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COMMONWEALTH OF PENNSYLVANIA

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Pennsylvania Code



Subchapter E. ADMINISTRATION OF GENERAL ANESTHESIA, DEEP SEDATION, CONSCIOUS SEDATION AND NITROUS
OXIDE/OXYGEN ANALGESIA


Sec.


33.331.    Definitions.
33.332.    Requirement of permit to administer general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia.
33.333.    Types of permits.
33.334.    Application for permit.
33.335.    Requirements for unrestricted permit.
33.336.    Requirements for restricted permit I.
33.336a.    Requirements for unrestricted permit and restricted permit I.
33.336b.    Approved peer evaluation organizations for administering clinical evaluations and office inspections.
33.336c.    Standards for office inspections and clinical evaluations.
33.336d.    Qualifications of peer evaluators conducting office inspections and clinical evaluations.
33.336e.    Confidentiality of peer evaluation reports.
33.337.    Requirements for restricted permit II.
33.337a.    Requirements for temporary permit.
33.338.    Expiration and renewal of permits.
33.339.    [Reserved].
33.340.    Duties of dentists who are unrestricted permitholders.
33.340a.    Duties of dentists who are restricted permit I holders.
33.340b.    Duties of dentists who are restricted permit II holders.
33.341.    Duties of dentists who are not permitholders.
33.342.    Inspection of dental offices.
33.343.    Suspension, revocation, limitation of permit; refusal to issue or renew.
33.344.    Requirement of anesthesia permit for nonparenteral premedication of dental patients—statement of policy.

§ 33.331. Definitions.

 The following words and phrases, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise:

   AAOMS—American Association of Oral and Maxillofacial Surgeons.

   AAOMS Guidelines—AAOMS Parameters and Pathways 2000 Clinical Practice Guidelines for Oral and Maxillofacial Surgery, Anesthesia in Outpatient Facilities (AAOMS Par Path 2000), 4/15/99.

   AAOMS Manual—AAOMS Office Anesthesia Manual, 6th Edition, 2000.

   AAPD—American Academy of Pediatric Dentistry.

   AAPD Guidelines—AAPD Guidelines for the Elective Use of Conscious Sedation, Deep Sedation and General Anesthesia in Pediatric Dental Patients (May, 1998).

   ACLS—Advanced Cardiac Life Support.

   ADA—American Dental Association.

   ADA Guidelines—ADA Guidelines for the Use of Conscious Sedation, Deep Sedation and General Anesthesia for Dentists (October, 2000).

   Adult patient—A patient 18 years of age or older.

   Authorized agent—An organization or individual that the Board has officially authorized to act as the Board’s agent in carrying out the mandates of the Board, the act or this chapter.

   BLS—Basic Life Support.

   Board—The State Board of Dentistry.

   CRNA—A registered nurse certified as a Registered Nurse Anesthetist by the Council on Certification or Recertification of Nurse Anesthetists of the American Association of Nurse Anesthetists authorized to administer anesthesia under §  21.17 (relating to the administration of anesthesia by a registered nurse.)

   Clinical evaluation—A determination of the dentist’s current technical competency to safely administer general anesthesia, deep sedation or conscious sedation and to effectively respond to anesthesia related emergencies, in accordance with the AAOMS Manual for OMSs or the ADA Guidelines (for adult patients) and the AAPD Guidelines (for pediatric patients) for general dentists.

   Communications equipment—Equipment capable of being used to elicit a response in an emergency by voice, video or electronic data transmission, such as a telephone, video link, intercom, two-way radio or other similar device.

   Conscious sedation—A minimally depressed level of consciousness that is produced by a pharmacologic method, a nonpharmacologic method, or a combination of both, in which the patient retains the ability to maintain an airway independently and continuously and to respond appropriately to physical stimulation or verbal command.

   Deep sedation—A controlled, pharmacologically induced state of depressed consciousness from which the patient is not easily aroused and which may be accompanied by a partial loss of protective reflexes, including the ability to maintain a patent airway independently or respond purposefully to physical stimulation or verbal command, or both.

   General anesthesia—A controlled state of unconsciousness that is produced by a pharmacologic method, a nonpharmacologic method, or a combination of both, and that is accompanied by a complete or partial loss of protective reflexes that include the patient’s inability to maintain an airway independently and to respond purposefully to physical stimulation or verbal command.

   General dentist—A dentist who is not an oral and maxillofacial surgeon.

