(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.

Source Note: The provisions of this §130.48 adopted to be effective November 1, 2018, 43 TexReg 6953