certificate of need application
TRANSCRIPT
Certificate of Need Application
to
Acquire Additional Biplane
Project #5874
Mercy Hospital South
St. Louis, Missouri
June 2021
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Certificate of Need Program NEW OR ADDITIONAL EQUIPMENT APPLICATION Applicant’s Completeness Checklist and Table of Contents
Project Name:________________________________________________________ Project No:_____________________________
Project Description:_______________________________________________________________________________________________
Done Page N/A Description
Divider I. Application Summary:
__ ________ __ 1. Applicant Identification and Certification (Form MO 580-1861) __ ________ __ 2. Representative Registration (From MO 580-1869) __ ________ __ 3. Proposed Project budget (Form MO 580-1863) and detail sheet with documentation of costs.
Divider II. Proposal Description:
__ ________ __ 1. Provide a complete detailed project description and include equipment bid quotes.
__ ________ __ 2. Provide a timeline of events for the project, from CON issuance through project competition.
__ ________ __ 3. Provide a legible city or county map showing the exact location of the project.
__ ________ __ 5. Provide 2025 population projections for the proposed geographic service area.__ ________ __ 6. Provide other statistics to document the size and validity of any user-defined geographic service area.__ ________ __ 7. Identify specific community problems or unmet needs the proposal would address.__ ________ __ 8. Provide the historical utilization for each of the past three years and utilization projections through the
__ ________ __ 9. Provide the methods and assumptions used to project utilization.__ ________ __ 10. Document that consumer needs and preferences have been included in planning this project and describe
h how consumers had an opportunity to provide input.
__ ________ __ 11. Provide copies of any petitions, letters of support or opposition received.
Divider III. Service Specific Criteria and Standards:
__ ________ __ 1. For new units, address the need formula for the proposed geographic service area.
first three (3) FULL years of operation of the new equipment.
__ ________ __ 2. For new units, address the minimum annual utilization standard for the proposed geographic service area.
__ ________ __ 3. For any new unit where specific need and utilization standards are not listed, provide the methodology fordetermining need.
__ ________ __ 4. For additional units, document compliance with the optimal utilization standard, and if not achieved,provide documentation to justify the additional unit.
__ ________ __ 5. For evolving technology address the following:- Medical effects as described and documented in published scientific literature;
__ ________ __
- The degree to which the objectives of the technology have been met in practice;- Any side effects, contraindications or environmental exposures;
Divider IV. Financial Feasibility Review Criteria and Standards:
1. Document that sufficient financing is available by providing a letter from a financial institution or anauditor's statement indicating that sufficient funds are available.
2. Provide Service-Specific Revenues and Expenses (Form MO 580-1865) projected through three (3) FULLyears beyond project completion.
__ ________ __
3. Document how patient charges are derived.
- The relationships, if any, to existing preventive, diagnostic, therapeutic or management technologies and
__ ________ __
4. Document responsiveness to the needs of the medically indigent.
the effects on the existing technologies;
__ ________ __
- Food and Drug Administration approval;- The need methodology used by this proposal in order to assess efficacy and cost impact of the proposal;
__ ________ __
- The degree of partnership, if any, with other institutions for joint use and financing.
MO 580-2503 (03/20)
__ ________ __
__ ________ __
__ ________ __
__ ________ __
__ ________ __
__ ________ __
4. Define the community to be served.
__ ________ __
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Divider I
Application Summary
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DIVIDER I – Application Summary
1. Application Identification and Certification (Form MO 580-1861).
The Application Identification and Certification form is included in
Divider I – Attachments.
2. Representative Registration (Form MO 580-1869).
The Representative Registration form for Dan Eckenfels is included in Divider I –
Attachments.
3. Proposed Project Budget (Form MO 580-1863) and detail sheet with documentation
of costs.
The Proposed Project budget form is included in Divider I – Attachments.
The proposed project budget includes:
• ARTIS icono biplane IR Pro $1,990,269
• Shielding $25,409
Total Project Cost $2,015,678
Quotes from Siemens Medical Solutions and MUSICK Construction for the items listed
above are included in Divider II – Attachments.
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Attachments
Divider I
Application Summary
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6
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Certificate of Need Program
PROPOSED PROJECT BUDGET
DollarsDescriptionCOSTS:* (Fill in every line, even if the amount is “$0”.)
1. New Construction Costs ***
2. Renovation Costs ***
3. Subtotal Construction Costs (#1 plus #2)
4. Architectural/Engineering Fees
5. Other Equipment (not in construction contract)
6. Major Medical Equipment
7. Land Acquisition Costs ***
8. Consultants’ Fees/Legal Fees ***
9. Interest During Construction (net of interest earned) ***
10. Other Costs ***
11. Subtotal Non-Construction Costs (sum of #4 through #10
12. Total Project Development Costs (#3 plus #11) **
FINANCING:13. Unrestricted Funds
14. Bonds
15. Loans
16. Other Methods (specify)
17. Total Project Financing (sum of #13 through #16) **
* Attach additional page(s) detailing how each line item was determined, including all methods andassumptions used. Provide documentation of all major costs.
** These amounts should be the same.
*** Capitalizable items to be recognized as capital expenditures after project completion.
**** Include as Other Costs the following: other costs of financing; the value of existing lands, buildings and equipment not previously used for health care services, such as a renovated house converted to residential care, determined by original cost, fair market value, or appraised value; or the fair market value of any leased equipment or building, or the cost of beds to be purchased.
