JA Redacted_Redacted.pdf

FEB 2023

4. Authority Cited: 41 United States Code 1901 as implemented in Federal Acquisition Regulation 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

5. Reason for Authority Cited: The USAF 59th Medical Wing, Science and Technology Office currently utilizes the GE Healthcare & GE Research SIGNATM MR750 MRI System which is outdated in terms of research imaging efficacy, unreliable for clinical imaging, and a risk to patient safety. The MAGNUS is a state-of-the-art magnetic resonance imaging system with unprecedented spatial resolution and the ability to quantify axonal anatomy and cellular microstructure. The MAGNUS was developed in collaboration with the Uniformed Services University of the Health Sciences (USUHS) and GE Healthcare to develop new imaging biomarkers for characterization of traumatic brain injury and other neurological injuries and pathologies. The MAGNUS upgrade will allow unparalleled biomedical and diagnostic imaging performance.

The GE Healthcare & GE Research SIGNA Premier 3.0T MAGNUS MRI System�s groundbreaking, . Market research has indicated that the GE SIGNATM Premier 3.0T MAGNUS is the only scanner available that can achieve these performance specifications, operating at over 4-5 times the gradient slew rate and gradient amplitude compared to other commercially available scanners. The unique operational capabilities of this MRI System are unachievable on other current commercial scanners and will allow researchers to quantify axonal anatomy and morphology and cellular microstructure at an unprecedented scale. The current GE SIGNATM MR750 3.0T scanner has a complement of accessory equipment to support the conversion without incurring additional installation and facility modification costs. Not only is this the only MRI system available that will meet the required specifications, but it is also proprietary to General Electric Company, GE Research as it is equipment that was manufactured by GE Healthcare & GE Research. Only GE can perform the upgrade on their proprietary equipment and no third-parties are authorized to perform the upgrade.

Outside of the technical aspects of this requirement, utilizing a different machine or manufacturer would not be cost effective as the entire MRI scanner would need to be replaced with a new or refurbished MRI scanner which market research has shown will result in a higher price than the upgrade.

The GE Healthcare & GE Research SIGNATM Premier 3.0T MAGNUS MRI System (Ultra-High Performance Gradient System) is the most current and up-to-date MRI System for ensuring the USAF 59th Medical Wing�s current operational tempo. Due to the unique specifications and proprietary nature of the General Electric Company, GE Research�s SIGNATM MR750 MRI System, as well as a higher cost to purchase a new alternative MRI system, a sole source contract is required for this action to allow for full implementation of the MRI upgrade.

6. Efforts to Obtain Competition: A detailed market and literature search was conducted to determine if other commercial or investigational devices met the high operating specifications of the SIGNATM Premier 3.0T MAGNUS MRI System. It was determined that no other vendors manufacture a machine that operates in the gradient slew rate and amplitude ranges of the SIGNATM Premier 3.0T MAGNUS for either head-only or whole-body functions. In addition, the main component of the GE 3.0T Premier MAGNUS is its proprietary advanced gradient System. The MAGNUS gradient is a collaboration between GE Healthcare, GE Research Center and the USUHS. MRI System components are all proprietary and cannot be outfitted into another manufacturer's system; therefore, the source can only be the original equipment manufacturer, GE Healthcare, GE Research Center as there are no authorized resellers of this product. Therefore, due to the proprietary nature of General Electric Company, GE Research�s SIGNATM MR750 MRI System no competition could be found to perform the upgrade.

A Request for Information (RFI) was published on SAM.gov on 06 September 2023 with a closing date of 13 September 2023 by 12:00 PM EDT. An email was received from one vendor, Concordat Business Solutions, LLC; however, the response did not provide any information regarding the company�s capabilities and was determined non-responsive. No other correspondence was received in response to this RFI.

7. Actions to Increase Competition: The only way to preclude future limitations of sources will be the commercial availability of other manufacturer produced systems that are comparable which has yet to become a reality. Based on the results of the market research, there have been no further actions taken to increase competition. The acquisition team will continue to monitor the market for other qualified sources.

8. Market Research: The USAF 59th Medical Wing technical experts conducted market research which consisted of contacting knowledgeable people (Government and Industry); conducting site visits; searching various internet sources; obtaining source lists of similar services from other contracting activities, agencies, and trade associations; and contacting USUHS for information. Based on the results of this market research, it was determined that no other vendors operate in the gradient slew rate and amplitude ranges of the SIGNATM Premier 3.0T MAGNUS for either head-only or whole-body functions. In addition, the Contracting Office posted a RFI to SAM.gov, as discussed above in Section 6 of this document, and did not receive any acceptable responses which met the requirement. Lastly, the Contracting Office published a Notice of Intent to Sole Source to General Electric Company (GE), GE Research on 13

September 2023 with a closing date of 29 September 2023 at 12:00 PM EDT. No correspondence was received in response to this notice.

9. Interested Sources: The notices required by FAR 5.201 have been published and, to date, no qualified sources have responded to the Requests for Information posted on GSA and SAM.gov nor the Notice of Intent to Sole Source posted to SAM.gov to express an interest in this requirement. In addition, this justification shall be posted to SAM.gov within 14 days after contract award in accordance with FAR 13.501(a)(iii).

10. Other Facts: The main component of the GE 3.0T Premier MAGNUS is its proprietary advanced gradient System. The MAGNUS gradient is a collaboration between GE Healthcare, GE Research Center and the USUHS. MRI System components are all proprietary and cannot be outfitted into another manufacturer's System; therefore, the source can only be the original equipment manufacturer, GE Healthcare, GE Research Center.

a. Procurement history. The GE Healthcare & GE Research SIGNATM MR750 MRI System currently in use was previously procured from General Electric Company (GE), GE Research. The shelf life of MRI Systems is over 10 years; therefore, the previous equipment was purchased so long ago that the contract numbers and other acquisition details are unknown.

b. Other facts. Not applicable.