NoticeofIntenttoSoleSource-NI_HemoDynamicPump.pdf

36C24920Q0313

NOTICE OF INTENT TO SOLE SOURCE

EV1000 NI_HEMODYNAMIC SYSTEM

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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 eCMS knowledge base FY20.09C 06/18/2020, Federal Acquisition Circular (FAC) 2020-

06 06/05/2020. The NAICS code is 339112 with a size standard of 1000 employees.

BACKGROUND: This is an add-on to existing Noninvasive (NI) Blood Pressure Measurement

(BPMS) Systems used at Memphis VA Medical Center. Memphis’s standard NI BPMS is the EV1000

Clinical platform from Edwards Lifesciences.

In order to conform to the VA's standardization directive and ensure excess costs from duplication and delays are mitigated, the requested source is the only one with the capability to suffice the needs of the government.

Standardizing equipment allows better equipment management and lessens risk to patient and staff safety for compliance with single Manufacturer Instructions For Use (IFU)s and cleaning procedures.

The Department of Veterans Affairs (VA) NCO-9, intends to issue a sole source firm-fixed priced contract to Edwards Lifesciences for the procurement of the following requirement description to

Memphis VA Medical Center [Facility].

DESCRIPTION OF REQUIREMENT:

QTY: 4, HEMODYNAMIC MONITOR SYSTEM EV 1000 CLEARSIGHT PUMP KIT

QTY: 4, EV1000 CLINICAL PLATFORM NI KIT

QTY: 4, EV1000 FLOTRAC CABLE 16 FT

QTY: 4, PRESSURE CONTROLLER COVER

QTY: 4, ROLL STAND

Option for Additional Quantities:

None sought.

Service Requirement:

QTY:1, 24-MO, SERVICE AGREEMENT WITH PREVENTIVE MAINTENANCE

Salient Characteristics:

1. Must meet FDA 510k PMN standards:

o Regulation Number: 21 CFR 870.1130 o Regulation Name: Noninvasive Blood Pressure Measurement System o Regulatory Class: Class II o Product Code: DXN, DSB, DXG

2. Given brand name make and model required

The estimated cost for these commercial products is expected to be below the Simplified Acquisition

Threshold, currently at $250,000.00.

SCOPE OF WORK: The Facility seeks to establish this PO/contract before September 30, 2020.

Interested parties should submit responses by Monday, July 27, 2020 at 8:00am EST to:

sascha.hertslet@va.gov, subject line: 36C24920Q0313-EV1000.

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

36C24920Q0313

NOTICE OF INTENT TO SOLE SOURCE

EV1000 NI_HEMODYNAMIC SYSTEM

2 | P a g e

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.