VA797H-14-D-0007-001.pdf

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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 17, VA Medical

Center Houston, TX and will be executed by the Department of Veterans Affairs National

Acquisition Center (NAC – 36A797) located in Hines, IL.

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

This activity intends to issue a sole-source delivery order against Indefinite Quantity contract VA797H-14-D-0007 awarded to Accuray, Inc. (“Accuray”) to upgrade the existing RT Linac system at the Houston, TX VAMC.

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

The customer is in need of hardware and software upgrades to an existing CyberKnife system.

The system was last upgraded in 2014, since then, the vendor has introduced several new modules, software, and hardware that will help the department be more efficient, increase throughput, and allow for planning multiple patients simultaneously. The upgrade will allow additional functionality that will help with the following modules listed below.

The upgrade allows the performance of deformable registration, which will account for changes in the patient’s anatomy. As the patient progresses during treatment, the patient can gain or lose significant weight. This module allows the end user to evaluate the impact of the planned dose and provides the MD’s a tool to evaluate the safe and continued use of the planned treatment or if re-planning is needed.

Many patients have cancer recurrences or are present with new tumors. To treat these new tumors with radiation, it is difficult to assess the contribution of the previous radiation treatments. To plan for the new tumor, this module allows the end user to account for contribution from the previous radiation to the new tumor site and vice versa. A key safety concern is accounting for dose limits to critical organs; overdosing these critical organs can significantly harm the patient.

The estimated total value of this equipment and software is $360,250.00.

(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

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This order will be issued on a sole-source basis in accordance with Federal Acquisition

Regulation (FAR) 16.505(b)(2)(i)(B) as only one source is capable of providing the supplies and services at the level of quality required. Only Accuray, the original equipment manufacturer (OEM) of the existing RT Linac in Houston, TX is able to provide the FDA approved software that controls the Accuray equipment

The equipment was originally procured and installed in 2014 and has received only minor updates over the past 5years. The OEM is the only vendor able to provide the upgrade due to the proprietary nature of the system. The OEM is the only organization capable of owning trade information on the system and therefore is the only one qualified to provide and perform the upgrade.

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

All items to be purchased as part of this upgrade are currently on contract VA797H-14-D-

0007. The quoted price for each item is at or below the contract price, and pricing has been determined fair and reasonable at the contract level.

(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 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 justification is accurate and complete to the best of their knowledge.

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(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). Only one source can provide the required supplies and services.

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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.

Biomedical Engineer

Michael E. DeBakey VA Medical Center

2002 Holcombe Blvd

Houston, TX 77030

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.

Iliana Jorge

Contracting Officer

VA National Acquisition Center – Hines

High-Tech Medical Equipment Ordering Division

Reagan P. Criddle

VA National Acquisition Center – Hines

Chief, High-Tech Medical Equipment Ordering Division