(a)Initial Application for Nitrous Oxide/Oxygen
Inhalation /Sedation. [Education and Professional Requirements.
] A dentist applying for a nitrous oxide/oxygen inhalation 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)[(1)] satisfactory completion
of one of the following education programs:
(A)an American Dental Association
(ADA) Commission on Dental Accreditation (CODA) approved or recognized
pre-doctoral dental or postdoctoral dental training program that affords
comprehensive training administering and managing nitrous oxide/oxygen
inhalation sedation, commensurate with the ADA’s Guidelines
for Teaching Pain Control and Sedation to Dentists and Dental Students;
or
(B)a comprehensive training program
consistent with that described for nitrous oxide/oxygen inhalation
sedation administration in the American Dental Association (ADA) Guidelines
for Teaching Pain Control and Sedation to Dentists and Dental Students.
This includes a minimum of fourteen (14) hours of training, including
a clinical component of at least four hours of in-person clinical
experience in the administration and management of nitrous oxide,
during which competency in inhalation sedation technique is achieved.
Acceptable courses include those obtained from academic programs of
instruction recognized by the Commission on Dental Accreditation (CODA);
or courses approved and recognized by the ADA Continuing Education
Recognition Program (CERP); or courses approved and recognized by
the Academy of General Dentistry (AGD) Program Approval for Continuing
Education (PACE). [a comprehensive training program consistent
with that described for nitrous oxide/oxygen inhalation sedation administration
in the American Dental Association (ADA) Guidelines for Teaching Pain
Control and Sedation to Dentists and Dental Students. This includes
a minimum of fourteen (14) hours of training, including a clinical
component, during which competency in inhalation sedation technique
is achieved. Acceptable courses include those obtained from academic
programs of instruction recognized by the ADA Commission on Dental
Accreditation (CODA); or courses approved and recognized by the ADA
Continuing Education Recognition Program (CERP); or courses approved
and recognized by the Academy of General Dentistry (AGD) Program Approval
for Continuing Education (PACE);]
[(2)satisfactory completion of an
ADA/CODA approved or recognized pre-doctoral dental or postdoctoral
dental training program which affords comprehensive training necessary
to administer and manage nitrous oxide/oxygen inhalation sedation;
or]
[(3)is a Texas licensed dentist,
has a current Board-issued nitrous oxide/oxygen inhalation sedation
permit, and has been using nitrous oxide/oxygen inhalation sedation
in a competent manner immediately prior to the implementation of this
chapter on June 1, 2011. Any dentist whose Board-issued nitrous oxide/oxygen
inhalation sedation permit is active on June 1, 2011 shall automatically
continue to hold this permit.]
(b)Maintenance of Permit. A dentist
must comply with the requirements of rule 110.9 to qualify for annual
renewal of a nitrous oxide/oxygen inhalation sedation permit.
(c)Administration of Nitrous Oxide/Oxygen
Inhalation Sedation 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 performing nitrous oxide/oxygen inhalation sedation 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 nitrous oxide/oxygen
inhalation 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) 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)Administration of Nitrous Oxide Following Anxiolysis
or Analgesia. A dentist, who does not hold a Level 1 Minimal Sedation
permit or higher, shall not administer nitrous oxide to a patient
if the patient was treated with anxiolysis or analgesia administered
by the dentist within the twelve hours prior to the dental treatment
at which nitrous oxide will be administered.
(2)Patient Evaluation. Patients considered for nitrous
oxide/oxygen inhalation 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 a review of their current
medical history and medication use. However, 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.
(3)Pre-Procedure Preparation and Informed Consent.
(A)The patient, parent, guardian, or care-giver must
be advised of the risks associated with the delivery of nitrous oxide/oxygen
inhalation sedation 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 inhalation agents prior to use on each patient.
(C)Baseline vitals must be obtained in accordance
with rules 108.7 and 108.8.
(4)Personnel and Equipment Requirements.
(A)In addition to the dentist, at least one member
of the assistant staff should be present during the administration
of nitrous oxide/oxygen inhalation sedation in nonemergency situations.
(B)The inhalation equipment 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.
(C)If nitrous oxide and oxygen delivery equipment
capable of delivering less than 30% oxygen is used, an in-line oxygen
analyzer must be utilized.
(D)The equipment must have an appropriate nitrous
oxide/oxygen scavenging system.
(E)The ability of the provider and/or the facility
to deliver positive pressure oxygen must be maintained.
(5)Monitoring.
(A)The dentist must induce the nitrous oxide/oxygen
inhalation sedation and must remain in the room with the patient during
the maintenance of the sedation until pharmacologic and physiologic
vital sign stability is established.
