RULES AND REGULATIONS
Title 49—PROFESSIONAL AND VOCATIONAL STANDARDS
STATE BOARD OF DENTISTRY
[ 49 PA. CODE CH. 33 ]
Dental Hygiene Scope of Practice; Local Anesthesia
[39 Pa.B. 6982]
[Saturday, December 12, 2009]The State Board of Dentistry (Board) hereby amends §§ 33.1, 33.3, 33.102, 33.205, 33.301, 33.302 and 33.402, and adds §§ 33.115, 33.116 and 33.205b (relating to local anesthesia permit; certification of public health dental hygiene practitioners; and practice as a public health dental hygiene practitioner) to read as set forth in Annex A.
Effective Date
The final-form rulemaking will be effective upon publication of the final-form rulemaking in the Pennsylvania Bulletin.
Statutory Authority
Under section 3(d), (j.2) and (o) of the Dental Law (law) (63 P. S. § 122(d), (j.2) and (o)), the Board has authority to adopt, promulgate and enforce regulations for the general supervision, scope of practice and continuing education of dental hygienists. The act of July 20, 2007 (P. L. 376, No. 51) (Act 51) requires amendments to the regulations to implement a new class of certificate for ''public health dental hygiene practitioners.''
Background and Purpose
The final-form rulemaking accomplishes three goals: to implement a new classification of Board-regulated practitioner created by Act 51—the public health dental hygiene practitioner; to make revisions to the scope of practice of dental hygienists, including the addition of the administration of local anesthesia; and to revise the supervision requirements for dental hygienists.
Summary of Comments and the Board's Response
Notice of proposed rulemaking was published at 38 Pa.B. 4777 (August 30, 2008), followed by 30 days of public comment. During the public comment period, the Board received numerous public comments. In addition, as part of their review under the Regulatory Review Act, the House Professional Licensure Committee (HPLC) and the Independent Regulatory Review Commission (IRRC) submitted comments. The following represents a summary of the comments received and the Board's response.
Comments from the House Professional Licensure Committee
The only comment received from the HPLC requested that the Board clarify whether a newly graduated dental hygienist can apply for an initial license and a local anesthesia permit simultaneously. If an applicant meets the qualifications for licensure and for a local anesthesia permit, the applicant can apply for both credentials simultaneously. The Board will consider the application for a dental hygiene license first, and once that license is issued, will then consider the application for local anesthesia permit. The Board must review the applications sequentially because one of the requirements for issuance of a local anesthesia permit is that the applicant hold a current license in good standing to practice as a dental hygienist in this Commonwealth.
Comments from the Independent Regulatory Review Commission
IRRC first asked the Board to generally address the Board's statutory authority for allowing dental hygienists to administer local anesthesia, and how allowing them to do so protects the public health, safety and welfare. Answering this question requires an overview of the legislative and regulatory scheme in the practice of dentistry. The definition of the practice of dentistry in section 2 of the law (63 P. S. § 121) is a very broad definition—it includes treating any disease, pain or injury, or regulating any deformity or physical condition of the human teeth, jaws or associated structures. It also includes the administration of ionizing radiation. Every procedure performed in a dental office is ''the practice of dentistry.'' Some of the procedures require the professional competence and skill of a dentist. Those dental procedures that do not require the professional competence and skill of a dentist may be delegated to others. Dental hygiene encompasses a subset of dental procedures that do not require the professional competence and skill of a dentist. Specifically, there are certain ''intra-oral'' procedures that licensed dental hygienists are educated to perform. There is another subset of dental procedures that may only be performed by expanded function dental assistants. It is all ''the practice of dentistry.'' Some of it is reserved for dentists, some of it may be done by dental hygienists, some of it may be done by EFDAs, and some of it may be delegated to any competent person under section 11.8 of the law (63 P. S. § 130i).
The law also provides the authority to the Board to determine by regulation which dental procedures may be performed by dental hygienists, including the necessary education and level of supervision required. IRRC noted that the definition of the practice of dentistry includes administering anesthetic agents, a broad term which encompasses a wide range of agents from topical anesthetics (such as a gel one might use on a teething baby or to dull the pain of a toothache) through general anesthesia. IRRC also pointed out that the law further limits the administration of general anesthesia, deep sedation, conscious sedation and nitrous oxide/oxygen analgesia to licensed dentists. It is significant to note that there is no statutory limitation placed on the administration of local anesthesia or topical anesthetics. The Board is of the opinion that, if the General Assembly had meant to limit local anesthesia to be performed only by dentists, it would have done so when section 11.2 of the law (63 P. S. § 130c), pertaining to anesthesia, was amended in 2002. Therefore, it is left to the Board to determine whether local anesthesia falls within the range of procedures that may be performed by a dental hygienist.
Clearly, the Board may only permit dental hygienists to perform those procedures they are educated to perform. At the time of this writing, 41 states and the District of Columbia permit dental hygienists to administer local anesthesia. Therefore, many dental hygienists currently practicing have been educated to perform this procedure. However, because dental hygienists in this Commonwealth have not been permitted to perform the procedure for a number of years, most dental hygiene programs located in this Commonwealth do not include the administration of local anesthesia in the dental hygiene curriculum. For these reasons, the Board determined that the administration of local anesthesia could only be delegated to those dental hygienists who meet the educational criteria in § 33.115 or have been administering local anesthesia lawfully under the laws and regulations of another jurisdiction. In addition, the administration of local anesthesia may only be performed by a dental hygienist under the direct supervision of a licensed dentist who has examined the patient, has authorized the procedure to be performed and takes full professional responsibility for it. Therefore, if a dentist does not believe the dental hygienist can safely perform the procedure, the dentist should not authorize it. Finally, the Board has placed additional safeguards in the regulation by limiting dental hygienists to using local infiltration anesthesia and intraoral nerve block anesthesia limited to the 2nd (maxillary) and 3rd (mandibular) divisions of the trigeminal nerve. The Board believes these limitations, along with the education and supervision requirements, properly safeguard the public health, safety and welfare.
Additionally, as noted by many of the commentators, the Board believes this change will in many instances increase access to and enhance the quality of dental care in this Commonwealth. As an example, the removal of subgingival calculus is often painful for the patient. If a patient needs to have local anesthesia to tolerate the procedure, currently a dentist must administer it. This means that if the dentist is not available to administer the local anesthesia because the dentist is involved in the treatment of another patient, the choices are to either terminate the treatment and reschedule, or to continue with the treatment in spite of the pain to the patient. In either event, the patient may not return to complete the treatment. Even if the dentist were able to administer the local anesthesia, it would require the dentist to interrupt the treatment of another patient, causing delays and inefficiencies in offering dental services to all patients. Therefore, the Board believes this change to the scope of practice for hygienists, as appropriately limited in these regulations, does not pose a significant risk to the public health, safety and welfare, and in the long run, will increase access to and enhance the quality of oral health care being delivered by dentists and dental hygienists.
