(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 must be available when 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.
(g)A dentist who holds a moderate
sedation permit shall not intentionally administer deep sedation or
general anesthesia.
[(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.]
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 December 5, 2016
TRD-201606155 Kelly
Parker
Executive Director
State Board of Dental Examiners
Earliest possible date of adoption: January 15, 2017
For further information, please call: (512) 475-0977
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