36C24125Q0699.docx

SUBJECT*

Intent to Sole Source to LB OEM: Proprietary and Exclusive

GENERAL INFORMATION

SET-ASIDE

VAMC Togus

1 VA Center

CONTACT INFORMATION

VAMC Bedford 200 Springs Road Bedford MA 01730-1114

POINT OF CONTACT*

Contracting Specialist Sebastian Freeze sebastian.freeze@va.gov

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

Presolicitation Notice

DESCRIPTION

Presolicitation Notice

Intent to Sole Source to LB OEM

Page 1 of

Presolicitation Notice

DESCRIPTION

INTENT TO SOLE SOURCE: VITREA CORE PROPRIETARY AND EXCLUSIVE SINGLE SOURCE SOLE OEM AUTHORIZED DISTRIBUTOR Page 1 of Page 1 of Page 1 of

THIS IS NOTICE OF INTENT TO SOLE SOURCE FOR Canon Medical Informatics VITREA CORE: VAMC TOGUS ME

INTENT TO SOLE SOURCE FOR PURCHASE REQUISITION: This is not a request for competitive proposals. This is not a solicitation or request for offers. No solicitation package is available, and telephone requests will not be honored.

The Department of Veterans Affairs VA Medical Center intends to award a one-time, Firm Fixed Price, Sole Source contract for the VITREA CORE. This procurement is for an upgrade to the current unsupported operating system on the Canon Medical Informatics Vitrea equipment that is used in multi-modalities within the Radiology service to enhance diagnostic images and provide better care to veterans throughout Togus VAMC.

Technology, knowledge, technical expertise, and servicing capabilities for the VITREA CORE are proprietary and peculiar to the LB OEM (Original Equipment Manufacturer) Canon Medical Informatics. Government distribution for this equipment is available only through Canon Medical Informatics, for the specific product being procured.

A Sole Source Letter has been provided by the OEM describing the proprietary nature of the VITREA CORE, establishing this product as being peculiar to Canon Medical Informatics as the OEM. The letter states that only the OEM can distribute this product to the Government. No other vendors in any class aside from the OEM are authorized to distribute this VITREA CORE product.

The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901. This statute is implemented for restricting competition on this procurement via FAR 13.106-1(b)(1)(i).

The intent is to procure these services on a sole source basis. No solicitation will be posted to Contract Opportunities. The primary North American Classification System Code (NAICS) is 334118: Computer Terminal and Other Computer Peripheral Equipment Manufacturing. The most current Business Size Rating for this NAICS is 1000 employees.

Capable parties may identify their interests and authorization to respond to this requirement by July 31st, 2025, at 16:30 (EDT).

A determination by the Government not to compete this proposed award upon response to this notice is solely within the discretion of the Contracting Officer.

STATEMENT OF WORK

Canon Medical Vitrea Upgrade

VA MEDICAL CENTER, AUGUSTA, ME

General Information:

Contractor shall provide all necessary equipment, tools, and documentation for the delivery of the Vitrea hardware equipment. The service shall include prestaging of hardware, project management, installation, and training. The equipment is located at the VA Maine Health Care System, 1 VA Center Augusta, ME 04330

Type of Contract: Firm-Fixed Price

Quotation Number: 16660 and 16808

Contract Number: N/A

Scope of Work

Equipment to be procured:

VE-HP-VITEXTWKS

Vitrea Extend, Hardware HP Z8 G4 workstation (SKU # 6Q3U1UC) §

• Two (2) Intel Xeon Gold 5218 2.3 GHz 2667 MHz 16C CPU

• 96 GB (6x16GB) DDR4-3200 ECC RAM

• Four (4) 1 TB 7200 RPM SATA hard drives in RAID 10

• 2 NVIDIA Quadro RTX A2000 12 GB graphics cards

• Optional monitors (These are not included in the SKU.)

o HP Z24n G3 24-inch widescreen (native resolution: 1920 x 1200) (optional) o HP Z27xs G3 27-inch widescreen (native resolution: 3840 x 2160) (optional)

• Supported Operating Systems:

o Microsoft Windows Server 2019 Standard with Desktop Experience

- Three (3) Windows Server 2019 Standard additional license APOS (4 Core)

• Network: 1.0 Gbps network connection

• Heat dissipation typical 2419 BTU/HR max 4626 BTU/HR

• 5U Height

• 2x Mini display adapter comes with system

• Single power supply: 110 Volt

VE-VIT-SRVOS

VitreaExtend, Microsoft Server Operating System

VS-VIT-RMT

Services, Consulting Remote Hourly Prestaging of hardware One hour of telephone consulting services provided by Consulting

VS-VIT-RMT

Services, Consulting Remote Hourly Project Management One hour of telephone consulting services provided by Consulting

VS-VIT-RMT

Services, Consulting Remote Hourly Installation One hour of telephone consulting services provided by Consulting.