With regard to § 33.1 (relating to definitions), IRRC asked the Board to add the term ''public health dental hygiene practitioner'' to the existing definition of ''board-regulated practitioner.'' After receiving this comment, the Board's final-form rulemaking pertaining to ''sexual misconduct'' was published at 38 Pa.B. 6279 (November 15, 2008), which included the requested amendment. IRRC also asked that the second sentence of the definition of ''local anesthesia'' be moved to § 33.115 because it applies only to that section. The Board has made the requested change.
IRRC noted that § 33.115(c)(3) requires a dental hygienist seeking a local anesthesia permit to provide ''acceptable documentation'' to the Board, and recommended that the final-form regulation specify the type of documentation that would be acceptable to the Board. IRRC also noted that this section also requires dental hygienists to certify certain information to the Board and recommended that the final-form regulation specify how that information can be ''certified.'' The Board has amended § 33.115 to specify what type of documentation must be submitted for each of the three avenues to obtaining a local anesthesia permit and to clarify the certification process. Specifically, a dental hygienist seeking a local anesthesia permit based on having graduated from a CODA-accredited dental hygiene program which included the successful completion of a course in the administration of local anesthesia would need to provide a ''certificate of education'' completed by the dental hygiene program on a form provided by the Board. Similarly, if the dental hygienist was seeking the permit based on completion of a 30-hour course sponsored by a dental or dental hygiene program, a ''certificate of education'' would be required from the dental or dental hygiene program. Finally, if the dental hygienist is seeking the local anesthesia permit based on similar authority issued by the proper licensing authority of another state, territory or district of the United States, or of a province or territory of Canada, the dental hygienist would have to submit a certificate or letter of good standing from that jurisdiction verifying that the jurisdiction required completion of a course in the administration of local anesthesia as a prerequisite and that there had been no disciplinary action against the dental hygienist related to the administration of local anesthesia. The Board also clarified that the dental hygienist is required to sign a ''certification statement'' on the application for local anesthesia permit verifying that the dental hygienist actively engaged in the administration of local anesthesia under a current license or permit within the 5 years immediately preceding the filing of the application for local anesthesia permit, and that the dental hygienist at all times administered local anesthesia in accordance with all applicable laws and regulations of that jurisdiction.
IRRC raised four concerns regarding the requirement in § 33.116(b)(3) which requires professional liability insurance. First, IRRC asks what is the Board's statutory authority for requiring public health dental hygiene practitioners to obtain professional liability insurance. Section 4 of Act 51 amended the law by adding section 11.9, which sets forth the requirements for public health dental hygiene practitioners. See 63 P. S. § 130; Section 11.9(a)(3) establishes the statutory requirement that a public health dental hygiene practitioner ''purchase a malpractice policy in an amount determined to be adequate by the board.'' IRRC noted that no other practitioner regulated by the Board is required by statute or regulation to obtain professional liability insurance and asked why public health dental hygiene practitioners are required to do so. In response, the Board notes that it is a statutory requirement provided by Act 51, and that the only discretion the Board had was in the ''amount determined to be adequate by the board.'' However, the Board believes the policy behind the requirement was one of public protection because public health dental hygiene practitioners are authorized to practice on the public without the ''authorization, assignment or examination of a dentist'' who would normally ''take full professional responsibility'' for the acts of those dental hygienists under the dentist's supervision. Additionally, although the law does not require dentists to obtain professional liability insurance, all prudent dentists would have such coverage.
IRRC also noted that some employers of public health dental hygiene practitioners provide liability coverage for their employees and asked if the Board would consider the coverage provided by the employer acceptable. In response, the Board amended the rulemaking to require applicants for certification as a public health dental hygiene practitioner to provide documentation demonstrating that the dental hygienist has obtained professional liability insurance or is a named insured covered by a group policy. IRRC also asked what would be considered acceptable proof of coverage. The Board has clarified in the final-form rulemaking that this documentation may include a certificate of insurance issued by the insurer, or a copy of the declarations page of the professional liability insurance policy. Finally, IRRC asked if coverage provided by an employer is less than the minimum amount specified in the regulation, would supplemental coverage for the difference be required. A dental hygienist must demonstrate coverage in the minimum amount of $1,000,000 per occurrence and $3,000,000 per annual aggregate. The Board has surveyed a number of insurance providers and determined that the average annual premium for such a policy for dental hygienists in this Commonwealth is currently approximately $100—$125. Even if coverage by the employer is less than the minimum amount required, the Board does not believe that the cost of obtaining a conforming policy is prohibitive. Otherwise, the Board would have no objection to a dental hygienist meeting this requirement by combining two or more professional liability policies.
With regard to § 33.205 (relating to practice as a dental hygienist), IRRC asked the Board to define ''subgingival agents.'' As noted in the preamble to the proposed rulemaking, dental hygienists are qualified to administer a wide range of antimicrobial, antibiotic, antiseptic or anesthetic agents below the gum line. These agents may be delivered by a variety of methods, including injectable systems for pastes, ointments and gels, as well as degradable and non-degradable fibers, films, strips, spheres, discs or chips. In response to IRRC's comment, the Board has added a definition of the term to § 33.1.
IRRC also raised three concerns with proposed § 33.205b. First, IRRC asked the Board to define what it means by schools, correctional facilities, and Federally-qualified health centers. In response the Board has clarified those terms in the final-form rulemaking. IRRC also asked the Board to ensure that the final-form rulemaking is consistent with existing statutory and regulatory provisions that apply to dental hygienists that practice in school districts. The Board believes that, with regard to permitting public health dental hygiene practitioners to practice in ''schools,'' the intent was to cover any public or private educational institution that provides elementary or secondary instruction to school aged children, which are required under Article XIV of the Public School Code of 1949 to provide dental and dental hygiene services to their students (see 24 P. S. §§ 14-401 and 14-403). Additionally, in response to IRRC and the various school dental hygienists who commented, the Board does not believe the intent was to relieve anyone of their responsibilities under the Public School Code or the regulations of the State Board of Education to be certified as an educational specialist. In addition, under the regulations of the Department of Health in 28 Pa. Code § 23.35 (relating to dental hygienists), a dental hygienist providing dental hygiene services in schools must be licensed by the Board and certified by the Department of Education. This has not changed. The only change is that if a dental hygienist wants to work in the schools without the supervision of a dentist, the dental hygienist must also be certified as a public health dental hygiene practitioner. Otherwise, the dental hygienist must be under the general supervision of a dentist as set forth in § 33.205(d)(2).
