| (a) Education and Professional Requirements.
(1) A dentist applying for a Level 2 Moderate Sedation
permit (limited to enteral route of administration) must satisfy at
least one of the following educational/professional criteria:
(A) satisfactory completion of a comprehensive training
program consistent with that described for moderate enteral sedation
in the American Dental Association (ADA) Guidelines for Teaching Pain
Control and Sedation to Dentists and Dental Students. This includes
a minimum of twenty-four (24) hours of instruction, plus management
of at least ten (10) case experiences in enteral moderate sedation.
These ten (10) case experiences must include at least three live clinical
dental experiences managed by participants in groups of no larger
than five (5). The remaining cases may include simulations and/or
video presentations, but must include one experience in returning
(rescuing) a patient from deep to moderate sedation; or
(B) satisfactory completion of an advanced education
program accredited by the ADA Commission on Dental Accreditation (CODA)
that affords comprehensive and appropriate training necessary to administer
and manage enteral moderate sedation, commensurate with the ADA's
Guidelines for Teaching Pain Control and Sedation to Dentists and
Dental Students; or
(C) is a Texas licensed dentist who was issued an enteral
sedation permit before June 1, 2011 and whose enteral sedation permit
was active on June 1, 2011. Dentists in this category shall automatically
have their permit reclassified as a Level 1 Minimal Sedation permit
on June 1, 2011. A Texas licensed dentist whose permit is reclassified
from an enteral sedation permit to a Level 1 Minimal Sedation permit
on June 1, 2011 may continue to administer enteral sedation until
January 1, 2013. On or before January 1, 2013, the dentist shall either
provide proof that adequate education has been obtained by submitting
an application for a Level 2 permit on or before that date, or shall
comply with the requirements of a Level 1 permit after that date.
A dentist shall always follow the standard of care and clinical requirements
for the level of sedation he or she is performing.
(2) A dentist applying for a Level 3 Moderate Sedation
permit (inclusive of parenteral routes of administration) must satisfy
at least one of the following educational/professional criteria:
(A) satisfactory completion of a comprehensive training
program consistent with that described for parenteral moderate sedation
in the ADA Guidelines for Teaching Pain Control and Sedation to Dentists
and Dental Students. This includes a minimum of sixty (60) hours of
didactic training and instruction and satisfactory management of a
minimum of twenty (20) dental patients, under supervision, using intravenous
sedation; or
(B) satisfactory completion of an advanced education
program accredited by the ADA/CODA that affords comprehensive and
appropriate training necessary to administer and manage parenteral
moderate sedation, commensurate with the ADA's Guidelines for Teaching
Pain Control and Sedation to Dentists and Dental Students; or
(C) satisfactory completion of an internship or residency
which included intravenous moderate sedation training equivalent to
that defined in this subsection; or
(D) is a Texas licensed dentist who had a current parenteral
sedation permit issued by the Board and has been using parenteral
sedation in a competent manner immediately prior to the implementation
of this chapter on June 1, 2011. A Texas licensed dentist whose Board-issued
permit to perform parenteral sedation is active on June 1, 2011 shall
automatically have the permit reclassified as a Level 3 Moderate Sedation
(inclusive of parenteral routes of administration) permit.
(3) A dentist applying for a Level 2 or 3 Moderate
Sedation permit must satisfy the following emergency management certification
criteria:
(A) Licensees holding moderate sedation permits shall
document:
(i) Current (as indicated by the provider), successful
completion of Basic Life Support (BLS) for Healthcare Providers; AND
(ii) Current (as indicated by the provider), successful
completion of an Advanced Cardiac Life Support (ACLS) course, OR current
(as indicated by the provider), successful completion of a Pediatric
Advanced Life Support (PALS) course.
(B) Licensees holding Level 2 or Level 3 Moderate Sedation
permits who provide anesthesia services to children (age twelve (12)
or younger) must document current, successful completion of a PALS
course.
(b) Standard of Care Requirements. A dentist must maintain
the minimum standard of care as outlined in §108.7 of this title
and in addition shall:
(1) adhere to the clinical requirements as detailed
in this section;
(2) maintain under continuous personal supervision
auxiliary personnel who shall be capable of reasonably assisting in
procedures, problems, and emergencies incident to the use of moderate
sedation;
(3) maintain current certification in Basic Life Support
(BLS) for Healthcare Providers for the assistant staff by having them
pass a course that includes a written examination and a hands-on demonstration
of skills; and
(4) not supervise a Certified Registered Nurse Anesthetist
(CRNA) performing a moderate sedation procedure unless the dentist
holds a permit issued by the Board for the sedation procedure being
performed.
(c) Clinical Requirements.
(1) Patient Evaluation. Patients considered for moderate
sedation must be suitably evaluated prior to the start of any sedative
procedure. In healthy or medically stable individuals (ASA I, II)
this should consist of at least a review of the patient's current
medical history and medication use. However, patients with significant
medical considerations (ASA III, IV) may require consultation with
their primary care physician or consulting medical specialist.
(2) Pre-Procedure Preparation and Informed Consent.
