Immunology Quality Assessment (IQA) Program

The purpose of the proposed contract will be to continue to provide a Immunology Quality Assessment Program (IQA) resource to evaluate and enhance the ability of U.S. and non-U.S. laboratories (Labs) to participate in NIAID-funded and collaborative clinical studies by: (1) monitoring the ability of Labs to reliably perform study-specified immunological tests and cryopreserve peripheral blood mononuclear cells (PBMCs) and other human biological samples; (2) facilitating the optimization, standardization and validation of immunological assay methodologies, with focus on laboratory-developed-tests (LDTs) for implementation in NIAID-supported studies; (3) helping Labs meet sponsor and regulatory requirements for good clinical laboratory practices (GCLP) and submission of data to regulatory agencies; and (4) hosting and maintaining an electronic data management system and document library in support of contract activities. Increases in the level of effort, in order to support unanticipated increases in demand related to support of additional Labs, as well as performance of late-stage assay validation and/or immunological assay testing of clinical samples in a CLIA-certified laboratory, are also within the scope of the contract and would be implemented through the exercise of contract options, at the discretion of the Government. It is anticipated that a cost reimbursement, term/level of effort, type contact will be awarded. The period of performance will be for one year (Base Period) plus six (6) one-year options to extend the term of the contract that may be exercised by the Government unilaterally, for a total possible period of performance of seven (7) years, beginning approximately June 30, 2021. The requirement will be the delivery of 8.50 full time equivalents (FTEs) per year for the base period (Year 1) and 8.50 FTEs per year for Options 1-6 (Years 2-7). If Options 1-6 are exercised, the services required will be the same as provided during the Base period. The percentage of effort includes the effort of subcontracts and consultants. In addition, the Government may unilaterally exercise options to accommodate unanticipated increases in demand, as follows: Options 7 - 27: Increased Level of Effort for Additional Labs: During the course of the contract, it may be necessary to incorporate additional PBMC cryopreserving and/or leukapheresis processing Labs to support new NIAID-supported clinical trials. Such an increase would require an increase in the Contractor's activities, to be activated at the discretion of the Government as an Option. Each Option of this type will implement work commensurate with the addition of 10 Labs or the subsequent maintenance of those Labs that were added via the exercise of an option. If the Government elects to exercise this Option, the Contractor shall provide an additional 1.0 FTE. The period of performance of an Option for Increased Services will not exceed the term of the base year or Option year in which the Option is exercised. One Option for adding new Labs may be exercised once per year, beginning with Year 2 of the contract, and one option per each previously added set of 10 Labs (those Labs that were added via the exercise of an option) may be exercised each subsequent year, in order to maintain each previously added set of 10 Labs (those Labs that were added via the exercise of an option), to a total of 21 options during the life of the contract, as follows: Year 2 (Option 7), Year 3 (Options 8 and 9), Year 4 (Options 10, 11, and 12), Year 5 (Options 13, 14, 15, and 16), Year 6 (Options 17, 18, 19, 20, and 21), and Year 7 (Options 22, 23, 24, 25, 26, and 27). The period of performance of an Option for Increased Level of Effort will not exceed the term of the Option year in which the Option is exercised. The percentage of effort includes the effort of subcontracts and consultants. Options 28 - 33: Increased Level of Effort for the Addition of a CLIA Certified Lab: During the course of the contract, it may become necessary to use new and novel immunologic assays in clinical trials where results will be used for clinical decisions within the trial. This will necessitate the use of a CLIA certified laboratory for late stage validation of the assay and for clinical testing. If necessary, this will be provided through the exercise of options to this contract. Should the Government elect to exercise these options, the Contractor shall provide resources for the unanticipated increase in work volume by 1.0 FTE for each option exercised. One option may be exercised per year in Years 2 through 7. The period of performance of an Option for increased level of effort for this purpose will not exceed the term of Option year in which the Option is exercised. The percentage of effort includes the effort of subcontracts and consultants. Any responsible offeror may submit a proposal, which will be considered by the Agency. This RFP will be available electronically, on/about April 16, 2020, and may be accessed through SAM http://beta.sam.gov/. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted. For this solicitation, the NIAID requires proposals to be submitted online via the NIH's electronic Contract Proposal Submission (eCPS) website at https://ecps.nih.gov. Submission of proposals by facsimile or e-mail is not acceptable. For directions on using eCPS, go to the website (https://ecps.nih.gov) and then click on "How to Submit."