(a) Initial Application Requirements for Level
2 Moderate Sedation (enteral). A dentist applying for a Level 2 Moderate
Sedation Permit shall demonstrate the following: [Education
and Professional Requirements.]
(1)current certification in Basic
Life Support (BLS) for Healthcare Providers;
(2)current certification in Advanced
Cardiac Life Support (ACLS); and
(3)satisfactory completion of one
of the following education programs:
(A)an advanced education program accredited by the
American Dental Association (ADA) Commission on Dental Accreditation
(CODA) that affords comprehensive and appropriate training in administering
and managing enteral moderate sedation, commensurate with the ADA's
Guidelines for Teaching Pain Control and Sedation to Dentists and
Dental Students; or
(B)completion of a board-approved education program
that includes a minimum of sixty (60) hours of didactic training and
instruction, and satisfactory management of at least twenty (20) case
experiences in moderate sedation. These twenty (20) case experiences
must include at least ten 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. A board-approved education program shall include,
at a minimum, the following components:
(i)Eight hours pharmacology;
(ii)12 hours pre-procedure evaluation, patient selection,
anatomy, and ASA classification;
(iii)Four hours anesthesia technique, monitoring,
and equipment;
(iv)12 hours inter-operative management and recognition
of emergencies and complications;
(v)Six hours emergency preparedness, including running
scenarios and management of complications; and
(vi)Four hours management of geriatric patients.
[(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)Initial Application Requirements
for Level 3 Moderate Sedation (parenteral). A dentist applying for
a Level 3 Moderate Sedation permit shall demonstrate the following:
(1)current certification in Basic Life Support (BLS)
for Healthcare Providers;
(2)current certification in Advanced Cardiac Life
Support (ACLS); and
(3)satisfactory completion of one of the following
education programs:
(A)an advanced education program accredited by the
ADA CODA that affords comprehensive and appropriate training in administering
and managing parenteral moderate sedation, commensurate with the ADA's
Guidelines for Teaching Pain Control and Sedation to Dentists and
Dental Students; or
(B)an internship or residency that included intravenous
moderate sedation training equivalent to that defined in this subsection;
or
(C)a board-approved education program that 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. A board-approved education
program shall include, at a minimum, the following components:
(i)Eight hours pharmacology;
(ii)12 hours pre-procedure evaluation, patient selection,
anatomy, and ASA classification;
(iii)Four hours anesthesia technique, monitoring,
and equipment;
(iv)12 hours inter-operative management and recognition
of emergencies and complications;
(v)Six hours emergency preparedness, including running
scenarios and management of complications; and
(vi)Four hours management of geriatric patients.
(c)Maintenance of Permit. A dentist
must comply with the requirements of rule 110.9 to qualify for annual
renewal of a Level 2 or Level 3 sedation/anesthesia permit.
(d)Administration of Level 2 or Level
3 Sedation/Anesthesia to Pediatric Patients. A dentist shall comply
with all requirements regarding the treatment of pediatric patients,
including those described in rule 110.11. Additionally 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.
(e)Delegation and Supervision Requirements.
A dentist must maintain the minimum standard of care, including, but
not limited to the requirements outlined in (f) below, and in addition
shall:
(1)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;
(2)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
(3)not supervise a Certified Registered Nurse Anesthetist
(CRNA) performing any level of sedation unless the dentist holds a
permit issued by the board for the level of sedation to be administered
during the dental procedure being performed.
(f)Standard of Care and Clinical
Requirements. A dentist must maintain the minimum standard of care
in the administration of sedation/anesthesia in accordance with rule
108.7, including but not limited to the following 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 shall consist of at least a review of the patient's current medical
history and medication use. Patients with significant medical considerations
(ASA III, IV) require review of their current medical history and
medication use, as well as documented verbal or written consultation
with the patients’ 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 rules 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.
(D)The dentist’s record of the patient’s
treatment shall include all records created by or for the sedation
provider.
(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.
Cont'd...
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