The Board has also provided a definition of correctional facilities, which the Board intends to cover all Federal, State, regional, county and local prisons, jails, detention facilities and correctional institutions located within this Commonwealth. Finally, the Board provided a cross reference to the definition of ''federally qualified health center'' in section 1905(l)(2)(B) of the Social Security Act (42 U.S.C. § 1369d(l)(2)(B)). In addition, in response to a number of comments, the Board clarified that this term includes Federally-qualified health center look-alikes, which qualify for, but do not receive, grants under section 330 of the Public Health Service Act (42 U.S.C.A. § 254b).
Thirdly, IRRC noted that under § 33.205b(d), public health dental hygiene practitioners are required to maintain dental records for 5 years, but that the regulation does not specify whether the records are required to be maintained in written form, or if electronic records are acceptable. The Board would also point out that the Board's regulations in § 33.209 (relating to preparing, maintaining and retaining patient records), which require dentists to maintain dental records for 5 years also does not dictate the format of those records. To date, the Board has not determined it necessary to distinguish between formats in which the records may be maintained, so long as they are accurate, legible and complete. However, due to the increase in the utilization of electronic records in medical and dental practice, the Board is considering the possibility of future regulations relating to standards for electronic recordkeeping, which would apply to dentists and public health dental hygiene practitioners.
With regard to § 33.302 (relating to requirements for personnel performing radiologic procedures), IRRC asked what the Board's statutory authority is for allowing public health dental hygiene practitioners to perform radiologic procedures without the supervision of a dentist and whether the health and safety of the public is adequately protected if a public health dental hygiene practitioner is allowed to perform these procedures. Section 3 of Act 51 amended Section 11.4 of the law (63 P. S. § 130c) pertaining to radiologic procedures by adding subsection (e), which specifically states that, ''[n]otwithstanding the supervision requirements of this act, a public health dental hygiene practitioner may perform radiological procedures in any setting without supervision of a dentist on or after the effective date of this subsection.'' Additionally, in response to a related comment by the Pennsylvania Academy of General Dentistry (PAGD), to protect patients from unnecessary exposure to ionizing radiation and to enhance the public health and safety, the Board has added a provision that requires a public health dental hygiene practitioner to provide to the patient a copy of any radiograph taken, along with a referral to a dentist.
Finally, IRRC pointed out an error in § 33.116(c), which inadvertently referred to biennial renewal of the local anesthesia permit, rather than the public health dental hygiene practitioner certificate. This has been corrected in the final-form rulemaking.
Comments from the Pennsylvania Dental Hygienists' Association
The Pennsylvania Dental Hygienists' Association (PDHA) was generally supportive of the proposed amendments, but asked the Board to consider certain amendments in the final-form rulemaking. PDHA recommended that the Board insert the words ''and the dental hygienist'' into § 33.205(d)(1)(ii) and (iii) to include dental hygienists in the decision making process regarding the level of supervision required. In response, the Board elected to leave the final decision with the dentist, ''with input from the dental hygienist'' and has made that amendment to the final-form rulemaking. PDHA also asked the Board to consider an alternate definition of ''direct supervision'' for the administration of local anesthesia by dental hygienists, which would not include the requirement that the dentist re-examine the patient after the completed injection procedure. After extensive discussion, the Board agreed with the PDHA that their intent was not to require the dentist to ''directly supervise'' the individual injection procedure, but rather to ''directly supervise'' the dental hygienist's overall provision of dental hygiene services, including the administration of local anesthesia. Therefore, the Board revised the definition of direct supervision for purposes of the administration of local anesthesia to mean supervision by a dentist who has examined the patient and authorized the procedure to be performed, is physically present in the dental facility and available during the performance of the procedure, and takes full professional responsibility for the completed procedure.
PDHA was among the numerous commentators that asked the Board to include ''federally qualified health center look-alikes'' as sites where public health dental hygiene practitioners may practice without the supervision of a dentist. As noted previously, the Board has made this change. In addition, PDHA asked the Board to consider adding free and reduced-fee nonprofit clinics. The Board considered this request and agreed to add it to the rulemaking in § 33.205b(c)(10).
PDHA also asked the Board to consider a change in the heading of Subchapter D and of § 33.302 by deleting the references to ''auxiliary personnel'' in that public health dental hygiene practitioners who work without the supervision of a dentist do not fit the definition of ''auxiliary personnel.'' The Board has made these amendments. PDHA also suggested that the Board consider amending the proposed rulemaking in § 33.402(c) (relating to continuing education subject areas) to permit both dental hygienists and dentists to complete at least three of the required continuing education credit hours in communications. The Board considered, but rejected, this suggestion. Generally, the regulations require that continuing education credit hours must be completed in subjects that contribute to the Board-regulated practitioner's clinical competence and specifically excludes courses in nonclinical subjects such as communication skills. The proposed amendment to subsection (c) provided an exception for dental hygienists, who are permitted to complete up to 3 hours in communications. This exception was based on the very definition of ''dental hygienist'' included in the law, which provides that a dental hygienist is licensed to perform ''educational, preventive, and therapeutic services and procedures.'' The essence of an educator is the ability to communicate information to one's patients. Therefore, the exception for dental hygienists, which permits, but does not require, courses in communications is directly related to the professional services being provided by dental hygienists. While the Board agrees with PDHA that the dentist-patient relationship could benefit from courses in communications, the Board has elected to continue to require that all 30 hours of required continuing education must be in areas that contribute to the dentist's clinical competence. However, the Board notes that the required 30 hours is a minimum requirement and joins PDHA in encouraging dentists to acquire additional continuing education in the area of communications.
Comments from the Pennsylvania Academy of General Dentistry
The PAGD expressed concerns about public health dental hygiene practitioners treating patients with severe or life-threatening systemic disease (ASA Class III—ASA Class V) without supervision. Historically, the Board determined the level of supervision required for dental hygienists based on the American Society of Anesthesiologists (ASA) classification of the health status of the patient. However, when the General Assembly adopted Act 51, it required the Board to reconsider the supervision requirements in their entirety. (See section 5 of Act 51, which abrogated the Board's supervision regulations.) By definition, a public health dental hygiene practitioner provides dental hygiene services in certain public health settings without the authorization, assignment or examination of a dentist. The legislature did not provide any exceptions based on the health status of the patient.
