PROPOSED RULEMAKING
STATE BOARD OF DENTISTRY
[49 PA. CODE CH. 33]
Administration of General Anesthesia, Deep Sedation, Conscious Sedation and Nitrous Oxide/Oxygen Analgesia
[34 Pa.B. 1949] The State Board of Dentistry (Board) proposes to amend Subchapter E (relating to administration of general anesthesia, conscious sedation and nitrous oxide/oxygen analgesia) to read as set forth in Annex A.
A. Effective Date
The proposed rulemaking will be effective upon final-form publication 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 (act) (63 P. S. §§ 122(o) and 130c(a)).
C. Background and Purpose
In 1986, the act was amended to establish standards for the administration of general anesthesia and conscious sedation in a dental office. Subchapter E was adopted to implement the amendments to the act at 18 Pa.B. 3045 (July 9, 1988). In 1999, the Commonwealth Court in Watkins v. State Board of Dentistry, 740 A.2d 760 (Pa. Cmwlth. 1999) invalidated a provision of § 33.340 (relating to duties of dentists who are permit holders) concerning ''appropriate monitoring equipment'' required for the administration of general anesthesia as unconstitutionally vague.
In response to the Watkins decision, the Board undertook a comprehensive review of all regulations dealing with the administration of general anesthesia, conscious sedation and nitrous oxide adopted under the 1985 amendments to the act. While the Board focused its attention primarily upon clarifying necessary monitoring equipment, it considered the need to update and improve other requirements of the regulations to conform to current standards of safe dental practice.
The Board empanelled an Anesthesia Committee (Committee) which was tasked with reviewing state-of-the-art equipment, procedures and protocols for safe and effective delivery of anesthesia and analgesia in dental offices. The Committee sought input from 138 dental associations, schools and interested licensees. From the discussions, the Board published a proposed rulemaking at 31 Pa.B. 6691 (December 8, 2001). The Board entertained public comment on the proposal and considered comments and suggestions on regulatory review throughout the following year. On November 25, 2002, the act of November 25, 2002 (P. L. 1109, No. 135) (Act 135) was enacted which amended section 11.2 of the act, further regulating the administration of anesthesia and sedation in dental offices. Section 2 of Act 135 required the Board to promulgate regulations necessary to implement the amendments within 1 year of the effective date, December 26, 2002.
Act 135 amended section 11.2 of the act as follows:
1. Section 11.2(a)(1) of the act requires the Board to establish minimal training and education or certification to issue permits to dentists to administer general anesthesia on an outpatient basis and requires a minimum of 1 year of advanced training in anesthesiology beyond graduation from dental school.
2. Section 11.2(a)(2) of the act requires the Board to establish further requirements for use of general anesthesia including equipment standards and conducting workplace inspections, permit fees, temporary permit fees, biennial renewal fees, office inspection fees and clinical evaluation fees.
3. Section 11.2(a)(3) of the act requires the Board to establish minimal training and education for conscious sedation permits and directs the Board to require a minimum period of didactic instruction/clinical experience in accredited program.
4. Section 11.2(a)(4) of the act requires the Board to establish further requirements for use of conscious sedation including equipment standards, conducting workplace inspections and collection of permit fees, temporary permit fees, biennial renewal fees, office inspection fees and clinical evaluation fees.
5. Section 11.2(a)(5) of the act requires the Board to establish minimal training and education for nitrous permits and directs the Board to require a minimum period of didactic instruction/clinical experience in an accredited program.
6. Section 11.2(a)(6) of the act requires the Board to establish further requirements for use of nitrous oxide/oxygen analgesia including equipment standards, conducting workplace inspections and collection of permit fees.
7. Under section 11.2(b)(1) of the act, beginning April 1, 2004, prior to issuing initial permits to administer general anesthesia, deep sedation or conscious sedation, the Board is to require applicants to satisfactorily undergo clinical evaluations and office inspections. The Board may contract with dental schools, organizations or individuals with expertise in dental outpatient anesthesia to perform office inspections and clinical evaluations and requires written reports of all inspections and evaluations to be provided to the Board. If the results of an evaluation or inspection are deemed unsatisfactory, subsequent evaluations or inspections may be conducted upon written request of the applicant, and no permit may be issued until the applicant satisfactorily completes a clinical evaluation and office inspection.
8. Under section 11.2(b) of the act, beginning April 1, 2004, prior to issuing initial nitrous permits, the Board must require applicants to provide the make, model and serial number of all nitrous equipment and certify that the equipment is in proper working order. Thereafter, permit holders must provide evidence that equipment is properly calibrated, at least once every 6 years.
