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PA Bulletin, Doc. No. 04-607a

[34 Pa.B. 1949]

[Continued from previous Web Page]

§ 33.334.  Application for permit.

   (a)  A dentist who desires to obtain a permit to administer general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia, or a temporary permit, shall submit an application on a form provided by the Board, pay the permit fee prescribed in § 33.339 (relating to fees for issuance of permits) and meet the requirements for the permit applied for as prescribed in this subchapter.

*      *      *      *      *

§ 33.335.  Requirements for unrestricted permit.

   (a)  To secure an unrestricted permit, a dentist shall have done one of the following:

   (1)  Successfully completed at least [1 year] 2 years in a postgraduate program for advanced training in anesthesiology and related academic subjects that conforms to Part II of the American Dental Association's Guidelines for Teaching the Comprehensive Control of Pain and Anxiety in Dentistry.

   (2)  [Be certified] Possess current certification as a Diplomate of the American Board of Oral and Maxillofacial Surgeons, a Fellow of the American Association of Oral and Maxillofacial [Surgeons] Surgery or a Fellow of the American Dental Society of [Dental] Anesthesiology, or be eligible for examination by the American Board of Oral and Maxillofacial [Surgeons] Surgery.

   [(3)  Administered general anesthesia on a regular basis in the course of his dental practice for at least 5 years prior to January 1, 1986, if the applicant:

   (i)  Is competent to administer general anesthesia.

   (ii)  Administers general anesthesia in a properly equipped dental office as prescribed in § 33.340 (a)(2) (relating to duties of dentists who are permit holders).

   (b)  To determine whether the requirements of subsection (a)(3) are satisfied, the Board will require the applicant to undergo a clinical evaluation and office inspection conducted by the Board through its authorized agents. The clinical evaluation and office inspection will be conducted in accordance with the American Association of Oral and Maxillofacial Surgeons' Office Anesthesia Evaluation Manual.

   (c)  A dentist who applies for a permit under subsection (a)(3) shall do so by January 9, 1990.]

§ 33.336.  Requirements for restricted permit I.

   [(a)]  To secure a restricted permit I, a dentist shall have [done one of the following:

   (1)  Successfully] successfully completed a course on conscious sedation comprising at least [80] 60 hours of undergraduate or postgraduate didactic instruction and clinical experience in a program that conforms to Part I (for an undergraduate program) or Part III (for a postgraduate program) of the [American Dental Association's] ADA's Guidelines for Teaching the Comprehensive Control of Pain and Anxiety in Dentistry.

   [(2)  Administered conscious sedation on a regular basis in the course of his dental practice for 5 or more years prior to January 1, 1986, if the applicant:

   (i)  Is competent to administer conscious sedation.

   (ii)  Administers conscious sedation in a properly equipped dental office as prescribed in § 33.340 (a)(2) (relating to duties of dentists who are permit holders).

   (b)  To determine whether the requirements of subsection (a)(2) are satisfied, the Board will require the applicant to undergo a clinical evaluation and office inspection conducted by the Board through its authorized agents. The clinical evaluation and office inspection will be conducted in accordance with the American Association of Oral and Maxillofacial Surgeons' Office Anesthesia Evaluation Manual.

   (c)  A dentist who applies for a permit under subsection (a)(2) shall do so by January 9, 1990.]

§ 33.336a.  Requirements for unrestricted permit and restricted permit I.

   (a)  Office inspections and clinical evaluations.

   (1)  Initial permits. Beginning April 1, 2004, all initial unrestricted and restricted I permit applicants shall satisfactorily complete an office inspection and clinical evaluation conducted by an approved peer evaluation organization under § 33.336b (relating to approved peer evaluation organizations for administering clinical evaluations and office inspections).

   (2)  First renewal permit after April 1, 2005. Beginning April 1, 2005, all renewal unrestricted and restricted I permit applicants shall satisfactorily complete an office inspection and clinical evaluation as a condition for permit renewal. Completion of an office inspection and clinical evaluation may be waived if the applicant can demonstrate satisfactory completion of an office inspection and clinical evaluation, administered by an organization approved by the Board, within 6 years preceding April 1, 2005.

