SOURCES SOUGHT
A -- External Quality Assurance Program Oversight Laboratory
- Notice Date
- 10/28/2015
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions, 5601 Fishers Lane, 3rd Floor, MSC 9821, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIAID(AI)-SBSS-15-055
- Archive Date
- 11/28/2015
- Point of Contact
- Lorna A. Finn, Phone: 240-669-5153, John R. Manouelian, Phone: 240-669-5152
- E-Mail Address
-
lorna.finn@nih.gov, manouelj@niaid.nih.gov
(lorna.finn@nih.gov, manouelj@niaid.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- 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 mission of the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), is to increase basic knowledge of the pathogenesis and transmission of the human immunodeficiency virus (HIV), support the development of therapies for HIV infection and its complications, and support the development of vaccines and other prevention strategies. Reliable laboratory data are essential to the clinical evaluation of candidate HIV vaccine platforms and immunogens. Data from multiple laboratories performing assays in support of single or multiple vaccine candidate trials must be accurate and reproducible. The purpose of the External Quality Assurance Program Oversight Laboratory (EQAPOL) is to provide confidence that individual laboratories generate reliable data to support vaccine immunogen advancement. EQAPOL supports these efforts by participating in the development and availability of validated assays, providing common and well-characterized reagents and Standard Operating Procedures (SOPs), and providing external quality assurance (EQA) programs to measure and monitor laboratory performance. The current contract was awarded in 2010 (HHSN272201000045) to Duke University and established proficiency testing programs serving over 60 laboratories in greater than 40 sites worldwide and provided a panel of fully characterized viruses from early acute HIV infections used to develop new assays and validate assay platforms. The contract also established a peripheral blood mononuclear cell (PBMC) bank and EQA reagent repository of characterized material used to support EQAPOL proficiency testing programs and made available to NIAID supported investigators. Purpose and Objectives The proposed contract will support existing activities, develop new assays, and provide assistance in the standardization, validation, and development of new proficiency testing programs. The contract will continue to make materials available to NIAID-sponsored domestic and international investigators. Options will be included to extend the term of the contract up to six years beyond the base year, increase level of effort for unanticipated increases in demand, final transition, and to develop/implement a new EQA program. Requirement changes from previous EQAPOL competition include an EQA Program for Multiplex/Array, EQA of Mucosal Specimens, and an option for HIV Incidence Assays. Project requirements This contract's scope involves both quality assurance/quality control (QA/QC) and operational activities. QA/QC activities include (1) providing proficiency testing programs and the evaluation of the performance of laboratories conducting assays measuring cellular, antibody, and cytokine responses in a variety of tissue types; (2) development of new assays; and (3) acquire/establish/characterize unique clade-specific virus panels. Operational activities include (1) the maintenance and expansion of a specimen and reagent repository; (2) maintenance of a database to support contract activities; and (3) advise on assay validation, regulatory compliance and statistical issues. Specifically, the Contractor will be required to: (1) maintain and expand a peripheral blood mono-nuclear cell (PBMC) bank and EQA reagent repository; (2) develop, set up, manage and coordinate an interferon-gamma (IFNγ) ELISpot proficiency program; (3) develop, set up, manage and coordinate a flow cytometry ICS program; (4) develop, set up, manage and coordinate a Luminex cytokine assay EQA program; (5) participate in assay development and validation for mucosal immune factors and assist in development of an EQA program to assess collection, storage, and testing parameters of mucosal specimens for host pathogens (microbiota) or anti-vaccine immune responses; (6) support the development of antibody characterization assays and EQA programs; (7) establish and characterize unique clade-specific HIV virus panels; (8) operate and maintain a central web database for contract related activities; (9) coordinate optimization efforts for new assays and advise on assay validation, regulatory, compliance, and statistical issues; (10) plan and conduct contract related meetings and teleconferences; and (11) conduct initial and final transition. Anticipated period of performance It is anticipated that one (1) cost reimbursement, level-of-effort (term) type contract will be awarded. The period of performance will be for one (1) year (Base Period) plus six (6) one year options (terms) that may be exercised by the Government unilaterally, for a total possible performance period of seven (7) years, beginning on or about June 30, 2017. The requirement will be for the delivery of 16.82 full time equivalents (FTEs) per year for the Base Period (Year 1) and each option period (Years 2 through 7). In addition, the Government may unilaterally 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: (1) Increased Level of Effort (Options 7-34): These options provide for an increase in the level of effort to accommodate the addition of 1.00 FTE up to 4 times/year for unanticipated increases in demand for such things as proficiency testing in areas such as ELISpot EQA program, Flow Cytometry-based assays and/or to expand the panel of characterized HIV isolates and other viral isolates that may be required to respond to emerging needs or public health emergencies. (2) Increased Level of Effort for (Options 35-41). These options provide for an increase in the level of effort in order to develop/implement an EQA program for HIV incidence assays. If the Government elects to exercise these options, the Contractor shall provide an additional 2.00 FTEs. One (1) Option per year may be exercised during years 1 through 7 of contract performance, for a total of seven (7) Options during the life of the contract. Other important considerations The Contractor's laboratory shall perform work following the DAIDS Guidelines for Good Clinical Laboratory Practice (GCLP) Standards: http://www.niaid.nih.gov/LabsAndResources/resources/DAIDSClinRsrch/Documents/gclp.pdf. Contractor staff shall have appropriate accreditations where applicable (e.g. College of American Pathologists (http://www.cap.org) and/or American Association for Laboratory Accreditation (http://www.a2la.org). When necessary, the Contractor shall have local Institutional Review Board (IRB) approval for its activities. Capability statement / information sought Capability Statements submitted as a result of this announcement should demonstrate the Respondent's qualifications, expertise and experience, specifically providing evidence as to the capability to perform this requirement. Capability Statements should clearly convey the following information: (1) a summary list of similar work previously performed; (2) the professional qualifications and specific experience of staff who may be assigned to the requirement; (3) resumes for proposed key personnel, including the Principal Investigator/co-PI, which reflect education, and previous work relevant to the proposed requirement; (4) a general description of the facilities and other resources needed to perform the work; (5) corporate experience and management capability; (6) examples of prior completed Government contracts, references, and other related information; and (7) demonstrated ability to carry out the work. 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 Respondent may need to utilize the expertise and resources of subcontractors and specialized consultants to provide the full spectrum of requested activities. The Respondent shall be responsible for ALL work performed under this contract, including any work performed by any subcontractors and consultants. The Respondent shall 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 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. Required Business Information: 1.DUNS. 2.Company Name. 3.Company Address. 4.Company Point of Contact, Phone and Email address 5.Current GSA Schedules and/or Government-wide Acquisition Contracts (GWACs) appropriate to this Sources Sought. 6.Do you have a Government approved accounting system? If so, please identify the agency that approved the system. 7.Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the Central Contractor Registration (CCR) located at http://www.ccr.gov/index.asp. 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). 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 Lorna Finn, Contract Specialist, at lorna.finn@nih.gov in MS Word or Adobe Portable Document Format (PDF). The e-mail subject line must specify HHS-NIH-NIAID(AI)-SBSS-15-055. Facsimile responses will not be accepted. Common Cut-off Date: Electronically submitted tailored capability statements are due no later than 3:00 PM, Eastern Prevailing Time on November 13, 2015. 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. The Government will not entertain questions regarding this Market Research; however, general questions may be emailed to the following addresses: Contract Specialist: Lorna A. Finn Email Address: lorna.finn@nih.gov Contracting Officer: John Manouelian Email Address: manouelj@mail.nih.gov 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.
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