Lab Analyzer and Lab Automation System

This solicitation for commercial items is prepared in accordance with FAR 13.501(a). This announcement constitutes only the solicitation; proposals/quotes are not being requested. The solicitation number is (N62645-20-R-0042) and is linked to Notice of Intent (NOI) Posting (N6264520RCES051) dated 21 April 2020. The solicitation issues as a request for quotation (RFQ). There are not set-aside restrictions for this requirement. It is the contractor's responsibility to be familiar with the applicable clauses and provisions. The clauses may be accede in full test at these addresses: http://acquisition.gov/far/ http://www.acq.osd.mil/dpap/dars/dfarspgi/current/index.html The NAICS code is 334516, with a small business size of 1,000 employees. The Naval Medical Logistics Command (NMLC) intends to negotiate on a sole source basis (IAW FAR 13.501(a), Sole Source, as supplemented with additional information included in this notice. The requirement is for two (2) analyzers, laboratory, molecular assay, infectious microorganism [ECRI Institute Device Code:20-802], one (1) automation system, laboratory, reagents, quality control, maintenance, and consumables for Naval Medical Center (NMC) Portsmouth. The Government intends on awarding a Firm, Fixed-Price (FFP) contract. The proposed source is Hologic, Inc. of 250 Campus Drive, Marlborough, MA 01752. The analyzers shall be automated analyzers capable of analyzing nucleic acids from urine and swab samples to test for bacteria and DNA/rRNA/mRNA that causes sexually transmitted infections, including Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC), Trichomonas vaginalis (TV), and Human Papillomavirus (HPV). The analyzer units shall be capable of accommodating an estimated annual workload of the following quantities: Test Qty. CT 32.000 GC 32,000 TV 2,000 HOV 16/18 1,500 COVID-19 260,000* *Note only an initial Qty. of 5,000 COVID-19 tests are anticipated with this requirement, although the capability of the analyzer system shall be to run 260,000 COVID-19 tests as an estimated annual workload. a)The two (2) analyzer units shall be able to accommodate a total throughput of at least 1,500 tests over a 24 hour period. b) The analyzer units shall be a fully automated, random access robotic system. c) The analyzer units shall be capable of analyzing nucleic acids from male and female urine samples, endocervical samples, vaginal samples, and male urethral swabs. d) The analyzer units shall utilize Food and Drug Administration (FDA)-approved tests to test for CT, GC, TV, and HPV. e) The analyzer units shall be capable of conducting FDA-approved assays for HPV Genotype 16 and HPV Genotype 18. f) The analyzer units shall be FDA-approved for testing female gynecological specimens collected in ThinPrep Pap Test vials containing PreservCyst solution. g) The analyzer units shall be capable of testing for COVID-19 pending FDA approval. h) The analyzer units shall be capable of simultaneously testing for the presence of CT, GC, TV, and HPV in the same sample. i) The analyzer units shall utilize nucleic acid amplification testing (NAAT) technology to perform simultaneous amplification and detection of target DNA or rRNA for CT, GC, TV, and E6/E7 mRNA for HPV. j) Once loaded the vendor provided solution shall be capable of directly sampling from tubes without removing caps, automatically dispensing all reagents, and performing all automated steps for NAAT. k) The vendor shall provide a solution capable of performing the following procedures: sample preparation, separation suspension, hybridization, separation, and detection. l) Specimen flow from start to finish shall be fully-automated to include waste collection. m) The analyzers shall be able to read Code 39 barcodes. n) The analyzers shall be capable of specimen storage stability of at least seven (7) days in a transport container for urine and swab samples stored at a minimum range of 2'C to 30'C. o) Samples shall be able to be kept at -20'C for up to 90 days if the time of transport/storage exceeds 30 days. p) The analyzer units shall have integrated software that allows for on-board maintenance/error code generation and automated troubleshooting procedures. q) The software shall document procedures. r) The analyzer units shall bi-directionally interface with the Composite Health Care System (CHCS) and with the laboratory information system (LIS), as specified in the Statement of Work (SOW). s) The analyzer units shall meet the performance characteristics for accuracy and precision, as defined by the 1988 Clinical Laboratory Improvement Act (CLIA). The analyzer equipment shall include sufficient safety features to avoid unnecessary exposure to biohazardous and chemical material. t) The units shall include an uninterruptable power supply (UPS) capable of providing all necessary electrical power to each analyzer. u) The power requirements is 120 V, 60Hz. v) The two (2) analyzers together shall not exceed a dimensional footprint greater than 144'x48 (WxD). The laboratory automation system shall automate the sample aliquoting process. The system shall be able to handle The vendor shall provide installation, validation testing, user training, and preventive maintenance coverage. The vendor shall provide validation of the analyzers, including normal range verification, demonstration of linearity, reportable range, replication studies, recovery studies, and establishment of initial control ranges using control materials. Corrective system maintenance coverage shall include response times, as specified in the SOW. Training shall be provided by the vendor, as specified in the SOW. The vendor shall provide two (2) operational and two (2) service manuals, each in English. Support shall be provided for a period of performance from 01 May 2020 - 30 April 2021, with four (4) subsequent one-year option periods. The system, 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 system shall be installed in compliance with the 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 equipment/system such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty, and service associated with the equipment/system 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.