Inactive

Inactive

Notice of Intent to Sole Source The Naval Medical Logistics Command (NMLC) intends to negotiate a sole source contract modification under the authority of FAR § 13.106-1(b)(1)(i) and 41 U.S.C. 1901 wi... Notice of Intent to Sole Source The Naval Medical Logistics Command (NMLC) intends to negotiate a sole source contract modification under the authority of FAR § 13.106-1(b)(1)(i) and 41 U.S.C. 1901 with BioFire Diagnostics, LLC, 515 Colorow Dr, Salt Lake City, UT, 84108-1248, one (1) analyzer, laboratory, molecular assay, infectious microorganism [ECRI device code: 20-802] reagents, quality control, annual maintenance coverage, and consumables for the Naval Medical Center Portsmouth, VA for a base period of one-year and four one-year option periods. The contract is a CPT contract, meaning the Government agrees to pay a certain price per each test run and that prices include the equipment, reagents, all maintenance, and consumables. Delivery, installation, and training shall be completed as soon as possible. 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 analyzer shall be capable of testing for the Coronavirus Disease 2019 (COVID-19). 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: 1,500 per year Blood Culture Identification (BCID): 450 per year Meningitis/Encephalitis Panel Assay (ME): 150 per year Gastrointestinal Panel Assay (GI): 600 per year Pneumonia Panel Assay: 300 per year 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 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 20 targets per respiratory panel assay, 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, 22 targets per GI panel assay, and 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 (height by width by depth (HxWxD)). The electrical requirements are 120 volts AC power (VAC) and 60 hertz (Hz). The analyzer shall be a self-contained unit and shall not require facility hook-ups for water, drainage or heat dissipation. The Contractor shall provide installation, validation testing, on-site user training and preventive maintenance coverage. The Contractor shall provide the validation reagent kit and complete validation of the analyzer upon installation. Corrective maintenance coverage shall be provided and include response times. Training shall be provided by the Contractor. The Contractor shall provide two (2) operational and two (2) service manuals, each in English. Support shall be provided for a period of one-year from the date of installation with four (4) subsequent one-year option periods. 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 Occupational Safety and Health Administration (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 Contractor shall make arrangements for the storage. The Contractor shall also be responsible for the initial instrument operational and performance validations. This notice of intent is not a request for competitive proposals and no solicitation document exists for the requirement. Sources interested in responding to this notice are required to submit a capability statement that includes product/technical data, in sufficient detail and with convincing evidence that clearly demonstrates the capability to provide the required items. All capability statements received by the due date of this notice will be considered by the Government. A request for documentation or additional information, or submissions that only ask questions will not be considered as an affirmative response. 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 or to proceed with a sole source contract. Capability statements are due by 4:30 PM Local Time, 29 April 2020. Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to the following email address: rachel.a.turk2.civ@mail.mil IN SUBJECT LINE REFERENCE: “BioFire”