6515--NX EQ Extracorporeal Perfusion Pumps

Amendment to Combined Synopsis-Solicitation

36C10G25Q0056 0002

The purpose of this amendment is to:

Extend the Due Date for the solicitation.

The Due Date of the Combined Synopsis-Solicitation is extended to Thursday, 06/26/2025 at 11:59 PM ET.

Dissolve Set-Aside. This requirement will be solicited as Full and Open.

Correct Attachment D Section D.6 VOLUME II- Past Performance:

All other terms and conditions of the solicitation remain unchanged.

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Amendment to Combined Synopsis-Solicitation

36C10G25Q0056 0001

The purpose of this amendment is to:

Extend the Due Date for the solicitation.

The Due Date of the Combined Synopsis-Solicitation is extended to Tuesday, 06/03/2025 at 11:59 PM ET.

Add VAAR Clause 852.222-71 COMPLIANCE WITH EXECUTIVE ORDER 13899. (DEVIATION) (APR 2025)

All other terms and conditions of the solicitation remain unchanged.

SECTION C - CONTRACT CLAUSES

C.14 852.222-71 COMPLIANCE WITH EXECUTIVE ORDER 13899. (DEVIATION) (APR 2025)

As prescribed in 822.810(h), insert the following clause:

Compliance with Executive Order 13899. (DEVIATION) (APR 2025)

(a)The contractor shall comply with Executive Order 13899, Combating Anti-Semitism, pursuant to Title VI of the Civil Rights Act of 1964 (Title VI), 42 U.S.C. 2000d et seq.

(b)The contractor shall timely disclose, in writing, to the Contracting Officer, whenever, in connection with the award, performance, or closeout of this contract or any subcontract thereunder, the Contractor has credible evidence that a principal, employee, agent, or subcontractor of the Contractor has committed a violation under Executive Order 13899, Combatting Anti-Semitism pursuant to the Civil Rights Act of 1964 (Title VI), 42 U.S.C. 2000d et seq.

(c)The contractor shall include the terms and conditions of this clause in every subcontract or purchase order so that these terms will be binding on every subcontractor or vendor. (End of clause)

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Combined Synopsis/Solicitation Notice

Combined Synopsis/Solicitation Notice

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DESCRIPTION

Combined Synopsis/Solicitation Notice

Combined Synopsis/Solicitation Notice

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Solicitation Number: 36C10G25Q0056

Notice Type: Combined Synopsis/Solicitation

Synopsis: COMBINED SYNOPSIS/SOLICITATION

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 separate written solicitation will not be issued.

Solicitation number 36C10G25Q0056 is issued for this combined synopsis/solicitation; this solicitation is being issued as a Request for Quote (RFQ). This combined synopsis/solicitation incorporates provisions and clauses in effect through Federal Acquisition Circular (FAC) 2025-03, dated January 17, 2025.

Requirement Description:

The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has a requirement to purchase Terumo® Extracorporeal Perfusion Pumps or equal to deliver patient care at its VA Medical Centers around the country.

The Terumo® Extracorporeal Perfusion Pumps or equal are designed for extracorporeal gas exchange and reinfusion of blood, typically during heart-lung bypass procedures. These pumps (known as extracorporeal perfusion or arterial pumps) consist of either a mechanism that uses centrifugal force (i.e., centrifugal pump) or rollers that cyclically compress the arterial line tubing (i.e., roller pumps). Extracorporeal Perfusion Pumps typically receive blood from the vena cava and deliver it back through the aorta by means of a plastic cannula after processing the blood in an oxygenator/heat exchanger, bypassing the heart and lungs completely. Both a backup arterial pump and connection to an emergency power system are necessary to ensure reliable pump operation.

A single award Requirements contract will be awarded IAW FAR 52.211-6 Brand Name or Equal in accordance with all terms, conditions, provisions, specifications, and schedule of this solicitation herein. Quotes shall contain the terms for cost/price and technical capabilities of the brand 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 334510 Electromedical and Electrotherapeutic Apparatus 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 a Small Business (SB) set-aside.

This acquisition is for FAR Part 16.5 for Terumo® Extracorporeal Perfusion Pumps as identified in ATTACHMENT A - PRICE COST SCHEDULE - NX EQ Extracorporeal Perfusion Pumps and paragraph 2 below. All interested companies shall provide a proposal for all Contract Line-Item Numbers (CLINs) listed in ATTACHMENT A - PRICE COST SCHEDULE - NX EQ Extracorporeal Perfusion Pumps.

The ordering period is for one 12-month base year with four 12-month option years. Delivery is FOB Destination. Firm-Fixed Price Orders will be placed against this contract in writing and will provide the delivery locations, delivery dates and exact quantities.

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.

The Offeror is to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications -- Commercial Items, with its offer.

Clause at 52.212-4, Contract Terms and Conditions -- Commercial Items, applies to this acquisition and a statement regarding any addenda to the clause. Addendum is attached.

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. Addendum is attached.

All interested quoters must be registered in the System for Award Management (SAM) prior to submitting a quote. You may access SAM at https://sam.gov/SAM/.

