PROPOSED RULEMAKING
STATE BOARD OF DENTISTRY
[49 PA. CODE CH. 33]
Administration of General Anesthesia, Deep Sedation, Conscious Sedation and Nitrous Oxide/Oxygen Analgesia
[31 Pa.B. 6691] The State Board of Dentistry (Board) proposes revisions to its anesthesia regulations in Chapter 33, Subchapter E (relating to administration of general anesthesia, deep sedation, conscious sedation and nitrous oxide/oxygen analgesia) to read as set forth in Annex A.
A. Effective Date
The amendments will be effective upon publication of final-form regulations in the Pennsylvania Bulletin.
B. Statutory Authority
The Board is authorized to adopt regulations concerning anesthesia under sections 3(o) and 11.2(a) of the Dental Law (law) (63 P. S. §§ 122(o) and 130c.(a)).
C. Background and Purpose
The proposed amendments are in response to a Commonwealth Court opinion in the matter of Watkins v. State Board of Dentistry, 740 A.2d 760 (Pa. Cmwlth. 1999), which vacated and remanded the decision of the State Board of Dentistry imposing an 18 month suspension on Dr. Watkins for failing to assure that his office contained ''appropriate monitoring equipment.''
Dr. William E. Watkins had been charged with and found by the Board to have engaged in unprofessional conduct under section 4.1(8) of the law (63 P. S. § 123.1(8)). The charge and finding of unprofessional conduct relevant to the issue resulted from his failure to have the ''appropriate monitoring equipment'' required by § 33.340(a)(2) (relating to duties of dentists who are unrestricted permit holders). The incident which triggered the disciplinary action involved the administration of anesthesia by another dentist to a 3-1/2 year old child in Dr. Watkins' office. The child lost all pulse during a procedure and was pronounced dead after being taken to hospital.
At the formal hearing the Commonwealth presented experts who maintained that ''appropriate monitoring equipment'' which should have been, but was not, in the office included a pulse oximeter, a blood pressure apparatus, a stethoscope and an EKG machine.
In appealing his disciplinary suspension to the Commonwealth Court, Dr. Watkins argued that the Board's regulation requiring ''appropriate monitoring equipment'' was unconstitutionally vague because it did not give notice to the practitioner of what equipment would be considered appropriate. After reviewing cases under which statutes or regulations were declared unconstitutionally vague, the court held that ''the term 'appropriate monitoring equipment' is not defined in the regulation and what is 'appropriate' is subject to many different meanings.'' Watkins, 740 A.2d at 765. Again, in footnote number 8 of the decision the Court focused on the term ''appropriate monitoring equipment'': ''Because we have decided that the term ''appropriate monitoring equipment'' is too vague. . . .Id.
While the Board focused its attention primarily upon clarifying necessary monitoring equipment, it also updated and improved other anesthesia requirements, and attempted to respond to numerous legislative concerns.
The Watkins decision was issued by Commonwealth Court on November 8, 1999. On December 2, 1999, the first meeting of the Dental Board's Anesthesia Committee was held. This Committee was tasked with reviewing state of the art equipment, procedures and protocols for safe and effective delivery of anesthesia and analgesia in dental offices. An initial draft was prepared and presented to the Committee at its January 21, 2000, meeting. At subsequent meetings on March 9, 2000, a second draft was presented and reviewed and on March 12, 2000, a third draft was developed.
A fourth draft was completed on April 10, 2000, and on April 28, 2000, sent to 138 dental associations, schools and interested individuals for predraft comments. In response to predraft comments received, a fifth draft was prepared on May 30, 2000. Legal and Board changes resulted in a sixth draft on June 9, 2000, and a seventh draft on June 27, 2000. Further development was postponed temporarily until the Anesthesia Committee could review information concerning a new oral anesthesia and reports of child deaths due to anesthesia in another state, and consider appropriate regulation of deep sedation. As a result, on October 12, 2000, an eighth draft was prepared and discussed by the Committee with the full Board on December 1, 2000. From those discussions, a ninth draft was prepared on December 14, 2000, and reviewed by the Committee. This draft was provided to the entire Board on January 24, 2001. Board, legal, and additional legislative suggestions comprised a tenth draft on March 9, 2001, and a 10A draft on March 22, 2001. On March 23, 2001, the Board approved draft 10B for promulgation as proposed rulemaking. On April 5, 2001, draft 10B was sent to the House Professional Licensure Committee and the Senate Consumer Protection and Professional Licensure Committee for review and comment prior to official promulgation as proposed amendments.
