HT940625P0027 JA _Redacted.pdf

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Source Selection Information - See FAR 2.101 and 3.104-4

2 NOV 2024

5. Rationale Justifying Use of Authority Cited:

The need for a sole source bridge can be confirmed using the equipment list. BioFire Defense is the only vendor that can provide a molecular diagnostic laboratory analyzer capable of integrated sample preparation, thermocycle amplification, detection and nested multiplex PCR analysis. Nested multiplex PCR analysis allows for several tests to be conducted at once in one (1) channel. Units without the above capabilities will increase the time required per test, and potentially require additional analyzers to maintain the increased workload demand*. No other vendors can provide a molecular diagnostic laboratory analyzer capable of integrated sample preparation, thermocycle amplification, detection and nested multiplex PCR analysis of the required targets stated in the minimum requirements.

This requirement is a bridge to mitigate a lapse in services to support the mission of two MTFs, Naval Hospital Camp Pendleton, CA and Naval Medical Center, Portsmouth, VA. The current contract, N6264520P0020, will expire 14 April 2025. The new action for this requirement is being worked, as a sole source, however, a complete package has not been submitted at this time due to not having an approved Logicole request. There have been cyber security issues regarding the BioFire Defense. The products that are of greatest concern are the Myla suite and the BioFire/BioFire Torch. Biomerieux has not complied with RMF requirements and has announced that they will only focus on RMF standards for new products. While there were actions in progress to prohibit the purchase of future Biomerieux instruments and if necessary to disconnect existing instrument from the network, the Assistant Department Head, Laboratory, at NMC Portsmouth, confirmed that the molecular diagnostic laboratory analyzers are not connected to the network, and they were giving approval to continue operating by the DHA J6. Additionally, the DoD is working with the company on obtaining a current ATO. This system is currently operating and has for the last 4 years and the MTFs have not been directed to remove it by J6.

The suggested replacement was found to be insufficient for the laboratory needs. The Chief of Laboratory Operations for Center for Laboratory Medicine Services, DHA, stated that “BioMerieux (BM) and CyberLog” have been in regular contact to bring BM analyzers/software into compliance and to his knowledge there is not anything that should be prohibiting the acquisition or connection of BM analyzers to the network.

It was also, noted that BioFire Diagnostics, LLC was acquired in 2014 by BioMerieux, Inc. and BioMerieux continued to operate as BioFire Diagnostics, LLC through the end of the current contract date of 14 April 2025. The customer Transfer Letter dated March 2022, noted that all BioFire products after the April 2025 date will be quoted and made available through BioFire Defense.

Given the short time before the incumbent contract expires (less than 2 months), it is in the government’s best interest to award a bridge extension on a sole source basis to the incumbent, BioFire Diagnostics, LLC now BioFire Defense, to maintain continuity of care for maintenance and service of critical molecular diagnostic laboratory analyzers equipment until such time as the Logicole issue is resolved and a new contract can be awarded. If this action is not allowed, the MTFs will lose critical services for at least 4 months (the estimated discussion schedule suggested by the COR).

A separate SCO Approval to Issue a Bridge Contract Action is not required per DHA Procurement Directive 06-02 as the follow-on contract requirement is non-competitive in accordance with FAR 13.501(a)(1)(ii).

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3 NOV 2024

6. Efforts to Obtain Competition:

Historically, no other business has been able to meet the MTF’s requirement and current Market Research does not indicate any new businesses in the area capable of providing these services. A Notice of Intent to Sole Source to BioFire Diagnostics, LLC (for this bridge) was posted to SAM.gov on 13 February 2024.

No challenge letters were received in response to this posting providing further confirmation that no other source is available to provide the required services.

7. Actions to Increase Competition/Remove or Overcome any Barriers to Competition:

Any attempt to obtain competition at this juncture would require replacing the molecular diagnostic laboratory analyzers, reagents, quality control, annual maintenance coverage, and consumables at two MTFs. The cost of a lapse in services, due to the time it would take to acquire Logicole approval, would not be realized. The current contract has DHA approval to continue operating.

All future requirements will be handled on a case-by-case basis with an emphasis on competition-based solicitations.

8. Market Research:

In-depth Market Research was conducted for this requirement in November 2024. It included a search of the Internet using Google, GSA Advantage, and the ECRI Sourcebook. Vendors who could potentially provide a contract for molecular diagnostic laboratory analyzer included BioFire Diagnostics LLC (BioFire), Cepheid, GenMark Diagnostics, Inc. (GenMark), Luminex Molecular Diagnostics, Inc.

(Luminex), Becton Dickinson (BD), Hologic, Abbott Molecular, Analytik Jena, BioRad Laboratories, Labnet International, Roche Molecular, Cole-Parmer, ThermoFisher Scientific, and Wealtec Corporation.

The molecular diagnostic laboratory analyzer provided by GenMark was only capable of respiratory and BCID testing. The molecular diagnostic laboratory analyzer provided GenMark was not capable of GI or ME testing, thus GenMark did not meet the minimum requirements of the Government.

Hologic could have provided a molecular diagnostic laboratory analyzer, although the analyzer would not adhere to the required cybersecurity language. Thus, Hologic did not meet the minimum requirements of the Government.

The molecular diagnostic laboratory analyzers provided by Cepheid, Luminex, BD, Abbott Molecular, Analytik Jena, BioRad Laboratories, Labnet International, Roche Molecular, Cole-Parmer, ThermoFisher Scientific, and Wealtec Corporation were not capable of integrated sample preparation, thermocycle amplification, detection and nested multiplex PCR analysis. Thus, Cepheid, Luminex, BD, Abbott Molecular, Analytik Jena, BioRad Laboratories, Labnet International, Roche Molecular, Cole-Parmer, ThermoFisher Scientific, and Wealtec Corporation did not meet the minimum requirements of the Government.

BioFire was the only vendor that could provide a molecular diagnostic laboratory analyzer capable of integrated sample preparation, thermocycle amplification, detection and nested multiplex PCR analysis.

BioFire could provide products via their Federal Supply Schedule (FSS) contract, V797D-30085, however, the full needs of the Government are not available via their FSS vehicle. The Government would not be able to get the molecular diagnostic laboratory analyzer, reagents, quality control, annual maintenance coverage, and consumables together under the FSS contract. Thus, utilizing FFS contract V797D-30085 was not recommended. BioFire could provide a contract for one (1) molecular diagnostic laboratory analyzer, reagents, quality control, annual maintenance coverage, and consumables open market. BioFire was the only vendor that could meet the minimum requirements of the Government. A Notice of Intent to Sole Source was posted to SAM.gov on 13 February 2025 with no responses further confirming no other

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source is available.

9. Other Facts:

a. Procurement History:

(1) Is this a new requirement? No.

(2) If 9.a.(1) is No, was the action just prior to this one competed? No.

(3) If 9.a.(2) is Yes, what has changed where this action cannot be competed? Not Applicable.

b. Additional Information:

Services provided by the incumbent are already established at the MTFs and performance under the current contract is considered satisfactory.

10. Interested Sources:

To date, no other sources have written to express an interest. The notices required by FAR 5.201 have been published, and any bids or proposals received shall be considered.

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8 NOV 2024

Approval Based on the foregoing justification, I hereby approve the procurement of one (1) analyzer, laboratory, molecular assay, infectious microorganism [device code: 20-802] reagents, quality control, annual maintenance coverage, and consumables for $1,538,009.04 on sole source basis pursuant to the authority of 41 United States Code 1901 as implemented in FAR 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items, subject to availability of funds, and provided that the supplies and/or services herein described have otherwise been authorized for acquisition.