36C26124Q0821.docx

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6515--NEW | AC3 OPTIMUS INTRA-AORTIC BALLON PUMP
Solicitation number
36C26124Q0821
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This document is a Sources Sought notice from the Department of Veterans Affairs (VA) regarding the AC3 Optimus Intra-Aortic Balloon Pump. The VA is performing market research to determine if vendors can meet the requirements and specifications outlined in the attached Statement of Work. This is not a solicitation at this time. The NAICS code is 334510 with a small business size standard of 1,250 employees.

The VA is seeking information from interested and capable vendors, regardless of business size, including their company name, point of contact, DUNS number, socioeconomic status, capability statements, estimated price, and an authorized distributor letter from the manufacturer. Responses are due by 10:00 AM Hawaii Standard Time on July 16, 2024. The VA will not respond to questions at this time. As this is a service acquisition, the Limitations on Subcontracting requirement applies. The VA reserves the right to cancel this requirement at its discretion.

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Brand Name or Equal Worksheet (“Salient Characteristics”)

SUBJECT*
NEW | AC3 OPTIMUS INTRA-AORTIC BALLON PUMP

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE*
96813
SOLICITATION NUMBER*
36C26124Q0821
RESPONSE DATE/TIME/ZONE
07-16-2024 10:00 AM HONOLULU, HAWAII, USA
ARCHIVE
15 DAYS AFTER THE RESPONSE DATE
RECOVERY ACT FUNDS
N

SET-ASIDE

PRODUCT SERVICE CODE*
6515
NAICS CODE*
334510
CONTRACTING OFFICE ADDRESS
Department of Veterans Affairs

Network Contracting Office(NCO21) VA Pacific Islands Health Care System 711 Kapiolani Blvd Suite 200 Honolulu HI 96813

POINT OF CONTACT*

Haunani Freeman(AKA Darralynn) darralynn.freeman@va.gov Darralynn.Freeman@va.gov 808-539-1311

PLACE OF PERFORMANCE

ADDRESS
VA Central California Healthcare System

2615 E Clinton Ave

Fresno, CA 93703-223

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

AGENCY’S URL
http://www.va.gov/
URL DESCRIPTION
Department of Veteran Affairs

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

This is a Sources Sought only. The Department of Veterans Affairs (VA) is performing market research to determine if there are any vendors, regardless of business size, that can outline the requirements and specifications for the AC3 Optimus Intra-Aortic Ballon Pump. (See attached SOW).

There is no solicitation document as this time. The NAICS is 334510 with Small Business size of 1250 employees. NOTE: Please ensure that System for Award Management (SAM) (www.sam.gov) indicates this NAICS code if you are interested in the requirement.

Only firms interested and capable should send their information and/or capability statement and any questions by email to darralynn.freeman@va.gov no later than 10:00 AM Hawaii Standard Time, Tuesday, July 16, 2024. Questions will not be responded to at this time.

If interested, please provide the following information:

· Name of Company

· Point of Contact Name, phone number, and email address

· DUNS number

· Socio-economic status such as Service-Disabled Veteran Owned Small Business, VOSB, Women-Owned Small Business, etc. should be included. SDVOSB/VOSB status will be verified using VetBiz.

· Capability statements

· Estimated Price

· Authorized Distributor Letter from Manufacture

Before responding please carefully read and consider the following:

As this is a service acquisition, the Small Business Administration and the Federal Acquisition Regulation have a Limitations on Subcontracting requirement. For all small businesses, to include SDVOSB and VOSB, “At least 50 percent of the cost of contract performance incurred for personnel shall be expended for employees of the concern.” See FAR 52.219-14 and FAR 52.219-27 available in full text at https://www.acquisition.gov/far/html/52_217_221.html Please see the Statement of Work attached for further details.

DISCLAIMER

This Sources Sought notice is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this request that is marked proprietary will be handled accordingly. The Government will not compensate an offeror for providing information in response to this sources sought. Furthermore, the Government reserves the right to cancel this requirement at its discretion. This is simply a sources sought notice.

Sources Sought Notice Sources Sought Notice

*= Required Field
Sources Sought Notice

Sources Sought Notice

AC3 Optimus Intra-Aortic Balloon Pump The AC3 Optimus Intra-Aortic Pump provides intra-beat inflation timing to address cardiogenic shock conditions in Catheterization laboratory procedures. This is achieved by inserting a balloon into the circulatory system and with the use of the AC3 Optimus Intra-Aortic Balloon Pump, the device can increase the volume of blood while decreasing blood pressure in the body. This device is lifesaving for someone in cardiogenic shock by providing accurate inflation and deflation allowing optimized aortic flow and blood pressure.

Brand Name Item: AC3 OPTIMUS INTRA-AORTIC BALLON PUMP Essential/significant physical, functional, or performance characteristics.

· Device must be able to rescue patients in the event of cardiogenic shock

· Device must include a color, high-definition touch screen

· Device must offer a 360 ° viewable indicator denoting the pump is alarming and the priority level

· Device must show heart rate with assisted hemodynamic, unassisted hemodynamic and balloon pressure values and waveforms

· Device must offer a horizontal FOS port

· Device must include no scheduled replacement parts

· Device must offer balloon volume adjustments by at least 0.5 cc increments

· Device must offer a pumping volume range of at least 0.5cc to 50cc

· Device must make end-users confirm routine checks have been completed

· Device must offer therapy status reports

· Device must be able to store alarm history and offer reports

· Device must be able to support patients with severe arrhythmias and heart rates as high as 200 bpm

· Device must offer a Counterpulsation rate range of at least 40 to 200 pulsations/min

· Device must be able to continuously analyze up to 6 ECG sources

· Device must offer feature that allows the unit to auto and manually update inflation and deflation timing, and triggering parameters

· Device Inflation Timing Methods must include Aortic flow, Predictive, and Weissler

· Device Deflation Timing Methods must include R-Wave, Predictive, and Weissler

· Device must offer operations statuses including, but not limited to Operational mode, trigger mode, AP zero status, AP alarm/battery charge status, balloon volume, battery charge icon and status, zeros status icon

· Device must include diagnostic alarm/help messages

· Device must include handle and wheels for easy mobility

· Device must offer a lockable the touch screen

· Device screen must have a visual indicator of battery power level

· Device screen must include a visual indicator of Helium tank level

· Device must operate using a standard 120V outlet

· Device must offer patient hemodynamics including, but not limited to: Heart rate, AP-systolic, augmented, diastolic, and mean arterial

· Device must be able to freeze at least 5 seconds of patient data on the screen

· Device must include time display

· Device must include a cursor to measure waveforms

· Device must include condensation removal

· Device Operator mode must allow user control of most pump functions

· Device recorder must include Selectable recording length and adjustable automatic print times, ECG, AP, or balloon pressure waveforms, and Alphanumeric data

a)Compatibility – N/A
b)Industry Standard – yes
c)Purpose – An intra-aortic balloon pump (IABP) is a therapeutic device used during Cath Lab procedures to help the patient’s heart pump more blood throughout the body.
d)Governing Body or Organization – Veterans Health Administration

1) Complete generic identification – Intra-Aortic Balloon Pump

2) Applicable model/make/catalog number – AC3 Optimus

3) Manufacturer name – Arrow

Per VAAR 811.104 and 811.105, I certify the following regarding the above information:

· The salient characteristics listed above are essential to the Government’s requirements.

· To my knowledge, the restrictions listed above will not limit the acquisition to an item peculiar to one manufacture.

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