Scope of Work_Ultrasound_PR_final.pdf

Great Plains Area Indian Health Service

ULTRASOUND SYSTEM FOR THE PINE RIDGE SERVICE UNIT

Statement of Work (SOW)

1.0 Title

Ultrasound System Acquisition for Pine Ridge Service Unit (Kyle Health Center)

2.0 Background

Kyle Health Center’s Radiology Department currently operates an ultrasound system that has reached end-of-service-life status. Replacement of the system is required to maintain continuity of patient care, reduce the risk of equipment downtime, and support compliance with applicable accreditation and regulatory requirements.

2.1 Objective

The objective of this procurement is to acquire, deliver, install, configure, and provide operational training for one diagnostic ultrasound system and associated accessories for use at the Pine Ridge Service Unit. The system shall meet the minimum salient characteristics identified in this SOW or equal.

3.0 Scope

The Contractor shall furnish all labor, materials, equipment, transportation, supervision, and incidental services necessary to provide a complete and fully operational ultrasound system, including delivery, installation, configuration, testing, and user training.

Required components include:

• Ultrasound console/system (GE LOGIQ E10s or equal)

• L2-9-D XDclear Linear Array Probe or equal

• ML4-20-D Probe or equal

• L6-24-D Linear Array Probe or equal

• C1-6-D XDclear Convex Array Probe or equal

• IC5-9-D Microconvex Array Probe or equal

• Measure Assist OB package

• Auto Abdominal package

• Power Assistant Cart

• Clinical Training

• Installation and Configuration Services

The Government has identified the GE LOGIQ E10s as the reference product. Any proposed equal product must clearly demonstrate compliance with all salient characteristics identified in Attachment 1, Salient Characteristics.

The Government will provide reasonable access to the facility and coordinate site access, network connectivity support, and PACS coordination as required. Any evaluation of room shielding or facility infrastructure shall be limited to verification activities necessary for installation and shall not constitute construction work unless specifically authorized in writing by the Contracting Officer.

4.0 Contractor Requirements

The Contractor shall:

• Provide new, non-refurbished equipment unless otherwise approved.

• Deliver all manufacturer-required accessories, software, licenses, and documentation.

• Perform installation and operational verification.

• Provide onsite clinical application training for Government personnel.

• Ensure equipment complies with applicable FDA requirements and manufacturer specifications.

• Provide warranty information and service contact procedures.

• Comply with all applicable Federal, HHS, IHS, OSHA, and facility safety requirements while performing onsite services.

5.0 Type of Contract

Firm-Fixed-Price (FFP).

6.0 Period of Performance

The period of performance shall begin upon contract award and continue for ninety (90) calendar days or until all deliverables have been accepted by the Government, whichever occurs later.

7.0 Place of Performance

Kyle Health Center 1000 Health Center Rd Kyle, SD 57752

8.0 Deliverables and Acceptance

Deliverable Description Due Date Acceptance Criteria

1. Ultrasound System & Accessories Delivery

Delivery of the complete ultrasound system, probes, cart, software, licenses, manuals, and all required accessories as specified in the contract.

Within the Period of Performance

All equipment received, inspected, & verified against contract requirements. No visible shipping damage.

2. Installation & Configuration

Installation of the ultrasound system and integration/configuration necessary for operational use, including DICOM connectivity support as applicable.

Within the Period of Performance

System installed and configured in accordance with manufacturer specifications and operational

Deliverable Description Due Date Acceptance Criteria requirements.

3. Operational Testing & Verification

Performance of manufacturer-recommended operational testing and system verification.

Immediately following installation

System successfully passes operational testing and demonstrates full functionality of all contracted components.

4. Clinical/User Training

On-site training for designated Government personnel on operation, basic maintenance, and workflow functions of the system.

Prior to Government acceptance

Training completed and attendance documented.

Government personnel demonstrate ability to operate the system at a basic user level.

5. Installation & Service Report

Written report documenting installation, configuration, testing results, training completion, and any identified deficiencies or corrective actions.

Within five (5) business days after installation completion

Report received and determined complete by the COR.

6. Warranty Documentation

Manufacturer warranty certificates, service contact information, and support procedures.

At time of acceptance

Documentation received and warranty coverage verified.

