16 Tex. Admin. Code § 130.37

Current through Register Vol. 49, No. 48, November 29, 2024

Section 130.37 - Nitrous Oxide/Oxygen Inhalation Conscious Sedation-Registration Requirements, Guidelines, and Direct Supervision

(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.

16 Tex. Admin. Code § 130.37

Adopted by Texas Register, Volume 49, Number 47, November 22, 2024, TexReg 9544, eff. 12/1/2024