Justification for an Exception to Fair Opportunity 553B50053 Unacceptable Delay CT REDACTED.pdf

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6525--36A79725F0220, 553B50053, 553B50056, NM Spect-CT, Modality: URGENT, Siemens Healthineers VISN 10, Detroit VAMC (VA-25-00086744)
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36A79725F0220
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Summary

This is a Justification for an Exception to Fair Opportunity (FAR 16.505(b)(2)(i)(A)) submitted by the Department of Veterans Affairs National Acquisition Center on behalf of VISN 10, Veterans Affairs Medical Center John D Dingell in Detroit, Michigan. The justification seeks approval to issue a sole-source delivery order against an existing Indefinite Delivery/Indefinite Quantity contract to procure a replacement SPECT-CT imaging system. The current Symbia T16 SPECT-CT equipment reached end-of-life and end-of-support status in 2024, with the original equipment manufacturer excluding it from maintenance service due to unavailable replacement parts. Despite a thorough search, Detroit VAMC located only one third-party vendor willing to service the equipment for one year at prohibitively high costs. The facility requires the replacement equipment installed by December 2025 to maintain uninterrupted nuclear medicine services for veterans, including cardiac stress tests, amputee imaging, DATSCANS for neurology, and other diagnostic studies. A competitive procurement through the regular consolidation cycle would not allow timely award and installation before the current equipment becomes completely out of coverage.

The justification identifies the exception as unacceptable delays under FAR 16.505(b)(2)(i)(A), as proceeding through normal fair opportunity procedures would significantly delay equipment acquisition and installation, disrupt an already constrained construction schedule, and risk service disruptions to the veteran population. The Contracting Officer performed a price audit and determined the proposed cost is fair and reasonable, with overall cost savings compared to existing contract prices. Installation work was evaluated as non-segregable from equipment furnishing, and Davis Bacon Act requirements were determined inapplicable. Supporting certifications were provided by the Chief Biomedical Engineer and facility clinical end users confirming the technical requirements were met. The justification was approved based on demonstrated urgency and the unique medical necessity of the combined SPECT-CT functionality that cannot be achieved through alternative vendors or equipment.

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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)(A) Unacceptable Delays

(1) Identification of the agency and the contracting activity.

This Justification for an Exception to Fair Opportunity is on behalf of VISN 10, Veterans Affairs Medical Center John D Dingell in Detroit, MI, and will be executed by the Department of Veterans Affairs National Acquisition Center 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 (IDIQ) Contract No. as awarded to .

Delivery Order No.:

Requisition Order No.:

Equipment:

Manufacturer:

The current CT Spect (Symbia T16) was end of life and end of support in 2024. The Original Equipment Manufacturer has excluded this equipment from the maintenance service contract because they cannot guarantee availability of replacement parts. The station has been unable to locate a third party willing to service the equipment for one year (2025); therefore, at the end of this calendar year this equipment will be out of coverage.

If this procurement were to undergo our regular procurement process via our upcoming consolidation cycle, an award could not be made timely enough to acquire and install the equipment prior to December 2025. Additionally, competing this acquisition would significantly stall an already constrained construction and installation schedule and place undue risk on the service our veteran population.

In consideration of the foregoing, this activity proposes to issue a sole-source delivery order as an urgent procurement against Indefinite Delivery/Indefinite Quantity contract awarded to for replacing VAMC Detroit Symbia T 16 Spect-CT system.

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

A Spect-CT Camera is used for all Nuclear Medicine studies. Currently it is especially used for:

amputations.

the DSPECT cardiac chair is down for service or having preventive maintenance performed.

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Spect- , Hida Scans, GI Bleeds or any other study, if the INTEVO is down for scheduled maintenance or repair services.

Services to patients will be improved with a new Spect-CT because it will have updated software, improved application processes and faster imaging processes. Nuclear Medicine will be able to offer:

Quicker throughput for Cardiac imaging.

Decreased waitlist for DATSCANS, increasing to 4/week, eliminating backlog.