   (3)  Subsequent renewal permit. Following the applicant's initial permit renewal after April 1, 2005, all unrestricted and restricted permit I renewal applicants shall satisfactorily complete an office inspection and clinical evaluation once every 6 years.

   (4)  Report of office inspection and clinical evaluation. An application for an initial or renewal permit shall contain an original letter from the peer review organization that conducted the office inspection and clinical evaluation that evidences the applicant's satisfactory completion of an office inspection and clinical evaluation and a written report of the results of the office inspection and clinical evaluation.

   (b)  Standards for anesthesia administration.

   (1)  An OMS applicant for an unrestricted or restricted I permit shall attest that the administration of anesthesia to adult and pediatric patients will be conducted in conformance with the standards outlined in the AAOMS Guidelines and the AAOMS Manual.

   (2)  A general dentist applicant for an unrestricted or restricted I permit shall attest that the administration of anesthesia to adult patients will be conducted in conformance with the standards outlined in the ADA Guidelines and that the administration of anesthesia to pediatric patients will be conducted in conformance with the standards outlined in the AAPD Guidelines.

   (c)  ACLS/PALS certification.

   (1)  Adult patients. An applicant for an unrestricted or restricted I permit shall have successfully completed and maintained current certification in ACLS prior to the administration of anesthesia to an adult patient.

   (2)  Pediatric patients. An applicant for an unrestricted or restricted I permit shall have successfully completed and maintained current certification in PALS prior to the administration of anesthesia to a pediatric patient.

   (d)  Continuing anesthesia education.

   (1)  Beginning April 1, 2005, and for all subsequent renewal periods, the following hours of continuing education are required as a condition of permit renewal:

   (i)  Unrestricted permit. An applicant for an unrestricted permit shall have completed 15 hours of Board approved courses related to general anesthesia and deep sedation.

   (ii)  Restricted permit I. An applicant for a restricted permit I shall have completed 15 hours of Board approved courses related to conscious sedation.

   (2)  Continuing anesthesia education will be credited toward the permit holder's continuing education requirement under § 33.401(a)(1) (relating to credit-hour requirements).

§ 33.336b.  Approved peer evaluation organizations for administering clinical evaluations and office inspections.

   (a)  The following organizations are deemed qualified to conduct clinical evaluations and office inspections and do not require prior approval from the Board:

   (1)  The American Association of Oral and Maxillofacial Surgeons (AAOMS)

   (2)  The Pennsylvania Society of Oral and Maxillofacial Surgeons (PSOMS)

   (b)  An organization of oral and maxillofacial surgeons or of unrestricted permit holders that does not qualify as an organization to conduct clinical evaluations and office inspections under subsection (a) may apply to the Board for approval to serve as an organization to conduct clinical evaluations and office inspections. In determining whether to grant approval, the Board will consider the following factors:

   (1)  Whether the organization agrees to utilize peer evaluators meeting the following criteria:

   (i)  A minimum 5 years experience administering general anesthesia and deep sedation within the last 7 years.

   (ii)  A current unrestricted permit.

   (iii)  Completion of a minimum 7-hour course in conducting office inspections and clinical evaluations.

   (2)  Whether the organization has sufficient peer evaluators that meet the criteria listed in § 33.336d (relating to qualifications of peer evaluators conducting office inspections and clinical evaluations) to conduct office inspections and clinical evaluations.

   (3)  Whether the organization has the technical competence to administer office inspections and clinical evaluations to applicants for initial and renewal permits.

   (4)  Whether the organization's fee for office inspections and clinical evaluations is based upon reasonable costs.

   (5)  Whether the organization has standards for satisfactory completion of an office inspection and clinical evaluation.

   (6)  Whether the organization has an internal appeal procedure to contest the office inspection or clinical evaluation.

   (7)  Whether the organization has a peer review oversight committee whose members meet the following criteria:

   (i)  A minimum 5 years experience administering general anesthesia and deep sedation.

   (ii)  A current unrestricted permit.

   (8)  Whether the organization has procedures to facilitate fair, unbiased and equitable office inspections and clinical evaluations.

   (9)  Whether the organization agrees to make records of all office inspections and clinical evaluations available to the State Board of Dentistry upon request.

