Attachment B - Scope of Work.doc

A

INTRODUCTION:

The mission of the Phoenix Area Indian Health Service (PAIHS) is to raise the physical, mental, social, and spiritual health of the Native American population served at PAIHS to the highest level, on the Reservations located in the Phoenix Area, throughout the states of Arizona, Nevada and Utah. In order to achieve this mission, IHS intends to procure one premium Ultrasound System to new equipment, installation, software and services.

B

PURPOSE OF CONTRACT:

The Phoenix Area Indian Health Service (IHS) Phoenix Indian Medical Center (PIMC) depends on contracting outside resources with a wide range of expertise in order to provide products and services not readily available within IHS. This firm-fixed unit priced contract will provide for a premium Ultrasound System to include new equipment, installation, software and services.

In addition, it is critical that the equipment, installation, software and service be supplied from one vendor so as to standardize and manage the installation throughout the medical center. It is the contractor responsibility to ensure that the equipment, installation, software and services communicate properly. Contractor shall demonstrate that the entire system works as designed.

The unit price paid to the Contractor shall be considered as payment in full for the product and services provided under this contract.

C

BACKGROUND INFORMATION:

The Phoenix Area Indian Health Service serves forty-three (43) Tribal nations in the States of Arizona, Nevada and Utah. The user populations are approximately 850,000 patient visits annually; the Area Office facility is located in the central down town area of Phoenix, Arizona. There are fourteen ambulatory care hospitals and health centers located on/or around the reservations and 15 tribally run ambulatory care hospitals and health centers.

PIMC is an inpatient community hospital associated with a busy Emergency Department and numerous busy outpatient clinics.

D

SCOPE OF SUPPLIES AND SERVICES

The scope of this requirement is to provide for the procurement for one premium Ultrasound System, Preventive Maintenance and Emergency Repair/Nonemergency Repair Services for the Phoenix Indian Medical Center, (PIMC). Services are all connected and need to be ordered together to ensure no services start or stop during transition from setting up the Ultrasound Services allowing for exiting and starting coverage of the PM/Emergency Repair Services.

The Ultrasound system shall be Food and Drug Administration (FDA) approved and be on the list of approved VistA Imaging Approved Digital Imaging and Communications in Medicine (DICOM) Modality Interfaces list dated February 28, 2019. The Ultrasound machine will be used for adult cardiac echoes only. The adult probes 2D imaging, pulse and continuous wave and non-imaging probe for evaluation of valve disease.

The Ultrasound will include 2D capabilities with M mode. The Ultrasound will be able to do contrast echo studies.

The following are the two major components of this requirement.

1. Ultrasound System GE Vivid™ E95 – 2D Ultra Edition v204 package includes:

-One (1) Vivid E95 w/ OLED monitor v204 console

-One (1) ECG cable and lead set

-Software: Streaming, DICOM® Viewer

-Hardware: DVD/CD-R drive, Software media backup USB

-Education & Training: Three (3) days of Clinical Applications training

-Peripherals: AIUM Booklet, US Country kit

Ultrasound Equipment Specifications

22” wide screen OLED monitor

-Scan Assist (Stress/CRT protocols)

-Scan Assist Pro (protocol driven exams)

-UD Clarity

-HD Imaging

-Code Phase Inversion

-AMM/Curved AMM

-TVI/Tissue Tracking

-Auto Optimization

-ASO

- Compound

-True Confocal Imaging

-Virtual apex imaging

-Virtual convex imaging

-Adaptive Contrast Enhancement (ACE)

-Extended Field of View (LOGIQView)

-Q-Analysis: Qstress/ QTVI/ QContrast

-Advanced Vascular (B-flow/BFI/Speckle Reduce)

-Z Scores for pediatrics

-DICOM Media

-DICOM SR (Cardiac/Pediatrics/Vascular)

-Heart Failure Report

-DICOM Connectivity Package (Modality Worklist/Print/Storage)

-Integrated EchoPAC™/Patient Archive

-Report Designer/Statement Engine/Normal Values/E-Sign-off

-Configurable prospective/retrospective capture

-LVO Contrast included as preset as well as a QuickApp

-Enhanced security features (Disk Encryption, LDAP, secure password policies)

-QuickApps

-Cardiac Auto Doppler

-Ability to transfer Systole Only in stress to PACS

-AI based selectable raw data transfer to PACS

-Windows® 10 operating system

-White listing

-Advanced QScan Imaging

Power Supply:

Adjustable dynamic range, infinite upper level

Nominal input voltage: 100-240 VAC, 50/60 Hz

Typical power consumption: 500 W @ default cardiac preset with M5Sc

Rated power consumption: 700 W

Ultrasound Ports:

Ethernet – 10 Mbps, 100 Mbps, 1 Gbps

Multiple USB 2.0 ports

Ultrasound Image Storage:

On-board database of patient information from past exams

Storage formats:– DICOM®-compressed or uncompressed, single/multi-frame, with/without raw data, storage via clipboard and/or seamlessly directly to destination device– Transfer/ “Save As”

JPEG, MPEG, AVI, DICOM, Raw DICOM and VolDicom formats.