   Nitrous oxide/oxygen analgesia—The diminution or elimination of pain in the conscious patient through the use of nitrous oxide/oxygen.

   OMS—Oral and Maxillofacial Surgeon who is a current member of the PSOMS or AAOMS.

   Office inspection—A determination as to whether the offices where the dentist administers anesthesia is properly equipped as prescribed in §  33.340(a)(2), §  33.340a(a)(2) or §  33.340b(a)(2) (relating to duties of dentists who are unrestricted permitholders; duties of dentists who are restricted permit I holders; and duties of dentists who are restricted permit II holders), as appropriate to the type of permit, and in accordance with the AAOMS Manual for OMSs, or the ADA Guidelines (for adult patients) and the AAPD Guidelines (for pediatric patients) for general dentists.

   PALS—Pediatric Advanced Life Support.

   PSOMS—Pennsylvania Society of Oral and Maxillofacial Surgeons.

   Patient physical evaluation—An assessment of the patient’s physical and mental condition relevant to the surgery to be performed and anesthesia or anesthetic to be utilized.

   Pediatric patient—A patient under 18 years of age.

   Peer evaluation organization—An entity approved by the Board for administering a program whereby licensed dentists conduct office inspections and clinical evaluations for dentists seeking initial or renewal unrestricted or restricted I permits in accordance with §  33.336b (relating to approved peer evaluation organizations for administering clinical evaluations and office inspections).

   Peer evaluator—A licensed dentist with a current unrestricted permit or restricted permit I who conducts an office inspection or clinical evaluation under the auspices of an approved peer evaluation organization.

   Physician—A Pennsylvania licensed medical or osteopathic physician who is currently certified by the American Board of Anesthesiology or the American Osteopathic Board of Anesthesiology, or is credentialed to administer anesthesia in a hospital or ambulatory surgical facility licensed by the Department of Health.

Authority

   The provisions of this §  33.331 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 §  33.331 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 page (238326).

Cross References

   This section cited in 49 Pa. Code §  33.341 (relating to duties of dentists who are not permitholders).

§ 33.332. Requirement of permit to administer general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia.

 (a)  Permit required for administration of anesthetic modality in dental office. A dentist shall possess a current permit issued by the Board under this subchapter before administering, or supervising the administration of, general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia in a dental office.

 (b)  Permit not required for administration of anesthetic modality in other facilities. A dentist is not required to possess a permit under this subchapter before administering, or supervising the administration of, general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia in a State- or Federally-regulated facility other than a dental office.

 (c)  Failure to comply. A dentist’s failure to comply with subsection (a) 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 §  33.332 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 §  33.332 adopted July 8, 1988, effective July 9, 1988, 18 Pa.B. 3045; amended July 7, 1989, effective July 8, 1989, 19 Pa.B. 2953; amended May 13, 2005, effective May 14, 2005, 35 Pa.B. 2880. Immediately preceding text appears at serial pages (238326) to (238327).

Cross References

   This section cited in 49 Pa. Code §  33.110 (relating to volunteer license).

§ 33.333. Types of permits.

 The Board will issue the following permits to licensees qualified under this subchapter:

   (1)  Unrestricted permit. A permit which authorizes the holder to administer general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia.

   (2)  Restricted permit I. A permit which authorizes the holder to administer conscious sedation or nitrous oxide/oxygen analgesia.

   (3)  Restricted permit II. A permit which authorizes the holder to administer nitrous oxide/oxygen analgesia.

   (4)  Temporary permit. A permit limited to 1 year which authorizes the applicant for an unrestricted, restricted I or restricted II permit to administer the appropriate type of anesthesia relevant to the applicant’s qualifications.

Authority

   The provisions of this §  33.333 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 §  33.333 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 page (238327).

Cross References

   This section cited in 49 Pa. Code §  33.110 (relating to volunteer license).

§ 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.

 (b)  Application forms may be obtained from the State Board of Dentistry, Post Office Box 2649, Harrisburg, Pennsylvania 17105-2649.

Authority

   The provisions of this §  33.334 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 §  33.334 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 (238327) to (238328).

§ 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 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)  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 Surgery or a Fellow of the American Dental Society of Anesthesiology, or be eligible for examination by the American Board of Oral and Maxillofacial Surgery.

