Recently Adopted tsbde rules

Click the green triangles to see detailed information on each rule.

CLICK HERE

(a) Pursuant to §258.1557 of the Act, all permit holders, including nitrous oxide, must develop written emergency preparedness policies and procedures specific to the permit holder’s practice setting that establish a plan for the management of medical emergencies in each practice setting in which the dentist administers sedation/anesthesia.
(b) The emergency preparedness policies and procedures must include written protocols, policies, procedures, and training requirements specific to the permit holder’s equipment and drugs for responding to emergency situations involving sedation/anesthesia, including information specific to respiratory emergencies.
(c) The permit holder must annually review the emergency preparedness policies and procedures to determine whether an update is necessary. The permit holder must maintain documentation of the dates of the emergency preparedness policies and procedures’ creation, the most recent update, and the most recent annual review.
(d) Policies and procedures develop by all permit holders must include basic life support protocols, advanced cardiac life support rescue protocols, and/or pediatric advanced cardiac life support rescue protocols if treating pediatric patients, consistent with the requirements of §§110.3 – 110.6 of this chapter, as applied to the permit holder.
(e) Policies and procedures developed by all permit holders must include, at a minimum, the following documents:
(1) Specific protocols for response to a sedation/anesthesia emergency, including specific protocols for advanced airway management techniques;
(2) Staff training log, documenting staff training in emergency prevention, recognition, and response on at least an annual basis;
(3) Emergency drug log documenting annual reviews for assurance of unexpired supply;
(4) Equipment readiness log indicating annual reviews for assurance of function of the equipment required by §110.15 of this chapter; and
(5) Individual office staff roles and responsibilities in response to an emergency, including roles and responsibilities specific to a response to a respiratory emergency.

On-Site office emergency preparedness evaluation and training Curriculum

(a) Pursuant to Section 258.1556 of the Act, the Board establishes minimum emergency preparedness standards and requirements for the administration of sedation/anesthesia.
(b) At any time a permit holder administers sedation/anesthesia, the permit holder must have immediately available:
(1) an adequate and unexpired supply of drugs and anesthetic agents, including but not limited to pharmacologic antagonists and resuscitative drugs appropriate for the sedation/anesthesia drugs used.
(2) an automated external defibrillator, as defined by Section 779.001 of the Texas  Health and Safety Code; 
(3) a positive pressure ventilation device
(4) supplemental oxygen
(5) appropriate monitors and equipment, including but not limited to:
(A) stethoscope
(B) sphygmomanometer or automatic blood pressure monitor
(C) pulse oximeter
(D) an oxygen delivery system with adequate full face masks and appropriate connectors that is capable of delivering high flow oxygen to the patient under positive pressure, together with an adequate backup system
(E) suction equipment which permits aspiration of the oral and pharyngeal cavities and a backup suction device which will function in the event of a general power failure
(F) a lighting system which permits evaluation of the patient’s skin and mucosal color and a backup lighting system of sufficient intensity to permit completion of any operation underway in the event of a general power failure. 
(G) precordial/pretracheal stethoscope, size-and-shape appropriate advanced airway device, intravenous fluid administration equipment, and /or electrocardiogram, consistent with the requirements of §§110.3, 110.4, 110.5, and 110.6, as applied to the permit holder.
(c) A permit holder who is administering sedation/anesthesia for which a Level 4 permit is required must use capnography during the administration of the sedation/anesthesia, as required by Section 258.1555 of the Act.
(d) Each permit holder must conduct an emergency drug inspection for assurance of unexpired supply at least annually. Documentation of emergency drug inspections must be maintained in the permit holder’s emergency drug log, required by §110.14.
(e) Each permit holder must conduct an equipment inspection for assurance of function at least annually. Documentation of equipment inspections must be maintained in the permit holder’s equipment readiness log, required by §110.14.

