AIHC 3D Mammo SOW.docx

SCOPE OF WORK

3D Digital Mammography Anadarko Indian Health Center Anadarko, Oklahoma

A. Overview of Project

1. The intent and objective of this Scope of Work is for new installation of Digital Mammography equipment in which 2D and 3D images are acquired in a single exposure to the patient, replacing the current Mobile Mammogram Bus that is available on a limited basis, with the newest available Mammography Screening equipment available within the Clinic on a daily basis, thereby being able to meet more of the patient population needs We intend to purchase the 3D Digital Mammography equipment with in the next 3 months. To ensure a smooth transition to 3D Mammogaphy the project will need to be turnkey, with the vendor providing necessary updates to the Mammography room up to and including flooring and painting the walls.

B. Services to be Performed by the Vendor

1. The Vendor will sell to the Lawton Service Unit a state of the art 3D Digital Mammography system

2. The Vendor purchased 3D Mammography unit will consist of the following items:

i. 3D Digital Mammography System

ii. Complete room update to 3D Mammography Standards

3. Vendor will provide the following setup and installation services:

i. Deliver 3D Digital Mammography unit

ii. Complete setup of 3D Digital Mammography unit

· Setting 3D Mammography unit in designated room including leveling and anchoring

· Connect utility service at the Anadarko Indian Health Service’s source

· Connect phone and data to the Anadarko Indian Health Service’s network

· Startup and testing of 3D Digital Mammography unit

· Physicist Inspection and Acceptance for compliance by Physicist of Anadarko Indian Health Service’s Imaging, Clifford Richter, PHD; cliffordrichterphd@sbcglobal.net; 405-340-1195

4. Minimum System Requirements

i. The 3D Mammography System

· Operating System- Win 10/64 or better Embedded

· Ethernet- 10/100/1000 base-T

· Removable Storage- CD/DVD +/- R/W

· USB Ports- Dual USB 2.0

· Image buffer- 2D: 9,000 4-view studies; 3D: 3,000

· Advanced capabilities- Generated 2D Imaging

· Cenova Server

· ICad

· ImageChecker 2D CAD License

· 3D CAD License

· ImageChecker CAD

· Quantra 2D and 3D breast density analysis software license

· Software/Connectivity- Print, Query, Storage, Storage Commitment, Worklist

· IHE Profiles- Mammography Image, Patient Information Reconciliation, Scheduled Workflow

· TomoHD, Low-dose screening 2D, 3D and FFDM

· Design-Split C-Arm, biopsy and tomosynthesis capable

· Vertical Range- 70.5 cm +5.1 cm to 141 cm

· Vertical Travel- Motorized

· Rotation- 2D +195 to -155; Biopsy and 3D +180 to -140

· Source to Image Distance- 70cm

· Patient Face Shield- 2D Removable; 3D Retractable and Removable

· Modes of Operation- Selected by Operator

· Pre-compression Range- 67 to 134 N

· Full-compression Range- 89 to 178 N

· Dual-compression Function- 1st activation: pre-compression; Subsequent activations: Incremental increase up to full-compression

· Manual-compression Force Limit- 300N

· Compression Tilt- User selectable

· Platform- Lightweight

· Magnification Factors- 1.5x 1.8x

· Collimation Modes- Fully-automatic or User-controlled

· Pre-defined Collimation Sizes- 24x29 cm, 18x24 cm, 15x15 cm, 10x10 cm, 7x8.5 cm, 18x29 cm

· Digital Image Receptor Type- TFT-based direct capture

· X-ray Absorption Material- Amorphous selenium

· Image Receptor Size- Single plate 24 cm x 29 cm

· Pixel Size- 70 microns FFDM, 70 microns (HRTomo), 140 microns (SRTomo)

· Limiting Spatial Resolution- 2D 7.1 lp/mm; 3D 3.5 lp/mm

· Dynamic Range- Linear response over 400:1 in X-ray exposure

· Captured image Bit Depth- 14 bits

· Saturation X-ray Exposure Level- >500 mR

· Image Capture Geometry Non-Magnified- 24 cm x 29 cm center position; 18 cm x 24 cm left, center and right positions

· Magnified- 18 cm x 24 cm center position

· Grid Structure- Linear grid

· Grid Behavior- Auto-retracts for magnified 2D and all 3D exam views

· Storage Temperature Range 10 C to 30 C

· Maximum Rate of Temperature Change- < 10 C per hour

· Relative Humidity Range- 10% to 80%, non-condensing

· Subsystem Integrated Generator Design- Zero footprint, fully integrated

· Type- Constant Potential High Frequency Inverter

· Rating- 7.0 kW max. (ISOwatt); 200mA @ 35 kV

· Electrical Power Capacity- 9.0 kW max.

· kV Range- 2D: 20 to 39 kV, 2D 1 kV steps (0.5 kV steps option); 3D: 20 to 49 kV, 2D, 1 kV steps

· mAs Range- 3.0 to 500 mAs

· mA Range- 200 mA, large focal spot; 50 mA, small focal spot

· X-ray Tube Anode Type- Tungsten, rotating

· Anode Design- Bi-angular

· Anode Speed- 9500 RPM (high speed)

· Heat Capacity- 222 kJ (300,000 HU)

· Target Tube Angle- 16 degrees, large focal spot; 10 degrees, small focal spot

· Filtration- 0.05 mm Rhodium (RH); 0.05 mm Silver (Ag); 0.70 mm Aluminum (Al); 0.30 mm Copper (Cu)

· Port- 0.63 mm Beryllium

· Electrical Requirements Input Line Voltage- 200/209/220/230/240 VAC

· Input Current- 3.5 A standby; 65 A for 5 s at 208 VAC; 40 a max. breaker rating

