SOLICITATION NOTICE
65 -- MULTI-TECHNOLOGY LABORATORY ANALYZER
- Notice Date
- 3/5/2012
- Notice Type
- Presolicitation
- Contracting Office
- N62645 Naval Medical Logistics Command 693 Neiman Street Ft. Detrick, MD
- ZIP Code
- 00000
- Solicitation Number
- N626452RCE0146
- Response Due
- 3/21/2012
- Archive Date
- 5/31/2012
- Point of Contact
- BRIAN MILLER 301/ 619-1086
- Small Business Set-Aside
- N/A
- Description
- The Naval Medical Logistics Command (NMLC) intends to negotiate on a sole source basis (IAW FAR Part 6.302-1) on behalf of Naval Medical Center San Diego (NMCSD). The proposed source is Bio-Rad Laboratories, 1500 John F Kennedy Blvd Ste, 800 Philadelphia, PA 19102-1737. NMCSD has a requirement for a cost per reportable test contract for a multi-technology laboratory analyzer, reagents, calibrators and control items. The system shall allow for full automation from the time of adding the specimen to the analysis of results and transfer for those results to the Laboratory Information System (LIS). The system shall be capable of detecting serological immune markers directly from human plasma. The system shall use flow cytometry based technology and fluorescent microbeads to detect multiple targets simultaneously from patient plasma. The system shall be random-access allowing different tests to be performed on samples without requiring users to organize, group, or batch specimens to perform testing. The system shall be capable of multiplex analysis through the performance of different tests simultaneously on each individual specimen. Automated steps in the specimen processing shall include; specimen processing, incubation, wash steps, analysis, and data distribution. The system shall be capable of processing at least 50 patient specimens per hour, with multiple tests capable of being performed simultaneously on each specimen. The system shall be able to process samples randomly directly from sample tubes. Sample analysis shall include detection of at least 50 beads/assay sample size markers. The system shall be capable of testing for: Measles IgG, Mumps IgG, Rubella IgG, Varicella IgG, Toxoplasma IgM/IgG, Cytomegalovirus IgM/IgG, Herpes Simplex Virus 1 and 2 IgG, Epstein-Barr Virus IgM/IgG markers (EAD, EBNA, VCA), and Treponema pallidum (Syphilis) IgG. The system shall be able to screen for autoimmune anti-nuclear antibodies (ANA) as a panel. The system shall be capable of differentiating between the following markers without requiring additional testing: dsDNA, Chromatin DNP, ribosomal P, ss-A, ss-B, Sm, Sm/RNP, Scl-70, Jo-1, and Centromere B. The system shall be capable of reading Type 39 bar codes in real time. The system shall be capable of bi-directional communication allowing test orders to be downloaded and patient results to be reported. The bi-directional communication should go through an interface with the Composite Health Care System (CHCS) laboratory information system (LIS). The software shall be capable of independent data analysis that does not require the user to manipulate flow cytometry gates, adjustment of fluorescent laser intensity (gain), and other sample analysis parameters. Data reporting shall be qualitatively (positive or negative) calculated based on the threshold number of positive fluorescent microbeads required for a positive results (> 50 beads/assay). The system shall allow users to access raw data to aid in troubleshooting and/or further analysis of results. The system shall include an internal control that is analyzed alongside all tests performed on each patient specimen. The electrical requirement for the system is 120VAC, 60Hz, 20 Amps and single phase. The system and all of the components, shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America, even should delivery be requested outside of the United States. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States. The equipment and reagents shall be compliance with OSHA requirements. Vendor 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 vendor shall be responsible for uncrating the unit/system and transporting it through the facility to the location of intended use for installation. If interim storage is required, the vendor will make arrangements for the storage. This acquisition is being conducted under simplified acquisition procedures FAR 13. There are not set-aside restrictions for this requirement. The intended procurement will be classified under North America Industry Classification System (NAICS) 511210 with a small business size standard of $25.0. 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 Brian Miller at brian.miller4@med.navy.mil. In addition, challenges can be faxed to 301-619-1132 Attn: Brian Miller. Email challenges are preferred. Closing date for challenges is no later than 10:00 AM. ET on 21 March 2012. No phone calls will be accepted.
- Web Link
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- Record
- SN02689051-W 20120307/120305234203-cd656ddf5b3c85fc47ebfbb937f01427 (fbodaily.com)
- Source
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