75N91024P00581_JandA.pdf

necessary to maintain the equipment in accordance with the most recent OEM maintenance and service procedures.

b. Project background.

In September 2014, the ROB acquired a Varian TrueBeam radiotherapy treatment linear accelerator and its associated components (H192104), and then in May 2017, the ROB acquired a second Varian TrueBeam radiotherapy treatment accelerator and associated components (H193045).

Linear accelerators like the TrueBeams are used to treat patients with radiation according to clinical protocols. This allows the physicians and staff to perform research to better understand the role of radiation in the treatment of cancer.

The Varian TrueBeam systems are critical to patient treatment; therefore, any malfunctions with the equipment must be diagnosed and corrected quickly. The accelerator must be calibrated accurately and maintained according to the manufacturer’s specifications, because any deviation from the design specifications could result in patient harm and compromise the integrity of data for ongoing research studies. Service outage due to equipment failure must be remedied promptly with emergency services to avoid harmful delays to patient treatment schedules.

A maintenance service agreement will also provide resources to answer user questions that may arise during clinical operations, service equipment on a regular basis as part of a preventative maintenance schedule and provide hardware and software upgrades as necessary to keep the equipment current in terms of functionality. These services shall be performed by highly trained service engineers, either remotely (e.g. – phone help desk, remote monitoring and diagnosis) or on-site depending on the nature of the issue.

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

a. Project title.

Maintenance and Service Agreement for two (2) Varian TrueBeam Radiation Therapy Systems.

b. Project description.

The purpose of this requirement is to procure annual maintenance and support services for two (2) Varian Medical System TrueBeam linear accelerators and their associated accessories. These systems are used extensively by NCI in providing critical care to patients. As such, it is essential that instruments are maintained to the highest standards.

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).

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

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

Varian Medical Systems is the designer and Original Equipment Manufacturer (OEM) of the TrueBeam radiotherapy treatment linear accelerators and their subsystems. To NCI’s knowledge Varian Medical Systems does not authorize third-party service providers, and as such is the only source for technically qualified staff with necessary access to proprietary parts, data, software, and drawings necessary to perform all aspects of maintenance and repairs, as well as provide technical support for the TrueBeam systems. It is essential that all parts, software, and work performed are seamlessly compatible with the OEMs intended design, as any deviation could potentially cause treatment delivery errors that may lead to serious injuries or death.

As the only vendor capable of providing technically qualified staff, Varian Medical Systems is also the only source able to provide an onsite response time of four (4) hours, which is essential for preventing disruptions to ROB’s clinical operations. Extended equipment downtimes for repairs could also have unintentional adverse effects on patients care efforts, making it essential that equipment is restored to an operational status in a timely manner. To further ensure minimal downtimes, Varian Medical Systems also provides secure remote monitoring capabilities for detecting and predicting pending component failures, which automatically alerts the technicians so that replacement parts can be ordered, and services scheduled without compromising patient care schedules.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a SAM.gov 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 of intent to sole source #75N91024Q00135 was posted to SAM.gov on 06/21/24 thru 06/28/24.

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

An Independent Government Estimate (IGE) was developed using historical data from past requirements for similar services, and the COR’s knowledge of the requirement and industry. Prior to awarding this requirement, the Contracting Officer (CO) will make a determination that the price is fair and reasonable. It is anticipated that determination will be made utilizing the IGE and historical data;

however, the CO reserves the right to utilize any other means deemed appropriate in accordance with FAR 13.106-3 (a)(2).

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 marketplace, there are no known additional sources for these services. The Project Officer conducted market research via internet, search engine, and professional journals, and was unable to identify other vendors that service this equipment. The posted Pre-solicitation notice of intent to sole source, as described in section 6 above, substantiates the Project Officer’s market research results as it only received one (1) response from the source stated under section 5 above.

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

All relevant facts supporting the utilization of procedures for other than full and open competition have been stated above.

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

In response to this requirement, only one (1) response was received. This response was from the proposed contractor stated under section 5 above.

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 its requirements to be successfully met under this requirement. However, upon the completion of the proposed purchase order, if additional services are required, the NCI program office and the Contracting Officer will conduct market research to determine if the level of services being procured are proper, and whether other suitable sources for services meeting the Government’s needs have become available in the marketplace.