P03 36C242-23-AP-3159 - Approved.pdf

36C242-23-AP-3159

Effective Date: 02/01/2022 Page 1 of 4

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C242-23-AP-3159

1. Contracting Activity: Department of Veterans Affairs, VISN 02, James J. Peters Bronx VA Medical Center 130 West Kingsbridge Road, Bronx, NY 10468.

Requesting service at New Jersey VA Healthcare System, East Orange Campus 385 East Tremont Ave East Orange, NJ 07018.

Funded 2237 number 561-24-2-668-0006.

2. Nature and/or Description of the Action Being Processed:

The New Jersey VA Healthcare System East Orange Campus requires a maintenance supportive service contract for the Elekta Equipment inclusive of Oncentra Prostate, MOSAIQ and Elekta LINAC.

Elekta is the sole provider of the services required for this requirement. The contractor will provide all labor, supplies, equipment, maintenance and supervision necessary.

A firm-fixed price contract, base year with 4 option years contract is contemplated.

The anticipated period of performance is for 01/01/2024 – 12/31/2024 with the provision of four (4) option years.

Independent Government Cost Esitmate that was provided is for an annual cost of $465,541.68 with an estimated total cost of $2,327,708.40

Elekta Inc. provided a quote for one base year and four (4) option years:

Infinity Service, covers only the base year and three (3 ) option years as the system is due to reach End of Life on 5/1/2028; this will be about five months after the end of the 4th option year. Elekta will need to re-evaluate coverage availability with parts and service support to offer continued support past End of Life, at which point we would only be able to offer year to year coverage.

Period of Performance:

Base Year: 01/01/2024 – 12/31/2024 Option Year 1: 01/01/2025 – 12/31/2025 Option Year 2: 01/01/2026 – 12/31/2026 Option Year 3: 01/01/2027 – 12/31/2027 Option Year 4: 01/01/2028 – 12/31/2028

Contract Description Service level Term Total Service Fee (in USD) Elekta Infinity™ Maintenance and Support Fee

Total Confidence (Platinum) 48 Months $1,160,000.00

OIS Maintenance and Support Fee

Gold 60 Months $415,500.00

Oncentra Prostate Maintenance and Support Fee

Gold 60 Months $130,000.00

Total Maintenance and Support Fee $1,705,500.00

Effective Date: 02/01/2022 Page 2 of 4

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

The VA New Jersey Healthcare System, East Orange Campus is requesting the Elekta equipment service and maintenance service contract. The Elekta equipment allows the VA New Jersey Healthcare System Radiation Oncology department to provide safe, efficient, consistent care to our veterans. The Contractor shall provide all replacement parts required to keep the equipment performing within the Original Equipment Manufacturer (OEM) specifications. The Elekta equipment can provide high-energy x-ray beams and electrons for cancer treatment. Without this contract the equipment will not be able to be maintained in appropriate working manner as required by the Original Equipment Manufacturer (OEM).

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 ( ) 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):

Only One Responsible Source (FAR 13.5) – Elekta provided documentation to support that they are the sole source for maintenance and updates to their Elekta equipment used at the VA New Jersey Healthcare System, East Orange Campus.

The Elekta equipment is manufactured, installed and supported by Elekta. All of the equipment is proprietary and Elekta is the sole source service provider for a technical support plan. Elekta is also the only source for maintenance/updates, or modifications and upgrades to the Elekta equipment.

Accordingly, Elekta 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:

A notice of “Intent to Sole Source” synopsis number 36C24223Q1118 was posted on Contract

Opportunities on 10/13/2023. Zero responses were received from interested vendors.

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

Pricing analysis shall be accomplished by reviewing procurement history

Effective Date: 02/01/2022 Page 3 of 4 beginning in FY11 to the present to determine prices to be fair and reasonable. Elekta, Inc., has been the sole provider of the maintenance and support for the Brachytherapy system and a detailed history of pricing is available. In addition, the Contracting Officer reviewed the Independent Government Cost Estimate (IGCE) and estimates identified in acquisitions for similar products and service and compared prices paid for the same or similar commercial items under comparable terms and conditions by both Government and commercial customers. All sources were receiving similar pricing for similar work to be performed by Elekta, Inc.

The Contracting Officer has determined that the anticipated cost to the Government for the supplies/services covered by the J&A will be fair and reasonable.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted:

A search was conducted in SBA / Dynamic Small Business Search (DSBS) using keyword “Elekta” and NAICS 811210. Zero vendors were identified on DSBS.

A search was conducted on GSA, searching Elekta, with no contracts identified.

A search was conducted on FPDS for awarded contracts for services to the equipment resulted in many contracts for services to equipment awarded to Elekta Inc. as sole source awards.

A sole source letter was provided from Elekta Inc. from Jon Hyink, Healthcare Sales Director verifying that they are the sole provider and only vendor able to service the Elekta Infinity Linear Accelerator, MOSAIQ Radiation Oncology, and Oncentra Prostate.

There were no Service-Disabled Veteran Owned Small Business (SDVOSB) or Veteran Owned Small Business (VOSB) identified in the market research therefore the VA Rule of Two does not apply to this requirement.

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

Not applicable.

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

No expressions of interest were received.

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:

Elekta, Inc., is the OEM and the only source of the proprietary hardware and software required for maintaining the equipment. Market research will be conducted on a continuing basis to determine if additional sources enter the market.

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.

Emmanuel Sherman Date Staff Biomedical Engineer

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

VA New Jersey 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.

Natalie Acevedo Date Contracting Officer

NCO 2

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.

Tony Clemente Date NCO/PCO 02 Branch Chief

c. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve ($750K to $7.5 million (or $15.0 million for acquisitions described in FAR 13.500(c)) for other than full and open competition.

Joseph P. Maletta Date VHA Head of Contracting Activity (HCA)