(B)After pharmacologic and physiologic vital sign
stability has been established, the dentist may delegate the monitoring
of the nitrous oxide/oxygen inhalation sedation to a dental auxiliary
who has been certified to monitor the administration of nitrous oxide/oxygen
inhalation sedation by the State Board of Dental Examiners.
(6)Documentation.
(A)Pre-operative baseline vitals must be documented.
(B)Individuals present during administration must
be documented.
(C)Maximum concentration administered must be documented.
(D)The start and finish times of the inhalation agent
must be documented.
(E)The dentist’s record of the patient’s
treatment shall include all records created by or for the sedation
provider.
(7)Recovery and Discharge.
(A)Recovery from nitrous oxide/oxygen inhalation sedation,
when used alone, should be relatively quick, requiring only that the
patient remain in an operatory chair as needed.
(B)Patients who have unusual reactions to nitrous
oxide/oxygen inhalation sedation should be assisted and monitored
either in an operatory chair or recovery room until stable for discharge.
(C)The dentist must determine that the patient is
appropriately responsive prior to discharge. The dentist shall not
leave the facility until the patient meets the criteria for discharge
and is discharged from the facility.
(8)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 the nitrous oxide, 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. The dentist, personnel and
facility must be prepared to treat emergencies that may arise from
the administration of nitrous oxide/oxygen inhalation sedation.
[(b)Standard of Care Requirements.
A dentist performing nitrous oxide/oxygen inhalation 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 nitrous oxide/oxygen
inhalation 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 nitrous oxide/oxygen inhalation sedation procedure
unless the dentist holds a permit issued by the Board for the sedation
procedure being performed. This provision and similar provisions in
subsequent sections address dentists and are not intended to address
the scope of practice of persons licensed by any other agency.]
[(c)Clinical Requirements. A dentist
must meet the following clinical requirements to utilize nitrous oxide/oxygen
inhalation sedation:]
[(1)Patient Evaluation. Patients considered for nitrous
oxide/oxygen inhalation 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
the patient's 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 of the risks associated with the delivery of nitrous oxide/oxygen
inhalation sedation 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 inhalation agents prior to use on each patient.]
[(C)Baseline vitals must be obtained in accordance
with §108.7 and §108.8 of this title.]
[(3)Personnel and Equipment Requirements.]
[(A)In addition to the dentist, at least one member
of the assistant staff should be present during the administration
of nitrous oxide/oxygen inhalation sedation in nonemergency situations.]
[(B)The inhalation equipment 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.]
[(C)If nitrous oxide and oxygen delivery equipment
capable of delivering less than 30% oxygen is used, an in-line oxygen
analyzer must be utilized.]
[(D)The equipment must have an appropriate nitrous
oxide/oxygen scavenging system.]
[(E)The ability of the provider and/or the facility
to deliver positive pressure oxygen must be maintained.]
[(4)Monitoring.]
[(A)The dentist must induce the nitrous oxide/oxygen
inhalation sedation and must remain in the room with the patient during
the maintenance of the sedation until pharmacologic and physiologic
vital sign stability is established.]
[(B)After pharmacologic and physiologic vital sign
stability has been established, the dentist may delegate the monitoring
of the nitrous oxide/oxygen inhalation sedation to a dental auxiliary
who has been certified to monitor the administration of nitrous oxide/oxygen
inhalation sedation by the State Board of Dental Examiners.]
[(5)Documentation.]
[(A)Pre-operative baseline vitals must be documented.]
[(B)Individuals present during administration must
be documented.]
[(C)Maximum concentration administered must be documented.]
[(D)The start and finish times of the inhalation agent
must be documented.]
[(6)Recovery and Discharge.]
[(A)Recovery from nitrous oxide/oxygen inhalation
sedation, when used alone, should be relatively quick, requiring only
that the patient remain in an operatory chair as needed.]
[(B)Patients who have unusual reactions to nitrous
oxide/oxygen inhalation sedation should be assisted and monitored
either in an operatory chair or recovery room until stable for discharge.]
[(C)The dentist must determine that the patient is
appropriately responsive prior to discharge. The dentist shall not
leave the facility until the patient meets the criteria for discharge
and is discharged from the facility.]
[(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 the nitrous oxide, 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. The dentist, personnel and
facility must be prepared to treat emergencies that may arise from
the administration of nitrous oxide/oxygen inhalation sedation.]
[(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.]
(f)[(d)] A dentist who holds
a nitrous oxide/oxygen inhalation sedation permit shall not intentionally
administer minimal sedation, moderate sedation, 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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