Washington Administrative Code
Title 246 - Health, Department of
FACILITY STANDARDS AND LICENSING
Chapter 246-310 - Certificate of need
Section 246-310-800 - Kidney disease treatment centers-Definitions

Universal Citation: WA Admin Code 246-310-800

Current through Register Vol. 24-18, September 15, 2024

The definitions in this section apply to WAC 246-310-800 through 246-310-833, unless the context clearly indicates otherwise:

(1) "Affiliate" or "affiliated" means:

(a) Having at least a 10 percent but less than 100 percent ownership in a kidney disease treatment center;

(b) Having at least a 10 percent but less than 100 percent financial interest in a kidney disease treatment center; or

(c) Three years or more operational management responsibilities for a kidney disease treatment center.

(2) "Base year" means the most recent calendar year for which December 31st data is available as of the letter of intent submission date from the Network's Modality Report.

(3) "Capital expenditures," as defined by Generally Accepted Accounting Principles (GAAP), means expenditures made to acquire tangible long-lived assets. Long-lived assets represent property and equipment used in a company's operations that have an estimated useful life greater than one year. Acquired long-lived assets are recorded at acquisition cost and include all costs incurred necessary to bring the asset to working order. Capital expenditure includes:

(a) A force account expenditure or acquisition (i.e., an expenditure for a construction project undertaken by a center as its own contractor).

(b) The costs of any site planning services (architect or other site planning consultant) including, but not limited to, studies, surveys, designs, plans, working drawings, specifications, and other activities (including applicant staff payroll and employee benefit costs, consulting and other services which, under GAAP or Financial Accounting Standards Board (FASB) may be chargeable as an operating or nonoperating expense).

(c) Construction cost of shelled space.

(d) Building owner tenant improvements including, but not limited to: Asbestos removal, paving, concrete, contractor's general conditions, contractor's overhead and profit, electrical, heating, ventilation and air conditioning systems (HVAC), plumbing, flooring, rough and finish carpentry and millwork and associated labor and materials, and utility fees.

(e) Donations of equipment or facilities to a center.

(f) Capital expenditures do not include routine repairs and maintenance costs that do not add to the utility of useful life of the asset.

(4) "Concurrent review" means the process by which applications competing to provide services in the same planning area are reviewed simultaneously by the department.

(5) "Dialysis facility report (DFR)" means the kidney disease treatment center reports produced annually for Centers for Medicare and Medicaid Services (CMS). The DFR is provided to individual dialysis centers and contains summary data on each center compiled from multiple sources. The DFR facilitates comparison of patient characteristics, treatment patterns, transplantation rates, hospitalization rates, and mortality rates to local and national averages.

(6) "Dialysis facility compare (DFC) report" means the kidney dialysis facility compare quarterly report that is produced by CMS and posted on the medicare DFC website. This report provides information about statistically measurable practice patterns in kidney disease treatment centers including, but not limited to, mortality, hospitalization, late shifts, and availability of home training.

(7) "End-of-year data" means data contained in the fourth quarter modality report or successor report from the Network.

(8) "End-of-year in-center patients" means the number of in-center hemodialysis (HD) and self-dialysis training patients receiving in-center kidney dialysis at the end of the calendar year based on end-of-year data.

(9) "Exempt isolation station" means one certificate of need approved certified station per center dedicated to patients requiring medically necessary isolation. This station may not be used for nonisolation treatments. This one approved station is included in the kidney disease treatment center's total CMS certified station count. However, for purposes of certificate of need, this one isolation station is not included in the center's station count for projecting future station need or in calculating existing station use. Providers may operate more than one isolation station, but only one is excluded from the center's station count for purposes of projecting future station need and in calculating existing station use.

(10) "Kidney disease treatment center" or "kidney dialysis facility" means any place, institution, building or agency or a distinct part thereof equipped and operated to provide services, including outpatient dialysis. In no case will all stations at a given kidney disease treatment center or kidney dialysis facility be designated as self-dialysis training stations. For purposes of these rules, kidney disease treatment center and kidney dialysis facility have the same meaning.

