WAC 246-310-800. Kidney disease treatment centers — Definitions

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 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 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 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 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 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 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 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 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 hemodialysis (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).