22 Tex. Admin. Code § 110.6 - Deep Sedation or General Anesthesia
(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.
(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.
(C) The
dentist must determine and document that the patient's level of consciousness,
oxygenation, ventilation, and circulation are satisfactory prior to 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.
(7) Special Situations.
(A) Special Needs Patients. Because many
dental patients undergoing deep sedation or general anesthesia are mentally
and/or physically challenged, it is not always possible to have a comprehensive
physical examination or appropriate laboratory tests prior to administering
care. When these situations occur, the dentist responsible for administering
the deep sedation or general anesthesia shall document the reasons preventing
the pre-procedure management.
(B)
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.
(8)
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
deep sedation or general anesthesia, 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, emergency medications and a defibrillator must be
immediately available.
(C)
Appropriate pharmacologic agents must be immediately available if known
triggering agents of malignant hyperthermia are part of the anesthesia
plan.
Notes
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