N02RC92815-76_HHSN261201600102P--Redacted_SSJ_Redacted.pdf

Justification and Approval for Sole Source Acquisition Under the Test Program for

Commercial Items “Source Selection Information – see FAR 2.101 and 3.104”

1. Identification of the agency and contracting activity:

a. Federal agency and contracting activity: HHS, National Institutes of Health (NIH)

Sponsoring organization. National Cancer Institute (NCI) Center for Cancer Research (CCR) Radiation Oncology Branch (ROB)

b. Project Officer Information:

Project Officer Name:

Mailing address: 9000 Rockville Pike, Bethesda, Maryland 20892

E-mail address:

Telephone number:

2. Nature and/or description of the action being approved.

a. Acquisition purpose and objectives.

The Radiation Oncology Branch (ROB) of the Center for Cancer Research (CCR), National Cancer Institute (NCI) requests to enter into a service contract to maintain, repair, and provide software updates for a Government-owned Varian TrueBeam STX radiotherapy accelerator and its subsystems. The accelerator is utilized to care for patients receiving radiotherapy as part of their cancer treatment.

b. Project background.

In October 2014, the ROB, CCR purchased a Varian TrueBeam STX radiotherapy accelerator and associated components to treat cancer patients with radiation according to approved clinical protocols, and to perform research to better understand the role of radiation in the treatment of cancer. That Purchase Order number is HHSN261201300110U / V797P6077B (PIID / Referenced PIID) procured via the Defense Logistics Agency (DLA). The DLA was contacted, as part of the Market Research for this requirement, which stated that they did not currently have a maintenance contract with Varian or for this specific piece of equipment. The accelerator came with a one (1) year warranty that expired on October 27, 2015. A separate Purchase Order will allow for maintenance to the accelerator and its associated components through December 31, 2015; at which time this requirement for a service contract for a one (1) year base period plus four (4) Term Options will be established.

The delay in awarding a long term agreement is due to not receiving funding to enter into a new maintenance agreement nor having the required approvals to award a sole source maintenance contract prior to the expiration date of the equipment’s one (1) year warranty.

The Varian accelerator is critical in maintaining a patient’s treatment schedule for a successful outcome; therefore, any malfunctions with the equipment must be diagnosed and corrected quickly. Varian Medical Systems, Inc. is the sole manufacturer and distributor of the Varian TrueBeam STX radiotherapy accelerator, and is the only known source capable of providing the required maintenance services. The accelerator must be calibrated accurately and maintained according to the manufacturer’s specifications because any deviation from the unique design specifications could ruin countless hours of work, distort and destroy the integrity of information and/or ruin further studies, and significantly delay the Radiology Oncology Branch’s throughput.

A service contract will also correct problems that may arise during clinical operations, as well as monitor equipment on a quarterly basis as part of a preventative maintenance schedule, and will also provide hardware and software upgrades as necessary to keep the equipment current in terms of functionality. In addition, the agreement will allow the clinical environment to have immediate access to highly trained service engineers, and the ROB physicists and engineers can receive advise on first-line troubleshooting (which in many cases can fix the problem), as well as have the engineers arrive on-site quickly, if necessary to determine the root cause of the equipment failure, and then order and install the required parts to fix the problem.

The TrueBeam STX Radiotherapy Accelerator System consists of the following components:

Varian TruBeam-2 STXTrueBeam, S/N H192104;

High Definition Multi-leaf Collimator, S/N HHM0460;

MV Imager, S/N HXMB060;

KV Imager, S/NHXKB060;

RapidArc Controller, S/N HRD3000;

Optical Imager, S/N HOIB060;

SRS Intracranial package, S/N HOM0084;

SABR Extracranial package, S/N HCL1171;

Advanced IGRT and motion software package, and the PerfectPitch 6 degree-of-freedom (6DOF) couch, S/N HPR0153

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Project title. Preventative Maintenance and Service Agreement for Varian TrueBeam

STX S/N 2104

b. Project description. Varian Medical System shall provide: 1) four (4) quarterly preventive maintenance inspections; 2) emergency repair within twenty-four (24) hours of request for service; 3) all required replacement parts with the exception of consumable parts at no additional cost to the Government; 4) telephone and email trouble shooting support; and 5) free software upgrades where applicable.

Contractor personnel shall have a minimum of two (2) years of specialized factory training and experience on Varian accelerators and the TrueBeam system.

Requirement type.

Research & development (R&D) R & D support services X Support services (non-R&D)

Supplies/equipment Information technology (IT) Construction Architect-engineer (A & E) services Design-build Other (specify): ____________________

Type of action.

X New requirement Follow-on Other (specify): ______________________

Proposed contract/order type.

X Firm-fixed-price Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ Cost-plus-fixed-fee Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________ Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________ Other (specify): ___________ Completion Form Term form

Acquisition identification number. N02RC92815-76

c. Total estimated dollar value and performance/delivery period.

Total Independent Government Estimate (base and all option periods):

Period of Performance shall be:

Base Year: January 1, 2016 – December 31, 2016

Option Year 1: January 1, 2017 – December 31, 2017 Option Year 2: January 1, 2018 – December 31, 2018 Option Year 3: January 1, 2019 – December 31, 2019 Option Year 4: January 1, 2020 – December 31, 2020

4. Identification of the statutory authority permitting other than full and open competition.

This acquisition is conducted under the authority of 41 United States Code

(U.S.C.) 253(c)(1) as set forth in Federal Acquisition Regulation (FAR) 6.302-1.

