Brand Name Justification.pdf

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Fluent 480 w/ airFCA & RGA-FES & HEPA
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12639524Q0210
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This document is a Brand Name Justification for a sole source acquisition of a Tecan Fluent 480 Base Unit for the USDA Animal and Plant Health Inspection Service (APHIS) National Veterinary Services Laboratories (NVSL).

The USDA APHIS is seeking to acquire the Tecan Fluent 480 Base Unit to automate sample processing and testing for a Highly Pathogenic Avian Influenza (HPAI) outbreak. The Tecan Fluent 480 is the only machine capable of meeting the agency's specific requirements, which include scanning barcodes, temperature control, plate washing, pipetting, plate sealing, and compatibility with existing software. Market research found the Tecan machine to be the only viable option, as competing products from Eppendorf and Hamilton did not fully meet the requirements. The justification cites the need for urgent action to respond to the HPAI outbreak as the basis for a sole source procurement under simplified acquisition procedures. The estimated value is not provided. APHIS plans to post the justification publicly to encourage future competition, and may release a competitive solicitation as time permits.

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United States Department of Agriculture Justification for Exception to Fair Opportunity

Brand Name Justification

FAR 16.505

Section 1: Limited Sources Justification

1.1 Identification of the Agency and Contracting Activity

USDA Marketing and Regulatory Programs, Information Technology Division (MRP-ITD), Contracting Activity:

USDA Animal and Plant Health Inspection Service (APHIS) 4700 River Road, Unit 45 Riverdale, MD 20737

1.2 The Nature and/or Description of the Action Being Approved

The USDA, APHIS, VS is managing a Highly Pathogenic Avian Influenza (HPAI) outbreak among poultry. HPAI and bovine. HPAI is a serious disease and requires a rapid response when validating the accuracy of the samples.

APHIS works with its federal, state, local and industry partners to quickly provide testing results.

The fully automated sample processing and testing machine targeted in this document is to be used to minimize the requirement for staff handling of diagnostic samples that could be a threat to their health or the environment. The machine must have these basic specifications:

• Scanning the barcode of each tube and generating an electronic document for the samples manipulated

• The ability to keep 96-well microplates warm or cold

• Shake 96-well microplates

• Wash microplates with specified buffer and maintain the ability to utilize 3 or more buffers for plate washing

• Pipetting 5uL to 1000uL of sample from each of the tubes and placing that sample in either a standard 96-well PCR plate or a standard 96-well deep well plate

• Sealing the PCR plate or Deep well plate with a plate sealer

• Must have an 8-channel pipetting arm

• Machine must be built as a stand-alone item

• Must be an air-based system

• Must be compatible with our current scripts (Fluent Control or Evo Software)

All of these activities must be performed inside a fully-enclosed, HEPA filtered benchtop cabinet. As described above, the utility of a cabinet that would perform all of these functions is to minimize the hands-on time for manipulation of diagnostic samples submitted to NVSL with unknown infection status therefore, technician manipulations must not be required for the length of the machine process.

Due to various circumstances and capabilities of the leading robotics companies machines (see below), the Tecan machine is the only company capable of meeting all of the above needs with a modified version of the Fluent 480 (see attached quote).

1.3 Description of the Supplies or Services Required to Meet the Agency’s Needs (Including the Estimated Value)

The proposed action is to renew the Cognos licenses, a web-based integrated business intelligence suite by IBM. It provides a toolset for reporting, analytics, monitoring of events and metrics and enables users to extract, analyze and report data. It also enables users to create interactive dashboards that helps MRP-ITD make informed IT decisions.

The Contractor shall provide the following products and services for each year of performance:

The machine must have these basic specifications:

• Scanning the barcode of each tube and generating an electronic document for the samples manipulated

• The ability to keep 96-well microplates warm or cold

• Shake 96-well microplates

• Wash microplates with specified buffer and maintain the ability to utilize 3 or more buffers for plate washing

• Pipetting 5uL to 1000uL of sample from each of the tubes and placing that sample in either a standard 96-well PCR plate or a standard 96-well deep well plate

• Sealing the PCR plate or Deep well plate with a plate sealer

• Must have an 8-channel pipetting arm

• Machine must be built as a stand-alone item

• Must be an air-based system

• Must be compatible with our current scripts (Fluent Control or Evo Software)

All of these activities must be performed inside a fully-enclosed, HEPA filtered benchtop cabinet. As described above, the utility of a cabinet that would perform all of these functions is to minimize the hands-on time for manipulation of diagnostic samples submitted to NVSL with unknown infection status therefore, technician manipulations must not be required for the length of the machine process.

Due to various circumstances and capabilities of the leading robotics companies machines (see below), the Tecan machine is the only company capable of meeting all of the above needs with a modified version of the Fluent 480 (see attached quote).

1.4 Authority and Supporting Rationale

1.4.1 Unusual and Compelling Urgency

HPAI can strike suddenly and spread fast, and it’s devastating for dairy industries and is considered an animal disease emergency. The USDA, APHIS is responsible for providing an immediate response to HPAI outbreaks to contain and eradicate the disease and protect our country’s animal health. If HPAI is not contained it would cause considerable and irreparable financial harm to the dairy industry and the federal government. It would also impact VS’ ability to meet its mission to protect the country’s animal health. If HPAI is not addressed, it would have a large effect on the nation’s dairy supply. The contracts needed to be awarded under Simplified Acquisition Procedures FAR 13.5 using the unusual and compelling authority of FAR 13.106-1 (b) (2) to obtain an immediate contractor response. In accordance with FAR

13.501 acquisitions conducted under the simplified acquisition procedures are exempt from FAR part 6, however this justification is prepared in accordance with FAR part 6.