   (10)  Whether the organization agrees to conduct a subsequent office inspection or clinical evaluation within a reasonable time if the results of the initial office inspection or clinical evaluation are unsatisfactory.

   (11)  Whether the organization agrees to conduct office inspections and clinical evaluations in conformance with the standards outlined in the AAOMS Manual and AAOMS Guidelines, and in accordance with §§ 33.340 and 33.340a (relating to duties of dentists who are unrestricted permit holders; and duties of dentists who are restricted permit I holders).

   (c)  An approved peer evaluation organization may not require a permit applicant to become a member of the organization as a precondition for the organization to conduct a clinical evaluation and office inspection for the applicant.

§ 33.336c.  Standards for office inspections and clinical evaluations.

   Office inspections and clinical evaluations shall be conducted in accordance with the AAOMS Manual and AAOMS Guidelines.

§ 33.336d.  Qualifications of peer evaluators conducting office inspections and clinical evaluations.

   (a)  A peer evaluator shall be a licensed dentist holding a current unrestricted permit.

   (b)  A peer evaluator shall be independent from, and have no conflict of interest with, the dentist or dental practice being reviewed.

   (c)  The administering approved peer evaluation organization shall ensure that its peer evaluators are qualified under this section.

§ 33.336e.  Confidentiality of peer evaluation reports.

   (a)  Office inspection and clinical evaluation reports and related information shall remain confidential except as provided in § 33.336a(a)(4) (relating to requirements for unrestricted permit and restricted permit I) and the act of June 21, 1957 (P. L. 390, No. 212) (65 P. S. §§ 66.1--66.4), known as the Right-to-Know Law.

   (b)  An administering approved peer evaluation organization must notify the Board within 30 days from the date the office inspection and clinical evaluation was conducted as to whether office inspection and clinical evaluation report has been accepted or rejected by the peer evaluation organization.

§ 33.337.  Requirements for restricted permit II.

   (a)  To secure a restricted permit II, a dentist shall have [done one of the following:

   (1)  Successfully] successfully completed a course in nitrous oxide/oxygen analgesia comprising at least [40] 14 hours of undergraduate or postgraduate didactic instruction and clinical experience in a program that conforms to Part I (for an undergraduate program) or Part III (for a postgraduate program) of the [American Dental Association's] ADA's Guidelines for Teaching the Comprehensive Control of Pain and Anxiety in Dentistry.

   [(2)  Administered nitrous oxide/oxygen analgesia on a regular basis in the course of his dental practice for 5 or more years prior to January 1, 1986, if the applicant:

   (i)  Is competent to administer nitrous oxide/oxygen analgesia. The Board will consider an applicant competent if there are no reported or discovered incidents of mortality or morbidity resulting from the applicant's administration of nitrous oxide/oxygen analgesia.

   (ii)  Administers nitrous oxide/oxygen analgesia in a properly equipped dental office as prescribed in § 33.340(a)(2) (relating to duties of dentists who are permit holders).]

   (b)  [A dentist who applies for a permit under subsection (a)(2) shall do so by January 9, 1990.]

   Initial permits. Beginning April 1, 2004, all initial restricted II permit applicants shall provide the following:

   (1)  The make, model and serial number of any nitrous oxide/oxygen analgesia equipment utilized by the applicant.

   (2)  Certification that the equipment is properly calibrated, contains a fail-safe system and is in working order.

   (3)  An attestation that the applicant has written office procedures for administering nitrous oxide/oxygen analgesia and handling emergencies related to the administration of nitrous oxide/oxygen analgesia.

   (c)  Subsequent renewal permits. Following the applicant's initial permit renewal after April 1, 2004, for each subsequent renewal period, an applicant shall provide an attestation to the Board, in accordance with § 33.338(b)(4) (relating to expiration and renewal of permits), that the nitrous oxide/oxygen analgesia equipment that the applicant uses is properly calibrated and contains a fail-safe system.

§ 33.337a.  Requirements for temporary permit.

   (a)  To secure a temporary unrestricted permit, restricted permit I or restricted permit II, an applicant shall include with the application proof that the applicant possesses the qualifications required for the type of permit requested.