Storage Devices: UBB memory stick – 16GB; CD-RW Storage 700MB; DVD Storage –

R(4.7GB); Hard drive image storage 0.5 TB

1. Ultrasound – Matrix Phased Array Probe

Matrix Phased Array probe with GE’s highest performing XDclear transducer, and innovative combination of advanced materials and acoustic design providing ultra-wide bandwidth and superb image quality.

2. Ultrasound – Pencil Probe Non-imaging pencil probe for CW Doppler examinations of cardiac flow.

3. Ultrasound – Software

The Vivid™ E95 2D Ultra Edition Advanced Software Bundle includes the most common used software features for the Vivid E95 2D system, providing a significant savings by purchasing as a bundle. The bundle includes the following software options

-AFI 3.0

-Auto EF 3.0

-AI Auto Measure

-AFI Stress

-Stress

-ECG Cable set

AFI 3.0 - third-generation parametric imaging tool giving quantitative data for global and segmental left ventricular strain. It allows a complete assessment at a glance by combining the 3 apical views into one comprehensive selectable bulls-eye view, including one according to the ASE standard. AFI 3.0 is integrated into the M&A package with specialized report templates. AFI 3.0 provides intuitive and streamlined workflow with fully automated ROI tracing, adaptive ROI width, simple ROI editing of both endo- and epicardial borders, selectable full wall/endocardial strain calculation, display of ejection fraction, DICOM® export of the running loop with tracking overlay, Standard TTE AFI, TriPlane AFI (may not be available on all scanners) and AFI with TEE are all supported on GE raw data images. The Artificial Intelligence based View Recognition feature (may not be available on all scanners) enables images acquired on these scanners to be automatically recognized and labelled.

AFI 3.0 introduces the ability to analyze not only GE raw data images, but also DICOM images from 3’rd party ultrasound scanners. It should be limited to adult TTE and TEE as well as pediatric TTE data. Like before AFI 3.0 also offers calculation of ejection fraction, LV Volumes, DICOM export, and “Easy AFI” which is the ability to exit the tool after only have analyzed one or two views.

AutoEF 3.0 - adds support for LV volume and EF quantification of DICOM images from other vendors in addition to providing support for GE’s raw data images as before. Like for raw data it provides a simple and intuitive workflow with simplified ROI editing. Standard TTE AutoEF is supported. The Artificial Intelligence based View Recognition feature (may not be available on all scanners) enables images acquired on scanners to be automatically recognized and labelled and the labels are used to automatically preselect matching views to the one selected by the user

AI Auto measure - This option enables two features: The AI Auto Measure - 2D feature enables automated quantification of the most common distance measurements performed on parasternal LAX 2D images, with minimal user guidance. The AI Auto Measure - Spectrum Recognition feature enables automated recognition of the most common Doppler spectra and automatically starts the Auto Doppler measurement (where available), or opens the according manual measurement folder.

AFI Stress - provides access to dedicated stress analysis protocol templates combining conventional stress echo acquisition with Automated Function Imaging (AFI) analysis. At each stress level one can perform AFI analysis in order to obtain objective quantification of longitudinal contraction throughout systole. The end result displays conventional wall motion score (WMS) bullseyes as well as AFI bullseyes from multiple stress levels.

Stress - includes support for treadmill-, bicycle- as well as pharmacological stress protocols, including a continuous capture mode for acquisition and selection of projection views. Note: 4D Stress in included in the basic offering of Vivid E95 and does not require this option in order to work.

Vivid is a trademarks of General Electric Company

DICOM is the registered trademark of the National Electrical Manufacturers Association for its standards publications relating to digital communications of medical information.

Installation of Equipment:

Contractor shall include installation to be performed by a certified service and installation technician to ensure a safe and functional installation. Contractor shall provide equipment installation schedules to include all lead times. Technician inspection/testing following the installation to ensure that the “Ultrasound System” and all components meet Federal regulatory requirements; (Copy of report is to be provided to the COR and PIMC Biomedical Department.) Installation shall include commissioning start up and all functions of the Ultrasound systems are working.

Training:

Ultrasound System Package includes three (3) days of On-site Applications Training. The On-site Applications Training must be completed within six (6) months after Product delivery.

One Annual Preventative Maintenance and Repair Service:

The contractor shall provide all supervision, labor, parts, materials, tools, supplies, maintenance, ground transportation, and equipment necessary to perform 12 month annual service for all ultrasounds and probes.

Contractor will need to coordinate the following process (contractor may propose a better solution):

a. Install the new equipment;

b. Starting the PM and Repair service;

Contractor will present a timeline showing the process and time needed for each action.

E

SITE LOCATIONS:

Phoenix Indian Medical Center

4212 N. 16th Street

Phoenix, AZ 85016

F

HOURS OF OPERATION:

Installation shall take place between the hours of 8 am to 4:30 pm Monday through Friday, excluding Federal Holidays.

G

MINIMUM QUALIFICATIONS:

a. Contractor shall have 5 years of installation, set-up, Configuration, Ultrasound System experience.

b. Contractor shall have 5 years of service and repair of Ultrasound System experience