SOURCES SOUGHT
A -- EXTERNAL QUALITY ASSURANCE PROGRAM OVERSIGHT LABORATORY
- Notice Date
- 7/6/2009
- 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, 6700 B Rockledge Room 3214 MSC7612, Bethesda, Maryland, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- HHS-NIH-NIAID(A)-SBSS-09-067
- Archive Date
- 8/4/2009
- Point of Contact
- Nancy M Hershey, Phone: 301-496-0193, EileenWebster-Cissel , Phone: 301-496-0349
- E-Mail Address
-
nhershey@niaid.nih.gov, webstere@mail.nih.gov
(nhershey@niaid.nih.gov, webstere@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- NIAID/DAIDS EXTERNAL QUALITY ASSURANCE PROGRAM OVERSIGHT LABORATORY (EQAPOL) RFP: HHS-NIH-NIAID (AI)-SBSS-09-067 Type of Requirement Re-competition (Contract No.:N01-AI-85341) Place of performance is unknown at this time Recompetition Sera Care BioServices 217 Perry Parkway Gaithersburg, Maryland 20877 Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions, 6700-B Rockledge Drive, Room 3214, MSC 7612, Bethesda, MD, 20892-7612 Sources Sought Notice Information General Information Document Type: Sources Sought Notice Solicitation Number: Reference Number: NIH-NIAID-DAIDS-A1022 Posted Date: July 6, 2009 Original Response Date: July 20, 2009 Current Response Date: July 20, 2009 Original Archive Date: Current Archive Date: Classification Code: A -- Research & Development NAICS Code: 541712 -Research and Development in the Physical, Engineering and Life Sciences 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; women-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 Acquired Immunodeficiency Syndrome (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), was formed in 1986 to address the national research needs created by the advent and spread of the HIV/AIDS epidemic. The mission of DAIDS is to help ensure an end to the HIV/AIDS epidemic by increasing basic knowledge of the pathogenesis and transmission of the human immunodeficiency virus (HIV), supporting the development of therapies for HIV infection and its complications, supporting prevention strategies and the development of vaccines. The DAIDS Vaccine Research Program (VRP) supports basic, preclinical, and clinical research of candidate vaccines. VRP activities include (1) oversight of grants, contracts, and cooperative agreements that support preclinical and clinical vaccine research, (2) evaluation of the safety and efficacy of vaccine candidates, (3) promotion of research programs to discover novel vaccine strategies for the treatment and prevention of HIV, and (4) work with the pharmaceutical industry and the U.S. Food and Drug Administration (FDA) to facilitate the evaluation and approval of new vaccines. Reliable laboratory data are essential to the clinical evaluation of candidate HIV vaccine platforms and immunogens. The data provide key information to investigators on the immunogenicity and efficacy of vaccine concepts and may be used to prioritize and/or reject potential vaccine designs and optimize vaccine candidates prior to clinical advancement. Presently there are multiple organizations conducting HIV-1 vaccine trials globally. In the absence of a single central laboratory to perform all assays for these trials, it is imperative that the data from multiple laboratories performing assays in support of single or multiple vaccine candidates are accurate and reproducible. Such standardization and validation allow for effective assessment and comparison of data for scientific evaluation and on which to base sound decisions about product advancement and/or product improvement. To support these efforts, the availability of validated assays, common reagents and Standard Operating Procedures (SOPs), and the implementation of external quality assurance (EQA) programs to measure and monitor laboratory performance are essential. In FY1998 NIAID DAIDS awarded a contract (N01-AI-85341) entitled "Laboratory Support for AIDS Vaccine and Other Prevention Trials" to SeraCare BioServices, Inc. to provide services that included: (1) management of EQA programs in national and international laboratories for interferon gamma (IFNγ) ELISpot, intracellular cytokine staining (ICS), and adenovirus 5 neutralization assays; (2) maintenance and quality assurance/quality control (QA/QC) of a frozen bank of peripheral blood mononuclear cell specimens for EQA programs; (3) maintenance and QA/QC of a reagent bank for the EQA programs; and (4) development of an interferon gamma ELISpot kit under Good Manufacturing Practices for commercial application. The continued and expanded need for DAIDS EQA programs for additional immunological and virological assays requires the renewal and expansion of this contract. Purpose and Objectives The objective of an External Quality Assurance Program Oversight Laboratory (EQAPOL) is includes support for development of the following: (1) Peripheral blood mononuclear cell (PBMC) EQA program. NIAID/DAIDS clinical trials often include immunological testing such as ELISpot, ICS determinations and T-cell subset immunophenotyping to be performed on frozen PBMCs at a central laboratory. Therefore, it is important to assess the ability of US and international site-associated laboratories (where blood is collected from volunteers enrolled in clinical protocols) to adequately process, cryopreserve, store and ship PBMCs. It is imperative that the quality, integrity, and functional viability of PBMCs is preserved throughout processing, freezing, storage, shipping and thawing as this will impact the immunological function of thawed cells in subsequent immunogenicity or endpoint assays. The NIAID/DAIDS VRP has established a QA program for the isolation and cryopreservation of PBMCs from whole blood for laboratories that collect and process blood from NIAID/DAIDS-funded and/or -sponsored clinical trials. This program is designed to ensure consistent and acceptable standards for QA monitoring of