Attachment A - JA Final Redacted.pdf

Control Number:

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

JAN 2024

Memorandum for Record – Limiting Competition at or below the Simplified Acquisition

Threshold

1. Contracting Activity: The Contracting Office is the U.S. Army Medical Research Acquisition Activity (USAMRAA), 808 Schreider Street, Fort Detrick, MD 21702

2. Description of Action: Hemosphere Advance Patient Monitor with Swan-Ganz Module

Nature of Requirement

IZI New Requirement IZI Purchase Order

□ Blanket Purchase Agreement (BPA)

□ Order against BPA # Click or tap here to enter text.

□ Order against Multiple Award IDIQ Contract # Click or tap here to enter text.

□ Order against Single Award IDIQ Contract # Click or tap here to enter text.

□ Order against FSS Contract # Click or tap here to enter text.

□ Follow-on Requirement to Contract/Order # Click or tap here to enter text.

□ Modification against existing Contract/Order #Click or tap here to enter text.

Contract Type

IZI Fixed Price

□ Time & Materials/Labor Hours

□ Cost Reimbursable

□ Hybrid Click or tap here to enter text.

Funding

□ Operations & Maintenance (O&M) IZI Research, Development, Test & Evaluation (RDT&E)

□ Other - Click or tap here to enter text.

Fiscal Year: RDTE FY23, expires FY24 Controlled by: Defense Health Agency (DHA) Controlled by: USAMRAA CUI Category: Source Selection Limited Dissemination Control: FED ONLY POC: Daniil Pikus

Control Number:

Source Selection Information - See FAR 2.101 and 3.104-4

JAN 2024

USAMRICD has experience with the Edwards LifeScience product line and data configurations.

Additionally, this model system is an identical technical replacement for the legacy unit in use which is configured to meet our specific for the project milestones. It also interfaces with accessories previously purchases. Procurement of the Edwards Hemosphere will reduce costs by preventing the excess spending on alternate cables and accessories as well as additional government employee labor on training and reconfirmation of a new system.

To complete our milestones as dictated for scientific integrity, continuity, and preventing the need to re-validate or calibrate additional/new/alternate models at increased cost and milestone delay, USAMRICD must use only the Edwards Lifescience Hemosphere Monitor and Swan- Ganz module add-on to complete data collection. Change to a different hemodynamic monitor will cost the government additional to training the staff on the new equipment, added cost to purchase associated accessories and consumables for the unit, additional cost in animals to validate the monitor as part of the research model. Running additional animals and test experiments also will add man hours for the research staff. This added cost will be over $20,000 in supplies and animal costs, not including added man hours. If this specific monitor and configuration is not procured, USAMRICD will fail to complete the project and research milestones for the funding agency.

6. Publicizing Contract Actions:

The public display and synopsis requirements of FAR 5.101 and FAR 5.203:

IZI Apply and will be followed.

□ Do not apply due to the contract action falling below the threshold in FAR 5.101(a)(1).

□ Do not apply due to the following exception: FAR 5.202(a) Enter applicable exception from FAR 5.202(a).

Brand-Name justifications in accordance with FAR 13.105(c), or FAR 16.505(a)(4)(iii)(A):

□ Not applicable IZI Brand-name justification will be posted with the solicitation

□ Action is a brand-name restriction in accordance with FAR 16.505 and under $30K, no posting required.

7. Market Research: USAMRICD performed market research in March 2024. Government databases such as CHESS, General Services Administration (GSA), FEDMALL, UNICOR, and AbilityONE databases were queried and searched for alternative sources to produce the require hemodynamic and continuous cardiac output monitoring. One vendor responded to the RFI in GSAAdvantage but did not meet MECs for this procurement. The response was missing required measurement parameters and interface with the Swan-Ganz pulmonary catheters. A search on FPDS.gov for “Hemosphere advanced” and “Hemosphere advanced Swan-Ganz” found 2 vendors who previously sold this equipment to the Government, Edwards Lifesciences and 1st American Medical Distributors. A Sources Sought Notice was posted for this requirement allowing other vendors to submit a capability statement for this requirement. The notice was posted on 23 JUL 2024 with responses due on 29 JUL 2024. No responses were received regarding this notice.

8. Other Facts:

a) Procurement history: