| (a) As used in this section, conscious sedation means
the production of an altered level of consciousness in a patient by
pharmacological or non-pharmacological methods.
(b) Conscious sedation of a patient by nitrous oxide
is the administration by inhalation of a combination of nitrous oxide
and oxygen producing a minimally depressed level of consciousness
while retaining the patient's ability to maintain a patent airway
independently and continuously, and to respond appropriately to physical
stimulation and verbal command.
(c) Conscious sedation of a patient by nitrous oxide
must be induced, maintained, and continuously supervised only by the
practitioner or by the assistant under continuous direct supervision
of the practitioner. The nitrous oxide must not be flowing if the
practitioner is not present in the room.
(d) To use nitrous oxide/oxygen inhalation conscious
sedation on a patient for podiatric medical purposes in the State
of Texas, the practitioner must first register with the department
and provide the following:
(1) proof that the practitioner has completed a didactic
and clinical course which includes aspects of monitoring patients
and the hands-on use of the gas machine. The didactic and clinical
course must:
(A) be directed by a licensed and certified M.D., D.O.,
D.D.S., or D.P.M., in the State of Texas with advanced educational
and clinical experience with routine administration of nitrous oxide/oxygen
inhalation conscious sedation;
(B) include a minimum of four hours didactic work in
pharmacodynamics of nitrous oxide/oxygen inhalation conscious sedation;
and
(C) include a minimum of six hours of clinical experience
under personal supervision;
(2) proof that the practitioner has completed a CME
course in nitrous oxide/oxygen inhalation conscious sedation that
includes training in the prevention and management of emergencies
in the podiatric medical practice; and
(3) proof that the practitioner has completed a basic
and advanced CPR program sponsored by the American Heart Association,
the American Red Cross, or the Health and Safety Institute. Proof
of current certification is the responsibility of the podiatric physician.
Additionally, the D.P.M. must provide documented training or emergency
procedures to office personnel.
(e) The department may, at any time and without prior
notification, require an on-site office evaluation to determine that
all standards regarding nitrous oxide/oxygen inhalation conscious
sedation are being met.
(f) Registration Term and Renewal. A registration is
valid for one or two years.
(1) A registration is valid for one year if the registration
was issued before January 1, 2025, or two years if the registration
was issued on or after January 1, 2025.
(2) A registration renewed by the department is valid
for one year if the registration was renewed before January 1, 2025,
and must be renewed annually, or two years if the registration was
renewed on or after January 1, 2025, and must be renewed every two
years. A registration renewal is completed by submitting a registration
renewal application in a form and manner prescribed by the department
and paying the required fee under §130.60.
(3) A registration will not be renewed if a current
certificate of inspection of the gas machine is not filed with the
department.
(g) A registrant must inform the department within
10 business days of any address change.
(h) When a registration is issued, it must be clearly
displayed in the office.
(i) All office personnel who assist the practitioner
in the nitrous oxide/oxygen inhalation conscious sedation procedure
must:
(1) be trained in basic life support;
(2) have annual reviews of emergency protocols, contents,
and use of emergency equipment; and
(3) have annual reviews of basic CPR.
(j) Documentation verifying these annual reviews must
be maintained in the office of the practitioner who employs the personnel
and must be provided to the department if requested.
(k) The practitioner must evaluate and document in
the patient's medical record, prior to the nitrous oxide/oxygen inhalation
conscious sedation procedure, the patient's health and medical status
to ensure that nitrous oxide/oxygen inhalation conscious sedation
is medically appropriate.
(l) Equipment used must meet the following safety criteria:
The gas machine must have:
(1) 30% minimum oxygen flow;
(2) Glass flow tubes;
(3) Nitrous oxide fail-safe (will not flow without
oxygen);
(4) Automatic room air intake in the event the bag
is empty;
(5) Non-rebreathing check valve;
(6) Oxygen flush; and
(7) Auxiliary oxygen outlet with one demand valve resuscitation
assembly per office.
(m) All practitioners administering nitrous oxide must
have:
(1) a functioning vacuum system;
(2) a scavenger system;
(3) appropriate emergency drugs and equipment for resuscitation;
(4) a manifold to provide for protection against overpressure.
The manifold must be equipped with an audible alarm system. The machine
must have a service check on a three-year basis, a copy of which must
be filed with the department; and
(5) a method of locking the nitrous oxide tanks after
business hours.
|