PBMC Quality Indicators (QIs). The QIs include: cell yields, cell viability, and total time from blood collection to cryopreservation of PBMCs including processing time, and functional immunological assessments by ELISpot or other assays on randomly selected frozen PBMC. (2) ELISpot EQA Program Historically DAIDS has provided an IFNγ ELISpot assay EQA program to NIAID/DAIDS-supported and other interested research laboratories. The IFNγ ELISpot proficiency testing program involves two annual tests using provided reagents (IFNγ monoclonal antibody-coated plates, enzyme-conjugated antibodies, Cytomegalovirus (CMV) and chicken embryo fibroblast (CEF) peptide pool stimulant reagents, and controls) and cryopreserved PBMCs with known reactivity to CMV and CEF. NIAID/DAIDS-supported laboratories participating in this program receive standardized protocols for cell counting and an IFNγ ELISpot assay kit. The laboratories also have the option to use their in-house validated procedures and conduct the proficiency testing with the reagents, IFNγ monoclonal antibody-coated plates, and PBMCs provided through DAIDS. Each participating laboratory reports the experimental results using an electronic template. In addition, the developed ELISpot plates used by the laboratory are shipped back to a central laboratory for re-counting under optimized conditions. Statistical assessment, troubleshooting, final reporting and discussion of results occurs between participating laboratories and NIAID/DAIDS. (3) Flow Cytometry EQA Program NIAID/DAIDS conducts a flow cytometry-based ICS assay quality assurance program and is developing additional functional assay QA programs (e.g. Carboxyfluorescein succinimidyl ester (CFSE) cell proliferation assay) that include biannual testing by NIAID/DAIDS-supported laboratories. Participating laboratories receive a recommended protocol and perform assays with the supplied cells and reagents. The laboratories report their data back via an electronic spreadsheet as well as provide access to the raw data for potential troubleshooting purposes. (4) Establish and Characterize Unique Clade Specific HIV Virus Panels NIAID/DAIDS is currently involved in the development of a characterized global HIV isolate repository. Current HIV viral panels are poorly characterized, more than 15 years old, and not representative of currently circulating strains. Clade B is the most frequent virus type in the Americas and in parts of Asia. Clade C strains are most prevalent in southern Africa and Asia and represent the most abundant genetic subtype worldwide. The spread of new infections with clades normally not present in those geographical areas throughout the globe, coupled with the virus' propensity to mutate and recombine has led to the identification of many new circulating recombinant forms (CRFs) of the virus. As new assays are developed to detect and monitor HIV infections there may be difficulties evaluating, comparing and validating these assays using existing available viral panels. For example, some of the more rare serotypes (such as F, H, O and CRFs) are missing from or incompletely characterized on current panels. There are very few G subtypes and the ones that are available are actually A/G recombinants. It is critical that endpoint assays be tested and optimized against all possible clades since in many cases vaccine candidate efficacy is evaluated by measuring viral load. The development and refinement of an updated panel will be accomplished by NIAID/DAIDS collaborating with international blood banks, the Centers for Disease Control and Prevention (CDC), and field researchers to obtain blood samples from newly identified HIV (acute or recently) infected individuals with interesting, rare, or difficult to identify isolates. These will be evaluated, characterized, fully sequenced and added to a repository/database which can be included in virus panels for use in optimizing and validating viral load assay platforms. EQAPOL will be integral to the overall VRP, DAIDS and NIAID mission by providing a mechanism to ensure that the assessment of clinical specimens from NIAID/DAIDS-sponsored vaccine trials and other clinical research is accurate, reliable, and reproducible. It will also ensure that trial data support product advancement and meet regulatory agency requirements. NIAID-sponsored domestic and international investigators, e.g., NIAID/DAIDS clinical trial networks and Partnership for AIDS Vaccine Evaluation partners (PAVE) ( http://www.hivpave.org ), and other NIAID Divisions will have access to these resources. Project Requirements In order to respond to this notice, Contractors must be able to clearly convey its experience and/or ability to perform the following tasks identified: The scope of activities to be carried out under this contract involves both QA/QC and operational activities and includes: (A) maintenance of a PBMC bank and EQA reagent repository (B) establishment of a PBMC EQA program to assess the ability of laboratories to reliably process, freeze, store, and ship viable and functional PBMCs (C) preparation and distribution of proficiency panels and reagents to laboratories that conduct enzyme-linked immunosorbent spot (ELISpot) assays and evaluation of test results (D) preparation and distribution of materials and reagents to laboratories that perform intracellular cytokine staining (ICS), novel T cell assays, and/or other flow cytometry based assays, and evaluation of test results (E) acquisition, establishment, and characterization of unique clade-specific HIV virus panels, as needed, to help ensure assay quality and validity of new assay platforms (F) creation and maintenance of a central web database for the above activities (G) advice on Food and Drug Administration (FDA) regulatory, compliance, and statistical issues and coordination of optimization efforts among laboratories to develop validation