6515--BNOE NX EQ Circulatory Assist Units: Intra-Aortic Balloon

This is a combined synopsis/solicitation for Brand Name or Equal Commercial Items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. Solicitation number 36C10G24Q0107 is issued for this combined synopsis/solicitation; this solicitation is being issued as a Request for Quote (RFQ). This notice incorporates provisions and clauses in effect through Federal Acquisition Circular (FAC) 2024-03, dated 23 February 2024 and may be accessed in full text at FAR | Acquisition.GOV. Requirement Description: The Veterans Health Administration (VHA) Equipment Life Cycle Management (ELCM) Program identified Circulatory Assist Units: Intra-Aortic Balloon as a candidate for a VA-wide (otherwise referred to as national ) single award Requirements contract. Circulatory Assist Units: Intra-Aortic Balloon produce mechanical counter pulsation to reduce the afterload to the heart and increase coronary and cerebral blood flow. These devices consist of an inflatable balloon catheter, which is placed in the aorta attached to an external unit that includes a pneumatic system, regulating the automated inflation and deflation of the balloon in synchronism with the cardiac cycle; they include monitors of the physiologic parameters of the patient (e.g., heart rate, arterial pressure) and also of balloon pressure and volume. The inflated intra-aortic balloon forces the blood toward the heart during each diastolic phase of the cardiac cycle. Intra-aortic balloon circulatory assist units are used to improve cardiovascular functioning during cardiac failures that constitute life-threatening emergencies. The salient characteristics (SC) for these commercial items are identified in the NX EQ Circulatory Assist Units: Intra-Aortic Balloon, Product Description. A single award Requirements contract will be awarded IAW FAR Clause 52.211-6, Brand Name or Equal and FAR 11.104, Use of Brand Name or Equal Purchase Descriptions, in accordance with all terms, conditions, provisions, specifications, and schedule of this solicitation herein. Proposals shall contain the terms for cost/price and technical capabilities of the band name or equal equipment. The Government reserves the right to award without discussions. The associated North American Industrial Classification System (NAICS) code for this procurement is 339113 Surgical Appliance and Supplies Manufacturing, Product Service Code: 6515 Medical and Surgical Instruments, Equipment, and Supplies, and the associated size standard is 800 employees. This procurement action is issued as Unrestricted. The proposed acquisition is for a Requirements Contract with Firm-Fixed Price (FFP) orders IAW FAR 16.503, Requirements Contract. This requirement will be solicited and awarded IAW FAR clause 52.211-6, Brand Name or Equal which requires the offeror indicate that each product being offered as an equal product to the Circulatory Assist Units: Intra-Aortic Balloon. All interested companies shall provide a propose for all Contract Line-Item Numbers (CLINs) listed in ATTACHMENT A PRICE LIST- Circulatory Assist Units. This procurement effort is to establish a 12-month base contract with four (4) 12-month option periods. Delivery is FOB destination and requires delivery to VA medical facilities throughout the United States. Firm-Fixed-Price Orders will be placed against this contract in writing and will provide the exact delivery locations, delivery dates, and exact quantities. Delivery shall be provided within 30 days after receipt of order (ARO). The FAR provision at 52.212-1, Instructions to Offerors -- Commercial, applies to this acquisition including attached addenda to the provision. The FAR provision at 52.212-2, Evaluation -- Commercial Items, and the specific evaluation criteria as attached addenda also applies to this acquisition. Offerors shall include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications -- Commercial Items, with its offer, if not available in the System for Award Management (SAM). Vendors are required to complete all fill-in Provisions listed on Attachment D - Solicitation Provisions. Clause at 52.212-4, Contract Terms and Conditions -- Commercial Items, applies to this acquisition and a statement regarding any addendum to the clause. Clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items, applies to this acquisition and a statement regarding which, if any, of the additional FAR clauses cited in the clause are applicable to the acquisition and found in Attachment C - Contract Clauses. The FAR Provision found at 52.204-7(b)(1) requires that All interested Offerors must be registered in SAM prior to submitting an offer or quotation. You may access the SAM website at https://www.sam.gov/portal/public/SAM/. All proposers must be certified with the appropriate NAICS code on the SAM website. All SDVOSB offerors must be verified in the Small Business Administration (SBA) database at: Veteran Small Business Certification (sba.gov) at the time of proposal submission. Questions regarding this