Questions regarding this combined synopsis/solicitation are due via email no later than May 09, 2025, by 11:59 PM EST, to Contract Specialist, Daleta Coles at Daleta.Coles@va.gov and Contracting Officer, Kimberly LeMieux at Kimberly.LeMieux@va.gov. No calls will be accepted.

Quotes are due via email no later than May 19, 2025, by 11:59 PM EST to Contract Specialist, Daleta Coles at Daleta.Coles@va.gov and Kimberly LeMieux at Kimberly.LeMieux@va.gov.

1. SCOPE OF WORK:

The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified the Extracorporeal Perfusion Pumps product line as a candidate for a VA-wide (otherwise referred to as national ) single Requirements contract award.

Terumo® Extracorporeal Perfusion Pumps or equal are designed for extracorporeal gas exchange and reinfusion of blood, typically during heart-lung bypass procedures. These pumps (known as extracorporeal perfusion or arterial pumps) consist of either a mechanism that uses centrifugal force (i.e., centrifugal pump) or rollers that cyclically compress the arterial line tubing (i.e., roller pumps). Extracorporeal Perfusion Pumps typically receive blood from the vena cava and deliver it back through the aorta by means of a plastic cannula after processing the blood in an oxygenator/heat exchanger, bypassing the heart and lungs completely. Both a backup arterial pump and connection to an emergency power system are necessary to ensure reliable pump operation.

The Contractor must demonstrate the ability to meet all requirements for the solicitation. The objective is to provide Extracorporeal Perfusion Pumps to be used by clinicians throughout the VA medical centers and facilities located in the Continental United States (CONUS) or Outside of the Continental United States (OCONUS). 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 quoter to indicate that each product being offered as an equal product to the Terumo Extracorporeal Perfusion Pumps or equal. 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 quoter must also clearly identify the item by brand name (if any) and make/model number. Finally, the quoter 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.

The following line items comprise the Extracorpreal Perfusion Pumps product line:

Contract Line Item#

Brand

Part Number

Description

0001

Terumo

816571

Roller Pump, 6" (15.2 cm) Diameter

0002

Terumo

816570

Roller Pump, 4" (10.2 cm) Diameter

0003

Terumo

801093

Pole Mount Pump Rest with Bracket

0004

Terumo

816477

Dual Pumps Pole Mount Bracket

0005

Terumo

816483

Descending Pole Mount Pump Bracket

0006

Terumo

164267

Drive Motor

0007

Terumo

816571

Control Unit

0008

Terumo

164268

Manual Drive

0009

Terumo

804372

Pole Mount Centrifugal Display Bracket

0010

Terumo

816620

Flexible Mounting Arm

The Department of Veterans Affairs (VA) is seeking vendors who can provide Terumo® Extracorporeal Perfusion Pumps 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.

CLIN 0001 applies to SC 1

CLIN 0002 applies to SC 2

CLINs 0001-0002 applies to SC 3, SC 8, and SC9

CLINs 0003-0006 applies to SC 6

CLINs 0006-0007 applies to SC 5, SC 8, and SC9

CLIN 0008 applies to SC 4

CLINs 0009-0010 applies to SC 7

SC #

SALIENT CHARACTERISTICS

METHOD OF EVALUATION

PAGE # WHERE SC IS FOUND IN TECHNICAL LITERATURE

SC 1

Roller pump with 6-inch head diameter capable of a flow rate of 0-10 L/min

Literature Review

SC 2

Roller pump with 4-inch head diameter capable of a flow rate of 0-4 L/min

Literature Review

SC 3

Capable of pulsatile flow

Literature Review

SC4

Hand crank option for emergency operation

Literature Review

SC 5

Centrifugal pump capability with adjustable RPMs

Literature Review

SC 6

Brackets/hardware for mounting roller pumps to a heart-lung bypass cart

Literature Review

SC 7

Brackets/hardware for mounting centrifugal pump and control unit to a heart-lung bypass cart

Literature Review

SC 8

FDA Approval

Literature Review

SC 9

Manufacturer Warranties - should outline any length and coverage of warranties/guarantees associated with their products, as these can provide assurance of quality and reliability to the government

Literature Review

In addition to meeting the Salient Characteristics the following sub factors will be evaluated:Â

Sub-factors

Safety

Safety features and functions of the offered equipment will be evaluated. Areas may include but are not limited to the following:

FDA Approval

Single-Directional Hand Crank for Roller Pumps

Sensors with applicable Visual and Audible Alerts, including Alarm Messages

Design

Design features and functions of the offered equipment will be evaluated. Areas may include but are not limited to the following:

Supports Customization/Modular Configuration for all Major Brands

Supports Pole Mounting and/or Mounting at the Base of the Heart-Lung Bypass System

Localized Control Settings (Directly on Pump) and/or via Heart-Lung Bypass System Control Center

Capable of Pulsatile Flow

Performance

Equipment will be evaluated for its ability to perform its intended function. Areas may include but are not limited to:

Flow Rates

Workflow Integration

Quality/Construction

Aspects of the construction and quality of material of the equipment will be evaluated and may include but not limited to:

Life Span/Warranty

Equipment Integration

Maintenance Requirements

Service Program

Training

For each product (brand name and part number), the response must include descriptive literature demonstrating the product meets or exceeds the SCs specified above.

