Varian_J&A_Redacted.doc

Justification and approval for other than full and open competition

1. IDENTIFICATION OF THE AGENCY AND THE CONTRACTING ACTIVITY:

This justification is executed by the Naval Medical Logistics Command (NMLC), Fort Detrick, MD, on behalf of the Navy to meet Naval Medical Center (NMC) Portsmouth requirements.

2. NATURE/DESCRIPTION OF CONTRACT ACTION:

The proposed action is to support Government-owned Varian Linear Accelerator Radiotherapy Systems hardware and associated software located at Naval Medical Center (NMC) Portsmouth. 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. (CAGE: 0MAZ9), 3100 Hansen Way, Palo Alto, CA, 94304-1030, United States of America.

3. DESCRIPTION OF REQUIRED SUPPLIES/SERVICES:

Naval Medical Center (NMC) Portsmouth has a requirement for a non-personal services and maintenance contract for designated Government-owned Varian Linear Accelerator Radiotherapy 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 remote support (as allowable, via any existing authorized Defense Information Systems Agency (DISA) Business to Business Gateway). Coverage shall be included for all Linear Accelerator Radiotherapy Systems, subsystem components, and assemblies listed in the performance work statement. All maintenance provisions shall apply to hardware, firmware, and software, as appropriate, unless otherwise stated. The Contractor shall provide all parts, labor, materials, travel, personnel, supervision, and freight for the scheduled (preventive) and unscheduled (corrective) maintenance for all equipment identified in the performance work statement. Maintenance and support shall be provided for a period of performance spanning seven months, initiating 01 November 2019 and ending 21 May 2020. Subsequent to the base period of coverage, two (2) option years shall be available without lapse. Software support shall be provided for a period of performance spanning one year, initiating 01 November 2019 and ending 30 April 2020. Subsequent to the base year of software coverage, four (4) option years shall be available, without lapse.

The contractor shall provide telephonic and e-mail technical support during standard business hours (Monday–Friday, 7:30AM–5:00PM, local time). This contract shall provide unscheduled support/service coverage between the hours of 7:30AM and 5:00PM, local time in Portsmouth, from Monday through Friday, unless otherwise specified in the equipment listing in Technical Exhibit 1. Preventive maintenance shall occur outside of the first shift of Radiation Oncology, at a mutually agreed upon time, so as to avoid interruption of clinical workflow and overall patient care. The vendor and Contracting Officer’s Representative (COR) or Biomedical Equipment Repair Department (BIOMED) Technical Liaison shall agree upon such a time to conduct the four (4) quarterly preventive maintenance service instances.

The Contractor shall maintain the equipment within the original equipment manufacturer’s (OEM) specifications, in accordance with all US, State, and Local law and regulations, US Navy regulations, instructions, and Joint Commission requirements. The contractor must maintain the system, such that it meets Navy and DHA Cybersecurity requirements.

Vendor shall be an Original Equipment Manufacturer (OEM) authorized maintenance contractor for the proposed equipment/systems, such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty, and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

Defense Health Program (DHP) funds, in the amount of $265,818.00, will be used to fund the FY 20 maintenance contract. The total value of this contract, including all option years, will be $1,669,098.00.

4. IDENTIFICATION OF THE STATUTORY EXCEPTIONS PERMITTING OTHER THAN FULL AND OPEN COMPETITION:

The statutory exception permitting other than full and open competition for this acquisition is 10 USC 2304(c)(1) and FAR 13.501(a), Only One Responsible Source.

5. DEMONSTRATION THAT THE PROPOSED CONTRACTOR’S UNIQUE QUALIFICATIONS OR THE NATURE OF THE ACQUISITION REQUIRES USE OF THE AUTHORITY CITED:

Varian Medical Systems, Inc. (Varian) is the original equipment manufacturer (OEM) of NMC Portsmouth’s TrueBeam Linear Accelerator Radiotherapy System and associated ARIA Oncology Information System and Eclipse Treatment Planning System software. Varian field service engineers directly service the Linear Accelerator; Varian does not authorize any third-party service distributors. Furthermore, Varian has access to technology and software updates required to keep equipment fully functional and to meet all applicable standards and risk mitigation strategy milestones, including Food and Drug Administration (FDA) MedWatch and cybersecurity requirements. Parts and software updates/patches required for repairs are proprietary. Only Varian Medical Systems, Inc. can provide the required services for NMC Portsmouth’s Linear Accelerator Radiotherapy System, in accordance with the OEM recommendations, under a maintenance agreement.

