SOURCES SOUGHT - MRI Equipment - VA Palo Alto HCS - OM.docx

The VHA Network Contracting Office 21, on behalf VA Palo Alto Healthcare System in Palo Alto, CA, is conducting this Sources Sought to identify contractors who possess the capabilities to provide the following brand name only equipment to determine source availability, capability. and adequacy:

Iradimed MRidium 3860+ with Accessories, Installation, and Training. BRAND NAME ONLY.

The Veterans Health Administration (VHA) requires Iradimed MRidium 3860+ Non-Magnetic IV Infusion Pump with SpO2, and associated components at VA Palo Alto Health Care, in a new Basement MRI at Building 100 Palo Alto, CA in Santa Clara County. The Iradimed MRidium 3860+ Non-Magnetic IV Infusion Pump integrates with each other, and VA network systems, and software.

This requirement includes the product, delivery services, installation and facilitation of training for the MRidium MRI Infusion System with SpO2, and their associated components.

List of Items:

· QTY 1 - MRidium MRI Infusion System with SpO2, MPN: 3860+

· QTY 1 - MRidium “Side car” Modular Pump Channel MPN: 3861

· QTY 1 - MRidium Wireless Remote Control, MPN: 3865

· QTY 1 - MRidium Non-Magnetic IV Pole, MPN: 1119

· QTY 1 - Reusable Grip Sensor Pack (Size 1, 2 and 3), MPN: 1171

· QTY 1 - MRidium SpO2 Fiber Optic Sensor Kit, MPN: 1170

· QTY 1 - DERS INITIAL LIBRARY ENTRY BUNDLEs, MPN: 9992B

· QTY 1 - Training 2 Day (IV Pump), MPN: 9999

· QTY 1 - MRidium Premium Maintenance Agreement: 3 YR. (Point of Sale), MPN: 9593P

· QTY 1 – Sidecar Premium Maintenance Agreement: 3 YR. (Point of Sale), MPN: 9693P

· QTY 1 - Remote Premium Maintenance Agreement 3 YR. (Point of Sale), MPN: 9793P

Specifications:

1. Volumetric infusion pump/ monitor Electrical Characteristics:

· HI/LO Line Voltage Requirements: 100 to 240 VAC +/-10%, 50/60 Hz.

· Power Sources Available: Internal battery power with separate AC charger/power supply.

· Power Consumption: <18 Volt-Amperes @ 120 VAC nominal at 125 mL/hr. (<100 VA maximum during charging)

· Battery type: Rechargeable Lithium Polymer Pack, 14.8v at 5.8 Ah.

· Battery Capacity: >12 hours at ≤ 125 mL/hr. Rate

· Battery charge time: <9 hours to 95% capacity

· Battery Cycle life: >200 charge/ discharge cycles

· Leakage current: <20 µA RMS (Patient), <300µA RMS (chassis)

· Impedance, Chassis to Earth Ground: <0.1 ohms (with power supply)

Mechanical Characteristics:

· Dimension: 6” D x 8” W x 9.5” H. Weight: 11.5 lbs. with battery.

· Temperature Range: +10° to +44°C (operating), -40° to +70°C

· Relative Humidity Range: 0% to 80% RH, non-condensing

· Pole Clamp Mounting (diameter) range: 1.0 to 1.5 inch diameter

2. Infusion pump performance characteristic:

· Flow Rate range: 0.1 to 1400 mL/hr. 0.1 to 99.9 mL/hr. increments, 100 to 1400 mL/hr. in 1 mL increments.

· Flow Rate Display range: 0.1 to 99.9, 100 to 1400 mL/hr.

· Flow Rate accuracy: +/-10% (0.1 to 0.9 mL/Hr.), +/- 5% (1 to 1400 mL/Hr.)

· Volume to be infused (VTBI) range: 0.1 to 999 mL

· Total Volume Infused (VI) range: 0.1 to 9,999 mL in 0.1 mL increments

· Keep Vein Open (KVO) Rate Range: Adjustable, 1 to 5 mL/hr., or Set Rate, whichever is less.

· Downstream (proximal) Occlusion: 1 to 10 psi, user-adjustable, +/- 10% detection range.

· Occlusion Detection (no flow) time: Typically <30 sec, dependent on selected Flow Rate.

· Intel Pressure Detector: Detects inlet side occlusions.

