Notice of Sole Source Award and Redacted J&A - Cost Per Test - Viral Load Reagents for In-Vitro Diagnostics (IVD) Platform

The Regional Health Contracting Office-Central (RHCO-C) is issuing this Sources Sought Notice to find potential sources to provide one fully automated in-vitro diagnostic (IVD) molecular analyzer with all necessary reagents, consumables, controls, training and maintenance service to conduct testing under a Cost-Per-Test Agreement (CPT)for the Brooke Army Medical Center (BAMC) Department of Pathology and Area Laboratory Services (DPALS) Molecular Microbiology Laboratory, Fort Sam Houston, Texas. A base period of performance plus four (4) option periods are contemplated. THIS IS NOT A SOLICITATION ANNOUNCEMENT - This is a Sources Sought Notice and is issued solely for information and planning purposes - it does not constitute a Request for Quote (RFQ) or a promise to issue an RFQ in the future. Solicitations are not available at this time and requests for a solicitation will not receive a response. This notice does not constitute a commitment by the United States Government to contract for any supply or service whatsoever. All information submitted in response to this announcement is voluntary; the United States Government will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the United States Government. Not responding to this Sources Sought Notice does not preclude participation in any future Request for Quote (RFQ), should one be issued. It is the responsibility of the potential offerors to monitor this site for additional information pertaining to this requirement. The Government will use responses to this notice in formulating its acquisition strategy. If the Government does not receive sufficient information in response to this notice to verify the potential for competition exists, it is possible that a sole-source contract, supported by a Justification and Approval document, will be issued to support the Government's requirement. RHCO-C is seeking the following information (please answer paragraph below with your response): 1. Company name, DUNS number, CAGE code, and point of contact information (including phone number and email address), and socio-economic category(ies) as related to NAICS 325413 (In-Vitro Diagnostic Substance Manufacturing), such as 8(a), HUBZone, Women-Owned, Service-Disabled Veteran-Owned, Small, or Other-than-Small. 2. Capability Statement (limited to ten pages), describing how your company meets the below objectives, providing additional proof (such as FDA approval) where appropriate: a. Provides molecular analyzer, reagents, consumables, controls, training, and maintenance service for the following comprehensive viral load assays: - Provide testing materials for the testing: Human Immunodeficiency Virus Type 1 Viral Load (HIV-1) Hepatitis B Viral Load (HBV) Hepatitis C Viral Load (HCV) Cytomegalovirus Viral Load (CMV) - Testing system must include testing for the following: Human Immunodeficiency Virus Type 1 Viral Load (HIV), Hepatitis B Viral Load (HBV), Hepatitis C Viral Load (HCV), and Cytomegalovirus Viral Load (CMV). - Testing must be performed on a fully automated IVD platform. - Platform and reagents must be FDA approved for HIV-1, HCV, HBV and CMV viral load monitoring. - The CMV quantitative assay must be approved for use as an aid in the management of solid-organ transplant patients who are undergoing anti-CMV therapy. Limit of detection should be at least 45 IU/mL and a linear quantitative range from at least 137 IU/mL to at least 9.1 x10^6 IU/mL. - Linear / reportable range should be within 15% CV. The HCV quantitative assay must use a dual probe design that provides built in redundancy against current and potential future polymorphisms with a lower limit of quantification and lower limit of detection of at least 15 IU/mL across all genotypes 1-6, with an upper limit of quantitation of at least 100 million IU/mL. - The HIV quantitative assay must use a dual target approach utilizing targets that are not current targets for anti-viral therapy such as the gag and LTR regions of the HIV-1 genome to mitigate the risk for underquantitation. This assay must have a lower limit of quantitation and lower limit of detection of at least 20 copies/mL and an upper limit of quantitation of at least 10 million copies/mL. - The HBV quantitative assay must use targets that provide A-H genotype coverage with a lower limit of quantitation and lower limit of detection of at least 20 IU/mL and an upper limit of quantitation of at least 170 million IU/mL. - The testing platform must be capable of running HIV-1, HCV, HBV, and CMV simultaneously. - Platform must have sample in and result out capability designed for viral load monitoring. - Must be capable of overnight, unattended operation. - Must consist of two separate units: Unit 1 - Sample processing/extraction unit; Unit 2 Amplification/detection unit for acceptable analysis. - Must contain automated system for the transfer of samples