The State Board of Dental Examiners (Board) adopts new rule 22 TAC §110.18, concerning the inspection of sedation/anesthesia providers. This new rule is being adopted without changes to the proposed text as published in the June 22, 2018, issue of the Texas Register (43 TexReg 4011), and the rule will not be republished. This new rule will require permit holders to undergo compliance inspections within one year of receiving a level 2, 3, or 4 sedation/anesthesia permit, as well as an inspection for all other level 2, 3, or 4 permit holders by September 1, 2022. This new rule is being adopted to comply with the requirements of Senate Bill 313 (S.B. 313) from the 85th regular session of the Texas Legislature.

The Board received four timely comments regarding the adoption of this rule.

The Texas Dental Association submitted a comment requesting the Board add additional sections to the rule and proposed inspection checklist document. Specifically, the comment requested that the Board add requirements for the inspection to confirm dental office safeguards such as handicapped access and sanitation compliance. Additionally, the comment requested specific checklist documents for each permit level, and an addition to the checklist document directing staff to provide notice of violations identified "by the end of the inspection visit." The Board disagrees with this comment. Inspections of providers under the authority granted by Texas Occupations Code §258.156 are to be conducted by the terms of the statute, "as necessary to enforce this subchapter." Subchapter D of Texas Occupations Code Chapter 258 is the "Administrative of Anesthesia" subchapter, and does not include requirements on handicapped access or sanitation requirements. As a result, these additional requirements are outside of the scope of the inspections contemplated by this rule under the direction of SB313. The Board also disagrees that additional forms are necessary to complete the inspections, and does not agree that it would benefit the inspection process to provide notice of a violation by the end of the inspection visit. Instead, the Board intends to provide adequate training for inspection staff based upon the document substantially in the same form as the attached graphic to this new rule. Based upon Board policy, inspection staff will articulate the violations in written form as soon as possible to the inspected licensee. If additional research or review is necessary, providing the notice of violation before the end of the inspection visit will hamper the safe and complete inspection process. The new rule as written will not require a licensee to cease and desist until the identification of a violation, which means if the inspection staff cannot articulate a violation at the end of the inspection visit, then the licensee will not be expected to cease and desist practice until the inspection staff has adequately provided notice of a violation. This will ensure that the inspection process results in a fair assessment of the quality and safety of the licensee's sedation/anesthesia equipment and preparedness.

The Texas Society of Oral and Maxillofacial Surgeons submitted a comment requesting the Board increase the number of audited cases to two under subsection (d), for a "broader and possibly more comprehensive review." Additionally, the comment requests a timeline for re-inspection of permit holding licensees, as the rule does not set out any further dates for mandatory inspections after September 1, 2022. The Board disagrees with this comment. The initial Tier 1 inspection will be attempting to identify deficiencies in equipment and preparation, as well as any clear issues of procedure during sedation/anesthesia. The inspection is not intended to be an in-depth analysis of the licensee's sedation records, as a Tier 2 inspection would be. As a result, increasing the number of audited cases would not necessarily serve the purpose of the inspection, and may significantly delay the process for investigative staff. The Board acknowledges there is no timeline for a re-inspection, but notes that the requirements of SB313 and Texas Occupations Code §256.156 do not require such a timeline. Instead, the Board is directed to develop risk-based policies for inspection. The Board has done so with the provisions of subsection (e) of the proposed rule.

The Texas Academy of General Dentists submitted a comment in support of the proposed new rule.

BresnenAssociates submitted a comment on behalf of the Association of Dental Support Organizations, generally in support of the rule as written.

This rule is adopted under Texas Occupations Code §254.001(a), which gives the Board authority to adopt rules necessary to perform its duties and ensure compliance with state laws relating to the practice of dentistry to protect the public health and safety, and Texas Occupations Code §258.156, which authorizes the Board to establish an inspection program for all providers of level 2, 3 or 4 sedation/anesthesia permits.