STATE BOARD
OF DENTISTRY
[ 49 PA. CODE CH. 33 ] [ Correction ]
EFDA Program Approval An error occurred in the proposed rulemaking which appeared at 39 Pa.B. 5597 (September 26, 2009).
The State Board of Dentistry (Board) proposes to amend §§ 33.1, 33.3, 33.102 (relating to definitions; fees; and professional education) and to add § 33.117 (relating to EFDA program approval), to read as set forth in Annex A.
Effective Date
The amendments will be effective upon publication of the final-form rulemaking in the Pennsylvania Bulletin.
Statutory Authority
The proposed rulemaking is authorized under section 3(a) and (b), (d.1)(1) and (o) of the Dental Law (63 P. S. § 122(a), (d.1)(1) and (o)). Section 3(a) authorizes the Board to ''establish and alter, from time to time, the standards of preliminary and professional education and training required for . . . certification for expanded function dental assistants.'' Section 3(b) authorizes the Board to ''investigate and determine the acceptability and to approve and disapprove institutions and colleges of this State and of other states and countries for the education of students desiring to be . . . certified as expanded function dental assistants, and to revoke approvals where such institutions and colleges are no longer deemed proper.'' Section 3(d.1)(1) provides the general authority for the Board to provide for and to regulate the certification of expanded function dental assistants. 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
The act of December 27, 1994, (P. L. 1361, No. 160) (Act 160) amended the Dental Law to require the certification and regulation of expanded function dental assistants (EFDAs). Act 160 required dental assistants who desired to be certified as EFDAs to complete an education program and pass an examination approved by the Board. The Board, through regulations published on May 13, 2000, determined that the examination would include both a written component and a clinical component to ensure that certificateholders possess the requisite knowledge and skills to properly and safely perform their job functions. At the time, many interested parties and stakeholders, including dentists, dental hygienists, dental assistants and their professional associations participated in the development of the rulemaking. A major impetus for including the clinical component came from the dental assisting community itself, who felt that a clinical exam was necessary.
Ultimately, after years of attempts at obtaining a suitable examination through ''requests for proposals'' as well as through sole-source contracting, the Board was unable to identify a vendor who could provide a valid, reliable and defensible clinical exam that was also affordable to candidates. Because there is no widely available regional or National examination for EFDAs, the costs of developing and administering a Pennsylvania-specific examination for EFDAs would have to be borne by a rather small pool of candidates. Due in part to the projected costs of the clinical component of the examination, temporary permit holders and members of the legislature asked the Board to take another look at the clinical component requirement. As a result, the Board held a public hearing on July 21, 2001. Based upon the testimony received, as well as written comments, the Board was persuaded that the clinical component could be eliminated while still meeting its goals of public protection by placing more emphasis on standardizing EFDA education. Thereafter, the Board initiated proposed rulemaking to eliminate the clinical component of the examination and developed nonbinding ''guidelines'' for EFDA education programs.
In the intervening years, the Board developed five drafts of the ''EFDA curriculum guidelines'' by working with members of the dental community as well as dental educators. Eventually, the Board determined that the guidelines should be promulgated as regulations in order to assure that all EFDA education programs meet minimum requirements and that all candidates for EFDA certification must demonstrate competence in performing each of the dental procedures permitted under the Dental Law prior to graduation from an EFDA program. An ''exposure draft'' of the proposed rulemaking was distributed to over 150 interested parties and stakeholders in September of 2006, including each of the EFDA training programs currently operating in the Commonwealth. The Board received comments from the Pennsylvania Dental Hygienist's Association, the Pennsylvania Dental Association, the Pennsylvania Academy of General Dentistry, the Pennsylvania Association of Private School Administrators, Harcum College's EFDA Program Director, the Bradford School, Temple University School of Dentistry, the Independent Regulatory Review Commission (IRRC) and five individual dentists. As a result of the comments received, the Board is proposing the following amendments to its regulations relating to EFDA program approval.
Description of Proposed Amendments
The Board proposes to amend § 33.1 (relating to definitions) to include a definition of ''EFDA program.'' Section 33.3 (relating to fees) would be amended to include a fee of $80 for EFDA program approval applications.
Section 33.102 (relating to professional education) would be amended to provide for the certification of an EFDA who graduates from a ''board-approved'' EFDA program that meets the criteria set forth in proposed § 33.117 (relating to EFDA program approval).
Section 33.117(a) proposes definition of terms relating to EFDA program approval including: ''clinical setting,'' ''clinical evaluation,'' ''clinical instruction,'' ''competencies,'' ''competent'' and ''laboratory or preclinical instruction.'' Subsection (b) sets forth the requirement for EFDA programs to apply for approval and pay an application fee. It also outlines the contents of the application for EFDA program approval.
Subsection (c) sets forth the criteria for EFDA program approval. Paragraph (1) sets forth standards relating to planning and assessment. It requires EFDA programs to establish program goals and objectives and to develop specific criteria for measuring levels of competency to reflect the acceptable and prevailing standards and expectations of the dental community for each of the procedures an EFDA is authorized to perform under § 33.205a (relating to practice as an expanded function dental assistant). Paragraph (2) sets forth the requirements for institutional accreditation. Paragraph (3) sets forth the requirement of a program director who is responsible for the operations of the EFDA program. Paragraph (4) sets forth the qualifications required of EFDA program faculty. Paragraph (5) sets forth the requirement for physical facilities and equipment, and provides for off-campus clinical facilities and extramural dental offices for internships or externships. Paragraph (6) sets forth the minimum requirements for EFDA program curriculum. Paragraph (7) requires candidates for graduation from an EFDA program to demonstrate certain required competencies, and that clinical competency be determined by at least one licensed dentist evaluator in a clinical setting. It also provides for documentation of the student's competency attainment to be maintained by the EFDA program for a minimum of 5 years from graduation or completion of the program and that the documentation be provided to the Board as part of the student's initial application for certification as an expanded function dental assistant.
Finally, subsection (d) sets forth the procedure for denying approval to an EFDA program or for removing an EFDA program from the approved list.
Fiscal Impact and Paperwork Requirements
The proposed amendments should have no fiscal impact on the Commonwealth or its political subdivisions because the costs associated with processing EFDA program approval applications will be borne by applicants.
The proposed amendments will require the Board to develop an application for EFDA program approval, but 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 regulations. 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.,
ChairpersonFiscal 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 printed in regular text to 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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