(A) The patient, parent, guardian, or care-giver must
be advised regarding the procedure associated with the delivery of
any sedative agents and must provide written, informed consent for
the proposed sedation. The informed consent must be specific to the
procedure being performed and must specify that the risks related
to the procedure include cardiac arrest, brain injury, and death.
(B) The dentist shall determine that an adequate oxygen
supply is available and evaluate equipment for proper operation and
delivery of adequate oxygen under positive pressure.
(C) Baseline vital signs must be obtained in accordance
with §108.7 and §108.8 of this title.
(D) A focused physical evaluation must be performed
as deemed appropriate.
(E) Pre-procedure dietary restrictions must be considered
based on the sedative technique prescribed.
(F) Pre-procedure verbal or written instructions must
be given to the patient, parent, escort, guardian, or care-giver.
(3) Personnel and Equipment Requirements.
(A) In addition to the dentist, at least one additional
person trained in Basic Life Support (BLS) for Healthcare Providers
must be present.
(B) A positive-pressure oxygen delivery system suitable
for the patient being treated must be immediately available.
(C) When inhalation equipment is used, it must have
a fail-safe system that is appropriately checked and calibrated. The
equipment must also have either:
(i) a functioning device that prohibits the delivery
of less than 30% oxygen; or
(ii) an appropriately calibrated and functioning in-line
oxygen analyzer with audible alarm.
(D) An appropriate scavenging system must be available
if gases other than oxygen or air are used.
(E) The equipment necessary to establish intravenous
access must be available.
(4) Monitoring. The dentist administering moderate
sedation must remain in the operatory room to monitor the patient
continuously until the patient meets the criteria for recovery. When
active treatment concludes and the patient recovers to a minimally
sedated level, the dentist may delegate a qualified dental auxiliary
to remain with the patient and continue to monitor the patient until
he/she is discharged from the facility. The dentist must not leave
the facility until the patient meets the criteria for discharge and
is discharged from the facility. Monitoring must include:
(A) Consciousness. Level of consciousness (e.g., responsiveness
to verbal command) must be continually assessed.
(B) Oxygenation.
(i) Color of mucosa, skin, or blood must be evaluated
continually.
(ii) Oxygen saturation must be evaluated by pulse-oximetry
continuously.
(C) Ventilation.
(i) Chest excursions must be continually observed.
(ii) Ventilation must be continually evaluated. This
can be accomplished by auscultation of breath sounds, monitoring end-tidal
CO2 or by verbal communication with the patient.
(D) Circulation.
(i) Blood pressure and heart rate must be continually
evaluated.
(ii) Continuous EKG monitoring of patients sedated
under moderate parenteral sedation is required.
(5) Documentation.
(A) Documentation must be made in accordance with §108.7
and §108.8 of this title.
(B) A written time-oriented anesthetic record must
be maintained and must include the names and dosages of all drugs
administered and the names of individuals present during administration
of the drugs.
(C) Pulse-oximetry, heart rate, respiratory rate, and
blood pressure must be continually monitored and documented at appropriate
intervals of no more than ten (10) minutes.
(6) Recovery and Discharge.
(A) Oxygen and suction equipment must be immediately
available if a separate recovery area is utilized.
(B) While the patient is in the recovery area, the
dentist or qualified clinical staff must continually monitor the patient's
blood pressure, heart rate, oxygenation, and level of consciousness.
(C) The dentist must determine and document that the
patient's level of consciousness, oxygenation, ventilation, and circulation
are satisfactory for discharge. The dentist shall not leave the facility
until the patient meets the criteria for discharge and is discharged
from the facility.
(D) Post-procedure verbal and written instructions
must be given to the patient, parent, escort, guardian, or care-giver.
Post-procedure, patients should be accompanied by an adult caregiver
for an appropriate period of recovery.
(E) If a reversal agent is administered before discharge
criteria have been met, the patient must be monitored until recovery
is assured.
(7) Emergency Management.
(A) The dentist is responsible for the sedation management,
adequacy of the facility and staff, diagnosis and treatment of emergencies
associated with the administration of moderate sedation, and providing
the equipment and protocols for patient rescue. This includes immediate
access to pharmacologic antagonists and equipment for establishing
a patent airway and providing positive pressure ventilation with oxygen.
(B) Advanced airway equipment and resuscitation medications
must be available.
(C) A defibrillator should be available when ASA I
and II patients are sedated under moderate sedation. A defibrillator
must be available when ASA III and IV patients are sedated under moderate
sedation.
(D) Because sedation is a continuum, it is not always
possible to predict how an individual patient will respond. If a patient
enters a deeper level of sedation than the dentist is qualified to
provide, the dentist must stop the dental procedure until the patient
returns to the intended level of sedation. The dentist administering
moderate sedation must be able to recover patients who enter a deeper
state of sedation than intended.
(8) Management of Children. For children twelve (12)
years of age and under, the dentist should observe the American Academy
of Pediatrics/American Academy of Pediatric Dentists Guidelines for
Monitoring and Management of Pediatric Patients During and After Sedation
for Diagnostic and Therapeutic Procedures.
(d) A dentist who holds a moderate sedation permit
shall not intentionally administer deep sedation or general anesthesia.
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