Rapid Blood Donor Screening Prototype

This solicitation, issued by the U.S. Army Medical Research Acquisition Activity (USAMRAA), represents a Request for Prototype Proposal (RPP) in support of the U.S. Army Medical Materiel Development Activity (USAMMDA). The award(s) will be managed by the Warfighter Protection and Acute Care Project Management Office (WPAC PMO) in support of the Rapid Donor Screening Capability (RDSC) development effort at USAMMDA. The RDSC working group will provide consultative input into the project as needed and conduct annual in-progress reviews with the Milestone Decision Authority, as well as interim reviews if needed more frequently.The objective of this prototype project is to develop, test and gain U.S. Food and Drug Administration (FDA) approval of a multiplex assay that can provide results in 15 minutes or less for blood type, Rh factor, Human Immunodeficiency Virus (HIV), hepatitis B and C. The DoD desires a new capability that can be fielded at all military medical roles in an operational environment where stored whole blood may be unavailable, including on U.S. Navy casualty receiving ships, at Role 1 Battalion Aid Stations, and Special Operations or Expeditionary teams. The goal of the RDSC is to support low risk contingency blood transfusions. Ultimately, a successful prototype project will result in an FDA cleared/approved device and assays that meet all of the Government?s minimum requirements listed in Paragraph 5 of the Government?s Statement of Objectives (SOO) attached to this RPP. The Government may also make a determination that a successful prototype projects has been achieved for purposes of a non-competitive follow-on contract or transaction in order to purchase quantities necessary for military use testing and evaluation. Upon the Government?s determination that a successful prototype has been achieved, the Government may elect to make an award of a follow-on production contract(s) or transaction(s) without the use of competitive procedures pursuant to 10 U.S.C. 4022(f). The Government estimates that any such follow-on contract(s) or transaction(s) will involve an ordering period beginning with a determination by the Government that a successful prototype has been achieved through the execution of a sustainment contract for the device and panels/cartridges by the Defense Logistics Agency (DLA). The Government estimates that up to 500 devices and 10,000 panels/cartridges may be ordered pursuant to the follow-on contract(s) or transaction(s) herein described. A successful prototype will have uses during commercial blood donor drives, by foreign military, and in countries without robust donor screening capabilities, all markets which will sustain the commercialized product. Attached to this solicitation is an Example OT Agreement. Please, with proposal submission, include a redline copy of anything which may need to be adjusted in both the RPP and the OT agreement to accommodate the proposal. Please submit all questions by 3 PM Eastern on 18 April 2023. 5 April 2023 - Please note the question period has been extended to 18 April 2023, and the proposal period has been extended to 21 May 2023.