The PAGD also expressed concern about public health dental hygiene practitioners performing radiologic procedures without the supervision of a dentist. As noted previously, Act 51 provides specifically that ''[n]otwithstanding the supervision requirements of this act, a public health dental hygiene practitioner may perform radiologic procedures in any setting without supervision of a dentist.'' The Board has no statutory authority to require any supervision with regard to public health dental hygiene practitioners when they are providing services in the enumerated public health settings set forth in section 11.9 of the law. However, the PAGD suggested that the Board include a requirement that any radiograph taken by a public health dental hygiene practitioner be reviewed by a dentist within 1 week to determine the absence or presence of any diagnosable conditions. Inasmuch as all dental hygienists, including public health dental hygiene practitioners, are specifically prohibited from diagnosis or treatment planning, and considering the fact that it is considered unprofessional conduct for a dentist or dental hygienist to unnecessarily expose a patient to ionizing radiation under the Board's existing regulations in § 33.211(a)(6) and (b)(5) (relating to unprofessional conduct), the Board found this suggestion reasonable. However, after extensive discussion and public comment at its March 20, 2009, Board meeting, the Board determined that the 1 week time frame suggested by the PAGD was unduly restrictive and elected to require radiographs taken by public health dental hygiene practitioners to be reviewed by a dentist within 1 month. Subsequently, the Board received correspondence dated June 11, 2009, from the Pennsylvania Dental Association (PDA) suggesting alternative language to that suggested by the PAGD. Rather than simply require the radiograph to be reviewed by a dentist within 30 days, PDA suggested that the public health dental hygiene practitioner provide to the patient a copy of the radiograph and a referral to a dentist with instructions to consult the dentist. Thereafter, upon presentation of the patient, the dentist would be required to examine the patient, review the radiograph and report any findings to the patient and the public health dental hygiene practitioner. The PDHA sent a letter to the Board on July 26, 2009, indicating that while they did not object to the content of the recommendation of the PDA, they felt that it was not necessary to amend the final rulemaking because standard dental hygiene protocols would require a public health dental hygiene practitioner to refer a patient to a dentist with a copy of any radiograph taken if the public health dental hygiene practitioner observed a need for further evaluation and treatment. The Board considered PDA's proposal at its meeting on July 31, 2009, and based on the input received at that meeting from representatives of the PDA, PAGD and PDHA, voted to incorporate PDA's proposal into the final rulemaking. The language requiring referral has been added to § 33.302(a).
Finally, the PAGD suggested that the Board consider a requirement for all dental hygienists administering local anesthesia to complete at least 3 hours of continuing education in pharmacology or other related courses, instead of courses relating to communication skills. The Board considered this comment and has amended § 33.402 to add subsection (f) which requires a dental hygienist who holds a local anesthesia permit to complete at least 3 hours of continuing education in courses relating to the administration of local anesthesia, including pharmacology. However, because the 3 credit hours in communications skills are permitted, but not required, the Board did not make a change in that aspect of the proposed rulemaking.
Comments from other public commentators
Dr. Dino Angelici, Chief of Dentistry for the Department of Corrections (DOC), raised a concern about the need for public health dental hygiene practitioners who work in correctional facilities to maintain professional liability insurance. He indicated that employees of the DOC are already covered by the DOC for their dental practice within the Commonwealth's correctional system. He also suggested that many insurance companies will not provide coverage for dentists and dental hygienists for correctional practice due to the fact that inmates can be extremely litigious, even though most claims are determined to be frivolous and are subsequently dismissed. Unfortunately, the Board does not believe it has the statutory authority to waive the requirement for malpractice insurance. The Board would, however, support an amendment to the act if the DOC determines one is warranted.
A number of certified school dental hygienists commented in opposition to the proposed rulemaking because they believed that the Board intended to permit public health dental hygiene practitioners to work in public schools without meeting the requirements of the Department of Health and the Department of Education, which require school dental hygienists to hold both a license issued by the Board and a certificate issued by the Department of Education. The Board believes the amendments to § 33.205b(c)(1) described previously clarify that a public health dental hygiene practitioner may only practice in schools in accordance with the applicable laws and regulations of the Department of Health and the Department of Education.
Dr. Charles M. Ludwig, a former member of the Board, commented in opposition to the proposed amendments. He suggested that because in 1993, the Board unsuccessfully tried to add the administration of local anesthesia and nitrous oxide/oxygen conscious sedation to the scope of practice for dental hygienists, the Board may not again propose to add the administration of local anesthesia at this point in time. The Board would point out that, in amending the act in 2002, the General Assembly specifically addressed the administration of anesthesia. The 2002 amendments to section 11.4 of the law reserve the administration of general anesthesia, deep sedation, conscious sedation and nitrous oxide/oxygen analgesia to dentists. The General Assembly did not at that time restrict the administration of local anesthesia. The Board believes that had the General Assembly intended to restrict the administration of local anesthesia to dentists, it would have done so at that time. Because it did not, it is within the authority of the Board to determine whether the administration of local anesthesia is a procedure that may be safely delegated to dental hygienists.
Dr. Ludwig also suggested that Act 51 is unconstitutional because it creates conflicting provisions in the law. Specifically, he suggested that a public health dental hygiene practitioner is prohibited from diagnosis and treatment planning, yet they would need to do a certain amount of diagnosis and treatment planning to determine what dental hygiene services to provide to a patient. The Board is without the authority to rule on the constitutionality of a statute passed by the General Assembly and signed by the Governor. The Board's role is to implement the provisions of Act 51. These regulations are intended to implement the law in accordance with the legislative mandate. Dr. Ludwig also opposed the amendment to § 33.102 (relating to professional education) to license dental hygienists who have graduated from a dental hygiene program accredited by an approved United States Department of Education-recognized regional accrediting agency. However, this amendment was made by Act 51, and the Board is simply amending its regulations to conform to the amendment to the act. Dr. Ludwig further objects to the Board's proposed amendment to the definition of ''general supervision.'' The Board believes that Dr. Ludwig misapprehends the amendment's intent. This provision does not give the hygienist up to 1 year to schedule a procedure assigned by the dentist as the hygienist sees fit, as Dr. Ludwig would suggest. It is not a ''wait period'' added for the convenience of the hygienist. It is not intended to delay treatment for up to 1 year. It essentially gives the dentist the authority to assign up to 1 year's worth of dental hygiene procedures to a dental hygienist, which could then be completed by the dental hygienist even if the dentist is not physically present in the facility at the time the procedures are performed. The dentist is still responsible for examining the patient, developing the treatment plan, authorizing the dental hygienist to perform the procedures, and taking full professional responsibility for the completed procedures. The Board believes this change, allowing the dentist the flexibility to authorize dental hygiene services up to 1 year in advance, rather than 90 days, will provide more efficiency in the delivery of dental hygiene services and increase access to care for this Commonwealth's citizens.
Finally, Dr. Ludwig objects to the creation of two standards of dental hygiene care—one for patients in private dental offices, and one for patients in public health settings. The Board disagrees with Dr. Ludwig's assessment. The standard of care for the delivery of dental hygiene services is the same regardless of the setting in which it is performed. A dental hygienist shall always conform to the standards of acceptable and prevailing dental hygiene practice in this Commonwealth. The only difference is how closely the hygienist is supervised by a dentist in the provision of those services.