· Air-in-Line Detection Method: Ultrasonic bubble detector, > 100µL

· MRI Magnet compatibility: 0.2 to 3.0 Tesla MRI systems

· Magnetic Field Limit: 10,000 Gauss line (1T magnetic field line) – Minimal ferrous material used inside Pump (<15 grams); non-magnetic motor used inside pump.

· Compliance with standards: IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-24, ISO 9919, AAMI ID 26, UL60601

3. Pulse oximeter performance characteristic:

· Sensor type: Fiberoptic MRI SpO2 sensor with no RF conductive components

· Sensor length: 90 inches

· Accuracy: 70-99% SpO₂ +/-3-digit Adult/Pediatric/Infant. Heart rate +/-3 BPM (no motion).

· Display ranges: Pulse Oximeter 70-99% SpO₂, Heart rate 40-240 BPM.

Delivery Location:

VA Palo Alto Healthcare System, 3801 Miranda Ave. Palo Alto, CA. 94304

As permitted by FAR Part 10, this is a market research tool being utilized for informational and planning purposes. Your responses will assist the Government in developing its acquisition strategy for a possible Request for Quote (RFQ), to be issued at a future date, and in determining if any type of small business set-aside is possible for this procurement and if full and open competitive procedures should be utilized. If full and open competition is ultimately utilized, responses to this synopsis will be used to aid in establishing small business subcontracting goals.

This notice shall not be construed as a RFQ or as any commitment or obligation on the part of the Government to issue a solicitation. The Government does not intend to award a contract based on this request, so quotes will not be considered. No reimbursement will be made for any costs associated with providing information in response to this synopsis or with any follow-up information requests.

Response is strictly voluntary - it is not mandatory to submit a response to this notice to participate in any formal RFQ process that may take place in the future. However, it should be noted that information gathered through this notice may significantly influence the VA’s acquisition strategy for this procurement. All interested parties will be required to respond separately to any solicitations posted from this Sources Sought notice.

Submission Instructions:

Please email your response to this Sources Sought notice to Corey R. Kline, email corey.kline3@va.gov, by no later than 12:00 Noon PDT, Tuesday, April 29, 2025. Your response must include the information requested below. This Sources Sought notice is strictly for market research purposes, and the Government will not entertain any questions. Respondents will not be notified of the results of the evaluation. We appreciate your interest and thank you in advance for responding to the Sources Sought notice.

Qualified firms shall submit the following:

A statement of interest on company letterhead demonstrating the firm’s qualifications to perform the defined work. Responses must be complete and sufficiently detailed to address the specific information. The documentation shall address, at a minimum, the following:

Business Name and Address:

Business SAM UEI Number:

Business Sales Rep Name, Email Address, Phone Number:

Business Size (Small/Large/Other):

Business Socioeconomic Category (SDVOSB*, VOSB*, Minority, Women, Disadvantaged, etc.):

Are Items Currently Available on GSA FSS Contract (Y/N)?

If Items Are Currently on GSA FSS Contract, State Contract Number:

Is your Company an Approved Distributor for the products requested? Provide a copy of the Distributor Letter of Authorization.

The Government will review all responses from vendors proposing equipment equal to above stated equipment. Please provide any product information / capability statements.

* Respondents who wish to be considered an SDVOSB or VOSB for market research purposes must complete VAAR Clause 852.219-76 (VA NOTICE OF LIMITATIONS ON SUBCONTRACTING – CERTIFICATE OF COMPLIANCE FOR SUPPLIES AND PRODUCTS (JAN 2023) (DEVIATION) and submit with their response to this notice (see next page).

852.219-76 VA Notice of Limitations on Subcontracting—Certificate of Compliance for Supplies and Products.

As prescribed in 819.7011(c), insert the following clause. The contracting officer shall tailor the clause in paragraph (a)(2)(iii) as appropriate:

VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—CERTIFICATE OF COMPLIANCE FOR SUPPLIES AND PRODUCTS (JAN 2023) (DEVIATION)

(a) Pursuant to 38 U.S.C. 8127(l)(2), the offeror certifies that—

(1) If awarded a contract (see FAR 2.101 definition), it will comply with the limitations on subcontracting requirement as provided in the solicitation and the resultant contract, as follows: [Offeror check the appropriate box]

(i) [ ] In the case of a contract for supplies or products (other than from a non-manufacturer of such supplies), it will not pay more than 50% of the amount paid by the government to it to firms that are not certified SDVOSBs listed in the SBA certification database as set forth in 852.219-73 or certified VOSBs listed in the SBA certification database as set forth in 852.219-74. Any work that a similarly situated certified SDBOSB/VOSB subcontractor further subcontracts will count towards the 50% subcontract amount that cannot be exceeded. Cost of materials are excluded and not considered to be subcontracted.

