6515--Vitaflow Capital Bundle w/ Cart Brand Name or Equal

Combined Synopsis-Solicitation for Commercial Products and Commercial Services Effective Date: 01/15/2026 Revision: 03 Description This is a combined synopsis/solicitation for commercial products and commercial services prepared in accordance with the format Revolutionary FAR Overhaul (RFO) in Federal Acquisition Regulation (FAR) subpart 12.202, Streamlined Procedures for Evaluation and Solicitation for Commercial Products and Commercial Services, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued. This solicitation is issued as an RFQ. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2026-01. This solicitation is set aside for Small-Business The associated North American Industrial Classification System (NAICS) code for this procurement is 339112, with a small business size standard of 1,000 Employees The FSC/PSC is 6515. The West Haven VA Medical Center 950 Campbell Avenue West Haven VA, CT 06516 2770 is seeking to purchase the following items from below. The West Haven VA Medical Center is seeking (1) Vitaflow Capital Bundle w/ Cart Brand Name Medtronic or Equal. This is a new brand name or equal requirement. All interested companies shall provide quotations for the following: Supplies/Services Line Item Description Quantity Unit of Measure VITALFLOW CAPITAL BUNDLE WITH CART INCLUDES: 1 EA 58100 VITAL FLOW CONSOLE(INCLUDES FLOW & BUBBLE SENSOR, POWER CORD) 1 EA 58102 58102 MOTOR DRIVE & HOLDER; 1 EA 58103 58103-EMERGENCY HANDCRANK; 1 EA 58130 58130-OXYGENATOR DATA CABLE 1 EA 58120 58120-VITALFLOW TRAVEL CADDY 1 EA ECM-9688-1 VITALFLOW CART 1 EA DELIVERY LOCATION: West Haven VA Medical Center Jamaica Plain VA Medical Center 950 Campbell Avenue West Haven VA, CT 06516 2770 FOB: Destination Statement of Work West Haven VA Medical Center ECMO System Statement of Work    1. General Information  The Extracorporeal Membrane Oxygenation (ECMO) system requested under this Statement of Work is an advanced life support platform that temporarily takes over the function of a patient's heart and lungs. It is designed to provide cardiopulmonary support for critically ill adults facing acute, life-threatening respiratory or cardiac failure.  This is a brand name or equal requirement. The Medtronic VitalFlow ECMO system is cited as representative of the salient characteristics required (see Section 5, Equipment Specifications/Salient Characteristics). Any product offered as an equal must meet or exceed all salient characteristics listed. This is not a sole-source or brand-name-only requirement.    2. Background  The Surgical Department at the West Haven VA Medical Center (VA Connecticut Healthcare System) has identified a need for an ECMO system to support cardiopulmonary care for critically ill Veterans. Any offered system, including VitalFlow or an equal, will be evaluated against the salient characteristics in Section 5.    3. General Requirements  The Vendor shall be capable of delivering the entire required quantity of units to all designated sites within the required time frames.  Vendor shall ensure compliance with all applicable laws concerning construction, packaging, labeling, registration, and transportation of the equipment.  The Vendor shall not make unannounced alterations to the design or components of delivered equipment without prior notification and written approval by the Contracting Officer's Representative (COR).  The Vendor shall deliver all units within 60 days of contract award.   4. Regulatory and Compliance Requirements  The offered system, whether VitalFlow or an equal, shall hold current FDA clearance/approval (e.g., 510(k) or PMA, as applicable) for its intended use in adult cardiopulmonary life support.  The offered system shall comply with applicable VA medical device cybersecurity requirements, including VA Handbook 6500 and Medical Device Isolation Architecture (MDIA) requirements, where applicable.    5. Equipment Specifications / Salient Characteristics  To be considered an acceptable "equal" product, an offered ECMO system must meet or exceed the following salient characteristics.  Characteristic  Required Specification  FDA clearance / regulatory classification  Class II device cleared under 21 CFR 870.4100 (Extracorporeal Circuit and Accessories for Long-Term Respiratory/Cardiopulmonary Failure), or equivalent product code classification (e.g., QNR for pump/console, BYS for oxygenator)  Indicated duration of use  Indicated for continuous ECMO support up to 48 hours  Indicated patient population  Adult patients with acute respiratory failure or acute cardiopulmonary failure, where other treatment options have failed  System configuration  Complete system including console, centrifugal blood pump, membrane oxygenator, backup/emergency manual drive mechanism, and mobile transport cart  Console weight  9 kg (console unit only, excluding cart/accessories)  Intra-hospital transport certification  Certified for intra-hospital patient transport per ISO 60601-1 (or equivalent recognized standard)  Emergency backup drive  Manual emergency hand-crank or equivalent non-electric backup drive mechanism, independent of external power  External/DC motor drive option  DC-powered external drive motor compatible with the pump, for use during transport or power loss  Blood-contacting material composition  DEHP-free blood-contacting surfaces on the disposable circuit/set  Oxygenator/pump disposable set  Complete single-patient disposable set including oxygenator, tubing, and priming/prime bag, compatible with the offered pump and console  Mobility/cart configuration  Configurable mobile cart or stand permitting bedside and transport use, with accessory mounting (oxygenator holder, pole mounts, etc.)  Training/education support from vendor  Vendor-provided clinical education and hands-on training (see Section 6)    6. Education and Training  The Vendor shall provide comprehensive education and hands-on training on the offered ECMO system for VA hospital clinical staff, ensuring safe and effective use in patient care.  All relevant clinical staff shall be trained, including perfusionists, physicians, nurses, respiratory therapists, and biomedical engineers who will work with the device.   Training format on-site, virtual, or hybrid]  Number of training sessions and duration]   Competency validation/sign-off requirements]  Provisions for ongoing/refresher training and training for new hires post-award]    7. Records Management Language for Statement of Work (SOW)  The following standard items relate to records generated in executing the contract and shall be included in the procurement contract:  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.  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 as it determines to be in the public interest.  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.  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.  Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.  The Government Agency owns the rights to all data/records produced as part of this contract.  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. Contractors must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.  Contractor agrees to comply with Federal and Agency records management policies, including those associated with safeguarding 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.), mode of transmission (e-mail, fax, etc.), or state of completion (draft, final, etc.).  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.  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.    The following solicitation provisions and clause apply to this acquisition: FAR 52.212-1, Instructions to Offerors Commercial Products and Commercial Services The following applies: 52.203-11, 52.203-18, 52.203-17, 52.204-7, 52.204-13, 52.203-17, 52.203-19, 52.209-10, 52.212-2, 52.212-4, 52.219-1, 52.219-28, 52.222-3, 52.222-19, 52. 222-36, 52.222-50, 52.222-90, 52.224-3, 52.226-8, 52.232-90, 52.233-4, 52.233-33, 52.240-92,52.252-1, 852.203-70, 852.211-76, 852.212-71, 852.219-73, 852.219-76, 852.239-71, 852.246-71 All quoters shall submit the following: QUOTE All quotes shall be sent to the Contract Specialist, Glorimar Estevez Cortorreal, glorimar.estevezcortorreal@va.gov Award will be based upon a comparative evaluation of quotes in accordance with the Simplified Acquisition Procedures of RFO FAR 12. The following are the decision factors: price, past performance, product support, speed of delivery, help desk support The award will be made to the response most advantageous to the Government. Responses should contain your best terms, conditions. ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEVIATION AUG 2025) Provisions that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The version of FAR 52.212-1 in the addendum is tailored for Simplified Acquisition Procedures and supersedes the current version of FAR 52.212-1 contained in the FAR. The following provision is incorporated into 52.212-1 as an addendum to this solicitation: 52.212-1 Instructions to Offerors Commercial Products and Commercial Services (DEVIATION AUG 2025) (a) Submission of offers. Submit signed and dated offers to the office specified in this solicitation at or before the exact time specified in this solicitation. As a minimum, offers shall include (1) The solicitation number; (2) The name, address, telephone number of the Offeror; (3) The Offeror s Unique Entity Identifier (UEI) and, if applicable, Electronic Funds Transfer (EFT) indicator; (4) Information necessary to evaluate the factors contained in the provision at 52.212-2 or as described in the solicitation; (5) Responses to provisions that require Offeror completion of information, representations, and certifications (other than those collected via the System for Award Management (SAM)); and (6) A statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation and any solicitation amendments. (b) Period for acceptance of offers. The Offeror agrees to hold the prices in its offer firm for 60 calendar days from the date specified for receipt of offers, unless another time period is specified in an addendum to the solicitation. (c) Late submissions, modifications, revisions, and withdrawals of offers. (1) Offerors are responsible for submitting offers and any modifications or revisions to the Government office designated in the solicitation by the time specified in the solicitation. (2) Any offer, modification, or revision received after the time specified for receipt of offers is late and will not be considered unless it is received before award is made and the Contracting Officer determines that accepting the late offer would not unduly delay the acquisition. However, a late modification of an otherwise successful offer that makes its terms more favorable to the Government will be considered at any time it is received and may be accepted. (3) If an emergency or unanticipated event interrupts normal Government processes so that offers cannot be received at the Government office designated for receipt of offers by the exact time specified in the solicitation, and urgent Government requirements preclude amendment of the solicitation or other notice of an extension of the closing date, the time specified for receipt of offers will be deemed to be extended to the same time of day specified in the solicitation on the first work day on which normal Government processes resume. (4) Offerors may withdraw their offers by written notice to the Government received at any time before award. (d) Contract award (not applicable to Invitation for Bids). The Government intends to evaluate offers and award a contract without discussions with Offerors. Therefore, the Offeror s initial offer should contain the Offeror s best terms. However, the Government reserves the right to conduct discussions, if necessary. The Government may reject any or all offers if such action is in the public interest, accept other than the lowest offer, and waive informalities and minor irregularities in offers received. (e) Debriefings. If a postaward debriefing is given to requesting Offerors, the Government will disclose the following information, if applicable: (1) The agency s evaluation of the significant weak or deficient factors in the debriefed Offeror s offer. (2) The overall evaluated cost or price and technical rating of the successful Offeror and the debriefed Offeror and past performance information on the debriefed Offeror. (3) The overall ranking of all Offerors when any ranking was developed by the agency during source selection. (4) A summary of the rationale for award. (5) For acquisitions of commercial products, the make and model of the product to be delivered by the successful Offeror. (6) Reasonable responses to relevant questions posed by the debriefed Offeror as to whether the agency followed source-selection procedures set forth in the solicitation, applicable regulations, and other applicable authorities. (End of provision) www.sam.gov registration is required to be complete at time of submission of response. Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://sam.gov/. FAR 52.212-4, Contract Terms and Conditions Commercial Products and Commercial Services To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows: "The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition." OR "The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:" Quoters shall list exception(s) and rationale for the exception(s), if any. Submission of your response shall be received not later than 8 AM EST on Wednesday, August 26, 2026 to glorimar.estevezcortorreal@va.gov Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Point of Contact listed below. Point of Contact Contract Specialist Glorimar Estevez Cortorreal glorimar.estevezcortorreal@va.gov