(a)Initial Application Requirements for Level
1 Minimal Sedation. [Education and Professional Requirements.]
A dentist applying for a Level 1 Minimal Sedation permit shall demonstrate
the following: [meet one of the following educational/professional
criteria:]
(1)current certification in Basic
Life Support (BLS) for Healthcare Providers; and
(2)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 training in administering and managing
minimal sedation, commensurate with the ADA's Guidelines for Teaching
Pain Control and Sedation to Dentists and Dental Students; or
(B)a board-approved education program of at least
sixteen (16) hours of didactic training and instruction in which competency
in enteral and/or combined inhalation-enteral minimal sedation technique
is demonstrated. A board-approved education program shall include,
at a minimum, the following components: training in pharmacology;
pre-procedure evaluation, patient selection, anatomy, and ASA classification;
anesthesia technique and monitoring, equipment, and emergency preparedness,
including running scenarios and management of complications; and managing
special needs patients.
[(1)satisfactory completion of training
to the level of competency in minimal sedation consistent with that
prescribed in the American Dental Association (ADA) Guidelines for
Teaching Pain Control and Sedation to Dentists and Dental Students,
or a comprehensive training program in minimal sedation that satisfies
the requirements described in the ADA Guidelines for Teaching Pain
Control and Sedation to Dentists and Dental Students. This includes
a minimum of sixteen (16) hours of didactic training and instruction
in which competency in enteral and/or combined inhalation-enteral
minimal sedation technique is demonstrated; or]
[(2)satisfactory completion of an
advanced education program accredited by the ADA Commission on Dental
Accreditation (CODA) that affords comprehensive training necessary
to administer and manage minimal sedation, commensurate with the ADA's
Guidelines for Teaching Pain Control and Sedation to Dentists and
Dental Students; or]
[(3)is a Texas licensed dentist,
has a current Board-issued enteral permit, and has been using minimal
sedation in a competent manner immediately prior to the implementation
of this chapter on June 1, 2011. Any 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 shall automatically have
the 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.]
(b)Maintenance of Permit. A dentist
must comply with the requirements of rule 110.9 to qualify for annual
renewal of a Level 1 permit.
(c)Administration of Level 1 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.
(d)Delegation and Supervision Requirements.
A dentist must maintain the minimum standard of care, including, but
not limited to the requirements outlined in (e) below, and in addition,
shall:
(1)maintain under continuous direct supervision auxiliary
personnel who shall be capable of reasonably assisting in procedures,
problems, and emergencies incident to the use of minimal 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.
(e)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 minimal
sedation must be suitably evaluated prior to the start of any sedative
procedure. In healthy or medically stable patients (ASA I, II), this
shall consist of a review of the patients’ current medical history
and medication use. Patients with significant medical considerations
(ASA III, IV) require review of the patients’ 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.
(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.
(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 and 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.
(4)Monitoring. The dentist administering the sedation
must remain in the operatory room to monitor the patient until the
patient meets the criteria for discharge to the recovery area. Once
the patient meets the criteria for discharge to the recovery area,
the dentist may delegate monitoring to a qualified dental auxiliary.
Monitoring during the administration of sedation must include:
(A)Oxygenation.
(i)Color of mucosa, skin, or blood must be evaluated
continually.
(ii)Oxygen saturation monitoring by pulse-oximetry
should be used when a single drug minimal sedative is used. The additional
use of nitrous oxide has a greater potential to increase the patient's
level of sedation to moderate sedation, and a pulse oximeter must
be used.
(B)Ventilation. The dentist (or appropriately qualified
individual) must observe chest excursions and must verify respirations
continually.
(C)Circulation. Blood pressure and heart rate should
be evaluated preprocedurally, post-procedurally and intra-procedurally
as necessary.
(5)Documentation.
(A)Documentation must be made in accordance with rules
108.7 and 108.8 of this title and must include the names and dosages
of all drugs administered and the names of individuals present during
administration of the drugs.
(B)A time-oriented sedation record may be considered
for documentation of all monitoring parameters.
(C)Pulse oximetry, heart rate, respiratory rate, and
blood pressure are the parameters which may be documented at appropriate
intervals of no more than 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 in the recovery area if a separate recovery area is utilized.
(B)The qualified dentist must monitor the patient
during recovery until the patient is ready for discharge by the dentist.
The dentist may delegate this task to an appropriately qualified dental
auxiliary.
(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)Emergency Management. 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
is responsible for the sedative management, adequacy of the facility
and staff, diagnosis and treatment of emergencies related to the administration
of minimal sedation, and providing the equipment and protocols for
patient rescue. A dentist must be able to rescue patients who enter
a deeper state of sedation than intended.
[(b)Standard of Care Requirements.
A dentist performing minimal sedation shall maintain the minimum standard
of care for anesthesia, and in addition shall:]
[(1)adhere to the clinical requirements as detailed
in this section;]
[(2)maintain under continuous direct supervision auxiliary
personnel who shall be capable of reasonably assisting in procedures,
problems, and emergencies incident to the use of minimal 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 minimal sedation procedure unless the dentist
holds a permit issued by the Board for the sedation procedure being
performed.]
[(c)Clinical Requirements. A dentist
must meet the following clinical requirements for utilization of minimal
sedation:]
[(1)Patient Evaluation. Patients considered for minimal
sedation must be suitably evaluated prior to the start of any sedative
procedure. In healthy or medically stable individuals (ASA I, II),
this may consist of a review of their 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.]
[(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 and 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.]
[(4)Monitoring. The dentist administering the sedation
must remain in the operatory room to monitor the patient until the
patient meets the criteria for discharge to the recovery area. Once
the patient meets the criteria for discharge to the recovery area,
the dentist may delegate monitoring to a qualified dental auxiliary.
Monitoring during the administration of sedation must include:]
[(A)Oxygenation.]
[(i)Color of mucosa, skin, or blood must be evaluated
continually.]
[(ii)Oxygen saturation monitoring by pulse-oximetry
should be used when a single drug minimal sedative is used. The additional
use of nitrous oxide has a greater potential to increase the patient's
level of sedation to moderate sedation, and a pulse oximeter must
be used.]
[(B)Ventilation. The dentist (or appropriately qualified
individual) must observe chest excursions and must verify respirations
continually.]
[(C)Circulation. Blood pressure and heart rate should
be evaluated preprocedurally, post-procedurally and intra-procedurally
as necessary.]
[(5)Documentation.]
[(A)Documentation must be made in accordance with §108.7
and §108.8 of this title and must include the names and dosages
of all drugs administered and the names of individuals present during
administration of the drugs.]
[(B)A time-oriented sedation record may be considered
for documentation of all monitoring parameters.]
[(C)Pulse oximetry, heart rate, respiratory rate,
and blood pressure are the parameters which may be documented at appropriate
intervals of no more than 10 minutes.]
[(6)Recovery and Discharge.]
[(A)Oxygen and suction equipment must be immediately
available in the recovery area if a separate recovery area is utilized.]
[(B)The qualified dentist must monitor the patient
during recovery until the patient is ready for discharge by the dentist.
The dentist may delegate this task to an appropriately qualified dental
auxiliary.]
Cont'd...
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