A02 Final Redacted JA Sole Source Mass Spectrometer System Water.pdf

CUI//SP-SSEL//FED ONLY

Control Number:

CUI//SP-SSEL//FED ONLY or FEDCON Source Selection Information - See FAR 2.101 and 3.104-4

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FEB 2023

Sole Source Justification and Approval Under FAR 13.501

1. Contracting Activity: United States Army Medical Research Acquisition Activity (USAMRAA). The requiring activity is the Walter Reed Army Institute of Research

(WRAIR).

2. Description of Action: This is a new requirement to supply a Waters Technologies Corporation Xevo TQ Absolute System and an ACQUITY UPLC H-Class PLUS Binary Systems for the Experimental Therapeutics (ET) Branch. This is a Firm Fixed Price contract with DHP Operation and Maintenance (O&M) funds. Upon delivery, the vendor will also provide proper installation of the systems, provide 3 days of professional service training for end-users, remove the old system, and provide a 1-year warranty including preventative maintenance.

3. Description of Supplies/Services: This action is to purchase a Waters TQ Mass Spectrometer System along with shipping, installation, deactivation/removal of old Mass Spectrometer System, onsite training (three days), and a 1-year warranty including preventative maintenance. Subsequent support will be coordinated through WRAIR's Medical Maintenance's service contract with Waters. The estimated total value is $412,982.05.

The Mass Spectrometer (MS) is an analytical platform used daily in the ET Branch of WRAIR to verify the presence of compounds based on their respective molecular weight. It is a crucial part of the analytical setup necessary to analyze results from all assays run in the Drug Metabolism and Disposition section.

4. Authority Cited: 41 United States Code 1901 as implemented in Federal Acquisition Regulation 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

Controlled by: Defense Health Agency (DHA) Controlled by: USAMRAA

CUI Category (ies): Source Selection Information Distribution/Limited Dissemination Control: FED ONLY

POC: Sharew Hailu, 301-619-9201

Control Number:

CUI//SP-SSEL//FED ONLY or FEDCON Source Selection Information - See FAR 2.101 and 3.104-4

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5. Reason for Authority Cited: The sole source justification is requested to ensure continuity and support in the laboratory. This item will replace a similar system that has reached the end-of-life cycle. This instrument must meet specific criteria in order to continue to support projects within ET’s portfolio. This criteria includes the instrument’s ability to: scan for fragments up to 2000 mass to charge, operate on the Masslynx platform, switch between MS mode (fragmentation of the parent compound) to MS/MS mode (secondary fragmentation of the fragmented ions from MS mode) in 3 milliseconds without compromising data quality, and detach/replace ion source systems allowing for different ionization techniques to be applied depending upon the test compound. Size limitations exist as the new item must fit in the space the aged instrument currently occupies. In addition, LC-MS systems have software and user maintenance requirements with a steep learning curve. Our operators have familiarity with Waters equipment, and replacement with similar equipment will ease the transition between instruments and eliminate unnecessary downtime during transition uninstall/install. The transfer of analytical methods between Waters instruments would also eliminate the need to revalidate previous studies.

The existing equipment has been in place for 8 years. If a different instrument is selected that does not meet these minimum essential criteria, ET would be unable to compare past and future data, unable to reach proper detection limits for planned and future experiments, and ultimately unable to provide the same level of support to our internal and external partners. Award to any other source would result in substantial duplication of effort of past data and unacceptable delays in fulfilling the agency’s requirements.

6. Efforts to Obtain Competition In accordance with FAR 5.201, a notice was published on 15 August 2023 on Sam.GOV announcing the Government intent to award a sole source contract to Waters Technologies Corporation on a non-competitive. As a result, no responses were received. WRAIR will continue monitoring the market for equipment that can meet its requirement.

7. Actions to Increase Competition: No action was taken following market research to increase competition as sufficient competition exists in the market.

8. Market Research: Market research was conducted by Contracting Officer Representative on 21 June 2023 in accordance with FAR Part 10. The requested model was not available through Source America (AbilityOne Program) or GSA Advantage. Additional internet research was conducted and was able to find at least two companies that provide used and refurbished equipment; however, these companies are not able to provide the full suit of support to include installation, training, and warranty which is a key component to ensuring full operability of equipment. A Request for Quote (RFQ) was sent to the manufacturer, Waters Technologies Corporation, and the company provided a quote including a removal the old system.

9. Interested Sources: To date, no other sources have written to express an interest.

Notices required by FAR 5.201 have been published, and that any bids or proposals received shall be considered.

Control Number: JA-23-08-1428

CUI//SP-SSEL//FED ONLY or FEDCON Source Selection Information - See FAR 2.101 and 3.104-4

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10. Other Facts: Not Applicable

11. Technical Certification:

I certify that the supporting data under my cognizance, which are included in the justification are accurate and complete to the best of my knowledge and belief.

12. Requirements Certification:

I certify that the supporting data under my cognizance, which are included in the justification are accurate and complete to the best of my knowledge and belief.

13. Fair and Reasonable Cost Determination:

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable.

The basis for this determination is price analysis and Independent Government Cost Estimate (IGCE)

14. Contracting Officer Certification:

I certify that this justification is accurate and complete to the best of my knowledge and