***** Divide new construction costs by total new construction square footage.
****** Divide renovation costs by total renovation square footage.
18. New Construction Total Square Footage
19. New Construction Costs Per Square Foot *****
20. Renovated Space Total Square Footage
21. Renovated Space Costs Per Square Foot ******
MO 580‐1863 (02/13) 8
Divider II
Proposal Description
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DIVIDER II – Proposal Description
1. Provide a complete detailed project description and include equipment bid quotes.
Mercy Hospital South will be requesting approval to acquire an additional Biplane
Imaging System. The new system will be a Siemens ARTIS Icono Biplane IR Pro, and
will be installed in a remodeled Interventional Radiology room. Mercy Hospital South
currently has one neuro-interventional capable Biplane Imaging System. Based on stroke
volumes and stroke program recognition, Mercy Hospital South has identified a need for
two systems running concurrently.
This application has been prepared for a full CON review due to the current Siemens
Axiom ARTIS unit remaining in service.
The project involves purchase of an ARTIS Icono Biplane IR Pro and room shielding
costs. An existing Interventional Radiology room will be remodeled to accommodate the
new Biplane.
Quotes for the following are included in Divider II – Attachments:
2. Provide a timeline of events for the project, from CON issuance through project
completion.
Project timeline assumes CON Issuance in September 2021:• Equipment Arrival: October – November 2021
• Construction Completion & Equipment Installation: November 2021
• Training & Testing: November-December 2021
• Go-Live: December 2021
SIEMENS
Siemens Icono Biplane IR Pro 1,892,970.00$
Accessory-Equipment 97,299.00$
MUSICK
Shielding 25,409.00$
2,015,678.00$ Total Project Cost
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3. Provide a legible city or county map showing the exact location of the project.
4. Define the community to be served.
Mercy Hospital South serves patients from a large geographic area throughout
metropolitan St. Louis, including St. Louis County, Jefferson County, Franklin County,
and St. Louis City in Missouri. Additionally, Mercy Hospital South serves patients in
Monroe and St. Clair Counties in Illinois.
As one of the larger hospitals in the St. Louis area, Mercy Hospital South’s Emergency
Department is the 2nd busiest of 25 hospitals in the St. Louis region and the 4th busiest of
138 hospitals in Missouri, with 62,283 emergent patient visits over the past 12 months. It
is one of the few hospitals in the St. Louis area designated as a Joint Commission
Comprehensive Stroke Center and the only Level II Trauma Center in south St. Louis
County and Jefferson County. Mercy Hospital South serves 28 EMS districts, 2 of which
are supervised directly by Mercy Hospital South. Additionally, Mercy Hospital South is
licensed for a total of 767 beds. The hospital employs 2,847 co-workers, discharges
20,820 patients, and performs 12,284 surgeries annually.
Mercy Hospital St. Louis
Primary Service Area
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5. Provide 2025 population projections for the proposed geographic service area.
Mercy Hospital South’s primary service area includes Jefferson County, St. Louis
County, Franklin County, and St. Louis City in Missouri. The hospital also provides care
for Monroe County and St. Clair County, located in Illinois.
The Missouri Department of Health and Senior Services provided the following 2025
population projections for these locations in Missouri. Truven data sources provided the
2025 population projections for Illinois locations.
6. Provide other statistics to document the size and validity of any user-defined
geographic service area.
As mentioned previously, Mercy Hospital South serves patients from a large geographic
area, including St. Louis county, Jefferson County, Franklin County, and St. Louis City
in Missouri. Additionally, Mercy Hospital South serves patients in Monroe and St. Clair
Counties in Illinois.
The 2025 population projections listed in the table directly above for 6 different
geographies show data collected by The Missouri Department of Health and Senior
Services as well as Truven data sources.
Not only does Mercy Hospital South serve a large geographic area and complex patient
base, but it cares for the 2nd most stroke patients in the St. Louis area. Having an
expansive Interventional Radiology program is essential for successful treatment of
complex stroke patients in the St. Louis area.
Location Total 65+
Jefferson County, MO 228,389 40,939
St. Louis County, MO 990,180 202,698
Franklin County, MO 106,645 21,530
St. Louis City, MO 277,256 45,114
Monroe County, IL 34,940 7,181
St. Clair County, IL 249,932 47,271
Total 1,887,342 364,733
2025 Population Projection
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7. Identify specific community problems or unmet needs the proposal would address.
Mercy Hospital South is the second largest stroke center in the St. Louis region and
recently became a Comprehensive Stroke Center accredited by The Joint Commission in
April 2021. Data for the top 6 stroke patient volume facilities in the St. Louis area for
2019 is as follows:
2019 Calendar Year Stroke Records
Barnes-Jewish Hospital (Comprehensive) 1342
Mercy Hospital South (Comprehensive) 1024
Mercy Hospital St. Louis 760
SSM Saint Louis University Hospital 654
SSM DePaul Hospital (Comprehensive) 666
SSM St. Clare Hospital 520
The Interventional Radiology services are key to supporting our growing community’s
needs in stroke care. Although Mercy Hospital South currently operates a neuro biplane,
the additional unit will allow our team to simultaneously care for 2 stroke activations
expected with future growth, and provide redundancy, as our current unit is aging.
8. Provide historical utilization for each of the past three years and utilization
projections through the first three (3) full years of operation of the new equipment.