VS-VIT-EDUNITS

Services, Education Units

AV-VIT-VITREAADDLCCUSER

Vitrea, Additional Concurrent User The concurrent user package allows one concurrent user access to basic advanced visualization tools to view and evaluate anatomy and pathology. One user license includes general advanced visualization vascular workflows and vessel probe. Included Applications: .CT Abdominal Analysis .CT Aorta Analysis .CT Circle of Willis Analysis .CT General Carotid Analysis .CT Larynx Airway Analysis .CT Musculoskeletal Analysis .CT Renal Analysis .CT Runoff Analysis .Global Illumination .MR Abdominal Analysis .MR Brain Tumor Analysis .MR Musculoskeletal Analysis .MR Vascular Analysis .Multi Modality Viewer .Multi Modality Viewer - PET .Multi Modality Viewer - US .Multi Modality Viewer - XA .Multi Modality Viewer 3D .Multi Modality Viewer - Spectral Fusion .VesselProbe .Vitrea Runtime User .Vitrea Advanced Runtime User

Location: Building Radiology Service, VA Maine Health Care System, 1 VA Center Augusta, ME 04330

1. CONFORMANCE STANDARDS: Contractor shall provide installation service and ensure that the equipment functions in accordance with the equipment manufacturer’s technical performance specifications. Contractor shall conform to all regulations to include but not be limited to federal, state and local governing any chemicals, equipment or work which may be used or performed in the work under this contract.

2. SOFTWARE ENHANCEMENTS: Periodic software enhancements shall be provided as part of the firm fixed price contract and shall be considered within scope.

3. LABOR & TRAVEL EXPENSES: All labor and travel conducted during normal business hours: Monday through Friday, 8:00am – 5:00pm relative to customer’s local time, (excludes Canon Medical company holidays).

4. CERTIFIED TRAINED TECHNICIANS AND KEY PERSONNEL: The installation and testing shall be performed by Canon Medical trained personnel in accordance with the agreement. Technicians shall include fully qualified Facility Service Engineers (FSE) and a fully qualified FSE who will serve as the backup and show proof of competency, as shown by training conducted on said system. "Fully Qualified" is based upon training and on experience in the field. For training, the FSE(s) has successfully completed a formalized training program, for the equipment identified in this statement of work. For field experience, the FSE(s) has a minimum of two years of experience (except for equipment newly on the market) with respect to installation and testing. Proof of training shall be provided upon demand and be immediately sent via fax, upon demand to the COR. All FSE’s and technicians shall be authorized by the Contractor to perform the installation services. All work shall be performed by "Fully Qualified" competent FSE's. The COR and/or designated representative specifically reserve the right to reject any of the Contractor's personnel and refuse them permission to work on the VAMC equipment.

It is anticipated that any hospital regulatory inspections (TJC, etc.) will have the vendor providing proof that they meet industry standards of quality, and traceable standards, as used to calibrate this device-system; at the time of the installation event.

5. SERVICE MANUALS/TOOLS/EQUIPMENT: The VAMC shall not provide tools, (test) equipment, service manuals or service diagnostic software to the contractor. The contractor shall obtain, have on file, and make available to its Facility Service Engineer’s (FSE) all operational and technical documentation (such as; operational and service manuals, schematics, and parts list) which are necessary to meet the performance requirements of this contract. The location and listing of the service data manuals, by name and/or the manuals themselves shall be provided to the COR and CO upon request.

6. DOCUMENTATION/REPORTS: The documentation shall include detailed descriptions of the installation procedures performed. Such documentation shall meet the guidelines as set forth in the Conformance Standards section. Installation reports must be sent to the COR or the requesting entity upon completion of the work. In addition, each report must, at a minimum, document the following data legibly and in complete detail:

NOTE: - Any additional charges claimed must be approved by the COR or designated representative before service is completed!

