| (a) Education and Professional Requirements.
(1) A dentist applying for a permit to administer deep
sedation or general anesthesia must satisfy one of the following criteria:
(A) satisfactory completion of an advanced education
program accredited by the American Dental Association (ADA) Commission
on Dental Accreditation (CODA) that affords comprehensive and appropriate
training necessary to administer and manage deep sedation or general
anesthesia; or
(B) is a Texas licensed dentist who holds a current
permit to administer deep sedation or general anesthesia issued by
the Board and who has been using deep sedation or general anesthesia
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 deep sedation or general anesthesia is active on
June 1, 2011 shall automatically have the permit reclassified as a
Level 4 Deep Sedation or General Anesthesia permit.
(2) A dentist applying for a permit to administer deep
sedation or general anesthesia must satisfy the following emergency
management certification criteria:
(A) Licensees holding deep sedation or general anesthesia
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 deep sedation or general anesthesia
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 for the administration of anesthesia
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 direct supervision a
minimum of two qualified dental auxiliary personnel who shall be capable
of reasonably assisting in procedures, problems, and emergencies incident
to the use of deep sedation and/or general anesthesia;
(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 deep sedation/general anesthesia 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 deep
sedation or general anesthesia must be suitably evaluated prior to
the start of any sedative procedure. In healthy or medically stable
individuals (ASA I, II) this must consist of at least a review of
their current medical history, medication use, and NPO status. 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 or anesthetic agents and must provide written, informed
consent for the proposed deep sedation or general anesthesia procedure.
The informed consent must be specific to the deep sedation and/or
general anesthesia 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/anesthetic technique prescribed.
(F) Pre-procedure verbal and written instructions must
be given to the patient, parent, escort, guardian, or care-giver.
(G) An intravenous line, which is secured throughout
the procedure, must be established except as provided in paragraph
(7) of this subsection, regarding Pediatric and Special Needs Patients.
(3) Personnel and Equipment Requirements.
(A) Personnel. A minimum of three (3) individuals must
be present during the procedure:
(i) a dentist who is qualified to administer the deep
sedation or general anesthesia who is currently certified in ACLS
and/or PALS; and
(ii) two additional individuals who have current certification
of successfully completing a course in Basic Life Support (BLS) for
Healthcare Providers, one of which must be dedicated to assisting
with patient monitoring.
(B) Equipment.
(i) A positive-pressure oxygen delivery system suitable
for the patient being treated must be immediately available.
(ii) 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.
(iii) An appropriate scavenging system must be available
if gases other than oxygen are used.
(iv) The equipment necessary to establish intravenous
access must be available.
(v) Equipment and drugs necessary to provide advanced
airway management and advanced cardiac life support must be immediately
available.
(vi) If volatile anesthetic agents are utilized, an
inspired agent analysis monitor and capnograph should be considered.
(vii) Emergency medications and a defibrillator must
be immediately available.
(4) Monitoring. A qualified dentist administering deep
sedation or general anesthesia must remain in the operatory room to
monitor the patient continuously until the patient meets the criteria
for discharge to the recovery area. 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) Oxygenation.
(i) Color of mucosa, skin, or blood must be continually
evaluated.
(ii) Oxygenation saturation must be evaluated continuously
by pulse oximetry.
(B) Ventilation.
(i) Intubated patient: End-tidal CO2 must be continuously
monitored and evaluated.
(ii) Non-intubated patient: Breath sounds via auscultation
and/or end-tidal CO2 must be continually monitored and evaluated.
(iii) Respiration rate must be continually monitored
and evaluated.
(C) Circulation.
(i) Heart rate and rhythm via EKG and pulse rate via
pulse oximetry must be evaluated throughout the procedure.
(ii) Blood pressure must be continually monitored.
(D) Temperature.
(i) A device capable of measuring body temperature
must be readily available during the administration of deep sedation
or general anesthesia.
(ii) The equipment to continuously monitor body temperature
should be available and must be performed whenever triggering agents
associated with malignant hyperthermia are administered.
(5) Documentation.
(A) Documentation must be made in accordance with §108.7
and §108.8 of this title and must include the names, times and
dosages of all drugs administered and the names of individuals present
during administration of the drugs.
(B) A written time-oriented anesthetic record must
be maintained.
(C) Pulse oximetry and end-tidal CO2 measurements (if
taken with an intubated patient), heart rate, respiratory rate, and
blood pressure must be continually recorded at five (5) minute intervals.
(6) Recovery and Discharge.
(A) Oxygen and suction equipment must be immediately
available if a separate recovery area is utilized.
(B) The dentist or clinical staff must continually
monitor the patient's blood pressure, heart rate, oxygenation, and
level of consciousness.
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