P02 Notice of Intent to Sole Source sources sought.docx

NOTICE OF INTENT TO SOLE SOURCE

The Department of Veterans Affairs, Network Contracting Office (NCO) 22, located at 4811 Airport Plaza Drive, Long Beach, CA 90815 is issuing this Notice of Intent (NOI) to inform industry contractors of the Government’s intent to execute a firm fixed price, Sole Source Award.

The intended Contractor is a large business vendor Medtronic located at 12705 Ingenuity Drive, Orlando, FL 32526

The Department of Veterans Affairs (VA) Loma Linda VA Medical Center requires the acquisition and implementation of a complete GI Endoflip 300 Impedance Planimetry System and Supplies. This upgrade is for the existing GI Impedance Planimetry System and is necessary to address current system deficiencies and improve overall reliability in the interest of responding to codes expeditiously for patient care.

The existing GI Impedance Planimetry System have reached end of service support and are no longer reliable for patient care. GI Impedance Planimetry System is proprietary and currently Medtronic is the only manufacture of this type of GI Impedance Planimetry System and Supplies.

At present, the existing GI Impedance Planimetry System are in a state of progressive failure and are impacting patient care.

Given the criticality and uniqueness of the technology, an upgrade from the existing Impedance Planimetry System is the only appropriate course of action. No other procurement avenues exist due to the proprietary nature of the products, which is owned and exclusively supported by the current developer, Medtronic.

Place of Performance

Department of Veteran Affairs VA Loma Linda Healthcare System 11201 Benton Street Loma Linda, CA 92357

DRAFT STATEMENT OF WORK

Objective & Scope

The contractor shall provide all supplies, software, hardware, project management, installation services, field support, and post-implementation support necessary to successfully upgrade the existing MRI safe IV Pumps and Supplies. All work shall be performed on a firm-fixed-price basis, inclusive of all time, materials, labor, travel, and incidental costs.

The scope includes delivery, installation, configuration, testing, training (as required), and support of the following items:

Products:

1. Medtronic ENDOFLIPTM 300 SYSTEM – Quantity: 1

2. Medtronic ENDOFLIP 300 PUMP SYSTEM – Quantity: 1

3. Medtronic ENDOFLIP 300 DISPLAY SYSTEM – Quantity: 1

4. Medtronic ENDOFLIP 300 CART – Quantity: 1

5. Medtronic ENDOFLIPTM 300 3 YEAR SERVICE PLAN – Quantity: 1

Tasks & Deliverables

SEE ATTACHMENT B STATEMENT OF WORK

Contractor Qualifications & Other Responsibilities

a) The contractor shall have direct OEM (Original Equipment Manufacturer) experience and expertise with Medtronic Endoflip 300 Impedance Planimetry System and Supplies.

b) All work must be accomplished by qualified personnel in accordance with the original manufacturer’s instructions, including, but not limited to, installation manuals, configuration guides, and safety protocols.

c) The contractor shall have full access to all software (OEM privileges), technical support resources, firmware updates, and diagnostic tools necessary to successfully install and support the Impedance Planimetry System and Supplies.

d) The contractor shall furnish all test parts, equipment, tools, and materials required for performance of the contract. The contractor is responsible for all logistics, shipping, receiving, inventory management, and disposal of any replaced equipment (if applicable).

e) The contractor shall comply with all VA security, privacy, and safety requirements, including obtaining necessary access credentials and completing required training prior to on-site work.

Changes to the Statement of Work:

Only the specified services stated herein are authorized under this contract. Before performing any service or repairs of a non-contract nature, the VA POC or Contracting Officer must be advised of the reasons for this additional work. If appropriate, the Contracting Officer or their designee may authorize the additional services or repairs under a separate purchase authorization. The Vendor is cautioned that only the Contracting Officer may authorize additional services or repairs and that reimbursement will not be made unless this prior authorization is obtained. Changes to the statement of work requires Contracting Officer approval. Acceptance of changes to the statement of work from an unauthorized individual shall be at the risk of, and shall be the sole responsibility of, the contractor or supplier. Acceptance of changes to the statement of work from an unauthorized individual may result in non-payment for services as cancellation of this agreement

Contractor’s Key Personnel

The Contractor shall be responsible for the assignment, managing and overseeing the activities of all Contractor personnel. The Contractor's management responsibilities shall include all activities necessary to ensure the accomplishment of timely and effective support, performed in accordance with the requirements contained in the statement of work.

The Contracting Officer may notify the Contractor and request immediate removal of any personnel assigned to the order by the Contractor that are deemed to have a conflict of interest with the government or if the performance is deemed to be unsatisfactory. The reason for removal will be documented and replacement personnel shall be identified within three business days of the notification. Employment and staffing difficulties shall not be justification for failure to meet established schedules.

Contractor Point of Contact

The Contractor shall assign a Point of Contact (POC) and an alternate POC for the purpose of ensuring compliance with all the terms and conditions of this contract and who shall be responsible for administration and clinical matters in the performance of services under this contract. The POC shall have full authority to act for the Contractor on all matters relating to the daily operation of this contract. The POC shall be available by telephone Monday through Friday, between 8AM to 5PM PDT. excluding Federal Holidays.

Normal Working Hours:

Contractor will shall be performing services between 8AM to 5PM PDT, Monday - Friday with exceptions to Federal Holidays. Contractors must report to the VA POC or designee prior to starting work and check out with the VA POC or designee prior to departing the job site.

Overtime & Federal Holidays:

Any overtime or holiday pay that may be entitled to the Contractor’s employees shall be the sole responsibility of the Contractor and shall not be billed to nor reimbursed by the Government.

