|(a) Permits. (1) To employ nitrous oxide/oxygen inhalation conscious sedation for any medical purpose, the podiatric physician must obtain a permit from the Texas State Board of Podiatric Medical Examiners. (2) Any podiatric physician who is employing nitrous oxide/oxygen inhalation conscious sedation on the effective date of this regulation must apply for the permit in order to continue using nitrous oxide/oxygen inhalation conscious sedation. (3) The Texas State Board of Podiatric Medical Examiners 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. (4) Once a permit for nitrous oxide/oxygen inhalation conscious sedation is issued, the Texas State Board of Podiatric Medical Examiners shall renew the permit by January 31 of each year, unless the Board determines that for good cause an evaluation of the permit is appropriate, and of which the permit holder shall be promptly and fully informed so as to prevent inadvertent use of the technique when the permit status is in question. A permit will not be renewed if a current three-year certificate of inspection of the gas machine is not filed with the Board. (5) Permits shall be renewed annually by submitting a registration application, and paying a $25 fee to the Board by cashier's check or money order. All permits shall be renewed by January 31 of each calendar year. (A) If the annual registration fee is not received on or prior to the expiration date of the registration, the following penalty will be imposed: (i) one to 90 days late--$5.00 plus the annual registration fee; (ii) over 90 days late--registration may not be renewed. The person may obtain a new registration by complying with the requirements and procedures for obtaining an original certification. (B) Registrants shall inform the Board of any address change no later than 10 business days after the change is made. (6) When a permit is issued, it must be clearly displayed in the office alongside the original license. (b) Overview/Direct Supervision (1) Conscious sedation is the production, be pharmacological or non-pharmacological methods, or a combination thereof, of an altered level of consciousness in a patient. (2) 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 paten airway independently and continuously, and to respond appropriately to physical stimulation and verbal command. (3) 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 podiatric physician. The nitrous oxide shall not be flowing if the podiatric physician is not present in the room. (c) Office Safety Criteria/Equipment and Medical Supplies (1) Equipment used must meet the following safety criteria: The gas machine must have (A) 30% minimum oxygen flow; (B) Glass flow tubes; (C) Nitrous oxide fail-safe (will not flow without oxygen); (D) Automatic room air intake in the event the bag is empty; (E) Non-rebreathing check valve; (F) Oxygen flush, and (G) Auxiliary oxygen outlet with one demand valve resuscitation assembly per office. (2) All podiatric physicians administering nitrous oxide must have a functioning vacuum system (in case of vomiting or aspiration). (3) All podiatric physicians administering nitrous oxide must have a scavenger system ( to collect nitrous oxide in the office). (4) All podiatric physicians administering nitrous oxide must have appropriate emergency drugs and equipment for resuscitation. (5) The office should be equipped with 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 office of the Texas State Board of Podiatric Medical Examiners. (6) There must be a method of locking the nitrous oxide tanks after business hours. (d) Nitrous Oxide/Oxygen Inhalation Conscious Sedation Permit Requirements. (1) To induce and maintain nitrous oxide/oxygen inhalation conscious sedation of patients having podiatric surgical procedures in the State of Texas, the following requirements must be met; (2) Professional Requirements. To use nitrous oxide/oxygen inhalation conscious sedation on a patient for podiatric medical purpose in the State of Texas, the podiatric physician must first provide to the Texas State Board of Podiatric Medical Examiners documentary proof that: (A) The podiatric physician has completed a didactic and clinical course which includes aspects of monitoring patients and the hands-on use of the gas machine approved by the Texas State Board of Podiatric Medical Examiners approved post-graduate residency training program. The didactic and clinical course must: (i) 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; (ii) include a minimum of four (4) hours didactic work in pharmacodynamics of nitrous oxide/oxygen inhalation conscious sedation; (iii) include a minimum of six (6) hours of clinical experience under personal supervision. (B) The podiatric physician 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. (C) The podiatric physician must have 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 his/her personnel. (e) Auxiliary Personnel. All auxiliary personnel employed in Texas in an office of a podiatric physician 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 podiatric physician who employs the auxiliary personnel and shall be submitted upon demand to the Texas State Board of Podiatric Medical Examiners. (f) Pre-operative Evaluation. The podiatric physician 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 insure that nitrous oxide/oxygen inhalation conscious sedation is medically appropriate.