Attachment A - Scope of Work Amend-15.docx

Attachment A – Scope of Work R&F, DR and Portable

A. Digital Radiography and Fluoroscopy Unit:

Contractor to include delivery, installation, testing, set-up, training, removal of existing units and service requirements for the procurement for 1 true patient-side control Fluoroscopy/Digital Radiography unit, 1 remote control Fluoroscopy/Digital Radiography unit, 1 Digital Radiology unit and 2 Digital Radiology portables (excludes trade in of portables) for the Phoenix Indian Medical Center, (PIMC). (This requirement excludes trade-in of the Detector Panels (DR) units). The System shall be Food and Drug Administration (FDA) approved and be on the Vista Imaging Digital Imaging and Communications in Medicine (DICOM) Modality Interfaces list dated August 1-31, 2022 (Attachment C - Vista Imaging DICOM Modality Interfaces August 1-31, 2022). It must interface with Vista Imaging and Vista Rad, which are supported by the Veteran’s Administration. Descriptions herein describe the minimum system requirements to be provided by the Contractor, which if properly configured and installed, shall utilize the source of ionized radiation to expose and process diagnostic images in the medical treatment of PIMC patients. These systems shall be utilized by Registered Diagnostic Radiologic Technologists and Radiologists. The contractor shall provide connectivity with Vista Rad and Vista Imaging Picture archiving and Communication System (PACS). The contractor shall demonstrate with the Contracting Officer Representative (COR) that the system has connectivity and is functioning. All detectors must be interchangeable between rooms and mobile DR units.

System will require a TURN-KEY installation due to the nature of the control panel installation and control room updates, to include electrical.

Below is the manufacture and model to include salient characteristics and is listed in accordance with *52.211-6 Brand Name or Equal.

I. EQUIPMENT:

A. Fluoroscopy and Digital Radiography Unit (Unit is to provide both Fluoroscopy and Digital Radiography exams) Quantity: 2 Units (1 unit is patient-side control and 1 unit is remote control) Manufacturer: Siemens Model: Luminos Lotus Max Model: Luminos Agile Max

Salient Characteristics:

1. Table Weight Capacity Minimums:

1. Static (Table flat, not moving) – 600 lbs.

2. Dynamic (Table flat, moving) – 500 lbs.

3. Table tilted – 500 lbs.

4. Standing on footrest (Table at 90 degrees) – 500 lbs.

2. 80 kW generator

3. One unit must be true patient-side control fluoroscopy unit and one unit must be remote control fluoroscopy unit:

· True patient-side control fluoroscopy unit (not a modified remote system), which includes bedside display system – ceiling mounted vs. floor trolley, depending on the space in the room.

4. Detector system must include:

1. 17 x 17” flat detector (static in Bucky wall stand) (one unit per machine)

2. Wireless 14 x 17” detector (one unit per machine)

3. Wireless detectors should be interchangeable between rooms of the same manufacturer.

4. Charging system – In table tray or wall stand versus external charger.

5. Detector holder for Radiology Department, ED and OR exams (1 in the department), preferably wheeled.

5. Bucky wall stand with height-adjustable detector tray, with static 17 x 17” detector

6. For remote control fluoroscopy unit:

1. Wireless footswitch - preferred

2. Bedside control panel (required)

3. Display system (required) - ceiling mounted vs. floor trolley, depending on space in room

4. Intercom system - preferred

5. SID maximum - at least 58”

7. For tableside fluoroscopy unit:

1. Lead curtain

2. Minimum source to tabletop distance – 20”

8. Fluoroscopy

1. Storage and review system (Ex- barium swallow studies)

2. Ability to separate fluoroscopy series

9. External Digital Video Interface (DVI)

1. CD/DVD writer for patient studies

2. Interface ready for addition of aftermarket TIMS Medical Video Platform Unit.

10. Tube

1. Tube tracking

2. Tube touchscreen

3. Ceiling-mounted

4. Heat unit capacity – at least 500,000 HU

11. Anti-scatter grids for radiation reduction – one for wall stand and one for the table.

12. Grid holder.

13. Patient leg supports (left and right) for hysterosalpingograms – preferred.

14. Foot board and side handles that can be attached

15. Mattress – radiolucent and easily cleaned, meeting Phoenix Indian Medical Center infection control standards

16. Compression device – built in

17. DICOM Query/Retrieve

18. DICOM Send and Print

19. Power Conditioner and Uninterrupted Power Supply

a) The contractor will provide power conditioner and Uninterrupted Power Supply for the unit. The intent is to protect the unit from PIMC generator testing which may cause power electrical fluctuations.

