SOLICITATION NOTICE
A -- Recipient Epidemiology and Donor Evaluation Study-III (REDS-III) – Domestic Sites
- Notice Date
- 10/16/2009
- Notice Type
- Presolicitation
- 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-11-03
- Point of Contact
- Tara Knox, Phone: 301-402-0834, Allison M Stang, Phone: 301-435-0359
- E-Mail Address
-
knoxt@nhlbi.nih.gov, stanga@nhlbi.nih.gov
(knoxt@nhlbi.nih.gov, stanga@nhlbi.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Department of Health and Human Services (HHS) anticipates that Request for Proposals (RFP) No. NHLBI-HB-11-03 will be available on or about October 30, 2009. The solicitation will be for the Domestic Hubs for the program entitled ‘Recipient Epidemiology and Donor Evaluation Study-III (REDS-III).' It is anticipated that up to four awards will be made under full and open competition to domestic sites in January 2011 for a period of seven years. The goal of this highly structured, multicenter, 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. NHLBI plans to support one data coordinating center (DCC), one central laboratory, up to four domestic hubs, and up to four international collaborative programs involving U.S. investigators and investigators at international blood centers. This notice addresses the domestic hubs 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 program will include 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 that 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; the remaining two thirds of the investigations will address adult transfusion recipient safety concerns. Comprehensive databases including information on donors and their donations/components, and on adult patients considered for, or receiving a transfusion 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 DCC responsible for overall coordination, communications, data management, and analytical/statistical support. The domestic hubs and the international programs will 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 domestic component of the REDS-III program shall be structured to include geographically dispersed hubs with each hub consisting of a blood center and one or more transfusion services which support a mixed hospital base of tertiary care and community hospitals. This type of structure shall ensure access to demographically diverse adult patient populations, and access to services that perform most of the blood transfusions. The studies to be conducted in the REDS-III hospitals shall focus on adult patients. Hence, studies of pediatric in-hospital patient populations shall not be part of the REDS-III Domestic program. The offeror must meet the following two (2) mandatory qualification criteria at the time of receipt of proposal to be considered any further for award: 1) The offeror shall structure a hub consisting of a blood center and one or more transfusion services which support a mixed hospital base of tertiary care and community hospitals. The hub shall be led by a Principal Investigator and Co-Principal Investigator. The Principal Investigator must work either at one of the hospital transfusion services or at the blood center. If based at a transfusion service, the Co-Principal Investigator must work at the blood center. Conversely, if the Principal Investigator is based at the blood center, the Co-Principal Investigator must be based at a transfusion service. Each hub shall be required to include a mix of tertiary (at least one) and community (at least one) hospitals to ensure access to diverse adult patient populations and representation of all required services. Each hub is required to have access to, and the demonstrated ability to interact successfully with, the following five hospital services: intensive care unit(s), cardiac surgery, orthopedic surgery, oncology/cancer center, and trauma services. 2)To ensure the statistical relevance of the resulting data, the offeror shall provide evidence and supporting documentation for the last two years that at least 75,000 allogeneic donations per year were collected by the hub's blood center. Each domestic hub will perform the following program requirements: 1) Propose epidemiologic, survey, and/or laboratory studies that will advance blood transfusion safety in the U.S.; 2) Serve as a member of the REDS-III Oversight Committee; 3) Serve as a voting member of the REDS-III Domestic Steering Committee; 4) Develop and finalize REDS-III study protocols; 5) Ensure access to demographically diverse adult patient populations and services that perform most of the blood transfusions; 6) Include a blood center that collects a minimum of 75,000 allogeneic blood donations per year and serves as the major supplier of blood to the participating hospitals within the hub; 7) Participate in, coordinate, and successfully conduct the REDS-III research protocols that have been approved by the REDS-III Domestic Steering Committee; 8) Serve as a Centralized Data Collection Center (CCC); 9) Collect, process, store, and ship biospecimens as required by study protocols; 10) Administer the REDS-III hub scope of work, including study protocols, and transmit complete and accurate scientific data to the Data Coordinating Center, in accordance with procedures set forth in the protocols and Manuals of Operations, which shall be developed by the REDS-III investigators for this program; 11) Participate in educational activities, such as the promotion of public and health care provider education by disseminating research results and/or conducting research methodology training; 12) Mentor a minimum of one junior investigator in the areas of blood banking and/or transfusion medicine starting in Year 2 of the program, and prepare the investigator to apply for NHBLI career development awards; 13) Participate in all committee and subcommittee meetings, conference calls, and other organizational training sessions of which the Principal Investigator, Co-Principal Investigator, Co-Investigators, Project Director, and hub center staff are members. It will be desirable that a total of at least 20,000 RBC transfusion exposures occur per year at the hub's participating hospitals/outpatient clinics. It would also be desirable, although not required, that the consortium of hospitals participating in the hub admitted the following minimum number of cross-matched adult patients each year at the following hospital services: 1) intensive care units, minimum of 1,000 cross-matched adult patients per year; 2) cardiac surgery, minimum of 1,000 cross-matched adult patients per year; 3) orthopedic surgery, minimum of 500 cross-matched adult patients admitted per year; 4) oncology/cancer center, minimum of 1,000 cross-matched adult patients per year; and 5) trauma service, minimum of 1,000 cross-matched adult patients per year, or alternatively, participation in a level 1 trauma program. This announcement is not a request for proposals (RFP). Although up to four awards are anticipated, the Government is not committed to award a contract pursuant to this announcement. The RFP will be available on the FedBizOpps web page at www.fedbizopps.gov. Prospective offerors are responsible for downloading the RFP and all attachments. It is also the offerors' responsibility to monitor the FedBizOpps web page for the release of any amendments to the RFP. The RFP will contain all the information and details to allow potential offerors to prepare and submit a contract proposal. This acquisition has been designated as a full and open competition under the North American Industry Classification System (NAICS) code 541712. Subcontracting opportunities are anticipated during the course of this contract award. All responsible sources may submit a proposal, which shall be considered by the NHLBI.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-HB-11-03/listing.html)
- Record
- SN01987172-W 20091018/091016235410-1a1835f11641fe883a039f3c9807dbe6 (fbodaily.com)
- Source
-
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