(11) "Maximum treatment floor area square footage" means the sum of (a), (b), (c), and (d) of this subsection:

(a) One hundred fifty square feet multiplied for each general use in-center station and each nonisolation station;

(b) Two hundred square feet multiplied for each isolation station and each permanent bed station as defined in subsection (14) of this section;

(c) Three hundred square feet for future expansion of two in-center treatment stations; and

(d) Other treatment floor space is 75 percent of the sum of (a), (b), and (c) of this subsection. As of the effective date of these rules, maximum treatment floor area square footage identified in a successful application cannot be used for future station expansion, except as provided in (c) of this subsection. For example, the applicant may use the maximum allowable treatment floor area square footage. The number of stations may include one isolation station, one permanent bed station, eight general use in-center stations, two future expansion stations, and maximum other treatment floor space. In this example, the total maximum treatment floor area square footage in this example would equal 3,325 square feet.

(12) "Network" means end stage renal disease (ESRD) Network 16.

(13) "Operational" means the date when the kidney disease treatment center provides its first dialysis treatment in newly approved certificate of need stations, including relocated stations.

(14) "Patients per station" means the reported number of in-center patients at the kidney disease treatment center divided by counted certificate of need approved stations. The results are not rounded up. For example, 4.49 is not rounded to 4.5.

(15) "Permanent bed station" means a bed that would commonly be used in a health care setting.

(16) "Planning area" or "service area" means an individual geographic area designated by the department for which kidney dialysis station need projections are calculated. For purposes of kidney dialysis projects, planning area and service area have the same meaning. Each county is considered a separate planning area, except for the planning subareas identified for King, Snohomish, Pierce, and Spokane counties. If the United States Postal Service (USPS) changes zip codes in the defined planning areas, the department will update areas to reflect the revisions to the zip codes to be included in the certificate of need definitions, analyses and decisions. Post office boxes are not included.

(a) King County is divided by zip code into 12 planning areas as follows:

KING ONE

KING TWO

KING THREE

98028 Kenmore

98101 Business District

98070 Vashon

98103 Green Lake

98102 Eastlake

98106 White Center/West Seattle

98105 Laurelhurst

98104 Business District

98116 Alki/West Seattle

98107 Ballard

98108 Georgetown

98126 West Seattle

98115 View Ridge/ Wedgwood

98109 Queen Anne

98136 West Seattle

98117 Crown Hill

98112 Madison/ Capitol Hill

98146 West Seattle

98125 Lake City

98118 Columbia City

98168 Riverton

98133 Northgate

98119 Queen Anne

98155 Shoreline/ Lake Forest Park

98121 Denny Regrade

98177 Richmond

Beach

98122 Madrona

98195 University of Washington

98134 Harbour Island

98144 Mt. Baker/ Rainier Valley

98199 Magnolia

KING FOUR

KING FIVE

KING SIX

98148 SeaTac

98003 Federal Way

98011 Bothell

98158 SeaTac

98023 Federal Way

98033 Kirkland

98166 Burien/ Normandy Park

98034 Kirkland

98188 Tukwila/ SeaTac

98052 Redmond

98198 Des Moines

98053 Redmond

98072 Woodinville

98077 Woodinville

KING SEVEN

KING EIGHT

KING NINE

98004 Bellevue

98014 Carnation

98055 Renton

98005 Bellevue

98019 Duvall

98056 Renton

98006 Bellevue

98024 Fall City

98057 Renton

98007 Bellevue

98045 North Bend

98058 Renton

98008 Bellevue

98065 Snoqualmie

98059 Renton

98039 Medina

98027 Issaquah

98178 Skyway

98040 Mercer Island

98029 Issaquah

98074 Sammamish

98075 Sammamish

KING TEN

KING ELEVEN

KING TWELVE

98030 Kent

98001 Auburn

98022 Enumclaw

98031 Kent

98002 Auburn

98032 Kent

98010 Black Diamond

98038 Maple Valley

98047 Pacific

98042 Kent

98092 Auburn

98051 Ravensdale

(b) Pierce County is divided into five planning areas as follows:

PIERCE ONE

PIERCE TWO

PIERCE THREE

98354 Milton

98304 Ashford

98329 Gig Harbor

98371 Puyallup

98323 Carbonade

98332 Gig Harbor

98372 Puyallup

98328 Eatonville

98333 Fox Island

98373 Puyallup

98330 Elbe

98335 Gig Harbor

98374 Puyallup

98360 Orting

98349 Lakebay

98375 Puyallup

98338 Graham

98351 Longbranch

98390 Sumner

98321 Buckley

98394 Vaughn

98391 Bonney Lake

PIERCE FOUR

PIERCE FIVE

98402 Tacoma

98303 Anderson Island

98403 Tacoma

98327 DuPont

98404 Tacoma

98387 Spanaway

98405 Tacoma

98388 Steilacoom

98406 Tacoma

98430 Tacoma

98407 Ruston

98433 Tacoma

98408 Tacoma

98438 Tacoma

98409 Lakewood

98439 Lakewood

98416 Tacoma

98444 Parkland

98418 Tacoma

98445 Parkland

98421 Tacoma

98446 Parkland

98422 Tacoma

98447 Tacoma

98424 Fife

98467 University Place

98443 Tacoma

98498 Lakewood

98465 Tacoma

98499 Lakewood

98466 Fircrest

98580 Roy

(c) Snohomish County is divided into three planning areas as follows:

