3D Mammo Statement of Work - 2020.pdf

SCOPE OF WORK

3D Digital Mammography

Lawton Indian Hospital

Lawton, Oklahoma

A. Overview of Project

1. The intent and objective of this Scope of Work is to replace current Hologic Selenia Deminsions

2D and with 3D Digital Mammography equipment which 2D and 3D images are acquired in a single dose exposure to the patient. We would like to purchase the 3D Digital Mammography equipment with in the next 3 months. The addition of 3D Digital Mammography will make available the most update mammography services to the Lawton Service Unit patient population.

To ensure a smooth transition into a 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 shall sell to the Lawton Service Unit a state of the art 3D Digital Mammography system

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

i. 3D Digital Mammography System

ii. Complete room update to 3D Mammography Standards

3. Vendor shall 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 Lawton Service Unit’s source

• Connect phone and data to the Lawton Service Unit network

• Startup and testing of 3D Digital Mammography unit

• Physicist Inspection and Acceptance for compliance by Physicist of Lawton

Service Unit Imaging choice

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

• 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. Contractor shall 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

x. Trade in and de-installation of current Hologic Selenia Deminsions Mammography

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-June 1, 2021; The Pre-purchase Inspection is June 30, 2021.

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 mailto:judy.perkins@ihs.gov mailto:laquita.cormany@ihs.gov mailto:lenora.littledeer@ihs.gov