D. Description of Amendments
The revisions to Subchapter E make substantive and editorial changes to §§ 33.331--333.342.
§ 33.331. Definitions.
The Board proposes to add a definition for deep sedation derived from the American Academy of Pediatric Dentistry's (AAPD) Guidelines for the Elective Use of Conscious Sedation, Deep Sedation and General Anesthesia in Pediatric Dental Patients. This was done in recognition of the fact that even though sedation is on a continuum, deep sedation is a defined stage between general anesthesia and conscious sedation. The AAPD, the American Association of Oral and Maxillofacial Surgeons (AAOMS) and the American Dental Association (ADA) all recognize distinctions between general anesthesia and deep sedation.
Deep sedation is a state of depressed consciousness accompanied by a partial loss of protective reflexes, including the ability to continually maintain an airway independently. General anesthesia is a state of unconsciousness accompanied by a partial or complete loss of protective reflexes, including the ability to continually maintain an airway independently. ADA Guidelines for the Use of Conscious Sedation, Deep Sedation and General Anesthesia for Dentists (emphasis added). Because of the partial loss of protective reflexes with deep sedation, and the necessity to have similar monitoring and resusitation equipment as with general anesthesia, deep sedation was grouped with general anesthesia under the unrestricted permit. Consequently, only a licensee holding an unrestricted permit may administer general anesthesia or deep sedation.
§ 33.332. Requirement of permit to administer general anesthesia, conscious sedation or nitrous oxide/oxygen analgesia.
This amendment would clarify that a permit is required to administer deep sedation in a dental office.
§ 33.333. Types of permits.
This amendment would clarify that an unrestricted permit is required to administer deep sedation.
§ 33.334. Application for permit.
This section makes permit application requirements applicable to permission to administer deep sedation.
§ 33.335. Requirements for unrestricted permit.
This amendment would remove one of the three possible requirements that must be met for securing an unrestricted permit, specifically that of having administered general anesthesia on a regular basis in the course of dental practice for 5 years prior to January 1, 1986. The 1985 ''grandparenting'' clause of section 11.2(b) of the law (63 P. S. § 130c(d)), tracked in the regulation is no longer necessary.
All permit applicants would be required to have successfully completed and maintained current certification in Advanced Cardiac Life Support (ACLS) and attest that the administration of general anesthesia, deep sedation, and conscious sedation will be conducted in conformance with the American Association of Oral and Maxillofacial Surgeons' (AAOMS) Parameters and Pathways 2000: Clinical Practice, Guidelines for Oral and Maxillofacial Surgery, Anesthesia in Outpatient Facilities. For administration to children age 10 and under, applicants would have to attest that the administration will be conducted in conformance with the AAPD Guidelines for the Elective Use of Conscious Sedation, Deep Sedation and General Anesthesia in Pediatric Dental Patients.
The dental office of an unrestricted permit holder would have to pass an inspection conducted in accordance with the AAOMS Office Anesthesia Evaluation Manual and the American Dental Association's (ADA) Guidelines for the Use of Conscious Sedation, Deep Sedation and General Anesthesia for Dentists. A reinspection would occur at least every 6 years, and the make, model and serial number of all equipment would have to be available and noted in the inspection report.
Unrestricted permit holders would have to pass a clinical evaluation as part of the office inspection conducted in accordance with the AAOMS Office Anesthesia Evaluation Manual.