9. Under section 11.2(b)(3) of the act, the Board must establish standards and procedures necessary to perform clinical evaluations and office inspections to include the requirement that equipment be maintained in good working order and in accordance with manufacturer's specifications. Equipment standards must be updated periodically and all staff assisting in the administration of anesthesia must maintain, at a minimum, current CPR certification.
10. Under section 11.2(b)(4) of the act, itinerate permit holders must ensure that the office location they are working in has the required equipment and staff properly trained to handle anesthesia-related emergencies.
11. Under section 11.2(b)(5) of the act, nonpermit holders who allow itinerate permit holders to administer anesthesia in their offices must meet the same requirements pertaining to equipment and staffing.
12. Under section 11.2(b)(6) of the act, beginning April 1, 2005, as a condition for permit renewal, the Board must require unrestricted and restricted permit I holders to have satisfactorily passed a clinical evaluation and office inspection. This requirement may be waived if the permit holder can satisfactorily demonstrate a successful clinical evaluation administered by an organization acceptable to the Board, within 6 years preceding the effective date of section 11.2(b)(6) of the act. Thereafter, clinical evaluations and office inspections must be done at least once every 6 years.
13. Under section 11.2(c) of the act, beginning April 1, 2004, the Board may issue temporary permits, valid for 1 year which are not renewable.
14. Beginning April 1, 2005, as a condition of permit renewal, unrestricted permit holders must have completed 15 hours of Board-approved courses related to general anesthesia and deep sedation and restricted I permit holders must have completed 15 hours of Board-approved courses related to conscious sedation. Nonpermit holder dentists who maintain offices where general anesthesia, deep sedation or conscious sedation is administered must have completed 5 hours of Board-approved courses related to anesthesia. Continuing anesthesia education will be credited toward the licensee's continuing education requirement.
15. Permit holders are required under section 11.2(e) of the act to conduct a physical evaluation and take a medical history prior to the administration of general anesthesia, deep sedation, conscious sedation or nitrous, and maintain records.
16. Written informed consent is required under section 11.2(f) of the act prior to administration of general anesthesia, deep sedation, conscious sedation or nitrous to include the description of the procedure, risks and alternatives.
The Committee and the Department of State (Department) discussed problems with implementing the provisions of Act 135 within the time parameters specified in the act. The most difficult area has been implementing provisions that require clinical evaluations and office inspections as a condition of the issuance or renewal of a permit. Although current § 33.342 (relating to inspection of dental offices) authorizes the Board to make office inspections, none have been conducted due to difficulties encountered in obtaining qualified inspectors. The proposed rulemaking is designed to address these issues.
On September 5, 2003, the Board approved a new proposed rulemaking in response to the mandate of Act 135. In its proposal, the Board incorporates many proposed amendments from the proposed rulemaking published at 31 Pa.B. 6691.
D. Description of Proposed rulemaking
The proposed rulemaking to Subchapter E makes substantive and editorial changes to §§ 33.331--333.342.
§ 33.331 (relating to 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 (Guidelines). In so doing, the proposed rulemaking recognizes 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. (See the ADA Guidelines for the Use of Conscious Sedation, Deep Sedation and General Anesthesia for Dentists (Guidelines).) 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.
The Board also proposes to add definitions for ''AAOMS,'' ''AAOMS Guidelines,'' ''AAOMS Manual,'' ''AAPD,'' ''AAPD Guidelines,'' ''ADA'' and ''ADA Guidelines.''
The following acronyms and terms have also been defined in this proposed rulemaking: ''ACLS,'' ''adult patient,'' ''BLS,'' ''CRNA,'' ''clinical evaluation,'' ''communications equipment,'' ''general dentist,'' ''PALS,'' ''patient physical evaluation,'' ''pediatric patient,'' ''peer evaluation organization,'' ''peer evaluator,'' ''physician,'' ''OMS'' and ''office inspection.''
§ 33.332 (relating to requirement of permit to administer general anesthesia, conscious sedation or nitrous oxide/oxygen analgesia)
The proposed rulemaking clarifies that a permit is required to administer deep sedation in a dental office.
§ 33.333 (relating to types of permits)
The proposed rulemaking clarifies that an unrestricted permit is required to administer deep sedation and creates a new type of permit, a temporary permit, which is limited to 1 year, as required by Act 135.
§ 33.334 (relating to application for permit)
This section makes permit application requirements applicable to permission to administer deep sedation and to the temporary permit.
§ 33.335 (relating to requirements for unrestricted permit)
The proposed rulemaking removes 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 act, tracked in the regulation, is no longer necessary.