Cases
Actual FY19 2,612
FY20 3,052
FY21 2,924
Acquire mid-year FY22 2,939
YR 1 FY23 2,959
YR 2 FY24 2,973
YR 3 FY25 2,973
9. Provide the methods and assumptions used to project utilization.
Projected utilization is based on Mercy Hospital South’s historical experience in the
Interventional Radiology department. Mercy Hospital South expects a strong ongoing
increase in stroke related patient volumes. Additional growth will likely stem from
recent designation as one of the few facilities in the St. Louis region meeting
requirements for being a Comprehensive Stroke Center accredited by The Joint
Commission.
Additionally, with the average age of the population steadily increasing it is expected that
the rate of stroke patients in this geographic area will also increase. Risk factors increase
in an aging population that create more susceptibility to Ischemic, Hemorrhagic, and
Transient Ischemic strokes. The population reaching 65+ will continue to increase
dramatically for the next decade adding to the population at increased risk.
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10. Document that consumer needs and preferences have been included in planning this
project and describe how consumers had an opportunity to provide input.
A public notice seeking comment on this matter was published in the St. Louis Post
Dispatch on May 28, 2021. A copy of the notice is included in Divider II – Attachments.
The notice reads:
“Mercy Hospital South will file a certificate of need application with the Missouri Health
Facilities Review Committee, requesting approval to add a biplane imaging system at the
hospital, located at 10010 Kennerly Road, in St. Louis, Mo. Anyone with comments or questions
about this matter should contact Dan Eckenfels, Vice President of Finance for Mercy at
314.525.1483 or [email protected]”
When planning new services, Mercy Hospital South incorporates comments from
members of the medical staff, from patients, from area residents, and from Mercy co-
workers. Additionally, the Hospital’s board of directors includes community leaders who
provide input into the services of the Hospital.
11. Provide copies of any petitions, letters of support or opposition received.
Letters of support for this additional biplane imaging system have been received from
several physician members of the medical staff of Mercy Hospital South. These letters of
support are provided in Divider II - Proposal Description.
No opposition to this additional biplane imaging system has been received.
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Attachments
Divider II
Proposal Description
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Customer Number: 0000010133
MERCY HOSPTIAL SOUTH 10010 KENNERLY RDSAINT LOUIS, MO 63128
Date: 05/12/2021
Estimated Delivery Date: 09/15/2021
Estimated delivery date is subject to change based upon factory lead times, acceptance date of this quote,customer site readiness, and other factors. A Siemens representative will contact you regarding the final deliverydate.
Delivery dates and other contractual obligations of Seller may change due to the effects of the Covid-19 epidemicor other epidemic, including delays and disruptions in the supply chain, manufacturing, or execution as well ordersby authorities and prioritization of (new and existing) orders of customers which are essential for the publichealthcare. The magnitude of such changes cannot be predicted and might be substantial because it depends onthe development of the Covid-19 epidemic or other epidemic.
This is a CONFIDENTIAL, one-time multi-unit offer which may not be shared with any third parties, buyingevaluation groups or anyone not directly employed by customer. This offer is only valid if firm, non-contingentorders for quote #’s CPQ-267445, and CPQ-253841 are placed with Siemens by 06/30/2021. This date supersedesany other validity date indicated in the proposal.
This of fer is only valid if a firm, non-contingent order is placed with Siemens and a signed POS contract mustaccompany the equipment order.
Quote Nr. CPQ-253841 Rev. 4
ARTIS icono biplane IR Pro
All items listed below are included for this system:
Qty Part No. Item Description
1 14465009 ARTIS icono biplane IR ProARTIS icono biplane is a breakthrough in neuro interventions. The completelyredesigned multi-axis floor stand and agile lateral plane revolutionize positioningflexibility and movement speed enabling imaging capabilities and workflowimprovements that have never been seen before. At the same time ARTIS iconobiplane was designed for multidisciplinary usage making different disciplines feel athome in the same interventional lab. The lateral plane can be swiveled by anautomated drive with the click of a button to get to the preferred setting.Imaging two projections simultaneously saves time and contrast.Simplified operation of ARTIS icono with Touch2Move technology - functions thatcan be selected and invoked in a single step.The complete CARE+OPTIQ package offers constant image quality at a low dose.
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Digital acquisition technology and digital subtraction angiography with up to 7.5 f/s in1k/16 bit matrix are available.OPTIQ Roadmap comes with enhanced image quality improvements a t reducedradiation dose. Several directly accessible features ease the workflow and savetime.The Pro system platform allows acces to unique features like syngo DynaCT SineSpin, syngo DynaCT Multiphase and the preparation for 3D acquisitions with theagile lateral plane.It already contains the following functionalities:Live 2k Imaging, Fluoro Loop and Memory expansion (400k).Disclaimer:The products/features (here mentioned) are not commercially available in allcountries. Due to regulatory reasons their future availability cannot be guaranteed.Please contact your local Siemens organization for further details.
1 14465138 Biplane Imaging systemImage system computer for control of system operation and image acquisition.
Dual architectureIn order to provide highest level system availability, the imaging system consists oftwo independent computer systems that manage central tasks such as real-timeimage processing during fluoroscopy or acquisition as well as post-processing andnetworking functionality separately from one another. This ensures the best possiblesystem performance and availability.
Image storage capacity100,000 images in 1k matrix with a size of 2 MB25,000 images in 2k matrix with a size of 8MB
1 14432948 AutomapAutomatic stand positioning depending on the selected reference image andautomatic reference image selection depending on the stand positioning.
