PM_Part806.3_Atch5_FAR6_JA_OVER_SAT (002).pdf

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 5: Request for Sole Source Justification Format >SAT

OFOC SOP Revision 11 Page 1 of 5 Original Date: 03/22/11 Revision 11 Date: 02/11/2021

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C242-21-AP-2786

1. Contracting Activity:

Department of Veterans Affairs, VISN 2, 130 West Kingsbridge Road, Bronx, NY 10468-3904 service to be provided at Department of Veterans Affairs, NCO 2, Northport VA Medical Center, 79 Middleville Road, Northport NY 11768.

Purchase Request Number 632-22-1-454-0004

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

The proposed action is to support Government-owned Varian Linear Accelerator Systems hardware and associated software located at Northport VA Medical Center. The maintenance contract shall include all corrective maintenance, preventive maintenance, parts, labor, and travel. The Government intends on awarding a Firm Fixed Price (FFP) contract. The proposed source is Varian

Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304.

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

Northport VA Medical Center radiation Oncology has a requirement for a non-personal services and maintenance contract for designated Government-owned Varian Linear Accelerator Systems hardware and software licensing agreement for associated software.

The vendor shall provide unlimited telephone support, regularly scheduled preventive maintenance, inspections, calibrations, corrective maintenance tasks, unlimited emergency responses, and

SmartConnect remote support and compliance with applicable Federal and VA information confidentiality and security laws, regulations, and policies.

The vendor shall ensure that the equipment (hardware and software) functions in conformance with the latest Medical Device Regulations (FDA) including but not limited to (Class I, Class II, Class III and MDDS), validation, quality assurance and compliance), latest published edition of NFPA-99, TJC, OSHA, CDRH, ACR, and any other performance standards and specifications used when the equipment was procured by VA and any upgrades/updates.

Coverage shall be included for all Varian linear accelerator service system including ARIA and ECLIPSE Systems CLINAC-IX - H293437: Essentials and associated treatment planning system, components. All maintenance provisions shall apply to hardware, and software, as appropriate, unless otherwise stated. The vendor shall provide all parts, labor, materials, travel, personnel, OFOC SOP Revision 11 Page 2 of 5 Original Date: 03/22/11 Revision 11 Date: 02/11/2021

Acquisition Plan: 36C242-21-AP-2786 supervision, and freight for the scheduled (preventive) and unscheduled (corrective) maintenance for all equipment.

The vendor shall maintain the equipment within the original equipment manufacturer’s (OEM) specifications, by following the manufacturer’s recommendation for preventative maintenance (PM), repairs, calibrations, and modifications. Full-service contract shall include all necessary labor, tools, equipment, transportation, and parts required to perform repair and PM on listed equipment.

All equipment shall be maintained in proper operating condition as specified by the manufacturer.

Vendor shall have access to OEM’s parts, manuals, and schematics to perform the service. Vendors shall have their own schematics available on site at time of service. During scheduled service intervals, all parts including batteries and accessories shall be replaced.

Base period of 12 months plus four –12-month options, the estimated total amount is $1,348,885.00 Period of Performance:

Base Year: December 1, 2021-November 30, 2022 Option year one: December 1, 2022-November 30, 2023 Option Year two: December 1, 2023-November 30, 2024 Option Year three: December 1, 2024-November 30, 2025 Option Year four: December 1, 2025-November 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;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4 ( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by 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):

Varian Medical Systems, Inc. is the original equipment manufacturer (OEM) of the Varian linear accelerator service system including ARIA and ECLIPSE Systems CLINAC-IX - H293437: Essentials and associated treatment planning system software. Varian Medical Systems, Inc. field service engineers directly service the Linear Accelerator; Varian Medical Systems, Inc. does not authorize any third-party service distributors. Furthermore, Varian Medical Systems, Inc. has access to technology and software updates required to keep equipment fully functional and to meet all applicable standards and risk mitigation strategy milestones, and cybersecurity requirements. Varian’s Clinac, ARIA, Eclipse, and Velocity products use proprietary Varian technology. SmartConnect is Varian’s proprietary remote support and diagnostic service tool technology used by Varian support personnel. SmartConnect meets all VA cyber-security and PHI requirements and is fully vetted and

Acquisition Plan: 36C242-21-AP-2786

OFOC SOP Revision 11 Page 3 of 5 Original Date: 03/22/11 Revision 11 Date: 02/11/2021 approved through a Memorandum of Understanding (MOU) and interconnection security agreement between the Department of Veterans Affairs and Varian Medical Systems, Inc. Therefore, only Varian Medical Systems, Inc. can provide and install Varian software upgrades and firmware patches for the Varian linear Accelerator System.