On the other hand, some licensed dentists commented in favor of the proposed rulemaking. One dentist commented that the proposed amendments are needed because dental hygienists are well-educated and clinically competent dental professionals and an integral part of the dental health team. For the most part, those dentists who supported the proposed rulemaking felt that local anesthesia should be included in the scope of practice of a dental hygienist. They also noted that the changes would enable dental hygienists to improve the oral health of the citizens of this Commonwealth by providing necessary preventive oral health care.
A large number of commentators from the dental hygiene community, including educators, practicing dental hygienists and students currently enrolled in dental hygiene programs throughout this Commonwealth, wrote in support of the proposed amendments. They believe that the proposed amendments will expand public access to early and essential preventative dental heath services and ultimately lead to the reduction in more complex and costly dental care. They also believe that the changes will keep this Commonwealth from losing the best and the brightest hygienists due to lack of career choices and autonomy. Many of those who work in the public health field urged the Board to consider adding Federally-qualified health center look-alikes and free and reduced-fee nonprofit dental clinics to the practice sites for public health dental hygiene practitioners. The Board has responded by making these changes. Many of the dental hygienists who commented joined the PDHA in recommending input from the dental hygienist into the decision of the level of supervision required. As noted previously, the Board has responded by making amendments to the final-form rulemaking.
Description of Amendments
The definition of ''general supervision'' in § 33.1 is amended to extend general supervision to dental hygiene services to be performed within 1 year of an examination by a dentist, instead of the current standard of 90 days. Section 33.1 is also amended to define the terms ''local anesthesia,'' ''public health dental hygiene practitioner'' and ''subgingival agents.''
Section 33.3 (relating to fees) is amended to include the fees necessary for processing applications for and biennial renewal of local anesthesia permits and public health dental hygiene practitioner certificates.
Section 33.102 is amended to comport with changes made by Act 51.
Section 33.115 is added to set forth the requirement for a dental hygienist to secure a permit prior to administering local anesthesia. This section also sets forth the qualifications required by the Board for a dental hygienist to both secure and maintain a local anesthesia permit. This section has been amended in the final-form rulemaking to include the substantive language that had been included in the definition of ''local anesthesia'' in the proposed rulemaking and to clarify the types of documentation necessary to support an application for a local anesthesia permit.
Section 33.116 is added to implement the provisions of Act 51. This section has also been amended in the final-form rulemaking to clarify the types of documentation necessary to demonstrate the qualifications for a public health dental hygiene practitioner certificate and to correct a typographical error in the proposed rulemaking.
Section 33.205 is amended to make some minor changes to the description of certain dental hygiene services and to include the administration of local anesthesia by regional injection within the scope of practice of a dental hygienist in accordance with § 33.115. In addition, subsection (d)(1) pertaining to supervision requirements for dental hygienists in dental offices is amended in its entirety as a result of Act 51 which abrogated the prior language. In the final-form rulemaking, this section has been amended to include input from the dental hygienist into the decision regarding the level of supervision required, and to define ''direct supervision'' with regard to the administration of local anesthesia.
The Board adds § 33.205b to set forth the standards for public health dental hygiene practitioners in accordance with Act 51. Subsection (a) addresses the scope of practice of public health dental hygiene practitioners. Subsection (b) incorporates the requirement of referral set forth in Act 51. Subsection (c) establishes the practice settings in which a public health dental hygiene practitioner would be authorized to practice without supervision. This subsection has been amended in the final-form rulemaking to further define ''schools,'' ''correctional facilities'' and ''federally qualified health centers'' and to add Federally- qualified health center look-alikes, and free and reduced-fee health clinics to the list of practice sites for public health dental hygiene practitioners. It has also been amended to clarify that public health dental hygiene practitioners who wish to work in public schools must continue to comply with the regulations of the Department of Health and Department of Education, that is, they must hold a license from the Board and a certifica-tion from the Department of Education. In subsection (d), the Board establishes minimum standards for recordkeeping by public health dental hygiene practitioners.
The Board also is amending its regulations relating to the performance of radiologic procedures in Subchapter D. Section 33.301 is amended to establish the Radiation Health and Safety examination administered by the Dental Assisting National Board (DANB) as the required examination for auxiliary personnel who wish to administer ionizing radiation in a dental office. Section 33.302 is amended to comport with changes made by Act 51. In the final-form rulemaking, this section and the title of subchapter D have been renamed to reflect the fact that public health dental hygiene practitioners are not ''auxiliary personnel'' as that term is defined in § 33.1. In addition, at the suggestion of the PAGD and PDA, this section has been amended to include a requirement that public health dental hygiene practitioners provide to the patient a copy of the radiograph and a referral to a dentist for further evaluation and possible treatment. The amendment would also require dentists to review the radiograph, examine the patient and report any findings to the patient and the public health dental hygiene practitioner.
Finally, the Board is amending § 33.402 to permit dental hygienists to complete no more than three of the required 20 hours of continuing education in courses relating to communication skills; to require public health dental hygiene practitioners to complete five of the required 20 hours in public health-related courses; to permit public health dental hygiene practitioners who are also certified educational specialists by the Department of Education to submit evidence of compliance with section 1205.2 of the Public School Code (24 P. S. § 12-1205.2) to meet the 20-hour continuing education requirement; and to require dental hygienists who hold anesthesia permits to complete three of the required 20 hours in courses related to the administration of local anesthesia, including pharmacology or related courses.
Fiscal Impact and Paperwork Requirements
The amendments should have no fiscal impact on the Commonwealth or its political subdivisions because the costs associated with processing the local anesthesia permits and public health dental hygiene practitioner certificates will be borne by applicants. Dental hygienists who apply for local anesthesia permits will incur some costs associated with the permit application and renewal fees and possibly the costs of completing a local anesthesia course. Dental hygienists who wish to obtain certification as public health dental hygiene practitioners will incur costs associated with the permit application and biennial renewal fees. There are currently approximately 8,163 licensed dental hygienists in this Commonwealth. The Board has no way of knowing how many dental hygienists will apply for the local anesthesia permit or the public health dental hygiene practitioner certificate.
The amendments will require the Board to develop applications for the local anesthesia permit, public health dental hygiene practitioner certificate, and biennial renewal forms for each of these credentials, 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)), the Board submitted a copy of the notice of proposed rulemaking, published at 38 Pa.B. 4777, to IRRC, the Senate Consumer Protection and Professional Licensure Committee (SCP/PLC) and the HPLC for review and comment.
In compliance with section 5(c) of the Regulatory Review Act, the Board also provided IRRC, the SCP/PLC and the HPLC with copies of comments received as well as other documents when requested. In preparing the final-form regulations, the Board has considered the comments received from IRRC, the HPLC and the public.
