RULES AND REGULATIONS
STATE BOARD OF DENTISTRY
[ 49 PA. CODE CH. 33 ]
Expanded Function Dental Assistant Scope of Practice and Continuing Education
[42 Pa.B. 5736]
[Saturday, September 8, 2012]The State Board of Dentistry (Board) amends §§ 33.1, 33.205a and 33.402 (relating to definitions; practice as an expanded function dental assistant; and continuing education subject areas) to read as set forth in Annex A.
Effective Date
This final-form rulemaking is effective upon publication in the Pennsylvania Bulletin.
Statutory Authority
This final-form rulemaking is authorized by section 4 of the act of April 29, 2010 (P. L. 176, No. 19) (Act 19), which requires the Board to promulgate regulations within 18 months of its effective date (June 28, 2010); and by section 3(d.1), (j) and (o) of The Dental Law (act) (63 P. S. § 122(d.1), (j) and (o)), which authorizes the Board to regulate expanded function dental assistants (EFDA), regulate continuing education and promulgate regulations as may be deemed necessary by the Board and proper to carry into effect the powers conferred by the act.
Background and Purpose
Act 19 amended the act to expand the scope of practice of EFDAs to include performing coronal polishing, performing fluoride treatments and taking impressions of teeth for limited purposes. This final-form rulemaking amends § 33.205a to conform to Act 19. Additionally, the Board is concerned that many existing EFDAs may not have training in the area of coronal polishing. Therefore, the Board added a requirement that EFDAs, with three exceptions, complete 3 hours of continuing dental education in the area of coronal polishing. The three exceptions include the following: EFDAs who are also licensed as dental hygienists; EFDAs who completed coronal polishing training as part of the curriculum of a Board-approved EFDA training program after June 28, 2010; and EFDAs who took a qualifying 3-hour course in coronal polishing after June 28, 2010.
Summary of Comments
Notice of proposed rulemaking was published at 41 Pa.B. 4960 (September 17, 2011) with a 30-day public comment period. During the public comment period, the Board received comments from the Pennsylvania Dental Association (PDA), the Pennsylvania Dental Hygienists' Association (PDHA), Harcum College, David A. Schwartz, D.D.S. and Nancy L. Schwartz, EFDA. In addition, as part of the review under the Regulatory Review Act (71 P. S. §§ 745.1—745.12), on October 26, 2011, the House Professional Licensure Committee (HPLC) submitted comments and on November 16, 2011, the Independent Regulatory Review Commission (IRRC) submitted comments. The Senate Consumer Protection and Professional Licensure Committee (SCP/PLC) did not comment. Following is a summary of the comments received and the Board's response.
First, David A. Schwartz, D.D.S. and Nancy L. Schwartz, EFDA submitted identical comments regarding the Board's proposal that EFDAs complete a 3-hour continuing education course in coronal polishing. First, the commentators suggested that 3 hours is excessive. The Board considered the comment, and with input from existing EFDA education programs, determined that a 3-hour course is appropriate. The Board notes that in some states dental assistants may perform coronal polishing only after qualifying for and passing an examination and obtaining a certificate from the state's dental board. Based on input from EFDA educators, the Board believes a 3-hour course is reasonable to adequately cover the didactic and clinical instruction required for an EFDA to perform coronal polishing within the standard of care expected by the Board. The commentators also asked whether there are enough facilities in place to give courses for EFDAs and still meet the deadline of March 31, 2013. Because the Board amended this final-form rulemaking to provide additional exemptions from the continuing education requirement for those EFDAs already trained in this area, the Board believes that the remaining EFDAs who have not yet completed the training will be able to locate qualifying courses. The Board encourages approved continuing education providers and EFDA education programs to develop and offer these courses if they have not already done so.
