(a) A dentist who possesses a restricted
permit I issued under this subchapter shall ensure that:
(1) Prior to the administration of conscious
sedation or nitrous oxide/oxygen analgesia, the permitholder takes or updates a
patient medical history and gives the patient a physical evaluation sufficient
to determine the patient's suitability to receive conscious sedation or nitrous
oxide/oxygen analgesia.
(2) The
dental office in which the permitholder administers conscious sedation or
nitrous oxide/oxygen analgesia on an outpatient basis contains the following:
(i) An operating room.
(ii) An operating table or chair.
(iii) A lighting system.
(iv) Suction equipment commensurate with the
patient's age, size and condition.
(v) Oxygen and supplemental gas delivery
systems, including primary and back-up sources and a fail-safe control
mechanism.
(vi) A sterilization
area.
(vii) A recovery
area.
(viii) A gas storage area and
scavenger system.
(ix) Emergency
airway equipment and medications, including intravenous emergency
equipment.
(x) Communications
equipment.
(xi) Patient transport
equipment.
(xii) Monitoring
equipment, procedures and documentation to conform to the age, size and
condition of the patient and the AAOMS Manual and AAOMS Guidelines for adult
and pediatric patients (OMS); the ADA Guidelines for adult patients (general
dentists); and the AAPD Guidelines for pediatric patients (general
dentists.)
(xiii) Pulse
oximeter.
(xiv) ECG.
(xv) Blood pressure monitoring
device.
(xvi)
Defibrillator.
(xvii) Results of
patient medical history and patient physical evaluation, and identification of
anesthesia procedures to be utilized, prior to the administration of conscious
sedation or nitrous oxide/oxygen analgesia.
(xviii) Signed, written, informed patient
consent, prior to the administration of conscious sedation or nitrous
oxide/oxygen analgesia, which includes a description of the procedure, its
risks and possible alternative treatments. Consent for a minor patient shall be
obtained from the minor's parent or guardian.
(xix) Stethoscope.
(3) Auxiliary personnel who assist the
permitholder in the administration of conscious sedation:
(i) Are trained to perform the duties that
the permitholder delegates to them, if the duties do not require the
professional judgment and skill of the permitholder and do not involve the
actual administration of conscious sedation.
(ii) Perform their duties under the direct
on-premises supervision of the permitholder, who shall assume full
responsibility for the performance of the duties.
(iii) Do not render assistance in areas that
are beyond the scope of the permitholder's authority.
(iv) Are currently certified in
BLS.
(4) CRNAs who are
delegated the duties of administering conscious sedation:
(i) Perform their duties under the direct
on-premises supervision of the permitholder, who shall assume full
responsibility for the performance of the duties.
(ii) Do not perform duties that are beyond
the scope of the permitholder's authority.
(iii) Are currently certified in
ACLS.
(5) The dentist
possesses a current certification in ACLS for adult patients and PALS for
pediatric patients.
(6) The Board
receives a complete report of a death or incident requiring medical care and
resulting in physical or mental injury that directly resulted from the
administration of conscious sedation or nitrous oxide/oxygen analgesia by the
permitholder or by a CRNA working under the supervision of the permitholder.
The permitholder shall submit the report within 30 days of the death or
incident.
(7) The Board receives
prior notice of the first time that a dental office of the permitholder will be
used for the administration of conscious sedation or nitrous oxide/oxygen
analgesia.
(8) Monitoring equipment
and equipment used to administer conscious sedation and nitrous oxide/oxygen
analgesia is installed, maintained and calibrated according to the equipment
manufacturer's guidelines, contains a fail-safe system and is in proper working
condition prior to the administration of conscious sedation or nitrous
oxide/oxygen analgesia.
(9) If the
permitholder travels to the offices of non-permitholders for the purpose of
administering conscious sedation or nitrous oxide/oxygen analgesia, the
permitholder shall satisfactorily complete a clinical evaluation and the
equipment transported to a non-permitholder dentist's office for the
administration of conscious sedation or nitrous/oxide oxygen analgesia by a
permitholder must satisfactorily complete an inspection conducted by an
approved peer evaluation organization under §
33.336b(a)
(relating to approved peer evaluation organizations for administering clinical
evaluations and office inspections) in accordance with the requirements of the
AAOMS Manual and AAOMS Guidelines, the ADA Guidelines or the AAPD Guidelines,
as applicable. As part of that clinical evaluation and inspection, the
permitholder shall certify that each office location in which conscious
sedation or nitrous oxide/oxygen analgesia is administered has the equipment
required by paragraph (2) and that the staff is properly trained to handle
anesthesia-related emergencies.
(10) Conscious sedation and nitrous
oxide/oxygen analgesia is administered to adult and pediatric patients in
accordance with the AAOMS Guidelines and AAOMS Manual (OMSs) or to adult
patients in accordance with the ADA Guidelines (general dentists) or to
pediatric patients in accordance with the AAPD Guidelines (general dentists).
Conflicts between the AAOMS Guidelines, the AAOMS Manual, the ADA Guidelines,
or the AAPD Guidelines and this subchapter shall be resolved in favor of this
subchapter.
(11) Patient records
are prepared, maintained and retained in accordance with §
33.209 (relating to preparing,
maintaining and retaining patient records).