(a) For the purpose of this section, conscious sedation
means the production, by pharmacological or non-pharmacological methods,
or a combination thereof, of an altered level of consciousness in
a patient.
(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
shall be induced, maintained, and continuously supervised only by
the podiatric physician or by the assistant under continuous direct
supervision of the practitioner. The nitrous oxide shall 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 purpose 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 (4) hours didactic work
in pharmacodynamics of nitrous oxide/oxygen inhalation conscious sedation;
and
(C) include a minimum of six (6) hours of clinical
experience under personal supervision; and
(2) proof that the practitioner has completed a continuing
medical education 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 either the American Heart Association
or the American Red Cross. Proof of current certification shall be
the responsibility of the podiatric physician. Additionally, the D.P.M.
shall provide documented training or emergency procedures to office
personnel.
(e) The department may at any time at its own discretion
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) A registration will not be renewed if a current
certificate of inspection of the gas machine is not filed with the
department.
(g) Registrations are valid for one year and must be
renewed annually by submitting a department-approved application,
and paying the required fee.
(h) Registrants shall inform the department of any
address change no later than ten (10) business days after the change
is made.
(i) When a registration permit is issued, it must be
clearly displayed in the office.
(j) All personnel employed in Texas in an office of
a practitioner and who shall assist in the nitrous oxide/oxygen inhalation
conscious sedation procedure shall be trained in basic life support
and shall have annual reviews of emergency protocols, contents and
use of emergency equipment, and basic cardiopulmonary resuscitation.
Documentation verifying these annual reviews shall be maintained in
the office of the practitioner who employs the personnel and shall
be provided to the department if requested.
(k) The practitioner shall 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, and a copy of the
service check is to be filed with the department; and
(5) a method of locking the nitrous oxide tanks after
business hours.
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