Title of Regulation: 18VAC60-20. Regulations Governing Dental Practice (amending 18VAC60-20-195).

Statutory Authority: § 54.1-2400 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: November 21, 2012.

Effective Date: December 6, 2012.

Agency Contact: Sandra Reen, Executive Director, Board of Dentistry, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463, telephone (804) 367-4538, FAX (804) 527-4428, or email sandra.reen@dhp.virginia.gov.

Basis: Section 54.1-2400 of the Code of Virginia provides the Board of Dentistry the authority to promulgate regulations to administer the regulatory system. The Dental Practice Act (Chapter 27 of Title 54.1) permits the practice of dental assistants.

Purpose: The purpose of the amended regulation is to state more clearly the qualifications necessary for an unlicensed person to obtain certification in radiation safety. Without the amendments, dental hygiene and dental assisting programs are not clearly authorized to offer radiation safety courses. Persons who want to become dental assistants have fewer options to qualify them to place and expose dental x-rays, so there is concern about unavailability of qualified persons to perform those tasks in dental offices.

Additionally, the current regulations are unclear about which course and examination from the Dental Assisting National Board is acceptable. Without clarity in regulation, a person may present himself as "certified" by a short, three-hour refresher course, rather than the Radiation Health and Safety Review Course (12 hours) intended to cover the full scope of dental radiation safety. Such inadequate preparation could endanger the health and safety of dental patients throughout the Commonwealth.

Rationale for Using Fast-Track Process: The fast-track rulemaking process is necessary because all parties agree that recent changes to 18VAC60-20-195 eliminating "board-approved" courses and examinations has resulted in a reduction in the availability of radiation safety certification for unlicensed persons who assist in dental offices. The rule proposed by fast-track action is supported by submission of three petitions for rulemaking and numerous comments in support of those petitions.

Substance: The proposed amendments clarify the qualifications necessary for an unlicensed person to obtain certification in radiation safety. The proposal includes options for (i) a course and examination offered by a dental assisting or dental hygiene program accredited by the Commission on Dental Accreditation and (ii) a specific course provided by the Dental Assisting National Board.

Issues: The primary advantage to the public is a regulation that clearly states the qualification options for persons who will be employed by dentists to expose x-rays in their offices. If clearly stated and accurate, the options for certification will be more attainable and offer greater protection for the public. The primary advantage to the agency is clarity in the rules to reduce the number of questions and be responsive to petitions. There are no disadvantages to the public or the agency.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Board of Dentistry (Board) proposes to clarify the qualifications necessary for an unlicensed person to obtain certification in radiation safety.

Result of Analysis. The benefits likely exceed the costs for all proposed changes.

Estimated Economic Impact. In January 2011, the State Council of Higher Education (SCHEV) sought clarification from the Board about courses offered in dental radiation that claim to be in compliance with regulatory requirements of the Board. The Executive Director of the Board, after consultation with counsel, informed SCHEV that, in fact, the Board has no statutory authority to approve radiation safety courses and that regulations incorrectly state that there are guidelines or criteria for such approval.

Given the dilemma created by the existence of a regulation for which statutory authority does not exist and the problems for students who want to be certified and for schools seeking to offer radiation safety courses, the Board acted to eliminate option (iii) in Section 195 that references compliance with guidelines of the Board. Three options for radiation safety certification remain: 1) completion of a course and examination recognized by the Commission on Dental Accreditation of the American Dental Association, 2) certification by the American Registry of Radiologic Technologists, or 3) satisfactorily completed a radiation course and passed an examination given by the Dental Assisting National Board.

Subsequently, the Board received three petitions for rulemaking asserting that the elimination of a Board approved course and examination had created a dearth of available courses and a hardship for persons who wanted to be certified to expose x-rays. To resolve the problem in the short term, the Board decided to issue a guidance document stating that it interprets the "course or examination recognized by the Commission on Dental Accreditation of the American Dental Association" to include a "course with examination provided by a dental assisting, dental hygiene or dentistry program accredited by the Commission on Dental Accreditation of the American Dental Association." (Guidance document 60-20).

This interpretation will allow Commission on Dental Accreditation of the American Dental Association (CODA)-accredited dental assisting and dental hygiene programs to offer a dental radiation course in order to certify persons to place or expose dental x-ray film in dental offices. Since CODA does not "recognize" courses or examination, the language in the current regulation remains incorrect and confusing. Therefore the Board proposes to amend Section 195 to clarify the authority of institutions with CODA-accredited dental programs to offer courses in radiation safety.