The proposed rulemaking increases the time required in a postgraduate program for advanced training in anesthesiology from 1 year to 2 years to conform to the ADA's Guidelines.
§ 33.336 (relating to requirements for restricted permit I)
The proposed rulemaking removes 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, that requirement is no longer necessary.
The proposed rulemaking reduces the number of hours of undergraduate or postgraduate didactic instruction and clinical experience in a program conforming to Part I or III of the ADA Guidelines.
§ 33.336a (relating to requirements for unrestricted permit and restricted permit I)
Subsection (a) requires all initial unrestricted and restricted I permit applicants to have satisfactorily completed an office inspection and clinical evaluation conducted by an approved peer evaluation organization, beginning April 1, 2004. After April 1, 2005, all renewal applicants must complete an office inspection and clinical evaluation for permit renewal. If an applicant can demonstrate satisfactory completion of an office inspection and clinical evaluation within the 6 years preceding April 1, 2005, the office inspection and clinical evaluation may be waived.
This subsection also requires all renewal applicants to satisfactorily complete an office inspection and clinical evaluation every 6 years. Applications for initial or renewal permits must contain an original letter from the peer review organization that conducted the office inspection/clinical evaluation evidencing the applicant's satisfactory completion of the office inspection/clinical evaluation.
Subsection (b) requires an oral and maxillofacial surgeon (OMS) applicant to attest that the administration of anesthesia to adult and pediatric patients will be conducted in conformance with standards outlined in the AAOMS Guidelines for the Elective Use of Conscious Sedation, Deep Sedation and General Anesthesia in Pediatric Dental Patients (Guidelines) and the AAOMS Office Anesthesia Manual (Manual). It would require a general dentist applicant to attest that the administration of anesthesia to adult patients would be conducted in accordance with the ADA Guidelines and that the administration of anesthesia to pediatric patients would be conducted in conformance with the AAPD Guidelines.
Under subsection (c), applicants are required to have successfully completed and maintained current certification in advanced cardiac life support (ACLS) prior to the administration of anesthesia to an adult patient, and certification in pediatric advanced life support (PALS) prior to the administration of anesthesia to a pediatric patient.
Subsection (d) provides that as of April 1, 2005, applicants for unrestricted permits are required to complete 15 hours of Board-approved courses related to general anesthesia and deep sedation, and restricted permit I applicants have to complete 15 hours of Board-approved courses related to conscious sedation. These continuing anesthesia education hours would be credited toward the permit holder's regular continuing education requirement.
§ 33.336b (relating to approved peer evaluation organizations for administering clinical evaluations and office inspections)
This section specifies peer evaluation organizations approved by the Board for conducting clinical evaluations and office inspections. The Board proposes to initially approve the AAOMS and the Pennsylvania Society of Oral and Maxillofacial Surgeons. Other organizations may apply to the Board for approval to serve as an organization that conducts clinical evaluations and office inspections. Subsection (b) outlines factors the Board will consider in approving an organization.
§ 33.336c (relating to standards for office inspections and clinical evaluations)
This section proposes to conduct office inspections and clinical evaluations in accordance with the AAOMS Manual and the AAOMS Guidelines. This continues the current policy in § 33.342(e) of utilizing the AAOMS materials as they represent the most current and comprehensive standards, and should apply to any permit holder. In addition, the AAOMS Manual is the only office inspection manual of this caliber.
§ 33.336d (relating to qualifications of peer evaluators conducting office inspections and clinical evaluations)
This section proposes that peer evaluators must be licensed dentists holding a current unrestricted permit and be independent from, and have no conflict of interest with, the dentist or dental practice being reviewed.
§ 33.336e (relating to confidentiality of peer review evaluation reports)
Office inspection and clinical evaluation reports and related information would remain confidential except when included in the permit application to the Board and upon Board inquiry of the peer evaluation organization as to whether an applicant's office inspection or clinical evaluation reports have been accepted by the peer evaluation organization.
§ 33.337 (relating to requirements for restricted permit II)
This section removes 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 previous reasons. 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 14.
As of April 1, 2004, all initial restricted II applicants must provide to the Board the make, model and serial number of any nitrous equipment utilized; certify that the equipment is properly calibrated, contains a fail-safe system and is in working order; and attest 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.
After the initial permit renewal, applicants would provide an attestation to the Board every 6 years that the nitrous equipment that the applicant uses is properly calibrated.
§ 33.337a (relating to requirements for temporary permit)
This section requires an applicant for a temporary permit of any type to include with the application proof that the applicant possesses the qualifications for the permit requested. Temporary permits expire in 1 year and are not renewable.