Authority

   The provisions of this §  33.335 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 §  33.335 adopted July 8, 1988, effective July 9, 1988, 18 Pa.B. 3045; amended July 7, 1989, effective July 8, 1989, 19 Pa.B. 2953; amended May 13, 2005, effective May 14, 2005, 35 Pa.B. 2880. Immediately preceding text appears at serial page (238328).

Cross References

   This section cited in 49 Pa. Code §  33.110 (relating to volunteer license); and 49 Pa. Code §  33.339 (relating to fees for issuance of permits).

§ 33.336. Requirements for restricted permit I.

 To secure a restricted permit I, a dentist shall have successfully completed a course on conscious sedation comprising at least 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 ADA’s Guidelines for Teaching the Comprehensive Control of Pain and Anxiety in Dentistry.

Authority

   The provisions of this §  33.336 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 §  33.336 adopted July 8, 1988, effective July 9, 1988, 18 Pa.B. 3045; amended July 7, 1989, effective July 8, 1989, 19 Pa.B. 2953; amended May 13, 2005, effective May 14, 2005, 35 Pa.B. 2880. Immediately preceding text appears at serial page (238329).

Cross References

   This section cited in 49 Pa. Code §  33.110 (relating to volunteer license); and 49 Pa. Code §  33.339 (relating to fees for issuance of permits).

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

 (a)  Office inspections and clinical evaluations.

   (1)  Initial permits. 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 beginning April 1, 2005. Beginning April 1, 2005, 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, 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 documentation 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 permitholder’s continuing education requirement under §  33.401(a)(1) (relating to credit-hour requirements).

Authority

   The provisions of this §  33.336a issued 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 §  33.336a adopted May 13, 2005, effective May 14, 2005, 35 Pa.B. 2880.

Cross References

   This section cited in 49 Pa. Code §  33.110 (relating to volunteer license); and 49 Pa. Code §  33.338 (relating to expiration and renewal of permits).

§ 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 and restricted permit I 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 (for unrestricted permitholders) or conscious sedation (for restricted permit I holders) within the last 7 years.

     (ii)   A current unrestricted permit or restricted permit I.

     (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 Board upon request and agrees to maintain these records for at least 5 years.

   (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 (for OMSs) and the ADA Guidelines or AAPD Guidelines (for general dentists), and in accordance with § §  33.340 and 33.340a (relating to duties of dentists who are unrestricted permitholders; and duties of dentists who are restricted permit I holders).

   (12)  Whether the organization agrees to utilize peer evaluator teams consisting of at least two permitholders as follows:

     (i)   For office inspections and clinical evaluations of unrestricted permitholders and applicants, a team of at least two unrestricted permitholders.

     (ii)   For office inspections and clinical evaluations of restricted permit I holders and applicants, a team consisting of at least two unrestricted permitholders, or a team consisting of at least one unrestricted permitholder and one restricted permit I holder.

 (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.

Authority

   The provisions of this §  33.336b issued under sections 3(o) and 11.2(a) of The Dental Law (63 P. S. § §  122(a) and 130c(a)).

Source

   The provisions of this §  33.336b adopted May 13, 2005, effective May 14, 2005, 35 Pa.B. 2880.

Cross References

   This section cited in 49 Pa. Code §  33.331 (relating to definitions); 49 Pa. Code §  33.336a (relating to requirements for unrestricted permit and restricted permit I); and 49 Pa. Code §  33.340 (relating to duties of dentists who are unrestricted permitholders).

§ 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 for OMSs and the ADA Guidelines and AAPD Guidelines for general dentists.

Authority

   The provisions of this §  33.336c issued under sections 3(o) and 11.2(a) of The Dental Law (63 P. S. § §  122(a) and 130c(a)).

Source

   The provisions of this §  33.336c adopted May 13, 2005, effective May 14, 2005, 35 Pa.B. 2880.

Cross References

   This section cited in 49 Pa. Code §  33.336e (relating to confidentiality of peer evaluation reports).

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

 (a)  A peer evaluator conducting office inspections and clinical evaluations of unrestricted permitholders and applicants shall be a licensed dentist holding a current unrestricted permit.

 (b)  A peer evaluator conducting office inspections and clinical evaluations of restricted permit I holders and applicants shall be a licensed dentist holding either a current unrestricted permit or a current restricted permit I, provided that a peer evaluator holding a current restricted permit I may only conduct office inspections and clinical evaluations when part of a team consisting of at least one unrestricted permitholder.

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

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

Authority

   The provisions of this §  33.336d issued under sections 3(o) and 11.2(a) of The Dental Law (63 P. S. § §  122(a) and 130c(a)).

Source

   The provisions of this §  33.336d adopted May 13, 2005, effective May 14, 2005, 35 Pa.B. 2880.

Cross References

   This section cited in 49 Pa. Code §  33.336b (relating to approved peer evaluation organizations for administering clinical evaluations and office inspections).

§ 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 shall submit to the Board a written report of the results of the office inspection and clinical evaluation within 30 days from the date the office inspection and clinical evaluation was conducted that documents whether the applicant has successfully completed the office inspection and clinical evaluation.

 (c)  If a clinical evaluation or office inspection reveals that the noncompliance of a dentist or dental office presents an immediate and clear danger to the public health and safety, the administering approved peer evaluation organization shall immediately notify the Commissioner of the Bureau.

Authority

   The provisions of this §  33.336e issued under sections 3(o) and 11.2(a) of The Dental Law (63 P. S. § §  122(a) and 130c(a)).

Source

   The provisions of this §  33.336e adopted May 13, 2005, effective May 14, 2005, 35 Pa.B. 2880.

§ 33.337. Requirements for restricted permit II.

 (a)  To secure a restricted permit II, a dentist shall have successfully completed a course in nitrous oxide/oxygen analgesia comprising at least 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 ADA’s Guidelines for Teaching the Comprehensive Control of Pain and Anxiety in Dentistry.

 (b)  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 and maintained, 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 maintained and contains a fail-safe system.

Authority

   The provisions of this §  33.337 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 §  33.337 adopted July 8, 1988, effective July 9, 1988, 18 Pa.B. 3045; amended July 7, 1989, effective July 8, 1989, 19 Pa.B. 2953; amended May 13, 2005, effective May 14, 2005, 35 Pa.B. 2880. Immediately preceding text appears at serial pages (238329) to (238330).

Cross References

   This section cited in 49 Pa. Code §  33.110 (relating to volunteer license); and 49 Pa. Code §  33.339 (relating to fees for issuance of permits).

§ 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.

Authority

   The provisions of this §  33.337a issued under sections 3(o) and 11.2(a) of The Dental Law (63 P. S. § §  122(a) and 130c(a)).

Source

   The provisions of this §  33.337a adopted May 13, 2005, effective May 14, 2005, 35 Pa.B. 2880.

§ 33.338. Expiration and renewal of permits.

 (a)  A permit issued by the Board under this subchapter will expire at the same time as the permitholder’s dental license but may be renewed biennially at the same time the dental license is renewed.

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

   (1)  A renewal application on a form provided by the Board.

   (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 equipment used to administer general anesthesia, deep sedation, conscious sedation and nitrous oxide/oxygen analgesia has been installed, properly calibrated and maintained 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).

Authority

   The provisions of this §  33.338 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 §  33.338 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 page (238330).

Cross References

   This section cited in 49 Pa. Code §  33.337 (relating to requirements for restricted permit II).

§ 33.339. [Reserved].


Authority

   The provisions of this §  33.339 issued under sections 11.2 and 11.3 of The Dental Law (63 P.S. § §  130c and 130d); amended under sections 3(o), 4(a) and (b) and 11.2(a) of The Dental Law (63 P.S. § §  122(o), 123(a) and (b) and 130c(a)); deleted under sections 3(b), 3(f), 3(g.1), 3(j) and 3(o), 4(a) and (b), 11.2(a)(2), (4) and (6) and 11.11(a)(7) and (d) of The Dental Law (63 P.S. § §  122(b), (f), (g.1), (j) and (o), 123(a) and (b), 130c(a)(2), (4) and (6) and 130l(a)(7) and (d)).

Source

   The provisions of this §  33.339 adopted July 8, 1988, effective July 9, 1988, 18 Pa.B. 3045; amended May 13, 2005, effective May 14, 2005, 35 Pa.B. 2899 and 2880; amended December 20, 2013, effective December 21, 2013, 43 Pa.B. 7441; deleted November 4, 2022, effective November 5, 2022, 52 Pa.B. 6849. Immediately preceding text appears at serial page (369752).

Cross References

   This section cited in 49 Pa. Code §  33.3 (relating to fees); 49 Pa. Code §  33.334 (relating to application for permit); and 49 Pa. Code §  33.338 (relating to expiration and renewal of permits).

§ 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).

§ 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, the permitholder takes or updates a patient medical history and gives the patient 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 permitholder 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.

