SSJ - Osmometer et.pdf

Revision: 02 Effective Date: 12/30/2025 Page 1 of 3 Acquisition ID#

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW RFO 12.102(a) For

Over Micro-Purchase Threshold but Not Exceeding the Simplified Acquisition Threshold

Acquisition Plan Action ID: 36C249-26-AP-2397

1. Contracting Activity: Department of Veterans Affairs, VISN 09, James H. Quillen

VA Medical Center, Corner of Lamont and Veterans Way, Mountain Home, TN 37684.

2237: 621-26-3-091-0146

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

The James H. Quillen VA Medical Center in Mountain Home, TN requires the Osmo 1 Single-Sample Micro Osmometer. This is a new requirement for a Firm-Fixed Pirce supply acquisition for the purchase of one brand-name, Advanced Instruments (Nova Biomedical) Osmo1® Single‑Sample Micro‑Osmometer. This equipment will be used for the measurement of osmolality in serum/urine, plasma, and other body fluids to support patient care and meet Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP) requirements.

The estimate amount for this requirement is $28,981.00.

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

Advanced Instruments, LLC, the manufacturer of the Osmo1 Single-Sample Micro- Osmometer. and is the sole provider in North America. Advanced Instruments, LLC is the only manufacturer offering an instrument that fulfils the current technical, regulatory, and usability requirements. No other osmometer models reviewed offer touchscreen User Interface (UI), direct sampling, barcode scanning, and secure integration for lab workflows.

The current model, Osmo 1 Single Sample Osmometer has reached its end-of-life and is needs replacement.

Without a functioning osmometer, the lab is unable to perform these necessary measurements, impacting patient care and diagnostics. By purchasing this instrument, it is a direct upgrade and will allow for the least amount of downtime and transition period for laboratory personnel.

https://www.acquisition.gov/?q=/browse/far/13

Effective Date: 12/30/2025 Page 2 of 3 Acquisition ID#

All alternatives lack Laboratory Information System (LIS), barcode, audit trails, QC lockouts, or micro‑sample equivalence. These alternatives also typically lack end-to-end clinical data/compliance features at Osmo1’s level.

The Osmo1 is specifically designed for hospital and diagnostic laboratory operations. It is the only model that consistently delivers across: freezing-point accuracy, small sample, audit trails & QC lockouts, barcode/LIS connectivity, and vendor support. In regulated clinical settings, these are not “nice-to-have”—they are essential to minimize risk, pass accreditation, and ensure reliable patient results. In addition, the Osmo-1 freezing-point is favored in clinical labs as the gold standard because it remains accurate regardless of size and shape of solute particles and can detect volatiles (e.g., alcohols) which vapor-pressure osmometers may miss.

Advanced Instruments, LLC is the only manufacturer offering an instrument that fulfils the current technical, regulatory, and usability requirements of this acquisition.

The Osmo1 Single-Sample Micro-Osmometer is the only commercially available instrument that can ensure compliant, efficient, and reliable clinical osmolality testing aligned with current regulatory expectations and workflow needs of the VA clinical laboratory.

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

A search on the SBA VetCert returned two SBA certified VOSB or SDVOSB potential vendors in NAICS code 334516.

Utilizing ADD Up, 13 contracts were found for under “osmo1” and “osmo 1” search.

Additional market research identified three (3) similar alternatives:

• ELITech FreezePoint 6000 - Country of Origin – France

• Precision Systems Micro-Osmette – Massachusetts, USA

• ELITech Vapro 5600 - Country of Origin – Logan, Utah, USA

The Osmo1 is manufactured in Norwood, Massachusetts, USA.

According to an internet search, authorized distributors of the Advanced Instruments Osmo1 Single-Sample Micro-Osmometer are:

• Fisher Scientific/Thermo Fisher Scientific

• Cardinal Health

• Tecil

• Instrument Service Co, Inc

There are equivalent domestic end products available from a US manufacturer for the product/supplies:

• Micro-Osmette 500/6002 Touch modules manufactured by Precision System Inc. The Precision System complies with freezing-point methods but it does

Effective Date: 12/30/2025 Page 3 of 3 Acquisition ID# not have primary tube sampling, which requires pipetting to disposable tubes, which can result in pipetting errors. Additionally the QC/ Data management is limited and not ideal when results need full traceability for patient-critical testing.

• Vapro 5600 is manufactured by EliTech. The EliTech system is not compliant with freezing-point methods and does not have primary tube sampling which requires pipetting into the holders, which can result in pipetting errors. This model uses vapor-pressure osmometry, which is more sensitive to environmental conditions and cannot accurately test sample with volatile substances. Additionally, this model is not used in clinical laboratories for patient-impacting results.

Additional market research findings and details can be found in the Market Research Report.

5. Contracting Officer's Certification: Purchase is approved in accordance with RFO

12.102(a). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

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