Contractor will recommend the unit size needed, run and install power lines/cables and install the units.

20. Radiation Dose Reduction Software

21. Radiation Dose Tracking

22. In addition, the units the features below are minimum requirements:

I. DICOM – VA Vista Rad and Vista Imaging compatible; DICOM Worklist display II. Windows 10 or Unix;

III. Hard copy and digital copy, if available, of the original OEM System manuals, software CD/DVDs, schematic drawings, and any additional OEM documents for Digital Radiography and Fluoroscopy Unit;

IV. Attachment C - Vista Imaging DICOM Modality Interfaces August 1-31, 2022.

V. Complete the Indian Health Service Network Interconnection Security Agreement (ISA) for remote access.

B. Digital Radiography Unit:

Quantity: 1 Unit Manufacturer: Siemens Model: YSIO X.pree

Salient Characteristics:

1. Table weight capacity minimum – 700 lbs. static

2. 80 kW generator

3. Bucky wall stand with height-adjustable and tiltable detector tray, with static 17 x 17” detector

4. 14 x 17” wireless detector

5. 10” x 12” wireless detector

6. Detector charging system – In table tray or wall stand versus external charger.

7. Battery charger with detector batteries. Prefer batteries for 14” x 17” and 10” x 12” detectors be interchangeable.

8. Tube

1. Tube tracking

2. Tube touchscreen

3. Ceiling-mounted

9. Anti-scatter grids for radiation reduction – one for wall stand and one for the table.

10. Grid holder

11. DICOM Query/Retrieve

12. DICOM Send and Print

13. Stand with patient handles and any required equipment (including grids) and licensing needed to perform:

1. Standing and recumbent scoliosis and long leg studies with image stitching.

2. Standing studies of hips, knees, and feet.* *Government currently owns X-Cell X-Ray Corporation, which performs hips, knees and feet studies. Contractor to determine if this equipment can be integrated with the new proposed system. If determined possible, then the contractor is to be responsible for connection and testing for complete functionality. Contractor to obtain physicist review and certification of system. If the government-owned unit is not compatible with proposed system, then the contractor is to include alternative similar equipment to perform standing hips, knees and feet studies in the proposal. The alternative would have to include a detector panel protector at a minimum weight rating of 450 lb capacity.

14. Flat table top

15. Mattress – radiolucent and easily cleaned, meeting PIMC infection control standards

16. Power Conditioner and Uninterrupted Power Supply

a) The contractor will provide power conditioner and Uninterrupted Power Supply for the unit. The intent is to protect the unit from PIMC generator testing which may cause power electrical fluctuations.

Contractor will recommend the unit size needed, run and install power lines/cables and install the units.

b) Integrated 3D camera, which enables optimal patient monitoring and virtual collimation. – preferred, but not required.

c) Virtual collimation – preferred, but not required.

d) In addition, the equipment below are minimum requirements:

I. DICOM – VA Vista Rad and Vista Imaging compatible; DICOM Worklist display.

II. Windows 10 or Unix;

III. Hard copy and digital copy, if available, of the original OEM System manuals, software CD/DVDs, schematic drawings, and any additional OEM documents for Digital Radiology;

IV. Attachment C - Vista Imaging DICOM Modality Interfaces August 1-31, 2022.

V. Complete the Indian Heath Service Network Interconnection Security Agreement (ISA) for remote access.

C. Mobile Digital Radiography Unit:

Quantity: 2 Units Manufacture: Siemens Model: Mobilett Elara Max

Salient Characteristics:

1. 30 kW generator – at least

2. Wireless detector system

1. 14” x 17” detector with handle

2. Detectors should be interchangeable between rooms/devices from the same manufacturer.

3. Detector charges while loaded in the machine.

4. Anti-scatter grid

5. Plug-in or battery function

6. Storage capacity – at least 4500 images

7. DICOM Query/Retrieve

9. DICOM Send and Print

10. CD/DVD Recorder

11. In addition, the equipment below are minimum requirements:

I. DICOM – VA Vista Rad and Vista Imaging compatible; DICOM Worklist display.

II. Windows 10 or Unix;

III. Hard copy and digital copy, if available, of the original OEM System manuals, software CD/DVDs, schematic drawings, and any additional OEM documents for Mobile Digital Radiology Unit;

IV. Attachment C - VistA Imaging DICOM Modality Interfaces August 1-31, 2022.

V. Complete the Indian Health Service Network Interconnection Security Agreement (ISA) for remote access.

*52.211-6 Brand Name or Equal (Aug 1999)

(a) If an item in this solicitation is identified as “brand name or equal,” the purchase description reflects the characteristics and level of quality that will satisfy the Government’s needs. The salient physical, functional, or performance characteristics that “equal” products must meet are specified in the solicitation.

