NOI001640 - JA.pdf

FEDERAL BUREAU OF INVESTIGATION

FINANCE AND FACILITIES DIVISION | PROCUREMENT SECTION

JUSTIFICATION AND APPROVAL (J&A) FOR OTHER THAN

FULL AND OPEN COMPETITION

UNCLASSIFIED

UNCLASSIFIED

RequisiƟon Number: SHOP-PR-26-001640 Tecan Fluent 480

Date: 04/13/2026

EsƟmated Contract Dollar Value

1. IdenƟficaƟon of the agency and contracƟng acƟvity.

The U.S. Department of JusƟce, Federal Bureau of InvesƟgaƟon (FBI), Procurement SecƟon (PS), NaƟonal AcquisiƟon Programs Unit (NAPU), has prepared this jusƟficaƟon for other than full and open compeƟƟon for the acquisiƟon of a Tecan Fluent on behalf of the Laboratory Division (LD), Biometrics Analysis SecƟon (BAS), DNA Casework Unit (DCU).

The nature and/or descripƟon of the acƟon being approved, i.e., sole source, limited compeƟƟon, establishment of a new source, etc.

In accordance with a statutory excepƟon to the fair opportunity process, the FBI contemplates the award of a sole-source, firm-fixed-price, one-Ɵme, delivery order of one (1) Tecan Fluent 480 instrument to Tecan USA, Inc., 9401 Globe Center Drive, Suite 140, Morrisville, NC 27560.

2. A descripƟon of the supplies or services required to meet the agency’s needs.

The FBI Laboratory currently uses Tecan RoboƟc WorkstaƟons throughout the DNA analyƟcal process.

This equipment is manufactured by Tecan, U.S. Inc. and they are the only authorized vendor that can perform prevenƟve maintenance and rouƟne service on the Tecan RoboƟc WorkstaƟons. ValidaƟon was performed and the Tecan automated workstaƟons proved best suited for the DNA automated processes used by the FBI. This comprehensive evaluaƟon resulted in the recommendaƟon to use Tecan, US RoboƟc WorkstaƟons for DNA analysis at the FBI Laboratory.

JUSTIFICATION AND APPROVAL (J&A) FOR OTHER THAN

FULL AND OPEN COMPETITION

UNCLASSIFIED

The purchase of the Tecan Fluent 480 will result in more efficient processing of DNA samples, using the current validated roboƟc plaƞorm. Use of any other roboƟc workstaƟons other than those currently specified in the Laboratory Division’s quality documentaƟon would require development of new protocols, reviews, and approvals. Development of the aforemenƟoned protocols is a lengthy, Ɵme-consuming process that entails detailed input by all Biologists, Forensic Examiners, the Unit Chief and the SecƟon’s Technical Leader. The finished product requires review by the Quality Assurance and Training Unit and approval by the Unit Chief, Technical Leader and the FBI Quality Manager.

In summary, over a decade of work has been commiƩed to the DNA tesƟng process and the instrumentaƟon used. To make any changes would require extensive performance tesƟng, validaƟon, concordance tesƟng, and re-establishment of procedures and re-wriƟng of manuals, to remain in compliance with the QA Standards. A substanƟal commitment of Ɵme and resources has already been dedicated to establishing the current procedures. The LD does not at present have the staffing and other resources to dedicate to the lengthy process of tesƟng any new instrumentaƟon. In addiƟon, Tecan WorkstaƟons are fully integrated with the Sample Tracking and Control System (STaCS) SoŌware used by the FBI Laboratory. The use of any other roboƟc workstaƟon would require modificaƟons to the current version of STaCS SoŌware.

This product must meet defined technical, performance, and quality characterisƟcs to ensure compaƟbility with the exisƟng Lab workflow, compliance with accreditaƟon standards, and admissibility of results in judicial proceedings. The requirement supports high-volume, Ɵme-sensiƟve forensic operaƟons conducted at the FBI Laboratory facility. ConƟnuity and consistency of performance are essenƟal to avoid disrupƟon to forensic casework, revalidaƟon efforts, and potenƟal impacts to invesƟgaƟve and judicial outcomes.

3. The statutory authority permiƫng other than full and open compeƟƟon.

The statutory authority permiƫng other than full and open compeƟƟon is 41 U.S.C. 3304 (a)(1) as implemented by the Federal AcquisiƟon RegulaƟon (FAR) Overhaul – Part 6, 6.103-1, “Only One Responsible Source and No Other Supplies or Services Will SaƟsfy Agency Requirements.”

4. Demonstrate the unique qualificaƟons of the proposed contractor or the nature of the acƟon requiring the use of the authority.