§ 33.336. Requirements for restricted permit I.
This section would remove one of the two possible requirements for securing a restricted permit I, specifically that of having administered conscious sedation on a regular basis in the course of dental practice for 5 years prior to January 1, 1986. As described previously, the section is no longer necessary.
Restricted permit I applicants would be required to have successfully completed and maintained current certification in ACLS and attest that the administration of conscious sedation will be conducted in accordance with the AAOMS Parameters and Pathways 2000: Clinical Practice, Guidelines for Oral and Maxillofacial Surgery, Anesthesia in Outpatient Facilities.
Applicants administering conscious sedation to children age 10 and under would have to attest that the administration is conducted in accordance with the AAPD Guidelines for the Elective Use of Conscious Sedation, Deep Sedation and General Anesthesia in Pediatric Patients.
Dental offices of restricted permit I holders would have to pass an inspection in accordance with the AAOMS Office Anesthesia Manual and the ADA Guidelines for the Use of Conscious Sedation, Deep Sedation and General Anesthesia for Dentists. Reinspection would have to be done at least every 6 years and the make, model and serial number of all equipment must be available.
Restricted permit I applicants would have to pass a clinical evaluation as part of the office inspection conducted in accordance with the AAOMS Office Anesthesia Evaluation Manual.
§ 33.337. Requirements for restricted permit II.
This section would remove one of the two possible requirements that must be met for securing a restricted permit II, specifically that of having administered nitrous oxide/oxygen analgesia on a regular basis in the course of dental practice for 5 or more years prior to January 1, 1986, for the reasons set forth previously. Also, the Board proposes to reduce the number of required hours of undergraduate or postgraduate didactic instruction and clinical experience in a conforming program from 40 to 20.
Restricted permit II holders would have to attest that they have written office procedures for administering nitrous oxide/oxygen analgesia and handling emergencies and that the equipment has been installed and calibrated according to the equipment manufacturer's guidelines and contains a failsafe system.
§ 33.338. Expiration and renewal of permits.
Under the proposal, renewal requirements have been amended to include proof of current certification in ACLS for unrestricted and restricted I permits, an attestation that the administration of general anesthesia, deep sedation and conscious sedation has been conducted during the preceding biennial period in accordance with the appropriate guidelines, and an attestation that equipment has been installed and calibrated according to the equipment manufacturer's guidelines and contains a failsafe system.
§ 33.340. Duties of dentists who are unrestricted permit holders.
This section has been amended to require that a history be taken prior to the administration of general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia.
The equipment list for unrestricted permit holders has been amended to require suction equipment with appropriate oropharyngeal suction; age appropriate monitoring equipment, procedures and documentation conforming to the AAOMS Office Anesthesia Evaluation Manual/AAPD Guidelines for the Elective Use of Conscious Sedation, Deep Sedation and General Anesthesia in Pediatric Dental Patients; a pulse oximeter; an ECG; an automatic blood pressure monitoring device; an automatic external defibrilation device; results of patient history and physical evaluations; and signed patient consent.
This section was also amended to require that both the permit holder and auxiliary personnel assisting unrestricted permit holders in the administration of general anesthesia, deep sedation or conscious sedation (deletes reference to nitrous oxide/oxygen analgesia) be currently certified in ACLS.
A proposed amendment to this section would require that any general anesthesia requiring intubation be administered by the permit holder, certified registered nurse anesthetist, physician or other unrestricted permit holder to whom is delegated the duties of administration, while the dental procedures are performed by a dental licensee not involved in the anesthesia administration.
All monitoring equipment would have to be installed and calibrated according to equipment manufacturer guidelines, in proper working condition prior to administration, and used during the administration of general anesthesia.
Any equipment used for the administration of general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia must pass an inspection through the Board's authorized agents in accordance with the AAOMS Office Anesthesia Manual. The make, model and serial number of all equipment must be available and noted on the inspection report
§ 33.340a. Duties of dentists who are restricted permit I holders.
