The Naval Medical Logistics Command (NMLC) intends to negotiate on a sole source basis (IAW FAR Part 13.501(a)) on behalf of Naval Medical Center San Diego (NMCSD). The current contract is awarded to Governmt Scientific Source, 12351 Sunrise Valley Drive, Reston, VA 20191.  NMCSD has a need to increase the current requirement for a cost per reportable test contract for a multi-technology laboratory analyzer, reagents, calibrators and control items. The system allows 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 is capable of detecting serological immune markers directly from human plasma. The system uses flow cytometry based technology and fluorescent microbeads to detect multiple targets simultaneously from patient plasma. The system has random-access allowing different tests to be performed on samples without requiring users to organize, group, or batch specimens to perform testing. The system is 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 is capable of processing at least 50 patient specimens per hour, with multiple tests capable of being performed simultaneously on each specimen. The system is capable of process samples randomly directly from sample tubes. Sample analysis includes detection of at least 50 beads/assay sample size markers. The system is 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 is able to screen for autoimmune anti-nuclear antibodies (ANA) as a panel. The system is 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.

This modification to increase the current contract is necessary until a larger five (5) year requirement is competed and awarded. It is not in the Government's best interest to have a lapse prior to the larger requirement being awarded in 2016.

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.

If a vendor challenges the basis of this sole source requirement, please email product capability statements (formats for submission: PDF, MS Word, or MS Excel) to Brian Miller at [email protected]. Any challenges should reference number in the subject line: N62645-12-D-5053. Closing date for challenges is no later than 11:00am. ET on 23 December 2015.

No phone calls will be accepted.

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