NIAID Virology Quality Assurance

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases.

The Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), is seeking proposals from qualified offerors to provide a comprehensive quality assessment program for virologic assays for HIV, and other viral pathogens. The current contract is held by Duke University, Durham, North Carolina under contract number 75N93019C00015.

The period of performance of the current contract is June 21, 2019 through June 20, 2026. Description The purpose of the NIAID Virology Quality Assurance (VQA) program is to provide a comprehensive quality assessment program for virologic assays for HIV and other viral pathogens (including emerging pathogens and pandemic response) performed on samples collected from participants enrolled in NIAID-sponsored and collaborative multisite clinical studies.

The goal of the VQA program is to ensure the validity and inter- and intra-laboratory comparability of virologic laboratory data by providing laboratories with proficiency testing (PT) panels and real-time assay run controls and analyzing PT panel and assay run data within each laboratory and across laboratories participating in the program.

The VQA program implements standards of performance for new and existing state-of-the-art virologic assays, develops and employs biostatistical methods relating to the assays, and acquires, tests, stores and dispenses quality control materials (QCMs) and reagents.

The VQA program is critical to the scientific integrity of on-going and future studies concerning HIV diagnosis, pathogenesis, drug resistance, and cure, including the assessment of vaccine and treatment efficacy, post-exposure prophylaxis (PrEP), other preventive measures, and response to emerging viral pathogens of pandemic potential.

The VQA has been in operation since 1988 and has developed and standardized quality control procedures for numerous virologic assays in support of NIAID-sponsored and collaborative clinical trials. The VQA will continue to serve current and future NIAID-sponsored clinical trial networks, cohorts, and collaborating study groups (User Groups), as well as individual grantees conducting clinical research.

The Contractor shall provide laboratories (Labs) performing virologic testing for NIAID-sponsored and collaborative clinical trials with a comprehensive quality assessment program and real-time assay validation for virologic assays for HIV and other viral pathogens. The contract also provides for the planning and execution of single and multi-laboratory studies for the evaluation and development of new and existing virologic assays and supporting statistical methodologies.

QCMs necessary for this work will be acquired, characterized, stored, catalogued, and dispensed as necessary. This contract also includes Options to increase level of effort in support of:

(1) unanticipated increases in demand related to support of additional Labs;

(2) performance of late-stage assay validation and/or testing of clinical samples in a CLIA-certified laboratory; and (3) response to emerging viral pathogens and other public health emergency needs. The Contractor shall serve laboratories associated with current and future NIAID-sponsored clinical trial networks and collaborating study groups. Currently, the contract serves approximately 110 laboratories, with 55 international laboratories in 19 countries. The Government anticipates a potential need to increase the level of effort by exercising Options for the following additional support:

1) to expand the number of laboratories serviced by the Program during the period of the contract;

2) to expand expertise for similar services that address HIV related pathogens and other viral pathogens and 3) to add a CLIA certified lab for late-stage validation of assays for clinical testing.

Anticipated Period of Performance: It is anticipated that one 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 March 21, 2026. The requirement will be the delivery of 10.00 full time equivalents (FTEs) per year, including consultant and subcontractor effort, for the Base Period (Year 1) and 10.00 FTEs per year, including consultant and subcontractor effort, for Options 1-6 (Years 2-7).

In addition, the Government may exercise options for an increased level of effort that may result from unanticipated increases in demand for the activities supported by the base requirements of this contract. Options for increased services may include:

Options 7-26: Increased Level of Effort for Additional Labs During the contract, it may be necessary to incorporate additional Labs to support new NIAID-sponsored and collaborative clinical trials. Such an addition 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 5 Labs.

These options may be exercised during Years 2 through 7. Should the Government elect to exercise these options, the Contractor shall provide resources for the unanticipated increase in work volume by 0.25 FTE, including consultant and subcontractor effort, to accommodate these additional Labs during the first and each subsequent year of activation. The period of performance of an Option for increased level of effort for this purpose will not exceed the term of the Option year in which the Option is exercised.

Options 27-32: Increased Level of Effort for Additional Expertise During the contract, it may be necessary to develop a quality assessment program for assays associated with HIV-related viruses and/or emerging pathogens that would directly support high priority NIAID research programs. Should the Government elect to exercise these options, the Contractor shall provide resources for the unanticipated increase in work volume by 1.30 FTE, including consultant and subcontractor effort, for each option exercised. 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.

Options 33-38: Increased Level of Effort for the Addition of CLIA Certified Labs During the contract, it may become necessary to use new and novel virologic 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, including consultant and subcontractor effort, for each option exercised. 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. Any responsible offeror may submit a proposal which will be considered by the Agency.

This RFP will be available electronically on/about January 9, 2025 and may be accessed through 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 NIAID electronic Contract Proposal Submission (eCPS) website. 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."