§ 33.338 (relating to expiration and renewal of permits)
Under the proposed rulemaking, renewal requirements have been amended to include proof of current certification in ACLS or PALS, or both, for unrestricted and restricted I permits; an attestation that nitrous oxide/oxygen analgesia equipment has been installed and calibrated according to the equipment manufacturer's guidelines and contains a failsafe system; and proof of compliance with anesthesia continuing education requirements and proof of compliance with office inspection and clinical evaluation requirements.
§ 33.339 (relating to fees for issuance of permits)
Permit fees are proposed to be amended as follows: initial unrestricted permits and restricted permit I fees would be $100 and the initial restricted permit II fee would remain $15. The renewal unrestricted permit and restricted permit I fee would be $200 and the renewal restricted permit II fee would remain $15.
As a general rule, the establishment of a fee authorized by a licensing board in the Department is determined after an analysis by the Department's Budget Office of staff requirements to prepare forms and process applications. In the case of office inspections and clinical evaluations, however, the fees will be determined by dental professionals of the peer evaluation organizations approved by the Board to administer office inspections and clinical evaluations. The permit applicant will then select an approved peer evaluation organization to conduct his office inspection and clinical evaluation. The permit applicant will pay the fee charged by the approved peer evaluation organization to have the office inspection and clinical evaluation conducted. This is similar to what already occurs with the continuing education requirement (that is, an applicant selects an approved continuing education provider and pays the required course fee directly to the provider).
The Board proposes to lower the renewal permit fees for unrestricted permits and restricted permit based upon the Board's understanding that the clinical evaluation/office inspection fee would be in the range of $400 to $600, and the Board's understanding of the work performed by these dentist evaluators and the necessary and reasonable costs performed by dentists in the private sector.
The Board proposes to increase the one-time initial permit fee for those permit holders from $15 to $100 to cover additional administrative costs entailed in verifying compliance with new requirements. The Board had initially intended to promulgate regulations containing substantive anesthesia requirements, and to promulgate fee regulations at a later date when data became available upon which to base the new fees. However, Act 135 mandates promulgation of fee regulations by December 26, 2003, thus necessitating this approach.
§ 33.340
The proposed amendments to this section require that a patient medical 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 would be amended to require suction equipment commensurate with the patient's age, size and condition; monitoring equipment, procedures and documentation conforming to the AAOMS Manual/AAPD Guidelines; a capnograph for intubated patients and a pulse oximeter; an ECG; a blood pressure monitoring device; a defibrillator; a stethoscope; and results of patient medical history and physical evaluation, anesthesia procedures to be utilized and signed written patient consent.
The proposed amendments to this section also require that 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 basic life support. Certified registered nurse practitioners would be required to be certified in ACLS. Permit holders would be required to hold current certification in ACLS for adult patients and PALS for pediatric patients.
The Board proposes to require that general anesthesia or deep sedation administered to pediatric patients by or under the delegation of a general dentist must be administered by a person dedicated solely to the administration and monitoring of anesthesia, while the dental procedures are performed by a dental licensee not involved in the administration of the general anesthesia or deep sedation.
All monitoring equipment and equipment used to administer general anesthesia, deep sedation, conscious sedation and nitrous oxide/oxygen analgesia would have to be installed and calibrated according to equipment manufacturer guidelines, be in proper working condition prior to administration and monitoring equipment must be used during the administration of general anesthesia.
The nonpermit holder dentist's office and equipment transported to his office by an itinerate permit holder must satisfactorily complete an office inspection conducted by an approved peer evaluation organization in accordance with the requirements of the AAOMS Manual and the AAOMS Guidelines for OMSs and in accordance with the ADA Guidelines and the AAPD Guidelines for general dentists.
OMS permit holders would be required to administer general anesthesia, deep sedation, conscious sedation and nitrous oxide/oxygen analgesia in accordance with the AAOMS Guidelines and the AAOMS Manual. General dentists would be required to administer general anesthesia, deep sedation, conscious sedation and nitrous oxide oxygen to adult patients in accordance with the ADA Guidelines and to pediatric patients in accordance with the AAPD Guidelines.
The patient medical history and patient evaluation would be conducted by the permit holder, physician or certified registered nurse anesthetist.
§ 33.340a (relating to duties of dentists who are restricted permit I holders)
The proposed rulemaking amends this section in substantially the same manner as § 33.340 with the exceptions that a capnograph for intubated patients is not required and a separate person dedicated to the administration of anesthesia to a pediatric patient is not required.
