SPE2D1-19-D-0018-007.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 Acquisition will be executed by the Department of Veteran Affairs, National Acquisition Center

– National Contract Service, High Tech Medical Equipment Ordering Division, for the Department of

Veterans Affairs, VISN 8, VAMC Gainesville, FL.

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

The VISN 8, VAMC Gainesville, FL. intends to issue a sole-source delivery order against Indefinite

Quantity contract 36H79719D0002, awarded to Medtronic for the purchase of Stealthstation S8 System upgrade to support the VISN 8, VAMC Gainesville, FL, Healthcare system.

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

The Medtronic Image-guidance navigation system (IGS) Stealth Station S8 is for use in the Surgical

Service/Operating room. The Medtronic S8 IGS will be utilized with the ENT and Neurosurgery sections of Surgical Service in the North Florida-South Georgia (NF/SG) VA Medical Center

(VAMC). The health system has a requirement for an Image-guidance navigation system to include:

a platform, clinical software, surgical instrumentation and a referencing system (which includes patient and instrument trackers). The IGS tracks the position of instrumentation in relation to the surgical anatomy, known as localization, and then identifies this position on preoperative or intraoperative images of the patient. The IGS platform supports both optical and electromagnetic

(EM) localization.

The estimated cost of this procurement is $640,931.00.

(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 delivery order, in accordance with FAR 16.505(b)(2)(i)(C). Delivery Order 36A79720F0073 will be awarded under IDIQ contract

SPE2D1-19-D- 0018.

The Medtronic Stealth is the only system that is compatible with the current instrumentation being used at this facility. All disposables that will be required are already on inventory and being used at this facility. Salient characteristics of the navigation system were also taken into consideration and based on the information; Medtronic is the only vendor able to supply the needed/required items.

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

All items are currently on the vendor’s HTME IDIQ contract. The quoted price for each item is at or below the contract price and is considered fair and reasonable.

(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 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)(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.

Coleman Blincoe Date

Facility Biomedical Engineer

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.

Glennis M. Haynes Date

Contracting Officer

VA National Acquisition Center – Hines

High-Tech Medical Equipment Ordering Division

Monica E. Mende Date

VA National Acquisition Center – Hines

Chief, High-Tech Medical Equipment Ordering Division