SOURCES SOUGHT
A -- Immunology Quality Assessment Program
- Notice Date
- 10/19/2006
- Notice Type
- Sources Sought
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- 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, MD, 20892-7612, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- RFP-NIH-NIAID-DAIDS-07-31
- Response Due
- 9/11/2006
- Archive Date
- 9/24/2007
- Description
- THIS NOTICE IS FOR INFORMATION AND PLANNING PURPOSES ONLY AND DOES NOT COMMIT THE GOVERNMENT TO AWARD A CONTRACT NOW OR IN THE FUTURE. THIS IS NOT A REQUEST FOR PROPOSALS. THE GOVERNMETN DOES NOT INTEND TO AWARD A CONTRACT BASED ON RESPONSES UNDER THIS ANNOUNCEMENT. ANY PROPRIETARY INFORMATION SHOULD BE SO MARKED. INTERESTED ORGANIZATIONS PRESENTING A CAPABILITY STATEMENT IN RESPONSE TO THIS SOURCES SOUGHT ANNOUNCEMENT MUST IDENTIFY THEIR SIZE STATUS. BASED ON CAPABILITY STATEMENTS RECEIVED FROM THIS ANNOUNCEMENT THIS ACQUISITION MAY BE SOLICITED AS A 100% SMALL BUSINESS SET-ASIDE OR AS FULL AND OPEN. ALL SMALL BUSINESS ORGANIZATIONS (SB, SDB, WOSB, HUBZone, VOSB, and SDVOSB) ARE ENCOURAGED TO RESPOND TO THIS NOTICE. SMALL BUSINESS ORGANIZATIONS MUST HAVE THEIR SIZE STATUS CERTIFIED BY THE SMALL BUSINESS ADMINISTRATION. THE NAICS CODE IS 541710 WITH A SIZE STANDARD OF 500 EMPLOYEES. DESCRIPTION The scope of activities to be carried out under this project are: 1) design and execute proficiency testing programs to externally assess the ability of U.S. and non-U.S. DAIDS-support clinical trial sites (hereinafter referred to as Sites) to reliably: 1) perform immunological assays (e.g., T-cell subsets and other cytometry-based tests); 2) provide assistance and training to laboratories that are not performing according to established standards, especially to flow cytometry laboratories in non-U.S. resource limited countries; 3) conduct or support comparative evaluations of instruments, methods and reagents; 4) facilitate the development, standardization and assay characterization of new immunological assays, and of cheaper simpler methods to measure CD4, for implementation in multi-center investigations; and 5) evaluate the ability of Sites to adequately freeze viable peripheral blood mononuclear cells (PBMC) for future immunological tests. To accomplish these aims, the Contractor must: a) have access to a wide range of infected and non-infected donors to obtain human biological materials (e.g. plasma, PBMC, tissue); b) prescreen potential donors for existence of required characteristics (e.g. CD4 count, viral load level, HLA type, antigen response, vaccine titer); c) create panels of samples (coded when used for proficiency testing purposes), including replicates to assess within- and inter-laboratory variability; d) provide data management and statistical analysis capability; e) provide staff and facilities for on-site and off-site training; f) provide the facilities to store samples and reagents; and g) ship and track samples and reagents. In addition, the IQA laboratory shall be Clinical Laboratory Improvement Amendments (CLIA)-certified, conducting operations in accordance with Good Clinical Laboratory Practices (GCLP), and have local Institutional Review Board (IRB) approval for its activities. I. SUMMARY OF MAJOR FUNCTIONS A. Initial transition B. External assessment of Sites test performance C. Assistance and training D. Assay evaluation, characterization, optimization and standardization E. Acquisition, characterization, storage, documentation and disbursement of quality control materials F. Dissemination of IQA technical and scientific data G. Maintenance of computerized software systems H. Technical and administrative project management I. Final Transition J. Options Three options that may be exercised at the discretion of the Government shall provide for expansion of the IQA Program to additional U.S. and non-U.S. Sites as follows: Option 1 - CD4 Proficiency Testing Program: Addition of U.S. and Canadian Sites only to the CD4 Proficiency Testing Program. Option 2 - United Kingdom National External Quality Assessment Service (UK NEQAS) Proficiency Testing Program: Addition of non-U.S. Sites participating in the UK NEQAS CD4 proficiency testing program. Option 3 - Peripheral Blood Mononuclear Cells (PBMC) Cryopreservation Proficiency Testing Program: Addition of U.S. and non-U.S. Sites to the PBMC cryopreservation proficiency testing program. Potential sources must demonstrate and document their experience and ability to perform the following in their capability statements: 1) relevant experience in proficiency testing and assay research and development, site assistance, training and information dissemination; 2) Senior staff with adequate experience and qualifications to manage multiple projects simultaneously; 3) facilities, equipment, and resources that are adequate, suitable and immediately available for the conduct of immunology quality assessments; 4) willingness to prioritize Government projects within the organizations overall scheduling framework; 4) ability to maintain confidentiality of data. The government estimates an overall staffing requirement of approximately six (6) full time equivalents (FTEs) per year for a period of seven (7) years for this effort. Interested Small Business organizations should submit two copies of their capability statement addressing each of the areas cited above. Written capability statements should be received by the NIAID Contracting Officer at 3:30 PM Eastern time by September 11, 2006. Please reference the solicitation number on all related correspondence. No collect calls will be accepted. No facsimile transmissions will be accepted.
- Record
- SN01167842-W 20061021/061019220408 (fbodaily.com)
- Source
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