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PA Bulletin, Doc. No. 09-1785

PROPOSED RULEMAKING

[ 49 PA. CODE CH. 33 ]

EFDA Program Approval

[39 Pa.B. 5597]
[Saturday, September 26, 2009]

 The State Board of Dentistry (Board) proposes to amend § 33.103 (relating to examinations), to read as set forth in Annex A.

Effective Date

 The amendment will be effective upon publication of the final-form rulemaking in the Pennsylvania Bulletin.

Statutory Authority

 The proposed rulemaking is authorized under section 3(c), (d), (e) and (o) of the Dental Law, (63 P. S. § 122(c), (d), (e) and (o)). Section 3(c) and (d) authorize the Board to license dentists and dental hygienists by examination. Section 3(e) authorizes the Board to provide for the conduct of licensure examinations. Section 3(o) provides the general authority of the Board ''to adopt, promulgate and enforce such rules and regulations as may be deemed necessary by the Board.''

Background and Purpose

 Currently, the Board requires that applicants for licensure as a dentist or dental hygienist take and pass the National Board Dental or Dental Hygiene Examination administered by the Joint Commission on National Dental Examinations, Inc. (written examination) and the clinical examination administered by the Northeast Regional Board of Dental Examiners, Inc. (NERB). Over the last few years, the Board has been, and will continue to be involved in the efforts to adopt a National clinical examination, but to date, it has not come to fruition. In the absence of a National clinical examination, the Board has determined that applicants for licensure by examination should be able to take any of the five regional clinical examinations, that is, those examinations administered by NERB, the Southern Regional Testing Agency, Inc. (SRTA), the Western Regional Examining Board (WREB), the Central Regional Dental Testing Service, Inc. (CRDTS) or the Council of Interstate Testing Agencies, Inc. (CITA).

 In March of 2009, the Board solicited comments from stakeholders and interested parties regarding the proposal to expand the list of acceptable clinical examinations to include those administered by each of these five regional examining agencies. All of the commentators agreed in theory with the proposal to expand the list of acceptable examinations. However, the Pennsylvania Dental Association (PDA) suggested that the Board consider, instead of listing the five regional testing agencies, defining the criteria by which a clinical examination will be considered valid and reliable. However, the Board believes that, while many of the Board members are experienced dentists and dental hygienists, they are not psychometricians, nor are they trained in education measurement or quantitative psychology. Therefore, the Board is not able to evaluate whether a particular examination is psychometrically sound, valid, reliable or legally defensible. The Board currently relies on NERB to develop and administer an examination that is valid, reliable and legally defensible. The Board will continue to rely on each of the regional testing agencies to defend their examinations if challenged. The Board, however, has reviewed the content of the examinations, and finds them to be substantially similar. In addition, the American Dental Association (ADA) has advocated that each state dental board consider accepting all of the examinations administered by the various regional testing agencies, all of which, with the exception of CITA, have been in existence for decades.

 The PDA also noted that the proposed rulemaking does not address State-administered clinical examinations, nor does it include the American Board of Dental Examiners' ADLEX (dental) or ADHLEX (dental hygiene) examinations. The examinations administered by the five regional testing agencies, in combination, are accepted in all but a few states that administer their own examinations. In addition, some states that administer their own examinations also accept the results of at least one of the regional examinations. If an applicant in this Commonwealth licensure has not passed an examination administered by one of the five regional testing agencies as proposed by this rulemaking, that individual could still apply for licensure under § 33.107 (relating to licensure by criteria approval). Therefore, the Board determined that it would not address State administered examinations in this proposal. In addition, the ADLEX/ADHLEX examinations are not administered by the American Board of Dental Examiners (ADEX), but by a regional testing agency. In fact, NERB currently administers the ADLEX examination. To the Board's knowledge, no regional testing agency currently administers the ADHLEX examination. Therefore, the Board determined that it was not necessary to address these examinations in the proposed rulemaking at this time.

 The Board did not make any changes to the proposed rulemaking based on the PDA's comments. In general, the Board has determined that it was most prudent at this time to look to the existing regional examining agencies as a means of opening up the possibility of licensure in this Commonwealth to as many qualified individuals as possible. Most of the interested parties that commented on the proposal indicated that this is a positive step to permit more qualified individuals to obtain licensure in this Commonwealth, to increase access to dental care for residents of this Commonwealth, and to allow dentists and dental hygienists more flexibility and mobility.