§ 33.340b (relating to duties of dentists who are restricted permit II holders)
This section is added to require that patients be given a physical evaluation and a medical history be taken 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, a blood pressure monitoring device and a defibrillator, as specifically enumerated items. However, the permit holder's monitoring equipment, procedures and documentation must conform to the AAOMS Manual and the AAOMS Guidelines for adult and pediatric patients (if the permit holder is an OMS) or the ADA Guidelines for adult patients and the AAPD Guidelines for pediatric patients (if the permit holder is a general dentist).
Requirements for restricted permit II holders would be added to require that monitoring equipment and equipment used to administer nitrous oxide/oxygen analgesia be installed and calibrated according to the equipment manufacturers' guidelines, contain a fail-safe system and be in proper working condition.
§ 33.341 (relating to 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.
The nonpermit holder's office and equipment transported to the nonpermit holder dentist's office would have to satisfactorily complete an office inspection conducted by a Board approved peer evaluation organization. As of April 1, 2005, nonpermit holders who maintain offices in which general anesthesia, deep sedation and conscious sedation is administered, would be required to complete 5 hours of Board-approved courses related to anesthesia.
§ 33.342
Under the proposed rulemaking, the classifications of inspections, routine and special, are deleted. This section now allows inspections of dental offices by Board authorized agents. It also allows for a reinspection to take place within 30 days of an inspection finding deficiencies.
E. Fiscal Impact and Paperwork Requirements
Some of the provisions of this proposed rulemaking will have a fiscal impact upon permit holders. Fees for an office inspection and clinical evaluation will be set by the approved peer evaluation organizations. Although the fee amounts are not known at this time, the Board believes they will be in the $400 to $600 range for an office inspection and clinical evaluation. In view of this, the Board proposes to lower the permit renewal fees for both unrestricted and restricted permit I holders from $300 to $200. The one-time initial permit fee for these permit holders would be increased from $15 to $100. Permit fees for restricted permit II holders would remain the same ($15). 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. See the explanation for § 33.339.
F. Sunset Date
The Board continuously monitors its regulations. Therefore, no sunset date has been assigned.
G. Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on March 30, 2004, the Board submitted a copy of this proposed rulemaking and a copy of a Regulatory Analysis Form to the Independent Regulatory Review Commission (IRRC) and to the Chairpersons of the Senate Consumer Protection and Professional Licensure Committee and the House Professional Licensure Committee. A copy of this material is available to the public upon request.
Under section 5(g) of the Regulatory Review Act, IRRC may convey any comments, recommendations or objections to the proposed rulemaking within 30 days of the close of the public comment period. The comments, recommendations or objections shall specify the regulatory review criteria which have not been met. The Regulatory Review Act specifies detailed procedures for review, prior to final publication of the rulemaking, by the Board, the General Assembly and the Governor of comments, recommendations or objections raised.
H. Public Comment
Interested persons are invited to submit written comments, recommendations or objections regarding this proposed rulemaking to Deborah B. Eskin, Counsel, State Board of Dentistry, P. O. Box 2649, Harrisburg, PA 17105-2649 within 30 days following publication in the Pennsylvania Bulletin. Reference No. 16A-4614 (Administration of General Anesthesia, Deep Sedation, Conscious Sedation and Nitrous Oxide/Oxygen Analgesia) when submitting comments.
VEASEY B. CULLEN, Jr., D.M.D.,
ChairpersonFiscal Note: 16A-4614. 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 phrases, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise:
AAOMS--American Association of Oral and Maxillofacial Surgeons, with principal offices at 9700 W. Bryn Mawr Avenue, Rosemont, Illinois 60018.
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, with principal offices at 211 East Chicago Avenue, Suite 700, Chicago, Illinois 60611-2663.
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.
BLS--Basic Life Support.
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 general dentists.
Communications equipment--Equipment capable of eliciting a response in an emergency.
* * * * * 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[, including deep sedation,] 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.
* * * * * OMS--An 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 unresticted permit holders; 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 general dentists.
PALS--Pediatric Advanced Life Support.
PSOMS--Pennsylvania Society of Oral and Maxillofacial Surgeons, with principal offices at 2700 North Broad Street, Suite 106, Lansdale, Pennsylvania 19644.
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 with unrestricted permits conduct office inspections and clinical evaluations for dentists seeking initial or renewal unrestricted or restricted I permits.
Peer evaluator--A licensed dentist with a current unrestricted permit who conducts an office inspection or clinical evaluation under the auspices of a peer evaluation organization.
Physician--A Pennsylvania licensed medical or osteopathic physician who is currently credentialed to administer anesthesia in a hospital licensed by the Department of Health.
§ 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.
* * * * * (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.
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