P03 - JNA 506-B00058_Signed.pdf

1 | P a g e

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 10, Ann Arbor, MI Healthcare System and will be executed by the Department of Veterans Affairs National Acquisition Center, NAC, located in Hines, IL.

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

The activity proposes the issuance of a sole source delivery orders against Indefinite Quantity contract SPE2D1-19-D-0018 awarded to Medtronic for the purchase of Medtronic’s Stealth Station S8 System and trade-in of the Stealth S7. This will involve acquiring software, equipment, and installation services.

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

Medtronic’s Stealth Station S8 System is a surgical navigation system, and is composed of both software and hardware that is meant to be used during surgery to show a simulated image of the surgical tools over an medical image of the patient (for example, an image provided by the O-Arm that the Ann Arbor VA already possesses).

This feature provides the surgeon with immediate visual feedback during the surgery and is necessary when performing especially delicate or complex surgeries, when performing procedures on heavier patients, when performing Minimally Invasive Surgeries, and when requiring up-to-the-minute patient imaging.

We require the following equipment, accessories, software suites, and installation services:

Trade-in:

• STEALTHSTATION™ S7

Equipment:

• STEALTHSTATION™ EM KIT S8 CRANIAL ACCESSORIES

• CRANIAL INSTRUMENT SET - PASSIVE• PERCUTANEOUS PIN UPGRADE

• CRANIAL TOUCH-N-GO REGISTRATION KIT

• MICROSCOPE PROBE

• VERTEK PASSIVE BIOPSY KIT

2 | P a g e

• ENT NAVIGATION (INSTRUMENT SET)

• STEALTHSTATION™ EM KIT S8 FLAT EMITTER

Software:

• STEALTHSTATION™ SPINE SOFTWARE

• STEALTHSTATION™ CRANIAL SOFTWARE

• STEALTHSTATION™ 3D SOFTWARE

• STEALTHSTATION™ ENT SOFTWARE

• STEALTHSTATION™ MERGE SOFTWARE

• STEALTHSTATION™ DEEP BRAIN STIM (DBS+) STEREOTAXY SOFTWARE

Estimated Value = $ 509,646.55

(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).

Medtronic is the only manufacturer of the S8 Stealth Navigation System, which works in conjunction with the Medtronic O-Arm. Also, purchasing through the StealthSystem manufacturer (Medtronic) allows us to take advantage of trade-in discounts. The Ann Arbor VA currently possesses the Stealth S7 system (now entering end of life) and an O-Arm. The staff is currently trained on the StealthStation system, and the O-Arm’s vast set of unique advantages (on-demand imaging eliminates the need to send patient for radiology scanning; thus, reducing radiation exposure for both patient and staff,) which are only functional when connected to the StealthStation system. The Ann Arbor VA does not have any other surgical navigation system that can execute the features and functions of the O-Arm.

In addition, the O-Arm must be used in conjunction with the Stealth system to utilizes its maximum capabilities.

The installation cost savings and installation timelines will enable VISN 10, Ann Arbor, MI Healthcare System to provide uninterrupted care to patients. Moreover, the time necessary to do a pre-award survey during acquisition lifecycle planning would push the system life expectancy to dangerous levels, which would cause a break in service to on-going patient care where lifesavings measures are paramount in this environment. The Government would save time and money in support of the subject exception while also providing seamless support to patients while also continuing to support its mission.

(5) A determination by the Contracting Officer that the anticipated cost to the

3 | P a g e

Government will be fair and reasonable.

All items are currently on Medtronic’s. IDIQ contract SPE2D1-19-D-0018. 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.

(6) Any other facts supporting the justification.

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 Stealth S7 system at the Ann Arbor, MI Healthcare System without losing compatibility and functionality of the entire system.

(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.

4 | P a g e

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.

Date Prasad Manda Chief, 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.

Dante Allen Date

Contracting Officer

VA National Acquisition Center – Hines High-Tech Medical Equipment Ordering Division

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

VHAANNKoestD Cross-Out

VHAANNMandaP Typewritten Text 3/31/2021