Under section 5.1(j.2) of the Regulatory Review Act (71 P. S. § 745.5a(j.2)), these final-form regulations were approved by the HPLC on October 7, 2009, and deemed approved by the SCP/PLC on November 4, 2009. Under section 5.1(e) of the Regulatory Review Act, IRRC met on November 5, 2009, and approved the final-form regulation.
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 State Board of Dentistry 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 (relating to notice of proposed rulemaking required; and adoption of regulations).
(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 proposed rulemaking published at 38 Pa.B. 4777.
(4) This final-form rulemaking is necessary and appropriate for administering and enforcing the authorizing act identified in this preamble.
Order
The State Board of Dentistry, acting under its authorizing statutes, orders that:
(a) The regulations of the Board, 49 Pa. Code Chapter 33, are amended by amending §§ 33.1, 33.3, 33.102, 33.205, 33.301, 33.302 and 33.402, and by adding §§ 33.115, 33.116 and 33.205b to read as set forth in Annex A, with ellipses referring to the existing text of the regulations.
(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.
JOHN V. REITZ, D.D.S.,
Chairperson(Editor's Note: For the text of the order of the Independent Regulatory Review Commission relating to this document, see 39 Pa.B. 6705 (November 21, 2009).)
Fiscal Note: Fiscal Note 16A-4617 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:
* * * * * General supervision—In a dental facility, supervision by a dentist who examines the patient, develops a treatment plan, authorizes the performance of dental hygiene services to be performed within 1 year of the examination, and takes full professional responsibility for the performance of the dental hygienist. In facilities identified in § 33.205(c)(2) and (3) (relating to practice as a dental hygientist), general supervision is defined in § 33.205(d)(2).
* * * * * Local anesthesia—The elimination of sensations, especially pain, in one part of the body by regional injection of an anesthetic agent.
* * * * * Public health dental hygiene practitioner—A licensed dental hygienist who is certified by the Board as having met the requirements of section 11.9 of the act (63 P. S. § 130j), and who is authorized to perform dental hygiene services in accordance with § 33.205b (relating to practice as a public health dental hygiene practitioner) without the authorization, assignment or examination of a dentist.
* * * * * Subgingival agents—Therapeutic agents, including antimicrobials, antibiotics, antiseptics or anesthetics, placed below the free margin of the gingiva by a local delivery system or device, including injectable systems for ointments, gels or pastes, and degradable or nondegradable devices, such as fibers, films, strips, slabs, spheres, discs or chips.
§ 33.3. Fees.
(a) Following is the schedule of fees charged by the Board:
Application fee—dentists, dental hygienists and expanded function dental assistants $20 Application fee—certificate of public health dental hygiene practitioner $20 Application fee—local anesthesia permit $20 Criteria approval application fee—dentists, dental hygienists and expanded function dental assist-
ants$35 Fictitious name registration fee $35 Verification of license, permit or registration fee—dentists, dental hygienists and expanded function dental assistants $15 Certification of scores, permit or registration fee—dentists, dental hygienists and expanded function dental assistants $25 Biennial renewal fee—dentists (for the renewal period beginning April 1, 2005, and thereafter) $250 Biennial renewal fee—dental hygienists $40 Biennial renewal fee—expanded function dental assistants $25 Biennial renewal fee—certificate of public health dental hygiene practitioner $40 Biennial renewal fee—local anesthesia permit $40 Temporary permit—expanded dental assistants $15 Application fee—dental radiology authorization $20 Notification application—postgraduate training or faculty member $25 (b) For fees related to anesthesia permits, refer to § 33.339 (relating to fees for issuance of permits).
Subchapter B. LICENSURE OF DENTISTS AND DENTAL HYGIENISTS § 33.102. Professional education.
(a) Dentists.
(1) Candidates for licensure as dentists shall show compliance with section 3(c) of the act (63 P. S. § 122(c)) which requires a diploma from an ''approved institution or college,'' by submitting certification of graduation from a dental school accredited or provisionally accredited by the Commission on Accreditation of the American Dental Association.
(2) Candidates for licensure who received their professional education outside the United States in a nonaccredited school may satisfy the education requirement by submitting their credentials to an accredited or provisionally accredited school and obtaining additional preclinical and clinical training that will lead to the awarding of the D.M.D. or D.D.S. degree by that school.
(b) Dental hygienists.
(1) Candidates for licensure as dental hygienists shall show compliance with section 3(d) of the act by submitting certification of graduation from a dental hygiene school accredited or provisionally accredited by an approved United States Department of Education-recognized regional accrediting agency or the Commission on Dental Accreditation (CODA) of the American Dental Association, if the school's dental hygiene course of study comprises a minimum of 2 years of at least 32 weeks of at least 30 hours each week or its equivalent.
(2) Candidates for licensure who received their professional education outside the United States in a nonaccredited school may satisy the education requirement by submitting their credentials to an accredited or provisionally accredited school and obtaining additional training that will lead to the awarding of a degree in dental hygiene by that school.
(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 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 Accreditation of the American Dental Association.
(iii) Completion of a 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 of the American Dental Association.
(B) An accrediting agency approved by the United States Department of Education Council on Postsecondary Accreditation whose expanded function educational standards are approved by the Board.
(2) 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) 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.
§ 33.115. Local anesthesia permit.
(a) Permit required. A dental hygienist shall possess a current permit issued by the Board under this section before administering local anesthesia to a patient in a dental office. For purposes of this section, the term ''local anesthesia'' includes local infiltration anesthesia and intraoral nerve block anesthesia limited to the 2nd (maxillary) and 3rd (mandibular) divisions of the trigeminal nerve.
(b) Application. A dental hygienist who desires to obtain a permit to administer local anesthesia shall submit an application on a form provided by the Board, pay the permit fee prescribed in § 33.3 (relating to fees) and meet the qualifications for the permit as prescribed in this section.
(c) Qualifications. To obtain a local anesthesia permit, a dental hygienist shall:
(1) Hold a current license in good standing to practice as a dental hygienist in this Commonwealth.
(2) Hold current certification in Basic Life Support (BLS).
(3) Provide to the Board one of the following:
(i) Certification of education by the dental hygiene program on a form provided by the Board verifying that the dental hygienist graduated, within the 5 years immediately preceding the filing of the application for local anesthesia permit, from a dental hygiene program that meets the following criteria:
(A) The dental hygiene program is accredited by the American Dental Association's Commission on Dental Accreditation (CODA).
(B) The dental hygiene program included the successful completion of a didactic and clinical course in the administration of local anesthesia.
(ii) Certification of education by the dental or dental hygiene program on a form provided by the board verifying that the dental hygienist successfully completed, within the 5 years immediately preceding the filing of the application for local anesthesia permit, a course consisting of a minimum of 30 hours of didactic and clinical instruction in the administration of local anesthesia sponsored by a dental or dental hygiene education program accredited by CODA.
