Morgan Ransdell

This administrative regulation establishes the requirements for continued approval of dialysis technician (“DT”) training programs.

This regulation is necessary pursuant to KRS 314.137(2).

This regulation conforms to the content of KRS 314.137(2) by establishing standards for DT training programs.

This regulation will assist in the effective administration of KRS 314.021, as amended effective June 30, 2021, and KRS 314.137(2), by establishing standards for DT training programs.

The fee increases set forth in this amendment are addressed below. This amendment: expands site visit authorization, including the option of agency participation during site visit conducted by the CMS to evaluate DT training program compliance with 201 KAR 20:472 and 201 KAR 20:474; identifies specific criteria for DT training program annual reports, including student completion and certification rates; requires six month notice of voluntary closure, and provides a teach out option or an option under which current trainees transfer to other programs; requires applications and supporting documents seeking to continue approval status to be submitted more than 30 days prior to the expiration of approval status, and imposing a $300 fine when such materials are submitted less than 90 days prior to the expiration of approval status; increases the fee applicable to an active program’s application for continued approval status from $800 to $1,000; states that lapsed programs must cease all training activity; increases the fee required when a lapsed program applies for reinstatement of approval status from $950 to $1,000; clarifies the circumstances under which a site visit may occur, and provides for the recovery of hearing costs in cases where a hearing disposition under KRS Chapter 13B is adverse to the DT training program.

The regulation is necessary for the oversight of the practices and training of dialysis technicians, as required by KRS 314.021 (amendment effective June 30, 2021), and KRS 314.137(2).

The regulation conforms to the content of the authorizing statutes, KRS 314.131(1) and KRS 314.137(2), by establishing appropriate standards for DT training programs in order to protect and safeguard the health and safety of the citizens of the Commonwealth of Kentucky.

The regulation will assist in the effective administration of KRS 314.021 and KRS 314.137(2), by establishing standards for DT training programs.

As of April 8, 2021, there were 712 dialysis technicians with a current and active Kentucky DT credential. There are currently seven DT training programs that are located and licensed in Kentucky. The Kentucky Board of Nursing, the seven Kentucky DT training programs in the Commonwealth, and all renal dialysis organizations that provide dialysis services within the Commonwealth will all be affected by the repeal of 201 KAR 20:470 and the promulgation of 201 KAR 20:474. The two largest renal dialysis organizations in Kentucky are Davita, Inc., and Fresenius Medical Care North America.

Each existing DT training program and renal dialysis organization in Kentucky will need to evaluate their programmatic requirements and standards in light of 201 KAR 20:472 and 201 KAR 20:474, as the standards for program approval are also relevant to the evaluation of existing programs pursuant to 201 KAR 20:472 Section 2 and 201 KAR 20:474 Section 2(1). DT training program annual reports will be required to address eight specific factors, including student completion and certification rates; and programs seeking voluntary closure will be required to provide notification to the board 6 months prior to closure, rather than 30 days prior to closure as specified in 201 KAR 20:470.

The fee required when an active program applies for continued approval status has been increased by $200, from $800 to $1,000, and the fee required when a lapsed program applies for reinstatement of approval status has been increased by $50, from $950 to $1,000. The existing fees are not adequate to cover the staff cost associated with the provision of staff guidance to DT training programs, and the review of the program’s application and associated submissions, which requires 15-20 hours of work, on average, when a DT program that previously held approval status seeks continued approval status or reinstatement. The hourly salary inclusive of all benefits of the KBN employee who conducts program review is $69.98.

Compliance with 201 KAR 20:474 allows DT training programs to operate lawfully and avoid closure.

Implementation of 201 KAR 20:474 will result in a larger commitment of staff work hours, primarily due to the anticipated need for collaboration with existing programs that seek guidance with regard to expanded annual reporting requirements; however, it is impossible to calculate the precise cost of the additional demands upon staff that are anticipated. Agency costs associated with implementation of 201 KAR 20:474 are further addressed below in Section 3(c) of the Fiscal Note on State or Local Government.

Following implementation of 201 KAR 20:474, the agency cost associated with 201 KAR 20:474 will be attributable entirely to the work hours associated with coordination with previously approved DT training programs, associated document review, and any resulting enforcement activity. Agency costs associated with the continued enforcement 201 KAR 20:474 of are further addressed below in Section 3(d) of the Fiscal Note on State or Local Government.

Fees paid by DTs and DT training programs are the primary source of funding for implementation of 201 KAR 20:474.

The fee required when an active program applies for continued approval status has been increased by $200, from $800 to $1,000, and the fee required when a lapsed program applies for reinstatement of approval status has been increased by $50, from $950 to $1,000. These increases are implemented to address an existing inequity, as the review of a DT training program that previously held approval status, including communication with the program and review of all submissions, requires 15-20 hours of work, on average. The hourly salary, inclusive of all benefits, of the KBN employee who conducts program review is $69.98. The existing fees of $800 for active DT training programs seeking continued approval status, and $950 reinstatement fee, were determined immediately following passage of HB 184 in 2001, which is when the Kentucky Board of Nursing was first assigned regulatory authority over DTs and DT training programs. In the twenty years since, the fee has remained static, while personnel costs have increased.

The fee required when an active program applies for continued approval status has been increased by $200, from $800 to $1,000, and the fee required when a lapsed program applies for reinstatement of approval status has been increased by $50, from $950 to $1,000.

Tiering was not applied to 201 KAR 20:474, as the regulation treats all DT training programs similarly.

KRS 314.131 and KRS 314.137.

In FY2020, KBN revenues from receipts associated with the DT program were $15,106. For FY2021, revenues from receipts associated with the program are $7,973 to date. The precise amount of anticipated FY2022 DT program receipts is not known, but is expected to be approximately $15,000. The bulk of DT program receipts are attributable to DT renewal fees. These receipts are not consistent year to year, in light of the two-year DT renewal cycle. The fee increase for renal dialysis organizations seeking continued or reinstated program approval will not have a significant impact on agency receipts, as there are only seven DT training programs in Kentucky currently, and the Board does not anticipate a significant number of new program applications.

As there are only seven DT training programs that currently hold approval status, and as the agency is not anticipating a significant number of new DT training program applications, the fee increases specified in 201 KAR 20:474 will not have a substantial impact on revenues.

The agency expended $26,446.02 for the DT program in FY2020. The FY2021 budget for the DT program is $26,600, and $25,331.69 has been expended associated with the DT program to date in the current fiscal year. Board staff anticipates a similar level of expenditure in FY2022.

Board staff anticipates that DT program expenditures will rise from a baseline cost of $26,600 in future years, as personnel costs rise; however, the precise impact of possible personnel cost increases have not been determined.

As there are only seven DT training programs that currently hold approval status, and as the agency is not anticipating a significant number of new DT training program applications, the anticipated fiscal impact of the fee increases specified in 201 KAR 20:474 is small, amounting to $200 for each application for continued approval status, and $50 for each reinstatement application.