Harcum College asks whether ''air polishing'' would be included under § 33.205a(a)(1)(viii) as a type of ''coronal polishing.'' The Board does not believe the legislative intent extends beyond the traditional method of polishing utilizing a hand-held rotary instrument with a rubber cup and a polishing agent. The Board intends ''coronal polishing'' to be limited to the removal of light plaque and extrinsic stain from the exposed surfaces of the teeth using a rotary instrument with a rubber cup or brush and a polishing agent. The Board also notes that many other states that permit dental assistants to perform coronal polishing limit it in a similar manner. For this reason, the Board added a definition of ''coronal polishing'' to § 33.1 to clarify its intent.
Harcum College also suggested that the Board add a prohibition that EFDAs may not perform ''periodontal instrumentation'' to reinforce that EFDAs should not be going beneath the gum line or performing procedures that they have not been trained to do. The Board believes that the addition of the definition of ''coronal polishing'' has clarified the limited extent of this expansion of the scope of practice for EFDAs. The Board believes it is unnecessary as part of this final-form rulemaking to draft a complete list of every dental and dental hygiene procedure an EFDA may not perform. However, the Board has also defined ''coronal polishing'' to specifically exclude the removal of calculus, which shall be performed by a dentist or dental hygienist.
Finally, Harcum College points out that many EFDAs were proactive and took continuing education courses to learn the additional skill of coronal polishing when the act was amended and also that EFDA programs are now teaching the skill to current students. Harcum College argues that these individuals should be given credit for the training they have already received and should be exempt from the continuing education requirement. The Board agrees and amended this final-form rulemaking to provide for exemptions for EFDAs who can demonstrate that they have taken a qualifying course or obtained the training through an approved EFDA education program after the effective date of Act 19.
PDHA also suggested the Board include a prohibition to clarify that an EFDA may not perform ''prophylaxis, scaling (supragingival and subgingival), as it pertains to the practice of dental hygiene, root planning or periodontal probing.'' As previously noted, the Board believes that the definition of ''coronal polishing'' clarifies the limited degree of this expansion of the scope of duties for EFDAs. Also, § 33.205 (relating to practice as a dental hygienist) permits dental hygienists to perform periodontal probing, scaling and root planning. Nowhere in the act or the Board's regulations is there an authorization for EFDAs to go beyond coronal polishing as that term is defined in § 33.1, to perform a complete oral prophylaxis or perform other procedures that are within the scope of practice of dental hygienists and dentists.
PDHA also noted that many EFDAs have already been trained in the area of coronal polishing and believes that this course work, even if completed prior to April 1, 2011, should be acceptable to the Board as having met the requirement for continuing education in coronal polishing. The Board agrees and amended this final-form rulemaking to add exemptions from the requirement as previously stated.
PDA also submitted comments regarding the proposed continuing education requirement. PDA joined other commentators in urging the Board to either delete the requirement or amend it to provide exceptions for EFDAs who received formal training in polishing restorations and those who are now graduating from accredited programs ''who are sure to learn the skills necessary to perform coronal polishing on patients while they are enrolled in school.'' The Board declines to delete the requirement. However, the Board has provided for additional exemptions for EFDAs who have received qualifying training on coronal polishing after the effective date of Act 19. The Board determined that the effective date of Act 19 should govern because it was only upon that date that EFDAs were permitted to engage in coronal polishing, which previously was restricted to dentists and dental hygienists. The Board published regulations regarding EFDA program approval at 42 Pa.B. 769 (February 11, 2012) which require approved EFDA programs to include coronal polishing in the EFDA curriculum.
On October 26, 2011, the HPLC submitted one comment to the Board regarding the proposed continuing education requirement. The HPLC requested clarification as to whether this is an on-going continuing education requirement or a one-time demonstration of an additional 3 hours of training in coronal polishing and if not an on-going requirement, whether the Board intends to accept evidence of additional training in coronal polishing earned prior to April 1, 2011. The Board intends this to be a one-time demonstration of training in the area of coronal polishing. In addition, the Board is not requiring 3 additional hours of continuing education but that 3 of the 10 hours of continuing education already required as a condition of the renewal of the EFDA's certificate shall be completed in the area of coronal polishing. As previously noted, the Board agrees that EFDAs who received training in this area after the act was amended to permit them to perform coronal polishing should receive credit for that training and added additional exemptions to this final-form rulemaking. The Board believes it is in the best interest of the public health and safety to assure that EFDAs have received at least 3 hours of clinical training in this new area of practice.
