Q--AWARD NOTICE FOR REAGENT RENTAL AGREEMENT FOR CEPHEID GENEXPERT INFINITY 48

Sources Sought Notice: Reagent Rental Agreement for Cepheid GeneXpert Infinity 48 DESCRIPTION: This is a sources sought to determine the availability of potential sources having the skills and capabilities necessary to provide the SPECIFIED REQUIREMENT. All interested vendors are invited to provide information to contribute to this market survey/sources sought including commercial market information. THIS IS NOT A SOLICITATION ANNOUNCEMENT. This is a sources sought synopsis only. Questions should be submitted by email to contact@example.gov. Provide only the requested information below. The purpose of this synopsis is to gain knowledge of potential qualified sources and their size classifications (Service Disabled/Veteran Owned Small Business (SDVOSB/VOSB), Hub zone, 8(a), small, small disadvantaged, woman owned small business, FSS/GSA contract schedule holders or large business) relative to NAICS 325413, IN-VITRO DIAGNOSTIC SUBSTANCE MANUFACTURING (size standard 500 employees). Responses to this synopsis will be used by the Government to make appropriate acquisition decisions. After review of the responses to this sources sought synopsis, a solicitation announcement may be published on the FBO website. Responses to this sources sought synopsis are not considered adequate responses to the solicitation announcement. All interested offerors will have to respond to the solicitation announcement in addition to responding to this sources sought announcement. SPECIFIED REQUIREMENT: Network Contracting Office 7, Charleston, SC is seeking sources for a potential contractor to perform the following type of service: The Microbiology Laboratory of the Ralph H. Johnston VAMC in Charleston, SC needs an updated version of a highly automated and less labor intensive instrument to perform real-time PCR assays (Moderate complexity testing) from various clinical samples (nasal, stool, and other anatomical sites). The instrument must be easy to use, simple (no precision pipetting), require less hands-on time, random access testing capability, and a closed system. The PCR instrumentation is needed to support the VA mandate, and for MRSA, C. difficile, and Chlamydia/gonorrhea from clinical samples. The instrument must be able to use unprepared clinical samples with little or no preparation time (approximately two minutes or less). For a performance period of five (5) years, beginning October 1, 2013. 1. DESCRIPTION OF WORK AND REQUIREMENTS: a. The PCR instrument shall have a working interface with the VistA computer system. b. The instrument must be able to detect the etiologic agent rapidly. The turnaround time for MRSA and C. difficile tests must be 75 minutes or less. The turnaround time for Chlamydia/gonorrhea must be within approximately 90 minutes or less. c. The PCR instrumentation must be able to support the VA's current mission and be flexible to expand/support the VA's future molecular testing needs. d. The vendor must provide an FDA approved, CLIA Moderately complex, fully-integrated and automated analysis instrument. e. Sample extraction, amplification, and detection process should be fully automated in a single-use cartridge and integrated with an automated real-time PCR system. These features contribute to ease of use, productivity, reproducibility, and reduced turnaround time. f. Each assay should have sample processing control, internal control, and probe check control (no external controls required). g. The system must include on-board QC program capable of printing/displaying all internal QC/calibrations (e.g. when QC is out of limits). h. The instrument should have random access capability (different assay protocols may be run at the same time or may be started at different times and run at the same time). The system must have the ability to process samples continuously, providing true 24/7 results. The system must be simple enough to be operated during any shift and reports resultable by any trained staff member. The system should not have any special lab requirements for PCR setup and testing. i. The vendor is required to provide all needed assistance with the installation, correlation/validation studies required for all PCR testing. The vendor must provide education/training on site for basic operation and maintenance of the instrument. j. The vendor must provide all necessary procedure manuals in the CLSI (Clinical and Laboratory Standards Institute) format. k. The vendor must provide timely repair or replacement service of any defective parts of the instrument. The vendor is to provide alternative PCR testing if the PCR instrument is down in excess of 48 hours at no additional cost to the government. The costs are to be reimbursed by the vendor for those costs incurred during downtime to include, but not limited to, labor, supplies, and reference laboratory PCR testing. 3. PRICING SCHEDULE: a. The pricing of the molecular testing should be based on Cost per Test (CPT). The reagent cost should include the cost of instrument, service, parts, labor, training, etc. (all-inclusive pricing). The CPT for each PCR test (MRSA, C. difficile, Chlamydia/gonorrhea), complexity, and battery of other molecular tests available for the instrument should be provided. b. As the mission of the VA changes, the VA may add additional PCR testing. 4. FOB - DESTINATION: a. There should not be any additional costs for shipping of monthly reagents/kits. The delivery schedule for test kits will be provided. 5. ESTIMATED MONTHLY VOLUMES: a. MRSA - 360 tests b. C. difficile - 30 tests c. Chlamydia/gonorrhea - 250 tests The monthly standing order will be placed upon finalizing the contract. The monthly supplies shall be delivered to Ralph H. Johnson VAMC the first week of each month or as specified in the contract/delivery schedule. NOTE: As the Medical Center mission changes; the test volume could also change. The CPT table for various yearly volumes must be attached. A volume pricing discount is expected. REQUESTED INFORMATION: (1) STATEMENT OF CABABILITY: Submit a brief description, five (5) pages or less, that demonstrates how your company has the equipment, labor and experience to perform the reagent rental contract services described above. Include past experience in performing these services to the VA, other Government (Federal or State) agency, or for a private facility. Please specify your availability to start date and your address. (2) BUSINESS SIZE AND SOCIO-ECONOMIC STATUS: (a) Indicate whether your business is large or small (b) If small, indicate if your firm qualifies as a small, emerging business, or small disadvantaged business (c) If disadvantaged, specify under which disadvantaged group and if your firm is certified under Section 8(a) of the Small Business Act (d) Indicate if your firm is a certified Hub-zone firm (e) Indicate if your firm is a woman-owned or operated business (f) Indicate if your firm is a certified Service-Disabled Veteran Owned Small Business (SDVOSB) or Veteran Owned Small Business (VOSB) (g) Include the DUNS number of your firm. (h) State whether your firm is registered with the System for Award Management (SAM) at https://www.sam.gov/portal/public/SAM/ and/or the VetBiz Registry at http://vip.vetbiz.gov/. If not, please (i) NOTE that any future solicitation could only be awarded to a contractor who is registered in SAM and to receive award based on VOSB or SDVOSB status you must be registered in the VetBiz Registry. Responses must be emailed to contact@example.gov no later than 4:00pm EST, Monday, September 23, 2013. Your response should include both the STATEMENT OF CABABILITY and BUSINESS SIZE AND SOCIO-ECONOMIC STATUS information as explained above. Please place "Attention: Reagent Rental Agreement for Cepheid GeneXpert Infinity 48" in the subject line of your email. This notice is to assist the VA in determining sources only. A SOLICITATION IS NOT CURRENTLY AVAILABLE. If a solicitation is issued it will be announced at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this announcement.