Attachment 1 - Sole-Source Justification - AFDTL EMIT II Testing Kits - Redacted.pdf

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MEMORANDUM FOR

SOLE SOURCE JUSTIFICATION

EMIT II Plus Amphetamines Assay AF Form 4009 NO: 6284558334272600

Company Name: Siemens Healthcare Diagnostics Street Number/Box Number: 511 Benedict Ave City, State, Zip Code: Tarrytown, New York Cage Code: 10591-5005, United States

Estimated Dollar Value:

1. Description of action being approved: The Air Force Drug Testing Laboratory (AFDTL) at Joint Base San Antonio-Lackland, Texas has a requirement for EMIT II Plus Amphetamines Assay testing kits. This will be a BPA with a five (5) year ordering period.

2. Statute and/or Regulation supporting determination: Pursuant to Revolutionary Federal Acquisition Regulation Overhaul (RFO) 12.102(a), which allows for restricting competition for acquisitions at or below the SAT, and as supplemented by R-DFARS 211.204, this document justifies the use of a sole source. This justification is based on a review of the acquisition history, an assessment of government risk, and a determination of the most logical and suitable solution that serves the best interest of the government.

a. Agency and Nature/Description of the action being approved: T h e AFDTL use the reagent kit as an adjunct test to significantly reduce the need for more expensive and time consuming confirmation testing. This specific kit performs exceptionally well in tandem with our primary contract awarded AMP Kit. The effectiveness of an adjunct test cannot be determined by the product description alone. Our laboratory has performed extensive development and validation testing to confirm its suitability. Based on years of experience and rigorous testing, we know this kit is the best choice for our needs as an adjunct test

b. Description of supplies/services required to meet agency needs: The EMIT II Plus Amphetamines Assay testing kits is essential to the Government's requirements as no other product can meet the agency's needs without unacceptable schedule delays and duplication of cost.

3.Rationale: The Navy IDIQ contract N6264519D5004 used to obtain similar testing kits; however, the contract is expired and a follow-on contract wasn’t executed. This is the only testing kit the AFDTL is validated for based on testing multiple testing kits for accuracy and reliability. A search of KTFS was also conducted, which found four (4) amphetamine testing kit contracts awarded in the last seven (7) years. However, none of the contracts matched the specific item in this requirement.

Additionally, in accordance with the attachment - Email - Customer Justification for Sole Source mentioned that through the validation process, the AFDTL #10445421 reagents kits to meet the standards and regulatory guidance. This testing kit prevents them from using more expensive and time-consuming tests, as well as performing exceptional in conjunction with their other testing kits

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used. The customer also stated that the effectiveness of a test can’t be determined by a description, extensive testing and validation is required, and they’ve determined product #10445421 provides the greatest value in terms of effectiveness and price.

Finally, the customer stated this specific product optimizes laboratory resources by reducing the number of required confirmations from 1,388 to 402. Discontinuing its use would require an immediate expansion in laboratory capacity, including procurement of an additional GC-MS instrument costing and hiring a new GS-7 technician to operate the equipment (Attachment

Efforts to Obtain Competition: To maximize competition for this sole source requirement, the contracting team conducted market research that yielded 1 response from capable vendor, A further search was conducted on USASpending.gov; there were four (4) delivery orders from the Navy’s now expired IDIQ, N6264519D5004 with Siemens Healthcare Diagnostics. The price on the IDIQ was . On 23 January 2026, a source sought was posted on SAM.gov.

There was one response which was from the manufacturer, Siemens Healthcare Diagnostics, stating that they can fulfill this requirement.

On 14 January 2026, the customer provided two (2) quotes from the manufacturer, Siemens Healthcare Diagnostics. The individual purchase without a contract was and the price if we establish a contract is . This represents an increase of 953% without establishing a BPA with the manufacturer With this information the customer requested to establish a BPA for cost-saving purposes. By executing a single-source BPA with the manufacturer, the government will be saving per unit for a total of over the life of the ordering period.

In accordance with RFO 12.102(a) and R-DFARS 211.204, procuring the EMIT II Amphetamines Assay 1L, is essential to avoid a substantial duplication of costs related and to meet the mission need. The 502 CONS will continue to monitor the market for future opportunities to enhance competition. or modified for compatibility with the supply from other companies to meet the agency's needs.

Determination of Fair and Reasonable Cost: The CO anticipates that the resulting price for Amphetamines Assay 1L, part # 10445421 will be fair and reasonable if the government intends to solicit Sole Source to Siemen Healthcare Diagnostics. This determination will be based on adequate price competition among the IGCE. The IGCE is estimating per

6. Action taken to Preclude Future Brand Name Awards: To preclude the need for future sole source, the 502 CONS and the required activity will continuously monitor the commercial marketplace for emerging vehicles or small businesses that offer fair market pricing. Prior to subsequent acquisitions, the team will conduct updated market research to determine if other manufacturers can supply this particularly part #10445421. Until such compatible alternatives become available without causing a substantial duplication of costs or avoiding a failure of product, the Government will continue to maximize competition by restricting

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requirements to the solicitation via sole source to an other than small business.

7. Requiring Activity Certification that Supporting Data is accurate and complete: As evidenced by my signature below, I certify that any supporting data contained herein, which is my responsibility, is both accurate and complete.

8. Contracting Officer’s Certification that the Justification is accurate and complete:

As evidenced by my signature below, I certify that the justification is accurate and complete to the best of my knowledge and belief

RAMON MARRUFO, GS-13, DAF

, Contracting Officer

. Attachments:

Attachment Email - AMP Adjunct – Customer Justification for Sole Sourc

Attachment Email - Amp Adjunct - Customer Pricing from Manufacturer Lackland AMP Quote OFF CONTRACT Lackland AMP Quote ON CONTRACT

MARRUFO.RAM

ON.1513248489

Digitally signed by

MARRUFO.RAMON.1513248489

Date: 2026.06.01 09:30:16 -05'00'