36C25024Q0499 JOFOC_Redacted.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

Effective Date: 02/01/2022 Page 1 of 5

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C250-24-AP-1579

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: 541-24-3-032-0022

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 Phillips Ingenia with Compress SENSE, unstaffed (Current Mobile) for 365 Days.

ESTIMATED DOLLAR VALUE:

REQUIRED DELIVERY DATE: May 1, 2024 through April 30, 2025

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

( 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

Effective Date: 02/01/2022 Page 2 of 5

( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

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

Requires the Use of the Authority Cited Above (applicability of authority): Per FAR 11.105 Items peculiar to one manufacturer and 12.4-Unique Requirements Regarding Terms and Conditions for Commercial Items, Philips, is uniquely qualified to provide beds 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 VANEOHS 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 VANEOHS 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.

Accordingly, Rayus Radious 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. Thae 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 getting a 2268.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The anticipated cost will be considered fair and reasonable based on price comparison of the proposed price with prices found reasonable on previous purchases, comparison of independent Government estimate (IGCE), and current price lists, catalogs, or advertisemens. The determination of price fairness and reasonableness will be made IAW FAR Part 13.106-3.

Effective Date: 02/01/2022 Page 3 of 5

8. 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 and the service to identify available sources to meet the requirements as follows:

VetCert, MSPV, DSBS, SAM.gov, National Contracts, Interagency Contract Directory, GSA, ECAT, CM, BIC, and FPDS were reviewed with the following results:

In accordance with January 9, 2023, advisory for VetCert usage, VetCert was queried, as required, using NAICS 532490 The search provided 348 results. The SDVOSB and VOSB vendors in the market research were contacted to see if they can provide or are able to provide comparable equipment to no avail. Veteran Small Business Certification (sba.gov)

A search was conducted in the Medical Surgical Prime Vendor (MSPV) Contracts:

Equipment Home (dla.mil) with key words mobile MRI lease which resulted in no results.

A search was conducted in Small Business Administration (SBA) Dynamic Small Business Search (DSBS) SBA - SBA Search Results under NAICS CODE 532490 with key words mobile MRI lease which resulted in no results.

A search was conducted on SAM SAM.gov | Search under key words mobile MRI lease which resulted in no results matching the facilities needs.

A search was conducted on National Strategic Source Listing Medical/Surgical Prime Vendor (MSPV) Program - Office of Procurement, Acquisition and Logistics (OPAL) (va.gov) with key words mobile MRI lease which resulted in no results.

A search was conducted on the Interagency Contract Directory Interagency Contract Directory Portal with key words mobile MRI lease which resulted in no results.

A search was conducted on GSA eLibrary Product Detail (gsaadvantage.gov) with key words mobile MRI lease which resulted with no results.

A search was conducted in Federal Procurement Data System (FPDS) FPDS-NG ezSearch with key words mobile MRI lease in no results matching the facilities needs.

A search was conducted on Electronic Catalog (ECAT) DMMonline (dla.mil) with key words mobile MRI lease which resulted in no results.

A search was conducted on Category Management (CM) Quick Decisions Dashboard Equipment Home (dla.mil) with key words mobile MRI lease` which resulted in no results.

Effective Date: 02/01/2022 Page 4 of 5

IAW MB Memorandum M-19-13 Category Management: Making Smarter Use of Common Contract Solutions and Practices, this requirement cannot be satisfied through Best in Class contracting (BIC).

A search was conducted in The U.S. Food & Drug Administration (FDA) Search | FDA with key words mobile MRI lease which resulted in no results.

The NMR does apply to NAICS 334290, and SBA has not provided a class waiver for NAICS 334290.

Based on the market research conducted, two or more VetCert verified and capable SDVOSBs or VOSBs were not identified and appeared capable of performing the requirement. The VA Rule of Two and SBA Rule of Two cannot be met.

FITARA is not a requirement.

There are no Buy American Act (BAA) issues to be concerned with. There are no Trade Agreement Act (TAA) to be concerned with. This Philips Ingenia Mobile MRI is currently made in the United States of America.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: N/A

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.

Effective Date: 02/01/2022 Page 5 of 5

12. 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.

Ronnie D. Derrwaldt, DO 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

RONNIE

DERRWALDT

Digitally signed by

RONNIE DERRWALDT

Date: 2024.04.01 15:26:24 -04'00'

ADAM

WEBER

Digitally signed by ADAM

WEBER

Date: 2024.04.01 16:21:09 -04'00'

RACHELLE

HAMER

Digitally signed by

RACHELLE HAMER

Date: 2024.04.01 15:55:58 -04'00'