Pre-Solicitation Notice: Immunology Quality Assessment (IQA) Program, RFP: 75N93020R00007

Notice Number: NOT-AI-20-042

Key Dates
Release Date: April 6, 2020

Related Announcements
None

Issued by
National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

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 NIAID, Division of AIDS (DAIDS), has a requirement for reliable laboratory data, important for the meaningful interpretation of therapeutic and prevention clinical trials/studies and for the appropriate management of subjects enrolled in these studies. Immunological tests, as well as frozen peripheral mono-nuclear cells (PBMCs) for future or off-site testing, are included in many DAIDS-supported trials. It is, therefore, important to evaluate objectively the ability of laboratories to process PBMC and perform tests reliably, and to enhance laboratory performance by providing assistance and training when deficiencies are identified. The current Immunology Quality Assessment (IQA) Program (under Contract No. HHSN272201400014C) is held by Duke University.

The Division of AIDS (DAIDS) in the National Institute of Allergy and Infectious Diseases (NIAID) supports a global research portfolio to advance biological knowledge of human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS), its related co-infections, and its co-morbidities. With the ultimate goal of creating an “AIDS-Free Generation,” DAIDS develops and supports the infrastructure and biomedical research needed to: 1) reduce HIV incidence through the development of an effective vaccine and biomedical prevention strategies that are safe and desirable; 2) develop novel approaches for the treatment and cure of HIV infection; 3) develop interventions to treat and/or prevent HIV co-infections and co-morbidities of greatest significance; and 4) foster partnerships with scientific and community stakeholders to develop and implement effective interventions.

A variety of immunological laboratory tests are included in DAIDS-sponsored or -supported clinical trials designed to increase the durability of viral suppression and enable antiretroviral treatment (ART)-free remission, as well as address coinfections and comorbidities that impact the health of people living with HIV. Tests are used to screen for participants’ initial sensitivity and immunogenicity to study intervention, to determine the effect of study intervention, and to assess host/virus (or bacteria) interactions. High quality test results support the safety of study participants and the reliability of study results. DAIDS employs a variety of Laboratory Quality Assurance contractual resources, including this requirement, the Immunology Quality Assessment Program (IQA), to monitor and enhance the ability of laboratories to accurately and reliably perform trial-specified clinical laboratory testing (https://www.niaid.nih.gov/research/daids-clinical-research-policies-standard-procedures). The IQA focuses on the quality of immunological laboratory testing and the processing of specimens used in such testing.

The current contract was awarded to Duke University, Durham, NC, under Contract No. HHSN2722014000014C, on September 29, 2014, for a period of seven years. Currently, IQA supports approximately 50 non-U.S. CD4 T-cell enumerating laboratories in more than 15 countries, approximately 110 laboratories that perform viable freezing of human peripheral mononuclear cells (PBMCs), and 15 laboratories to process leukapheresis products. IQA will continue to support laboratories that are part of current and future NIAID-sponsored clinical trial networks (https://www.niaid.nih.gov/research/hivaids-clinical-trials-networks).

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.

Project Requirements

Offerors should have the qualifications, experience and capability to perform this requirement. Specifically, the Contractor will be responsible for the following:

1. Creating or obtaining proficiency testing (PT) panels accredited by ISO 17043 to monitor the ability of non-U.S. laboratories to reliably enumerate CD4 T Cells, statistically analyzing test performance results, and to providing assistance, guidance and training to laboratories with unacceptable test performance.

2. Evaluating the ability of laboratories to reliably freeze at the laboratory site viable peripheral blood mononuclear cells (PBMCs); providing guidance, assistance and training to laboratories when needed, including training workshops at the Respondent’s site, on how to properly process human leukapheresis products and viably freeze PBMCs.

3. Conducting in-house and facilitating multi-lab studies to optimize new or existing immunological methodologies, with emphasis on laboratory-developed-tests (LDTs), including the provision of quality control materials and the use of biostatistical methodologies for the evaluation and interpretation of study data.

4. Creating or obtaining, characterizing, storing materials and reagents needed for the assembly of PT panels and for studies of immunological methodologies. This will require access to well-characterized (e.g., HIV- or HCV- or HBV-positive with various viral load levels, CD4 numbers, etc.) human donors who can provide human samples (e.g., whole blood, plasma).

5. Guiding laboratories that perform study-specified LDTs on the required levels of assay characterization, qualification or validation based on requirements from regulatory bodies such as the Food and Drug Administration and the European Medicines Agency.

6. Providing guidance to PBMC freezing laboratories and immunology laboratories that perform LDTs on how to achieve good clinical laboratory practices.

7. Maintaining and hosting an existing IQA computerized data management system and document library to track and make available documents in support of activities performed under the contract. Further enhancement of the system may be necessary. The offeror must have the ability to maintain the computerized system security documentation as required by OMB Circular A-130, Appendix III and the Federal Information Security Management Act (FISMA).

8. Ability to add CLIA certified laboratories for late stage validation of immunological assays and for clinical testing, if the Government elects to exercise options for increased level of effort.

Other Important Considerations

The Respondent will be expected to maintain and host the existing computerized data management system and enhance it when necessary.
In addition, the Contractor will be expected to ship Quality Control Materials (QCMs), related to proficiency testing and the evaluation and interpretation of laboratory data, to specified domestic and international destinations under appropriate shipping conditions and in accordance with International Air Transport Association (IATA)/International Civil Aviation Organization (ICAO) dangerous goods shipping regulations and other relevant shipping regulations (https://www.iata.org/publications/dgr/Pages/index.aspx).

Anticipated Period of Performance

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."

Inquiries

Please direct all inquiries to:

Christopher Weaver
Contracting Officer
AIDS Research Contracts Branch
Office of Acquisitions
Division of Extramural Activities
National Institute of Allergy & Infectious Diseases
National Institutes of Health, DHHS
5601 Fishers Lane, Room 3C36, MSC 9821
Bethesda, MD 20892-9821
For Express Mail, change zip code to 20852
Telephone: 240-627-3219
Email: christopher.weaver@nih.gov


John Manouelian
Contracting Officer
AIDS Research Contracts Branch
Office of Acquisitions
Division of Extramural Activities
National Institute of Allergy & Infectious Diseases
National Institutes of Health, DHHS
5601 Fishers Lane, Room 3C31, MSC 9821
Bethesda, MD 20892-9821
For Express Mail, change zip code to 20852
Telephone: 240-669-5152
Email: manouelj@niaid.nih.gov