1 14465022 OPTIQ with as40HDR GIGALIX biplanOPTIQ image chain with the following tube, collimator and flat detectorconfiguration:as40HDR detector and GIGALIX tube, in both planesThe as40HDR flat detector is optimized for the requirements of radiology andsurgery.The GIGALIX X-ray tube concentrates high pulse power on small, square-shapedfocal spots (flat emitter technology for all focal spots). This provides unprecedentedimage quality for confidence in challenging situations.
1 14465015 Multimodality ViewingSupports the connection of external video sources such as Sensis/recordingsystems, PACS, HIS/RIS, Ultrasound, ECG, IVUS, OCT, external video, endoscope,mapping systems, and their visualization on the examroom display. Adapted to thelocal needs and depending on the availability of the cockpit option up to 24 externalsources can be connected.
1 14455573 Large Display (rail mount)Large color flat screen display (including cables) for the examination room, with apanel diagonal of 55”. This large display version provides an excellent clinical imagequality due to its new IPS panel technology.The Large display is fixed on a ceiling-mounted, longitudinally movable, rotatableand height-adjustable display holder in the examination room.
1 14465013 Large dual control room display
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Two large control room displays
Panel 31.5“
Resolution 3840 x 2160Pixel size 0.181 x 0.181 mmTypical contrast max. 1000 : 1Max. luminance 700 cd/m2Calibrated luminance 400 cd/m2Display area (diagonal) 800 mmDimensions without stand (W x H x D) 761 x 471 x 90 mm
1 14465044 ARTIS standard tableFloor-mounted patient table for all angiographic examinations and interventions.Large unobstructed cantilevered and free-floating tabletop with a wide range ofrotation enables access to patient from all sides and easy transfer and positioning.Telescoping column with motorized height adjustment.Table control module for operation of all table functions.
1 14455548 Mattress - thickMatching, special-foam mattress, 7 cm, incl. a latex-free cover.This visco-elastic comfort mattress reacts to temperature and has the specialproperty of adapting to the individual body shape under the influence of body weightand heat.Mattress thickness: 70 ± 5 mm / 2.8" ± 0.2"
1 14465054 Oper. contr. ARTIS tableFor an ideal workflow, full system operation can be performed directly at the tableside.This includes complete system operation through modular control elements forcontrolling C-arm movements, patient table, and collimator.The illuminated controls and touch display are easy to use – even when coveredwith drapes for sterile operation.
Pilot moduleThe pilot module provides comfortable and ergonomic operation of the system. Itallows the control of system and table movements, imaging parameters, theselection of examination protocols, image acquisition and evaluation and manyother functions. The touch screen can be configured to meet individual clinicalrequirements.The Touch2Move technology allows intuitive activation of system movements.
Table control module (with ARTIS multi-tilt table)The table operating module with panning knob for servo-assisted table movementenables virtually force-free movement of the patient regardless of table load andtable inclination.Table control module (with ARTIS standard table)Table control module with panning knob for free-floating tabletop movement.Collimator control moduleThe Collimator control module for controlling of all collimator functions, such asrectangular blade or wedge-shaped filters.Hand switchMulti-functional hand switch for acquisition control, switching acquisition frame ratesand/or step movements. (This switch might not be available in all countries.)
1 14465046 1st 8 pedal cable footswitch
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Wired 8-pedal for release of fluoroscopy, exposure and table brake, as well asconfigurable control function.
1 14465051 2nd 8 pedal wireless footswitchAdditional wireless 8-pedal footswitch for release of fluoroscopy, exposure and tablebrake, as well as configurable control function.
1 14465124 Operation in the control roomPreparation for system operation from control room.
1 14465095 Op. ctrl. - handswitch (C-Room)Additional handswitch for radiation release and additional control functions.
1 14455566 Injector connection (C-Room)Interface in the control room for controlling the contrast medium injector.Injectors can be offered by Siemens Healthcare Accessory Solutions.
1 14440419 Cable clips ECGCable clips for securing the ECG cable to the patient tabletop.It includes 10 cable clips.
Intended only for use with Artis / ARTIS tables1 14465062 Infusion bottle holder
This infusion bottle holder can be mounted at the accessory rail of the patient table.It holds up to 4 infusion bottles.It includes an infusion bottle holder made of stainless steel with 4 retaining rings.
Intended only for use with Artis/ARTIS tables.1 14440459 Arm rest
Arm support used for the arm approach. Length: 1 m (39.4''). Slides underneath thepatient mattress and is held in position by the patient’s weight.
Made of radiolucent carbon fiber material which is easy to clean. It includes twoadditional support pads of two different heights (4 and 7 cm).Length pad: 60 cm / 23.62''Width: 9 to 20 cm / 3.54'' to 7.87''Maximum weight: 5 kg (11.02 Ib)Weight (with pads): 2.1 kg / 4.63 lb
Intended only for use with Artis / ARTIS tables.1 14440460 Arm holder (pair)
The patient's arms can be comfortably placed along the body using these two armholders. They slide underneath the patient mattress and is held in position by thepatient’s weight.
It includes two pairs of arm holders of different length (540 mm / 690 mm - 21.2'' /27.2'') and height (85 mm / 115 mm - 3.35'' / 4.53''), suitable both for thick and thinpatient mattresses.
Intended only for use with Artis / ARTIS tables.1 14465057 Abdomen radiation prot. CARD/NEURO
This radiation shield protects the user from scattered radiation when standing at thetable side. It can be attached to the accessory rails either on the right or on the leftside of the patient positioning table.It provides the user an additional accessory rail.