In accordance with 5 U.S.C. 6103, Executive Order 11582 and Public Law 94-97 the following national holidays are observed and for the purpose of this contract are defined as “Legal Federal official holidays”:

New Year’s Day

Martin Luther King’s Birthday

President’s Day

Memorial Day

Juneteenth

Independence Day

Labor Day

Columbus Day

Veteran’s Day

Thanksgiving Day

Christmas Day

When a holiday falls on a Sunday, the following Monday will be observed as a National Holiday. When a holiday falls on a Saturday, the preceding Friday is observed as a National Holiday by U.S. Government Agencies. Also included would be any day specifically declared by the President of the United States of America as a National holiday.

This procurement is being conducted using commercial item procedures pursuant to FAR Part 12.

The North American Industry Classification System (NAICS) for this requirement is, 339112 – Surgical and Medical Instrument Manufacturing. Product of Service Code for this requirement is 6515 – Medical and Surgical Instruments, Equipment, and Supplies. The Small Business Administration (SBA) size standard for this sector is 1000 Employees.

If your company is interested and capable of providing the required supplies/services, please provide the information indicated below. Response to this notice should include company name, address, point of contact, size of business pursuant to the following questions:

(1) Submit your capabilities statement illustrating how your organization can/cannot meet the list of DRAFT SOW requirements (Attachment B). For instances where your company cannot meet the DRAFT SOW requirement(s), please explain. For instances where your company can meet the DRAFT SOW requirement(s), please show how your company meets/exceeds each requirement.

(2) Please provide preliminary pricing (Attachment A) s and provide any additional feedback or suggestions. If none, please reply as N/A.

(3) In the VA’s efforts to procure domestic end products, are you able to provide a domestic product or a domestic alternative product?

(4) Please indicate the size status and representations of your business, such as but not limited to: Service-Disabled Veteran-Owned Small Business (SDVOSB), Veteran-Owned Small Business (VOSB), HUBZone, Woman Owned Small Business (WOSB), Large Business, etc.

(5) Is your company considered small under the NAICS code identified in this RFI?

(6) Are you the manufacturer, authorized distributor, and/or can your company provide a solution to the required supplies/services described in the list of DRAFT SOW?

(7) If you are a large business, do you have any designated/authorized distributors? If so, please provide their company name, telephone, point of contact and size status (if available).

(8) If you’re a small business and you are an authorized distributor/reseller for the items identified above, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified.

(9) Limitations on Subcontracting: How does your business ensure compliance with the limitations on subcontracting as outlined in 13 CFR § 125.6?

(10) Are the items you are identifying/providing considered Commercial of the Shelf (COTS) items as defined in FAR Part 2.101 under commercial items?

(11) Non-Manufacturer Rule: If applicable, can you confirm your business complies with the Non-Manufacturer rule? Specifically, does your company: Provide a product from a small business manufacturer or processor? Not exceed 500 employees? Primarily engage in the retail or wholesale trade and normally sell the type of item being supplied? Take ownership or possession of the item(s) with its personnel, equipment or facilities in a manner consistent with industry practice?

(12) What is your lead time to deliver a single unit with all components? Is there scale in lead time with greater quantities? Please elaborate.

(13) What is estimated life span of your solution? What support/services does that entail?

(14) Does your proposed equipment have FDA clearance? Please specify what FDA clearance(s) have been obtained.

(15) Does your organization offer a leasing solution? Please elaborate.

(16) Does your company have a Federal Supply Schedule (FSS) GSA/NAC/SAC/BPA/NASA SEWP or any other Federal Government contract? If so, please provide the contract number(s).

(17) If you are an FSS GSA/NAC/SAC/BPA/NASA SEWP or any other Federal Government contract holder, are all the items/solutions you are providing information about available on your schedule/contract? Please state if all or some items are available on the contract.

(18) General pricing of your products/solution is encouraged. Pricing will be used for the purpose of market research only. It will not be used to evaluate for any type of award.

(19) Please provide your SAM.gov Unique Entity ID/Cage Code number.

Buy America Compliance Respondents shall provide sufficient detail to determine compliance with the Buy American Act, including country of origin, domestic content, and availability of domestic alternatives. Responses should be complete and supported with verifiable information.

1. Please identify the country of origin for the end product(s) being offered. Include the location of final assembly/manufacture.

2. Please provide the percentage of domestic content (by cost) for each product(s). Describe the origin of the major components.

3. Does your product qualify as a “domestic end product” in accordance with the Buy American Act?

4. Please identify the manufacturer name and location for the product(s). Confirm whether the manufacturer is U.S.-based.

5. Identify the country of origin of each product and indicate whether the product qualifies as a U.S.-made or designated-country end product in accordance with the Trade Agreements Act This notice of intent is neither a formal solicitation nor a request for competitive proposals. No solicitation document is available, and telephone requests will not be honored. No award will be made on the basis of unsolicited quotations or offers received in response to this notice. Any response to this notice must show clear, compelling and convincing evidence that competition will be advantageous to the Government. The intent of this synopsis is for informational purposes only. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. A determination by the Government not to compete this action based on this notice is solely within the discretion of the Government.

All inquiries and concerns must be addressed in writing via e-mail to Rebecca Gaba at Rebecca.Gaba@va.gov with the following information referenced in the subject line, 36C262-26-AP-7378 – Impedance Planimetry System and Supplies. A determination by the Government not to compete this proposed procurement based on the responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. All interested parties who are responsible, certified, and capable may identify their interest and may submit capability statement which shall be considered by the agency no later than 12:00 PM Pacific Daylight Time (PDT) on Wednesday, July 22nd , 2026 to Rebecca Gaba at Rebecca.Gaba@va.gov. The interested parties bear full responsibility to ensure complete transmission and timely receipt.

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