X This acquisition is conducted under the authority of section 4202 of the Clinger-

Cohen Act of 1996, as set forth in FAR Statute: 13.106-1 (b)(2) and FAR 13.501- (a)(1).

This acquisition is conducted under the authority of the Services Acquisition

Reform Act of 2003 (41 U.S.C. 428a).

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

Proposed Contractor: Varian Medical Systems 2250 Newmarket Parkway, Suite 120 Marietta, GA 30067

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

This acquisition is for a maintenance service contract for a Varian TrueBeam STX radiotherapy Accelerator S/N 2104, and all associated components located in Building 10 CRC, of the main NIH campus in Bethesda, MD.

Varian Medical Systems is the sole manufacturer and distributor of this accelerator, and the only source that can provide immediate access to a full range of Original Equipment Manufacturer (OEM) replacement parts. In addition, the TrueBeam accelerator, including associated components and operating software is highly specialized and complicated, and integrates many Varian proprietary technologies. Furthermore, the TrueBeam accelerator is an entirely new design made specifically to satisfy the Radiation Oncology Branches’ scientific requirement, and Varian has the only knowledge of multiple, complex OEM-designed/installed modifications to this uniquely designed system. Varian also have a primary local service engineer, which is supported by a senior local service engineer, as well as regional engineers (1-3 hour drive) and the factory design and service staff. The support reaches as far back as the factory floor, if necessary. This is important, as the design is so new that components are still being refined and improved, and no other known service group has this ability.

The software supplied with this equipment is proprietary, and updates and patches are solely available through Varian Medical Systems. Software support is critical for managing the TrueBeam, as it is highly digital; as are adapted components, such as the Optical Surface Monitoring System or the Calypso GPS Beacon R-F transponder system.

This support is provided via a secure network connection so the Varian software engineer can work remotely, but also in conjunction with the in-house physics and engineering staff. If the problem is not solved in this manner, the software engineer(s) will arrive on-site to assist the hardware engineers and in-house support staff to solve the problem. The engineers can also provide telephone support that includes the latest OEM knowledge and recommendations.

It is critical for the ROB research community to have the Varian TrueBeam STX radiotherapy Accelerator, and its subsystems, calibrated accurately and maintained according to the manufacturer’s specifications. Any deviation from the unique ROB design specifications could ruin countless hours of work, distort and destroy the integrity of information and/or ruin further studies, significantly delay the ROB’s throughput, and ultimately impede the ability to provide contemporaneous vital patient treatment.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

A pre-solicitation notice was posted on FedBizOpps.gov on Sept. 28, 2015, with a response date of Oct. 7, 2015 at 3:00 pm EDT.

Only one (1) vendor submitted a capability statement in response to the pre-solicitation posting, . The technical point of contact for this requirement was provided the vendor’s capability statement for evaluation, and subsequently found the vendor not capable of performing the technical requirements presented in the FBO notice. There were several deficiencies in the vendor’s capability statement, with the most significant deficiency being that the vendor did not demonstrate that it can service the specific manufacturer /model /serial number of the equipment reflected in the FBO notice.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

The NCI Contract Specialist will consider the Independent Government Estimate and previous purchase order prices as determining factors for price reasonableness.

Based on the aforementioned, there is no reason to believe that price will not be fair and reasonable to the Government.

A final determination will be conducted prior to the award of this contract.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

Based on the NCI Project Officer’s and laboratory staff’s technical and scientific knowledge of the market place, there are no known additional sources for this equipment. The Project Officer conducted market research via internet, searched engine and professional journals, and was unable to identify other vendors that market this equipment or another with similar capabilities.

The posted Pre-solicitation notice, as described in section 6 above, substantiates the Project Officer’s market research results.

9. Any other facts supporting the use of other than full and open competition.

No additional information.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

One (1) response to the pre-solicitation posting was received . The technical Point of Contact found the vendor incapable of performing the technical requirements due to several deficiencies. The most significant deficiency was did not demonstrate they can maintain and/or service the specific manufacturer /model/serial number of the equipment reflected in the pre-solicitation notice.

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

The NCI anticipates the needs to be met successfully with the fulfilment of this requirement.

Competition for the follow-on acquisition will be sought and promoted, in accordance with Full and Open Competition procedures per FAR 7.102 and 10.002(b), which will be evident by the market research and list of potential sources to be described and documented in the forthcoming Acquisition Plan.

15. Chief of the Contracting Office and Head of the Contracting Activity signature(s).

Official Name & Title Signature Date

Chief of the Contracting

Office

Kristen A. Mistichelli, Director, NCI Office of Acquisitions

Head of the Contracting

Activity

Diane J. Frasier, Head of Contracting Activity; Director, Office of Acquisition and Logistics Management

16. Competition Advocate signature.

Official Name & Title Signature Date

Competition Advocate

Richard G. Wyatt, M.D.;

Executive Director, Office of Intermural Research, NIH, Competition Advocate for Non-R & D