Statement of Need.docx

Eastern Colorado Healthcare System (ECHCS) Rocky Mountain Regional (RMR) VA Medical Center

1700 N. Wheeling Street Aurora, CO 80045

FY26 PARKS Flo-Lab 2100-SX2 – Medicine | RMR Statement of Need:

Purpose:

The Rocky Mountain Regional VA Medical Center (RMRVAMC) & the PFC Floyd K. Lindstrom VA Clinic have a requirement to purchase two (2) computerized vascular diagnostic systems and associated accessories to support diagnostic vascular testing within the Vascular Laboratory. This requirement is for a Brand Name or Equal product to meet the salient characteristics identified below.

The requested system will replace aging, end-of-life vascular diagnostic units currently in service and will ensure continuity of high-quality diagnostic testing for Veterans requiring evaluation of peripheral arterial and venous disease.

Table 1 – Package Item(s) Summary

Salient Characteristics:

The system offered must meet or exceed the following minimum salient characteristics:

1. Must be a computerized non-invasive vascular diagnostic system capable of physiologic arterial and venous testing.

1. Must support continuous wave (CW) Doppler, pulse volume recording (PVR), and photoplethysmography (PPG) modalities.

1. Must include a touchscreen display monitor suitable for clinical use.

1. Must operate on a commercially supported Windows 11-based operating system or equivalent embedded computing platform.

1. Must provide DICOM connectivity with structured reporting and modality worklist capability for integration with PACS systems.

1. Must include automatic programmable cuff inflation capability.

1. Must include a complete arterial cuff package suitable for upper and lower extremity studies.

1. Must include Doppler probes appropriate for vascular diagnostics.

1. Must support export and storage of diagnostic data in standard medical imaging formats.

1. Must be compatible with VA network security and interoperability requirements.

1. Must include all necessary hardware, software licenses, and accessories for full operational capability at delivery.

1. Must be new equipment with manufacturer warranty coverage.

Scope of Work:

This procurement supports the ongoing clinical mission of the ECHCS Vascular Laboratory by providing a modern physiologic vascular diagnostic system capable of performing non-invasive arterial and venous testing. The system will be utilized to perform ankle-brachial indices (ABI), toe-brachial indices (TBI), pulse volume recordings (PVR), continuous wave Doppler studies, thoracic outlet studies, AV fistula steal studies, Raynaud’s testing, and other physiological vascular examinations.

The equipment will integrate with the VA’s imaging environment through DICOM connectivity to allow transmission of diagnostic results to the facility Picture Archiving and Communication System (PACS). The system must support secure data transfer and compatibility with existing clinical workflows.

This acquisition directly supports patient safety, continuity of care, and diagnostic accuracy for Veterans with vascular disease, many of whom are at risk for limb loss or serious complications if timely diagnosis and monitoring cannot be maintained.

Equipment shall be delivered in original OEM packaging and inspected upon receipt to ensure the equipment is free of defects or damage. Partial shipments will not be accepted.

General Requirements:

· Equipment shall be new, unused, and not refurbished.

· Date of manufacture shall not exceed two (2) years prior to the purchase order date.

· Any batteries provided shall not be manufactured more than twelve (12) months prior to delivery.

· The vendor shall provide all applicable service manuals, operating manuals, maintenance requirements, and parts documentation.

· All components necessary for full operational capability shall be included at time of delivery.

Delivery:

· Delivery shall occur within 30 calendar days of award unless otherwise agreed upon in writing.

· Equipment shall be delivered to:

Rocky Mountain Regional VA Medical Center 1700 N. Wheeling Street Aurora, CO 80045

· Delivery hours: Monday–Friday, 0700–1500, excluding Federal Holidays.

· Delivery coordination shall be arranged with the designated facility Point(s) of Contact (POC).

Shipping documentation shall clearly identify:

· Facility Name: Rocky Mountain Regional VA Medical Center, 1700 N Wheeling Street, Aurora, CO 80045

· Department / POC: Megan Sadowski, Vascular Technologist - Medical/Cardiology

· Purchase Order Number: N/A

· Contract Number (if applicable): N/A Inspection and Acceptance:

Prior to acceptance, the equipment shall be inspected by authorized Government personnel to verify compliance with specifications, operational functionality, and absence of visible damage or defects.

Warranty:

The contractor shall provide all manufacturer’s standard warranties upon delivery. Warranty shall commence upon Government acceptance and verification of operational functionality. Warranty coverage shall include all parts, labor, and shipping costs associated with warranty repairs.

Deliverables:

· Fully operational vascular diagnostic system and accessories

· Operation and maintenance manuals

· Warranty documentation

· Manufacturer technical documentation Invoicing and Supporting Documentation:

The supporting documentation and invoice shall be submitted within 30 days at the end of each month. Subsequent changes or corrections shall be submitted by a separate invoice. In addition to information required for submission of a ‘proper’ invoice in accordance with FAR 52.212-4 (g), all invoices must include the following information:

a. Name and Address of Contractor

b. Contractor’s Tax Identification Number

c. Date of Invoice

d. Invoice Number

e. Contract Number

f. Purchase Order Number

g. Date of Service

h. Contract Line Item Number (CLIN)

i. Description, Quantity, Unit of Measure, Unit Price, and Extended Price of the items delivered

j. Total Price Recalls:

The Vendor shall immediately notify all affected VA Medical Centers and designated POC in the event of a device recall, removal, required adjustment, or required modification that is suggested or mandated by the Vendor, distributor, manufacturer, or any regulatory or government agency. The following information shall be included in this notification:

A complete item description and identification (to include lot or serial numbers where applicable); administrative identification data including order numbers and order date; reasons for recall, removal, adjustment, or modification; and Instructions for appropriate corrective action.

Special Work Requirements:

Installation Required (Yes ☐ No ☒) Training Required (Yes ☐ No ☒) Confidentiality and Non-Disclosure:

The equipment will connect to the VA network and exchange diagnostic imaging data. Coordination with local Office of Information & Technology (OIT), Biomedical Engineering, and Information Security Officer (ISO) shall occur prior to network connection and activation. All applicable VA cybersecurity, network, and information security requirements shall be met in accordance with VA policies and guidance.