6. DESCRIPTION OF EFFORTS MADE TO ENSURE THAT OFFERS ARE SOLICITED FROM AS MANY POTENTIAL SOURCES AS PRACTICABLE:

Market research was performed, the results of which are in paragraph 8. This requirement will be posted to NECO and/or FedBizOpps in accordance with FAR 5.202. The Government will evaluate any responses received.

7. DETERMINATION BY THE CONTRACTING OFFICER THAT THE ANTICIPATED COST TO THE GOVERNMENT WILL BE FAIR AND REASONABLE: The Contracting Officer shall determine the anticipated cost to the Government of the supplies/services covered by this Justification and Approval will be fair and reasonable by conducting a price analysis before an award is made. In addition, the Government anticipates that the negotiated contract price will reflect a discount from the vendor’s commercial price list and will be determined fair and reasonable.

8. DESCRIPTION OF THE MARKET SURVEY CONDUCTED AND THE RESULTS, OR STATEMENT OF THE REASONS A MARKET SURVEY WAS NOT CONDUCTED:

Market research was conducted in July and August 2019. It included a search of the Internet using Google, EDA, DLA Modality Matrix, and the ECRI Sourcebook. Accuray Incorporated, Elekta, Inc., and Varian Medical Systems, Inc. all manufacture and distribute their own linear accelerator radiotherapy systems. Accordingly, each also offers maintenance for its own hardware and software. Some also offer maintenance of other OEM hardware.

However, Varian Medical Systems, Inc. maintains proprietary control over software updates and upgrades to their manufactured TrueBeam linear accelerator. Further, no equipment technicians knowingly employed by third-party entities are OEM-certified by Varian to service Varian linear accelerators. Additionally, no authorized, official OEM part distributors were found during market research, nor noted by a representative of Varian. Therefore, Varian Medical Systems, Inc. is the only vendor capable of meeting the Government service and maintenance requirement.

9. OTHER FACTS SUPPORTING THE USE OF OTHER THAN FULL AND OPEN COMPETITION:

None.

10. LISTING OF SOURCES, IF ANY, WHICH EXPRESSED, IN WRITING, AN INTEREST IN THE ACQUISITION:

To date, no other sources have written to express an interest. This requirement will be posted on FedBizOpps in accordance with FAR 5.202. Any sources expressing interest in response to the synopsis will receive consideration.

11. STATEMENT OF ACTIONS, IF ANY, THE AGENCY MAY TAKE TO REMOVE OR OVERCOME ANY BARRIERS TO COMPETITION BEFORE ANY SUBSEQUENT ACQUISITION FOR THE SUPPLIES OR SERVICES REQUIRED:

Future requirements will be synopsized in accordance with FAR 5.203. For the reasons set forth in Paragraph 5, Naval Medical Logistics Command has no plans at this time to compete future contracts for the types of supplies/services covered by this document. If another potential source emerges, Naval Medical Logistics Command will assess whether competition for future requirements is feasible. However, there is constant attention to the market to insure that shall technology change, the source selection is reconsidered. U.S. Navy Subject Matter Experts are required to take into consideration the impact on the installed base of equipment when source selection occurs. All necessary components of integrated logistics support are taken into consideration.

12. POINT OF CONTACT:

The point of contact at the Naval Medical Logistics Command, Fort Detrick, Frederick, MD, regarding the contents of the Justification and Approval, is XXXXXXXXXXX who may be reached at 301-XXX-XXXX.

TECHNICAL AND REQUIREMENTS CERTIFICATION

REQUIRED BY FAR 8.405-6(e)(x)

I CERTIFY THAT THE FACTS AND REPRESENTATIONS UNDER MY COGNIZANCE WHICH ARE INCLUDED IN THIS JUSTIFICATION, WHICH FORM A BASIS FOR THIS JUSTIFICATION, ARE COMPLETE AND ACCURATE.

TECHNICAL COGNIZANCE

301-619-1101

Anthony Metzger, Code 03 Phone Date

Technical Reviewer

301-619-7002

Anthony Angelo, Code 03

Date

Requirements Cognizance

CONTRACTING OFFICER CERTIFICATION

REQUIRED BY FAR 8.405-6(h)(1)

I CERTIFY THAT THIS JUSTIFICATION IS ACCURATE AND COMPLETE TO THE BEST OF MY KNOWLEDGE AND BELIEF.

Date

Contracting Officer

301-619-0727

James Watkins, Code 02

Date

Contracting Officer

Level above KO Form 02.4G.AB 1 Nov 2012

LOG#15-10194