IRRC submitted comments on the proposed rulemaking to the Board on November 16, 2011. First, IRRC noted the commentator who questioned whether air polishing would be included and suggested that adding a definition would improve clarity. The Board agrees and added a definition of ''coronal polishing.'' Recognizing that the act explicitly states the procedures EFDAs cannot practice, IRRC asked whether the additional restrictions proposed by commentators are consistent with those in the act and, if so, whether the Board has considered including them in the final-form rulemaking. None of the procedures suggested by the public commentators (periodontal probing, scaling, root planning, and so forth) are included in the statutory list of prohibitions in section 11.10(b) of the act (63 P. S. § 130k(b)). The Board considered adding the suggested restrictions. However, the Board determined that it would be impossible to list all of the dental and dental hygiene procedures that an EFDA may not perform without leaving something out and risking an interpretation that a particular procedure was permitted simply because it was not included in the list of prohibitions. An EFDA is defined in section 2 of the act (63 P. S. § 121) as ''an individual who holds a current valid certification under this act to perform reversible intraoral procedures authorized by this act under the direct supervision of a licensed dentist'' and limits those procedures to those specified in section 11.10 of the act and other reversible procedures not designated by the act to be performed by licensed dentists and dental hygienists. The Board believes that the act and regulations are clear that the suggested procedures are to be performed by licensed dentists and dental hygienists and that the ''expanded functions'' that may be performed by EFDAs do not encompass the general practice of dental hygiene.
IRRC also raised six issues with regard to the new continuing education requirement regarding coronal polishing. First, in light of the comments received questioning the necessity of this training, IRRC asked the Board to explain not only the need for EFDAs to complete continuing education in this subject matter but also how the Board determined that 3 hours was an appropriate amount of training. As of June 28, 2010, the scope of practice of EFDAs was expanded to include coronal polishing, a procedure that until that date was performed exclusively by dentists and dental hygienists. The Board determined that in the interest of the public health and safety it should be necessary for EFDAs to demonstrate at least some minimal amount of training in coronal polishing. The Board conferred with EFDA educators to determine what they felt would be an adequate amount of time to provide a clinical course in coronal polishing. Based on the advice of these educators, the Board determined that 3 hours was adequate for an EFDA, who already has advanced training, to perform the procedure at a level within the standard of care expected by the Board. The Board notes that this requirement is significantly less burdensome than, for example, the contiguous state of Ohio, where a certified dental assistant is required to complete a 7-hour board-approved coronal polishing training program, pass an approved examination for coronal polishing and obtain a coronal polishing certificate from the Ohio board.
IRRC also asked the Board to clarify whether coronal polishing training received by certified EFDAs prior to April 1, 2011, would be accepted by the Board. As previously noted, the Board determined that it will accept evidence of appropriate training completed after the effective date of Act 19 instead of the required continuing education. IRRC also asked if there are existing certified EFDAs who would not have completed coronal polishing training and, if so, suggested that instead of applying to the current biennial renewal period, that the final-form rulemaking allow EFDAs certified by March 31, 2011, to complete coronal polishing continuing education hours prior to March 31, 2013. EFDA scope of practice did not include coronal polishing until June 28, 2010. Therefore, many existing EFDAs have not been trained to perform the function. It is this reason that the Board proposed the one-time 3-hour continuing education requirement. According to many of the public commentators, some proactive EFDAs, apparently recognizing their lack of training in this area, obtained training after the act was amended. For this reason, the Board amended this final-form rulemaking to provide an exemption from the continuing education requirement for EFDAs who have already received this training after the amendment to the act. However, remaining existing EFDAs who have not completed training in coronal polishing will need to complete training by March 31, 2013, as a condition of renewal of their licenses.
