A5 Limiting sources LeicaGT450.pdf

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United States Department of Agriculture Justification for Other than Full and Open Competition

Federal Acquisition Regulation (FAR) Part 6.3

1. Identification of the agency and the contracting activity.

Requesting Agency:

USDA APHIS FADDL

National Bio and Agro-Defense Facility (NBAF) 1980 Denison Ave Manhattan, KS 66502

Contracting Activity:

USDA, APHIS, MRPBS, ASD

Minneapolis Procurement Branch Butler Square, Fifth Floor 100 North 6th Street Minneapolis, MN 55403

2. The nature and/or description of the action being approved.

This contract action is for the acquisition of services for which the Government intends to solicit and negotiate with only one source under the authority of Federal Acquisition Regulation (FAR) Subpart 13.106-1(b) - Soliciting from a Single Source. The Foreign Animal Diagnostic Disease Laboratory (FADDL) intends to award a Firm Fixed Price, sole source purchase order to Leica Microsystems Inc located at 10 Parkway North, Suite 300, Deerfield, IL 60015 for annual preventative maintenance, on site repairs, update installations, and support services for the Leica Aperio GT 450 Next Generation Scanner and SAM server at Foreign Animal Diagnostic Disease Laboratory (FADDL). The Foreign Animal Diagnostic Disease Laboratory is responsible for pathologic diagnostic characterization of viral pathogens as part of United States agricultural defense and maintains the instruments that are critical to national and international outbreak responses.

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

This procurement includes the purchase of the Aperio GT 450 Next Generation Scanner maintenance/service plan. Contractor shall provide on-site annual service and preventative maintenance for an Aperio GT 450 Next Generation Scanner (SIN 12412) as well as the SAM server associated with it.

Service and repairs shall include:

• Preventative Maintenance Annual Service

• 1 Preventative Maintenance visit per year.

• Visits shall include any necessary installation updates.

• Onsite Repair and Service as necessary. These services include spare parts, travel costs, and labor.

• On-site repairs will be inclusive of the service as well as rapid diagnostic evaluation of the instrument and all parts.

• Contractor will provide service engineers that meet the following requirements:

• Have specific expertise in servicing the Aperio GT 450 Next Generation Scanner rapidly in the event of an instrument failure and be able to acquire parts that are proprietary to the instrument.

• Be able to perform annual preventive maintenance of the instrument to verify its continued operation.

• Be trained and certified as Field Service Engineers or Field Application Scientists by Leica.

• Be able to access and provide software and proprietary parts for the Aperio GT 450 Next Generation Scanner.

The total estimated cost for this Purchase Order is $34,937.88

4. The statutory authority permitting other than full and open competition.

41 U.S.C. 3304(a)(l), as implemented by FAR 6.302-1, titled "Only one responsible source and no other supplies or services will satisfy agency requirements." This equipment is manufactured by Leica is the only vendor that can perform preventative maintenance, repair, and upgrade services on the Aperio GT 450 Next Generation Scanner. The scanner has been identified as a critical need, therefore requiring subsequent upgrades when needed. Leica Microsystems Inc. does not currently have any authorized maintenance dealers for this equipment model. To continue the required accreditation and continued warranty agreement certification/preventative maintenance on the Aperio GT 450 Next Generation Scanner, this agreement must be made with Leica Microsystems Inc.

5. A statement demonstrating the unique qualifications of the proposed contractor or the nature of the action requiring the use of the authority.

FAR 6.302-1 is the proposed authority as Leica is the sole manufacturer of the instrument and the only company in the market approved to perform the maintenance on it. Therefore, Leica is the only one source from which this requirement may be satisfied, and which meets the factual test for the use of the exception cited above.

The Aperio GT 450 Next Generation Scanner is an automated, high-capacity digital pathology slide scanner with an associated Scanner Admin Manager server that allows the scanning and storage of up to 81 slides per hour at 400x magnification. This scanner allows for diagnostic pathology specimens to be viewed from remote locations as well as the archive of critically important historical samples from the Plum Island Animal Disease Center. Leica is the only company that can maintain this piece of equipment, as it is a new enough model that no other company has been trained in on the preventive maintenance and repair of this item.

FADDL is required to respond immediately to high consequence pathogen outbreaks, and pathology-based diagnostics have long been critical as ancillary confirmation of a disease process as well as identification of emerging diseases. Being able to scan multiple samples for interpretation is critical mission function for rapid foreign animal disease outbreak response in the US and our international partners.

Without the service contract, the instrument could become inoperable and no longer able to support the diagnostic mission. The service contract ensures that the Aperio GT 450 Next Generation Scanner is continuously operating at optimum capacity to prevent disruption to work.

6. A description of efforts made to ensure offers are solicited from as many potential sources as is practicable.

Only one responsible source and no other supplies or services will satisfy agency requirements.

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

Only one responsible source and no other supplies or services will satisfy agency requirements. The Contracting Officer will determine if the prices are fair and reasonable based on historical data for previous procurements of Aperio GT 450 Next Generation Scanner preventative maintenance service contracts.

8. A description of the market research conducted and the results or a statement of the reason Market Research was not conducted.

A search resulted in no other source for servicing the Aperio GT 450 Next Generation Scanner. Open market research suggests that only Leica can furnish the requirements, to the exclusion of other sources, as Leica has employees that are authorized and trained to maintain the equipment, as well as access to the proprietary software required for the software up-grade/instrument updates.

9. Any other facts supporting the use of other than full and open competition.

Propriety equipment that requires proprietary software upgrades/updates.

10. A listing of the sources, if there is any, that expressed a written interest in the acquisition.

None

11. A statement of action, if any, the agency may take to remove or overcome any barriers to competition if subsequent acquisitions are anticipated.

Due to the equipment being proprietary and requiring proprietary software updates, no additional actions can be taken at this time to remove or overcome barriers to competition.

Certifications & Approvals

Supporting data that forms the basis for and included in this justification are certified accurate and complete.

Alicia O Toole Veterinary Medical Officer

The information contained in this Justification for Other Than Full and Open Competition is certified accurate and complete to the best of my knowledge and belief.

Contracting Officer

13 June 2025