SOLICITATION NOTICE
A -- Retrovirus Epidemiology Donor Study-II (REDS-II) - Central Laboratory
- Notice Date
- 1/7/2004
- Notice Type
- Solicitation Notice
- 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
- NHLBI-HB-05-07
- Response Due
- 4/20/2004
- Archive Date
- 5/5/2004
- 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 National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health, will issue RFP No. NHLBI-HB-05-07 on or about January 22, 2004. It is anticipated that one cost reimbursement completion contract will be awarded. The contractor shall serve as a Central Laboratory for a new five-year multicenter research program, Retrovirus Epidemiology Donor Study-II (REDS-II). 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. REDS-II Central Laboratory responsibilities include, but are not limited to the following: 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. This is NOT a Request for Proposals (RFP), and the Government is not committed to award a contract pursuant to this notice. RFP: NHLBI-HB-05-07, Retrovirus Epidemiology Donor Study-II (REDS-II), Central Laboratory, will be available from the NHLBI Website at: http://www.nhlbi.nih.gov/funding/inits/index.htm#rfp and posted on FedBizOpps at: http://fedbizopps.gov. No collect calls will be accepted.
- Record
- SN00499722-W 20040109/040107211750 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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