(ii) [ ] In the case of a contract for supplies from a nonmanufacturer, it will supply the product of a domestic small business manufacturer or processor, unless a waiver as described in 13 CFR 121.406(b)(5) is granted. The offeror understands that, as provided in 13 CFR 121.406(b)(7), such a waiver has no effect on requirements external to the Small Business Act, such as the Buy American Act or the Trade Agreements Act.

(2) Manufacturer or nonmanufacturer representation and certification. [Offeror fill-in—check each applicable box below. The offeror must select the applicable provision below, identifying itself as either a manufacturer or nonmanufacturer]:

(i) [ ] Manufacturer or producer. The offeror certifies that it is the manufacturer or producer of the end item being procured, and the end item is manufactured or produced in the United States, in accordance with paragraph (a)(1)(i).

(ii) [ ] Nonmanufacturer. The offeror certifies that it qualifies as a nonmanufacturer in accordance with the requirements of 13 CFR 121.406(b) and paragraph (a)(1)(ii). The offeror further certifies it meets each element below as required in order to qualify as a nonmanufacturer. [Offeror fill-in—check each box below.] [ ] The offeror certifies that it does not exceed 500 employees (or 150 employees for the Information Technology Value Added Reseller exception to NAICS code 541519, which is found at 13 CFR 121.201, footnote 18).

[ ] The offeror certifies that it is primarily engaged in the retail or wholesale trade and normally sells the type of item being supplied.

[ ] The offeror certifies that it will take ownership or possession of the item(s) with its personnel, equipment, or facilities in a manner consistent with industry practice.

(iii) [ ] If this is a multiple item acquisition, the offeror certifies that at least 50% of the estimated contract value is composed of items that are manufactured by small business concerns.

(3) The offeror acknowledges that this certification concerns a matter within the jurisdiction of an Agency of the United States. The offeror further acknowledges that this certification is subject to Title 18, United States Code, Section 1001, and, as such, a false, fictitious, or fraudulent certification may render the offeror subject to criminal, civil, or administrative penalties, including prosecution.

(4) If VA determines that an SDVOSB/VOSB awarded a contract pursuant to 38 U.S.C. 8127 did not act in good faith, such SDVOSB/VOSB shall be subject to any or all of the following:

(i) Referral to the VA Suspension and Debarment Committee;

(ii) A fine under section 16(g)(1) of the Small Business Act (15 U.S.C. 645(g)(1)); and

(iii) Prosecution for violating 18 U.S.C. 1001.

(b) The offeror represents and understands that by submission of its offer and award of a contract it may be required to provide copies of documents or records to VA that VA may review to determine whether the offeror complied with the limitations on subcontracting requirement specified in the contract or to determine whether the offeror qualifies as a manufacturer or nonmanufacturer in compliance with the limitations on subcontracting requirement. Contracting officers may, at their discretion, require the contractor to demonstrate its compliance with the limitations on subcontracting at any time during performance and upon completion of a contract if the information regarding such compliance is not already available to the contracting officer. Evidence of compliance includes, but is not limited to, invoices, copies of subcontracts, or a list of the value of tasks performed.

(c) The offeror further agrees to cooperate fully and make available any documents or records as may be required to enable VA to determine compliance. The offeror understands that failure to provide documents as requested by VA may result in remedial action as the Government deems appropriate.

(d) Offeror completed certification/fill-in required. The formal certification must be completed, signed and returned with the offeror’s bid, quotation, or proposal. The Government will not consider offers for award from offerors that do not provide the certification, and all such responses will be deemed ineligible for evaluation and award.

Certification:

I hereby certify that if awarded the contract, [insert name of offeror] __________________________ will comply with the limitations on subcontracting specified in this clause and in the resultant contract. I further certify that I am authorized to execute this certification on behalf of [insert name of offeror] _____________________________.

Printed Name of Signee: ________________________________________

Printed Title of Signee: _________________________________________

Signature: ___________________________________________________

Date: _____________________

Company Name and Address: ______________________________________

(End of clause)