IRRC asked the Board to clarify whether there are enough existing coronal polishing course providers to allow existing EFDAs to meet the March 31, 2013, deadline. As previously noted, the Board believes the inclusion of the additional exemptions will reduce the demand for these courses and that the remaining EFDAs who have not yet completed the training will be able to locate qualifying courses. IRRC noted that EFDAs certified after March 31, 2011, shall complete coronal polishing during the first complete biennial renewal period after the initial certification is granted. However, many EFDAs certified after this date have already received this training as part of their formal education. IRRC asked whether the Board considered deleting § 33.402(g)(2) as unnecessary as suggested by PDA. While the Board agrees that many of the existing EFDA training programs have added training in the area of coronal polishing since the act was amended in 2010, the Board will not be able to confirm that they have all included this new function in their curricula until the Board implements the regulations regarding EFDA program approval. The Board recognizes that once the existing EFDA programs have been reviewed and approved by the Board, § 33.402(g)(2) will become less necessary as the exemption for EFDAs who have received this training as part of their formal education becomes the norm. However, until that time, the Board declines to delete § 33.402(g)(2). In general, the Board believes it is necessary to protect the public health and safety to assure that EFDAs have received this minimum amount of training in the area of coronal polishing.
IRRC noted that the Board reported in the Regulatory Analysis Form that the implementation of this final-form rulemaking will not impose costs on the regulated community. However, the proposed rulemaking also states that EFDAs may not complete their coronal polishing education hours online or through distance education. IRRC asks whether schools and providers offer this training at no cost to EFDAs and suggested that the Board provide further explanation of the potential fiscal impact that may result from this new continuing education requirement. Because EFDAs are already required to complete 10 hours of continuing education as a condition of renewal, and at least 50% of those hours shall be completed through lecture or clinical courses, the Board determined that this requirement would not impose additional costs on the regulated community. The Board did not mean to imply that these courses cost nothing—but that they would be accepted as part of the existing requirement to complete continuing education. The Board recognizes that in-person, hands-on clinical courses may cost more than online or video courses. Those costs will be dictated by the course providers and the Board is unable to estimate with precision what the additional costs might be. However, the Board believes that it is important that EFDAs not only observe coronal polishing being performed but that they have an opportunity to perform the new skill as part of their training. For this reason, the Board made clarifying amendments in the final-form rulemaking requiring the continuing education in coronal polishing be conducted through hands-on, clinical courses.
Description of the Amendments to the Final-Form Rulemaking
The final-form rulemaking was amended to add a definition of ''coronal polishing'' in § 33.1 to clarify that the expansion in the scope of practice of EFDAs is limited to the supragingival removal of light plaque and extrinsic stain from the exposed natural and restored surfaces of the teeth using a rotary instrument with a rubber cup or brush and a polishing agent and does not include calculus removal. In addition, the Board amended the continuing education requirement to provide two additional exemptions for EFDAs who have completed coursework including coronal polishing as part of their education at a Board-approved EFDA education program or who have completed a course in coronal polishing of at least 3 hours offered by an approved program sponsor, at any time after June 28, 2010, the effective date of Act 19. Finally, the final-form rulemaking was amended to clarify that the required 3-hour course in coronal polishing may not be completed in a video, online or distance education course. The required 3-hour course shall be completed through a hands-on clinical course offered by an approved continuing education program sponsor or through an approved EFDA education program.
Fiscal Impact and Paperwork Requirements
The final-form rulemaking should not have fiscal impact on the Commonwealth or its political subdivisions. The final-form rulemaking may have some minimal fiscal impact on the regulated community due to the requirement that the coronal polishing course be provided in a hands-on clinical context, rather than through video, online or distance education.
The final-form rulemaking should not result in additional legal, accounting or reporting requirements for the Commonwealth or the regulated community. However, existing EFDAs will be required to certify completion of the required training, or the applicability of one of the three exemptions, when renewing their certificates in 2013.
Sunset Date
The Board continuously monitors the cost effectiveness of its regulations. Therefore, a sunset date has not been assigned.
Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on September 6, 2011, the Board submitted a copy of the notice of proposed rulemaking, published at 41 Pa.B. 4960, to IRRC and the Chairpersons of the HPLC and the SCP/PLC for review and comment.
