Immunology Quality Assessment (IQA) Program

Introduction: This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are: small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. Background: 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 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 leukopheresis 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). Purpose and Objectives: 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. 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). The percentage of effort includes the effort of subcontracts and consultants. 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: 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. 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 during any year of the contract, beginning with Year 2 of the contract, to a total of 21 options during the life of the contract, as follows: Year 2 (Option 7), Year 3 (Options 8 & 9), Year 4 (Options 10, 11, 12), Year 5 (Options 13, 14, 15, 16), Year 6 (Options 17, 18, 19, 20, 21), and Year 7 (Options 22, 23, 24, 25, 26, 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. Increase 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. 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). Capability Statement/Information Sought: Capability statements submitted as a result of this announcement should demonstrate the Offeror's qualifications, expertise and experience, specifically providing evidence as to the capability to perform this requirement, with particular attention to 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 leukopheresis 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 Responder 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. Personnel/Management: The prospective contractor must have a Principal Investigator and key staff with training, experience and expertise with respect to clinical immunology testing, regulatory requirements for immunological assay characterization that support product licensures, and knowledge of good clinical laboratory practice standards, including principles of proficiency testing, immunological assay characterization and biostatistical analysis; as well as experience with projects of similar size, scope and complexity. Additionally, interested parties must indicate availability of key professional and technical staff for the proposed project. Past Performance: Past performance is considered essential. In addition to demonstrating that they have met the above qualifications, interested parties must identify at least three other projects of similar size and complexity. Capability statements submitted as a result of this announcement should demonstrate the Offeror's qualifications, expertise and experience, specifically providing evidence as to the capability to perform this requirement. Capability Statements should clearly convey information regarding the respondent's capabilities, including: (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information. Required Business Information: - DUNS. - Company Name. - Company Address. - Company Point of Contact, Phone and Email address - Current GSA Schedules and/or Government-wide Acquisition Contracts (GWACs) appropriate to this Sources Sought. - Do you have a Government approved accounting system? If so, please identify the agency that approved the system. - Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the System for Award Management (SAM) located at https://beta.sam.gov/. This indication should be clearly marked on the first page of your Capability Statement (preferable placed under the eligible small business concern's name and address). NIAID recognizes that no single organization or institution may have the expertise and facilities required to perform all of the tasks mentioned above. Therefore, the Contractor may need to utilize the expertise and resources of subcontractors and specialized consultants to provide the full spectrum of requested activities. The Contractor shall be responsible for ALL work performed under this contract including that performed by any subcontractors and consultants. The Contractor will ensure that any and all processes meet international, federal, local and state regulations to ensure the continuity and validity of the resulting product. Page Limitations: Interested qualified small business organizations should submit a tailored Capability Statement not to exceed five (5) pages, excluding resumes. Capability Statements must not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information. Font size must be 10 to 12 points. Spacing must be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text. Print margins must be at least one-inch on each edge of the paper. Print setup should be single-sided on standard letter size paper (8.5 x 11" in the U.S., A4 in Europe). All proprietary information should be marked as such. Number of Copies: Please submit one (1) electric copy of your response as follows: All Capability Statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via e-mail) to Christopher Weaver, Contracting Officer, at christopher.weaver@nih.gov in MS Word or Adobe Portable Document Format (PDF). The e-mail subject line must specify SBSS75N93020R00007. Facsimile responses will not be accepted. Common Cut-off Date: Electronically submitted tailored capability statements are due no later than 3:00 p.m., EST., JANUARY 31, 2020. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).