Desription for Intent to Sole Source 36C26323Q0953- Hemosphere Adv Monitoring Sys.pdf

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6515--INTENT TO SOLE SOURCE to 1st American Medical Distributors, LLC. , for Continuous Cardiac Output Monitors - Hemosphere Advanced Monitoring Systems
Solicitation number
36C26323Q0953
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This notice is an intent to sole source a contract to 1st American Medical Distributors, LLC for the acquisition of two Hemosphere Advanced Monitoring Systems by Edwards Lifesciences. The Department of Veterans Affairs requires these continuous cardiac output units, which can perform multiple critical hemodynamic and tissue monitoring functions in a single device, for use in cardiac-thoracic surgeries and postoperative intensive care. Interested parties were requested to provide company and product information by August 11th if seeking consideration to fulfill the requirement, though the notice indicates the Government's intent to award directly to the named SDVOSB distributor. The specialized physiological monitors must include proprietary arterial-based cardiac output monitoring technology trademarked as "Acumen" to predict hypotensive events.

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INTENT TO SOLE SOURCE - 36C26323Q0953

Department of Veterans Affairs intends to issue a Firm-Fixed Price contract to a single source, 1st

American Medical Distributors, LLC., a verified SDVOSB, for Advanced Cardiac Output Monitors /

Hemosphere Advanced Monitoring System. This procurement is authorized by FAR 13.106-1 and is in accordance with VAAR 819.7007 which allows sole-source awards to a verified service-disabled veteran-owned small business (SDVOSB) under 38 USC §8127(c) where contracts awarded using this authority shall be supported by a written justification and approval described in FAR 6.303 and 6.304, as applicable. The NAICS code is 334510 and the Non-Manufacturing Rule does not apply as there is a class waiver for code 334510. The PSC code is 6515.

This notice of intent is not a request for competitive quotations. However, all responsible sources may submit a capability statement, which shall be considered by the Government. The Government will consider responses received by the closing date of this notice. Information received will be considered solely for the purpose of determining whether or not to conduct a full and open competitive procurement or a small business set aside competitive procurement. The Government will not pay for any information received in response to this announcement.

If the Government decides to compete this requirement, a synopsis shall be issued utilizing the combined synopsis/solicitation procedure identified in FAR 12.603.

A determination not to compete this requirement based upon responses to this notice is solely within the discretion of the Government.

POTENTIAL SOURCES SHALL PROVIDE THE FOLLOWING INFORMATION IN THEIR RESPONSE:

1. Company name, address, primary contact(s), e-mail address & phone number.

2. A letter from the OEM confirming your firm is an authorized distributor.

3. SAM UEI number.

4. State if your firm is a large business, small business, service-disabled-veteran-owned small business, veteran-owned small business, HUB zone 8(a), women-owned small business or a small disadvantaged business

5. State if your firm has required items on Schedule (FSS, GSA, SEWP, other…).

6. If your firm is a Socio-economic small business (WOSB, VOSB, SDVOSB…) and is not on a Schedule, state if your firm is a Non-Manufacturer under the Non- Manufacturing Rule. Information regarding the Non- Manufacturer Rule can be found at these links:

a. Nonmanufacturer rule | U.S. Small Business Administration (sba.gov)

-OR-

https://www.sba.gov/partners/contracting-officials/small-business-procurement/nonmanufacturer-le#:~:text=What%20is%20the%20nonmanufacturer%20rule,if%20it%20is%20a%20nonmanufacturer https://www.sba.gov/partners/contracting-officials/small-business-procurement/nonmanufacturer-rule#:~:text=What%20is%20the%20nonmanufacturer%20rule,if%20it%20is%20a%20nonmanufacturer https://www.sba.gov/partners/contracting-officials/small-business-procurement/nonmanufacturer-le#:~:text=What%20is%20the%20nonmanufacturer%20rule,if%20it%20is%20a%20nonmanufacturer https://www.sba.gov/partners/contracting-officials/small-business-procurement/nonmanufacturer-le#:~:text=What%20is%20the%20nonmanufacturer%20rule,if%20it%20is%20a%20nonmanufacturer

How to Respond:

All responses must have the VA Identifier: 36C26323Q0953 in the subject line of the email.

All responses must be received no later than: 04:00 pm CST, Friday August 11, 2023.

All responses must be submitted to this email address: Joseph.Bennett@va.gov

Nature and/or Description of the Requirement:

The requirement is for 2 Continuous Cardiac Output (CCO) units – Hemosphere Advanced Monitoring Systems by Edwards Lifesciences sold by their authorized distributor 1st American Medical Distributors, LLC., a verified SDVOSB.

These specialty physiological monitoring systems are used during cardiac-thoracic surgery procedures and in post-Op ICU recovery. The advanced hemodynamic monitoring features provide additional and unique critical parameters not available on traditional physiological monitoring systems.

The unique character of the required equipment is that the required advanced cardiac output monitoring units can perform the following multiple functions in one unit:

-Continuous Hemodynamic non-invasive monitoring (the monitoring of tissue perfusion) that provides continuous blood pressure data and advanced hemodynamic parameters.

-Precise tissue oximetry monitoring, cerebral and somatic, with site specific algorithms.

-Arterial based cardiac output monitoring with the technology to predict hypotensive events.

-Continuous assessment of flow, pressure, oxygen delivery and consumption via an inter-arterial catheter.

Purchasing these brand name units pre-empts the need to purchase multiple separate units of different brands to obtain all of the required functions.

Additionally, the Government requires the arterial based cardiac output monitoring with technology to predict hypotensive events trademarked as “Acumen” which is proprietary and a brand name of Edwards Lifesciences.

Description of Supplies/Services Required to Meet the Agency’s Needs:

*** End *** mailto:Joseph.Bennett@va.gov

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