     (xix)   Stethoscope.

   (3)  Auxiliary personnel who assist the permitholder in the administration of 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 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 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 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 conscious sedation or nitrous oxide/oxygen analgesia.

   (8)  Monitoring equipment and equipment used to administer conscious sedation and nitrous oxide/oxygen analgesia is installed, maintained 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)  If the permitholder travels to the offices of non-permitholders for the purpose of administering conscious sedation or nitrous oxide/oxygen analgesia, the permitholder shall satisfactorily complete a clinical evaluation and the equipment transported to a non-permitholder dentist’s office for the administration of conscious sedation or nitrous/oxide oxygen analgesia by a permitholder must 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, the ADA Guidelines or the AAPD Guidelines, as applicable. As part of that clinical evaluation and inspection, the permitholder shall certify that each office location in which conscious sedation or nitrous oxide/oxygen analgesia is administered has the equipment required by paragraph (2) and that the staff is properly trained to handle anesthesia-related emergencies.

   (10)  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.

   (11)  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 §  33.340a issued 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 §  33.340a adopted May 13, 2005, effective May 14, 2005, 35 Pa.B. 2880.

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).

§ 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, the permitholder takes or updates a patient medical history and gives the patient a physical evaluation sufficient to determine the patient’s suitability to receive nitrous oxide/oxygen analgesia.

   (2)  The dental office in which the permitholder 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, maintained 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.

   (5)  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 §  33.340b issued 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 §  33.340b adopted May 13, 2005, effective May 14, 2005, 35 Pa.B. 2880.

Cross References

   This section cited in 49 Pa. Code §  33.331 (relating to definitions); 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).

§ 33.341. Duties of dentists who are not permitholders.

 (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 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 permitholders; 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.

     (ii)   A physician as defined in §  33.331 (relating to definitions).

   (4)  Either the dentist who performs the dental procedure or the CRNA, physician or permitholder who administers the general anesthesia, deep sedation or conscious sedation possesses a current certification in ACLS.

   (5)  The nonpermitholder dentist receives a written certification from the permitholder that all monitoring equipment and equipment used to administer general anesthesia, deep sedation, conscious sedation and nitrous oxide/oxygen analgesia is present in the nonpermitholder’s office, is properly installed, maintained 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 that monitoring equipment is being used during the administration of general anesthesia.

   (6)  The nonpermitholder receives a written certification from the permitholder that the permitholder has satisfactorily completed 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 has satisfactorily completed 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 inspection), in accordance with the requirements of the AAOMS Manual and AAOMS Guidelines (OMS), ADA Guidelines or AAPD Guidelines, as applicable.

 (b)  A dentist shall submit to the Board a complete written report on a death or 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 incident.

 (c)  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).

 (d)  Beginning April 1, 2005, and for all subsequent renewal periods, non-permitholder 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 nonpermitholder licensee’s continuing education requirement under §  33.401(a)(1) (relating to credit hour requirements).

Authority

   The provisions of this §  33.341 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 §  33.341 adopted July 8, 1988, effective July 9, 1988, 18 Pa.B. 3045; amended July 7, 1989, effective July 8, 1989, 19 Pa.B. 2953; amended May 13, 2005, effective May 14, 2005, 35 Pa.B. 2880. Immediately preceding text appears at serial pages (266045) to (266046).

Notes of Decisions

   Notice

   In the absence of a clause exempting from the notice requirements those who administered anesthesia prior to the effective date of the regulation or a clause stating that the regulation applied only to new practitioners, the State Board of Dentistry’s interpretation that the regulation applies to all dentists upon becoming effective is a reasonable interpretation of that regulation; the dentist was required to give notice the first time he used general anesthesia in his office after the effective date of the regulation. Watkins v. State Board of Dentistry, 740 A.2d 760 (Pa. Cmwlth. 1999).

Cross References

   This section cited in 49 Pa. Code §  33.342 (relating to inspection of dental offices).

§ 33.342. Inspection of dental offices.

 (a)  Inspections. The Board, through its authorized agents, may conduct 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 permitholders; duties of dentists who are restricted permit I holders; and duties of dentists who are restricted permit II holders) or as follows:

   (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.

   (2)  Upon a complaint that the office or the dentist who operates the office is not in compliance with this subchapter.

   (3)  Upon a reasonable belief that conditions exist in the office that pose a danger to the health or safety of the public.

 (b)  Notice of inspection. Prior to the start of 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.