Under section 5(c) of the Regulatory Review Act, IRRC, the HPLC and the SCP/PLC were provided with copies of the comments received during the public comment period, as well as other documents when requested. In preparing the final-form rulemaking, the Board has considered all comments from IRRC, the HPLC, the SCP/PLC and the public.
Under section 5.1(j.2) of the Regulatory Review Act (71 P. S. § 745.5a(j.2)), on August 1, 2012, the final-form rulemaking was approved by the HPLC and the SCP/PLC. Under section 5.1(e) of the Regulatory Review Act, IRRC met on August 2, 2012, and approved the final-form rulemaking.
Contact Person
Further information may be obtained by contacting Cynthia Montgomery, Regulatory Counsel, State Board of Dentistry, P. O. Box 2649, Harrisburg, PA 17105-2649.
Findings
The Board finds that:
(1) Public notice of proposed rulemaking was given under sections 201 and 202 of the act of July 31, 1968 (P. L. 769, No. 240) (45 P. S. §§ 1201 and 1202) and the regulations promulgated thereunder, 1 Pa. Code §§ 7.1 and 7.2.
(2) A public comment period was provided as required by law and all comments were considered.
(3) The amendments to the final-form rulemaking do not enlarge the purpose of the proposed rulemaking published at 41 Pa.B. 4960.
(4) This final-form rulemaking is necessary and appropriate for administering and enforcing the authorizing act identified in this preamble.
Order
The Board, acting under the authorizing statutes, orders that:
(a) The regulations of the Board, 49 Pa. Code Chapter 33, are amended by amending §§ 33.1, 33.205a and 33.402 to read as set forth in Annex A, with ellipses referring to the existing text of the regulations.
(Editor's Note: Section 33.1 was not included in the proposed rulemaking published at 41 Pa.B. 4960.)
(b) The Board shall submit this order and Annex A to the Office of General Counsel and the Office of Attorney General as required by law.
(c) The Board shall certify this order and Annex A and deposit them with the Legislative Reference Bureau as required by law.
(d) This order shall take effect upon publication in the Pennsylvania Bulletin.
PHILIP T. SIEGEL, D.D.S.,
Chairperson(Editor's Note: For the text of the order of the Independent Regulatory Review Commission relating to this document, see 42 Pa.B. 5452 (August 18, 2012).)
Fiscal Note: Fiscal Note 16A-4624 remains valid for the final adoption of the subject regulations.
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:
* * * * * Continuing education certificate—A document prepared by the program sponsor which contains the title of the course, the dates attended or completed and the hours of education completed.
Coronal polishing—
(i) A procedure limited to the supragingival removal of light plaque and extrinsic stain from the exposed natural and restored surfaces of the teeth using a rotary instrument with a rubber cup or brush and a polishing agent.
(ii) The term does not include calculus removal.
Credit hour—A minimum unit of continuing education consisting of 60 minutes of instruction. Programs longer than 60 minutes will be credited in 30 minute increments.
* * * * *
Subchapter C. MINIMUM STANDARDS OF CONDUCT AND PRACTICE § 33.205a. Practice as an expanded function dental assistant.
(a) Scope of professional practice.
(1) An expanded function dental assistant may offer to perform or perform the following services:
(i) Placing and removing rubber dams.
(ii) Placing and removing matrices.
(iii) Placing and removing wedges.
(iv) Applying cavity liners and bases.
(v) Placing and condensing amalgam restorations.
(vi) Carving and contouring amalgam restorations.
(vii) Placing and finishing composite resin restorations or sealant material, or both.
(viii) Performing coronal polishing as defined in § 33.1 (relating to definitions).
(ix) Performing fluoride treatments, including fluoride varnish.
(x) Taking impressions of teeth for study models, diagnostic casts or athletic appliances.
(2) Each of the professional services identified in paragraph (1) shall be performed under the direct supervision of a dentist.
(b) Prohibitions. An expanded function dental assistant may not perform the following procedures:
(1) Complete or limited examination, diagnosis and treatment planning.
(2) Surgical or cutting procedures of hard or soft tissue.
