REVISED Justification for an Exception to Fair Opportunity (002) 36A79721F0070.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 Saint Louis 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.

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 a Radiation Oncology Treatment Planning System for VISN 15; VA Saint Louis Health Care System This acquisition is for new O-ARM to expand the OR staff’s capabilities to perform spinal surgery/diagnosis and through the use of 3D imaging

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

The Medtronic O-Arm O2 with Navigation, Multiple FOV, Advanced Viewing, ISO WAG, Collimated Axial 3D, and HD 3D.

The total estimated value is $553,044.00

(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).

Purchase Order# 657-B10030 will be awarded under IDIQ contract SPE2D1-19-D-0018.

The new O-ARM is a replacement of the Radiation Oncology Treatment Planning System at the VA Saint Louis Health Care System. The purchase of O-ARM will have the ability to capture 3D images and increasing accuracy and efficiency and will prevent disruption of service. This replacement will also fit with the current Medtronic Stealth Spinal Navigation System that is currently in place. Only one awardee can provide the supplies or services to meet the needs of the Government. Medtronic is the original equipment manufacturer (OEM) and the only manufacturer of the O-ARM.

This purchase request 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 by the government. No other manufacturer can provide the necessary technology to replace the O-ARM at the VA Saint Louis 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 Medtronic IDIQ contract SPE2D1-19-D-0018. 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.

This is a medical device which received FDA 510K medical device certification in the specific configuration between the O-ARM and the Stealth.

(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 requirements package was reviewed and certified by the facility Biomedical Engineering and end user (Surgical) staff and determined to be 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)(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.

Ryan M Pourcillie

VISN 15

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.

Michelle Williams Contracting Officer VA National Acquisition Center Hines High-Tech Medical Equipment, Contract Admin Division

Monica E. Mende Chief VA National Acquisition Center Hines High-Tech Medical Equipment Ordering Division