P03-JNA 523B31050-SIGNED.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 VISN 1, Roxbury, Massachusetts Veterans Affairs Medical Center (VAMC), and will be executed by the Department of Veterans Affairs (VA) National Acquisition Center (NAC) located in Hines, Illinois.

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

The activity proposes the issuance of a sole-source delivery order against Indefinite Delivery Indefinite Quantity (IDIQ) contract SPE2D117D0023 awarded to Siemens Medical Solutions, USA, Inc. for the purchase of a NAETOM Alpha Computed Tomography (CT) scanner.

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

The Radiology department requires the NAETOM Alpha CT scanner to diagnose disease or injury as well as to plan medical, surgical or rations treatments. Radiological services are crucial to early detection and treatment for numerous internal conditions throughout the body.

The estimated value of this order is $2,874,296.41

(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).

This system is classified as a medical device which has received FDA 510(k) medical device certification in the specific configuration it was manufactured by Siemens Medical Solutions, USA, Inc. Only one such awardee is capable of providing the supplies or services. The Siemens Naetom Alpha CT scanner is a new type of CT scanner called a Photon-Counting Detector (PCD) CT scanner which uses substantially different detector technology than a standard/conventional CT scanner. Siemens Medical Solutions is the only manufacturer that has a stationary Photon-counting Detector (PCD) CT scanner that is FDA cleared for clinical use, and the only Stationary PCD CT scanner on the

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VA’s High Tech Medical Equipment (HTME) IDIQ contract.

A Photon-Counting Detector (PCD) CT is a new CT technology utilizing a direct conversion X-ray detector, where incident X-ray photon energies are directly recorded as electronical signals. The design of the photon-counting detector itself facilitates improvements in spatial resolution (via smaller detector pixel design) and iodine signal (via count weighting) while still permitting multi-energy imaging. PCD- CT can eliminate electronic noise and reduce artifacts due to the use of energy thresholds. Improved dose efficiency is important for low dose CT. A Photon- Counting Detector (PCD) CT scanner allows for a very low radiation dose scans and contrast dose injections to reduce harm to the patients, while still greatly improving images and the improved ability to make critical diagnosis.

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

Government will be fair and reasonable.

All items are currently on Siemens IDIQ contract SPE2D117D0023. 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.

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 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.

The technical information contained in the proposal was reviewed and certified by the facility’s Biomedical Engineer and clinical end user and determined to meet the Government’s minimum requirements. 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) because the supplies or services are unique or highly specialized, as Siemens Medical Solutions, USA, Inc. is the only contractor capable of providing their proprietary equipment.

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

Date

Lisa Bradley Biomedical Engineer VA Boston Healthcare System-West Roxbury campus

CONTRACTING CERTIFICATION:

Julie Talley Contracting Specialist High Tech Medical Equipment, Contract Admin Division

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.

LaTonya Whiteside Date Senior Contracting Officer High Tech Medical Equipment, Contract Admin Division

Regina Blair Date VA National Acquisition Center-Hines Chief, HTME Ordering Division

COMPETION ADVOCATE APPROVAL:

Christopher D. Parker Date Head Contracting Activity Strategic Acquisition and National Acquisition Center Competition Advocate (orders > $750,000 up to $15,000,000) Pursuant to 16.505(b)(2)(ii)(C)(2)