Att3_BNJ_Varian_Signed_Redacted.pdf

oncology radiation equipment, and it securely interfaces with NIH health systems.

Varian Medical Systems is the original software publisher for the ARIA and Eclipse software. ARIA is designed to manage all therapeutic and diagnostic data for each patient, including clinical images such as CT (computerized tomography) scans. The Eclipse treatment planning component takes this patient data and simulates radiation delivery mapped onto the clinical images, using sophisticated proprietary algorithms to calculate the correct radiation dose and path. This treatment plan is transferred to the Varian Medical Systems TrueBeam linear accelerators which deliver the correct therapeutic radiation to the patient.

The ARIA-Eclipse system also stores all these parameters as well as data from the TrueBeam treatment sessions to ensure that the patient is receiving the same correct dose over the days or weeks of daily fractionated dose radiotherapy.

No patients can be treated in the Radiation Oncology Branch clinic without the ARIA-Eclipse software, so it is essential that it these software packages are covered with a comprehensive SSA contract. The Varian Premier Assurance Essentials program provides periodic maintenance inspections for software and associated computer hardware, software upgrade/updates, training for software upgrades or an annual refresher in the absence of an upgrade, remote software support, on-site regular hours and emergency service if remote service is unable to remedy an issue, and parts coverage (except consumables). The Essentials coverage plan also provides for discounts on labor rates, additional training, and the purchase of additional licenses.

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

a. Project title. Varian ARIA-Eclipse Software Support

b. Project description. See Statement of Work (SOW)

Requirement type.

Research & development (R&D) R & D support services Support services (non-R&D) Supplies/equipment Information technology (IT) Construction Architect-engineer (A & E) services Design-build Other (specify): ____________________

Type of action.

New requirement Follow-on (PO# HHSN261201800587P) Other (specify): ______________________

Proposed contract/order type.

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): IDIQ Other (specify): ___________ Completion Form Term form

Acquisition identification number.

Requisition #6626953

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

Total estimated dollar value for this portion of the requirement is

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 modified to reflect that the procedures in FAR subpart 13.5.

This acquisition is conducted under the authority of FAR subpart

13.5 in accordance with 41 U.S.C. 1901 or 1903.

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 brand name producer:

Varian Medical Systems 3290 Northside Parkway Atlanta, GA

b. Nature of the acquisition and proposed unique qualifications of the brand name items:

The NIH/NCI/ROB utilizes Food and Drug Administration (FDA) approved ARIA-Eclipse-TrueBeam medical treatment systems for radiation treatment of cancer patients. These radiation systems include the base units, peripheral devices, and software. Currently, the ROB requires ten

(10) additional ARIA RO Smart Space licenses, and one (1) ARIA eDoc license to accommodate access for additional staff to this system. To NCI’s knowledge there is no other FDA-approved software’s which are currently compatible with the Varian TrueBeams, and Eclipse and Insightive software currently utilized by the ROB.

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.

As required by FAR Subpart 5.2, a SAM.gov combined synopsis solicitation will be publicized and cited as a commercial item purchase (as stated FAR Part 12) with the authority to use simplified procedures for certain commercial items as authorized in FAR 13.500(a). In accordance with FAR 5.102(a)(6), the brand name justification will be published with the solicitation.

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

In accordance with FAR 13.106-3 (a)(2), the Contracting Officer will make a price reasonableness determination as appropriate and will document it in the award file. It’s anticipated that this determination will be based off historical data from the previous awards for similar services, and the Independent Government Estimate provided by the Program Officer.

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.

NCI/CBIIT staff assessed the feasibility of other software solutions other than the brand name. The ARIA, Eclipse, and TrueBeam systems are heavily integrated systems that are FDA approved and utilized for ongoing patient care. A change from ARIA currently is not feasible. ARIA is currently used to support these systems, and to provide accurate patient care and no other software is currently able to be integrated with the Eclipse and TrueBeam, while upholding FDA compliance.

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

All facts are annotated above.

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

Currently, no other sources have expressed interest in the requirement in writing.

However, as annotated above in Section 6, this justification is to be posted with the solicitation. If additional sources express interest in this requirement, it will be documented in the contract file.

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.

In the event NCI requires additional service not covered under this procurement, the proposed requirement will be synopsized through SAM.gov. The Government anticipates future follow-on renewals of this requirement. This is an integrated software system installed on a computer hardware platform. These components work as integrated system, and it is therefore not feasible to “break out” the services provided by this requirement into segments to facilitate competition.

12. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Official Name & Title Signature Date

Project Officer

Project Officer’s

Immediate Supervisor

13. Contracting Officer certification.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Official Name & Title Signature Date

Contracting Officer