programs for novel T or B cell functional assays (H) establishment and support of an Independent External Advisory Group (I) expand staffing from the base period if any of the options are exercised as directed by the NIAID/DAIDS. Options include increasing the level of effort for the above tasks in addition to establishing and characterizing panels for virus isolates other than HIV, and for the development/implementation of a proficiency panel to assess pre-existing vaccine vector immunity, and support for the development of antibody characterization assays. To accomplish these aims, the Contractor's laboratory shall be Clinical Laboratory Improvement Amendments (CLIA)-certified ( www.cms.hhs.gov/clia ) and when necessary have local Institutional Review Board (IRB) approval for its activities. Anticipated Period of Performance It is anticipated that a term type contact will be awarded. The performance requirement will be for the delivery of 12.35 full time equivalents (FTEs) for one year beginning approximately August 30, 2010 through August 29, 2011. It is anticipated that the Government will exercise options to extend the term of the contract for six additional years. The requirement will be the delivery of 12.35 FTEs per year for Option periods 1-6 (Years 2-7). In addition, the Government may exercise options for the delivery of additional services (increased level of effort) as follows: • Accommodate the addition of 2-3 laboratory sites per year to the PBMC QA program. These sites may be at U.S. or non-U.S. locations. It is estimated that this will require an additional.50 FTEs per year. • Accommodate the addition of 2-3 laboratory sites per year to the ELISpot EQA program. These sites may be at U.S. or non-U.S. locations. It is estimated that this will require an additional.65 FTEs per year. • Accommodate the addition of 2-3 laboratory sites per year to the EQA program for flow cytometry-based assays. These sites may be at U.S. or non-U.S. locations. It is estimated that this will require an additional.75 FTEs per year. • Expand the panel of characterized HIV isolates. One option may be exercised each year of the contract for up to 50 additional virus characterizations per year. It is estimated that this will require an additional 4.0 FTEs per year. • Establish and characterize panels for virus isolates other than HIV. One option may be exercised each year of the contract for up to 50 additional virus characterizations per year. It is estimated that this will require an additional 4.3 FTEs per year. • Develop/implement a proficiency panel to assess pre-existing vaccine vector immunity. One option may be exercised each year of the contract. It is estimated that this will require 2.75 FTEs per year. • Develop antibody characterization assays. One option may be exercised each year of the contract. It is estimated that this will require 2.60 FTEs per year. Capability Statement/Information Sought Capability Statements should clearly convey information regarding the respondents' 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. Interested Contractors must submit a capability statement (five page limitation, excluding resumes) describing their company's experience and ability to perform this effort which includes the following: (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; and (5) demonstrated ability to carry out the work. Each response should include the following Business Information: a. DUNS number b. Company Name c. Company Address d. Company Points of Contact (both technical and administrative), including names, titles, addresses, telephone and fax numbers and Email addresses e. Current GSA Schedule appropriate to this Sources Sought. f. Do you have a Government-approved accounting system? If so, please identify the agency that approved the system. g. Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the Central Contractor Registration (CCR). All offerors must be registered in CCR which is located at http://www.ccr.gov/ Teaming Arrangements: All teaming arrangements should also include the above cited information and certification for each entity on the proposed team. Teaming arrangements are encouraged. 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. Responses must be submitted no later than 3:00 PM, July 20, 2009. Capability statements will not be returned and will not be accepted after the due date. These statements may be submitted by e-mail or paper copy to Nancy Hershey, Contracting Officer. She can be emailed at the address provided below. Electronic submissions should be submitted in PDF format, however, Microsoft Word or Corel WordPerfect will be accepted. In the subject line, please reference: HHS-NIH-NIAID (AI)-SBSS-09-067. A paper copy can be sent via regular mail at the address provided below. If sending a paper copy, please send an original and one copy. Nancy Hershey Contracting Officer Office of Acquisitions National Institute of Allergy and Infectious Diseases National Institutes of Health 6700 B Rockledge Drive, Room 3214, MSC 7612 Bethesda, Maryland 20892-7612 Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response to this notice. 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 Presolicitation synopsis and solicitation may be published in the 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: Contracting Officer: Nancy Hershey Email Address: nhershey@niaid.nih.gov Contracting Officer: Eileen Webster-Cissel Email Address: webstere@niaid.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.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIAID/HHS-NIH-NIAID(A)-SBSS-09-067/listing.html)
- Place of Performance
- Address: Place of performance is unknown at this time., United States
- Record
- SN01866531-W 20090708/090707000533-6590897a76e4a8de23dbf2d3a58121ec (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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