NoticeofIntenttoSoleSource-CVi_ContrastInjector.pdf

36C24920Q0279

NOTICE OF INTENT TO SOLE SOURCE

ACIST CVi CONTRAST DELIVERY SYSTEM

1 | P a g e

This procurement is being conducted in accordance with (IAW) 41 USC 3304(a)(1) and FAR 13.106-1(b), Soliciting from a Single Source; therefore, the requirements of FAR Part 6, Competitive Requirements, are not applicable. The resultant award will include all applicable provisions and clauses in effect through the

Federal Acquisition Circular (FAC) 2020-06 (eff. 05/06/20). The NAICS code is 339112 with a size standard of 1000 employees.

The Department of Veterans Affairs (VA) NCO-9, intends to issue a sole source firm-fixed priced contract/purchase order for the procurement of the following description to Memphis VA Medical Center

(Facility), Memphis, TN.

BACKGROUND: This is a new requirement. Facility is currently modifying their MedRad injectors to operate outside of their normal operating ranges when using microcatheters to perform embolization procedures. This process results in multiple failures that lead to longer than necessary procedure times, and excessive waste of contrast medium solutions at greater risk to patient comfort and health.

DESCRIPTION OF REQUIREMENT: Facility’s market research identified the Acist CVI Standard

Contrast Delivery Injector System as the only device to properly support embolization procedures for

Interventional Cardiology and Interventional Radiology Do procedures twice a week.

Salient Characteristics:

• Compatible with:

o Terumo Medical Microcatheters o Siemens Artis Zee Imaging System

• Air detection feature that automatically stops contrast injection process to prevent harm to patient

• System must be able to inject contrast at variable and fixed rates.

• System must have contrast injection pressure upper limit capable of 1200 psi (pounds per square inch)

• System must have contrast volume range upper limit capable of 80ml minimum with adjustable increments

• Meet FDA 510k Pre-market Notification standards o Regulation Number: 21 CFR 870.1650 o Regulation Name: Angiographic Injector And Syringe o Regulatory Class: Class II o Product Code: DXT

Deployment (Installation & Integration)

Not required.

The total estimated cost is expected to be below the Simplified Acquisition Threshold, currently at

$250,000.00.

SCOPE OF WORK: The Facility seeks to procure this product before September 30, 2020. No options for additional quantities or extension of terms of service were considered.

Interested parties should submit responses by Monday, July 7, 2020 at 12:00pm Eastern Standard Time

(EST) to: sascha.hertslet@va.gov, subject line: 36C24920Q0279-CVi_Contrast_Injector.

All responsible sources may submit a bid, proposal, or quotation, which shall be considered by the agency, if it shows they can offer comparable products that meet or exceed the standards described above.

mailto:sascha.hertslet@va.gov

36C24920Q0279

NOTICE OF INTENT TO SOLE SOURCE

ACIST CVi CONTRAST DELIVERY SYSTEM

2 | P a g e

Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point

(Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number

(TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

Any respondent who claims to be a nonmanufacturer must meet the SBA’s definition of a nonmanufacturer IAW 13 CFR 121.406- https://www.sba.gov/partners/contracting-officials/small-business-procurement/non-manufacturer-rule All nonmanufacturer respondents must state how they take possession or ownership with their personnel, facility, or equipment for the product they offer. They also must include an authorized distributor letter/memo from the manufacturer.

Responses received will be reviewed; however, a determination by the Government not to compete the proposed procurement based upon responses received to this notice is solely within the discretion of the

Government.

http://www.sam.gov/ https://www.sba.gov/partners/contracting-officials/small-business-procurement/non-manufacturer-rule https://www.sba.gov/partners/contracting-officials/small-business-procurement/non-manufacturer-rule