   (b)  Temporary permits expire 1 year following the effective date and may not be renewed.

§ 33.338.  Expiration and renewal of permits.

*      *      *      *      *

   (b)  A dentist who desires to renew a permit shall submit [a] the following:

   (1)  A renewal application on a form provided by the Board [and pay the].

   (2)  The permit renewal fee prescribed in § 33.339 (relating to fees for issuance of permits).

   (3)  Proof of current certification in ACLS (adult patients) or PALS (pediatric patients), or both (for unrestricted permits and restricted I permits).

   (4)  An attestation, on the renewal application, that any nitrous oxide/oxygen analgesia equipment utilized has been installed, properly calibrated according to the equipment manufacturer's guidelines and contains a fail-safe system (for all permits).

   (5)  Proof of compliance with the continuing anesthesia education requirement under § 33.336a(d) (relating to requirements for unrestricted permit and restricted I permit).

   (6)  Proof of compliance with the office inspection and clinical evaluation requirements under § 33.336a(a).

§ 33.339.  Fees for issuance of permits.

   The following fees are charged for the issuance of permits under this subchapter:

   (1)  Unrestricted permit.

   (i)  [Issuance under § 33.335(a)(1) or (2)] Initial$[15] 100
   (ii)  [Issuance under § 33.335(a)(3)] Renewal$[300] 200
   (iii)  Temporary $100
   (2)  Restricted permit I.
   (i)  [Issuance under § 33.336(a)(1)] Initial $[15] 100
   (ii)  [Issuance under § 33.336(a)(2)] Renewal $[300] 200
   (iii)  Temporary $100
   (3)  Restricted permit II.
   (i)  [Issuance under § 33.337(a)(1)] Initial $15
   (ii)  [Issuance under § 33.337(a)(2)] Renewal $15
   (iii)  Temporary $15

§ 33.340.  Duties of dentists who are unrestricted permit holders.

   (a)  A dentist who possesses [a] 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 a patient medical history is taken or updated and the patient is given a physical evaluation sufficient 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 permit holder administers general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia on an outpatient basis contains the following:

*      *      *      *      *

   (iv)  Suction equipment commensurate with the patient's age, size and condition.

*      *      *      *      *

   (xii)  [Appropriate monitoring] 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.

   (xiv)  Stethoscope.

   (3)  Auxiliary personnel who assist the permit holder in the administration of general anesthesia, deep sedation or conscious sedation [or nitrous oxide/oxygen analgesia]:

   (i)  Are trained to perform the duties that the permit holder delegates to them, if the duties do not require the professional judgment and skill of the permit holder and do not involve the administration of general anesthesia, deep sedation or conscious sedation [or nitrous oxide/oxygen analgesia].

*      *      *      *      *

   (iv)  Are currently certified in BLS.

   (4)  Certified registered nurse anesthetists who are delegated the duties of administering general anesthesia, deep sedation or conscious sedation [or nitrous oxide/oxygen analgesia]:

*      *      *      *      *

   (iii)  Are currently certified in ACLS.

   (5)  [He] The dentist possesses a current certification [to administer cardiopulmonary resuscitation (CPR)] in ACLS for adult patients and PALS for pediatric patients.

   (6)  The Board receives a complete report of a death or [unusual] 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 permit holder or by a certified registered nurse anesthetist working under the supervision of the permit holder. The permit holder shall submit the report within 30 days of the death or [unusual] incident.

   (7)  The Board receives prior notice of the first time that a dental office of the permit holder 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 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)  The nonpermit holder dentist's office and equipment transported to the nonpermit holder dentist's office for the administration of general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia by a permit holder shall satisfactorily complete an office 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).

   (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 (OMS) 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)  The patient medical history and patient physical evaluation are conducted by the permit holder, physician or CRNA.

*      *      *      *      *

§ 33.340a.  Duties of dentists who are restricted permit I holders.

   (a)  A dentist who possesses a restricted permit I issued under this subchapter shall ensure that:

   (1)  Prior to the administration of conscious sedation or nitrous oxide/oxygen analgesia, a patient medical history is taken or updated and the patient is given a physical evaluation sufficient to determine the patient's suitability to receive conscious sedation or nitrous oxide/oxygen analgesia.

