JA VISN 15 Xeleris - Redacted.pdf

Control Number: VA-23-00031757

JUSTIFICATION FOR A SOLE SOURCE AWARD

FOR CERTAIN COMMERCIAL ITEMS

1. Contracting Activity: Department of Veterans Affairs (VA)

Office of Procurement, Acquisition, and Logistics Technology Acquisition Center

23 Christopher Way Eatontown, NJ 07724

2. Description of Action: The proposed action is for a new contract for Brand Name General Electric (GE) Healthcare Xeleris software licenses and training utilized at various Veterans Integrated Service Network (VISN) 15 sites.

3. Description of the Supplies or Services: VISN 15 requires 20 concurrent user licenses for the GE Xeleris platform and additional licensing for advanced applications for Cedars, Advanced Recon, Cardiology, Neurology, Quantification, Dosimetry, Quantem, and Exini Bone. The proposed action also includes applications support, training, and licensing for the Nuclear Medicine platform. GE Healthcare’s Xeleris software is a molecular imaging virtual processing, analysis, and review solution for molecular imaging i.e., Nuclear Medicine (NM), Positron Emission Tomography (PET), NM/Computerized Tomography (CT), and PET/CT, designed to remove the restraints of a dedicated processing and review station. This platform is utilized in a number of VISN 15 facilities currently.

The period of performance shall be 12 months from installation with four (4) option years. The total estimated price of the proposed action, inclusive of options, is

4. Statutory Authority: The statutory authority permitting other than full and open competition for the following brand name requirement is 41 U.S.C. 1903 as implemented by the Federal Acquisition Regulation (FAR) 13.501, entitled “Special Documentation Requirements”.

5. Rationale Supporting Use of Authority Cited Above: The proposed source for this action is TrillaMed LLC, 30100 Telegraph Road, Suite 366, Bingham Farms, MI, 48025. Based on market research, as described in Section 8 of this justification it was determined that only the GE Healthcare Xeleris software licenses can meet the government’s needs. Further, it was determined that there is no competition among vendors for the required software and that TrillaMed LLC is the sole Government provider of GE Xeleris software licenses. TrillaMed is GE’s sole authorized reseller of Xeleris software. Currently, the Wichita, Poplar Bluff, Saint Louis, Marion, and Columbia VAMCs within VISN 15 utilize the Xeleris platform. GE Healthcare’s Xeleris system is intended for use by NM or Radiology practitioners and referring physicians for display, processing, archiving, printing, reporting, and networking of NM data, including planar scans and tomographic scans acquired by gamma cameras or PET scanners.

The NM or PET data can be coupled with registered and/or fused CT or MR scans, and with physiological signals in order to depict, localize, and/or quantify the distribution of

VISN 15 Xeleris Control Number: VA-23-00031757 radionuclide tracers and anatomical structures in scanned body tissue for clinical diagnostic purposes. The facilities are running various older software versions that require an upgrade to be consistent with information security standards and supported Operating System requirements. By centralizing the upgrade as a VISN procurement all sites can utilize a more cost-effective upgraded version of Xeleris and save the government the cost of implementing a completely new system and workflows clinically.

Only GE Xeleris licenses can meet the Government’s requirements as only GE’s software will work with the existing GE Xeleris platform without an intermediary interface. GE Xeleris uses a modified version of the DICOM image language, so its imaging equipment has to either talk to its proprietary Xeleris software or be converted via some kind of intermediary translator interface. Based on market research, the translator interface would cost as much as the Xeleris platform and when converted via interface the data loses some of the more detailed information which then does not allow certain post-processing and visualization of the data which the Xeleris platform is capable of in the native GE language.

Due to the proprietary nature of medical software, no other brand would be able to provide a viable solution without incurring significant costs and time delays to VISN 15.

Use of another platform would require new equipment to interface with and in some facilities perhaps even new imaging modalities. If the sites want to maintain all of the functionality that a GE imaging modality to GE imaging software provides then they would consider replacing Nuclear Medicine cameras in at least two (2), possibly three

(3) facilities. It is estimated that three (3) systems like that would cost somewhere between $750,000 to $1 million depending on final configuration of the equipment.

Based on experience with other systems, the delay in deploying an all-new system would likely be about a year at this point in time. All other recent software platform deployments have significant shipping lead times. Additionally, technical resources would need time to create the new network segmentations, configure new workflows, and then complete technical and clinical training to familiarize all staff with using the new system. In clinical time alone, it would require a large number of Radiologists (~25) across the VISN taking approximately three (3) to five (5) days away from clinical care to learn a new system. The technical man hours on most deployments is about 90 to 100 hours depending on complexity. So, in total, VA estimates 500 manhours, plus another 50 hours for miscellaneous coordination of other staff, for a total cost of about $50,000 on staffing alone. That understates the clinical patient care impact though because the facilities have to ramp down work to allow those Radiologists to train with a smaller workload, so they limit appointments and/or re-route care out to community partners. This results in either a delay in care to a Veteran or additional cost to the medical center that’s probably on average $5,000 to $10,000 per patient depending on the scans and care they are getting in the community. None of the estimated costs above would be anticipated to be recovered through competition.

6. Efforts to Obtain Competition: Market research was conducted, details of which are in the market research section of this document. This effort did not yield any additional sources that can meet the Government’s requirements. Additionally, the proposed

VISN 15 Xeleris Control Number: VA-23-00031757 action will be synopsized on the Contracting Opportunities Page in accordance with FAR 5.201. The ordering activity will make publicly available the justification along with the solicitation in accordance with FAR 13.501(a)(1)(iv). Any proposals that are received shall be evaluated.

7. Actions to Increase Competition: The Government will continue to conduct market research to ascertain if there are changes in the marketplace that would enable future actions to be competed.

8. Market Research: VISN 15 conducted market research to evaluate alternative solutions to Xeleris, however all alternatives would require investment in new equipment, new workflows, and implementation of a new system. Alternative solutions reviewed included Siemens Syngo.via, Canon Vitrea, and Change Healthcare Nuclear Medicine Advanced Visualization Solution. Each platform had limitations that would impact clinical care or not optimize resources of VA. Siemens Syngo.via is not capable of processing the proprietary GE DICOM data format, so certain studies performed on GE Nuclear Medicine scanners cannot be utilized to the fullest clinical value. Canon’s Vitrea solution features limited Nuclear Medicine image processing, but also is not capable of processing the proprietary GE DICOM data format, so certain studies performed on GE Nuclear Medicine scanners cannot be utilized to the fullest clinical value. Change Healthcare’s Nuclear Medicine Solution focuses on Cardiology functions and lacks a more generalized Nuclear Medicine toolset. Additionally Change Healthcare is not capable of processing the proprietary GE DICOM data format, so certain studies performed on GE Nuclear Medicine scanners cannot be utilized to the fullest clinical value. As detailed in Section 5, utilizing any of these alternative platforms would involve significant effort which would result in additional cost to the government and clinical time as radiologists would be tied up in learning new systems, defining new workflows, and customizing a new system.

Additional market research was conducted by reaching out to GE Healthcare for a list of authorized SDVOSB resellers of Xeleris. GE Healthcare responded with one

(1) authorized SDVOSB reseller. Based on this market research, VA’s subject matter expert determined that only TrillaMed LLC can meet the Government’s requirement.

9. Other Facts: None.