On-Site office emergency preparedness evaluation and training Curriculum

(a) For purposes of this rule, the following definitions apply:
(1) “High-risk patient” means a patient who has a level 3 or 4 classification according to the American Society of Anesthesiologists Physical Status Classification System (ASA).
(2) “Board-approved education program” means an in-person or online program provided by a recognized continuing education provider pursuant to Board rule 22 Tex. Admin. Code § 104.2 and any subsequent amendments.
(b) For the purposes of this chapter, ASA classifications are defined as follows:
(1) ASA I: a normal healthy patient.
(2) ASA II: a patient with mild systemic disease.
(3) ASA III: a patient with severe systemic disease.
(4) ASA IV: a patient with severe systemic disease that is a constant threat to life.
(c) On or after September 1, 2019, a permit holder may not administer sedation/anesthesia under a level 2, level 3, or level 4 permit to a high-risk patient unless the permit holder has completed the requirements of subsection (c)(1) or (c)(2) below. Permit holders must have:
(1) completed a university or hospital-based residency at least 12 months in length. All permit holders completing a university or hospital-based residency after September 1, 2019, must confirm that during the residency, the permit holder completed satisfactory management of sedation/anesthesia in at least ten (10) cases involving high-risk patients sedated/anesthetized at the highest level of permit held. At least five (5) of the cases must involve the hands-on administration of sedation/anesthesia as the primary provider. No more than five (5) cases may be observed. The ten (10) cases must involve either live patients and/or high-fidelity emergency sedation/anesthesia simulations; or
(2) completed a board-approved education program that includes a minimum of sixteen (16) hours of didactic training and instruction in sedation/anesthesia of high-risk patients. The entire board-approved education program, including all didactic and clinical requirements, must be completed within a two-year period of beginning the Board-approved program. Successful completion of the program must include passing an evaluation to demonstrate satisfactory completion of the course requirements. Didactic education must include:
(A) pre-anesthetic patient assessment/evaluation for medically compromised and geriatric patients;
(B) physical evaluation and medical history of high-risk patients, including obesity, pregnancy, and obstructive sleep apnea syndrome, cardiovascular disease, metabolic or genetic disorders, hematologic disorders, and other systemic diseases/conditions affecting sedation/anesthesia;
(C) high-risk patient anatomical and/or physiological differences;
(D) medical consultations;
(E) high-risk respiratory assessment, including airway anatomy, physiology, and management;
(F) informed consent by patient, parent, or guardian;
(G) sedation/anesthesia pharmacology;
(H) sedation/anesthesia management of patients identified with special health care needs;
(I) high-risk patient monitoring;
(J) peri-operative complications and emergencies;
(K) emergency management of high-risk patients, including high-risk anesthesia equipment and resuscitation supplies;
(L) sedation/anesthesia technique;
(M) sedation/anesthesia record keeping;
(N) patient recovery and discharge;
(O) appropriate patient selection; and
(P) permit holders shall have completed satisfactory management of sedation/anesthesia in at least ten (10) cases involving high-risk patients sedated/anesthetized at the highest level of permit held. At least five (5) of the cases must involve the hands-on administration of sedation/anesthesia as the primary provider. No more than five (5) cases may be observed. The ten (10) cases must involve either live patients and/or high-fidelity emergency sedation/anesthesia simulations. All of the cases must be performed and documented under the on-site instruction and direct supervision of a licensed dentist authorized to administer sedation/anesthesia to high-risk patients.
(d) A permit holder is authorized to administer sedation/anesthesia under a level 2, level 3, or level 4 permit to a high-risk patient if they have completed the requirements above and have requested and received authorization from the Board to administer sedation/anesthesia to high-risk patients. Board staff shall promulgate appropriate forms for permit holders qualifying under (c)(1) and (c)(2) of this rule. The permit holder must attest to their advanced training satisfying the requirements of (c)(1) or (c)(2) above, and will be required to produce proof of completion as part of a permit inspection or an investigation of a complaint involving sedation/anesthesia of a high-risk patient.
(e) The education hours described in subsection (c)(2) of this section can be applied towards the permit holder’s continuing education requirement for maintaining a sedation/anesthesia permit.
(f) If qualifying under (c)(2) above, the didactic and clinical training described in subsection (c)(2) of this section may not be fulfilled by the same didactic and clinical training used to fulfill the requirements for initial sedation/anesthesia permit issuance.

