CO_Signed_JEFO Over SAT_CO Memorandum_PO_691B40043 LOS ANGELES CA_approved.pdf

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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 Los Angeles CA Department of Veterans Affairs (VA) Medical Center and will be executed by the VA National Acquisition Center, NAC, located in Hines, IL.

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

This procurement is for Brainlab’s Exactrac SRT patient positioning system for the new LINAC replacement. This procurement will be integrated to work with the new LINAC to provide stereoscopic Xray and surface tracking for patient treatment. This will include the work to install onto the new LINAC.

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

Brainlab Exactrac Dynamic, which provides the ability for surface tracking and stereoscopic x-ray patient positioning to an existing LINAC for stereotactic radiosurgery and labor for install which needs to be coordinated with new equipment implementation: $528,720.29.

(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).

Only one such awardee is capable of providing the equipment and service. A new functioning x-ray patient positioning system is needed for the new LINAC in oncology to continue operating as needed. The Exactrac system is able to provide this needed tracking system for accuracy and precision in medical treatment.

Brainlab is the only vendor who can provide the needed surface tracking system for stereotactic x-ray positioning for Varian LINACs. The tracking system required is proprietary to Brainlab, and it is not available from other vendors in NAC HTME Program. Further, Brainlab also historically works closely with the vendor in their deployments and setups for LINACs to coordinate the installation of this system, which reduces costs and any oversights in the planning and requirements for this equipment installation. As this procurement is intended to be installed alongside the new LINAC installation, this will minimize any downtime, additional construction, and cost for labor hours. This sole-source procurement will decrease the impacts to

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Oncology’s ability to provide patient care, which is of a very time sensitive nature and requires precise timing and execution to effectively provide life-saving treatment.

Additionally, being procured as a sole source saves time and will allow the procurement to coincide with the LINAC installation, which saves government funds, manhours, and downtime for the machine which is beneficial to the government and veteran care.

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

All items are currently on Brainlab’s IDIQ contract 36H79719D0002. All items are priced at or below the contract price, previously determined to be fair and reasonable at the time of contract award. Although there have been changes to the industry and market conditions due to supply chain shortages and inflation, the prices remain stable and consistent with the awarded contract price.

(6) Any other facts supporting the justification.

Oncology treatment depends on and benefits heavily from timing precision to minimize impact to patient care and treatment planning for oncology patients who come specifically for this treatment.

(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.

At this time, there are no actions that can be taken to remove or overcome barriers that led to the exception to fair opportunity. All future requirements will be addressed on a case-by-case basis.

(8) The contracting officer’s certification that the justification is accurate and complete to the best of the contracting officer’s knowledge and belief.

I hereby determine that the anticipated cost/price to the Government for this contract action will be fair and reasonable and that this Justification is accurate and complete to the best of my knowledge and belief.

(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 proposal was reviewed and certified by the facility Biomedical Engineering and clinical end user and determined to meet the governments minimum requirements.

(10) A written determination by the approving official that one of the circumstances in (b)(2)(i)(A) through (E) 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 the supplies or services are unique or highly specialized, as Brainlab Inc. is the only contractor capable of providing their proprietary equipment.

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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.

Paul Dorregaray Date VAMC Los Angeles, CA VISN 22 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.

James Sullivan Date Contracting Officer VA National Acquisition Center – Hines High-Tech Medical Equipment Post Award Division

John Lewandowski Date Chief VA National Acquisition Center – Hines High-Tech Medical Equipment Post Award Division