7. REPORTING REQUIREMENTS: The Contractor shall be required to report to the Clinical Engineering Department to log in. This check- in is mandatory. When the service is completed, the FSE shall document services rendered on a legible ESR(s). The FSE shall be required to log out with Biomedical Engineering and submit the ESR(s) to the COR or designated representative. ALL ESRs shall be submitted to the equipment user for an "acceptance signature" and to the COR or designated representative for an "authorization signature". If COR or designated representative is unavailable, a signed, authorized copy of the ESR will be left with the user.

VA COR: Nina Warah-Cano, DHSc, x5772 (Secondary)

8. PAYMENT: - Invoices will be paid upon the completion and acceptance of the procured equipment. Invoices shall include at a minimum, the following information: Contract Number, Purchase Order/Task Order Number, Contractor Name, and Item(s) installed. All invoices shall be mailed to the Department of Veterans Affairs Financial Services Center’s address as follows:

9. ADDITIONAL CHARGES: There shall be no additional charge for time spent at the site (during, or after the normal hours of coverage) awaiting the arrival of additional FSE and/or delivery of parts.

10. CONDITION OF EQUIPMENT: The Contractor shall accept responsibility for the equipment. Failure to inspect the equipment prior to installation of equipment will not relieve the Contractor from performance of the requirements of this contract.

11. TEST EQUIPMENT: Prior to commencement of work on this contract, the Contractor shall provide the VAMC with a copy of the current calibration certification of all test equipment which is to be used by the Contractor on VAMC's equipment. This certification shall also be provided on a periodic basis when requested by the VAMC. Test equipment calibration shall be traceable to the Original Equipment Manufacture’s standard.

12. IDENTIFICATION, PARKING, SMOKING, AND VA REGULATIONS: The Contractor's FSE's shall wear visible identification at all times while on the premises of the VAMC. The Contractor shall park in the appropriate designated parking areas. Information on parking is available from the VA Police Section. The VAMC will not invalidate or make reimbursement for parking violations of the Contractor under any conditions. Smoking is prohibited inside any buildings at the VAMC. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court.

13. TRAINING: The Contractor shall provide first call Clinical Engineering training for current qualified technicians at the VAMC, ME during regular service hours of Monday through Friday from 8:00am – 5:00 PM EST.

14. TRANSPORTATION CHARGES: All costs associated with transportation, from shipping point to the destination specified above, and all costs of removal after contract completion, shall be paid by the Contractor, and incorporated in the price proposal. The Contractor shall be responsible for all damage in transit including any transportation costs for replacement.

15. COMPLIANCE WITH OSHA BLOODBORNE PATHOGENS STANDARD:

The Contractor shall comply with the Federal/California OSHA Bloodborne Pathogens Standard. The Contractor shall:

a. Have methods by which all employees are educated as to risks associated with bloodborne pathogens.

b. Have policies and procedures which reduce the risk of employee exposure to bloodborne pathogens.

c. Have mechanisms for employee counseling and treatment following exposure to bloodborne pathogens.

d. Provide appropriate personal protective equipment/clothing such as gloves, gowns, masks, protective eyewear, mouthpieces for the employee during performance of the contract.

16. MISCELLANEOUS

Additional equipment may be added and/or removed throughout the life of this contract and shall be considered within scope.

17. CONTRACTOR PERSONNEL SECURITY REQUIREMENTS

Security Requirements: All contractor personnel shall obtain a short-term identification badge issued by the COR or government designated representative. Such badge shall be worn by the individual and prominently displayed at all times while on VA Property. No employee of the contractor shall enter the project site without a valid identification badge issued by the VA. In order to obtain a short-term identification badge, contractor personnel shall present to the COR a valid (non-expired) photo identification issued by a US federal, state or local government agency.

Escort will be provided as required in sensitive work areas.

The C&A requirements do not apply and the security accreditation package is not required.

The identified Sole Source Vendor shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in standard acquisition guidelines.

Per the VA handbook 6500.6, no VA sensitive information will be transferred, shared, or stored with said vendor. As such, no additional mechanisms will be needed to ensure the protection of information.