Hybrid educational Curriculum to satisfy §110.16

(a) For purposes of this rule, the following definitions apply:
(1) “Pediatric patient” means a patient younger than 13 years of age.
(2) “Board-approved education program” means an in-person or online program provided by a recognized continuing education provider pursuant to Board rule 22 Tex. Admin. Code § 104.2 and any subsequent amendments.
(b) On or after September 1, 2019, a permit holder may not administer sedation/anesthesia under a level 2, level 3, or level 4 permit to a pediatric patient unless the permit holder has completed the requirements of subsection (b)(1) or (b)(2) below. Permit holders must have:
(1) completed a university or hospital-based residency at least 12 months in length. All permit holders completing a university or hospital-based residency after September 1, 2019, must confirm that during the residency, the permit holder completed satisfactory management of sedation/anesthesia in at least fifteen (15) cases involving pediatric patients sedated/anesthetized at the highest level of permit held. The cases must include at least three (3) live cases in which the permit holder is the primary sedation/anesthesia provider, no more than seven (7) cases observed on live patients, and no more than five (5) cases performed as part of a hands-on high-fidelity sedation simulation center or program; or
(2) completed a board-approved education program that includes a minimum of sixteen (16) hours of didactic training and instruction in sedation/anesthesia of pediatric patients. The entire board-approved education program, including all didactic and clinical requirements, must be completed within a two-year period of beginning the Board-approved program. Successful completion of the program must include passing an evaluation to demonstrate satisfactory completion of the course requirements. Didactic education must include:
(A) pre-anesthetic patient assessment/evaluation for medically compromised and geriatric patients;
(B) physical evaluation and medical history of pediatric patients, including obesity, limited neck mobility, micro/retrognathia, macroglossia, Mallampati score, and limited oral opening;
(C) pediatric anatomical and/or physiological differences;
(D) pediatric respiratory assessment, including airway anatomy, physiology, and management;
(E) informed consent by parent, guardian, or care-giver;
(F) sedation/anesthesia pharmacology;
(G) sedation/anesthesia management of pediatric patients;
(H) pediatric patient monitoring;
(I) peri-operative complications and emergencies;
(J) emergency management of pediatric patients, including pediatric anesthesia equipment and resuscitation supplies;
(K) sedation/anesthesia technique;
(L) sedation/anesthesia record keeping;
(M) patient recovery and discharge;
(N) pediatric case selection and reference behavior scale; and
(O) permit holders shall have completed satisfactory management of sedation/anesthesia in at least fifteen (15) cases involving pediatric patients sedated/anesthetized at the highest level of permit held. The cases must include at least three (3) live cases in which the permit holder is the primary sedation/anesthesia provider, no more than seven (7) cases observed on live patients, and no more than five (5) cases performed as part of a hands-on high-fidelity sedation simulation center or program. All of the cases must be performed and documented under the on-site instruction and direct supervision of a licensed dentist authorized to administer sedation/anesthesia to pediatric patients.
(c) A permit holder is authorized to administer sedation/anesthesia under a level 2, level 3, or level 4 permit to a pediatric patient if they have completed the requirements above and have requested and received authorization from the Board to administer sedation/anesthesia to pediatric patients. Board staff shall promulgate appropriate forms for permit holders qualifying under (b)(1) and (b)(2) of this rule. The permit holder must attest to their advanced training satisfying the requirements of (b)(1) or (b)(2) above, and will be required to produce proof of completion as part of a permit inspection or an investigation of a complaint involving sedation/anesthesia of a pediatric patient.
(d) The education hours described in subsection (b)(2) of this section can be applied towards the permit holder’s continuing education requirement for maintaining a sedation/anesthesia permit.
(e) If qualifying under (b)(2) above, the didactic and clinical training described in subsection (b)(2) of this section may not be fulfilled by the same didactic and clinical training used to fulfill the requirements for initial sedation/anesthesia permit issuance.