   (2)  The dental office in which the permit holder administers 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)  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 conscious sedation or nitrous oxide/oxygen analgesia.

   (xviii)  Signed, written, informed patient consent, prior to the administration of 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.

   (xiv)  Stethoscope.

   (3)  Auxiliary personnel who assist the permit holder in the administration of conscious sedation:

   (i)  Are trained to perform the duties that the permit holder delegates to them, if the duties do not require the professional judgment and skill of the permit holder and do not involve the administration of conscious sedation.

   (ii)  Perform their duties under the direct on-premises supervision of the permit holder, 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 permit holder's authority.

   (iv)  Are currently certified in BLS.

   (4)  Certified registered nurse anesthetists who are delegated the duties of administering conscious sedation:

   (i)  Perform their duties under the direct on-premises supervision of the permit holder, who shall assume full responsibility for the performance of the duties.

   (ii)  Do not perform duties that are beyond the scope of the permit holder's authority.

   (iii)  Are currently certified in ACLS.

   (5)  He 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 conscious sedation or nitrous oxide/oxygen analgesia by the permit holder or by a certified registered nurse anesthetist working under the supervision of the permit holder. The permit holder 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 permit holder will be used for the administration of conscious sedation or nitrous oxide/oxygen analgesia.

   (8)  Monitoring equipment and equipment used to administer conscious sedation and nitrous oxide/oxygen analgesia is installed and calibrated according to the equipment manufacturer's guidelines, contains a fail-safe system and is in proper working condition prior to the administration of conscious sedation or nitrous oxide/oxygen analgesia.

   (9)  The nonpermit holder dentist's office and equipment transported to the nonpermit holder dentist's office for the administration of conscious sedation or nitrous/oxide oxygen analgesia by a permit holder must satisfactorily complete an office 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.

   (10)  Conscious sedation and nitrous oxide/oxygen analgesia is administered to adult and pediatric patients in accordance with the AAOMS Guidelines and AAOMS Manual (OMS) 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.

   (11)  The patient medical history and patient physical evaluation are conducted by the permit holder, physician or CRNA.

   (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).

§ 33.340b.  Duties of dentists who are restricted permit II holders.

   (a)  A dentist who possesses a restricted permit II issued under this subchapter shall ensure that:

   (1)  Prior to the administration of nitrous oxide/oxygen analgesia, a patient medical history is taken or updated and the patient is given a physical evaluation sufficient to determine the patient's suitability to receive nitrous oxide/oxygen analgesia.

   (2)  The dental office in which the permit holder administers 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)  Dental office suction equipment.

   (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 gas storage area and scavenger system.

   (viii)  Communications equipment.

   (ix)  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).

   (x)  Results of patient medical history, patient physical evaluation and identification of the nitrous oxide/oxygen analgesia procedure to be utilized, prior to the administration of nitrous oxide/oxygen analgesia.

   (xi)  Signed, written, informed patient consent, prior to the administration of 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.

   (xii)  Stethoscope.

   (3)  Nitrous oxide/oxygen analgesia is administered to adult and pediatric patients in accordance with the AAOMS Guidelines and AAOMS Manual (OMS) 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.

   (4)  Monitoring equipment and equipment used to administer nitrous oxide/oxygen analgesia is installed and calibrated according to the equipment manufacturer's guidelines, contains a fail-safe system and is in proper working condition prior to the administration of nitrous oxide/oxygen analgesia.

   (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).

§ 33.341.  Duties of dentists who are not permit holders.

   (a)  [Effective January 9, 1990, a] A dentist who does not possess a permit issued under this subchapter may not allow general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia to be administered on an outpatient basis in his dental office unless the following conditions are met:

   (1)  The Board receives prior notice of the first time that the dental office will be used for the administration of general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia.

   (2)  The dental office has been inspected and meets the appropriate equipment and facility requirements prescribed in § 33.340(a)(2), § 33.340a(a)(2) or § 33.340b(a)(2) (relating to duties of dentists who are unrestricted permit holders; duties of dentists who are restricted permit I holders; and duties of dentists who are restricted permit II holders) and the Board receives a written certification from the dentist to that effect.

