6515--NX EQ Infusion Pumps Multitherapy Ambulatory

Amendment to Combined Synopsis-Solicitation

36C10G25Q0081 0003

The purpose of this amendment is to correct an error posted on Amendment 0002.

The solicitation remains as SDVOSB Set-Aside from originally posted.

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Amendment to Combined Synopsis-Solicitation

36C10G25Q0081 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 Wednesday, 06/18/2025 at 11:59 PM ET.

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Amendment to Combined Synopsis-Solicitation

36C10G25Q0081 0001

The purpose of this amendment is providing questions and answers to the RFQ.

FDA Recalls and Safety History Consideration

- In alignment with the VHA National Center for Patient Safety (NCPS) goals to promote patient safety, will the VA conduct or require an analysis of FDA recall data, safety alerts, MAUDE database adverse events, and historical safety performance for all proposed infusion pump models and manufacturers during the evaluation process?

Answer to question a: SC#1 Must be FDA approved.

Pre-Award Recall Screening Procedures

Regarding the Combined Synopsis/Solicitation notice (page 11), how does the VA currently incorporate active recalls, pending investigations, or historical manufacturer safety issues (e.g., high recall frequency) into the technical evaluation or source selection process?

Answer to question b: Active recall or pending investigation items should not be submitted for competition.

Weight of Safety Record in Source Selection Criteria

Will the infusion pump s historical safety performance and regulatory track record (including FDA Warning Letters or safety alerts) be a weighted factor in the award decision? If so, can the VA clarify the evaluation methodology or point assignment for this area?

Answer to question c: FDA Warning can be evaluated for past performance.

Request for Onsite Demonstration or Virtual Demonstration

To better understand how brand name or equal products meet or exceed the Salient Characteristics (SCs), would the VA consider an onsite or virtual demonstration, usability test, or comparative evaluation by clinical and biomedical stakeholders?

Answer to question d: No on site or virtual demonstration for this RFQ.

Opportunity to Submit Supplementary Product Information

Can offerors provide supplementary documentation beyond descriptive literature (e.g., white papers, safety risk assessments, product training videos) to illustrate unique safety features, error-reduction technology, or clinical usability enhancements?

Answer to question e: yes, it is encouraged.

Fielding and Training Proposal

Should offerors provide a proposal for fielding the pumps and training users?

If so, please provide estimates for how many facilities will be fielded per year

Answer to question f.a.: yes fielding & training must be coordinated with the ordering facility as appropriate.

Please clarify if the quantity per year for each CLIN in the Price+Cost+ Schedule is for each facility or the entire VA?

Answer to question f.b.: entire VA.

Can the VA also clarify how a proposed fielding and training plan will be evaluated?

Answer to question f.c.: will not be evaluated. However, fielding & training must be coordinated with the ordering facility as appropriate.

Instructions to Quoters

D.6 ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO QUOTERS COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES ITEMS (SEP

2023), A.1. 2nd paragraph states The quote shall consist of the five (5) volumes listed below.

The Volumes listed are:

Volume I: Technical

Volume II: Past Performance

Volume III: Price

Volume IV: Offer, Amendments, and Certifications & Representations

- Please confirm there are in fact only four (4) volumes required to submitted.

Answer to question g.a.: Quotes submitted in response to this solicitation shall contain four (4) separate volumes listed in the Table below with the titles as shown.

VOLUME NUMBER

FACTOR

FILE NAME

Volume I

Technical

Your Company Name - Tech.pdf

Volume II

Past Performance

Your Company Name Performance.pdf

Volume III

Price

Your Company Name - VetPref.pdf

Volume IV

Offer, Amendments, and Certifications & Representations

Your Company Name Price.xls

Page 10, VOLUME II PAST PERFORMANCE:

The opening paragraph states: The Offeror shall complete Attachment G: Past Performance Reference in its entirety, listing a total of three contracts/orders for work performed in the past three years or currently being performed, for nationwide delivery of Washer Decontamination Units.

Please confirm that Past Performance References should be for nationwide delivery of Infusion Pumps Multitherapy Ambulatory.

Answer to question g.b.: Past Performance References should be for nationwide delivery of Infusion Pumps Multitherapy Ambulatory. Corrected Attachment D Section D.6 VOLUME II- Past Performance, see below image.

Attachment A Price Cost Schedule

In Attachment A Line 2-6 for CADD Solis and VIP pumps, are the quantities listed per facility or total nationwide?

Answer to question h.: total nationwide/entire VA.

Delivery and Training Timeline

What are the expectations/timeframe for pump delivery, rollout, and training?

Answer to question i.: this is as needed per ordering facility.

Can we get a list of tubing cassettes utilized by part number for planning purposes?

Answer to question j: Vendors are encouraged to provide any product solution or configuration so long as they meet the SCs.

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Combined Synopsis/Solicitation Notice

Combined Synopsis/Solicitation Notice

Page 7 of 7

Combined Synopsis/Solicitation Notice

*= Required Field

Combined Synopsis/Solicitation Notice

Page 1 of 6

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:

Contract Line Items

Manufacture

Part Number

Description

0001

ICU Medical

21-2111-0402-51

CADD-Solis Ambulatory Infusion (Grey)

0002

ICU Medical

21-2112-0402-51

CADD-Solis Ambulatory Infusion (Yellow)

0003

ICU Medical

21-2120-0105-01

CADD-Solis VIP 2120 ambulatory infusion pump, PharmGuard enabled

(blue label)

0004

ICU Medical

21-2125-0105-01

CADD-Solis VIP Pump with Factory Library (Select Protocols)

(green label)

0005

ICU Medical

21-2127-0105-01

CADD-Solis VIP 2120 ambulatory infusion pump, Manual Mode (Standard Settings)

(black label)

0006

ICU Medical

21-2194-0403-25

CADD-Solis Medication Safety S

0007

ICU Medical

21-2135-25

Polemount Adapter CADD-Solis

0008

ICU Medical

21-6120-24

Polemount Bracket Lockable CADD

0009

ICU Medical

21-6118-24

Polemount Bracket Non-Lockable CADD

0010

ICU Medical

21-2160-51

CADD Solis Battery

Pack, Rechargeable

0011

ICU Medical

21-2131-01

CADD-Solis Wireless Communication Module for use with CADD-Solis v4 pumps US

0012

ICU Medical

21-0270-25

AC Adapter - Wallmount For use with CADD-Solis pumps

0013

ICU Medical

21-2186-25

Remote Dose Cord (CADD-Solis pump)

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:

SC #

SALIENT CHARACTERISTICS

METHOD OF EVALUATION

PAGE # WHERE SC IS FOUND IN TECHNICAL LITERATURE

SC 1

U.S. FDA clearance

Literature Review

SC 2

Unit able to be mounted to pole

Literature Review

SC 3

Capable of infusion mode: patient-controlled analgesia (PCA)

Literature Review

SC 4

Total Weight including batteries less than or equal to 0.6 kg

Literature Review

SC 5

Has audio volume control for audio alarms

Literature Review

The following SCs apply to CLINs 0006-0013:

SC #

SALIENT CHARACTERISTICS

METHOD OF EVALUATION

PAGE # WHERE SC IS FOUND IN TECHNICAL LITERATURE

SC 6

Must be compatible with CLINs 0001-0005

Literature Review

The following SCs apply to CLINs 0001-0013:

SC #

SALIENT CHARACTERISTICS

METHOD OF EVALUATION

PAGE # WHERE SC IS FOUND IN TECHNICAL LITERATURE

SC 7

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

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.