P03-JNA 626-B20012_Signed.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)(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 The Department of Veterans Affairs, Medical Center, Nashville, TN, VISN 9, and will be executed by The Department of Veterans Affairs National Acquisition Center (NAC) High Tech Medical Equipment Ordering Division, located in Hines, Illinois.

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

This activity proposes to issue a sole-source delivery order against Indefinite Delivery Indefinite Quantity contract SPE2D1-19-D-0018 awarded to Medtronic USA, Inc. for the purchase of the O-ARM O2 BASE UNIT for VISN 9, VAMC Nashville, TN. This system will be able to capture 3D images and provide axial views for surgeons to support pedicle screw placements and it offers lateral patient access without compromising mobility.

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

This request is for the O-ARM O2 BASE UNIT (mobile R/F unit) with complete Multidimensional Surgical Imaging System to support advanced 3D imaging for Neuro- Surgical cases. It will provide faster imaging with automated real-time, and pre-set positioning. The 2K x 1.5K digital flat detector enables higher dynamic range and resolution. The automated multi-plane imaging eliminates manual repositioning or the need for a second system (bi-planar Fluoro). This system includes the O-arm Imaging Stand, Mobile View Station (MVS) and DICOM 3.0 Compliant. The system supports sending locally created images across the network to another system. The Medtronic O-Arm is an approved VistA Imaging DICOM Modality interface, which means it has been tested in the VA environment and is approved for being able to send images to the VistA electronic medical record (EMR). It supports saving images to CD. It includes an X-Ray Grid that achieves improvement in contrast with higher grid ratio and carbon cover and it meet the needs of the VAMC Nashville, TN. This request will include associated software and hardware that are affected by this upgrade.

The total estimated value is $566,854.00

(4) An identification of the exception to fair opportunity (see 16.505(b) (2)) and the supporting rationale, including a demonstration that the proposed 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 626-B20012; DO 36A79722F0341 will be awarded under IDIQ contract SPE2D1-19-D-0018. The VAMC Nashville, TN requires that all equipment be compatible and compliant for patient care. Medtronic USA Inc. is the original equipment manufacturer (OEM) and the only vendor capable of providing this equipment. This upgrade has proprietary software and hardware which only the original vendor can secure, implement, and support. The new system is compatible with the existing equipment and will work as required without any additional costs to the facility to replace any existing infrastructure.

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. No other manufacturer can provide the necessary technology required 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 USA Inc. IDIQ contract SPE2D1-19-D-0018. Even though there have been increases to the industry and market changes because of the COVID-19 pandemic, the prices under the Medtronic USA Inc. IDIQ contract remain the same from when they were awarded. 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 certification that the justification is accurate and complete to the best of the contracting 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 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 proposal was reviewed and certified by the facility Biomedical Engineering and clinical end user and determined to meet 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.

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:

Wade Sidley

Biomedical Engineer

VISN 9

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 Admin Division (003B6C2)

LaTonya L. Whiteside Senior Contracting Officer VA National Acquisition Center Hines High-Tech Medical Equipment Admin Division (003B6C2)

Regina Blair Chief VA National Acquisition Center Hines High-Tech Medical Equipment Ordering Division (003B6C2)

, HTME Ordering Division