combined synopsis/solicitation are due via email by 11:59 AM EST on May 10, 2024, to Contract Specialist, , Lesa Duran at [email protected] and Contracting Officer, Deidre Parker at [email protected]. No calls will be accepted. All questions received by the stated deadline will be answered via a solicitation amendment and posted on the Contracting Opportunities (https://sam.gov/ ) website. Proposals are due via email by 11:59 AM EST on May 22, 2024, to Contract Specialist, Lesa Duran at [email protected] and Contracting Officer, Deidre Parker at [email protected]. PRODUCT DESCRIPTION 1. SCOPE OF WORK: The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified the Circulatory Assist Units: Intra-Aortic Balloon product line as a candidate for a VA-wide (otherwise referred to as national ) single Requirements contract award. Circulatory Assist Units: Intra-Aortic Balloon produce mechanical counter pulsation to reduce the afterload to the heart and increase coronary and cerebral blood flow. These devices consist of an inflatable balloon catheter, which is placed in the aorta attached to an external unit that includes a pneumatic system, regulating the automated inflation and deflation of the balloon in synchronism with the cardiac cycle; they include monitors of the physiologic parameters of the patient (e.g., heart rate, arterial pressure) and also of balloon pressure and volume. The inflated intra-aortic balloon forces the blood toward the heart during each diastolic phase of the cardiac cycle. Intra-aortic balloon circulatory assist units are used to improve cardiovascular functioning during cardiac failures that constitute life-threatening emergencies. The Contractor must demonstrate the ability to meet all requirements for the solicitation. The objective is to provide Circulatory Assist Units: Intra-Aortic Balloon to be used by clinicians throughout the VA medical centers and facilities. The period of performance is for a base of 12-months with four 12-month option periods. 2. REQUIREMENT This requirement will be IAW FAR clause 52.211-6, Brand Name or Equal which requires the proposer indicate that each product being offered as an equal product to the brand and equipment name. For each equal product, the offeror must include a description reflecting the salient characteristics (SC) and level of quality that will satisfy the salient physical, functional, or performance characteristics of the equal product(s) specified in the solicitation. The proposer must also clearly identify the item by brand name (if any) and make/model number. Finally, the proposer must include descriptive literature, such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer, and clearly describe any modifications it plans to make to a product to make it conform to the solicitation requirements. Table 1 - Contract Line Items Contract Line Item# Brand Part Number Description 0001 Getinge 0998-00-0800-53 Cardiosave Hybrid Intra-Aortic Balloon Pump includes accessory kit (D0020-00-0480-01), 2 Li-Ion battery pack (D146-00-0097), Helium Tanks (D075-00-0024-03) and CARDIOSAVE Li-Ion Single Battery Transport PART NUMBER (D202-00- 0206-01) (Protective transport case required by fed regs). MANUFACTURER PART NUMBER (D202-00- 0206-01) - charger integral to Cardiosave cart 0002 Getinge 0998-00-0803 Cardiosave Trainer 0003 Getinge ZSUSBZCDSVPOSEW CRDSVE - GCare Preventative - EW 1Y 0004 Getinge ZSUSSVCDSVPOSEW CRDSVE - GCare Professional - EW 1Y 0005 Getinge ZSUSGDCDSVPOSEW CRDSVE - GCare Premium - EW 1Y The Department of Veterans Affairs (VA) is seeking vendors who can provide Getinge Cardiosave equipment name or equal as listed above which meet all the following salient characteristics: Vendors may quote any product solution or configuration so long as they meet the salient characteristics. Products quoted in the technical volume must be captured on the Vendor s pricing volume (Attachment A, Price Cost Schedule) of the solicitation. Vendors may quote any additional ancillary products which they deem to be essential to the functionality of the proposed solution; these items must be captured in the Vendor s pricing volume with a quantity of zero. Proposers must complete the highlighted section below and identify where your supporting documentation is located. Table 2 Salient Characteristics SC # SALIENT CHARACTERISTICS METHOD OF EVALUATION APPLICABLE CLINS VENDOR S PROVIDE PAGE # WHERE EACH SC IS MET IN YOUR TECHNICAL LITERATURE SC 1 Automatic, semiautomatic or manual modes of operation Literature Review 0001 SC 2 Multiple triggering modes Literature Review 0001 SC 3 Event/History Log capable Literature Review 0001 SC 4 Maximum Pump Rate of 200 bpm Literature Review 0001 SC 5 Auto condensation removal capable Literature Review 0001 SC 6 Display with parameters (e.g., ECG, heart rate, arterial pressure) Literature Review 0001 SC 7 QRS Indicator Literature Review 0001 The following attachments are incorporated by reference. All criteria outlined in the attachments are applicable to this combined synopsis/solicitation.