Additionally, regulations of the Department of Health for radiation protection specify that an x-ray machine can only be operated by a licensee of the Department of Health Professions or, in the case of a dental assistant, by someone who complies with the radiation certification requirements for Section 195 of 18VAC60-20-10 et seq. Therefore, it is necessary for someone to be licensed or qualified under Section 195 in order to place and expose x-rays in dental offices.

Without the amendments, dental hygiene and dental assisting programs are not clearly authorized to offer radiation safety courses. Persons who want to become dental assistants have fewer options to qualify them to place and expose dental x-rays, so there is concern about unavailability of qualified persons to perform those tasks in dental offices. Thus the proposed amendments are clearly beneficial and do not introduce any new cost.

Businesses and Entities Affected. The proposed amendments potentially affect persons interested in employment as dental assistants or chair-side assistants who take dental x-rays in dental offices. Since the Department of Health Professions does not regulate dental assistants who take dental x-rays, there is no estimate of the number of positions available and the number of persons who might seek training in radiation safety. There are currently 6,392 licensed dentists in the Commonwealth many of whom likely employ staff who will seek radiation safety certification.

Localities Particularly Affected. The proposed amendments do not disproportionately affect particular localities.

Projected Impact on Employment. The proposed amendments reduce the likelihood that persons interested in employment as dental assistants or chair-side assistants who take dental x-rays are unable to find certification sufficient radiation safety training. Thus, the proposed amendments may have a moderate positive impact on employment.

Effects on the Use and Value of Private Property. The proposed amendments are unlikely to significantly affect the value of private property.

Small Businesses: Costs and Other Effects. The proposed amendments reduce the likelihood that persons interested in employment as dental assistants or chair-side assistants who take dental x-rays are unable to find approved training. Thus, the proposed amendments may moderately reduce potential costs for dental practices to obtain certification-sufficient radiation safety training for staff.

Small Businesses: Alternative Method that Minimizes Adverse Impact. The proposed amendments do not adversely affect small businesses.

Real Estate Development Costs. The proposed amendments are unlikely to significantly affect real estate development costs.

Legal Mandate. The Department of Planning and Budget (DPB) has analyzed the economic impact of this proposed regulation in accordance with § 2.2-4007.04 of the Administrative Process Act and Executive Order Number 14 (10). Section 2.2-4007.04 requires that such economic impact analyses include, but need not be limited to, the projected number of businesses or other entities to whom the regulation would apply, the identity of any localities and types of businesses or other entities particularly affected, the projected number of persons and employment positions to be affected, the projected costs to affected businesses or entities to implement or comply with the regulation, and the impact on the use and value of private property. Further, if the proposed regulation has adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include (i) an identification and estimate of the number of small businesses subject to the regulation; (ii) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the regulation, including the type of professional skills necessary for preparing required reports and other documents; (iii) a statement of the probable effect of the regulation on affected small businesses; and (iv) a description of any less intrusive or less costly alternative methods of achieving the purpose of the regulation. The analysis presented above represents DPB's best estimate of these economic impacts.

Agency's Response to Economic Impact Analysis: The Board of Dentistry concurs with the analysis of the Department of Planning and Budget for the proposed regulation, 18VAC60-20, Regulations Governing the Practice of Dentistry and Dental Hygiene, relating to radiation safety certification.

Summary:

The proposed amendments clarify the qualifications necessary for an unlicensed person to obtain certification in radiation safety. The proposal includes options for (i) a course and examination offered by a dental assisting or dental hygiene program accredited by the Commission on Dental Accreditation or (ii) a specific course provided by the Dental Assisting National Board.

18VAC60-20-195. Radiation certification.

No person not otherwise licensed by this board shall place or expose dental x-ray film unless he has one of the following: (i) satisfactorily completed satisfactory completion of a radiation safety course or and examination recognized given by an institution that maintains a program in dental assisting, dental hygiene, or dentistry accredited by the Commission on Dental Accreditation of the American Dental Association, (ii) been certified certification by the American Registry of Radiologic Technologists, or (iii) satisfactorily completed a radiation course and passed an satisfactory completion of the Radiation Health and Safety Review Course provided by the Dental Assisting National Board or its affiliate and passage of the Radiation Health and Safety examination given by the Dental Assisting National Board. Any certificate issued pursuant to satisfying the requirements of this section shall be posted in plain view of the patient.