It includes a basic unit
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(89 cm x 75 cm / 35'' x 29.5'' (l x h);,one lower body radiation protection pivot swivel element(48 cm x 75 cm / 18.9'' x 30.3'' (l x h);one flip down element57 cm x 33 cm / 22.4'' x 12.99'' (l x h),;
and two clip-on units( 27 cm x 33 cm / 10.6'' x 12.99'',and27 cm x 25 cm / 10.6'' x 9.8'',with a lead of 0.5 mm / 0.02'' Pb.The maximum load of the accessory rails is 20 kg (44.1 Ib).
Intended only for use with Artis / ARTIS tables. It provides a smaller width, whatleads to a closer distance form operator to the patient. It might be damaged byregulary use of the maximum table penning. Please use the IR Version if customerinterventions need frequently the maximum table penning.
1 14434157 Moveable upper body rad. protectionThis radiation shield protects the user from scattered radiation.For room heights up to 290 cm / 114.2''.It includes a ceiling rail (4 m / 157.5''), a ceiling mounted and movable stand (80 cmor 57 cm / 31.5'' or 22,4"), a support arm (94 cm x 91 cm / 37'' x 35.8'') and anacrylic glass.The shield is made of acrylic glass with lead equivalent of 0.5 mm(w x h: 61 cm x 76 cm / 24'' x 29.9''), which can pivot and rotate around a fixed pointwith a range of 360 degrees.The operation range is limited when used with Artis floor/biplane MN.Max. weight: 18 kg / 39.68 Ib.
1 14432926 Card acq. mode w/high speedCard Highspeed enables image acquisition with up to 30 frames per second andhelps visualizing a moving heart.
1 14465096 QVA Vascular analysisVessel analysis with determination of degree of stenosis, distance measurementand calibration.
1 14465037 syngo interv. Neuro Engine ProApplication software for reconstruction, post-processing and handling of 3Dinformation including specific 2D and 3D applications for interventionalneuroradiology.
The package includes the following functionalities:
- 3D high-contrast and CT-like soft-tissue imaging (syngo DynaCT).
- 3D roadmap for dynamic overlay of planning data and 3D volumes on live images(fluoroscopy or roadmap).
- In-room control for table-side operation of advanced applications.
- 3D Wizard for expert step-by-step guidance in 3D acquisition.
- Parallel patient processing capabilities.
- Fusion functionality for integration of pre-interventional 3D datasets also from othermodalities into the Angio-room.
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- Marking of points or lines on the 3D geometry or MPRs and overlay of thesemarkings on live images (e.g. fluoroscopy).
3D functional imaging providing physiologic blood volume information (syngoDynaPBV Neuro), dedicated workflow support and measurements for aneurysmanalysis and 3D stenosis measurements.- 2D functional imaging for visualization of blood flow characteristics (syngo iFlow).
1 14465145 Twin SpinWhen acquiring a 3D volume with an according setup of start-position andacquisition program, the second plane will rotate in idle mode and does not need tobe parked, saving time and improving the clinical workflow.
1 14434323 syngo Dyna3D HighSpeedsyngo Dyna3D HighSpeed enables acquisitions to be generated down to less than 3seconds. As a result unintended patient motion and moving organs such as thelungs can be displayed with a lot fewer artifacts.
1 14440411 Intercom - ComfortIntercom system for communication between examination room and control room.It includes- a microphone with a control box for the control room- a microphone with an adaptive acoustic filter for background noise suppression forthe examination room- a footswitch for conversation selection for the examination room
1 14465141 OEM recording system interfaceCable connection to an OEM measurement system.
Holder for the ECG interface when using an OEM measurement system in theexamination room.
Recording, storage, and display of an ECG lead. Displayed together with the imageinformation on a single monitor.
1 14455701 Mattress-thick f. tabletop - wideMattress thickMatching, special-foam mattress, 8 cm, incl. a latex-free cover.This visco-elastic comfort mattress reacts to temperature and has the specialproperty of adapting to the individual body shape under the influence of body weightand heat.
1 14440469 Head holder, deepHead pad with deep profile for securing the head during examinations.It includes a head holder made of wipeable plastic foam.Height: 8.5 cm / 3.3''Length: 17 cm / 6.7''Width: 16.5 cm / 6.5''
1 14465014 syngo DynaCT Sine Spinsyngo DynaCT Sine Spin helps neuroradiologists reduce cone beam CT artifacts inthe basal part of the brain and close to the skull. Before performing thrombectomyand after all neurointerventions.
syngo DynaCT Sine Spin brings cone beam CT of the brain to the next level. A newdouble oblique trajectory for image acquisition was developed to overcome artifactsfrom bony structures especially in imaging the basal part of the brain and close tothe skull.
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1 14465028 Laser crosshairs (A&B)Laser crosshairs integrated in the cover of the flat detector and tableside operationfor easier, quicker and dose-saving positioning of the patient.
1 14443011 Large Display diagn. ProtectionThe high quality laminated glass protective screen protects the panel of the monitoragainst mechanical damage and fluid ingress on the front.It is suited for clinical image evaluation.Features:The laminated glass enforces high mechanical strenght and resistivity againstmechanical impact,the special coating reduces reflections for a continuous image quality,excellent spectral transmisison of at least 98%,can be added to existing Artis Large Display installations.Weight: approx. 12kg (55“) up to 16kg (60“)
Note: Observe the maximum permissible load of the display suspension, acombination with other options mounted to the display suspension might berestricted.