(b) To be considered for award, offers of “equal” products, including “equal” products of the brand name manufacturer, must-

(1) Meet the salient physical, functional, or performance characteristic specified in this solicitation;

(2) Clearly identify the item by-

(i) Brand name, if any; and

(ii) Make or model number;

(3) Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and

(4) Clearly describe any modifications the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modifications.

(c) The Contracting Officer will evaluate “equal” products on the basis of information furnished by the offeror or identified in the offer and reasonably available to the Contracting Officer. The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer.

(d) Unless the offeror clearly indicates in its offer that the product being offered is an “equal” product, the offeror shall provide the brand name product referenced in the solicitation.

1. INSTALLATION

Contractor shall include installation to be performed by an OEM-certified service and installation engineer(s) to ensure a safe and functional installation. In addition, the contractor shall send out an OEM Project Manager to verify installation, certify that the room air conditions, room size, electrical and flooring will support the new proposed unit. This will take place one week after award or at a mutually agreed upon time with the COR. In addition, the contractor shall remove existing ceiling tiles and grid, remove existing flooring tiles and remove existing cove trim. Install new ceiling tiles and grid, flooring tiles, cove trim and paint walls for all Digital Radiology Rooms (1, 2 and 3) (excluding bathrooms).

A. Contractor shall provide equipment installation schedules to include all lead times and milestones; This will include plans for one DR Room to be operational at all time.

B. Contractors shall provide a room layout and elevation drawings depicting the intended system and all components to illustrate working space and general position within the available space;

C. Physicist* inspection/testing following the installation to ensure that the Digital Radiography/Fluoroscopy Units (2 units) and Digital Radiography Unit (1 unit) and Mobile DR units (2 units) and all components meet Federal regulatory requirements. (Copy of report is to be provided to the COR and PIMC Biomedical Department.)

D. Installation shall include commissioning start up and all functions of the Digital Radiography and Fluoroscopy Unit, Digital Radiography Unit and Mobile DR units are working. Demonstrate to the COR and PIMC Information Technology Department that the units are communicating with Vista Imaging and Vista Radiology, units can create CD’s and send images to PIMC Tele-Radiology contractor. Copy of system setting shall be saved to disk for future rest of system configurations.

E. If any walls, ceiling or floors are patched it must be patched in a manner approved by OSHA for lead shielding.

F. WALLS - Walls are to be painted. Paint shall be Sherwin Williams Semi-Gloss Toque White, 2 coats. This includes patch and prep walls for painting in a manner approved by OSHA for lead shielding.

G. CEILING - Ceiling tiles shall be Rockfon 31101RF Hygenic Plus tiles, ¾” thick. New t-grid shall be from the same manufacturer.

a. Contractor to use 2’ x 4’ tiles except where smaller tiles are necessary due to the new radiology equipment.

b. All impacted ceiling devices such as sprinklers, smoke detectors, duct detectors, HVAC registers, etc. shall be protected during construction. Coordinate with the Government Contracting Officer and COR any devices that need to move to accommodate the new radiology equipment.

H. FLOORING - Flooring shall be Armstrong Standard Excelon Vinyl Composite Tile.

a. Size shall be 12” x 12” x 1/8”

b. Adhesive shall be Armstrong S-515

c. Approved colors are 51836 – Shelter White and 51927 – Field Gray

d. 1” black transition strip shall be placed under the door at each room

e. VCT pattern will be centered in the room

f. VCT cuts shall be no small than 4”

g. Moisture, alkalinity, and bonding tests shall be performed per the Armstrong installation instructions

h. Tile shall be stripped per manufacturer’s recommendations and finished with four coats of Buckeye Castle Guard

Flooring - installation instructions require 24 hours post-install for foot traffic, 72 hours for rolling traffic, and 5 days before washing (therefore 5 days after install before stripping and finishing). Contractor shall plan out the installation time for the DR Rooms.

i.