SNOHOMISH ONE

SNOHOMISH TWO

SNOHOMISH THREE

98223 Arlington

98201 Everett

98012 Mill Creek/ Bothell

98241 Darrington

98203 Everett

98020 Edmonds/ Woodway

98252 Granite Falls

98204 Everett

98021 Bothell

98271 Tulalip Reservation/ Marysville

98205 Everett

98026 Edmonds

98282 Camano

Island

98208 Everett

98036 Lynnwood/ Brier

98292 Stanwood

98251 Gold Bar

98037 Lynnwood

98224 Baring

98043 Mountlake Terrace

98258 Lake Stevens

98087 Lynnwood

98270 Marysville

98296 Snohomish

98272 Monroe

98275 Mukilteo

98288 Skykomish

98290 Snohomish

98294 Sultan

(d) Spokane County is divided into two planning areas as follows:

SPOKANE ONE

SPOKANE TWO

99001 Airway Heights

99003 Chattaroy

99004 Cheney

99005 Colbert

99011 Fairchild Air Force Base

99006 Deer Park

99012 Fairfield

99009 Elk

99016 Greenacres

99021 Mead

99018 Latah

99025 Newman Lake

99019 Liberty Lake

99026 Nine Mile Falls

99022 Medical Lake

99027 Otis Orchards

99023 Mica

99205 Spokane

99030 Rockford

99207 Spokane

99031 Spangle

99208 Spokane

99036 Valleyford

99217 Spokane

99037 Veradale

99218 Spokane

99201 Spokane

99251 Spokane

99202 Spokane

99203 Spokane

99204 Spokane

99206 Spokane Valley

99212 Spokane Valley

99216 Spokane/Spokane Valley

99223 Spokane

99224 Spokane

(17) "Projection year" means the fifth calendar year after the base year. For example, reviews using 2015 end-of-year data as the base year will use 2020 as the projection year.

(18) "Quality incentive program" or "QIP" means the end-stage renal disease (ESRD) quality incentive program (QIP) administered by the Centers for Medicare and Medicaid Services (CMS). The QIP measures kidney disease treatment center performance based on outcomes assessed through specific performance and quality measures that are combined to create a total performance score (TPS). The QIP and TPS are updated annually and are publicly available on the CMS DFC website.

(19) "Quintile" means any of five groups into which a population can be divided according to the distribution of values of a particular variable.

(20) "Resident in-center patients" means in-center hemo-dialysis (HD) patients who reside within the planning area. If more than 50 percent of a kidney disease treatment center's patients reside outside Washington state, these out-of-state patients would be considered resident in-center patients.

(21) "Shelled space" means space that is constructed to meet future needs; it is a space enclosed by a building shell but otherwise unfinished inside unless the space designated for future needs is part of an existing, finished building prior to an applicant's proposed project. In that case, there is no requirement to degrade the space. The shelled space may include:

(a) Electrical and plumbing that will support future needs;

(b) Insulation;

(c) Sheet rock that is taped or other similar wall coverings that are otherwise unfinished; and

(d) Heating, ventilation, and air conditioning.

(22) "Temporary emergency situation" means a temporary emergency situation as defined in RCW 70.38.280 and WAC 246-310-825.

(23) "Training services" means services provided by a kidney disease treatment center to train patients for home dialysis. Home training spaces are not used to provide in-center dialysis treatments. Spaces used for training are not included in the center's station count for projecting future station need or in calculating existing station use. Stations previously designated as "training stations" may be used as in-center dialysis stations and will continue to be included in the center's current station count for projecting future station need or in calculating existing station use. For the purpose of awarding the point for home training in the superiority criteria section (WAC 246-310-823), training services include the following:

(a) Home peritoneal dialysis (HPD); and

(b) Home hemodialysis (HHD).

Disclaimer: These regulations may not be the most recent version. Washington may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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