1 14455544 Tabletop - narrowNarrow-shaped carbon fiber patient positioning tabletop with head-end recess. Idealfor cardiological applications. Tabletop tapered in the thorax area for maximumfreedom of C-arm angulation.Maximum patient weight: 280 kg / 617.3 lbWeight: 13 kg / 28.7 lbLength: 2287 ± 1 mm / 90.1" ± 0.04"Width head-end: 228 ± 0,5 mm / 9.0" ± 0.02"Width middle body: 480 ± 0.8 mm / 18.9" ± 0.03"Width lower body: 525 ± 0.5 mm / 20.7" ± 0.02"
Intended only for use with ARTIS tables.1 14455543 Tabletop - wide
Patient positioning tabletop made of carbon fiber in wide, straight design foruniversal use. The tabletop is straight all the way to the head area.Maximum patient weight: 280 kg / 617.3 lbWeight: 12.7 kg / 28.0 lbLength: 2287 ± 1 mm / 90.1" ± 0.04"Width: 525 ± 0.5 mm / 20.7" ± 0.02"
Intended only for use with ARTIS tables.1 14440512 LED Exam Light
Ceiling-mounted, flexible positionable examination light with focusable light system.It is fully integrated into the ceiling-installed radiation protection mounting unit.
- Luminance: Min 60,000 Lux for 100 cm / 39.4'' distance- Working distance: 70 to 140 cm / 27.6'' to 55.1''- Color rendering index Ra at 4500 Kelvin: min. 95- Color temperature: 4,100+-200 Kelvin- Focusable light field: 14 to 25 cm / 5.5'' to 9.8''- Total input power: Max. 24 VA
1 14446025 syngo DynaCT SMARTStreak Metal Artifact Reduction Technique for syngo DynaCT images.Metal implants, like coils and stent markers, create artifacts in the reconstructed
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images that might make it difficult to detect bleedings or restenosis around theends of the stent, for instance. syngo DynaCT SMART is a dedicated reconstructionalgorithm to reduce metal artefacts.. This type of integrated image reconstructionprotocol results in 3D volumes with reduced metal artefacts.
1 14465134 syngo Embolization Guidancesyngo Embolization Guidance is an application for planning and performingembolizations.
By manually marking a proximal start- and one or multiple distal target vesselpoint(s) in a syngo DynaCT, CTA or MRA dataset, the algorithm determins thecourse of the vessel (tree) that connects the start with the target point(s).Functionality for tumor segmentation with automatic tumor volume computation isavailable in addition.Segmented structures can be overlaid with live 2D imaging for guidance during theprocedure.
In combination with syngo DynaCT( ≥200° acquisition) or CT dataset with intra-arterial injection, the easy one-clicksyngo Embolization Guidance application automatically detects and highlightstumor-feeding vessels for targeted embolization of the liver – supporting completetumor embolization, which is important for an effective and safe treatment.
1 AXA_RIG_ICONO_BP
Standard Rigging icono BP
1 AXA_EDU_INTNEURO
Interventional Neuro Education PkgThis Interventional Neurology education package includes Post-Go Live training: -Dedicated Siemens Education Consultant: partnering with your EducationCoordinator to create a blended curriculum adapted to your facility’s individual
needs. - Blended Learning: onsite, digital (immersive, online & virtual), andinstructor-led classroom fortified by an ASRT approved checklist. - On-siteCustomization: optimizing system hardware, software, clinical workflow andoperating safety consistent with the cleared use of the system. - OngoingEducational Case Support: ability to request onsite case-support with a SiemensClinical Education Specialist for your advanced procedures. This education packageincludes: - Go Live: Onsite clinical applications sessions, guiding staff members,reinforcing concepts and practices acquired during pre-training during operation. -Warranty / Post-Go Live: Continuation of the CEP delivery. Ongoing case supporton advanced request and subject to availability. Parties will mutually agree ondeliverables and scheduling of the requested training.This educational offering mustbe utilized within 12 months following install end date. If this offering is notcompleted within the applicable time period, Siemens obligation to provide thetraining will expire without refund.
1 AXA_INITIAL_28 Initial onsite training 28 hrsUp to (28) hours of on-site clinical education training, scheduled consecutively(Monday – Friday) during standard business hours for a maximum of (4) imagingprofessionals. Training will cover agenda items on the ASRT approved checklist.Uptime Clinical Education phone support is provided during the warranty period forspecified posted hours. This educational offering must be completed (12) monthsfrom install end date. If training is not completed within the applicable time period,Siemens obligation to provide the training will expire without refund
1 AXA_FOLLOWUP_28
Follow-up training 28 hrsUp to (28) hours of follow-up on-site clinical education training, scheduledconsecutively (Monday – Friday) during standard business hours for a maximum of(4) imaging professionals. Uptime Clinical Education phone support is provided
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during the warranty period for specified posted hours. This educational offering mustbe completed (12) months from install end date. If training is not completed withinthe applicable time period, Siemens obligation to provide the training will expirewithout refund.
1 EPW935515UPS
Eaton Powerware 9355 15 kVA UPSIncludes UPS, battery, maintenance bypass panel, and one year on-site parts andlabor coverage (24x7) by Eaton Powerware. This UPS is recommended whenprotection and uninterruptible power is required for the Artis' C-arm and table.Emergency fluoroscopy is not available with this UPS. If emergency fluoroscopy isrequired, the 9390 - 160 kVA UPS is recommended for the full system. One UPSper lab.
