SSJ_Redacted.pdf
PDF 214 KB Posted
- Attached to
- CDI ONEVIEW PROCESSING CORE Federal contract opportunity
- Solicitation number
- 36C25026Q0599
About this file
This is a Single Source Justification document for a sole source purchase order under the Department of Veterans Affairs simplified acquisition procedures for awards exceeding the micro-purchase threshold but not exceeding the simplified acquisition threshold.
The Cleveland Veterans Affairs Medical Center (CLE VAMC) Network Contracting Office (NCO) 10 intends to award a firm-fixed-price sole source purchase order to Terumo Cardiovascular Systems Corporation for a CDI OneView Processing Core. The estimated dollar value is redacted, with a required delivery date of 60 days after receipt of order (ARO). The acquisition is justified on the basis that the Terumo CDI OneView Monitoring System is a proprietary blood parameter monitoring platform specifically designed for use during cardiopulmonary bypass and extracorporeal circulation procedures. The system incorporates proprietary processing cores, touchscreen displays, blood parameter monitoring modules, probes, calibrators, and associated hardware engineered to provide continuous real-time monitoring of critical physiological blood parameters. Installation and support are restricted to Terumo-authorized service representatives, and use of non-compatible monitoring systems could negatively impact equipment compatibility, perfusion workflow integration, clinical monitoring continuity, and patient safety.
Market research was conducted by the Contracting Officer and Service on 5/26/2026 across multiple sources including GSA eLibrary, ECAT, SAM.gov, Interagency Contract Directories, NAC, SEWP, FPDS, SCMC, MSVP, BIC, FDA, and the Small Business Service under NAICS Code 334510 using the keyword "processing core." No results were identified for the required CDI OneView Processing Core. The National Mobility Rule applies to this procurement; however, the VA and SBA Rule of Two cannot be met as no Service-Disabled Veteran-Owned Small Business (SDVOSB) or Veteran-Owned Small Business (VOSB) vendors were identified capable of providing the required system and components. The Contracting Officer certified the justification as accurate and complete on 5/27/2026.
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| File | Type | Posted |
|---|---|---|
| S02 ISS.docx | DOCX document |
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Text version
VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for MPT up to SAT
Revision: 02 Effective Date: 12/30/2025 Page 1 of 2 Acquisition ID#36C25026-AP-3742
DEPARTMENT OF VETERANS AFFAIRS
Justification for Single Source Awards IAW RFO 12 For
Over Micro-Purchase Threshold but Not Exceeding the Simplified Acquisition Threshold
Acquisition Plan Action ID: 36C250-26-AP-3742
1. Contracting Activity: The Department of Veterans Affairs, Veterans Integrated Service
Network (VISN) 10, Cleveland Veterans Affairs Medical Center (CLE VAMC) Network Contracting Office (NCO) 10.
Transaction: 541-26-3-250-0357
2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:
Network Contracting Office (NCO) 10 intends to award a new firm-fixed-price, sole source purchase order to Terumo Cardiovascular Systems Corporation, for CDI OneView Processing Core for the CLE VAMC.
ESTIMATED DOLLAR VALUE:
REQUIRED DELIVERY DATE: 60 Days ARO
3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: The Terumo CDI OneView Monitoring System is a proprietary blood parameter monitoring platform manufactured by Terumo Cardiovascular Systems Corporation and is specifically designed for use during cardiopulmonary bypass and extracorporeal circulation procedures performed by the Cleveland VA Medical Center Perfusion Service. The CDI OneView system incorporates proprietary processing cores, touchscreen displays, blood parameter monitoring modules (BPM), probes, calibrators, and associated hardware engineered to provide continuous real-time monitoring and display of critical physiological blood parameters during complex cardiac and perfusion procedures.
The CDI OneView system is designed to interface directly with extracorporeal circulation workflows and utilizes specialized monitoring technology intended to support continuous assessment of patient blood status during open-heart and other surgical procedures requiring perfusion support. The system provides real-time monitoring capabilities necessary to support perfusion management, procedural efficiency, and patient safety during cardiopulmonary bypass procedures. Use of non-compatible monitoring systems or components could negatively impact equipment compatibility, perfusion workflow integration, clinical monitoring continuity, and patient care operations.
VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for MPT up to SAT
Revision: 02 Effective Date: 12/30/2025 Page 2 of 2 Acquisition ID#36C25026-AP-3742
Additionally, Terumo Cardiovascular Systems Corporation confirmed that installation and support of the CDI OneView system is restricted to Terumo-authorized service representatives and proprietary system components. Therefore, no other source can provide the required proprietary CDI OneView monitoring system and associated components necessary to support the Government’s existing perfusion monitoring requirements.
4. Description of market research conducted and results or statement why it was not conducted: Market research was conducted by the Contracting Officer and the Service to determine if there were other vendors capable of providing CDI OneView Processing Core that meet CLE VAMC's specific requirements. The following sources were reviewed:
5/26/2026 GSA eLibrary, ECAT, SAM.gov, Interagency Contract Directories, NAC, SEWP, FPDS, SCMC, MSVP, BIC, and FDA were reviewed:
o Keywords Used: "processing core” o Results: No results identified for the required CDI OneView Processing Core.
On 5/26/2026 SBS was reviewed:
o NAICS Code Searched: 334510 o Keywords Used: "processing core" o Results: No results identified for the required CDI OneView Processing Core.
The NMR does apply to this procurement under NAICS 334510. The VA and SBA Rule of Two cannot be met, as no SDVOSB/VOSB vendors were identified capable of providing the required CDI OneView system and associated components. Therefore, this procurement is recommended for sole source award to Terumo Cardiovascular Systems.
Corporation.Contracting Officer's Certification: Purchase is approved in accordance with RFO 12. I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.
Rachelle J. Hamer Contracting Officer
NCO 10
RACHELLE
HAMER
Digitally signed by
RACHELLE HAMER
Date: 2026.05.27 11:32:15 -04'00'
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