 (c)  Access during inspection. 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.

   (3)  Interviews with auxiliary personnel.

 (d)  Guideline for inspection. An inspection will be conducted under provisions pertaining to office facilities and equipment in §  33.340(a)(2), §  33.340a(a)(2), §  33.340b(a)(2) or §  33.341(2) (relating to duties of dentists who are not permitholders).

 (e)  Inspection showing noncompliance.

 If 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.

Authority

   The provisions of this §  33.342 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 §  33.342 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 (266046) and (266047).

§ 33.343. Suspension, revocation, limitation of permit; refusal to issue or renew.

 The Board may, following notice and a hearing under section 4.1(c) of the act (63 P. S. §  123.1(c)), refuse to issue or renew a permit, or may suspend, revoke or limit a permit, for any of the following reasons:

   (1)  Noncompliance with the requirements of the act or this subchapter.

   (2)  Fraud or deceit in obtaining or attempting to obtain a permit.

   (3)  Knowingly aiding or abetting the improper issuance of a permit.

   (4)  Incompetence, negligence or misconduct in rendering services authorized by a permit.

   (5)  Having a dental license suspended or revoked under section 4.1 of the act.

Authority

   The provisions of this §  33.343 issued under sections 11.2 and 11.3 of The Dental Law (63 P. S. § §  130c and 130d).

Source

   The provisions of this §  33.343 adopted July 8, 1988, effective July 9, 1988, 18 Pa.B. 3045.

§ 33.344. Requirement of anesthesia permit for nonparenteral  premedication of dental patients—statement of policy.

 (a)  Background. Section 11.2 of the act (63 P. S. §  130c) directs the Board to establish minimal training and education for the issuance of permits to dentists to administer general anesthesia, conscious sedation and analgesia on an outpatient basis. Definitions of these three terms appear in section 2 of the act (63 P. S. §  121). The definition of conscious sedation as ‘‘a minimally depressed level of consciousness . . . produced by a pharmacologic or nonpharmacologic method, or combination thereof’’ has raised the question of whether nonparenteral premedication of patients constitutes conscious sedation and thus triggers the permit requirement.

 (b)  Purpose. The Board regards section 11.2 of the act as expressing the legislative purpose of reducing the risk of death or injury to dental patients who receive anesthetic modalities on an outpatient basis. In view of that purpose, and of the encompassing definition of conscious sedation adopted by the legislature, the Board believes that the protection afforded by the act extends to patients who, owing to a depressed level of consciousness produced by premedication, are at greater risk during the dental procedure and the recovery period thereafter. The Board believes further that such an increase in patient risk as a result of premedication requires the dentist to have training in preventing, recognizing and managing complications and emergencies associated with conscious sedation. It is this training which the conscious sedation permit requirement is designed to ensure.

 (c)  Implementation. The Board recognizes that many variables—such as dosage, time of administration and the patient’s physical and medical condition—bear on the effects of premedication during and after the dental procedure and that judgments as to these effects are the professional responsibility of the dentist. It is for the dentist therefore to determine whether premedication produces conscious sedation creating an increased risk of harm to the patient. If so, the dentist shall possess a restricted permit I or an unrestricted permit. In disciplinary proceedings brought against a dentist who has premedicated a patient without a permit, the Board will consider whether the average dentist in this Commonwealth, acting reasonably under the same circumstances, would have concluded, based on this section, the act and this chapter, that a permit was required.

 (d)  Guidelines. The Board cannot provide absolute directives as to when a dentist is required to possess a permit before premedicating patients. The Board offers, however, the following guidelines concerning patients who, in its judgment, are most and least likely to require the protection afforded by the permit requirement:

   (1)  The Board regards pediatric patients, geriatric patients, patients with handicapping conditions and patients who are medically compromised as principal candidates for nonparenteral premedication as well as the groups most at risk from this modality. Dentists who premedicate patients from these groups are advised to consider most carefully whether the permit requirement applies.

   (2)  The Board regards persons not in the groups enumerated in paragraph (1), for whom nonparenteral premedications are used solely to reduce mild situational anxiety, or for whom analgesics are prescribed preoperatively to relieve dentally related pain, as generally incurring no increased risk of injury. In the absence of obvious risk, premedication of these patients is not considered conscious sedation for purposes of the permit requirement.

Source

   The provisions of this §  33.344 adopted December 8, 1989, effective December 9, 1989, 19 Pa.B. 5223.



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