Notice of Intent to Sole Source - Rapid Micro Biosystems Automated Plate Incubator and Reader

This notice announces the intent by the U.S. Army Medical Research Acquisition Activity (USAMRAA) in support of the Walter Reed Army Institute of Research (WRAIR), Pilot Bioproduction Facility (PBF) to procure one (1) Rapid Micro Biosystems Automated Plate Incubator and Reader without competition as prescribed in FAR 13.106-1. Specifically, the Government will procure the workstation manufactured by Rapid Micro Biosystems.

Rapid Micro Biosystems is the manufacturer and sole distributor of the Automated Plate Incubator/ Reader (PN: E700-GD2) capable of meeting the Government's needs. This requirement shall include the Automated Plate Incubator/ Reader, a LIMS Connectivity Software License, a Refrigerator for storage of refrigerated media cassettes to be used in the Growth Direct unit, an all-inclusive Validation for Environmental Monitoring, a PQ (Performance Qualification) document and MQ (Method Qualification) document for the qualification of water bioburden testing, and an Air Monitor Conversion Kits (14 -Clip only) which will allow adaptation of the cassettes to SAS-100 Air Sampling units. Rapid Micro Biosystems is the only company that manufactures an automated, rapid test system that utilizes a nondestructive method similar to the standard growth method. The Rapid Micro Biosystems system does not use reagents and subsequently destroy the colonies, as a result, the PBF can use those same plates to identify the organisms - a necessary requirement for both the production efforts and efficiency.

The Minimum Essential Characteristics for the system are as follows:
• Growth-based system comparable to current compendial methods
• Shall accommodate both TSA (Tryptic Soy Agar) and R2A RODAC (Replicate Organism Detection And Counting) cassettes
• Shall have Automated incubation and plate reading (robotic arm moves plates between incubation and reading zones)
• Shall have Blue LED light technology for automated, non-destructive detection of microorganisms through autofluorescence imaging
• Plates tagged as having counts are not discarded (reincubated)
• Shall have automated reporting and integration with future LIMS
• Shall be Federal Drug Regulation 21 Code of Federal Regulations part 11 compliant (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11)
• Shall be barcode reader capable
• User access and controls shall be role-based, allowing the system to only allow certain users to print or transmit data
• Shall provide results in 1-3 days instead of compendial 3-7, with initial detection within hours
• Shall have automatic sorting of cassettes according to testing protocol
• Shall have automated alerts based on specified colony limits (according to test protocol)

The North American Industry Classification System (NAICS) for this requirement is 334516 with a size standard of 1,000 Employees.

This announcement fulfills the synopsis requirements under FAR 5.102(a)(6) and 5.203(a). USAMRAA intends to publish a solicitation no sooner than 15 days after publishing this synopsis. This Special Notice of Intent is not a request for competitive quotes. Information received in response to this notice will be considered solely for the purpose of determining whether a competitive procurement is in the best interest of the Government. If no written responses are received by the date listed below, which reflects at least fifteen (15) days after the publication of this notice, the solicitation will be issued as brand name sole source only.

All questions and responses concerning this notice shall be emailed to Jeffrey Sprecher at Jeffrey.b.sprecher.civ@mail.mil.

Interested concerns must identify their capability in writing to the above email address listed above no later than 12:00 PM ET, 6 September 2019.

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