P03- JNA 89B20047 SIGNED.pdf

DEPARTMENT OF VETERANS 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)(B) – Only One Capable Source

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

This Justification for an Exception to Fair Opportunity is on behalf of VISN 15, VA Kansas City, MO Health Care System, and will be executed by, the Veterans Affairs National Acquisition Center (NAC) located in Hines, Illinois.

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

Upgrade of Canon Toshiba Aquilion One Genesis 16cm/ 640slice CT scanner located at the Kansas City VAMC to the newest software revision which runs on Windows 10 Operating System (OS) to maintain compliance. This will include associated technical services necessary to complete hardware upgrades that are affected by the upgrade.

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

Upgrade to the existing Canon Toshiba 640-slice Aquilion One Genesis located at the

Kansas City VAMC.

The estimated total value of this equipment is $969,562.

(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).

The order will be issued on a sole-source basis in accordance with FAR 16.505(b)(2)(i)(B) Only One Capable Source as this is an upgrade to the original equipment ordered under delivery order VA797H-13-J-0821. The equipment was originally procured and installed in FY2016. Since that time, the manufacturer has released a “forklift upgrade” which allows the system to run on a Windows 10 OS. The original equipment manufacturer (OEM), Canon (formerly Toshiba) Medical Systems, is the only contractor who is able to provide the upgrade and as such is a logical follow-on to the original contract, due to the proprietary nature of the software upgrade. The OEM is the only organization capable of owning trade information about the system and as such is the only one qualified to provide and perform the upgrade, with the expectation that the systems continue operating as expected in a safe manner.

(5) A determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The items that are being requested are on the vendor’s High Tech Medical Equipment Indefinite Delivery/Indefinite Quantity (IDIQ) contract. The expected costs for the items on this contract have been determined to be fair and reasonable.

(6) Any other facts supporting the justification.

The order should be issued on a sole-source basis in the interest of economy and efficiency as a logical follow-on to a delivery order already issued under the IDIQ contract, provided that all the awardees were given fair opportunity to be considered for the original order:

Contract SPM2D1-09-D-8322/V797P-603 Delivery Order VA797H-13-J-0821. This is a medical device which received FDA 510K medical device certification in the specific configuration which the OEM manufactured it. This information is known only to the OEM.

(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.

At this time there are no actions that can be taken to remove or overcome barriers that led to the exception to fair opportunity. All future requirements will be addressed on a case-by-case basis.

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

I hereby determine that the anticipated cost/price to the Government for this contract action will be fair and reasonable and that this Justification is accurate and complete to the best of my knowledge and belief.

(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.

By signing this justification, the Facility Biomedical Engineer and end users (Radiology/Imaging) staff, certify 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)(B) because only one awardee can provide the supplies or services required at the level of quality required. 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.

Arturo Delfin VISN 15 Date Supervisory Biomedical Engineer VA Medical Center, Kanas City, MO

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.

Michele L. Mallicott Date Contracting Officer OPAL, National Acquisition Center High-Tech Medical Equipment, Ordering Division

Michael J. Kuchyak Date Senior Contract Officer OPAL, National Acquisition Center High-Tech Medical Equipment, Ordering Division

VHAKANDELFIA

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