N6809420RC33112-Molecular Analyzer-BioFire-PEN-Attachment IV-NOI_03_11_20.DOC

The Naval Medical Logistics Command (NMLC) intends to negotiate on a sole source basis (IAW FAR 13.501(a), Only One Responsible Source. The proposed source is BioFire Diagnostics, LLC of 515 Colorow Dr, Salt Lake City, UT, 84108-1248.

The automated molecular diagnostic laboratory analyzer shall be able to analyze polymerase chain reaction (PCR) samples to identify molecules of microorganisms within various pathogens. The analyzer shall be capable of testing specifically for respiratory targets, blood culture targets, gastrointestinal (GI) targets and meningitis/encephalitis (ME) targets. The automated molecular diagnostic laboratory analyzer shall be capable of performing at least, but not be limited to, the tests listed below.

Respiratory Panel Assay

The PCR analyzer shall be a single-platform walkaway analyzer capable of integrated sample preparation, thermocycle amplification, detection and nested multiplex PCR analysis. The analyzer shall be capable of deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) extraction and purification. The analyzer shall have a minimum of a twelve (12) sample load capacity. The analyzer shall be able to identify molecules of microorganisms in the following type of samples: swab, positive blood culture, stool, cerebrospinal fluid (CSF), bronchoalveolar lavage (BAL), or sputum.

The analyzer shall be capable of amplifying and detecting a minimum of twenty (20) targets per respiratory panel assay, twenty-four (24) organisms that cause blood stream infections per blood culture identification (BCID) panel assay, three (3) genetic markers that are known to confer antimicrobial resistance per BCID panel assay, twenty-two (22) targets per GI panel assay, and fourteen (14) targets per ME panel assay. The PCR analyzer shall include bar-code reading capability. The analyzer shall be able to generate, detect and analyze PCR melting curves. The unit shall be able to provide real-time analysis. The analyzer shall perform automatic quality control (QC) and routine operator maintenance without manual intervention. The PCR analyzer shall contain onboard diagnostics and help functions. The dimensions for the molecular assay analyzer shall not exceed 34x24x36 inches (HxWxD). The electrical requirements are 120 VAC and 60 Hz. The analyzer shall be a self-contained unit and shall not require facility hook-ups for water, drainage or heat dissipation.

The vendor shall provide installation, validation testing, onsite user training and preventive maintenance coverage. The vendor shall provide the validation reagent kit and complete validation of the analyzer upon installation. Corrective maintenance coverage shall be provided and include response times. On-site training shall be provided by the vendor. The vendor shall provide two (2) operational and two (2) service manuals, each in English. Support shall be provided for a base period of one (1) year with four (4) subsequent option years.

The analyzers, including claims made for the product, shall be compliant with Food and Drug Administration (FDA) regulations, with respect to marketing and delivering medical products for use in the United States of America. These requirements shall apply even if delivery is requested outside of the United States of America. The analyzers shall be installed in compliance with OSHA requirements.

Contractor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor, or authorized reseller for the proposed analyzers, such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty, and service associated with the analyzers shall be in accordance with the OEM terms and conditions.

Upon delivery, the contractor shall be responsible for uncrating the unit/system, transporting it through the facility to the location of intended use for installation, and removing of all trash created in this process. If interim storage is required, the vendor shall make arrangements for the storage. The vendor is also responsible for the initial instrument operational and performance validations.

There are not set-aside restrictions for this requirement. The intended procurement will be classified under North America Industry Classification System (NAICS) 334516. This notice of intent is not a request for competitive proposals and no solicitation document exists for this requirement. However, parties interested in responding to this notice will need to submit technical data sufficient to determine capability in providing the same product. All capability statements received by the closing date of this synopsis will be considered by the Government. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement.

If a vendor challenges the basis of this requirement, please email product capability statements (formats for submission: PDF, MS Word, or MS Excel) to Derek Bell at derek.j.bell.civ@mail.mil. Closing date for challenges is no later than 03:00 PM ET on 26 March 2020. No phone calls will be accepted.