Description of Proposed Amendments

 The Board proposes to amend § 33.103 to provide that applicants for licensure by examination may take and pass a clinical examination administered by any of the five regional examining agencies.

Fiscal Impact and Paperwork Requirements

 The proposed amendment should have no fiscal impact on the Commonwealth or its political subdivisions because the costs associated with examinations will be borne by candidates for licensure. The proposed amendment should not have an adverse fiscal impact on applicants because the fees for the various regional examinations are comparable and an applicant could choose the most cost-effective examination to take.

 The proposed amendment should not result in any additional legal, accounting or reporting requirements for the Commonwealth or the regulated community.

Sunset Date

 The Board continuously monitors the cost effectiveness of its regulation. Therefore, no sunset date has been assigned.

Regulatory Review

 Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on September 16, 2009, 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 House Professional Licensure Committee and the Senate Consumer Protection and 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 must specify the regulatory review criteria which have not been met. The Regulatory Review Act specifies detailed procedures for review of comments, recommendations and objections by the Board, the Governor and the General Assembly, prior to final publication of the rulemaking.

Public Comment

 Interested persons are invited to submit written comments, suggestions or objections regarding the proposed amendments to Cynthia Montgomery, Regulatory Counsel, State Board of Dentistry, P. O. Box 2649, Harrisburg, PA 17105-2649, within 30 days following publication of this proposed rulemaking.

JOHN V. REITZ, D.D.S. 
Chairperson

Fiscal Note: 16A-4616. 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 A. GENERAL PROVISIONS

§ 33.1. Definitions.

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

*  *  *  *  *

EFDA program—An expanded function dental assisting training program.

*  *  *  *  *

§ 33.3. Fees.

 (a) Following is a schedule of fees charged by the Board:

*  *  *  *  *

EFDA program approval application fee
$ 80

*  *  *  *  *

Subchapter B. LICENSURE OF DENTISTS AND DENTAL HYGIENISTS AND CERTIFICATION OF EXPANDED FUNCTION DENTAL ASSISTANTS

§ 33.102. Professional education.

*  *  *  *  *

 (c) Expanded function dental assistants.

 (1) Candidates for certification as expanded function dental assistants shall show compliance with section 3(d.1) of the act by submitting verification of one of the following:

 (i) Graduation from [an expanded function dental assisting program] a Board-approved EFDA program at a 2-year college or other institution accredited or provisionally accredited by an accrediting agency approved by the United States Department of Education Council on Postsecondary Accreditation which offers an Associate Degree.

 (ii) Graduation from a dental hygiene school which required the successful completion of at least 75 hours of clinical and didactic instruction in restorative functions accredited or provisionally accredited by the Commission on Dental Accreditation (CODA) of the American Dental Association.

 (iii) Completion of a Board-approved certification program in expanded function dental assisting of at least 200 hours of clinical and didactic instruction from a dental assisting program accredited by one of the following:

 (A) The Commission on Dental Accreditation (CODA) of the American Dental Association.

*  *  *  *  *

 (2) The Board will approve EFDA programs that meet the criteria in § 33.117 (relating to EFDA program approval).

[(2)](3) Candidates for certification who receive their professional education outside the United States or from a nonaccredited program may satisfy the education requirement by submitting their credentials to a program listed in paragraph (1) and obtaining additional training that will lead to the awarding of a degree by that school.

[(3)] (4) This subsection does not apply to persons who are not required to meet the educational requirements under section (3)(d.1)(2) of the act.

(Editor's Note: Proposed § 33.117 is new and is printed in regular text enhance readibility.)

§ 33.117. EFDA program approval.

 (a) Definitions. The following words and terms, when used in this section, have the following meanings, unless the context clearly indicates otherwise:

Clinical setting—

 (i) A setting in which expanded function dental assisting procedures are performed through direct patient care.

 (ii) The term does not include any setting where procedures are performed on typodonts, manikins or by other simulation methods.

Clinical evaluation—An evaluation system based on observation of a student's performance of clinical skills in contexts that resemble those the student will be expected to encounter as an expanded function dental assistant in a dental office.

Clinical instruction—A learning experience in a clinical setting where the student performs expanded functions on patients under the supervision of an instructor.

