(a) A dentist who possesses an unrestricted
permit issued under this subchapter shall ensure that:
(1) Prior to the administration of general
anesthesia, deep sedation, 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 general anesthesia, deep sedation, conscious sedation or
nitrous oxide/oxygen analgesia.
(2)
The dental office in which the permitholder administers general anesthesia,
deep sedation, 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) Capnograph for
intubated patients and 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 general
anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen
analgesia.
(xviii) Signed, written,
informed patient consent, prior to the administration of general anesthesia,
deep sedation, 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
general anesthesia, deep sedation or 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 general anesthesia, deep sedation or 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 general anesthesia, deep sedation or
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 general anesthesia, deep sedation, 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 general anesthesia, deep sedation, conscious sedation or
nitrous oxide/oxygen analgesia.
(8)
General anesthesia or deep sedation administered to pediatric patients by or
under the delegation of a general dentist is administered by a person dedicated
solely to the administration and monitoring of anesthesia, and the dental
procedures are performed by a dental licensee who is not involved in the
administration of the general anesthesia.
(9) Monitoring equipment and equipment used
to administer general anesthesia, deep sedation, conscious sedation and nitrous
oxide/oxygen analgesia is installed, maintained and calibrated according to the
equipment manufacturer's guidelines; is in proper working condition prior to
the administration of general anesthesia, deep sedation, conscious sedation or
nitrous oxide/oxygen analgesia; and monitoring equipment is being used during
the administration of general anesthesia.
(10) If the permitholder travels to the
offices of non-permitholders for the purpose of administering general
anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen
analgesia, the permitholder shall satisfactorily complete a clinical evaluation
and the equipment transported to the nonpermitholder dentist's office for the
administration of general anesthesia, deep sedation, conscious sedation or
nitrous oxide/oxygen analgesia by a permitholder shall 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 (OMS). As part of that clinical evaluation
and inspection, the permitholder shall certify that each office location in
which general anesthesia, deep sedation, conscious sedation or nitrous
oxide/oxygen analgesia is administered by the permitholder has the equipment
required by paragraph (2) and that the staff is properly trained to handle
anesthesia-related emergencies.
(11) General anesthesia, deep sedation,
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.
(12) Patient records are prepared, maintained
and retained in accordance with §
33.209 (relating to preparing,
maintaining and retaining patient records).