1.5 Statement Demonstrating the Unique Qualifications of the Proposed Contractor of the Nature of the Action Requiring the Use of the Authority

The three leading automation companies were solicited for information about their machine capabilities to perform the aforementioned operations. These were: Hamilton, Eppendorf and Tecan. The Eppendorf company was quickly found to be unsuitable as their machines are not capable of plate sealing and therefore was eliminated from the search. Looking at the remaining two companies, Tecan was the only company with compatible operating language and machines as NBAF, therefore the equipment was selected for its utility in the project.

This is a brand name justification in accordance with FAR 16.505(a)(4), the purpose of this acquisition is to renew Cognos that will allow the USDA, MPRBS to have a secure platform dashboard environment across the department that enables APHIS to deliver an integrated user interface, business intelligence, analytics and reporting solution that provides sophisticated data exploration capabilities, dashboarding, professional report authoring and automated data preparation.

The Tecan Fluent480 is able to fulfill the functions listed above and is compatible with the National Bio and Agro Defense Facility (NBAF; our sister facility) current automation setup as well as the NVSL preexisting scripts. One of the goals of this project is to standardize the techniques and platforms in use in the APHIS diagnostic sections at both the NVSL and NBAF.

Due to this reason and the below listed reasons, the market on this purchase should be limited to the aforementioned machine setup.

1.6 Description of the Market Research Conducted and the Results or a Statement of the

Reason Market Research Was Not Conducted

Market research was conducted for potential sources during previous acquisitions for depopulation services. For this HPAI emergency need the market research consisted of internet searches to determine potential local vendors for this service and contacting known contractors with a proven record of past performance to determine availability to meet the emergency need and provide personnel within a 1–2-day notice. Because of the needed response time it wasn’t possible to go through the standard market research process as would be done with non-emergency acquisitions. This justification will be posted on Contract Opportunities which will allow visibility for other prospective vendors. The market research conducted included Eppendorf and Hamilton Liquid handling machines. The Eppendorf machine was quickly excluded from the search as they do not have an accessory capable of sealing plates coming out of the machine (one of the requirements specified above). While the Hamilton machine is can fulfill the requirements listed, it is not as compatible with many of the machines we utilize both within the NVSL and at NBAF. While the purpose of this project is to synergize the equipment and testing within the NVSL and NBAF, it is crucial to the project that the Tecan Fluent 480 is purchased rather than other similar equipment. If this equipment is not purchases, we will not be able to fulfill the needs of both NVSL and NBAF synergistically.

1.7 Any Other Facts Supporting the Justification and Use of Other Than Full and Open Competition

No other supporting facts or information other than what is stated above.

1.8 Listing of the Sources, if any, that Expressed a Written Interest in the Acquisition

No sources expressed an interest in this acquisition for this specific item.

1.9 Statement of Actions, if any, the Agency May Take to Remove or Overcome Any Barriers to Competition if Subsequent Acquisitions are Anticipated

This justification will be posted on Contract Opportunities which will allow visibility for other prospective vendors to have familiarity of the acquisition and remove barriers for future procurements.

As time permits, the USDA APHIS may release a competitive solicitation to establish a contract for these services.

1.10 Determination by the Contracting Officer that the Anticipated Cost to the Government Will Be Fair and Reasonable

The contracting officer performed price analysis to verify the pricing is fair and reasonable.

Additionally, a comparison of rates was performed based on the previous contract rates.

Section 2: Certifications and Approvals

Certifications & Approvals ☒ The information provided for this justification has been reviewed and certified accurate and complete as acknowledged by the affixed signature.

2.1 Program or Technical Personnel

Supporting data which form the basis for and included in this justification are certified accurate and complete.

Karthik Shanmuganatham NVSL Associate Director

The information contained in this justification is certified accurate and complete to the best of my knowledge and belief.

Linda W. Washington Contracting Officer

Additional Reviews & Approvals

Signatures are required at each threshold up to the total estimated dollar value of the acquisition

Procuring Activity Competition Advocate (if over $750,000, but not exceeding $15 million).

I have reviewed this justification and find it to be accurate and complete to the best of my knowledge and belief. Therefore, unless additional approvals are required as prescribed below, as advocate for competition for the procuring activity/MASCO, I hereby approve this justification. If required, my approval constitutes clearance for submission to the Head of the Procuring Activity.

Larry Nelson Mission Area Advocate for Competition

Head of the Procuring Activity (if over $15 million, but not exceeding $75 million). I have reviewed this justification and find it to be accurate and complete to the best of my knowledge and belief. Therefore, unless additional approvals are required as prescribed below, as Head of the Procuring Activity, I hereby approve this justification. If required, my approval constitutes clearance for submission to the Senior Procurement Executive.

Head of the Procuring Activity United States Department of Agriculture

Senior Procurement Executive of the Agency (if over $75 million). I have reviewed this justification and find it to be accurate and complete to the best of my knowledge and belief. Therefore, as the Senior Procurement Executive, I hereby approve this justification.

Senior Procurement Executive United States Department of Agriculture

2024-06-13T14:24:25-0500
KARTHIK KUMAR SHANMUGANATHAM
2024-06-18T23:31:32-0400
LINDA WASHINGTON

File details come from the government source that posted it. Updated .