a permit holder practices dentistry and provides anesthesia/sedation services.(10) Facility inspection--an on-site inspection to determine if a facility where the applicant proposes to provide anesthesia/sedation is supplied, equipped, staffed and maintained in a condition to support provision of anesthesia/sedation services that meet the minimum standard of care.(11) General anesthesia--a drug-induced loss of consciousness during which patients are not arousable, even by painful stimulation. The ability to independently maintain ventilatory function is often impaired. Patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug-induced depression of neuromuscular function. Cardiovascular function may be impaired.(12) Immediately available--on-site in the facility and available for immediate use.(13) Incremental dosing--administration of multiple doses of a drug until a desired effect is reached, but not to exceed the maximum recommended dose (MRD).(14) Local anesthesia--the elimination of sensation, especially pain, in one part of the body by the topical application or regional injection of a drug.(15) Maximum recommended dose (applies to minimal sedation)--FDA maximum recommended dose (MRD) of a drug, as printed in FDA-approved labeling for unmonitored home use.(16) Minimal sedation--a minimally depressed level of consciousness, produced by a pharmacological method, which retains the patient's ability to independently and continuously maintain an airway and respond normally to tactile stimulation and verbal command. Although cognitive function and coordination may be modestly impaired, ventilatory and cardiovascular functions are unaffected. Medication administered for the purpose of minimal sedation shall not exceed the maximum doses recommended by the drug manufacturer. Nitrous oxide/oxygen may be used in combination with a single enteral drug in minimal sedation. During longer periods of minimal sedation in which the total amount of time of the procedures exceeds the effective duration of the sedative effect of the drug used, the supplemental dose of the sedative shall not exceed total safe dosage levels based on the effective half-life of the drug used. The total aggregate dose must not exceed one and one-half times the MRD on the day of treatment. The use of prescribed, previsit sedatives for children aged twelve (12) or younger should be avoided due to the risk of unobserved respiratory obstruction during the transport by untrained individuals.(17) Moderate sedation--drug-induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. Cardiovascular function is usually maintained. A Level 2 permit is required for moderate sedation limited to enteral routes of administration. A Level 3 permit is required for moderate sedation including parenteral routes of administration. In accordance with this particular definition, the drugs or techniques used shall carry a margin of safety wide enough to render unintended loss of consciousness unlikely. Repeated dosing of an agent before the effects of previous dosing can be fully appreciated may result in a greater alteration of the state of consciousness than is the intent of the dentist. A patient whose only response is reflex withdrawal from a painful stimulus is not considered to be in a state of moderate sedation.(18) Parenteral--the administration of pharmacological agents intravenously, intraosseously, intramuscularly, subcutaneously, submucosally, intranasally, or transdermally.(19) Patient Physical Status Classification: (A) ASA--American Society of Anesthesiologists(B) ASA I--a normal health patient(C) ASA II--a patient with mild systemic disease(D) ASA III--a patient with severe systemic disease(E) ASA IV--a patient with severe systemic disease that is a constant threat to life(F) ASA V--a moribund patient who is not expected to survive without the operation(G) ASA VI--a declared brain-dead patient whose organs are being removed for donor purposes(H) E--emergency operation of any variety (used to modify ASA I - ASA VI).(20) Portability--the ability of a permit holder to provide permitted anesthesia services in a location other than a facility or satellite facility.(21) Protective reflexes--includes the ability to swallow and cough effectively.(22) Satellite facility--an additional office or offices owned or operated by the permit holder, or owned or operated by a professional organization through which the permit holder practices dentistry, or a licensed hospital facility.(23) Supplemental dosing (applies to minimal sedation)--during minimal sedation, supplemental dosing is a single additional dose of the initial dose of the initial drug that may be necessary for prolonged procedures. The supplemental dose should not exceed one-half of the initial dose and should not be administered until the dentist has determined the clinical half-life of the initial dosing has passed. The aggregate dose must not exceed one and one-half times the MRD on the day of treatment.(24) Time-oriented anesthesia record--documentation at appropriate time intervals of drugs, doses, and physiologic data obtained during patient monitoring. Physiologic data for moderate sedation, deep sedation and general anesthesia must be taken and recorded at required intervals unless patient cooperation interferes or prohibits compliance.(25) Titration (applies to moderate sedation)--administration of incremental doses of a drug until the desired effect is reached. Knowledge of each drug's time of onset, peak response and duration of action is essential to avoid over-sedation. When the intent is moderate sedation, one must know whether the previous dose has taken full effect before administering an additional drug increment.22 Tex. Admin. Code § 110.1
The provisions of this §110.1 adopted to be effective May 10, 2011, 36 TexReg 2833