Ultrasound System SOW.pdf

Statement of Work (SOW)

Replacement of Ultrasound Units

Kayenta Alternative Rural Hospital (KARH) and Inscription House Health Center (IHHC)

1. Background

The Indian Health Service Kayenta Service Unit consists of the Alternative Rural Hospital (KARH) and Inscription House Health Center (IHHC). Both facilities currently utilize ultrasound (US) systems that have exceeded their recommended lifecycle.

• The ultrasound unit at KARH is over 10 years old.

• The ultrasound unit at IHHC is well over 26 years old.

Both systems are beyond their expected service life, upgrading both systems will support efforts to ensure patient needs are met by enabling more efficient and comprehensive imaging services.

It will also enhance timely reporting and diagnosing, which is critical to improving patient outcomes and streamlining treatment plans. These improvements will provide quality health care needs for the communities we serve.

Additionally, modernizing the US equipment and associated software will keep the facility aligned with current technological standards. Upgraded imaging and information technology systems will enhance diagnostic capabilities, support timely care delivery, and contribute to the ongoing effort to provide high-quality, culturally responsive care in an increasingly digital health care environment.

2. Purpose

This Statement of Work defines the scope, requirements, deliverables, and responsibilities for the procurement, delivery, installation, and commissioning. The purpose of this project is to acquire and upgrade two (2) new diagnostic ultrasound systems—one for KARH and one for IHHC—for a reliable, user-friendly US system to support:

• Ensure reliable and uninterrupted ultrasound imaging services.

• Improve diagnostic image quality and clinical efficiency.

• Maintain compatibility with current PACS/RIS and EHR systems.

• Enhance patient safety and data security.

• Meet current regulatory, privacy, and Section 508 requirements.

3. Scope

The system must be cost-effective, durable, and suitable for moderate patient volumes typical of a community health center. The contractor will provide all labor, materials, equipment, transportation, and supervision necessary to:

3.1 Equipment Provision

• Furnish and deliver:

o One (1) new ultrasound system for KARH.

o One (1) new ultrasound system for IHHC.

• One (1) new, GE LOGIQ E10s latest-generation digital ultrasound machine including carts, monitors, software licenses, and necessary accessories - probes/transducers appropriate for facility clinical needs (e.g., abdominal, OB/GYN, vascular, small parts, cardiac if applicable.

• Systems will be new, not refurbished.

3.2 Installation, Integration, and Commissioning

• Perform delivery, setup, and installation at both KARH and IHHC.

o Perform operational testing o Conduct electrical safety checks o Provide calibration certification o Perform demonstration scan for acceptance

• Coordinate with facility IT and Biomedical Engineering staff.

• Integrate systems with:

o Existing PACS/RIS systems.

o RPMS/EHR or other approved clinical information systems.

• Configure DICOM networking and image routing.

• Ensure compliance with IHS OIT security requirements.

3.3 Data Security and Privacy

Systems must:

• Support secure transmission of PII/PHI.

• Utilize encryption in transit and at rest where applicable.

• Meet applicable HHS, IHS, and HIPAA requirements.

3.4 Testing and Acceptance

• Perform system testing to ensure full functionality.

• Conduct image quality verification.

• Provide on-site operational validation with clinical staff.

• Final acceptance will be based on successful installation, integration, and performance testing.

3.5 Training

• Provide a minimum of 2 days of on-site user training for clinical staff at both locations including basic troubleshooting.

• Provide basic technical orientation for Biomedical and IT personnel.

• Supply user manuals and technical documentation in electronic format.

• Application training for OB measurements

3.6 Warranty and Support

• Provide a minimum two (2) year comprehensive warranty covering parts and labor.

• At least two (2) preventive maintenance visits during the warranty period.

• Service response time within 48 hours

• Availability of spare parts for minimum 5–7 years

• Provide information regarding extended service agreements.

4. Period of Performance

The period of performance will begin with the contract award date and continue through delivery, installation, training, and final acceptance. Delivery and installation are anticipated within 30 days of award, installation within 5 days of delivery (to be finalized upon procurement), training within 7 days of installation and Final Acceptance occurring within 10 days of installation.