Acceptance

The Contracting Officer's Representative (COR) shall inspect and verify that all required equipment, accessories, documentation, installation services, testing, and training have been completed in accordance with the contract requirements. Final acceptance shall occur when all deliverables have been satisfactorily completed and accepted by the Government.

Deficiencies

If deficiencies are identified during inspection or acceptance, the Contractor shall correct such deficiencies at no additional cost to the Government. The Contractor shall provide a corrective action plan and, if applicable, a quotation for any non-warranty items within five (5) business days of notification by the Government.

Documentation Requirements

The Contractor shall provide all applicable installation records, test results, warranty information, user manuals, service contact information, and training documentation.

Electronic copies are preferred unless otherwise specified by the Government.

9.0 Invoicing and Payment

Invoices shall be submitted through the U.S. Treasury Invoice Processing Platform (IPP) and shall include, at a minimum, contract number, invoice number, invoice date, description of supplies/services provided, dates of performance, and any other information required by the contract. Payment shall be made in accordance with the Prompt Payment Act and applicable FAR and HHSAR payment provisions.

10.0 Government-Furnished Support

The Government will provide reasonable facility access and coordinate appropriate points of contact. No Government employee other than the Contracting Officer may modify contract requirements, authorize additional work, or obligate Government funds.

11.0 Contracting Officer Authority

Only the Contracting Officer has authority to bind the Government, modify contract requirements, or authorize changes affecting price, schedule, quantity, or scope. Any direction received from personnel other than the Contracting Officer shall not be construed as authorization to perform work beyond the scope of the contract.

Attachment 1: Salient Characteristics for Ultrasound System

The offered system shall meet or exceed the following minimum requirements:

General System Requirements

1. New, current-production ultrasound system (not refurbished).

2. Cart-based, premium radiology ultrasound platform.

3. Digital beamforming architecture capable of whole-body imaging.

4. High-resolution color monitor, minimum 21 inches.

5. Adjustable control panel and monitor for ergonomic operation.

6. Minimum four (4) active transducer ports.

7. DICOM compatibility for image storage, print, worklist management, and PACS connectivity.

8. Capability to export studies in standard DICOM format.

9. Network connectivity supporting hospital PACS integration.

10. FDA-cleared for clinical use in the United States.

Imaging Modes

1. 2D B-Mode imaging.

2. M-Mode imaging.

3. Color Doppler imaging.

4. Power Doppler imaging.

5. Pulsed Wave Doppler.

6. Continuous Wave Doppler (if applicable to offered system).

7. Tissue Harmonic Imaging.

8. Advanced speckle reduction imaging.

9. High-resolution vascular imaging capability.

10. Elastography capability for tissue assessment.

Clinical Applications The system shall support:

• Abdominal imaging

• Small parts imaging

• Vascular imaging

• Musculoskeletal imaging

• Breast imaging

• OB/GYN imaging

• Pediatric imaging

• Interventional procedure guidance

Required Transducers (or Equivalent)

1. Linear array transducer comparable to L2-9-D.

2. High-frequency linear transducer comparable to L6-24-D.

3. Convex array transducer comparable to C1-6-D.

4. Microconvex transducer comparable to IC5-9-D.

5. Matrix or specialty transducer comparable to ML4-20-D.

Advanced Clinical Tools The system shall include:

1. Automated OB measurement package.

2. Automated abdominal measurement package.

3. Shear Wave Elastography or equivalent quantitative tissue elasticity assessment.

4. Liver attenuation/fat quantification capability (UGAP or equivalent).

5. Contrast-enhanced ultrasound capability (CEUS) or upgrade path.

6. Fusion imaging and/or image navigation capability.

7. AI-assisted workflow tools for automated measurements and exam efficiency.

Workflow Requirements

1. User-configurable exam protocols.

2. Automated measurement tools.

3. Image annotation package.

4. Reporting capability.

5. Raw data storage and post-processing capability.

6. Ability to review prior exams alongside current studies.

Installation and Training

1. Complete delivery, installation, and operational testing.

2. On-site application training for radiology staff.

3. All software licenses required for operation.

4. Manufacturer warranty documentation.

5. Service and support contact information.

Warranty

1. Minimum one-year manufacturer warranty covering parts and labor.

2. Telephone technical support during normal business hours.

3. Software updates provided during warranty period.

Attachment 1: Salient Characteristics for Ultrasound System