Morgan Ransdell

This administrative regulation establishes the requirements for 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 regulation: heightens the qualification requirements for a DT training program administrator and for faculty; creates an assistant program director and preceptor roles, and sets minimum qualifications for the roles; assigns responsibility for the overall conduct of a DT training program to a renal dialysis organization licensed pursuant to 902 KAR 20:018; requires the submission to the Board of Centers for Medicaid Services (CMS) reports, surveys and correction plans; specifies an “in state” requirement as a prerequisite for approval, but clarifies that graduates of out-of-state DT training programs may obtain the credential in Kentucky pursuant to 201 KAR 20:476 Section 1(1)(b); specifies that the two hundred hour clinical component last a minimum of ten weeks and involve direct patient contact; sets new DT training program curriculum requirements including principles of dialysis, psychosocial and physical needs of end stage renal disease patients, related principles of pharmacology, and infection control; requires Board approval for substantive syllabus and curriculum changes; allows for didactic education to be accomplished via distance learning technologies; requires publication of pre-admission requirements; requires students to be certified in basic life support; defines the internship phase of DT training, which replaces the “DT applicant” phase and designation; modifies program completion requirements; and modifies the format of the material incorporated by reference within the regulation (DT training program application and list of DT training program graduates).

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, KRS 314.131(1) 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 20:472. The two largest renal dialysis organizations in Kentucky are Davita, Inc., and Fresenius Medical Care North America. Students who are not currently certified in basic life support will be required to undergo training, and certain program administrators, faculty and preceptors who do not satisfy new minimum qualification requirements will have five years in which to meet the new requirements. Board staff is unaware of the number or identity of new renal dialysis organizations that will seek initial approval status following the effective date of 201 KAR 20:472.

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, 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). Any new DT training programs and renal dialysis organizations that seek to open in the Commonwealth will be guided by 201 KAR 20:472, and must meet the requirements set forth in the regulation. DT students who are not currently certified in basic life support will need to obtain such certification. Individual program administrators, faculty, and preceptors will require additional education within five years of the effective date of the regulation, if they do not currently satisfy new minimum qualification requirements.

New DT training programs seeking approval status will have a $2000 application fee, which is an increase from the current $950 fee. The existing fee is not adequate to cover the staff cost associated with the provision of staff guidance to the DT training program, and the review of the program’s application and associated submissions, which requires approximately 30 hours of work, on average. The hourly salary inclusive of all benefits of the KBN employee who conducts program review is $69.98.

Compliance with 201 KAR 20:472 allows DT training programs to operate lawfully and avoid closure. Compliance with educational requirements allows DT program administrators, faculty and preceptors to perform those roles. Compliance with the basic life support certification requirement will allows students to remain enrolled in DT training programs.

Implementation of 201 KAR 20:472 will result in a larger commitment of staff work hours in the review of materials submitted by renal dialysis organizations who seek to open a new program, and in collaboration with existing programs that seek guidance with regard to 201 KAR 20:472; 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 20:472 are further addressed below in Section 3(c) of the Fiscal Note on State or Local Government.

Following implementation of 201 KAR 20:472 by all existing DT training programs in the Commonwealth, additional agency cost associated with 201 KAR 20:472 will be attributable entirely to the work hours associated with coordination with new renal dialysis organizations, and associated document review. Agency costs associated with the continued enforcement 201 KAR 20:472 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 20:472.

The increase in the initial application fee, from $950 to $2,000, is implemented to address an existing inequity, as the review of a renal dialysis organization application pursuant to 201 KAR 20:472, and associated submissions, requires approximately 30 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 fee of $950 for new DT training programs was 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.

New DT training programs seeking approval status will have an application fee of $2,000, which is an increase from the current $950 fee.

Tiering was not applied to 201 KAR 20:472, as the regulation treats all renal dialysis organizations 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 initial 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 the agency is not anticipating a significant number of new DT training program applications, the fee increase specified in 201 KAR 20:472 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.

In light of the small number of new DT training program applications that are anticipated in future years, there being only seven active programs in the state at this time, the anticipated fiscal impact of the fee increase specified in 201 KAR 20:472 is small, amounting to $1,050 for each such application.