P03-JNA_646-B22020_Signed.pdf

DEPARTMENT OF VETERAN

AFFAIRS

Office of Acquisition and Logistics National Acquisition Center

P.O. Box 76 Hines, IL 60141

Justification for an Exception to Fair Opportunity FAR 16.505(b)(2)(i)(C) – Logical Follow-On

(1) Identification of the agency and the contracting activity.

This Justification for an Exception to Fair Opportunity is on behalf of VISN 4, Veterans Administration Medical Center (VAMC) Pittsburgh PA Healthcare system and will be executed by the Department of Veterans Affairs National Acquisition Center (NAC) located in Hines, Illinois.

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

This activity proposes to issue a sole-source delivery order as a logical follow-on against Indefinite Delivery Indefinite Quantity contract 36H79719D0018 awarded to Accuray Inc.

on September 9, 2019, for the purchase of the Radixact Synchrony® with ClearRT™ Helical Kilovolts Computed Tomography (kVCT) Max Package Software Upgrade for VISN 4, VAMC Pittsburgh, PA. Healthcare system.

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

This request is for the Radixact Synchrony® with ClearRT™ Helical kVCT Max Package Software Upgrade to the Linear Accelerator System and will be utilized by Radiation Therapy. This system will detect and deliver high dose radiation to the boundaries of tumors by using 3D computed data to guide its linear accelerator. This technique improves vascular enhancement by substantially increasing the relative vascular attenuation (in CT numbers) of contrast material and at the same time reduces radiation dose. This request will include associated software and hardware that are affected by this upgrade.

The total estimated value is $617,000.00

(4) An identification of the exception to fair opportunity (see 16.505(b) (2)) and the supporting rationale, including a demonstration that the proposed contractor’s unique qualification or the nature of the acquisition requires use of the exception cited. If the contracting officer uses the logical follow-on exception, the rationale shall describe why the relationship between the initial order and the follow-on is logical (e.g., in terms of scope, period of performance, or value).

This order will be issued on a sole-source basis as a logical follow-on to the following delivery order 36A79719N0402; PO 646-B82009, for $3,130,700.00 awarded in FY19 under contract 36H79719D0018 in accordance with FAR 16.505(b)(2)(i)(C). Purchase Order 646-B22020 will be awarded under Accuray Inc. IDIQ contract 36H79719D0018 delivery order 36A79723N0296. The Pittsburgh PA Healthcare system currently utilized Accuray Inc. Linear Accelerator System. This upgrade medical device has specific configurations compatible to the original equipment manufacturer (OEM) and is known only to the OEM. Upgrading Accuray Inc. Linear Accelerator System meets regulatory and safety requirements for this device and will extend the useful life of the system with the expectation that the system will continue operating as expected in a safe manner and continue to help VAMC Pittsburgh PA effectively take care of the Veterans. No other manufacturer can provide this service without losing compatibility and functionality of the entire system.

(5) A determination by the Contracting Officer that the anticipated cost to the

Government will be fair and reasonable.

All items are currently on Accuray Inc. IDIQ contract 36H79719D0018. The prices under the Accuray Inc. IDIQ contract remain the same from when they were awarded. The quoted price for each item is at or below the IDIQ not-to-exceed contract price, and the IDIQ contract pricing has been determined fair and reasonable by a contracting officer.

(6) Any other facts supporting the justification.

None

(7) A statement of the actions, if any, the agency may take to remove or overcome any barriers that led to the exception to fair opportunity before any subsequent acquisition for the supplies or services is made.

Future requirements will be handled on a case-by-case basis and all attempts will be made to provide fair opportunity to all schedule holders.

(8) The contracting officer’s certification that the justification is accurate and complete to the best of the contracting officer’s knowledge and belief.

By signing this justification, the requiring activity hereby certifies that the justification is accurate and complete to the best of their knowledge

(9) Evidence that any supporting data that is the responsibility of the technical or requirements personnel (e.g., verifying the Government’s minimum needs or requirements or other rationale for an exception to fair opportunity) and which form a basis for the justification have been certified as complete and accurate by the technical or requirements personnel.

The technical information contained in the proposal was reviewed and certified by the facility Biomedical Engineering and clinical end user and determined to meet the governments minimum requirements. By signing this justification, the requiring activity hereby certifies that the justification is accurate and complete to the best of their knowledge.

(10) A written determination by the approving official that one of the circumstances in (b)(2)(i)(A) through (F) of this section applies to the order

Based on the information contained herein, a determination has been made that this requirement meets the exception at FAR 16.505(b)(2)(i)(C) since it is a logical follow-on to an order already issued under the contract. The supplies or services ordered are unique and or highly specialized. All awardees were given a fair opportunity to be considered for the original order.

CERTIFICATION AND APPROVAL

TECHNICAL/REQUIREMENTS CERTIFICATION:

Pursuant to FAR 16.505(b)(2)(ii)(B)(9), I certify that any supporting data that is my responsibility and which forms a basis for the justification is complete and accurate to the best of my knowledge and belief.

Prepared by:

Caleb R. Abraham Biomedical Engineer

VISN 4

CONTRACTING OFFICER CERTIFICATION:

Pursuant to FAR 16.505(b)(2)(ii)(B)(8), I certify that the justification is complete and accurate to the best of my knowledge and belief.

Ann English Contracting Officer VA National Acquisition Center – Hines High-Tech Medical Equipment Ordering Division (003B6C2)

La Tonya Whiteside Senior Contracting Officer VA National Acquisition Center – Hines High-Tech Medical Equipment Contract Administrative Division (003B6C2)

Regina Blair Chief VA National Acquisition Center – Hines High-Tech Medical Equipment Ordering Division (003B6C2)