36C10G25Q0081_1.docx

Combined Synopsis/Solicitation Notice

GENERAL INFORMATION

OPAL | Strategic Acquisition Center

10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697

POINT OF CONTACT*

Contracting Officer Kimberly LeMieux Kimberly.LeMieux@va.gov

PLACE OF PERFORMANCE

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

DESCRIPTION

Combined Synopsis/Solicitation Notice

Solicitation Number: 36C10G25Q0081 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 36C10G25Q0081 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 ICU Medical ® brand name or equal Infusion Pumps Multitherapy Ambulatory to deliver patient care at its VA Medical Centers around the country.

The ICU Medical ® Infusion Pumps Multitherapy Ambulatory or equal deliver parenteral agents from syringes or collapsible bags and are small enough to be worn or carried by patients. They are used to deliver intravenous (IV), epidural, and, occasionally, arterial infusions. Solutions may be infused continuously (e.g., chemotherapy, total parenteral nutrition, human growth hormone) or intermittently (e.g., antibiotics). Solutions and their applications include (but not limited to) drugs for blood and cardiac therapy and solutions for wound site pain management. Patients who require infusion therapy can often be treated both in the hospital or at home with an ambulatory pump.

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 339112 - Surgical and Medical Instrument 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 Service-Disabled Veteran-Owned Small Business (SDVOSB) set-aside.

This acquisition is for FAR Part 16.5 for ICU Medical ® brand name or equal Infusion Pumps Multitherapy Ambulatory as identified in ATTACHMENT A - PRICE COST SCHEDULE - NX EQ Infusion Pumps Multitherapy Ambulatory 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 Infusion Pumps Multitherapy Ambulatory.

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.

Quoter is to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications -- Commercial Items, with their quote.

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 June 09, 2025, by 11:59 PM EST, to the Contracting Officer, Kimberly LeMieux at Kimberly.LeMieux@va.gov. No calls will be accepted.

Quotes are due via email no later than June 16, 2025, by 11:59 PM EST to the Contracting Officer Kimberly LeMieux at Kimberly.LeMieux@va.gov.

1. SCOPE OF WORK:

The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified the ICU Medical ® brand name or equal Infusion Pumps Multitherapy Ambulatory product line as a candidate for a VA-wide (otherwise referred to as “national”) single Requirements contract award.

ICU Medical ® brand name or equal Infusion Pumps Multitherapy Ambulatory are designed to deliver parenteral agents from syringes or collapsible bags and are small enough to be worn or carried by patients. They are used to deliver intravenous (IV), epidural, and, occasionally, arterial infusions. Solutions may be infused continuously (e.g., chemotherapy, total parenteral nutrition, human growth hormone) or intermittently (e.g., antibiotics). Solutions and their applications include (but not limited to) drugs for blood and cardiac therapy and solutions for wound site pain management. Patients who require infusion therapy can often be treated both in the hospital or at home with an ambulatory pump.

The Contractor must demonstrate the ability to meet all requirements for the solicitation. The objective is to provide Infusion Pumps Multitherapy Ambulatory 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 ICU Medical ® brand name Infusion Pumps Multitherapy Ambulatory. For each equal product, the quoter 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 Contract Line Items are being considered:

(blue label)

(green label)

(black label)

Pack, Rechargeable

The Department of Veterans Affairs (VA) is seeking vendors who can provide ICU Medical ® brand name or equal Infusion Pumps Multitherapy Ambulatory as listed above which meet all the below salient characteristics. Vendors may quote any product solution or configuration so long as they meet the salient characteristics.

The following SCs apply to CLINs 0001-0005:

The following SCs apply to CLINs 0006-0013:

The following SCs apply to CLINs 0001-0013:

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 ICU Medical ® brand name or equal Infusion Pumps Multitherapy Ambulatory 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 EQ Infusion Pumps Multitherapy Ambulatory.

See attached document: ATTACHMENT B - CONTRACT ADMINISTRATION -NX EQ Infusion Pumps Multitherapy Ambulatory.

See attached document: ATTACHMENT C - CONTRACT CLAUSES - NX EQ Infusion Pumps Multitherapy Ambulatory.

See attached document: ATTACHMENT D - SOLICITATION PROVISIONS - NX EQ Infusion Pumps Multitherapy Ambulatory.

See attached document: ATTACHMENT E - REPORTING TOOL NX EQ Infusion Pumps Multitherapy Ambulatory.

See attached document: ATTACHMENT F - PAST PERFORMANCE REFERENCE - NX EQ Infusion Pumps Multitherapy Ambulatory.

See attached document: ATTACHMENT G - PAST PERFORMANCE QUESTIONAIRE - NX EQ Infusion Pumps Multitherapy Ambulatory.

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Combined Synopsis/Solicitation Notice