5. Places of Performance

Kayenta Alternative Rural Hospital (KARH) Inscription House Health Center (IHHC) Highway 160, Milepost 394.3 Highway 98 & Navajo Route 16 Kayenta, AZ 86033 Shonto, AZ 86054 Telephone: 928-672-3000 Telephone: 928-697-4000

6. Deliverables

The contractor will provide:

• Two (2) fully functional ultrasound systems.

• Installation and integration services.

• Training sessions for clinical and technical staff providing training completion documentation.

• Warranty documentation.

• Technical and user manuals.

• Network configuration documentation as required.

• All specified probes

• Maintenance schedule

• Regulatory compliance certificates (FDA/CE or applicable authority)

8. Government-Furnished Property (If Applicable)

The Government will provide reasonable access to facility space, electrical connections, and network infrastructure necessary for installation.

9. Acceptance Criteria

Acceptance will occur after:

• Successful installation and integration.

• Completion of training.

• Verification of imaging performance.

• Demonstration of required imaging modes

• Submission of all documentation

• Confirmation of secure connectivity and compliance with privacy and security requirements.

• Sign-off by IHHC representative

Section 508/Accessibility

• This product must conform to the Revised Section 508 (https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines) and WCAG 2.1 Level AA standards as outlined below.

• Solicitations for supplies and services shall require the submission of a Section 508 Product Assessment Template. The template can be found at https://www.itic.org/policy/accessibility/vpat.

All Information and Communication Technology (ICT) deliverables under this contract (e.g., websites, applications, electronic documents, and multimedia) must comply with the Revised Section 508 Standards (36 CFR Part 1194) and the Web Content Accessibility Guidelines (WCAG)

2.1 Level AA standards. The Contractor shall ensure accessibility of all ICT deliverables and provide conformance documentation in the form of a Voluntary Product Accessibility Template (VPAT?) / Accessibility Conformance Report (ACR), or by completing the HHS Section 508 Accessibility Checklists. The current VPAT 2.5 template includes fields for reporting conformance to WCAG 2.1 and shall be used to document accessibility. The Contractor shall remediate any identified accessibility issues at no additional cost. The Contracting Officer will include the applicable Health and Human Services Acquisition Regulation (HHSAR) clauses 352.239-73 and 352.239-74 in the solicitation and resulting contract.

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APPENDIX A: EQUIPMENT SPECIFICATIONS

The objective is to acquire a reliable, user-friendly ultrasound system to support:

• Antenatal (OB) examinations

• Abdominal scans

• Pelvic imaging

• Basic small parts imaging

• Emergency point-of-care assessments

The Vendor will supply:

• One (1) new, GE LOGIQ E10s latest-generation digital ultrasound machine

• Minimum four(4) transducers (Matriz Phased Array, Linear Array, Covex Array, and

Microconvex Probes)

• Mobile cart-based or compact system suitable for limited space

• Built-in image storage and reporting functionality

• On Board Printer compatibility

• Required accessories (gel bottles, probe holders, power cables)

• Advanced abdominal tool package

• Power assistant, LOGIQ E10 Bin-Twin

3.2 Minimum Technical Specifications

The system will include:

• 2D B-mode imaging

• M-mode

• Color Doppler

• Power Doppler

• Pulsed Wave (PW) Doppler

• Minimum 15–21 inch high-resolution LCD monitor

• At least 2 active probe ports

• Multi-frequency probe capability

• Built-in measurement packages (OB, abdominal, pelvic)

• Automatic fetal biometry calculations

• Image storage (minimum 500GB or equivalent)

• USB export capability

• DICOM capability (preferred but optional depending on infrastructure)

• Battery backup (preferred for unstable power environments)

3.3 Transducers Required

• Convex probe (2–5 MHz) – for abdominal and OB imaging

• Linear probe (5–12 MHz) – for small parts and vascular access

• Other probes mentioned in specifcation

Optional (if OB/GYN services are frequent):

• Endocavitary probe (5–9 MHz)

The ultrasound systems will:

• Be FDA-approved for clinical diagnostic use.

• Provide high-resolution imaging suitable for general radiology applications.

• Include Doppler capabilities (color, power, and spectral).

• Support DICOM connectivity.

• Be compatible with existing facility infrastructure.

• Meet current cybersecurity standards.

• Comply with Section 508 accessibility requirements where applicable (software interfaces and documentation).