JA 25-MRCO-PACIFIC-195 W81K0225QA079_Redacted.pdf

Control Number: 25-MRCO-PACIFIC-195

SEP 2021

Sole Source Justification and Approval Under FAR 13.501

1. Contracting Activity: Joint Base Lewis-McChord Health Contracting Branch (JBLM-HCB), R6100 North 18th Street, Joint Base Lewis McCord, WA.

2. Description of Action: This action is for a new firm fixed price, indefinite delivery indefinite quantity (IDIQ) contract. This action’s minimum guarantee will be satisfied utilizing subject to the availability of fiscal year 2026 Defense Health Program funds.

3. Description of Supplies/Services: The Madigan Army Medical Center (MAMC) Department of Pathology has a requirement for two multiplex molecular analyzer systems (the BioFire FilmArray Torch Analyzer and the BioFire SpotFire Analyzer System) that can conduct multiplexed nucleic acid tests detecting multiple pathogens from a single sample providing results in 90 minutes or less. These systems will be leased. The Department of Pathology also requires the testing panel reagents for completing the tests from the patient stool, cerebrospinal fluid, blood, sputum/bronchoalveolar lavage, nasophyaryngeal and throat swab samples, in addition to the maintenance, installation, and training for these analyzer systems.

This requirement is for a 5-year ordering period with an estimated contract ceiling

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.

5. Reason for Authority Cited: MAMC Department of Pathology has a clinical requirement for multiplex molecular analyzer systems that can conduct multiplexed nucleic acid tests detecting multiple pathogens from a single sample and providing results in 90 minutes or less. This is a clinical requirement to support the emergency care and intensive care unit departments at MAMC with pathogen diagnoses of patients. These departments rely upon the multiplexed nucleic acid tests and short testing timeframes to diagnose patients in critical condition and provide rapid care. Traditional testing methods only test for a single pathogen per test and require cultures which can take between 24 and 72 hours to return test results leading to significant increases in treatment response time and an overall degradation of MAMC patient care.

BioFire FilmArray Torch Analyzer System comes with four different modules that can independently detect multiple pathogens (bacteria, viruses, yeast, parasites, and/or antimicrobial resistant genes) and bio-threat agents from a single sample. The modules can test independently, meaning the MAMC Department of Pathology can test four different patient specimens simultaneously from Stool, Cerebrospinal Fluid, Blood, or Sputum/Bronchoalveolar Lavage samples. This leads to rapid identification of any pathogen the patient may have. The BioFire FilmArray Torch Analyzer System returns test results typically within 90 minutes or less.

industry, manufacturers do all the work internally to ensure quality and safety are maintained in order to ensure their products are compliant with FDA guidelines. After considering this information, the contracting officer has determined that subcontracting possibilities do not exist for this requirement in accordance with FAR 19.705-2(c) and the approved determination has been completed.

7. Actions to Increase Competition: JBLM-HCB as well as the MAMC Department of Pathology will continuously monitor any changes in this requirement. As technology becomes available, research will be performed to consider other possible sources capable of meeting the government’s requirements. Ongoing market research will be performed to determine if alternative sources of supplies/services become available.

8. Market Research: The government conducted ongoing market research of the industry to determine if there were new entrants into the local market to meet the government’s requirements. Market research conducted within the past 12 months revealed that there are no additional sources that can meet our needs.

The MAMC Department of Pathology, as part of maintaining their expertise within their fields, routinely reviews industry capabilities, attends trade shows, and shares information with other medical facilities. Presently, there is no other known testing equipment on the market that can meet the technical requirements of this procurement.

A sources sought was posted to the Government Point of Entry (GPE) SAM.gov on 08 May 2025 through 19 May 2025. Two responses were received to the sources sought posting.

The first responding company The company submitted no documentation with their email and provided no additional data proving they are capable of satisfying the requirement. A review of the company’s website shows they are primarily a logistics company and engage in defense shipping needs.

The second responding company, a capabilities statement stating they can meet the government requirement. The contract specialist had the requiring activity’s subject matter expert (SME) review the company and their capabilities. The SME found does not have sufficient FDA approved testing reagents, and the majority of their stated capabilities are for research use only (not for patient testing use). In order to satisfy this requirement, the testing reagents and associated Multiplex Molecular Analyzer Systems must be FDA approved and intended for patient use. As such does not meet the required capabilities of this requirement.

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

10. Other Facts:

a. Procurement history: This requirement was previously satisfied through a sole source, firm fixed priced contract, W81K0221P0018, awarded to BioFire Diagnostics LLC on 01 October

2020, for a total amount of W81K0221P0018 was awarded under the same authority cited in paragraph 4 above. No actions were cited under this award as available options to the government to increase competition other than reviewing industry through further market research for other sources that may meet the government’s requirements. This continued market research has not identified further technological advances in industry and has not identified any other available sources.

b. Other facts: Not Applicable. All other facts have been addressed herein.