from sample processing unit to amplification/detection unit without intervention by a technician. - Must be FDA approved for both units to operate within the same room, side by side. - Must have FDA approved reagents and consumables compatible with instrument. - Reagents must be packaged in sealed, ready-to-use bar-coded reagent cassettes. - Reagents must be traceable to the World Health Organization standard. - Must contain QS (Quantitation Standard) in every reaction to function as an internal control and is coamplified with the target for the purpose of titer calculations within each reaction. - Instrument must use dedicated pipetting for reagents, which are physically separated from the portion of the instrument that performs sample handling. - Specimen processing must occur in dedicated units. - Specimens must be loaded on the instrument in closed, screw cap vials. - Pipetting must be performed utilizing aerosol barrier tips. - PCR reactions must contain a cross contamination control/product, such as Uracil-DNA glycosylase to reduce the risk of carryover PCR products, and must be added within the reagent Master Mix without manual addition. - Platform must be compatible with facility data transfer systems. - The system must provide a central data management hub, to which all major systems included in this SOW connect to Unit 1 - Sample processing/extraction unit; Unit 2 Amplification/detection unit. - The system must not require remote communication to outside sources to be functional. - The system must be capable of interfacing with the CHCS. - Platform must operate using one computer for both instruments. - Software must keep track of cassette usage. - Software must monitor the on-shelf expiration date, and the reagent on-board time. - Software must monitor the expiration date of pierced bottles. - Software must monitor cassette lot usage in addition to monitoring/tracking specific kit usage to avoid mixing of different reagent lots. - Software must have built-in reagent stability monitoring. - System must have FDA approved WINDOWS 10 Operating System. - No external Firewall will be allowed. - Software must track instrument maintenance requirements. - Software must have interface capabilities. - The analyzers will have an interface that is compatible to the government system (CHCS) and will be able to recognize CHCS generated bar-code labels (both code 39 and 128) on primary sample tubes. - Peripherals, to include Uninterruptable Power Sources (UPSs), electrical line conditioners as required, instrument-specific computer terminals/CPUs, printers to include toner for each as needed, and other equipment where required. - Pedestal(s) capable of supporting each work cell system as appropriate, to include computer terminals or other automated instruments/peripherals as appropriate, providing a neat work area (e.g., reagent, cable and tubing control/maintenance). b. The Contractor must provide all equipment, reagents/reagents packs, calibrators/standards, quality control materials, user-replaceable maintenance items, and analyzer specific tools/supplies to support the ongoing delivery of laboratory services using the equipment outlined in this section. - Reagents/consumables must meet the requirements of the 24/7 BAMC mission, workload, and test menu The Contractor must provide quality control materials acceptable to the section Medical Director. This includes third-party controls when requested/required by the laboratory. - In determining reagent requirements, the Contractor must consider requirements for routine quality control runs (as defined by the Laboratory Director), routine calibration, periodic calibration/calibration verification in accordance with departmental policy, and troubleshooting of out-of-control assays when calculating the yearly requirements. - Reagents used for troubleshooting analytical systems must be reimbursed (or replaced) by the Contractor at no additional cost. - The Contractor will provide, upon shipment, an electronic tracking mechanism whereby the Government is able to identify the shipping status of any equipment, reagents, or materials. Deliveries of required items must be in monthly drop shipments or as called in by the COR or ACOR. Large items must be shipped in a split order to arrive 2 weeks apart. Orders must arrive no later than one week from the requested date of delivery. Any supplies that are placed on back order shall be communicated electronically to the Government, clearly identified on the shipping documents and delivered in a timely manner, not to exceed ten (10) working days. In the instance a back-order exceeds 10 working days, the Contractor must provide testing services through local sub-contract at their cost. - Emergency orders will be delivered within 24 hours after the order is placed. The response due date for this Sources Sought Notice is 4:00 PM CST, June 29, 2020. All questions and comments regarding this announcement shall be submitted via e-mail to the below POCs: