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(a)The Board may conduct inspections to enforce Chapter
110 of this title (relating to Sedation and Anesthesia), 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. If, after a completed Compliance/Tier 1 inspection, the
only violation(s) identified by Board staff relate to the time-interval
recording requirements contained in the inspection items numbered
3 and 4 of the "Patient Record Audit" portion of the attached graphic
"Anesthesia Levels 2-4 Inspection Form" for this section, then the
violation(s) may be remedied by the Respondent through the execution
of a sworn affidavit provided by Board staff. The Respondent's affidavit
must attest that the Respondent shall observe the requirements of
the applicable sedation/anesthesia rule sections requiring time interval
recording for each permit level the Respondent holds. The inspection
checklist can be previewed here:
Figure: 22 TAC §110.18(d) (No change.)
(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 §107.63 of this title
(relating to Informal Disposition and Mediation). 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 may [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 may [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.
The agency certifies that legal counsel has reviewed
the proposal and found it to be within the state agency's legal authority
to adopt.
Filed with the Office
of the Secretary of State on June 26, 2023
TRD-202302273 Lauren Studdard
General
Counsel
State Board of Dental Examiners
Earliest possible date of adoption: August 6, 2023
For further information, please call: (512) 305-8910
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