0036-JOFOC-Hamer.pdf

Attachment 1: Request for Sole Source Justification Format >SAT

VHAPG Part 806.3 OFOC Page 1 of 4 Revision: 03 Effective Date: 04/15/24 Acquisition ID#: __________________

DDEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C250-25-AP-2126

1. Contracting Activity: The Department of Veterans Affairs, Veterans Integrated Service

Network (VISN) 10, Louis Stokes Cleveland Veterans Affairs Medical Center (CLE VAMC), Parma CBOC, Network Contracting Office (NCO) 10.

Transaction: 541-25-3-032-0036

2. Nature and/or Description of the Action Being Processed: Network Contracting Office (NCO) 10 intends to award a new, firm fixed price, one year purchase order for a Philips Ingenia Mobile MRI lease, that will be sole sourced through Rayus Radiology. The request is for a mobile MRI system.

This procurement is in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501, Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The request is to maintain the currently operated Philips Ingenia Mobile MRI scanner in operation at the CLE

VAMC – Parma CBOC located at 8787 Brookpark Rd, Parma, OH 44129.

Parked Mobile Coach and 1.5T Philips Ingenia with Compress SENSE

ESTIMATED DOLLAR VALUE: $511,000.00

REQUIRED DELIVERY DATE: May 1, 2025 through April 30, 2026

4. Statutory Authority Permitting Other than Full and Open Competition:

( X ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

VHAPG Part 806.3 OFOC Page 2 of 4 Revision: 03 Effective Date: 04/15/24 Acquisition ID#: __________________

55. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition

Requires the Use of the Authority Cited Above (applicability of authority): Philips is uniquely qualified to provide the MRI lease based on the following:

The CLE VAMC is currently leasing a Philips Ingenia Mobile MRI housed in a mobile coach and intends to re-lease it. The limited MRI capacity caused by flooding downtime requires the CLE VAMC to extend its hours on this machine even to scanning on weekends to try and keep up with demand. The compressed sense software capabilities allow for the CLE VAMC to do shorter studies with preserved signal to noise. The Compress SENSE” is a proprietary, special algorithm, imaging technique, along with a proprietary 70cm large bore magnet that allows this specific Philips Ingenia to do an MRI scan in half the time as a normal MRI scanner, but maintains the same level of image quality, which is important to how busy the CLE VAMC is currently. To replace this magnet, we would need whatever manufacturer to build a new magnet with latest generation reconstruction (e.g., Philips “compressed sense”, or GE’s Air Recon DL, or Siemens “Deep Resolve” reconstruction optimization). A magnet with these features would require a new build, not an old magnet repurposed for mobile use. A new build in today’s supply chain environment would take over 18 months. This would be an unacceptable delay and cost to the Government.

Even if another vendor could manufacture a comparable MRI system, the required development, regulatory approvals, and installation would result in significant delays, estimated at 18 months or more, which would be unacceptable for patient care at CLE

VAMC.

Accordingly, Rayus Radiology Corporation is the only firm capable of providing the supplies and services described in Section III above without the Veteran’s Health Administration experiencing substantial duplication of cost that could not be expected to be recovered through competition and unacceptable delays in fulfilling its requirements.”

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Market research was done and this product is proprietary and has no distributors. This product is custom fit to the building. The CLE VAMC has no intention of reconstruction with the space, due unnecessary cost. Rayus Radius is the only responsible source to provide MRI needed for patient care. Removal of the installed MRI equipment could result in decreased access to care, quality of care and continuity of care An Intent to sole source will be posted with the RFQ on SAM.gov after receiving a signed 2268.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable: The CO will use a comparison of the proposed prices to historical prices paid for the same/similar items and a comparison of the proposed price to the IGCE, as well as any of the other price analysis techniques identified in FAR 13.106-3(a)(2)(ii), as necessary, to determine the price to be fair and reasonable.

VHAPG Part 806.3 OFOC Page 3 of 4

Acquisition ID#: __________________

88. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research was conducted by the Contracting Officer to determine if there were other vendors capable of providing a comparable mobile MRI system that meets the CLE VAMC's specific requirements. The following sources were reviewed:

VetCert (VA’s Veteran-Owned Business Database):

o NAICS Code Searched: 532490 (Other Commercial and Industrial Machinery and

Equipment Rental and Leasing) o Results: 382 vendors identified, but none could provide a mobile MRI system with equivalent imaging capabilities and Compressed SENSE technology.

GSA eLibrary, ECAT, SAM.gov, Interagency Contract Directories, NAC, FPDS, SCMC, MSVP, BIC and FDA:

o Keywords Used: "mobile MRI scanner lease," "MRI equipment rental" o Results: No results matched the technical requirements for a Philips Ingenia

Mobile MRI lease.

DSBS:

o NAICS Code Searched: 532490 (Other Commercial and Industrial Machinery and Equipment Rental and Leasing) o Keywords Used: "mobile MRI lease," "MRI rental service" o Results: No results matched the technical requirements for a Philips Ingenia

Mobile MRI lease.

Based on these findings, no alternative vendors were identified that could fulfill the need without significant facility modifications, procurement delays, or operational disruptions.. The VA Rule of Two and SBA Rule of Two were not met,, and as a result,, Rayus Radiology remains the only responsible source..

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: FITARA is not needed as this is not an IT buy.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Rayus Radiology Gary Bell

(607) 227-1775 Gary.Bell@RAYUSradiology.com

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any

Barriers to Competition before Making subsequent acquisitions for the supplies or services required: On-going research of the industry market place will be conducted to determine if there are new entrants into this product arena.

VHAPG Part 806.3 OFOC Page 4 of 4

Acquisition ID#: __________________

112. Requirements Certification: I certify that the requirement outlined in this justification is a

Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Sarah A. Augustine Acting Chief of Radiology Service Nuclear Medicine Service Chief VISN 10, VA Northeast Ohio Healthcare System

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Rachelle J. Hamer Contracting Officer Network Contracting Office (NCO) 10

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Adam P. Weber Branch Chief – Supply Team #1 Network Contracting Office (NCO) 10

SARAH

AUGUSTINE

Digitally signed by SARAH

AUGUSTINE

Date: 2025.02.26 17:28:27 -05'00'

RACHELLE

HAMER

Digitally signed by

RACHELLE HAMER

Date: 2025.02.27 12:45:02 -05'00'

ADAM

WEBER

Digitally signed by

ADAM WEBER

Date: 2025.02.27 13:33:59 -05'00'