SOURCES SOUGHT
A -- Recipient Epidemiologu and Donor Evaluaiton Study (REDS-III) - Central Laboratory
- Notice Date
- 9/1/2009
- 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 Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-HB-11-01
- Archive Date
- 10/1/2009
- Point of Contact
- Dawn C Rabunsky, Phone: 301-435-0355
- E-Mail Address
-
drabunsk@nhlbi.nih.gov
(drabunsk@nhlbi.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The Blood Diseases and Resources Program of the National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), is conducting a market survey to assess the availability and potential technical capability of small business firms to perform as the central laboratory for the program entitled “Recipient Epidemiology and Donor Evaluation Study – III (REDS-III)”. The applicable NAICS code is 541712 and the size standard is 500 employees. It is anticipated that one award will be made in January 2011 for a period of seven years. The objectives of the REDS-III program are to assure safe and effective blood banking and transfusion medicine practices through a comprehensive, multi-targeted strategy involving basic, translational, and clinical research to improve the benefits of transfusion while reducing its risks. Improving blood component safety and availability in the U.S. and internationally through the conduct of epidemiologic, survey, and laboratory studies is the cornerstone of the REDS program. Transfusion therapy is the most commonly employed, and, arguably, one of the least understood medical procedures in the U.S. affecting about five million recipients annually. This research program is not only critical to public health in the U.S. but also to countries struggling with the HIV epidemic where blood safety and availability are major concerns. NHLBI plans to support one data coordinating center, one central laboratory, up to four domestic hubs, and up to 4 international collaborative programs involving U.S. investigators and investigators at international blood centers. THIS NOTICE ADDRESSES THE CENTRAL LABORATORY ONLY The REDS-III program will target the following blood banking and transfusion medicine areas: 1) donor targeted strategies; 2) blood banking; 3) transfusion practices in adult patients; and 4) education and training. The goal of this highly structured, multi-center, donor-recipient epidemiology, laboratory, and clinical outcomes program is to advance public health by conducting critical research to improve transfusion practices and the safety and adequacy of the blood supply in the U.S. and in countries affected by the AIDS epidemic. The program will include large survey, epidemiological and laboratory investigations. Clinical trials in potential recipients of blood products are NOT within the purview of the REDS-III program. The research portfolios of the REDS-III Domestic and International programs will be fashioned in response to contemporary scientific questions which need to be addressed to advance blood transfusion safety in the U.S. and in countries where REDS-III international blood centers are located. It is expected that about one third of the studies conducted in the REDS-III Domestic program will address donor and/or donation safety and availability issues, and other blood banking questions; and that about two thirds of the investigations will address adult transfusion recipient safety concerns. Most studies performed in the international setting, however, are expected to address blood banking concerns including donor and/or donation safety and availability issues although a small number of studies might address transfusion recipient safety concerns. Comprehensive databases including information on donors and their donations/components (required for the Domestic and International programs), and on adult patients considered for, or receiving a transfusion (required for the Domestic program only) will enable study investigators with the necessary scientific and analytical expertise to address in a timely fashion, important scientific issues in blood banking and transfusion medicine. The domestic hubs and the international programs will be supported by a Data Coordinating Center (DCC) responsible for overall coordination, communications, data management, and analytical/statistical support. The domestic hubs and the international programs shall also be supported by a central laboratory, which will be responsible for the necessary infectious disease, molecular, genetic, immunological, hematological and other testing conducted in the U.S., and for serving as the REDS-III biospecimen repository. The Central Laboratory of the REDS-III Program shall be responsible for: 1) providing technical laboratory expertise and serving as an active participant in developing and prioritizing all REDS-III domestic and international research activities; 2) proposing, developing, and conducting laboratory-based research studies; 3) performing infectious disease, genetic, molecular, immunological, hematological or other processing and testing of biospecimens from all domestic hubs and international sites participating in RED-III epidemiological and laboratory studies according to protocol; 4) arranging and managing subcontracts with other laboratory testing facilities, as appropriate; and 5) serving as the REDS-III biospecimen repository. Small business firms having demonstrated experience in performing the tasks described above are invited to submit capability statements. Capability statements must provide evidence of ability to perform and experience in performing the tasks described above and will be reviewed based on the following: 1) evidence of the firm’s status as a small business under NAICS code 541712 with a size standard of 500 employees; 2) qualifications and availability of personnel with training and/or experience in transfusion medicine and/or blood banking and at least in one of the following fields: epidemiology, virology, microbiology, parasitology, immunology, hematology, pathology, cell biology, molecular biology, genetics, or biochemistry;3) experience in laboratory research in the areas of blood banking and/or transfusion medicine; 4) experience participating in multiple large (> 5000 study participants) multi-center, long term collaborative epidemiological research studies that include laboratory research components; and 5) experience interacting with multiple blood centers and transfusion services and in handling a large number (>15,000 per year) of blood specimens from blood centers and/or transfusion services, including the accession, processing, testing, storage, and shipment of blood samples. Demonstration of detailed plans of quality control and quality assurance consistent with the principles of Good Laboratory Practices. This includes all aspects of laboratory function, including document control, validation, inventory control, transport, data integrity, and safety and transmission of laboratory data to the DCC. Capability statements submitted in response to this notice that do not provide sufficient information for review will not be considered. This is NOT a Request for Proposals (RFP), and responses should NOT include budgetary information. The Government intends to negotiate one contract for the period of seven years with an approximate award date of January 14, 2011. Firms responding to this notice shall provide capability statements (original and three copies) no later than 3:30pm EST on the fifteenth (15th) calendar day from the date of this announcement to the address below. Dawn Rabunsky, Contracting Officer, Office of Acquisitions, DERA National Heart, Lung, and Blood Institute, NIH, DHHS 6701 Rockledge Drive, Rockledge II, Room 6136, MSC 7902 Bethesda, MD 20892-7902 For overnight deliveries use zip code 20817, no MSC is required. Your submission shall include the name and telephone number of a point of contact. Please reference this notice number. Electronic copies of capability statements will be accepted and shall be sent to Dawn Rabunsky, Contracting Officer (email address: dawn.rabunsky@nih.gov).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-HB-11-01/listing.html)
- Place of Performance
- Address: Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN01936699-W 20090903/090902011156-748ad73a523d1796de73ed5276e92a7d (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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