Additional seismic brackets are required to make this system OSHPD approved.2 GEL1040136601
278Black anti-fatigue mat 36x60Black NewLife EcoPro anti-fatigue mat (36 inches x 60 inches), 3/4 inchpolyurethane foam, fluid and dirt resistant with anti-micorbial properties, mattetextured surface.
The ultimate employee benefit for workers who stand, are ergonomically designedto provide the perfect balance of premium comfort and optimal support. ProprietaryCellulon®Polyurethane Technology stands up to the tough demands of commercialenvironments while providing lasting comfort that won't bottom out over time. Thiseco-friendly line of anti-fatigue mats is certified by the National Floor Safety Institutefor its high traction bottom surface.
1 AM0180_AM0500
Adept IR System-radial,leftRadial positioning equipment intended for clinicians working on the left.Includes the STARBoard, extension and IR shield.
A key function of the STARBoard is its ability to present the patients wrist in thehyper-extended position whilst access is achieved, then simply return it to a morerelaxed, medially-rotated position, for the duration of the procedure, allowing greaterpatient comfort. Crafted in carbon fiber for superior strength, radiolucency anddurability, the STARBoard is light weight and compact.
The clip-on STARBoard Extension transitions your guide wire from the radial accesssite to your draped trolley and also provides a stable work surface for wiremanipulation.
Includes one year warranty through Adept.1 AXA_ADDL_RIG
GINGAdditional Rigging AXA $13,368
1 AXA_MISC_MATERIAL
Single fluoro monitor on a Cart $25,000
System Total $ 1,892,970.00
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OPTIONS on Quote Nr : CPQ-253841 Rev. 4
OPTIONS for ARTIS icono biplane IR Pro
Qty Part No. Item Description Extended Price 1 ACISTCVI003 ACIST CVi Contrast Injector System + $ 58,750.00
1 14446026 syngo Dyna4Dsyngo Dyna4D enables the visualization of flow patterns in 3D.With only one C arm scan it provides a view similar to virtually an unlimitednumber of DSA runs at no additional dose and contrast media.syngo Dyna4D helps to expand clinical capabilities in the angio suite byoptimizing patient selection and supporting individualized treatment strategies.
+ $ 30,797.00
1 14455928 VOLCANO Cable Set plusCable set for operating the Volcano s5i ultrasound system incl. s5iz and s5iu(CORE-System). It contains all cables for connecting the components at thepatient table to the s5i imaging system in the control room.This cable set will already be integrated into the Artis table in the factory.
With this item, a display is delivered additionally for the examination room if anArtis Large Display was not ordered. If an Artis Large Display or PanoramicDisplay is ordered, the configuration includes a connection kit instead of the 19"display.
Also with this item comes theAccessory spacer rail (Kenex Electro-Medical LTD.)This is an accessory rail for attachment of tableside rail equipment (for use withan extended lateral moving tabletop).This accessory allows tableside mounted equipment, to be used on a tablefeaturing extended lateral tabletop movement. Rail accessories which would strikethe table pedestal, are positioned outside of this movement range.
+ $ 7,752.00
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FINANCING: The equipment listed above may be financed through Siemens. Ask us about our full range off inancial products that can be tailored to meet your business and cash flow requirements. For further information,please contact your local Sales Representative.
Siemens Healthcare is pleased to submit this Preliminary Pricing Proposal. A Preliminary Pricing Proposal isprovided for planning purposes only; it is not contractually binding. To receive a contractually binding proposal forthe Products listed above, inclusive of Terms, Conditions, and Warranty coverage, please contact your SiemensHealthcare Sales Representative.
Siemens HealthcareDouglas Sohn
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May 12, 2021
Mr. Kevin Studer NorthStar Management Company 10820 Sunset Office Drive St. Louis, MO 63127
Re: Bi-Plane C-Arm Room Shielding
Mr. Studer
A breakout price for the shielding portion of the proposed Bi-Plane space at Mercy South is $25,409.00.
Thank you for the opportunity to work with you on this project. Feel free to contact me with any questions.
Sincerely,
Robert Brooke Vice President, Preconstruction
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June 18, 2021
Ms. Alison Dorge Program Coordinator Certificate of Need, DHSS 3418 Knipp Drive, Suite F Jefferson City, MO. 65109
To whom it may concern:
This letter is written in support of the acquisition of an additional Biplane imaging system at Mercy Hospital South, to be situated in the Interventional Radiology department. Mercy Hospital South is the second largest stroke center in the St Louis region. The hospital was a Level 1 Stroke Center program for many years until achieving the Comprehensive Stroke Center status in early 2021. Our program is not only a pillar to our South County region but serves many patients throughout southern Missouri communities.
Mercy Hospital South currently offers the biplane imaging system in a single room. The additional biplane system will not only offer back up in case of downtime, but more importantly will allow for simultaneous stroke interventional cases moving forward. This is essential to support the stroke patients seen at Mercy Hospital South.
Interventional stroke care is a rapidly growing area of emergent patient care that requires not only a team with special expertise but also specialized equipment. A new biplane platform is essential to our ever growing stroke patient volume and critical to the ability of Mercy Hospital South to continue providing high quality care to the patients we serve.
