New Detection Technologies

AMENDMENT #1: The purpose of this amendment is to provide the Response to Vendor Inquiries. ****************************************************************** The United States Department of Agriculture (USDA), Food Safety and Inspection Services (FSIS) intends to compete its requirement for New Detection Technologies. Pursuant to Federal Acquisition Regulation (FAR) 15.202, this acquisition will be conducted using the advisory multi-step process. This synopsis includes both Phase I and Phase II listed below, and offeror viability will be determined separately after each phase. Offerors will be notified in writing that they will either be invited to participate in the resultant acquisition, or based on the results of the technical evaluation of the offerors submission, that they are unlikely to be a viable competitor. The USDA/FSIS requests that potential Offerors submit information that will allow the Government to advise them about their potential as viable competitors. A written proposal submission is required in response to this notice. The information that must be submitted in response to this synopsis and the criteria that will be used to make the initial evaluation and resultant submitter's viability is described below in this document. The Offeror's written proposal shall be submitted electronically to Sheila Edmonds, Contracting Officer, at sheila.edmonds@fsis.usda.gov no later than 3:00 p.m. EST, Friday, September 8, 2017. Questions concerning this pre-solicitation may be submitted via email only to sheila.edmonds@fsis.usda.gov no later than 3:00 PM EST on Friday, August 25, 2017. No telephone inquiries will be honored. Faxed responses are not permitted. This pre-solicitation will include the following two (2) phases: Phase I: First, FSIS intends to determine viability of multiple vendors based on the highest rated scores as a result of the technical evaluation of Phase I (criteria listed below), and the availability of space to house the instruments in FSIS laboratories. Vendors who are not determined viable as a result of the Phase I evaluation will be notified directly. Vendors who are determined viable as a result of the Phase I evaluation will be expected to have their instruments installed at deemed FSIS laboratories within 45 days of viability determination. Phase I (Go, No Go) Mandatory Criteria-The Contractor must meet all of the following mandatory criteria and must demonstrate an acceptance of these requirements in its proposal. Technical responses shall be evaluated based on the responses to the mandatory/essential criteria as well as the supporting questions that may help USDA-FSIS determine fit-for-purpose. - The Contractor must provide commercially available reagents and kits for evaluation of each analyte. - The Contractor must have validation status (AOAC, AFNOR, etc.) for each analyte(s) being considered for evaluation by FSIS. - The Contractor must agree to allow placement of at least one (1) instrument in each of the three (3) FSIS Field Laboratories during the evaluation period-not expected to exceed six (6) months - The Contractor must provide instrumentation support, service, and parts as part of the technical evaluation period. - The Contractor must provide instrumentation support, service, and parts as part of the leasing contract. The Contractor's proposal must at a minimum provide the following information: - Stated limit of detection for each analyte - Validated matrices - Validation Status for each analyte (ex. AFNOR, AOAC) - Run-time for each assay - Maximum samples per run for each test kit - Sensitivity/False Negative Rate for each validated test kit - Specificity/False Positive Rate for each validated test kit In addition to the required information above, the Contractor must address the following evaluation questions in its response. The following questions will provide USDA/FSIS Laboratory Systems with additional useful information that will be used to evaluate the fit-for-purpose of the platform. Each response will be evaluated as shown below: - Does the platform and or test kit allow for quantitation of the pathogen? If "yes", please describe how this is accomplished. o For each pathogen capable of quantitation. (1 point/pathogen enumerated.) - Does the platform and/or test kit allow further characterization of isolates (e.g. serotype)? o For each pathogen capable of characterization beyond detection (e.g. Salmonella serotype, Campylobacter speciation). (1 point /pathogen characterized.) - Does the test platform require sample enrichment prior to analysis? o No enrichment step needed prior to pathogen detection (1 point). - If enrichment is needed, is the technology compatible with the current enrichment media listed in the MLG? o Company earns 1 point for each pathogen-detection technology which is compatible with current enrichment media. - Does the platform require a separate sample preparation step prior to automated-testing? If "yes", describe the preparation step (i.e. time needed, any additional equipment needed). o Ease of sample preparation. (1 point) - Is the test platform flexible enough to accommodate additional tests designed by the end user? (e.g. Can other STEC O-antigen groups be added at will? Can the software be manipulated to look at analytes that code for stx genes with or without eae genes?] o The platform allows an open test design. (1 point) o Assay targets are described (1 point). (Note: The actual gene sequences or peptide sequences are not required) - Can the Company provide a track record to substantiate the mean downtime of the system when the system is used daily and serviced routinely as suggested by the manufacturer? o Superior customer service and response time to service can be demonstrated (1 point). - Has software for the instrumentation been validated with Windows 7 and Windows 10? o Software has been validated on both Operating Systems (1 point). - Please describe the ease of use of method. o Reagent manipulation is minimal (1 point). o Hands-on time is minimized (1 point). o The number of steps required to use are minimal (1 point). o Automated data analyses applies (1 point), - Does accommodation of the equipment require any renovation at the location (i.e. is the footprint of the platform and accompanying instrumentation amenable to a typical laboratory)? o The footprint of the platform and the required accompanying instrumentation is feasible for the laboratory (1 point). Phase II: Placement of Instrument in USDA/FSIS Laboratories Viable vendors must place its instrument in each of the three (3) FSIS Field laboratories during a not to exceed six (6) month evaluation period. The government anticipates the Contractor shall place the instruments in each of the three (3) FSIS Field laboratories around October/December 2017. The Contractor must provide set-up and training to FSIS employees per manufacturer's protocols prior to Phase II evaluation of the Contractor's product. The Contractor must cover any required maintenance and repair costs to the equipment during Phase II. Once viable vendors have their instruments installed, they must provide all necessary kits and reagents to test 60 samples for each analyte, as well as provide all shipping costs for the kits and reagents between date of install and the issuance of formal RFP's in the first half of 2018. *Evaluation of Contractor Products in USDA/FSIS Laboratories USDA/FSIS laboratories shall evaluate the performance of the Contractor's products compared to the performance of the methods described in the FSIS Microbiology Laboratory Guidebook http://www.fsis.usda.gov/wps/portal/fsis/topics/science/laboratories-and-procedures/guidebooks-and-methods/microbiology-laboratory-guidebook/microbiology-laboratory-guidebook The technology under evaluation will be used by USDA/FSIS exactly as specified as per the manufacturer's explicit instructions as provided. Comparison studies shall be conducted by USDA/FSIS Field Laboratories following the FSIS-prescribed validation guidelines that can be found at the following link: https://www.fsis.usda.gov/wps/wcm/connect/966638c7-1931-471f-a79e-4155ce461d65/Validation_Studies_Pathogen_Detection_Methods.pdf?MOD=AJPERES For each bacterial analyte, USDA/FSIS shall test a minimum of three (3) matrices with sixty (60) samples per method-. Samples shall be artificially inoculated with the target analyte at fractional recovery levels (20-80% recovery). A paired-study design will be used to compare the reference method against the alternative method, which includes the technology under evaluation. From this, USDA/FSIS will determine the False Positive and False Negative rates, which will be used in evaluating the efficacy of the product in FSIS laboratories. Multiple vendors will be determined viable by FSIS at the end of the Phase II evaluation period based upon the evaluation criteria listed above. Vendors who are not determined viable as a result of the Phase II evaluation will be notified directly. Vendors who are determined viable as a result of the Phase II evaluation will also be notified directly. At this point, it is anticipated that multiple RFP's will be issued with anticipated awards in the first half of 2018.