(iii) A certificate or letter of good standing from the proper licensing authority of another state, territory or district of the United States, or of a province or territory of Canada, verifying that the dental hygienist possesses a current license or permit issued by the proper licensing authority of another state, territory or district of the United States, or by the proper licensing authority of a province or territory of Canada, where the dental hygienist is authorized under the laws of that jurisdiction to administer local anesthesia, provided that the following additional conditions are met:
(A) The jurisdiction where the dental hygienist is so licensed or permitted requires completion of a course in the administration of local anesthesia accredited by CODA or by the Commission on Dental Accreditation of Canada (CDAC) prior to obtaining certification, endorsement or other such authority.
(B) The dental hygienist signs a certification statement on the application for a local anesthesia permit verifying that the dental hygienist actively engaged in the administration of local anesthesia under a current license or permit within the 5 years immediately preceding the filing of the application for a local anesthesia permit.
(C) The dental hygienist signs a certification statement on the application for a local anesthesia permit verifying that, at all times prior to filing the application for local anesthesia permit, the dental hygienist administered local anesthesia in accordance with all applicable laws and regulations of the jurisdiction where the dental hygienist is so licensed or permitted.
(D) The jurisdiction where the dental hygienist is so licensed or permitted verifies that there has been no disciplinary action taken against the dental hygienist relating to the administration of local anesthesia.
(d) Expiration and biennial renewal. A local anesthesia permit issued by the Board under this section will expire at the same time as the permitholder's dental hygiene license but may be renewed biennially at the same time the dental hygiene license is renewed. A dental hygienist who desires to renew a local anesthesia permit shall submit the following:
(1) A renewal application on a form provided by the Board.
(2) The permit renewal fee set forth in § 33.3.
(3) Proof of current certification in BLS.
§ 33.116. Certification of public health dental hygiene practitioners.
(a) Application. A licensed dental hygienist who desires to obtain certification as a public health dental hygiene practitioner shall submit an application on a form provided by the Board, pay the application fee prescribed in § 33.3 (relating to fees) and meet the qualifications for certification as prescribed in this section.
(b) Qualifications. To qualify for certification as a public health dental hygiene practitioner, a dental hygienist shall:
(1) Hold a current license in good standing to practice as a dental hygienist in this Commonwealth.
(2) Provide to the Board a certification statement signed by a licensed dentist verifying that the dental hygienist has completed 3,600 hours of practice as a licensed dental hygienist under the supervision of the licensed dentist.
(3) Provide to the Board documentation demonstrating that the dental hygienist has obtained professional liability insurance or is a named insured covered by a group policy in the minimum amount of $1,000,000 per occurrence and $3,000,000 per annual aggregate. This documentation may include a certificate of insurance issued by the insurer, or a copy of the declarations page of the professional liability insurance policy.
(c) Expiration and biennial renewal. A certificate issued by the Board under this section will expire at the same time as the certificateholder's dental hygiene license but may be renewed biennially at the same time the dental hygiene license is renewed. A dental hygienist who desires to renew a public health dental hygiene practitioner certificate shall submit the following:
(1) A renewal application on a form provided by the Board.
(2) The permit renewal fee set forth in § 33.3.
Subchapter C. MINIMUM STANDARDS OF CONDUCT AND PRACTICE § 33.205. Practice as a dental hygienist.
(a) Scope of professional practice. A dental hygienist may offer to perform or perform services that involve:
(1) Placement of subgingival agents.
(2) Periodontal probing, scaling, root planning, polishing or another procedure required to remove calculus deposits, accretions, excess or flash restorative materials and stains from the exposed surfaces of the teeth and beneath the gingiva.
(3) Evaluation of the patient to collect data to identify dental hygiene care needs.
(4) The application of fluorides and other recognized topical agents for the prevention of oral diseases.
(5) Conditioning of teeth for and application of sealants.
(6) Taking of impressions of the teeth for athletic appliances.
(7) Administration of local anesthesia by regional injection in accordance with § 33.115 (relating to local anesthesia permit).
(b) Prohibition against independent practice. A dental hygienist is prohibited from establishing or maintaining an office or other workplace for the provision of dental hygiene services separate or independent from the office or other workplace in which the supervision of a dentist is provided.
(c) Practice sites. A dental hygienist may engage in professional practice at the following sites under the supervision of a dentist as required in subsection (d):
(1) In dental facilities.
(2) In public or private institutions such as schools, hospitals, public health care agencies, nursing homes, mobile health units and homes for juveniles, the elderly and the handicapped.
(3) In institutions under the jurisdiction of Federal, State or local health agencies.
(d) Supervision.
(1) In subsection (c)(1) practice sites (dental facilities), a dental hygienist shall provide professional services as follows:
(i) A dental hygienist may provide the professional services identified in subsection (a)(1) under the direct supervision of a dentist, except that these services may be provided under general supervision if the dentist has reviewed the patient's dental records and medical history and has written a prescription or given an order for the placement of subgingival agents by the dental hygienist.
(ii) A dental hygienist may provide the professional services identified in subsection (a)(2) under the general supervision of a dentist when the patient is free of systemic disease or suffers from mild systemic disease, as determined by the dentist with input from the dental hygienist and upon review of the patient's medical history.
(iii) A dental hygienist may provide the professional services identified in subsection (a)(2) under the direct supervision of a dentist when the patient is suffering from systemic disease which is severe, incapacitating, or life threatening, as determined by the dentist with input from the dental hygienist and upon review of the patient's medical history.
(iv) A dental hygienist may provide the professional services identified in subsection (a)(3)—(6) under the general supervision of a dentist.
(v) A dental hygienist may provide the professional services identified in subsection (a)(7) only under the direct supervision of a dentist. For purposes of this subparagraph, direct supervision means supervision by a dentist who has examined the patient and authorized the procedure to be performed, is physically present in the dental facility and available during the performance of the procedure, and takes full professional responsibility for the completed procedure.
(2) In subsection (c)(2) and (3) practice sites (public and private institutions and institutions under the jurisdiction of Federal, State or local health agencies), a dental hygienist shall provide professional services as follows:
(i) A dental hygienist may provide the professioinal services identified in subsection (a)(1) under the direct supervision of a dentist, except that these services may be provided under general supervision if a dentist has reviewed the patient's dental records and medical history and has written a prescription or given an order for the placement of subgingival agents by the dental hygienist.
(ii) A dental hygienist may provide the professional services identified in subsection (a)(3)—(6) under the general supervision of a dentist. For the purposes of this paragraph, general supervision is defined as supervision by a dentist who authorizes and takes full professional responsibility for the provision of the services. A single authorization may, when appropriate, apply to one or more classes or categories of students/patients.
