§ 33.340. Duties of dentists who are unrestricted permitholders.
(a) A dentist who possesses an unrestricted permit issued under this subchapter shall ensure that:
(1) Prior to the administration of general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia, the permitholder takes or updates a patient medical history and gives the patient a physical evaluationsufficient to determine the patient’s suitability to receive general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia.
(2) The dental office in which the permitholder administers general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia on an outpatient basis contains the following:
(i) An operating room.
(ii) An operating table or chair.
(iii) A lighting system.
(iv) Suction equipment commensurate with the patient’s age, size and condition.
(v) Oxygen and supplemental gas delivery systems, including primary and back-up sources and a fail-safe control mechanism.
(vi) A sterilization area.
(vii) A recovery area.
(viii) A gas storage area and scavenger system.
(ix) Emergency airway equipment and medications, including intravenous emergency equipment.
(x) Communications equipment.
(xi) Patient transport equipment.
(xii) Monitoring equipment, procedures and documentation to conform to the age, size and condition of the patient and the AAOMS Manual and AAOMS Guidelines for adult and pediatric patients (OMS); the ADA Guidelines for adult patients (general dentists); and the AAPD Guidelines for pediatric patients (general dentists).
(xiii) Capnograph for intubated patients and pulse oximeter.
(xiv) ECG.
(xv) Blood pressure monitoring device.
(xvi) Defibrillator.
(xvii) Results of patient medical history and patient physical evaluation, and identification of anesthesia procedures to be utilized, prior to the administration of general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia.
(xviii) Signed, written, informed patient consent, prior to the administration of general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia, which includes a description of the procedure, its risks and possible alternative treatments. Consent for a minor patient shall be obtained from the minor’s parent or guardian.
(xix) Stethoscope.
(3) Auxiliary personnel who assist the permitholder in the administration of general anesthesia, deep sedation or conscious sedation:
(i) Are trained to perform the duties that the permitholder delegates to them, if the duties do not require the professional judgment and skill of the permitholder and do not involve the actual administration of general anesthesia, deep sedation or conscious sedation.
(ii) Perform their duties under the direct on-premises supervision of the permitholder, who shall assume full responsibility for the performance of the duties.
(iii) Do not render assistance in areas that are beyond the scope of the permitholder’s authority.
(iv) Are currently certified in BLS.
(4) CRNAs who are delegated the duties of administering general anesthesia, deep sedation or conscious sedation:
(i) Perform their duties under the direct on-premises supervision of the permitholder, who shall assume full responsibility for the performance of the duties.
(ii) Do not perform duties that are beyond the scope of the permitholder’s authority.
(iii) Are currently certified in ACLS.
(5) The dentist possesses a current certification in ACLS for adult patients and PALS for pediatric patients.
(6) The Board receives a complete report of a death or incident requiring medical care and resulting in physical or mental injury that directly resulted from the administration of general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia by the permitholder or by a CRNA working under the supervision of the permitholder. The permitholder shall submit the report within 30 days of the death or incident.
(7) The Board receives prior notice of the first time that a dental office of the permitholder will be used for the administration of general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia.
(8) General anesthesia or deep sedation administered to pediatric patients by or under the delegation of a general dentist is administered by a person dedicated solely to the administration and monitoring of anesthesia, and the dental procedures are performed by a dental licensee who is not involved in the administration of the general anesthesia.
(9) Monitoring equipment and equipment used to administer general anesthesia, deep sedation, conscious sedation and nitrous oxide/oxygen analgesia is installed, maintained and calibrated according to the equipment manufacturer’s guidelines; is in proper working condition prior to the administration of general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia; and monitoring equipment is being used during the administration of general anesthesia.
(10) If the permitholder travels to the offices of non-permitholders for the purpose of administering general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia, the permitholder shall satisfactorily complete a clinical evaluation and the equipment transported to the nonpermitholder dentist’s office for the administration of general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia by a permitholder shall satisfactorily complete an inspection conducted by an approved peer evaluation organization under § 33.336b(a) (relating to approved peer evaluation organizations for administering clinical evaluations and office inspections) in accordance with the requirements of the AAOMS Manual and AAOMS Guidelines (OMS). As part of that clinical evaluation and inspection, the permitholder shall certify that each office location in which general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia is administered by the permitholder has the equipment required by paragraph (2) and that the staff is properly trained to handle anesthesia-related emergencies.
(11) General anesthesia, deep sedation, conscious sedation and nitrous oxide/oxygen analgesia is administered to adult and pediatric patients in accordance with the AAOMS Guidelines and AAOMS Manual (OMSs) or to adult patients in accordance with the ADA Guidelines (general dentists) or to pediatric patients in accordance with the AAPD Guidelines (general dentists). Conflicts between the AAOMS Guidelines, the AAOMS Manual, the ADA Guidelines, or the AAPD Guidelines and this subchapter shall be resolved in favor of this subchapter.
(12) Patient records are prepared, maintained and retained in accordance with § 33.209 (relating to preparing, maintaining and retaining patient records).
(b) A dentist’s failure to comply with this section will be considered unprofessional conduct and will subject the dentist to disciplinary action under section 4.1 of the act (63 P. S. § 123.1).
Authority The provisions of this § 33.340 issued under sections 11.2 and 11.3 of The Dental Law (63 P. S. § § 130c and 130d); amended under sections 3(o) and 11.2(a) of The Dental Law (63 P. S. § § 122(o) and 130c(a)).
Source The provisions of this § 33.340 adopted July 8, 1988, effective July 9, 1988, 18 Pa.B. 3045; amended May 13, 2005, effective May 14, 2005, 35 Pa.B. 2880. Immediately preceding text appears at serial pages (266043) to (266045).
Notes of Decisions Appropriate Monitoring Equipment
The term ‘‘appropriate monitoring equipment’’ for the administration of general anesthesia is unconstitutionally vague because it does not provide a reasonable standard by which a dentist is supposed to act; the lack of clear guidance as to what constitutes ‘‘appropriate’’ monitoring equipment lends itself to a situation in which the standards are left to be defined by the personal or professional views of individual members of the State Board of Dentistry. Watkins v. State Board of Dentistry, 740 A.2d 760 (Pa. Cmwlth. 1999).
Cross References This section cited in 49 Pa. Code § 33.331 (relating to definitions); 49 Pa. Code § 33.336b (relating to approved peer evaluation organizations for administering clinical evaluations and office inspections); 49 Pa. Code § 33.341 (relating to duties of dentists who are not permitholders); and 49 Pa. Code § 33.342 (relating to inspection of dental offices).
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