I. COVE - Cove base shall be Tarkett Tightlock for resilient flooring, 4.375”, black.

J. Square Footage: DR Room 1 300 sqft, DR Room 2 291 sqft and DR Room 3 290 sqft.

K. Power Conditioner and Uninterrupted Power Supply

a. Location for Install: The power conditioner and Uninterrupted Power Supply Unit are to be installed in the PIMC Basement. (See Attachment F Basement Drawing for UPS). Cage that holds the units will need lock and key options. Contractor is to provide all labor, supplies, equipment, tools, delivery and installation.

b. Electrical Power Installation: Contractor is to provide and install all electrical power lines/cables/conduit as needed, to supply the electrical power needs to the power conditioner and UPS and from the power conditioner and UPS to the Digital Radiography rooms. Contractor is to follow all PIMC infection control, local city and county electrical codes, fire safety installation regulations for medical facilities, Joint Commission and Occupational Safety and Health Administration (OSHA) regulations. Drawings are to be provided to PIMC showing the material used and layout of the path to each radiology room (hard copy print and Adobe drawings). All lines are to be run above the ceiling tiles. Submit with proposal. Running of electrical power/cable lines may need to be installed at night from 9 pm to 6 am - Monday through Friday. Contractor submit timeline for running of electrical power/cable lines and installation. Contractor is to provide all labor, supplies, equipment, tools, delivery and installation.

*Provide copy of Physicist certifications and state of licensure for Joint Commission Reporting.

2. EQUIPMENT REMOVAL (TRADE-IN)

Contractor shall remove the Shimazu Fluro/DR equipment in DR Room 2 and 3 and Del Medical DR equipment in Room 1 (except hard drives) and all required components and dispose of as required by Federal, State, and County regulations. Contractor shall include and credit the estimated salvage value of the system in the quote. Title of equipment/ownership shall become the property of the contractor. Contractor shall include and credit the estimated value of the existing system in the quote. It is noted that the Shimazu Fluro units are damaged and not operational in DR Rooms 2 and 3. Hard drives are to be removed by the Contractor and delivered to PIMC. Hard drives will not be part of the trade in and remain property of the Government. Hard drives are to remain on PIMC campus at all times.

Items not traded in shall include all Canon DR Plates and charging devices and 2 Shimadzu Digital Radiology portables.

If any walls, ceilings or floors are patched, they must be patched in a manner approved by OSHA for lead shielding.

Trade-In:

The government will be trading in the following units:

a. Shimadzu*, Sonial Safire Fluoro System, S/N: 3M5249D29002/SMSNO120049 XTV, Model: Sonial Safire Fluoro System and Bucky

b. Shimadzu*, Sonial Safire Fluoro System, S/N: 3M5249D33003, Model: Sonial Safire Fluoro System and Bucky

c. Del Medical* and Bucky

Contractor will record all serial numbers for all equipment for a, b and c. Contractor will provide a list of all serial numbers, make and model of all parts to the COR. Contractor will compete an HHS-22 Request For Property Action transferring property to contractor at time of removal.

One DR room must be operational at all times during equipment removal.

3. TRAINING

The purpose of this section is to understand the supplemental vendor Training Program fees throughout and after this procurement. The training audience shall include Radiologic Technologists, Radiologists and supporting imaging staff within the institution. PIMC seeks the costs of onsite training that follows the initial equipment install, in addition to the supplemental training to include distance learning, computer-based training, and/or web meetings.

Contractor training programs include the following minimum requirements:

A. Five (5) ten-hour days of onsite training for (4) four Radiologic Technologists on the system and all components following the initial installation and acceptance testing for

a. As a minimum, training should include: applications training, emergency shutdown procedures, any proprietary QA/QC testing procedures, and system administrative configuration procedures;

b. Ten-hour days are Monday through Friday from 8 am to 6:30 pm.

B. Follow up training five (5) ten-hour days of onsite training for (4) four Radiologic Technologists on the system and all components following the initial training, at a time at the discretion of the government within 12 months of installation:

a. As a minimum, training should include: applications training, emergency shutdown procedures, any proprietary QA/QC testing procedures, and system administrative configuration procedures;

b. Ten-hour days are Monday through Friday from 8 am to 6:30 pm.

8. Contractor shall also include access to web-based training for 12 months for Radiologist Technologist.

C. Five (5) ten-hour days of onsite training on the system and all components following integration to Radiology Information System Package (RPMS) and PACS and/or as needed for advanced follow-up training for (4) four Radiologic Technologists and PIMC PACS Administrator:

a. As a minimum, training should include: DICOM (MDWL, Store, Query/Retrieve, and Print) functionality training, applications training, any proprietary QA/QC testing in digital environment, and system administrative configuration procedures;

b. Ten-hour days are Monday through Friday from 8 am to 6:30 pm.

D. Training associated with proprietary Service Repair call systems, if applicable.

D. 12 months (unlimited) Remote/Online/Web training as needed.

E. Training off-site at contractor’s training facility for (4) four Radiologic Technologists.