(iii) A dental hygienist may provide the professional service identified in subsection (a)(7) only under the direct supervision of a dentist. For purposes of this subparagraph, direct supervision means supervision by a dentist who has examined the patient and authorized the procedure to be performed, is physically present and available during the performance of the procedure, and takes full professional responsibility for the completed procedure.
(3) For professional services not identified in subsection (a)(1)—(7) or § 33.302 (relating to auxiliary personnel performing radiologic procedures), the dentist shall compare the listed services and the supervision required with the unlisted service and utilize the appropriate supervision. Supervision for noncomparable services will be determined by the Board on a modality basis.
(4) Notwithstanding the supervision requirements in this subsection, a dental hygienist may provide oral health education and perform preliminary dental screenings in any setting without the supervision of a dentist.
§ 33.205b. Practice as a public health dental hygiene practitioner.
(a) Scope of professional practice. A public health dental hygiene practioner may perform the dental hygiene services set forth in § 33.205(a)(2)—(6) (relating to practice as a dental hygienist) in the practice settings identified in subsection (c) without the authorization, assignment or examination by a dentist. A public health dental hygiene practitioner may perform the dental hygiene services set forth § 33.205(a)(1) and (7) in accordance with § 33.205(d).
(b) Requirement of referral. A public health dental hygiene practitioner shall refer each patient to a licensed dentist on an annual basic. Documentation of the referral must be maintained in the patient's dental record. The failure of the patient to see a dentist as referred will not prevent the public health dental hygiene practitioner from continuing to provide dental hygiene services to the patient within the scope of professional practice set forth in subsection (a).
(c) Practice settings. A public health dental hygiene practitioner may perform dental hygiene services without the supervision of a dentist in the following practice settings:
(1) Public and private educational institutions that provide elementary and secondary instruction to school aged children under the jurisdiction of the State Board of Education, and in accordance with all applicable provisions of the Public School Code of 1949 (24 P. S. §§ 1-101—27-2702.), the regulations relating to the certification of professional personnel in 22 Pa. Code Chapter 49 (relating to certification of professional personnel), and the regulations of the Department of Health in 28 Pa. Code § 23.35 (relating to dental hygienists).
(2) Correctional facilities. For purposes of this section, correctional facilities include Federal prisons and other institutions under the jurisdiction of the United States Department of Justice, Bureau of Prisons which are located within this Commonwealth; institutions, motivational boot camps and community corrections centers operated or contracted by the Department of Corrections; and jails, prisons, detention facilities or correctional institutions operated or contracted by local, county or regional prison authorities within this Commonwealth.
(3) Health care facilities, as defined in section 802.1 of the Health Care Facilities Act (35 P. S. § 802a).
(4) Personal care homes, as defined in section 1001 Public Welfare Code (62 P. S. § 1001).
(5) Domiciliary care facilities, as defined in section 2202-A of The Administrative Code of 1929 (71 P. S. § 581-2).
(6) Older adult daily living centers, as defined in section 2 of the Older Adult Daily Living Centers Licensing Act (62 P. S. § 10225.102).
(7) Continuing-care provider facilities, as defined in section 3 of the Continuing-Care Provider Registration and Disclosure Act (40 P. S. § 3203).
(8) Federally-qualified health centers, as defined in section 1905(1)(2)(B) of the Social Security Act (42 U.S.C.A. § 1369(1)(2)(B)). For purposes of this section, the term includes Federally-qualified health center lookalikes that do not receiver grant funds under section 330 of the Public Health Service Act (42 U.S.C.A. § 254b).
(9) Public or private institutions under the jurisdiction of a Federal, State or local agency.
(10) Free and reduced-fee nonprofit health clinics.
(d) Recordkeeping. A public health dental hygiene practitioner shall maintain a dental record which accurately, legibly and completely reflects the dental hygiene services provided to the patient. The dental record must be retained for at least 5 years from the date of the last treatment entry. The dental record must include, at a minimum, the following:
(1) The name and address of the patient and, if the patient is a minor, the name of the patient's parents or legal guardian.
(2) The date dental hygiene services are provided.
(3) A description of the treatment or services rendered at each visit.
(4) The date and type of radiographs taken, if any, and documentation demonstrating the necessity or justification for taking radiographs, as well as the radiographs themselves.
(5) Documentation of the annual referral to a dentist.
Subchapter D. PERFORMANCE OF RADIOLOGIC PROCEDURES § 33.301. Definitions.
The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise:
Ionizing radiation—
(i) Gamma rays and X-rays; alpha and beta particles, high-speed electrons, neutrons, protons and other nuclear particles.
(ii) The term does not include ultrasound, sound or radio waves or visible, infrared or ultraviolet light.
Premises of the dentist—A location at which a dentist practices dentistry, other than a health care facility regulated by the Department of Health, Department of Public Welfare or the Federal government.
Radiologic procedure—A dental diagnostic procedure that utilizes ionizing radiaiton.
Radiologic procedure examination—The Radiation Health and Safety examination administered by The Dental Assisting National Board, Inc. (DANB).
§ 33.302. Requirements for personnel performing radiologic procedures.
(a) Public health dental hygiene practitioners may perform radiologic procedures in those settings set forth in § 33.205b(c) (relating to practice as a public health dental hygiene practitioner) without the supervision of a dentist. Public health dental hygiene practitioners shall take radiographs under this section in accordance with the following:
(1) Within 30 days of taking a radiograph, the public health dental hygiene practitioner shall provide to the patient a copy of the radiograph and a referral to a dentist indicating the reason the radiograph was taken and any observations noted by the public health dental hygiene pracitioner.
(2) The public health dental hygiene practitioner shall instruct the patient to consult with the dentist as indicated on the referral form.
(3) Upon presentation by the patient, the dentist shall perform an examiniation of the patient, review the radiograph and report any diagnosis to the public health dental hygiene practitioner and the patient.
(b) Dental hygienists may perform radiologic procedures in any setting under the general supervision of a licensed dentist. For the purpose of this subsection, ''general supervision'' means supervision by a dentist who examines the patient, develops a dental treatment plan, authorizes the performance of the radiologic services to be performed within 1 year of the examination, and takes full professional responsibility for performance of the dental hygienist.
(c) Auxiliary personnel who have passed the radiologic procedure examination adopted by the Board may perform radiologic procedures on the permises of a dentist under the direct supervision of a dentist. The dentist shall be on the premises when a radiologic procedure is performed, but is not required to personally observe performance of the procedure.
Subchapter F. CONTINUING DENTAL EDUCATION § 33.402. Continuing education subject areas.
(a) Except as provided in subections (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 act 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 three of the required 20 hours of continuing education in courses related to the administration of local anesthesia, including pharmacology or other related courses.
[Pa.B. Doc. No. 09-2275. Filed for public inspection December 11, 2009, 9:00 a.m.]
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