Justification for Exception to Fair Opportunity- over SAT 636-B14014_MW.pdf

1 Page Source Selection Info – See FAR 3.104 & FAR 2.101

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)(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 23, Iowa City, IA and will be executed by the Department of Veterans Affairs National Acquisition Center (NAC- 36A797) located in Hines, Illinois.

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

This activity intends to issue a sole-source delivery order against Indefinite Quantity contract

Medtronic USA, Inc. SPE2D1-19-D-0018 to upgrade the existing Medtronic O-ARM system at VISN 23, Iowa City, IA.

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

Iowa City, IA is in need of a new O-arm system. This purchase will aid in the expansion of the OR staff’s capabilities to perform spinal surgery/diagnosis using 3D imaging provided by the Medtronic O-ARM’s integration with the Iowa City VA owned Medtronic Stealth navigation system.

The estimated price for the Medtronic O- ARM O2 Base Unit is $499,028.00

(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).

The order will be issued on a sole-source basis in accordance with FAR 16.505(b)(2)(i)(B).

Only one such awardee can provide the supplies or services. Medtronic is the only manufacturer of an O-ARM. Other C-ARM technologies are available; however, they do not contain the ability to capture 3D images and to integrate them with the Medtronic Stealth Spinal Navigation System owned by the Iowa City VA Health Care System.

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

The contracting officer for the resultant order has determined the prices offered to be fair and reasonable for this justification for an exception to fair opportunity. All items are priced at or below the contract price, which was previously determined fair and reasonable at time of contract award, and there have been no significant changes to the industry or market conditions that would result in changes to the reasonableness of the underlying contract prices.

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(6) Any other facts supporting the justification.

This is a medical device which received FDA 510K medical device certification in the specific configuration between the O-ARM and the Stealth systems. This information is known only to the original equipment manufacturer.

(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 contract holders when appropriate.

(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 Contracting Officer hereby certifies that the justifications are 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.

By signing this justification, the requiring activity hereby certifies that the justifications are 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) as only one contract holder is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized. All awardees were given a fair opportunity to be considered for the original order.

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CERTIFICATION AND APPROVAL

TECHNICAL/REQUIREMENTS CERTIFICATION:

Pursuant to FAR 16.505(b)(2)(ii)(B)(8), 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.

Date Katherine Vink

VISN 23

Biomedical Engineer

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.

Alaina Anthony Date Contracting Officer VA National Acquisition Center – Hines High-Tech Medical Equipment Ordering Division

Marissa Wright Date VA National Acquisition Center – Hines Chief, High-Tech Medical Equipment Ordering Division

Digitally signed by KATHERINE

VINK

Date: 2021.07.12 10:16:38 -05'00'

7/12/2021