This section would be amended to require that a history be taken and a patient be given a physical evaluation to determine his/her suitability to receive conscious sedation or nitrous oxide/oxygen analgesia.
Equipment requirements would be amended, and would conform to the new equipment requirements for an unrestricted permit. Auxillary personnel and the certified registered nurse anesthetists assisting the permit holder in the administration of conscious sedation, as well as the permit holder, must be currently certified in ACLS.
Requirements for reporting and other equipment requirements are the same as for unrestricted permit holders.
§ 33.340b. Duties of dentists who are restricted permit II holders.
This section is amended to require that patients be given a physical evaluation prior to the administration of nitrous oxide/oxygen analgesia.
Equipment and operating room requirements are similar to those of restrictive permit I holders, with the exception that restricted permit II holders are not required to have a recovery area, patient transport equipment, an oximeter, an ECG, an automatic blood pressure monitoring device automatic defibrillation device and results of patient history.
§ 33.341. Duties of dentists who are not permit holders.
This section would require that a permit may not be issued unless the dental office has been inspected and meets the appropriate equipment and facility requirements.
Anyone administering general anesthesia, deep sedation or conscious sedation must possess current certification in ACLS.
A nonpermit holding dentist would be required to verify with the permit holder that all monitoring equipment is present in the nonpermit holder's office, is properly calibrated and in proper working condition, and is being used during the administration of general anesthesia.
All equipment transported to a nonpermit holder dentist's office would have to pass an inspection through the Board's authorized agents in accordance with the AAOMS Office Anesthesia Manual. The make, model and serial number of all equipment must be available and noted on the inspection report.
§ 33.342. Inspection of dental offices.
Under the proposal, subsection (f) has been amended to provide that a permit may be subject to an immediate temporary suspension and other disciplinary action if inspection reveals that the dental office is not in compliance with equipment, facility or procedure requirements prescribed in § 33.340(a)(2) or §§ 33.340a(a)(2) or 33.340b(a)(2) (relating to duties of dentists who are restricted permit I holders; and duties of dentists who are restricted permit II holders) and the noncompliance presents an immediate and clear danger to public health and safety.
E. Compliance With Executive Order 1996-1
The Board reviewed this rulemaking and considered its purpose and likely impact upon the public and the regulated population under the directives of Executive Order 1996-1. The proposal addresses a compelling public interest as described in this Preamble and otherwise complies with Executive Order 1996-1.
F. Fiscal Impact and Paperwork Requirements
Some of the provisions of this proposed rulemaking will have a fiscal impact upon permit holders. It may be necessary to set fees for office inspections and clinical evaluations or to raise existing permit fees to cover the cost of the issuance of a permit. In addition, requirements for current certification in ACLS and some additional required monitoring equipment may entail increased costs to permit holders. At this stage, it is not possible to estimate the fiscal impact with precision; however, cost data will be available at a later date.
G. Sunset Date
The Board continuously monitors its regulations. Therefore, no sunset date has been assigned.
H. Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on November 14, 2001, the Board submitted a copy of this proposed rulemaking to the Independent Regulatory Review Commission (IRRC) and to the Chairpersons of the House Professional Licensure Committee and the Senate Consumer Protection and Professional Licensure Committee. In addition to submitting the proposed rulemaking, the Board has provided IRRC and the Committees with a copy of a detailed Regulatory Analysis Form prepared by the Board in compliance with Executive Order 1996-1, ''Regulatory Review and Promulgation.'' A copy of this material is available to the public upon request.
Under section 5(g) of the Regulatory Review Act, if IRRC has objections to any portion of the proposed rulemaking, it will notify the Board within 10 days of the close of the Committees' review period. The notification shall specify that regulatory review criteria which have not been met by that portion. The Regulatory Review Act specifies detailed procedures for review, prior to final publication of the regulations, by the Board, the General Assembly and the Governor, of objections raised.
