SPE2D1-19-D-0018-009.pdf

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 12, VAMC Hines, IL Healthcare 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.

This activity proposes to issue a sole-source delivery orders against Indefinite Quantity contract SPE2D1-19-D-0018 awarded to Medtronic USA, Inc. for the purchase of the StealthSystem S8 System. This is an upgrade to the existing Medtronic USA, Inc. for VISN 12, VAMC Hines, IL Healthcare System. This purchase will also include associated 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.

The Hines, IL VA need an updated Medtronic USA, Inc. StealthSystem S8 System. Hines Neurosurgery service line currently has The StealthStation S7 and per the manufacturer this system is being discontinued and will not be in service after 2019. The StealthSystem S8 is the next upgraded system to the StealthStation S7. The StealthStation S8 is the only image guidance system available that can support and work two services, ENT and Neurosurgery patients. Significant ROI will be realized from joint-service line utilization and back-up redundancy.

The StealthSystem S8 improves on prior limitations in both hardware and software. The use of highly specialized S8 StealthStation image guidance has now become standard of care in the VA for sinus surgeries, cranial surgeries, skull base surgeries, and is constantly growing in use for spine surgery. Image guidance is crucial for safe and complete surgery when performing sinus surgery which involves clearing the skull base, operation around the orbit and opening the frontal sinuses. StealthStation S8 is state of the art highly unique resource for assisted surgery. Updating the hardware and software will allow the VA to maintain the best quality of care.

The total estimated value is $513,877.00.

(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 as a logical follow-on to delivery order VA690-P-0850 issued under PO# 578-GT9029 in the amount of $269,505.51 awarded 2/26/2009 in accordance with FAR 16.505(b)(2)(i)(C). Purchase Order # 578-B98035 will

1 'Page be awarded under Medtronic USA Inc. IDIQ contract SPE2D1-19-D-0018.

The new reading stations in Radiology is an upgrade to the current equipment's hardware and software. The updated server is required for VISN 5, VAMC Washington DC to be compatible and compliant for patient care. Only one such awardee can provide the supplies and service. The equipment was originally installed in FY2009. Since that time, the manufacturer has released an upgrade the StealthStation S8, that will continue to benefit the ENT and Neurosurgery patients.

The follow-on order will be issued on a sole-source basis as only one such awardee can provide the supplies or services required at the level of quality required for the workstation integration package. No other manufacturer can provide the necessary technology to upgrade the current purchased system with the VA without losing compatibility and functionality of the entire system. The expectation is that the systems continue operation 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.

All items are currently on Medtronic USA Inc. IDIQ contract SPE2D1-19-D-0018 awarded 6/4/2019. 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 in accordance with 13.106-3, 14.408-2 and Subpart 15.4.

(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.

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

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Sie e Campbel Business Managei; SSL Edward Hines J.R. VA Hospital, VISN 12

(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. 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:

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

Monica Mende Chief VA National Acquisition Center — Hines High-Tech Medical Equipment Ordering-B Division

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