· Frequency- 50/60 Hz +/- 5%

· Number of Phases- Single, permanently wired

· Integrated UPS- 1000 VA

· X-ray Control Manual- User selects all paramets

· Auto-Time- System selects mAs; User selects filter, kV

· Auto-kV- System selects kV, mAs; User selects filter

· Auto-Filter- System selects filter, kV, mAs

· X-ray Activation- Single exposure, either table-top button or integrated footswitch

ii. 3MP Color LCD

iii. Fast teleradiology transmission via DICOM

iv. 24x29cm Paddle

v. 18x24cm Paddle

vi. 10x23cm Small Breast Paddle

vii. Implant Paddle

viii. Sweep angle of at least 15 degrees

ix. 3D dose equivalent to dose of 2D standard acquisition of same view

x. Must acquire 2D and 3D images in same exposure, cannot have separate radiation dose exposure for required 2D imaging

xi. Touchscreen Tech Station

xii. ACR Breast Phantom

xiii. Wall Stand for paddles

xiv. Dual-function foot switches- Operator may compress or expose from foot switch

xv. Breast Density license

5. Turn-Key Installation

i. Provide full time superintendent

ii. All work will be performed between 0800-1700, Monday through Thursday. All electrical upgrades and room refinements is to be performed in one phase.

iii. Use of AIHC’s facilities shall be permitted during room refinement

iv. Daily broom cleaning of the job site and debris removed in the appropriate disposal.

v. Final cleaning is to be included, terminal clean to be performed by AIHC EVS personnel.

vi. Provide a dumpster for disposal of debris and material.

vii. Infection control will consist of blue ‘sticky’ mats at the entry door to the designated area, zipable ‘poly’ barriers, and a temporary HEP filtration unit to be exhausted into the designated area.

viii. Remove the VCT flooring and rubber base

ix. Remove ceiling tile and grid, as required to accommodate 3D Mammography equipment.

x. Level the floor beneath the footprint of the equipment.

xi. Furnish/install a 4’0” long plastic laminate upper cabinet with full height soffit.

xii. Furnish/install a 5’0” long plastic laminate bench and one (1) locker in the Dressing Room.

xiii. Furnish/install one (1) 3’0” x 7’0” solid core, unfinished, red oak door with 3’0” x 7’0” hollow metal frame for dressing room. Door hardware to include, hinges, lever set and door stop.

xiv. Dressing room walls will be completed with 3-5/8” metal studs and 5/8” sheetrock, to 6” above ceiling.

xv. Tape dressing room walls and patch demolition scars.

xvi. Paint all walls in the Mammography Suite and Dressing room with 2 coats of latex paint.

xvii. Paint exposed electrical raceways in the Mammography Suite, color to match the walls.

xviii. Furnish/install new sheet vinyl flooring and integral cove base in the Mammography Suite and Dressing room.

xix. Rework the existing ceiling tile and grid in the Mammography Suite as required.

xx. Furnish/install a new lay-in ceiling (tile and grid) in the dressing room.

xxi. Pain the Dressing room door frame.

xxii. Stain the Dressing room door.

xxiii. Furnish/install one (1) new sprinkler head in the Dressing room.

xxiv. Provide a certified test and balance of the AC unit serving the Mammography Suite.

xxv. Furnish/install a new 20-amp, 120-volt dedicated circuit.

xxvi. Furnish/install a 40-amp, 208-volt shut trip disconnect.

xxvii. Furnish/install a 40-amp, 208-volt source panel circuit breaker in the existing source electrical panel.

xxviii. Furnish/install a 40-amp, 208-volt equipment main power feeder.

xxix. Furnish/install raceways as per Mammography Vendor’s specifications.

xxx. Furnish/install a new EPO and associated raceway.

xxxi. Furnish/install a new x-ray in use light.

xxxii. Furnish/install one (1) new 2x2 flat panel LED light in the dressing room.

xxxiii. Provide a junction box and conduit to above ceiling for a new voice/date line in the Mammography Suite.

xxxiv. Provide all conduit, junction boxes and pull strings for AIHC’s computer network system to meet facility standards.

6. Contractor will provide the following support

i. On-line help

ii. Technical support

iii. Customized Equipment to support clinical needs

iv. Applications Training - 2 Days onsite 2D training 3 days onsite 3D training

v. Customer Support 24/7

vi. Site Assistance, Pre-planning and Set-up

vii. Transportation, On-Time Delivery

viii. Systems meet OEM Specifications or greater

ix. Equipment Maintenance

C. Pre-purchase Inspection:

Pre-purchase Inspection – pre-purchase inspection date is the date established in the contract documents when the 3D Digital Mammography is to be setup, fully functional, tested (i.e. images transmit to PACS), properly anchored and is ready to turn over to the Government. All deliverables shall be complete and submitted to the Government at that time.

D. Period of Performance:

Installation-April 1, 2023; The Pre-purchase Inspection is April 30, 2023.

E. Points of Contact:

Contractor Officer:

Judy Perkins 701 Market Drive Oklahoma City, OK 73114 405-951-3932, judy.perkins@ihs.gov

Contracting Officer Technical Representative:

Laquita J. Cormany, RT, R, CT, ARRT Lawton Service Unit Radiology Supervisor 1515 NE Lawrie Tatum Road, Lawton, OK 73505 580-354-5130, laquita.cormany@ihs.gov

Chief Executive Officer:

LCDR Lenora Littledeer CEO Lawton Service Unit, Indian Health Service 1515 NE Lawrie Tatum Road, Lawton, OK 73505 580-354-5407, lenora.littledeer@ihs.gov image1.png image2.png