I. Public Comment
Interested persons are invited to submit written comments, suggestions or objections regarding the proposed rulemaking to Deborah B. Eskin, Counsel, State Board of Dentistry, P. O. Box 2649, Harrisburg, PA 17105-2649 within 30 days following publication of the proposed rulemaking in the Pennsylvania Bulletin. Please reference No. 16A-4610 (Administration of General Anesthesia, Deep Sedation, Conscious Sedation and Nitrous Oxide/Oxygen Analgesia) when submitting comments.
NORBERT O. GANNON, D.D.S.
ChairpersonFiscal Note: 16A-4610. No fiscal impact; (8) recommends adoption.
Annex A
TITLE 49. PROFESSIONAL AND VOCATIONAL STANDARDS
PART I. DEPARTMENT OF STATE
Subpart A. PROFESSIONAL AND OCCUPATIONAL AFFAIRS
CHAPTER 33. STATE BOARD OF DENTISTRY
Subchapter E. ADMINISTRATION OF GENERAL ANESTHESIA, DEEP SEDATION, CONSCIOUS SEDATION AND NITROUS OXIDE/OXYGEN ANALGESIA § 33.331. Definitions.
The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise:
AAOMS--American Association of Oral and Maxillofacial Surgeons.
AAPD--American Academy of Pediatric Dentistry.
ACLS--Advanced Cardiac Life Support.
ADA--American Dental Association.
* * * * * 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.
* * * * * § 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. [Effective January 9, 1990, a] 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.
* * * * * § 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.
* * * * * § 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 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 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 or subsequent edition.
(2) [Be certified] Possess current certification as a Diploma of the American Board of Oral and Maxillofacial Surgeons, a Fellow of the American Association of Oral and Maxillofacial Surgeons or a Fellow of the American Society of Dental Anesthesiology, or be eligible for examination by the American Board of Oral and Maxillofacial Surgeons.
[(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.]
(b) An applicant, prior to the administration of general anesthesia, deep sedation or conscious sedation, shall have successfully completed and maintained current certification in ACLS and attest that the administration of general anesthesia, deep sedation and conscious sedation will be conducted in conformance with the standards outlined in the AAOMS Parameters and Pathways 2000: Clinical Practice, Guidelines for Oral and Maxillofacial Surgery, Anesthesia in Outpatient Facilities or subsequent edition.
(c) If the applicant desires to administer general anesthesia, deep sedation or conscious sedation to children age 10 and under, prior to the administration, the applicant shall attest that the administration of general anesthesia, deep sedation and conscious sedation will be conducted in conformance with the standards outlined in the AAPD Guidelines for the Elective Use of Conscious Sedation, Deep Sedation and General Anesthesia in Pediatric Dental Patients or subsequent edition.
(d) Office inspection requirements are as follows:
(1) The dental office where the applicant intends to exercise an unrestricted permit shall meet the requirements of § 33.340(a)(2) (relating to duties of dentists who are unrestricted permit holders), and the office shall pass an inspection conducted by the Board through its authorized agents in accordance with the AAOMS Office Anesthesia Evaluation Manual or subsequent edition and the ADA Guidelines for the Use of Conscious Sedation, Deep Sedation and General Anesthesia for Dentists or subsequent edition. Reinspection will take place at least every 6 years, or more frequently, as necessary. The make, model and serial number of all equipment shall be available and noted on the inspection report.
(2) As part of the office inspection, the applicant shall pass a clinical evaluation conducted by the Board through its authorized agents be in accordance with the AAOMS Office Anesthesia Evaluation Manual or subsequent edition.
§ 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 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 [post graduate] postgraduate program) of the American Dental Association's Guidelines for Teaching the Comprehensive Control of Pain and Anxiety in Dentistry or subsequent edition.
[(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.]
(b) An applicant, prior to the administration of conscious sedation, shall have successfully completed and maintained current certification in ACLS and attest that the administration will be conducted in conformance with the standards outlined in the AAOMS Parameters and Pathways 2000: Clinical Practice, Guidelines for Oral and Maxillofacial Surgery, Anesthesia in Outpatient Facilities or subsequent edition.