(3) Prescribing drugs, medicaments or work authorizations.
(4) Final inspection and approval of restorative and other treatment which affects occlusion and necessary occlusal adjustments.
(5) Pulp capping, pulpotomy and other endodontic procedures.
(6) Placement and intraoral adjustments of fixed and removable prosthetic appliances.
(7) Administration of local anesthesia, parenteral or inhalational sedation, nitrous oxide analgesia or general anesthesia.
(8) Take impressions other than for study models, diagnostic casts or athletic appliances.
(c) Supervision. Expanded function dental assistants shall perform under the direct supervision of a dentist. Direct supervision means that a dentist is in the dental office or treatment facility, personally diagnoses the condition to be treated, personally authorizes the procedure and remains in the dental office or treatment facility while the procedure is being performed by the expanded function dental assistant, and, before dismissal of the patient, personally evaluates the work performed by the expanded function dental assistant.
Subchapter F. CONTINUING DENTAL EDUCATION § 33.402. Continuing education subject areas.
(a) Except as provided in subsections (c)—(e), the required credit hours shall be completed in subjects which contribute directly to the maintenance of clinical competence of a dentist, dental hygienist, public health dental hygiene practitioner or expanded function dental assistant. Examples of acceptable subjects include:
(1) Diagnosis and treatment of oral pathosis.
(2) Clinical and technological subjects.
(3) Emergency procedures excluding hours required for cardiopulmonary resuscitation (CPR) certification.
(4) Infection control.
(5) Abuse and neglect.
(6) Medical and scientific subjects.
(7) Laws and regulations pertaining to dentists, dental hygienists and expanded function dental assistants.
(b) Credit hours will not be awarded in nonclinical subjects, including:
(1) Billing.
(2) Office management.
(3) Practice building.
(4) Insurance reimbursement.
(5) Communication skills, except as provided in subsection (c).
(c) A dental hygienist may complete no more than three of the required 20 hours of continuing education in courses relating to communication skills.
(d) A public health dental hygiene practitioner shall complete five of the required 20 hours of continuing education in public health-related courses.
(e) A school dental hygienist who is certified as a public health dental hygiene practitioner and who, as a certified educational specialist is required to obtain continuing professional education under the act and under section 1205.2 of the Public School Code of 1949 (24 P. S. § 12-1205.2) may submit evidence of the completion of education courses approved for certification by the school district to meet the 20-hour continuing education requirement.
(f) A dental hygienist who holds a local anesthesia permit shall complete 3 of the required 20 hours of continuing education in courses related to the administration of local anesthesia, including pharmacology or other related courses.
(g) Expanded function dental assistants shall comply with the following:
(1) Except as provided in paragraph (2), expanded function dental assistants shall complete 3 of the 10 required hours of continuing education in the area of coronal polishing as follows:
(i) Unless an exemption applies, an expanded function dental assistant certified by the Board by March 31, 2011, shall complete the 3 hours of continuing education in the area of coronal polishing as a condition of renewal for the biennial period which begins on April 1, 2013.
(ii) Unless an exemption applies, an expanded function dental assistant certified by the Board after March 31, 2011, shall complete the 3 hours of continuing education in the area of coronal polishing as a condition of renewal for the first complete biennial renewal period after initial certification.
(2) The following expanded function dental assistants are exempt from the requirement to complete 3 hours of continuing education in coronal polishing in paragraph (1):
(i) Expanded function dental assistants who are also licensed as dental hygienists.
(ii) Expanded function dental assistants who can document that they have completed coursework including coronal polishing as part of their education at a Board-approved EFDA education program at any time after June 28, 2010.
(iii) Expanded function dental assistants who can document that they have completed a course in coronal polishing of at least 3 hours offered by an approved program sponsor at any time after June 28, 2010.
(3) The requirements of this subsection may not be met through video, online or distance education, but shall be completed by physical attendance at a hands-on clinical training course offered by an approved program sponsor or an approved EFDA education program.
[Pa.B. Doc. No. 12-1732. Filed for public inspection September 7, 2012, 9:00 a.m.]
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