Justification Medela Thopaz signed.pdf

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6515--580-25-2-167-0073 for replacement Medla Thopaz Units Notice of Intent to Sole Source
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36C25625Q0420
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This is a Single Source Justification document for a simplified acquisition under the Simplified Acquisition Threshold (SAT) from the Department of Veterans Affairs NCO 16, Michael E. DeBakey VA Medical Center. The justification is for the procurement of 10 Medela Thopaz+ Digital Chest Drainage and Monitoring Systems for Cardiothoracic Surgery, with an estimated value of $55,620.00.

The document outlines that only Medela Inc. can provide these systems due to specific requirements: compatibility with current Operating Room and ICU equipment, interface capabilities with existing Medela perfusion pumps, and the ability to provide post-op mediastinal and pleural drainage with uninterrupted continuous drainage using battery operation modes. Market research confirmed no authorized distributors exist, and a Notice of Intent to Sole Source was posted to SAM due to urgency. The document is signed by Andrew Misfeldt and is effective as of 11/15/2024.

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VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Single Source Justification for SAP under the SAT

Revision: 01 Effective Date: 11/15/2024 Page 1 of 1 Acquisition ID#: 36C256-25-AP-1581

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C256-25-AP-1581

1. Contracting Activity: Department of Veterans Affairs, NCO 16, Michael E. DeBakey VA Medical Center, Operative Care Line. 2237: 580-25-2-167-0073

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

The Michael E. DeBakey VA Medical Center (MEDVAMC) is currently requesting 10 Medela Thopaz+ Digital Chest Drainage and Monitoring Systems for Cardiothoracic Surgery. This system is used after heart surgeries to manage and measure air and fluid leakage and allows for physicians to better decision making of when to remove the drain. MEDVAMC is requesting the purchase of 10 pumps.

Estimated amount $55,620.00.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

The systems must be compatible with the current Operating Room and ICU equipment. The units must interface with the existing Medela perfusion pumps. Must provide post op mediastinal and pleural drainage. Must have ability to provide uninterrupted continuous drainage with battery operation modes.

4. Description of market research conducted and results or statement why it was not conducted:

Searched for open FSS contracts and supply chain master catalog to find possible sources or existing contract ordering options. The OEM verified there are no authorized distributors at this time. Due to urgency of requirement Notice of Intent to Sole Source posted to SAM with this Justification memo.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Name Date Title

2025-01-24T06:51:12-0600
ANDREW MISFELDT

File details come from the government source that posted it. Updated .