   (3)  The general anesthesia, deep sedation, conscious sedation and nitrous oxide/oxygen analgesia are administered by one of the following:

   (i)  The holder of a permit under this subchapter or CRNA delegatee.

*      *      *      *      *

   (4)  Either the dentist who performs the dental procedure or the [person] certified registered nurse anesthetist, physician or other unrestricted permit holder who administers the general anesthesia, deep sedation or conscious sedation [or nitrous oxide/oxygen analgesia] possesses a current certification [to administer cardiopulmonary resuscitation (CPR)] in ACLS.

   (5)  The nonpermit holder dentist verifies with the permit holder that all monitoring equipment and equipment used to administer general anesthesia, deep sedation, conscious sedation and nitrous oxide/oxygen analgesia is present in the nonpermit holder's office, is properly installed and calibrated according to the equipment manufacturer's guidelines, contains a fail-safe system and 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.

   (6)  The nonpermit holder dentist's office and equipment transported to the nonpermit holder dentist's office for the administration of general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia by a permit holder shall satisfactorily complete an office inspection conducted by an approved peer evaluation organization under § 33.336b(a), in accordance with the requirements of the AAOMS Manual and AAOMS Guidelines (OMS).

   (b)  A dentist shall submit to the Board a complete written report on a death or [unusual] an 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 in his dental office. The report shall be submitted within 30 days of the death or [unusual] incident.

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   (d)  Continuing anesthesia education. Beginning April 1, 2005, and for all subsequent renewal periods, nonpermit holder licensees who maintain offices in which general anesthesia, deep sedation or conscious sedation is administered, shall have completed 5 hours of Board approved courses related to anesthesia. These 5 hours shall be credited toward the nonpermit holder licensee's continuing education requirement under § 33.401(a)(1).

§ 33.342.  Inspection of dental offices.

   (a)  [Routine inspections] Inspections. [No more than once a year during regular business hours, the] The Board, through its authorized agents, may conduct [a routine inspection] inspections of a dental office with or without prior notice, for the purpose of determining whether the office is in compliance with the equipment and facility requirements prescribed in§ 33.340(a)(2), § 33.340a(a)(2) or § 33.340b(a)(2) (relating to duties of dentists who are unrestricted permit holders; duties of dentists who are restricted permit I holders; and duties of dentists who are restricted permit II holders)[.] or as follows:

   [(b)  Special inspections. In addition to the routine inspections authorized by subsection (a), the Board, through its authorized agents, may conduct a special inspection of a dental office:]

   (1)  Upon a death or injury related to the administration of general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia in the office.

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   [(4)  As a follow-up to a previous inspection that revealed the office's noncompliance with the equipment and facility requirements prescribed in § 33.340(a)(2).

   (c)] (b)  Notice of inspection. Prior to the start of [a routine or special] an inspection of a dental office, the Board's authorized agents will advise the dentist whose office is being inspected that the inspection is being made under this section and is limited in scope by this section.

   [(d)] (c)  Access during inspection. [For purposes of a routine or special inspection, a] A dentist shall give the Board's authorized agents access to:

   (1)  Areas of the dental office where general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia are administered.

   (2)  Equipment, supplies, records and documents relating to the administration of general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia.

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   [(e)] (d)  Guideline for inspection. [A routine] An inspection will be conducted under provisions pertaining to office facilities and equipment in [the American Association of Oral and Maxillofacial Surgeons' Office Anesthesia Evaluation Manual] § 33.340(a)(2), § 33.340a(a)(2), § 33.340b(a)(2) or § 33.341(2).

   [(f)] (e)  Inspection showing noncompliance. If [a routine or special] an inspection reveals that a dental office is not in compliance with the equipment and facility requirements prescribed in § 3.340(a)(2), § 33.340a(a) (2), § 33.340b(a)(2) or § 33.341(2), the Board will give the dentist whose office was inspected written notice of the deficiencies and of the deadline for correcting the deficiencies. A reinspection shall take place within 30 days, and, if noncompliance is still shown, formal administrative charges may be initiated.

[Pa.B. Doc. No. 04-607. Filed for public inspection April 9, 2004, 9:00 a.m.]



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