WRNMMC JEFO signed_Redacted.pdf

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JUSTIFICATION FOR AN EXCEPTION TO FAIR OPPORTUNITY (JEFO)

SPECTRUM DYNAMICS MEDICAL INC

CONTRACT SPE2D1-20-D-0007

D-SPECT CARDIAC NUCLEAR MEDICINE GAMMA CAMERA

(1) Defense Logistics Agency (DLA) Troop Support, Medical Supply Chain, Capital Equipment

Division, is the contracting activity.

(2) The action submitted for approval is a JEFO supporting the acquisition of Spectrum Dynamics Medical D-SPECT Cardio Imaging System. The resultant delivery order will be issued under Spectrum Dynamics Medical�s Radiology and Imaging Systems Program contract, SPE2D1-20-D- 0007, which is valid through June 13, 2029. This Spectrum Dynamics Medical D-SPECT is for Walter Reed National Military Medical Center (WRNMMC), Bethesda, MD. This JEFO will allow an order to be placed against Spectrum Dynamics Medical�s contract without following the fair opportunity process.

(3) The requirement is for a cardiac nuclear medicine gamma camera. The acquisition includes hardware and software components including equipment, turnkey installation, and training. The total estimated dollar value of this action is

(4) The authority waiving the competition requirements is FAR 16.505(b)(2)(i)(B), only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized. Spectrum Dynamics Medical is the only vendor capable of meeting all requirements due to proprietary parts, system design, and functionality.

The use of this authority is necessary because WRNMMC has a requirement for a cardiac nuclear medicine gamma camera. A cardiac nuclear medicine gamma camera is required for nuclear cardiac stress test imaging of patients and beneficiaries of WRNMMC.

The required gamma camera must meet all of the following minimum requirements established by

WRNMMC:

a. Cardiology Specific � The Gamma Camera must be Cardiology specific.

b. Detector Type � The system shall be a Cadmium Zinc Telluride (CZT) based imaging system with parallel hole detector collimation. This offers the ability to have higher sensitivity and energy resolution specification than conventional SPECT cameras.

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c. Patient Imaging Position � The device must have the flexibility to image patients in seated, upright, and supine positions in order to allow patients with mobility restrictions as well as weight limitations to undergo imaging comfortably.

d. Gantry � The system must have an open gantry design to eliminate pinch points or claustrophobia caused by enclosed space of the camera�s gantry aperture.

Spectrum Dynamics Medical�s D-SPECT Cardio Imaging System is the only unit under contract that meets all of WRNMMC�s minimum requirements.

(5) The D-SPECT Cardio Imaging System is available on the Spectrum Dynamics Medical Radiology and Imaging Contract, SPE2D1-20-D-0007. The contract pricing has previously been determined fair and reasonable

A determination by the contracting officer that the anticipated cost to the Government will be fair and reasonable FAR 16.505(b)(2)(ii)(B)(5).

(6) WRNMMC performed market research in the form of a market survey from October 2024 through

November 2024, assessing whether manufacturers could offer a cardiac nuclear medicine gamma camera that meets all of their minimum requirements. Market research findings indicate that three

(3) manufacturers; Spectrum Dynamics, GE, and Digirad can provide a cardiac nuclear medicine gamma camera. However, the GE Discovery NM 530c and the Digirad Cardius X-ACT+ devices do not meet all of WRNMMC�s minimum requirements, more specifically, those provided below:

Detector Type � Digirad does not meet the requirement to provide Cadmium Zinc Telluride (CZT) based imaging system. GE meets this requirement.

Patient Imaging Position � GE does not meet the requirement to image patients in a seated position. GE�s unit is attached to a bed which hinders patients with mobility issues and weight limitations. Digirad meets this requirement.

DLA Troop Support also conducted their own separate market research in February 2025 to determine if any contract holders could meet all of WRNMMC�s minimum requirements. Findings indicate that Spectrum Dynamics Medical is the only supplier on contract that offers a cardiac nuclear medicine gamma camera that meets all the minimum requirements.

(7) In an effort to remove barriers to fair opportunity on subsequent acquisitions, DLA will continue to perform market research to locate other sources for any future procurements of Radiology equipment and upgrades. Current vendors in the Radiology and Imaging Systems Program have the opportunity to add new products that fall within the scope of the contract at any time throughout the year, enhancing competition for future acquisitions. Furthermore, DLA Troop Support will continue to monitor the market. In the event that another vendor outside of the Radiology and Imaging Systems Program offers Cardiac Nuclear Gamma Cameras, DLA Troop Support will encourage any such vendor/manufacturer to seek a contract under the Radiology and Imaging Systems Program. The