MONDAY, JULY 7, 2003

Parenteral Conscious Sedation

Adopted Amendment: N.J.A.C. 13:30-8.2

Proposed: July 15, 2002 at 34 N.J.R. 2367(a).

Adopted: October 2, 2002 by the New Jersey State Board of Dentistry, William A. Orlacchio, D.D.S., President.

Filed: June 10, 2003 as R.2003 d.262, without change.

Authority: N.J.S.A. 45:5-1 and 45:1-15.1.

Effective Date: July 7, 2003.
Expiration Date: March 10, 2005.

Federal Standards Statement

A Federal standards analysis is not required because the adopted amendments to N.J.A.C. 13:30-8.2 are governed by N.J.S.A. 45:6-1 et seq., and are not subject to any Federal standards or requirements.

Full text of the adoption follows:

< < NJ ADC 13:30-8.2 > >

13:30-8.2 Parenteral conscious sedation

(a) No dentist shall administer parenteral conscious sedation ("PCS") unless the minimum standards of training and procedure set forth in this section are satisfied.

(b) PCS is defined as a depressed level of consciousness produced by the parenteral administration of pharmacologic substances that allows the patient to retain the ability to independently and continuously maintain an airway and respond appropriately to physical stimulation or verbal command. This modality includes administration of medications via all parenteral routes, that is, intravenous, intramuscular, subcutaneous, submucosal, or inhalation, but does not include nitrous-oxide inhalation analgesia.

(c) No dentist shall use PCS for dental patients unless such dentist possesses a PCS permit issued by the State Board of Dentistry for a specified practice location which shall be renewed biennially. A dentist shall obtain a separate PCS permit for each practice location at which PCS is administered, except as set forth in (j) below.

(d) A dentist applying for a Board permit to administer PCS shall complete an application as provided by the Board. The dentist shall submit as part of a completed application a certification from an accredited university, teaching hospital or other training institution or facility approved pursuant to N.J.S.A. 45:6-2, establishing that the applicant has completed formal training in the administration of PCS. Such formal training shall consist of, at a minimum, a combined 80 hours in didactic instruction and supervised clinical training in the administration of PCS. Such formal training shall have been completed within three years preceding the date of application. Supervised clinical training shall consist of, at a minimum, delivering intravenous, intramuscular, subcutaneous, submucosal and inhalation medications, monitoring patient activity and managing patient care for 20 PCS patients. As part of the dentist's PCS permit application, the institution shall certify the applicant is competent to:

1. Evaluate the medical status of patients and perform risk management assessments according to American Society of Anesthesiology (ASA) Classification by use of patient histories, physical examinations, vital signs, and pertinent laboratory data and information obtained by medical consultations, and that the applicant can modify treatment plans accordingly;

2. Understand and evaluate the effects of conscious sedation agents on the medical, physical and psychological status of patients;

3. Perform venipunctures and maintain intravenous access during PCS procedures;

4. Recognize and manage complications from drug administrations;

5. Understand the clinical pharmacology and interactions of the drugs used for PCS;

6. Maintain patient airways and support ventilation;

7. Monitor patients during the administration of PCS using clinical evaluations and mechanical means including the use of an EKG monitor and a pulse oximeter and the interpretation of such readings;

8. Recognize and manage anesthetic and medical emergencies arising from the use of PCS;

9. Manage patients during the post-operative period and assess patients' suitability for discharge; and

10. Maintain accurate anesthetic records including drug dosages, vital signs and patient responses.

(e) An applicant for a PCS permit shall obtain emergency training by completing "Basic Life Support: Course C" of the American Heart Association or its equivalent or a course in Advanced Cardiac Life Support or its equivalent and shall maintain current certification in such course. The applicant shall furnish proof of this training and certification to the Board upon application for a PCS permit and proof of recertification upon biennial renewal of the permit.

(f) An applicant for a PCS permit shall certify to the Board upon application for a permit and upon biennial renewal of the permit that the dentist employs no fewer than two persons who will be present in the office, at least one of whom shall assist in monitoring the patient whenever PCS is employed. The applicant shall further certify that these persons are trained in and capable of monitoring vital signs and of assisting in emergency procedures and that they maintain current certification in "Basic Life Support: Course C" or its equivalent or in Advanced Cardiac Life Support or its equivalent.

(g) An applicant for a PCS permit shall certify as part of the application for a permit and upon biennial renewal of the permit that he or she possesses basic equipment and supplies to deal with emergency situations. The permit holder's facility shall contain the following readily accessible and properly operating equipment: emergency drug kit; positive pressure oxygen; stethoscope; suction; nasopharyngeal tubes; oropharyngeal tubes; a blood pressure monitoring device; an EKG monitor; and a pulse oximeter or its equivalent. The permit holder's facility shall also contain back-up, battery-operated equipment consisting of, at a minimum, lighting, suction and a pulse oximeter, which shall be readily accessible and properly operating.

(h) A licensee who holds a current general anesthesia permit issued by the Board of Dentistry shall be authorized to use PCS and shall not be required to apply for a PCS permit pursuant to this section. (i) A dentist who utilizes the services of a PCS permit holder or an M.D. or D.O. who is authorized to perform anesthesia services by the Board of Medical Examiners pursuant to N.J.A.C. 13:35-4A.1 shall not be deemed to be administering PCS, provided that the PCS permit holder or anesthesiologist remains present during the administration of PCS and bears full responsibility during the entire procedure until the patient has recovered fully and has been discharged.

(j) A PCS permit holder invited by a dentist to provide PCS services at a specific location shall bear full responsibility for compliance with all provisions of this section including the minimum requirements for assisting staff and equipment set forth in (f) and (g) above. When a PCS permit holder utilizes mobile equipment and supplies to administer PCS pursuant to this section, the mobile equipment and supplies of the permit holder shall be inspected by the Board or its designee not less than once every three years. "Mobile equipment and supplies," for purposes of this subsection, means any equipment and/or supplies which are transported and used by a permit holder to administer PCS in one or more locations. When more than one permit holder utilizes the mobile equipment and supplies, it shall be the responsibility of the permit holder using the equipment and supplies to ensure that the mobile equipment and supplies satisfy the requirements of this section as set forth in (g) above prior to the administration of PCS.

(k) Prior to the administration of a PCS agent for the purpose of controlling pain, a physical evaluation of the patient shall be made by the permit holder and a complete medical history shall be obtained which shall include previous medications, allergies and sensitivities. The patient history shall be maintained in the files of each dentist for a period of not less than seven years. Specific records on the use of PCS shall be kept as part of every patient chart and shall include the type of agent, the dosage, and the duration of sedation.

(l) A licensee who holds a PCS permit shall certify to the Board upon biennial renewal that the holder has completed a least 20 hours during the previous two- year period in continuing education courses devoted to PCS consistent with the requirements set forth in N.J.A.C. 13:30-5.1.

(m) Any designee of the Board shall be authorized during ordinary business hours to enter and inspect any dental office or mobile equipment and supplies for the purpose of enforcing the provisions of this rule.

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