DnF for OTFOC - Redacted.docx

DETERMINATION & FINDINGS FOR OTHER THAN FULL & OPEN COMPETITION

(ACTIONS SAT AND BELOW)

1. DESCRIPTION OF PROPOSED PROCUREMENT: Quantity six (6) Emka Technologies ecgTunnel systems for rodents

PROPOSED CONTRACTOR/MANUFACTURER:

EMKA Technologies 21515 Ridgetop Circle Suite 220 Sterling, VA 20166

POC: [REDACTED]

Email: [REDACTED]

CAGE: 3WHR4

Business Size: Small

Reseller:

Government Scientific Source, Inc.

12355 Sunrise Valley Dr., Ste 400 Reston, VA 20191-3497

POC: [REDACTED]

Email: [REDACTED]

CAGE: 0S908

Business Size: Small

1. ESTIMATED TOTAL VALUE:

$97,337.84

4. STATUTORY AUTHORITY PERMITTING CONTRACTING WITHOUT PROVIDING FOR FULL AND OPEN COMPETITION: The statutory authority permitting sole source is 41 USC 1901(e), implemented by FAR 13.106-1(b)(1)(i):

_X_ Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements ___ Unusual and Compelling Urgency ___ Industrial Mobilization; Engineering, Developmental, or Research Capability; or Expert Services ___ International Agreement ___ Authorized or Required by Statute ___ National Security ___ Public Interest

5. JUSTIFICATION FOR THE AUTHORITY CITED ABOVE:

The item(s) listed in section one above is available from only one source and competition is precluded for reasons indicated below. There are no substitutes available.

__ Compatibility: The item(s) must be compatible in all aspects (form, fit, and function) with existing systems presently installed. Describe the equipment you have now and how the new item/service must coordinate, connect, or interface with the existing system:

___ Proprietary: A patent, copyright, or proprietary data limits competition. The proprietary data are described as follows:

___ Experimental Continuity: The item(s) must be consistent with prior materials in order to ensure experimental continuity. Describe the conditions that necessitate the use of experimental continuity:

___ Warranty: Purchasing item(s) from another manufacturer/provider would void existing warranty. Provide a brief explanation for the use of this reason and the impact that would occur if the item was purchased from another manufacturer/provider:

___ Direct Replacement: These are “direct replacement” parts/components for existing equipment and no substitutes exist.

_X__ Other reasoning to support a sole-source buy:

The U.S. Army Combat Capabilities Development Command (DEVCOM), Special Projects Branch of the Biological & Biotechnology Sciences (BBS) Division at the Army Research Laboratory (ARL), requires six (6) echocardiogram (ECG) systems capable of simultaneously recording and analyzing plethysmography and non-invasive ECG signals in small animals. These systems are critical for a study focused on detecting subtle changes in cardiac and respiratory function following various physiological stressors. Given the expected sensitivity of these changes, the selected system must provide high-resolution data and be capable of detecting minute physiological variations to ensure reliable and accurate results.

For this research, it is essential that the ECG/plethysmography system records both cardiac and respiratory data from rodents without the use of anesthesia, surgical implantation of electrodes, or external adhesive ECG leads. This is to preserve animal welfare and avoid data artifacts introduced by invasive procedures. Furthermore, understanding the correlation between cardiac and respiratory effects is a key component of the study, requiring a unified system that captures both metrics concurrently.

Market research was conducted by [REDACTED], a Research Biologist in the BBS Division with over 20 years of experience. [REDACTED] examined offerings through the General Services Administration (GSA), reviewed government-wide databases, consulted with internal subject matter experts, and analyzed available catalogs and product literature. His research included companies such as DSI and Biopac. However, neither vendor could meet the Government’s requirements:

Only EMKA Technologies manufactures a system—the ecgTUNNEL—that combines non-invasive ECG and plethysmography recording into a single, integrated device. EMKA Technologies is the sole manufacturer and distributor of this system.

Failure to acquire the EMKA ecgTUNNEL system would severely compromise the research. It is the only solution that offers the necessary combination of data fidelity, functionality, and non-invasiveness. Using alternative systems would require multiple devices, resulting in fragmented data collection and the inability to capture synchronized cardiac and respiratory metrics. This would significantly degrade the quality and reliability of the results.

Moreover, adapting the project to use other systems would involve major changes to protocols, staff training, and equipment maintenance, resulting in delays and additional costs. The estimated cost to the Government from such disruptions is approximately $500,000, a loss that would not be recovered through competition. In contrast, the EMKA ecgTUNNEL system offers a unique, proven, and cost-effective solution aligned with the project's goals.

In conclusion, the EMKA ecgTUNNEL system is the only system capable of meeting the Government’s technical requirements but also the most efficient and reliable option for supporting this critical research.

1. FAIR AND REASONABLE PRICE DETERMINATION:

It has been determined that the anticipated cost to the Government will be fair and reasonable and that approval of this recommendation is in the best interest of the government. This justification is accurate and complete to the best of my knowledge and belief.

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