Competencies—Statements describing the necessary requirements to perform each procedure in § 33.205a (relating to practice as an expanded function dental assistant) to the level required to meet the acceptable and prevailing standard of care within the dental community in this Commonwealth.

Competent—Having sufficient knowledge, skill and expertise in performing expanded functions to meet and maintain the acceptable and prevailing standard of care within the dental community in this Commonwealth.

Laboratory or preclinical instruction—A learning experience in which students perform expanded functions using study models, typodonts, manikins or other simulation methods under the supervision of the instructor.

 (b) Application. EFDA programs shall apply for Board approval on forms to be provided by the Board and pay the fee set forth in § 33.3 (relating to fees). The application must include the following information:

 (1) EFDA program goals and objectives.

 (2) Criteria for measuring competencies.

 (3) Documentation of accreditation as required under section 3(d.1) of the act (63 P. S. § 122(d.1)).

 (4) The curriculum vitae and job description of the EFDA program director.

 (5) The curriculum vitae and job description of each faculty member assigned to the EFDA program.

 (6) A description of the physical facilities and equipment used by the EFDA program for laboratory, preclinical and clinical instruction.

 (7) A copy of the formal written agreement for the use of off-campus laboratory, preclinical or clinical facilities, if applicable.

 (8) Course outlines, course descriptions or syllabi for the EFDA program curriculum.

 (9) Other information requested by the Board.

 (c) Requirements for approval. The Board will approve EFDA programs that meet the following requirements:

 (1) Planning and assessment.

 (i) The EFDA program shall delineate its program goals and objectives for preparing individuals in the expanded function dental assisting procedures set forth in § 33.205a to a level consistent with the acceptable and prevailing standard of care within the dental community in this Commonwealth.

 (ii) The EFDA program shall develop specific criteria for measuring levels of competency for the procedures set forth in § 33.205a which must reflect the acceptable and prevailing standards and expectations of the dental community. Students shall be evaluated by faculty according to these predetermined criteria.

 (iii) The EFDA program shall record and retain student clinical evaluations as documentation of student competency for a minimum of 5 years from the student's graduation or completion of the EFDA program.

 (2) Institutional accreditation. The EFDA program shall comply with the accreditation requirements of section 3(d.1) of the act and § 33.102(c) (relating to professional education).

 (3) Program director. The EFDA program shall identify a program director who is responsible for and involved in the following:

 (i) Student selection.

 (ii) Curriculum development and implementation.

 (iii) Ongoing evaluation of program goals, objectives, content and outcomes assessment.

 (iv) Annual evaluations of faculty performance including a discussion of the evaluation with each faculty member.

 (v) Evaluation of student performance and maintenance of competency records for 5 years from graduation or completion of the EFDA program.

 (vi) Participation in planning for and operation of facilities used in the EFDA program.

 (vii) Evaluation of the clinical training and supervision provided in affiliated offices and off-campus facilities, as applicable.

 (viii) Maintenance of records related to the EFDA program, including instructional objectives and course outcomes.

 (ix) Instruction of all licensed dentists overseeing off-campus clinical procedures performed by EFDA students to ensure that the policies and procedures of the off-campus facility are consistent with the philosophy and objectives of the EFDA program.

 (4) Faculty. An EFDA program faculty member shall either be a dentist who holds a current license in good standing from the Board, or shall have or possess the following:

 (i) A current expanded function dental assistant certificate issued by the Board.

 (ii) A minimum of 2 years of practical clinical experience as an expanded function dental assistant.

 (iii) Current National certification as a certified dental assistant (CDA) issued by the Dental Assisting National Board.

 (iv) Completed, or is in the process of completing, a course in education methodology of at least 3 credits or 45 hours offered by an accredited institution of postsecondary education.

 (5) Facilities.

 (i) The EFDA program shall provide adequate physical facilities and equipment for laboratory, preclinical and clinical instruction.

 (ii) If the EFDA program contracts for off-campus laboratory, preclinical or clinical instruction facilities, the following conditions must be met:

 (A) There must be a formal written agreement between the EFDA program and the laboratory, preclinical or clinical facility.

 (B) In off-campus clinical facilities, a licensed dentist shall oversee all dental procedures performed on patients by EFDA program students. The licensed dentist shall receive instruction to ensure that the policies and procedures of the off-campus facility are consistent with the philosophy and objectives of the EFDA program.

