The VA Pittsburgh Healthcare System intends to negotiate on a sole source basis with BD GeneoHm, 6146 Nancy Ridge Drive, San Diego, CA 92121 for the BD GeneOhm MRSA assays. The BD GeneOhm MRSA (IDI-MRSA) test from BD GeneOhm Inc. is the only rapid, molecular-based assay cleared by the FDA and bearing the CE Mark for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA) from a nasal specimen. This assay is a qualitative in-vitro diagnostic test for the direct detection of nasal colonization by methicillin-resistant Staphyloccus aureus (MRSA) to aid in the prevention and control of MRSA infections in healthcare settings. The test performed on the Smart Cycle 2 instrument with a nasal swab specimen from patients at risk for colonization, utilizes polymerase chain reaction (PCR) for the amplification of MRSA DNA and fluorogenic target- hybridization probes for the detection of the amplified DNA. The test provides a definitive result with an assay time of less than two hours. The BD GeneOhm™ MRSA test detects a unique molecular sequence which confers a double specificity: half of this sequence comes from the S. aureus chromosome; the second half is within the genetic element carrying methicillin resistance, the SCCmec cassette. The test detects the SCCmec sequence using a specific protocol. The BD GeneOhm™ MRSA test kit is composed of the following assay specific reagents, which when used with the above protocol and the Smart Cycler® 2 instrument provide a definitive result within two hours. Sample buffer Tris-EDTA buffer Lysis tube Glass beads Master mix < 0.0005 % DNA polymerase complex < 0.001% Internal Control - non-infectious DNA containing MRSA-primer binding sequences and a unique sequence for probe hybridization < 0.002 % primers < 0.002 % molecular probes < 0.05 % dATP, dCTP, dGTP, dTTP Bovine serum albumin Carbohydrate MgCl2 < 0.001 % non-infectious Staphylococcus epidermidis genomic DNA (ATCC 14990) Control DNA Tris-EDTA buffer Carbohydrate < 0.001 % non-infectious genomic MRSA DNA (ATCC 43300) Diluent Tris-HCl buffer MgCl2 (NH4)2SO4 KCl This Notice of Intent is NOT a request for competitive proposals. Vendors who wish to identify their interest and capability to provide an MRSA test assay compatible with the Smart Cycle 2 as described above, may notify the Contracting Officer, in writing, no later than 9:00 A.M. on January 22, 2007. Such notification must include a complete description of proposed test assays, including narrative and capabilities described above. Responses may be sent to [email protected] or mailed to Kathleen Policicchio, Contracting Officer, (04A1-H), VA Pittsburgh Healthcare System, 7180 Highland Drive, Pittsburgh, PA 15206. Information received will be for the purpose of determining whether or not to conduct a competitive procurement or proceed with sole source negotiations. The determination to conduct a competitive procurement based on responses to this notice is solely within the discretion of the VAPHS Contracting Officer.

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