Inactive
Notice ID:W91YTZ20Q0242
Contractor, Hologic Inc., shall provide reagents and calibrators at agreed upon pricing to support FDA-approved in vitro diagnostics molecular testing for Chlamydia trachomatis, Neisseria gonorrhoeae,...
Contractor, Hologic Inc., shall provide reagents and calibrators at agreed upon pricing to support FDA-approved in vitro diagnostics molecular testing for Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Mycoplasma genitalium, Herpes Simplex virus on symptomatic or asymptomatic patients, Flu A/B and RSV. Additionally, the Vendor will provide reagents to support molecular testing for Zika virus and SARS-CoV-2 that possess at least an FDA EUA. These products must be manufactured by the Contractor and not by a third party. All assays must be Food & Drug Administration (FDA) approved or be under an Emergency Use Authorization (EUA). All reagents provided will be identical to those used in the FDA 510K approval application. For reagents with hazardous constituents, Contractor must provide a mechanism for the Laboratory to meet local discharge requirements. Unexpected changes in methodology/technology shall be at the expense of the Contractor. Alerts and notifications of all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the COR, Microbiology Supervisor and Lead Medical Technologist. Contractor shall make available any reagents for an emerging pathogen that obtains FDA approval or EUA at government pricing. Delivery of the reagents will be on an as needed basis. Individual orders will be placed by the COR or other designated authorized government personnel. Name and point of contact of authorized personnel will be provided to the Contractor. Any workload provided is an estimate based on projected annual volume. Orders of required items will be called or emailed to the Contractor. Deliveries shall arrive within five working days after the order is placed. No deliveries shall be accepted on weekends or federal holidays. Emergency orders placed before 2:00 PM Eastern Standard Time (EST) will be delivered within 24 hours after the order is placed. All reagents/reagent packs will be provided as follows: Be provided by the manufacturer of the equipment. Possess at least two months of the expiration date remaining at the time they are received in the laboratory Be marked with the required storage temperature. Be maintained at the proper storage temperature during transportation from the Contractor’s storage facility to the Government acceptance site and be delivered on time at the appropriate storage temperature. Specimen collection kits must be offered by the Contractor for use with their molecular assays. If the specimen collection kits differ from those currently in use, the Contractor will work with the laboratory and field personnel to ensure that an acceptable plan is in place to replace existing specimen collection kits with new specimen collection kits. Specimen collection kits should not require refrigeration for storage. In the event that the supplies are found to be defective and unsuitable for use with the Hologic Panther Fusion or the Contractor has failed to comply with the requirements, the Contractor shall replace the supplies within 24 hours of receipt of the order. Safety Data Sheets (SDS). For all products the Contractor must provide a mechanism for the laboratory to meet local discharge requirement. The Contractor shall provide one set of paper copy and two electronic copies on Compact Disk (CD) of SDS of all reagents and consumables to be used on the system.