(c) If the applicant desires to administer conscious sedation to children age 10 and under, prior to the administration, the applicant shall attest that the administration of conscious sedation will be conducted in conformance with standards outlined in the AAPD Guidelines for the Elective Use of Conscious Sedation, Deep Sedation and General Anesthesia in Pediatric Patients or subsequent edition.
(d) Office inspection requirements are as follows:
(1) The dental office where the applicant intends to exercise a restricted permit I shall meet the requirements of § 33.340a(a)(2) (relating to duties of dentists who are restricted permit I holders), and the office shall pass an inspection conducted by the Board through its authorized agents in accordance with the AAOMS Office Anesthesia Evaluation Manual or subsequent edition and the ADA Guidelines for the Use of Conscious Sedation, Deep Sedation and General Anesthesia for Dentists or subsequent edition. Reinspection will take place at least every 6 years, or more frequently, as necessary. The make, model and serial number of all equipment shall be available and noted on the inspection report.
(2) As part of the office inspection, the applicant shall pass a clinical evaluation conducted by the Board through its authorized agents in accordance with the AAOMS Office Anesthesia Evaluation Manual or subsequent edition.
§ 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] 20 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 Guidelines for Teaching the Comprehensive Control of Pain and Anxiety in Dentistry or subsequent edition.
[(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.]
(b) Applicants who administer nitrous oxide analgesia to adults or children shall attest to the following:
(1) That the applicant has written office procedures for administering nitrous oxide/oxygen analgesia and handling emergencies resulting therefrom.
(2) That the equipment for administering the nitrous oxide/oxygen analgesia has been installed and calibrated according to the equipment manufacturer's guidelines and contains a fail-safe system.
§ 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.
(3) Proof of current certification in ACLS (for unrestricted permits and restricted I permits).
(4) An attestation, on the renewal application, as appropriate to the type of permit requested, that the administration of general anesthesia, deep sedation and conscious sedation has been conducted during the preceding biennial period for adults (if appropriate) with the standards outlined in the AAOMS Guidelines and Parameters of Care for Oral and Maxillofacial Surgery, Anesthesia in Outpatient Facilities or subsequent edition; and for children (if appropriate) in conformance with standards outlined in the AAPD Guidelines for the Elective Use of Conscious Sedation, Deep Sedation and General Anesthesia for Pediatric Patients or subsequent edition.
(5) An attestation, on the renewal application, that the nitrous oxide/oxygen analgesia equipment has been installed and calibrated according to the equipment manufacturer's guidelines and contains a fail-safe system.
§ 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 history is taken 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 with appropriate oropharyngeal suction.
* * * * * (xii) [Appropriate monitoring] Monitoring equipment, procedures and documentation to conform to the age of the patient and the AAOMS Office Anesthesia Evaluation Manual or subsequent edition and the AAPD Guidelines for the Elective Use of Conscious Sedation, Deep Sedation, and General Anesthesia in Pediatric Dental Patients or subsequent edition.
(xiii) Pulse oximeter.
(xiv) ECG.
(xv) Automatic blood pressure monitoring device.
(xvi) Automatic external defibrillation device.
(xvii) Results of patient history and physical evaluation.
(xviii) Signed patient consent.
(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 ACLS.
(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 possesses a current certification [to administer cardiopulmonary resuscitation (CPR)] in ACLS.
(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 requiring intubation is administered by the permit holder, certified registered nurse anesthetist, physician or other unrestricted permit holder to whom is delegated the duties of administration, while the dental procedures are performed by a dental licensee who is not involved in the administration of the general anesthesia.
(9) Monitoring equipment 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 is being used during the administration of general anesthesia.
(10) Equipment transported to a 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 pass an inspection by the Board through its authorized agents in accordance with the AAOMS Office Anesthesia Manual or subsequent edition. The make, model and serial number of all equipment shall be available and noted on the inspection report.