Please refer to: MEMORANDUM OF UNDERSTANDING AND INTERCONNECTION SECURITY AGREEMENT Between Department of Veterans Affairs And Varian Medical Systems, Inc. January 14, 2020, Version 1.0

Linear Accelerator equipment is utilized during special therapy procedures in Radiation Oncology to destroy cancer cells in body tissue/organs. This particular equipment model is currently new, state-of-the-art and of high technical complexity. As such, only the Original Equipment Manufacturer (OEM) field service engineers are trained and experienced in the maintenance and repair requirements, and most importantly, have a full understanding of the equipment’s inherent safety risks for both patients and Radiation Oncology staff.

The Medical Center has only one Linear Accelerator on site. No other equipment can be utilized for this same purpose. It provides efficient, accurate, and advanced cancer treatment for both inpatients and outpatients. Each patient typically receives treatment several times weekly (sometimes daily) on a predetermined schedule over the course of several weeks and months. Any periods of equipment downtime will directly affect or disrupt a treatment schedule/plan. In the event of downtime, the Medical Center would be responsible for paying patient transportation and treatment costs at other location(s) and expose the VA to additional liability associated with transportation of critical patients and delayed treatments.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

Market research was performed, the results of which are in section 8. August 19, 2021 a notice to intent to award sole source was posted on Contract Opportunities (beta SAM) Notice ID:

36C24221Q1363, the notice received zero responses. This requirement will be sole sourced to Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304.

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

The anticipated price of this contract is estimated to be $1,348,885.00 for the period of performance December 1, 2021-November 30, 2026. The Contracting Officer shall compare proposed pricing to the IGCE and available data form previous contracts for similar procurements, such as contract Number VA242-17-P-0145 for the period of performance of November 1, 2016- October 31, 2021 the total value is $1,260,854.00.

If the Contracting Officer cannot determine whether an offered price is fair and reasonable, even after obtaining additional data from sources other than the offeror, then the Contracting Officer

OFOC SOP Revision 11 Page 4 of 5 Original Date: 03/22/11 Revision 11 Date: 02/11/2021 shall require the offeror to submit data other than certified cost or pricing data to support further analysis. This data may include history of sales to non-governmental and governmental entities, cost data, or any other information the Contracting Officer requires to determine the price is fair and reasonable.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

As described in Section 6 above, market research, in accordance with FAR Part 10, The Contracting Officer conducted additional market research for this new procurement which included a search on U.S. Department of Veteran Affairs (VetBiz), Small Business Administration (Dynamic Small Business) website, GSA (eBuy) RGQ ID:1515386, source sought notification was posted on Contract Opportunities (beta SAM) Notice ID: 36C24221Q1363 and a notice to intent to award sole source was posted on Contract Opportunities (beta SAM) Notice ID: 36C24221Q1363 on August 19, 2021, the notice received zero responses.

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

The Linear Accelerator Systems are proprietary to Varian Medical Systems, Inc. who do not train nor authorize other companies to provide services, repairs and software updated/upgrades. Delays associated with repair of major medical systems which provide diagnosis, surgical intervention, treatment for life threatening diseases and life-support are not tolerated because they result in study/treatment cancellations, additional cost to transfer patients to other institutions, and in certain instances can result in loss of life. The usage of any third-party vendor without expert experience on the Varian Medical System to provide service for sophisticated, highly-complex, is unheard of throughout the hospital community. There is too much liability when patient lives are at stake. Poorly maintained systems can fail in the middle of a procedure.

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

Varian Medical Systems, Inc.

3100 Hansen Way Palo Alto, CA 94304

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:

In situations involving medical equipment, it is difficult to remove barriers to competition because the OEM is the only qualified company capable to provide the repair and maintenance of its own medical equipment. This is especially true where proprietary software, specific diagnostics tools, and specialized electronics are used to maintain the equipment in accordance with OEM specifications and VA facilities practice standardization. Unless the manufacturer chooses to license its software and authorize local service providers to maintain the equipment, the only alternative would be to replace the existing equipment with a more generic brand. At this time, Northport VA

OFOC SOP Revision 11 Page 5 of 5 Original Date: 03/22/11 Revision 11 Date: 02/11/2021

Medical Center is satisfied with the quality and operation of the installed equipment, its maintenance and repair. Northport VA Medical Center currently does not have the sufficient budget to replace the Varian Linear Accelerator Systems. Considerations for new equipment will be made when the existing equipment reaches the end of its life cycle span.

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.

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.

Nader El-Miniawi DATE Chief, Biomedical Engineering/HTM Northport VAMC (632)

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.

Name: Safa Shleiwet Date Contracting Officer, Services II

Facility: 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.

Name: Rachel Beason Date

Branch Chief, Services II Facility: NCO 2

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 recommend approval (if over $75 million) or approve ($750K to $75 million) for other than full and open competition.

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

NADER EL-MINIAWI 154001 Digitally signed by NADER EL-MINIAWI 154001 Date: 2021.10.22 12:11:48 -04'00'

SAFA S. SHLEIWET

336871

Digitally signed by SAFA S.

SHLEIWET 336871

Date: 2021.10.25 09:24:44 -04'00'

Rachel A. Beason 966443 Digitally signed by Rachel A. Beason 966443 Date: 2021.10.26 11:55:26 -04'00'