Title of Regulation: 18VAC30-20. Regulations Governing the Practice of Audiology and Speech-Language Pathology (adding 18VAC30-20-141).

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

Public Hearing Information:

October 14, 2014 - 9 a.m. - Department of Health Professions, Perimeter Center, 9960 Mayland Drive, Conference Center, 2nd Floor, Training Room 2, Richmond, Virginia 23233

Public Comment Deadline: December 5, 2014.

Agency Contact: Leslie L. Knachel, Executive Director, Board of Audiology and Speech-Language Pathology, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463, telephone (804) 367-4630, FAX (804) 527-4413, or email leslie.knachel@dhp.virginia.gov.

Basis: Regulations Governing the Practice of Audiology and Speech-Language Pathology (18VAC30-20) are promulgated under the general authority of § 54.1-2400 of the Code of Virginia. Subdivision 6 of § 54.1-2400 provides the Board of Audiology and Speech-Language Pathology the authority to promulgate regulations to administer the regulatory system. In addition, the board has general authority to promulgate regulations specifying additional training as necessary pursuant to § 54.1-103 of the Code of Virginia.

Purpose: The purpose of the proposed regulatory action is to establish rules for the training, supervision, and practice of speech-language pathologists (SLPs) in the performance of fiber-optic endoscopic evaluation of swallowing (FEES). This regulation is needed because the board's policy statement (guidance document) states that an SLP who performs FEES must be "specially trained" and work under the supervision of a physician provided protocols are in place for emergency response.

While the board's guidance document is helpful to the practitioner community, it is not enforceable and does not set forth regulations delineating the meaning of "specially trained." Therefore, SLPs do not have a clear standard for their training and practice, and the board would have difficulty sanctioning an SLP for inadequate training and supervision. There is concern that patient safety and appropriate treatment could be compromised if SLPs perform FEES improperly and without necessary physician supervision and guidance. Proposed regulations will establish specific regulations to address those concerns.

Substance: Proposed regulations set forth the requirements for educational qualifications, supervised experience, and certification for performance of an endoscopic evaluation of swallowing by speech-language pathologists. Additional requirements for endoscopic evaluation include referral from a qualified physician, performance in a health care facility with protocols for emergency medical backup, and reports to the referring physician.

Issues: The primary advantage to the public is access to qualified health care practitioners to perform an evaluative procedure for patients with the protection of appropriate training, supervision, and protocols for emergencies. Patients who have difficulty with transportation or positioning issues may be evaluated in a setting where there is a physician readily available. There are no disadvantages because the requirements are consistent with requirements in other states and with professional standards for FEES. There are no advantages or disadvantages to the agency or the Commonwealth.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Board of Audiology and Speech-Language Pathology (the Board) proposes to require 1) that speech language pathologists complete 12 hours of education on endoscopic procedures if they are interested in performing such procedures, 2) that speech language pathologists performing endoscopic procedures maintain a current certification in basic life support, and 3) that successful performance of at least 25 flexible endoscopic procedures under supervision to be permitted to perform such procedures without supervision.

Result of Analysis. There is insufficient data to accurately compare the magnitude of the benefits versus the costs. Detailed analysis of the benefits and costs can be found in the next section.

Estimated Economic Impact. The Board proposes a few new regulatory requirements and numerous clarifying changes for speech language pathologists. The Board also proposes a grandfathering provision for persons who are currently practicing to continue their practice without meeting new requirements. So, the new requirements will apply to speech language pathologists who wish to perform endoscopic procedures after the effective date of these proposed changes.

One of the proposed changes will require that speech language pathologists complete 12 hours of education on endoscopic procedures if they are interested in performing such procedures. According to Department of Health Professions (DHP) endoscopic courses appear to cost approximately $75 for 2-3 hours and $380 for 10 hours. The proposed endoscopic courses can be counted toward existing continuing education requirements. Thus, this proposed change may or may not add to the compliance costs of speech language pathologists depending on whether they use the proposed new education on endoscopic procedures in fulfillment of their continuing education requirements. Similarly, this change will add to the demand for endoscopic courses offered by approved providers. Whether or not this demand will add to the provider revenues will depend on whether the speech language pathologists will take these courses in addition to their regular continuing education courses or in lieu of the continuing education courses they are currently taking.

Another proposed change will require that speech language pathologists performing endoscopic procedures maintain a current certification in basic life support. According to DHP, while this is a new requirement for the speech language pathologists, most of them already maintain this certification because it is commonly required by health care institutions where speech language pathologists work. However, if a speech language pathologist is currently not required to maintain certification in basic life support by his or her employer, this proposed requirement is expected to create additional compliance costs. Initial certification or renewal, which generally last two years, is expected to cost approximately $40 - $60 in tuition, approximately 2 – 4 hours to complete the curriculum, travel time and travel expenses, and classroom supplies. Similarly, providers of basic life support training would see an increase in demand for their services proportional to the number of speech language pathologists who will have to maintain current certification due to this proposed change.

Another proposed change will require successful performance of at least 25 flexible endoscopic procedures under supervision to be permitted to perform such procedures without supervision. According to DHP, while this is a new requirement, a hospital would typically require 25 or more procedures to be performed under supervision before it would credential a speech language pathologist to do endoscopic procedures. If all of the speech language pathologists complete at least 25 procedures under supervision, the proposed changes would not add to the compliance costs. However, if a speech language pathologist is currently required by his or her employer to complete less than 25 procedures, this proposed change represents additional costs that may be associated with performing additional procedures under supervision.