* * * * * § 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 history is taken 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 with appropriate oropharyngeal suction.
(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 of the patient and the AAOMS Office Anesthesia Evaluation Manual or subsequent edition and the AAPD Guidelines for the Elective Use of Conscious Sedation, Deep Sedation, and General Anesthesia in Pediatric Dental Patients or subsequent edition.
(xiii) Pulse oximeter.
(xiv) ECG.
(xv) Automatic blood pressure monitoring device.
(xvi) Automatic external defibrillation device.
(xvii) Results of patient history and physical evaluation.
(xviii) Signed patient consent.
(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 ACLS.
(4) Certified registered nurse anesthetists to whom 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.
(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 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) Equipment transported to a nonpermit holder dentist's office for the administration of conscious sedation or nitrous/oxide oxygen analgesia by a permit holder shall pass an inspection by the Board through its authorized agents in accordance with the requirements of the AAOMS Office Anesthesia Manual or subsequent edition. The make, model and serial number of all equipment shall be available and noted on the inspection report.
(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 history is taken 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) Suction equipment with appropriate oropharyngeal suction.
(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) Emergency airway equipment and medications, including intravenous emergency equipment.
(ix) Communications equipment.
(x) Monitoring equipment, procedures, and documentation to conform to the age of the patient and the AAOMS Office Anesthesia Evaluation Manual or subsequent edition and the AAPD Guidelines for the Elective Use of Conscious Sedation, Deep Sedation, and General Anesthesia in Pediatric Dental Patients or subsequent edition.
(xi) Results of patient history and physical evaluation.
(xii) Signed patient consent.
(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 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:
* * * * * (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 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 is being used during the administration of general anesthesia.
(6) Equipment transported to a nonpermit holder dentist's office for the administration of general anesthesia, deep sedation, conscious sedation or nitrous/oxide analgesia by a permit holder shall pass an inspection by the Board through its authorized agents in accordance with the requirements of the AAOMS Office Anesthesia Manual or subsequent edition. The make, model and serial numbers of all equipment shall be available and noted on the inspection report.
(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] an incident.
* * * * * § 33.342. Inspection of dental offices.
(a) Routine inspections. No more than once a year during regular business hours, the Board, through its authorized agents, may conduct a routine inspection 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 permit holders; duties of dentists who are restricted permit I holders; and duties of dentists who are restricted permit II holders).
(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.
* * * * * (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), § 33.340a(a)(2) or 33.340b(a)(2).
* * * * * (d) Access during inspection. For purposes of a routine or special 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.
* * * * * (e) Guideline for inspection. A routine inspection, with or without prior notice, will be conducted under provisions pertaining to office facilities, and equipment and procedures in the [American Association of Oral and Maxillofacial Surgeons'] AAOMS' Office Anesthesia Evaluation Manual or subsequent edition, and the ADA Guidelines for the Use of Conscious Sedation, Deep Sedation and General Anesthesia for Dentists or subsequent edition.
(f) Inspection showing noncompliance.
(1) If a routine or special inspection reveals that a dental office is not in compliance with the equipment [and], facility or procedure requirements prescribed in § 33.340(a)(2), [the Board will give the dentist whose office was inspected] 33.340a(a)(2) or 33.340b(a)(2), written notice of the deficiencies and of the deadline for correcting the deficiencies will be given to the dentist whose office was inspected. A reinspection will take place within 30 days, and, if noncompliance is still shown, formal administrative charges may be initiated.
(2) If a routine or special inspection reveals that a dental office is not in compliance with the equipment, facility or procedure requirements prescribed in § 33.340(a)(2), § 33.340a(a)(2) or § 33.340b.(a)(2), and the noncompliance presents an immediate and clear danger to the public health and safety, the permit holder's permit may be subject to an immediate temporary suspension and other disciplinary action.
[Pa.B. Doc. No. 01-2183. Filed for public inspection December 7, 2001, 9:00 a.m.]
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