The Government's intent is to include all ancillary items to ensure the equipment can function as designed by the Original Equipment Manufacturer and as clinically required. Vendors are encouraged to provide any product solution or configuration so long as they meet the SCs. Additionally, responses can include any additional product that may be beneficial. These items must be clearly identified by brand name and part number.

Vendors may propose any product solution or configuration so long as they meet the salient characteristics. Products proposed in the technical volume must be captured on the Vendor s pricing volume (ATTACHMENT A - Price Cost Schedule) of the solicitation. Vendors may propose 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.

SOFTWARE INSTALLATION AND UPDATES

The Contractor grants to VA non-exclusive, non-transferrable licenses to use the Terumo Extracorporeal Perfusion Pumps or equal and all associated accessories and software, including any documentation, for the systems intended purposes. At no additional cost, Customer will be entitled to Software updates when such updates are made generally available without cost to other licensees of the software. The Contractor shall coordinate the installation of any software upgrades with designated facility POC and Biomedical engineer.

MAINTENANCE, REPAIRS AND REPLACEMENT

Preventative Maintenance will be performed as prescribed by the manufacturer s specifications. Maintenance, repairs and replacement will be performed by authorized technicians and will be coordinated through the designated facility POC and Biomedical Engineer.

PRODUCT REFRESH

Product refresh is when a current CLIN is no longer being manufactured due to

obsolescence and the product item is being replaced with a newer, and more often, a

superior version of the same item. The current CLIN product will be revised to reflect the

refreshed product information, manufacturer s part number, IDIQ price (inclusive of

Service Level Agreement (SLA) fee), etc.

The Government reserves the right to not accept the products offered under

product refresh. The contractor will be notified in writing if a product refresh is not

accepted. All products offered shall be provided with the warranty that is agreed upon

for this contract.

The contractor agrees to ensure that all upgraded improved/replaced products

meet American with Disabilities Act (ADA) and Health Information Portability and

Accountability Act (HIPAA) Federal requirements.

The contractor shall provide the COR and CO the following information for product

refresh:

(1) A list of specific awarded item(s) being refreshed in the Price/Cost Schedule (to include commercial pricing, discount offered, and IDIQ price (inclusive of SLA fee)).

(2) Product literature for the item(s) refreshed.

(3) A detailed description of the differences or benefits of refreshed as compared to the item(s) being discontinued or added.

(4) Proper identification of any product requirements and/or procedures related to those product(s) proposed to be refreshed or upgraded.

(5) FDA approval, if applicable

(6) Provide historical sales to VA by item(s), if applicable

(7) Copy of Commercial Warranty.

The request shall be submitted to the COR, copy to the Contract Specialist and Contracting Officer, for review and recommendation of approval to be submitted to the CO. The CO shall prepare a bilateral modification for execution.

PRODUCT REMOVAL OR RECALL

For any product awarded under this contract removed or recalled by the manufacturer due to defects in the product or potential dangers to patients, or if any required removal or recall is suggested or mandated by a regulatory or official agency, the manufacturer agrees to take following steps immediately:

Notify the Contracting Officer (CO) at the Strategic Acquisition Center in writing, by the most expeditious manner possible.

Provide copies of the notification to CO, Contracting Specialist, Contracting Officer

Representative, and Manager at Product Recall Office, all Agencies and VA Facilities who purchased the product, which include, but not be limited to the following:

(1) Complete item description and/or identification, order numbers from

customers and the contract number assigned as a result of an issuance on

the solicitation;

(2) Reasons for modifications, removal or recall; and

(3) Necessary instructions for return for credit, replacement or corrective

action.

A copy of the notification will be provided to:

Manager, Product Recall Office

National Center for Patient Safety

Veterans Health Administration

24 Frank Lloyd Wright Drive, Lobby M

Ann Arbor, MI 48106

The following attachments are incorporated by reference. All criteria outlined in the attachments are applicable to this Combined Synopsis/Solicitation Notice.

See attached document: ATTACHMENT A - PRICE COST SCHEDULE - NX Extracorporeal Perfusion Pumps.

See attached document: ATTACHMENT B - CONTRACT ADMINISTRATION -NX EQ Extracorporeal Perfusion Pumps-25Mar Resolved.

See attached document: ATTACHMENT C - Contract Clauses Final 20250410.

See attached document: ATTACHMENT D - SOLICITATION PROVISIONS-NX EQ Extracorporeal Perfusion Pumps-04.10 Final.

See attached document: ATTACHMENT E - REPORTING TOOL - NX EQ EXTRACORPOREAL PERFUSION PUMPS.

See attached document: ATTACHMENT F - PAST PERFORMANCE REFERENCE - NX EQ Extracorporeal Perfusion Pumps.

See attached document: ATTACHMENT G - PAST PERFORMANCE QUESTIONAIRE - NX Extracorporeal Perfusion Pumps.