SOURCES SOUGHT
A -- Recipient Epidemiology and Donor Evaluation Study - III (REDS-III)
- Notice Date
- 8/25/2009
- 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-11-02
- Archive Date
- 9/23/2009
- Point of Contact
- Kathleen J. Marsden, Phone: (301) 435-0364, Lynn M Furtaw, Phone: 301-435-0357
- E-Mail Address
-
km66x@nih.gov, lf153x@nih.gov
(km66x@nih.gov, lf153x@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 Data Coordinating Center (DCC) 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 DATA COORDINATING CENTER 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 shall be supported by a DCC which shall be 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 shall 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 Data Coordinating Center (DCC) shall compile donation and patient data from the domestic centers (i.e., hubs) in 1) a centralized cumulative donor/donation/component database; 2) a centralized cumulative patient database; and 3) a centralized cumulative linked donor-recipient database that shall link all information on donors and their donations/components to information on the patients who received these components. The hub C entralized Data C ollection C enter (CCC) shall provide to the DCC the links that shall allow for the data from the donors, their donations and components to be linked with data on the recipients who received them. At least 20,000 RBC transfusion exposures must occur per year at each hub’s participating hospitals/outpatient clinics and the following minimum number of cross-matched adult patients must be admitted each year: 1) intensive care units: 1,000; 2) cardiac surgery, 1,000; 3) orthopedic surgery, 500; 4) oncology/cancer center, 1,000; and 5) trauma service, 1,000. Each hub’s blood center must collect at least 75,000 allogeneic blood donations per year. Analysis of all data compiled in the databases shall be conducted by the DCC. Additionally, the DCC shall be responsible for coordination, data management, and analytical/statistical support of an estimated five large epidemiological and/or survey studies and about ten laboratory studies [which may or may not be component(s) of the large epidemiological studies] during the course of the domestic program. The DCC shall compile donor and donation data from each international site in a centralized cumulative donor/donation database and shall be responsible for providing all statistical/analytical support for the analysis of these data. The blood centers participating in each international program must collect a total of at least 250,000 blood donations annually from at least three collaborating foreign collection sites located in a low or middle income country affected by the AIDS epidemic. Each foreign blood collection site must collect a minimum of 25,000 donations annually. Analysis of all data compiled in the database shall be conducted by the DCC. Additionally, the DCC shall be responsible for coordination, data management, and analytical/statistical support of an estimated three large epidemiological and/or survey studies and about three laboratory studies [which may or may not be component(s) of the large epidemiological studies] conducted at each of the REDS-III international collaborative programs. The DCC shall perform the following study requirements: 1) coordinate REDS-III activities and participate as a member of the Oversight and Steering Committees to develop and implement a coordinated plan to achieve program objectives; 2) develop and maintain operating procedures for the REDS-III program; 3) develop and maintain a public and private REDS-III website; 4) develop and finalize the protocols and associated Manuals of Operations for the cumulative centralized databases; 5) coordinate and participate in the development and finalization of REDS-III study protocols and develop corresponding Manuals of Operations; 6) provide all necessary data management and tracking systems; 7) track all REDS-III biospecimens and their associated data, and identify biospecimens for retrieval; 8) provide training sessions and conduct site visits, as appropriate; 9) provide biostatistical support during protocol development and analyze database and study data collected during REDS-III; 10) assist the Oversight Committee and Steering Committees in preparation of scientific reports for publication and presentation; 11) help coordinate and convene the REDS-III Observational Study Monitoring Board (OSMB), provide administrative and logistic support for OSMB meetings/calls, prepare and present data reports to the OSMB, and prepare minutes of the sessions; 12) coordinate and convene the REDS-III External Review Panel, assist the NHLBI COTR(s) with the selection and invitation of the External Review Panel, provide administrative and logistic support for the External Review Panel meetings, prepare minutes from External Panel sessions and coordinate and pay for External Review Panel members travel and honorarium; 13) prepare quarterly and annual technical reports; 14) interact with the COTR(s) on programmatic research activity issues; 15) At close-out of the study, or earlier as directed by the COTR(s), create public use data sets for each data collection activity with documentation; and 16) ensure an orderly transition of REDS-III resources to a successor contractor at contract expiration. Small business firms having demonstrated experience in performing tasks 1 through 16 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) ability to coordinate and manage a domestic and international multi-center, multi-project large epidemiologic, survey, and laboratory research program and fulfill the DCC functions described in tasks 1 through 16 above. This includes the ability to perform data management, biospecimen tracking and linking, statistical and analytical support, including assessing the reliability and validity of the data collected; preparation of public use data sets; and safeguarding federal information systems; 3) qualifications and availability of personnel with experience in the development, coordination, data management and statistical analysis of large (defined as including >1,000 participants) multicenter epidemiologic, complex survey, laboratory studies, and interventional studies, in the area of blood banking and transfusion medicine; 4) experience in the operation of a coordinating center for large multi-center international and domestic research programs; 5) adequacy of the organizational and administrative structure to participate in a multi-center international and domestic epidemiologic, laboratory and complex survey research program; 6) experience in the conduct/coordination of multiple large epidemiologic studies (descriptive, case-control, or cohort studies) and complex survey studies, both in the collection of epidemiologic data from multiple sites, as well as experience in monitoring the quality and timeliness of data collected on a large number of individuals (>5,000 for epidemiologic studies, >30,000 for surveys); and 7) availability of facilities, equipment, and resources necessary for the performance of the requirements identified above. 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 (15 th ) calendar day from the date of this announcement to the address shown above. 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 Kathleen Marsden, Contracting Officer (email address: marsdenk@mail.nih.gov ) and Lynn Furtaw, Contracting Officer (email address: furtawl@mail.nih.gov ).
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- SN01925381-W 20090827/090826000351-94fac6926eb85bdaf2bac38ea28e8d17 (fbodaily.com)
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