Fentanyl Immunoassay Reagent Test Kits

NOTE: THIS ACTION DEADLINE WAS EXTENDED AGAIN FOR SIGNIFICANT UPDATES. A REVISED FINAL SOLICITATION SHOULD BE POSTED BY JULY 14TH. THE DUE DATE IS NOW JULY 27TH, 2022. ADDITIONAL DETAILS WILL FOLLOW. The Naval Medical Readiness Logistics Command Detachment (NMRLCD) is advertising a full and open solicitation for the Department of Defense (DOD) Drug Demand Reduction Program (DDRP) requirement of fentanyl/norfentanyl immunoassay reagent kits in human urine samples. The materials shall be for the initial (screen) immunoassay for the detection of fentanyl in urine when present at a concentration equal to or greater than 1 ng/mL. Without modification of the instrumentation, the reagent shall be compatible with the Beckman Coulter AU5800 Series Clinical Chemistry Analyzers already in use at the Department of Defense (DOD) Forensic Toxicology Drug Testing Laboratories (FTDTLs) to include the Armed Forces Medical Examiner System (AFMES) Forensic Toxicology Division. The immunoassay is limited to a two (2) reagent assay procedure. A vendor's reagent proposal which requires a separate pre-treatment of each specimen prior to testing on the analyzer will not be considered acceptable. The reagent shall be compatible with the optimal throughput of the analyzer systems and shall not interfere with the optimum performance of the other immunoassay procedures performed on these instruments. The reagent shall not impose additional maintenance, servicing, or calibration requirements for the optimum performance of the contractor's reagent on the analyzer. Immunoassay kits shall have clearance approved from the FDA and Quality Management Documentation to meet the requirements of DODI 1010.16 revised 15th June 2020. The North American Industrial Classification System {NAICS) Code is 325413. The small business size standard is 1,250 employees. The solicitation is for a single award IDIQ contract. The estimated number of tests shall accommodate up to 500,000 tests per month. The proposed contract has an anticipated period of performance from 1 December 2022 through 30 November 2026. The solicitation will be issued as a Request for Proposal utilizing commercial Acquisition Procedures per FAR 12. This finalized solicitation will be issued via https://www.SAM.gov on or about 30 June, 2022. The solicitation number will be N62645-22-R-0004. It is each Offeror's responsibility to download the solicitation from the internet website. No paper copies will be provided. Notification of amendments shall be made via the Internet as well. It is therefore the contractors' responsibility to check the SAM website daily for any posted changes to solicitation. Contractors may view and/or download this solicitation and all amendments from the Internet after solicitation issuance at the following Internet address: https://www.SAM.gov. Offeror's must be registered with the System Award Management (SAM), in order to submit a proposal on a Government solicitation. To register, the SAM Internet address is: https://www.sam.gov/SAM. The new contract specialist for this solicitation will be Chris Tate. All questions or comments should be forwarded via SAM.gov to christopher.r.tate6.civ@mail.mil.