P03_-_PM_Part806.3_Atch2_FAR6_JA_OVER_SAT.pdf

OFOC SOP Revision 08 Page 1 of 4 Original Date: 03/22/11 Revision 08 Date: 04/18/2018

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C242-19-AP-0412

1. Contracting Activity: Department of Veterans Affairs, VISN 2, VA New Jersey Healthcare System, East Orange Campus.

Purchase request number: 561-19-1-668-0043

2. Nature and/or Description of the Action Being Processed: Network Contracting Office (NCO) 2 intends to award a sole sole-source service contract for the procurement of radiation equipment maintenance and support Elekta linear accelerator and brachytherapy systems with Elekta Inc. The anticipated period of performance is from January 1, 2019 to December 31, 2019 with the provision of four (4) option years. The annual cost is $391,346.21 with an estimated total cost of $1,956,731.05.

Base Year 01/01/2019 to 12/31/2019 $391,346.21 Option Year 1 01/01/2020 to 12/31/2020 $391,346.21 Option Year 2 01/01/2021 to 12/31/2021 $391,346.21 Option Year 3 01/01/2022 to 12/31/2022 $391,346.21 Option Year 4 01/01/2023 to 12/31/2023 $391,346.21

Option pricing is consistent with the base period throughout the length of the contract with no increase in cost.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The New Jersey Healthcare System located at 385 Tremont Avenue, East Orange, NJ 07018-1023, requires preventative maintenance, equipment support and software support package for highly specialized Elekta, Inc., radiation and oncology equipment (linear accelerators and brachytherapy systems). These are state of the art, sophisticated Bio-medical machines, which require OEM qualified service technicians, readily available OEM factory parts and emergency support when needed.

(1) Agility - Gold

(5) Electron Energies – Gold

(3) Photon Energies – Gold

(1) Elekta Infinity – Gold

(1) VMAT – Gold

(1) XVI Imaging – Gold (1)iViewGT – Gold

(1) Lantics & Impac Software

(1) Oncentra Prostate

The purpose of the service agreement is to reduce service cost and improve equipment turn-around time and reliability.

OFOC SOP Revision 08 Page 2 of 4

Revision 08 Date: 04/18/2018

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 FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per FAR 6.302-3;

( ) (4) International Agreement per FAR 6.302-4 ( ) (5) Authorized or Required by Statute FAR 6.302-5;

( ) (6) National Security per FAR 6.302-6;

( ) (7) Public Interest per FAR 6.302-7;

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Due to the proprietary nature of the technical manual and diagrams required to service the Linear Accelerators and Brachytherapy systems, no company other than Elekta, Inc., is qualified to provide maintenance and repair services on the Linear Accelerators and Brachytherapy systems. The proprietary nature of the equipment and use of other manufactures or service companies would void the warranties in effect.

Additionally, the software for the system is proprietary with no alternate sources available. The required preventive maintenance and software support services can only be obtained from the OEM, Elekta, Inc., and there are no other options currently available for meeting the Agency needs.

Maintenance and repair by an unqualified company with an inability to access necessary diagrams would result in the risk of irreversible damage to critical medical equipment valued over $2.5 million. The original provider of these services for the Brachytherapy system was Nucletron, the worldwide leader in brachytherapy treatment planning and delivery. Nucletron was acquired by Elekta, Inc., in early autumn 2011. The only other known vendor for this equipment is Varian. The Elekta, Inc., machines are not interchangeable with the Varian machines and the sources, maintenance are proprietary to each company. Elekta, Inc., is the only entity licensed by the Nuclear Regulatory Commission (NRC) to service the Elekta, Inc., Linear Accelerator and Brachytherapy system and to provide the radioactive sources which are specific to the devices.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: In accordance with FAR Part 10, market research was conducted by synopsis of the proposed acquisition, advising industry of the pending acquisition, and soliciting inquiries from interested parties. Market research was conducted on November 2, 2018. A sources sought notification was posted on FBO, SEWP and GSA eBuy; however, no qualifying sources were identified. A large business, The Remi Group responded to the sources sought stating they can service the equipment, however, they are not OEM trained or certified through Elekta Inc. Elekta submitted a sole source letter stating that they are the sole source provider authorized and able to service the Elekta Infinity treatment delivery system and Brachtherapy system. Efforts were made through a search of the Small Business Dynamic search tool under NAICS 811219 utilizing the keyword Radiological Maintenance. The search did not return any small business sources.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. Pricing analysis shall be accomplished by reviewing procurement history 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 Office reviewed the Independent

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Revision 08 Date: 04/18/2018

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., and/or its only other known industry source, Varian. 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: Market research was conducted utilizing the SBA Dynamic Small Business search under key word Elekta and NAICS 811219 which resulted in negative listing of an available small business source.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: Elekta, Inc., is the OEM and the only source of the proprietary hardware and software required for maintaining the equipment. Elekta, Inc., has communicated there are no authorized contractors to service its equipment. An exhaustive search of FBO revealed several J&A's for sole source procurements of the exactly similar services to the Oncology equipment described herein.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: No other sources were identified.

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.