JEFO Varian - SAN DIEGO - redacted.pdf

JUSTIFICATION FOR AN EXCEPTION TO FAIR OPPORTUNITY (JEFO)

VARIAN MEDICAL SYSTEMS, INC.

1. Defense Logistics Agency (DLA) Troop Support, Medical Supply Chain, Capital Equipment Division, is the contracting activity.

2. The action submitted for approval is a JEFO for the acquisition of one (1) Radiation Oncology Treatment Planning System (TPS) and one (1) Record and Verify System (RVS) from Varian Medical Systems, Inc.’s Radiology and Imaging contract SPE2D1-19-D-0029, valid through September 05, 2024.

3. Naval Medical Logistics Command customers have ongoing requirements for Radiation Therapy. At Naval Medical Center San Diego (NMCSD), two (2) Varian TrueBeam Linear Accelerator (LINAC) Systems have been recently purchased and are currently being installed. NMCSD initially planned to reutilize their existing TPS and RVS solutions to support the new LINAC systems, but the existing TPS and RVS solutions do not comply with CyberLOG Cybersecurity/RMF requirements and this prohibits them from being reutilized. NMCSD will not be able to treat patients in need of Radiation Therapy treatment until a replacement TPS and RVS solution is procured. The estimated total dollar for the replacements is

4. The authority waiving the competition requirements is FAR 16.505(b)(2)(i)(B), only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized.

Varian is the only vendor that can provide a TPS solution and a RVS solution which interface with the existing two (2) LINAC systems and also comply with the Defense Health Agency (DHA) Cyber Logistics (CyberLOG) Cybersecurity/Risk Management Framework (RMF) Requirements (updated March 25, 2019). The existing TPS and RVS solutions are not in compliance with CyberLOG/RFM requirements preventing NMCDS from reutilizing them as originally planned. All medical systems are required to meet DHA’s Information Assurance (IA) terms and conditions for Cybersecurity and RMF requirements. RMF is the criteria that dictates how medical systems must be architected, secured, and monitored while being connected to a Government network. The Cybersecurity and RMF process is required before a vendor can go through the process for an Authority To Operate (ATO). In addition, the system is required to have a business-to-business (B2B) connection for remote service support (the lack of remote service support forces NMCSD staff to rely on telephone and email communications and on-site service support). Thus, at a minimum, the equipment’s B2B connection must be utilized with software that is both (1) compliant with Government IA Terms and Conditions, and (2) authorized via the Government’s Cybersecurity and RMF process which is required before a system can achieve an ATO.

Varian is the only vendor with the capability of establishing a B2B connection which meets the minimum requirements stated above.

5. The Varian Radiation Therapy contract includes both fixed prices and variable prices for the purchase and installation of LINAC equipment due to equipment customization and varying site conditions. The prices for the fixed price portion of this requirement were determined fair and reasonable at time of contract award based on a comparison to Varian’s top commercial customer pricing and discount policies and sales to commercial customers. DLA will make a fair and reasonable price determination on the variably priced items based on a comparison with similar commercial sales. Based on the above facts, the Contracting Officer has determined that the anticipated cost to the Government will be fair and reasonable.

6. Market research was conducted by the end user technical experts in February 2020. This research consisted of a review of similar previous procurements and a market survey through search engines of open market contractors and Federal Supply Schedule contractors. Search engines utilized include Google, Bing, GSA Advantage and the ECRI sourcebook catalog. Vendors that can provide a TPS solution and a RVS solution include Varian, and . The TPS solution, , cannot comply with IA Terms and Conditions necessary to complete RMF process and will not commit to establishing a B2B connection for in order to provide remote support. did provide remote support through sessions, however NMCSD stopped using the sessions because they were deemed a cybersecurity risk. In addition, the NMCSD IA security scans have identified end-of-life issues with the thin client hardware and virtual desktop client software. The RVS solution, , also cannot comply with IA Terms and Conditions necessary to complete the RMF process and will not commit to establishing a B2B connection for in order to provide remote support. Currently is not providing remote support and offers only on-site support. As stated above, NMCSD requires equipment to be (1) compliant with Government IA Terms and Conditions, and (2) authorized via the Government’s RMF process, in order to establish a B2B connection for remote support. As neither nor have committed to meeting the Government’s minimum requirements, Varian is the only vendor capable of providing a TPS solution and a RVS solution that meet the Government’s minimum requirements.

7. There are no other facts supporting the use of this JEFO.

8. Varian Medical Systems is the sole vendor capable of providing the TPS and RVS systems. DLA does not anticipate any actions can be undertaken to overcome or remove barriers to fair opportunity for any additional procurements concerning the LINAC systems currently being installed. However, when new Radiation Therapy systems are acquired for NMCSD, DLA anticipates that they will be acquired on a full and open competition basis.

9. As the Contracting Officer, I hereby certify that the information contained in this justification is accurate and complete to the best of my knowledge and belief.

DATE JOHN R. JACKSON

Contracting Officer FSHA

I hereby certify that the requirements which form the basis of this justification are accurate, that these supplies meet the Government’s minimum needs and that this justification is accurate and complete to the best of my knowledge.

DATE

DLA Troop Support, FSDB

04/22/2020

04/22/2020

Digitally signed by

JACKSON.JOHN.ROBERT.

1292221149 Date: 2020.04.22 14:40:49 -04'00'

I have reviewed this justification and recommend approval.

DATE

Chief, Capital Equipment Division

I have reviewed this justification for legal sufficiency.

DATE

DLA Counsel – Troop Support

I have reviewed and hereby approve this justification.

DATE

DLA Troop Support Competition Advocate

04/23/2020