Ability to increase services to Saginaw veterans by ability to do some same day services.

There will be no additional upkeep or other costs submitted to the NAC associated with this award. Any contract.

The extended installation proposal was evaluated by the Chief of Facilities engineer who compared the quote to the turnkey rubric and determined the installation work to be non-segregable from the equipment.

The Contracting Officer (CO) performed an assessment of the Davis Bacon Act (DBA) applicability. The CO made a determination based on the presented facts of the acquisition that the Statement of Work (SOW) includes construction work. In this case, the construction work included under the SOW is incidental and non-segregable to furnishing the equipment and is so merged with the non-construction work that it is not capable of being segregated as a separate contract. Under these conditions, FAR 22.402(b)(2) applies, and, therefore, the requirements under FAR Subpart 22.4, Labor Standards for Contracts Involving Construction, do not apply to this contract. The CO assessment has been documented to the contract files in eCMS.

IT IS IMPERATIVE TO HAVE A RELIABLE SYSTEM TO REPLACE THIS OUT-OF-SUPPORT EQUIPMENT.

Equipment Price:

Extended Installation Price:

(4) An identification of the exception to fair opportunity (see FAR 6.302-2) 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).

By combining Spect and CT, healthcare providers can obtain a comprehensive view of the body's function and structure, which is not possible with either scan alone. A Spect scan involves injecting, ingesting or inhaling a radiotracer before taking images. The main goal of a Spect scan is to look at the Veterans physiology and their body.

While Canon Medical Systems does offer a 64-slice CT, they do not offer the Spect unit. As a result, 3 | P a g e

The current was end-of-life and end of support in 2024. The OEM vendor has excluded this equipment from the maintenance service contract because it cannot guarantee availability of replacement parts. It was hard to find a third-party vendor willing to service the equipment for one year (2025); therefore, at the end of this calendar year this equipment will be out of coverage and if the equipment goes down it may stay down.

If this procurement were to undergo our regular procurement process via our upcoming consolidation cycle, an award could not be made timely enough to acquire and install the equipment prior to December 2025.

Detroit VAMC has selected a SPECT-CT with a layout very similar to the current equipment to decrease as much as possible the extended installation time needed to adjust the space to the new equipment requirements.

The new SPECT-CT will improve patient care in Nuclear Medicine, with updated software, improved application processes and faster imaging processes. We will be able to have:

increasing to 4/week, eliminating backlog.

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

A price audit was performed contract price and there is an overall cost savings of lower than the contract prices.

The Contracting Officer has determined that the proposed price is fair and reasonable.

(6) Any other facts supporting the justification.

pect-CT is 10 years. The current system was delivered and installed over 10 years ago in November 2014. The system was declared end of support in 2024 due to replacement parts no longer being produced for this system. Detroit VAMC could only find one third party vendor willing to service the end-of-life equipment for one year (2025), but due to the high costs the station did not choose to award a contract to this vendor. Detroit VAMC performed a thorough search of 3rd party vendors that could service the current Spect-CT, but none were able to offer reasonable prices. As a result, Detroit has an agreement with Siemens for best effort, but the equipment is completely out of coverage. If the equipment goes down it may stay down for lack of replacement parts.

To recap the current Spect-CT is end-of-life, end of support and out of coverage. Without fully replacing this equipment, Detroit VAMC will have to reduce patient load and send the Veterans out to receive care in the community at a high cost to the VA.

(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.

Radiology Service with the assistance of the Biomedical Engineering Department is creating a 5-year plan that will monitor all high-tech/high-cost medical equipment that is end of life and end of support to avoid encountering this situation in the future. Nonetheless, at this time, there are no actions that can be taken to

4 | P a g e remove or overcome barriers that led to the exception to fair opportunity.

(8) The Contracting O certification that the justification is accurate and complete to the best of the Contracting O 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 Engineer and clinical end user and determined to meet the G 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 FAR 16.505

(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)(A), whereby the agency need for the supplies or services is of such urgency that providing fair opportunity would result in unacceptable delays.

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