18. Records Management Language for Contracts The following standard items relate to records generated in executing the contract and should be included in a typical Electronic Information Systems (EIS) procurement contract:

1. Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

1. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

1. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

1. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

1. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

1. The Government Agency owns the rights to all data/records produced as part of this contract.

1. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

1. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

1. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

1. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C241-25-AP-3367

1. Contracting Activity: Department of Veterans Affairs, VISN 01, VAMC Togus, 1 VA Center, Augusta ME.

Funding document: 402-25-3-100-0083

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

This procurement is for an upgrade to the current unsupported Canon Vitrea Core Radiology System. The service is seeking to expand capabilities by adding two (2) additional workstations, expanding current capabilities by adding (2) additional users.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: This purchase request is to upgrade the Canon Vitrea Radiology system that currently has an unsupported operating system and is a security risk to VA Maine and the veterans. The Canon Medical Vitrea system is a ‘highly specialized’ device requiring brand name equipment and software to implement the required upgrades. Per a sole source letter provided by the large business (LB) OEM Canon Medical Informatics, the Canon Vitrea Core Technology, software, and services are proprietary and exclusive to Canon. All technology and software licensing are peculiar to Canon. All servicing and downloads require Canon-trained FSEs (Field Service Engineers), or other Canon employed professionals.

The Canon Medical Vitrea Radiology System equipment is used for multi-modalities within the Radiology service at VAMC Togus and throughout VISN 1. The addition of the (2) workstations will enhance diagnostic images and will provide better care to our veterans throughout VA Maine, die to the upgrade and the expanded capabilities. The installation and upgrades require OEM expertise.

Canon Medical Vitrea Radiology System equipment is used for multi-modalities within the Radiology service at VAMC Togus and throughout VISN 1. The addition of the (2) workstations will enhance diagnostic images and will provide better care to our veterans throughout VA Maine, die to the upgrade and the expanded capabilities. The denial or delay of this purchase could result in diminished patient care at the VA Maine HCS.

4. Description of market research conducted and results or statement why it was not conducted:

Market Research Findings: Market Research was conducted IAW FAR 10.001: The following sources were utilized: General Service Administration (GSA) Advantage, North American Industry Classification System (NAICS) Database, Federal Procurement Data System (FPDS), Supply Chain Master Catalog (SCMC), MedSurg Catalog Search (NAC), Dynamic Small Business Search, ADDS UP, GSA e-Library, and Ability One.

· MANDATORY SOURCES: The Vitrea Core expansion and upgrade is not available via any mandatory sources. Ability One: was searched using the terms “Radiology Imaging Software” and “Radiology Visualization Software.” There were no results for either search term.

· VFCP: A Veteran search was conducted through SBA DSBS: No potentially capable vendors were identified at the SBA DSBS database.

4. Description of market research conducted and results or statement why it was not conducted:

Market Research Findings:

· NON-MANDATORY CONTRACTS: Contracting searched non-mandatory contract sites such as the NAC, GSA Advantage, and GSA e-Library using the terms “Radiology Imaging Software” and “Radiology Visualization Software.” There were no results for either term.

· FPDS: An FPDS search was conducted using the terms “Radiology Imaging Software,” “Radiology Visualization Software,” “Canon Medical Informatics,” and “Vitrea.” There were fifty-six (56), zero, six (6) and 106 results respectively. Sixteen (16) of the results from the Vitrea search were for Canon Medical, with eight 8 prior contracts from Canon Medical.

· MARKET RESEARCH SUMMARY: The market research findings indicates that the Vitrea system is the only viable option for this acquisition, based on the specific needs of the customer and the lack of suitable options for replacement. The Vitrea Core Workstation and Upgrade are required to best integrate with the existing Canon Vitrea Core Radiology Systems at VAMC Togus. This will ensure system integrity: fit, form, and function, and system compatibility.

Recommendation: The recommended strategy is for a sole source award to the LB OEM Canon Medical Informatics: one (1) source for Vitrea Core workstation additions. This acquisition will provide an extension of the current Vitrea Core Radiology System capabilities, due to the addition of two (2) integration systems. The required product and associated licensing are proprietary and exclusive to the OEM. They are unique in their ability to provide the software. There is an NMR waiver for the NAICS code 334118; however, there are no authorized distributors for this product. The required product is available on a Government-Wide Acquisition Contract (GWAC): SPE2D1-19-D-0012, IAW 13.106-1(b)(1)(i).

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Contracting Officer VAMC White River Junction VT, NC01 RPOE

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