Here at Mercy Hospital South, my role is director of the Radiology department and Interventional Radiology. Because of my role, I am an integral part of this service line and fully support adding another bi-plane imaging system to increase quality, expand service capabilities, and better serve our community.
Please do not hesitate to contact me with questions concerning this letter of support.
Regards,
B. Kirke Bieneman, MDDepartment of Interventional RadiologyMercy Hospital [email protected]
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Divider III
Service Specific
Criteria and Standards
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DIVIDER III – Service Specific Criteria and Standards
1. For new units, address the need formula for the proposed geographic service area.
Not applicable.
2. For new units, address the minimum annual utilization standard for the proposed
geographic service area.
Not applicable.
3. For any new unit where specific need and utilization standards are not listed,
provide the methodology for determining need.
Not applicable.
4. For additional units, document compliance with the optimal utilization standard,
and if not achieved, provide documentation to justify the additional unit.
Not applicable.
5. For evolving technology address the following:- Medical effects as described and documented in published scientific literature;
- The degree to which the objectives of the technology have been met in practice;
- Any side effects, contraindications or environmental exposures;
- The relationships, if any, to existing preventive, diagnostic, therapeutic or
management technologies and the effects on the existing technologies;
- Food and Drug Administration approval;
- The need methodology used by this proposal in order to assess efficacy and cost
impact of the proposal;
- The degree of partnership, if any, with other institutions for joint use and financing.
Not applicable.
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Divider IV
Financial Feasibility Review
Criteria and Standards
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DIVIDER IV – Financial Feasibility Review Criteria and Standards
1. Document that sufficient financing is available by providing a letter from a financial
institution or an auditor’s statement indicating that sufficient funds are available.
Ernst & Young LLP conducted the external audit for Mercy Health, the applicant’s parent
organization, for fiscal year ending June 30, 2020. The consolidated balance sheet
(included in Divider IV – Attachments) verifies the ability of the applicant to fund this
project.
2. Provide Service-Specific Revenues and Expenses (Form MO 580-1865) projected
through three (3) Full years beyond project completion.
The Service-Specific Revenues and Expenses Form for the projected period is included in
Divider IV – Attachments.
3. Document how patient charges are derived.
Charges for Biplane procedures are already established, as the applicant currently offers
these services. Changes are not anticipated to the charge structure with the addition of
this new unit other than normal inflationary increases in future years.
4. Document responsiveness to the needs of the medically indigent.
Mercy is a Catholic, not-for-profit organization. Collection policies are sensitive to those
patients who do not have the ability to meet full financial obligations. Mercy provides
financial assistance to patients based on need as determined by the Federal Poverty
Guidelines. Patients who qualify for financial assistance will not be required to pay more
than amounts normally billed to individuals who have insurance. The amount billed is a
discounted percentage of the amount due based on federal poverty guidelines.
In FY2021 through 9 months, Mercy Hospital South provided $13.5 million in charity
care (based on the cost of providing services) and $13.1 million in unreimbursed care for
patients with Medicaid coverage.
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Attachments
Divider IV
Financial Feasibility Review
Criteria and Standards
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2020 2019Assets Current assets:
Cash and cash equivalents 1,007,076$ 346,890$ Accounts receivable, net 632,709 767,977 Inventories 113,891 114,642 Short-term investments 37,917 36,727 Other current assets 109,838 117,053
Total current assets 1,901,431 1,383,289 Investments 2,473,364 2,468,153 Property and equipment, net 3,110,858 3,049,078 Other assets 1,009,181 649,228 Total assets 8,494,834$ 7,549,748$
Liabilities and net assets Current liabilities:
Current maturities of long-term obligations 69,134$ 22,444$ Accounts payable 246,079 272,405 Accrued payroll and related liabilities 407,518 459,181 Accrued liabilities and other 1,043,407 222,489
Total current liabilities 1,766,138 976,519 Insurance reserves and other liabilities 797,364 513,925 Pension liabilities 400,178 344,306 Long-term obligations, less current maturities 1,828,340 1,686,369 Total liabilities 4,792,020 3,521,119
Net assets: Without donor restrictions 3,558,110 3,920,342 With donor restrictions 144,704 108,287
Total net assets 3,702,814 4,028,629 Total liabilities and net assets 8,494,834$ 7,549,748$
See accompanying notes.
Mercy Health
Consolidated Balance Sheets(In Thousands)
June 30
2005-349134837
*Utilization will be measured in “patient days” for licensed beds, “procedures” for equipment,or other appropriate units of measure specific to the service affected.
**Indicate how the average charge/procedure was calculated.
***Only on long term debt, not construction.
****Indicate how overhead was calculated.
MO 580-1865 (08/06)
SERVICE-SPECIFIC REVENUES AND EXPENSESCertificate of Need Program
Historical Financial Data for Latest Three Full Years plus Projections Through Three Full Years Beyond Project Completion
_______ _______ _______ Use an individual form for each affected service with a sufficient number of copies of this form to cover entire period, and fill in the years in the appropriate blanks.
Year
Amount of Utilization:*
Revenue:Average Charge**
Gross RevenueRevenue Deductions
Operating Revenue Other Revenue
TOTAL REVENUE
Expenses: Direct Expenses
Salaries Fees Supplies Other
TOTAL DIRECT
Indirect Expenses Depreciation Interest*** Rent/Lease Overhead****
TOTAL INDIRECT
TOTAL EXPENSES
NET INCOME (LOSS):
Project Title: Project #:
TOTAL INDIRECT
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