Attachment 1 Single Source Justification MPT to SAT_Redacted.pdf

Revision: 02 Effective Date: 12/30/2025 Page 1 of 3 Acquisition ID# 36C256-26-AP-2812

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

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

Acquisition Plan Action ID:_36C256-26-AP-2812

1. Contracting Activity: Network Contracting Office (NCO) 16 in support of the

Department of Veterans Affairs, VISN 16, Central Arkansas Veterans Healthcare System (CAVHS), John L. McClellan Veterans Medical Center, Little Rock, AR 72205.

Purchase Request:

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: This is a new requirement for a Firm-Fixed Pirce supply acquisition for the purchase and installation 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.

3. Unique characteristics that limit availability to only one source, with the 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 was purchased in 2018.

This model instrument has exceeded its end-of-life and is no longer serviceable.

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.

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.

Effective Date: 12/30/2025 Page 2 of 3 Acquisition ID# 36C256-26-AP-2812

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:

Sources Sought Notice 36C25626Q0592 was posted to the Contract Opportunities portal on 3/31/2026 with a closing date of 4/7/2026. No responses were received.

A search on the SBA VetCert returned 336 SBA certified VOSB or SDVOSB designated as small in NAICS code 334516.

Utilizing ADD Up, 66 contracts were found for Single Sample Micro Osmometer purchases.

Additional market research identified four (4) primary alternatives:

➢ Gonotec Osmomat 300 – Country of Origin Germany

➢ 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.

The Advanced Instruments Osmo1 Single-Sample Micro-Osmometer authorized distributors are:

➢ Fisher Scientific/Thermo Fisher Scientific (official distributor) (LB – under

NAICS 334516 )

➢ VWR (Avantor) (LB under NAICS 334516)

➢ Medline (LB under NAICS 334516)

Effective Date: 12/30/2025 Page 3 of 3 Acquisition ID# 36C256-26-AP-2812

➢ Instrumed Service Co., Inc (SB under NAICS 334516)

➢ John Morris Group (SB under NAICS 334516

➢ Hyland Scientific (SB under NAICS 334516)

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 is not optimized for clinical critical samples and has a larger sample volume. More suitable for benchtop QC or research labs. Not suitable for hospital labs.

➢ OSM100100 Freezing-Point Osmometer manufactured by 4E’s

USA. This performance is suitable for general lab applications. It lacks advanced calibration automation and reference-grade stability. It is not validated for clinical diagnostic use. Not designed for CAP/CLIA environments.

The above products’ performance is respectable, but neither domestic alternative matches Osmo1’s precision, micro-sample, and clinical workflow optimization.

Neither Precision Systems nor 4E’s USA meets clinical laboratory regulatory expectations, which makes them not equivalent for VA clinical use.

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

13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

____________________________ _April 22, 2026_____________