 (iii) The standards in this paragraph are equally applicable to extramural dental offices or clinic sites used for clinical practice experiences, such as internships or externships.

 (6) Curriculum. The curriculum of an EFDA program must consist of the following components:

 (i) General education. The EFDA program shall include general education subjects as determined by the educational institution with a goal of preparing the student to work and communicate effectively with patients and other health care professionals.

 (ii) Dental sciences. The EFDA program shall include content in general dentistry related to the expanded functions set forth in § 33.205a, including courses covering the following topics:

 (A) Dental anatomy.

 (B) Occlusion.

 (C) Rubber dams.

 (D) Matrix and wedge.

 (E) Cavity classification and preparation design.

 (F) Bases and liners.

 (G) Amalgam restoration.

 (H) Composite restoration.

 (I) Sealants.

 (J) Crown and bridge provisional fabrication.

 (K) Dental law and ethics.

 (iii) Clinical experience component. The EFDA program shall include a minimum of 120 hours of clinical experience performing expanded function dental assisting procedures as an integral part of the EFDA program. The clinical experience component shall be designed to achieve a student's clinical competence in each of the expanded function dental assisting procedures set forth in § 33.205a.

 (7) Demonstrating competency.

 (i) General education. Students of the EFDA program shall be required to demonstrate competency in general education subjects by attaining a passing grade on written or oral examinations.

 (ii) Laboratory and preclinical instruction. Students of the EFDA program shall be required to demonstrate competency by attaining a score of at least 80% in all laboratory and preclinical courses. Students shall be required to demonstrate the knowledge and skills required to:

 (A) Carve the anatomy of all teeth.

 (B) Establish proper contact areas, embrasures, marginal adaptation, as well as facial and lingual heights of contour so as to restore the proper tooth form and function in all restorative materials.

 (C) Apply the basic concepts and terms of occlusion and carving concepts in the restoration of proper occlusal relationships.

 (D) Describe the problems associated with improper contouring of restorations.

 (E) Identify and differentiate G.V. Black's cavity classifications.

 (F) Select, prepare, assemble, place and remove a variety of matrices and wedges.

 (G) Place and finish Class I-VI restorations with correct marginal adaptation contour, contact and occlusion.

 (H) Assemble, place and remove rubber dams.

 (I) Place sealants.

 (J) Crown and bridge provisional fabrication.

 (K) Understand the act and this chapter as they apply to an expanded function dental assistant's responsibilities.

 (iii) Clinical experience. EFDA program students shall be evaluated and deemed clinically competent by at least one licensed dentist evaluator in a clinical setting. The EFDA program director shall instruct the dentist clinical evaluators regarding the required competencies to ensure consistency in evaluation. Clinical competency is achieved when the dentist evaluator confirms the student has sufficient knowledge, skill and expertise in performing expanded functions to meet and maintain the acceptable and prevailing standard of care within the dental community in this Commonwealth.

 (iv) Documenting competency.

 (A) The EFDA program faculty and program director shall document the student's general education, preclinical and laboratory competency attainment.

 (B) The licensed dentist evaluator shall document the student's clinical competency attainment prior to graduation from the EFDA program.

 (C) The EFDA program director shall provide documentation of the student's competency attainment to the Board as part of the student's application for certification as an expanded function dental assistant.

 (D) The EFDA program shall retain the student's competency documentation for a minimum of 5 years from graduation or completion of the EFDA program.

 (d) Refusal or withdrawal of approval. The Board may refuse to approve an EFDA program or may remove an EFDA program from the approved list if it fails to meet and maintain the requirements in this section, in accordance with the following:

 (1) The Board will give an EFDA program notice of its provisional denial of approval or of its intent to remove the program from the approved list.

 (2) The notice will set forth the requirements that are not being met or maintained by the EFDA program.

 (3) A program served with a provisional denial or notice of intent to remove will be given 45 days in which to file a written answer to the notice.

 (4) The EFDA program will be provided an opportunity to appear at a hearing to demonstrate why approval should not be refused or withdrawn.

 (5) The Board will issue a written decision.

 (6) The Board's written decision is a final decision of a governmental agency subject to review under 2 Pa.C.S. § 702 (relating to appeals)

[Pa.B. Doc. No. 09-1785. Filed for public inspection September 25, 2009, 9:00 a.m.]



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