Hybrid educational Curriculum to satisfy §110.17

(a) The Board may conduct inspections to enforce Chapter 110 of the Board’s rules, including inspections of a licensee, an office site, equipment, a facility, and any document required by Board rules. The inspections shall not identify violations outside the applicable sedation/anesthesia rules in effect for each permit level at the time of the inspection. The Board may employ Board staff or contract with another state agency or qualified person to conduct these inspections.
(b) Unless it would jeopardize an ongoing investigation, the Board shall provide at least ten business days’ notice before conducting an on-site inspection under this section.
(c) Regardless of issue date, all level 2, 3 and 4 permit holders will be subject to at least one inspection prior to September 1, 2022. All level 2, 3, and 4 permit holders who received their initial permit after March 1, 2018, must be inspected within a year of receiving their permit.
(d) Compliance/Tier 1 inspections: The initial inspection will be a compliance inspection, in which a Board staff member will evaluate the permit holder’s compliance with the Board’s rules through completing a checklist and auditing one sedation/anesthesia record of the inspector’s choosing that was completed prior to the date the Board notified the licensee of the inspection. The record shall be of treatment for the highest level of sedation/anesthesia permit held by the permit holder, and will apply the Board rules in effect at the time the patient was treated. The inspector shall be a member of Board staff and will receive training in recognizing the checklist requirements and in evaluating sedation/anesthesia records. If the inspection results in the identification of a violation of the Board’s rules found in Chapter 110, the permit holder must immediately cease providing sedation/anesthesia services until satisfactory proof is provided to Board staff that the violation has been corrected. Board staff shall provide contact information for both an inspector and supervisor of the inspector so that the permit holder may provide proof of remediation as soon as possible. Any violation of this cease and desist requirement shall represent grounds for disciplinary action. A failure by Board staff to respond within two business days to permit holder’s satisfactory proof of remediation shall represent an affirmative defense to disciplinary action. Additionally, the permit holder shall pay an amount of not more than five hundred dollars ($500.00) as necessary to cover the expenses of additional review and inspection by Board staff as a result of any violations identified during the initial inspection. The inspection checklist can be previewed here: Attached Graphic A.
(e) Risk-based/Tier 2 inspections: A permit holder with a violation on a compliance/tier 1 inspection that is not remedied within thirty (30) days shall be referred to a risk-based inspection. Additionally, a Board member sitting on an informal settlement conference panel pursuant to Tex. Occ. Code § 263.0072 may refer a permit holder to a risk-based inspection. The risk-based inspection will include the same factors as a compliance inspection, as well as a competency evaluation consisting of an audit of five sedation/anesthesia records of the inspector’s choosing. The records shall be of treatment records for the highest level of sedation/anesthesia permit held by the permit holder, and shall apply the Board rules in effect at the time the patient was treated. Review of the five sedation/anesthesia records shall be performed by members of the Board’s
dental review panel process pursuant to Tex. Occ. Code § 255.0065 who currently hold the same or higher level of sedation/anesthesia permit. The dental review panel reviewer shall prepare a report and note any violations or concerns with the permit holder’s competency, and the report shall be reviewed following the procedure described in Tex. Occ. Code § 255.0067. Any violation found during the risk-based inspection may result in the filing of a complaint and complaint resolution pursuant to the Board’s informal disposition process in 22 Texas Admin. Code § 107.63. The Executive Committee of the Board may order the emergency temporary suspension of a permit if the risk-based inspection reveals evidence of a clear, imminent, or continuing threat to the health or well-being of the public.
(f) Inactive status: A permit holder may forego an inspection if they submit a notarized, Board-issued affidavit that they will not administer levels 2, 3, or 4 sedation/anesthesia until first notifying the Board in writing that they wish to resume those activities. A permit holder must complete a compliance/Tier 1 inspection prior to resuming the administration of sedation/anesthesia at the inactive permit level. The permit holder must comply with continuing education and any other permit requirements during this time. During the period of inactive status, a permit holder may not delegate any inactive-status level of sedation/anesthesia to a certified registered nurse anesthetist or any other dental or medical professional except a dentist with a permit issued by the Board for the procedure being performed or a physician anesthesiologist licensed by the Texas Medical Board. If the permit holder is later found to have administered or delegated the administration of level 2, 3, or 4 sedation/anesthesia while in inactive status, the Board shall pursue revocation of their dental license.
(g) Exempt-location status: The Board shall not inspect a level 2, 3, or 4 permit holder who provides those services exclusively in a state-licensed hospital or state-licensed ambulatory surgery center. The permit holder must attest to that fact with a notarized, Board-issued affidavit and may not provide those services at a non-exempt location until first notifying the Board in writing and successfully completing a compliance/Tier 1 inspection. During the period of exempt-location status, a permit holder may not delegate the administration of any level of sedation/anesthesia to a dental or medical professional outside a state-licensed hospital or state-licensed ambulatory surgery center. If they are later found to have administered or delegated the administration of level 2, 3, or 4 sedation/anesthesia in a non-exempt location, the Board shall pursue revocation of their dental license.
(h) Group practice inspections. The Board shall permit group practices to request an inspection of all permit holders in a single location during one inspection visit. Permit holders shall inform Board staff upon receiving notice of an inspection their wish to receive a combined group practice inspection, and Board staff shall accommodate this request as feasible while ensuring a group inspection shall not jeopardize an ongoing investigation. Board staff shall ensure that group practice inspection requests do not create unnecessary delays to the completion of the inspection process and may decline the request as needed to ensure timely completion of all scheduled inspections.

On-site inspection Evaluation and Preparatory Course