SOURCES SOUGHT
A -- Retrovirus Epidemiology Donor Study-II, Central Laboratory
- Notice Date
- 12/9/2003
- Notice Type
- Sources Sought
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung, and Blood Institute, Contracts Operations Branch 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, MD, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- RFP-NIH-NHLBI-HB-05-07
- Response Due
- 12/29/2003
- Archive Date
- 12/29/2003
- Point of Contact
- Joann Ciufolo, Contracting Officer, Phone (301) 435-0359, Fax (301) 480-3432, - Patricia Davis, Chief, BDR Section, Phone (301) 435-0355, Fax (301) 480-3432,
- E-Mail Address
-
jc84g@nih.gov, pd15j@nih.gov
- Description
- The Blood Diseases and Resources Program of the National Heart, Lung, and Blood Institute (NHLBI) is conducting a market survey to assess the availability and potential technical capability of small business firms to perform as the Central Laboratory for Retrovirus Epidemiology Donor Study-II (REDS-II). The applicable NAICS code is 541710 and the size is 500 employees. The objectives of REDS-II are to conduct epidemiological, laboratory, and survey research on volunteer blood donors to ensure the safety and availability of the Nation?s blood supply. This includes monitoring known blood-borne infectious agents, evaluating the impact of emerging pathogens, assessing the safety implications of changes in laboratory and/or blood donor screening protocols, and examining blood supply and availability issues. Issues to be addressed include: a) risks of transfusion-transmissible infections and trends through time (i.e. infectious agents undergoing laboratory screening and new and emerging agents such as West Nile Virus); b) ways to reduce risks of transfusion-transmissible infections; c) HIV, HTLV, HCV, and HBV test screening methodologies; d) donor characteristics, behaviors, and donation return patterns; and e) effectiveness and safety of various strategies implemented to increase the blood supply. The Central Laboratory will be expected to: 1) P.I.serve as a member of the Steering Committee and participate in the development and finalization of study protocols and manual of operations. 2) Propose laboratory studies involving blood banking and/or transfusion medicine to be performed in REDS. 3) Develop, with the Steering Committee, final protocols for collection of blood samples, processing, temporary storage and delivery to the Central Laboratory. The Central Laboratory shall provide self addressed containers to the blood centers for shipment of specimens. 4) In accordance with study protocols, perform tests such as antigen, antibody and nucleic acid assays for infectious agents, immune function assays and liver enzyme assays. 5) Develop and implement collection procedures for laboratory data. Using a computerized system, enter and edit the results of laboratory testing. 6) Transmit test results electronically to the REDS-II Coordinating Center in an acceptable format. Results from any quality control assessments specified in protocols shall be transmitted to the Coordinating Center. 7) Assure standardization of blood tests and other functions within the Central Laboratory. The Central Laboratory shall have ongoing quality control and quality assurance programs. 8) Store aliquots from participating blood centers according to study protocols. Samples will be stored at the central laboratory until no longer needed for study at which time they will be shipped to the NHLBI Biological Specimen Repository for long-term storage. 9) As a member of the Steering Committee, the contractor shall contribute to the analysis and reporting of study data. 10) As a member of the Steering Committee, serve as an active participant in developing and prioritizing proposed studies and in reviewing and approving presentations, publications and analyses. 11) Participate in all committee and subcommittee meetings, conference calls, and other organizational training sessions of which the Principal Investigator and laboratory staff are members. Capability statements must provide evidence of experience in performing the tasks described above and demonstrate the following: 1) Ability to propose research studies to conduct laboratory research in the area of blood banking or transfusion medicine. 2) Qualifications, experience, and availability of personnel to perform the tasks described above. 3) Adequacy of organizational and administrative structure to participate in a multicenter laboratory study; 4) Knowledge and ability to conduct quality control and quality assurance consistent with the principles of current cGMP. 5) Facilities and resources necessary for the performance of the requirements listed above; and 6) The firm?s status as a small business under NAICS code 541710. Capability statements in response to this market survey that do not provide sufficient information for evaluation will not be considered. This is NOT a Request for Proposals (RFP), and responses should not include budgetary information. The RFP release date is pending. The government intends to negotiate one contract for the period of four and one-half years with an approximate date of award March 1, 2005. Firms responding to this market survey should provide information pertinent to the requirements mentioned above (original and three copies) within fifteen (15) calendar days from the date of this announcement to the address shown above.
- Place of Performance
- Address: NA
- Record
- SN00483929-W 20031211/031209211807 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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