JUSTIFICATION AND APPROVAL (J&A) FOR OTHER THAN

FULL AND OPEN COMPETITION

UNCLASSIFIED

A sole source leƩer was obtained from TECAN USA, Inc. that they are the only vendor that sells the Tecan Fluent 480. An effort was made to search SAM.gov to see if there were addiƟonal current cerƟfied sellers or resellers for the brand Tecan Fluent 480, and there were none.

5. A descripƟon of efforts made to ensure that offers are solicited from as many potenƟal sources as is pracƟcable, including whether a noƟce was or will be publicized as required by Subpart 5.1 and, if not, which excepƟon under 5.101 applies.

The sole-source nature of this requirement is driven by compaƟbility, validaƟon, accreditaƟon, and evidenƟary reliability requirements rather than vendor preference. The FBI researched for sellers to provide Tecan Fluent instruments, and there are no resellers.

6. The anƟcipated dollar value of the proposed acquisiƟon, including opƟons if applicable, and a determinaƟon by the ContracƟng Officer that the anƟcipated cost to the Government will be fair and reasonable.

The contracƟng officer shall ensure all pricing is fair and reasonable by conducƟng cost price analysis on a previous Tecan U.S. Inc. contract with the FBI, 15F06725P0000888, as well as pricing research on other Government Wide sites for similar type requirements and vendors in both the open and GSA marketplace. The pricing has been consistent over the years with minimal increase from one POP to the next.

7. A descripƟon of the market research conducted and the results.

The Federal Bureau of InvesƟgaƟon’s descripƟon of the market research technique(s) it employed to determine the necessity of restricted (other than full and open) compeƟƟon is provided below.

Contacted knowledgeable individuals in Government and industry regarding market capabiliƟes to meet requirements. Ongoing contact with knowledgeable individuals in other DNA Government laboratories in the industry regarding market capabiliƟes and challenges of obtaining instrumentaƟon from different vendor resources. Querying the Governmentwide database of contracts and other requisiƟon instruments intended for use by mulƟple agencies available at hƩps://www.contractdirectory.gov/contractdirectory/ and other Government and commercial databases that provide informaƟon relevant to agency acquisiƟons. SHOP plaƞorm was searched for other FBI capabiliƟes that might meet the requirements, and none were available.

JUSTIFICATION AND APPROVAL (J&A) FOR OTHER THAN

FULL AND OPEN COMPETITION

UNCLASSIFIED

ParƟcipaƟng in interacƟve, on-line communicaƟon among industry, requisiƟon personnel, and customers.

ContacƟng industry personnel regarding market capabiliƟes in other DNA labs around the U.S.

Reviewing catalogs and other generally available product literature published by manufacturers, distributors, and dealers or available on-line.

Reviewed catalogs and other generally available product literature published by manufacturers, distributors, and dealers available on-line.

Reviewing contractor websites to ascertain available products to meet this requirement.

When considering the advancement of DNA tesƟng capabiliƟes or the replacement of products, the BAS rouƟnely evaluates offerings from different vendors. The intent is to idenƟfy the best product for the intended scienƟfic applicaƟon while also considering the producƟon level infrastructure into which that product must be integrated.

8. Any other facts supporƟng the use of other than full and open compeƟƟon.

Tecan U.S. Inc, is the only manufacturer and the only authorized seller of the Tecan Fluent 480. Tecan USA, Inc. does not permit any outside vendors to provide maintenance and such acƟon would void the instrument warranty. Per our QA/QC standards the annual PM service must be performed by the provider or a qualified outside vendor. This is for a product, the services would also be the maintenance from Tecan on their robots – also something that they only authorize to be performed by Tecan technicians.

ImplementaƟon of alternaƟve products would require extensive performance tesƟng, concordance studies, revision of standard operaƟng procedures, modificaƟon of quality assurance systems, retraining of personnel, and temporary disrupƟon or suspension of DNA uploads. Such disrupƟon would negaƟvely affect compliance with statutory mandates, backlog reducƟon efforts, and naƟonal security mission requirements.

9. A lisƟng of any sources that expressed a wriƩen interest in the acquisiƟon.

JUSTIFICATION AND APPROVAL (J&A) FOR OTHER THAN

FULL AND OPEN COMPETITION

UNCLASSIFIED

This requirement was not publicly synopsized. As such, no other sources have expressed an oral or wriƩen interest.

10. A statement of any acƟons the agency may take to remove or overcome any barriers to compeƟƟon, if subsequent acquisiƟons are anƟcipated.

The FBI will conƟnue to conduct market surveys and research available through industry shows and technology releases in the form of papers and journals. This will be used to idenƟfy potenƟal sources for subsequent acquisiƟons. If potenƟal sources are idenƟfied, it will be necessary to submit to both extended compaƟbility and eventual validaƟon studies, but due to the technical and specific nature of this instrument, no other vendor has been found at this Ɵme.