The main benefit of the proposed continuing education, maintaining certification in basic life support, and performing a specific number of endoscopic procedures is to make sure that practitioners who are allowed to assist in evaluation of swallowing disorders are qualified and trained to deal with unexpected situations.

Remaining proposed changes include clarifications of current processes, policies, or statutory requirements. Since all of these requirements are currently enforced in practice, no significant economic effect is expected other than improving the clarity of the requirements processes, policies, or statutory requirements enforced under these regulations.

Businesses and Entities Affected. There are approximately 3,737 licensed speech language pathologists in Virginia. However, the number of speech language pathologists who may be interested in endoscopic procedures is expected to be small.

Localities Particularly Affected. The proposed regulations apply throughout the Commonwealth.

Projected Impact on Employment. If the speech language pathologists interested in endoscopic procedures are already meeting the proposed requirements on continuing education, maintaining certification in basic life support, and performing a specific number of endoscopic procedures, no significant effect on employment would be expected. If the proposed changes force them to take additional continuing education courses, obtain certification in basic life support, and perform additional number of endoscopic procedures, an increase in their compliance costs would be expected. If the increase in compliance costs is significant, a decrease in speech language pathologists' demand for labor may occur. On the other hand, an increase in demand for labor to provide additional continuing education, to obtain certification in basic life support, and to perform additional number of endoscopic procedures may also occur.

Effects on the Use and Value of Private Property. Similarly, if the speech language pathologists are already meeting the proposed standards in the absence of regulations no effect on the asset value of their practices would be expected. Otherwise, an increase in the compliance costs would decrease the asset value of their practices.

Small Businesses: Costs and Other Effects. According to DHP, speech language pathologists typically work in large school or hospital systems or as a part of a physician practice. However, for those speech language pathologist practices that may be considered as small business, the proposed changes would introduce costs and other effects unless they already meet the proposed standards.

Small Businesses: Alternative Method that Minimizes Adverse Impact. There is no known alternative method that minimizes the adverse impact while accomplishing the same goals.

Real Estate Development Costs. No impact on real estate development costs is expected.

Legal Mandate. The Department of Planning and Budget (DPB) has analyzed the economic impact of this proposed regulation in accordance with § 2.2-4007.4 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 Audiology and Speech-Language Pathology concurs with the economic impact analysis of the Department of Planning and Budget.

Summary:

The proposed regulation sets forth (i) the educational qualifications, the supervised experience, and the certification necessary for a speech-language pathologist to perform an endoscopic evaluation of swallowing and (ii) requirements for endoscopic evaluation that include referral from a qualified physician, performance in a health care facility with protocols for emergency medical backup, and reports to the referring physician.

18VAC30-20-141. Performance of flexible endoscopic evaluation of swallowing.

A. For the purposes of this section, an endoscopic procedure shall mean a flexible endoscopic evaluation of swallowing limited to the use of flexible endoscopes to observe, collect data, and measure the parameters of swallowing for the purposes of functional assessment and therapy planning.

B. A speech-language pathologist who performs an endoscopic procedure shall meet the following qualifications:

1. Completion of a course or courses or an educational program offered by a provider approved in 18VAC30-20-300 that includes at least 12 hours on endoscopic procedures;

2. Successful performance of at least 25 flexible endoscopic procedures under the immediate and direct supervision of a board-certified otolaryngologist or another speech-language pathologist who has successfully performed at least 50 flexible endoscopic procedures beyond the 25 required for initial qualification and has been approved in writing by a board-certified otolaryngologist to provide that supervision; and

3. Current certification in basic life support.

C. The speech-language pathologist who qualifies to perform an endoscopic procedure pursuant to subsection B of this section shall maintain documentation of course completion and written verification from the supervising otolaryngologist or speech-language pathologist of successful completion of flexible endoscopic procedures.

D. An endoscopic procedure shall only be performed by a speech-language pathologist on referral from an otolaryngologist or other qualified physician.

E. A speech-language pathologist shall only perform an endoscopic procedure in a facility that has protocols in place for emergency medical backup. A flexible endoscopic evaluation of swallowing shall only be performed by a speech-language pathologist in either:

1. A licensed hospital or nursing home under the general supervision of a physician who is readily available in the event of an emergency, including physical presence in the facility or available by telephone; or

2. A physician's office at which the physician is on premises and available to provide onsite supervision.

F. The speech-language pathologist shall promptly report any observed abnormality or adverse reaction to the referring physician, an appropriate medical specialist, or both. The speech-language pathologist shall provide a report of an endoscopic procedure to the referring physician in a timely manner and, if requested, shall ensure access to a visual recording for viewing.

G. A speech-language pathologist is not authorized to possess or administer prescription drugs except as provided in § 54.1-3408 B of the Code of Virginia.

H. A speech-language pathologist who has been performing flexible endoscopic evaluations of swallowing prior to (insert effective date of regulation) may continue to perform such evaluations provided he has written verification from a board-certified otolaryngologist that he has the appropriate training, knowledge, and skills to safely perform such evaluations.