SOURCES SOUGHT
A -- Retrovirus Epidemiology Donor Study - II (REDS-II)
- Notice Date
- 6/6/2003
- 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
- NHLBI-HB-04-16
- Response Due
- 6/23/2003
- Archive Date
- 7/8/2003
- 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 Coordinating Center 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 Coordinating Center will be expected to collect monthly donation data from 6-8 participating blood centers representing a minimum of between 170,000 and 220,000 donations annually from an estimated 120,000 to 160,000 donors. During the course of the study, the Coordinating Center may also be expected to process survey forms for one or two major studies with an estimated 15,000 - 50,000 subjects each. The mode of survey administration will depend upon the study design. It is expected that the laboratory component of the study will generate about four studies annually for which the Coordinating Center will process, manage, and analyze data. The REDS-II Coordinating Center will perform the following tasks: 1) Coordinate and participate in development and finalization of study protocols, manuals of operation, and design of study forms, in addition to reproduction, distribution, and update of protocols, manuals of operation and study forms. 2) Coordinate and arrange Steering Committee and other key meetings as necessary; prepare and distribute agenda, reports, and minutes. 3) Develop and implement data collection procedures for epidemiologic and survey studies; perform all activities of a coordinating center (collecting, organizing and storing for analysis data from blood centers including infectious disease marker data [screening and confirmatory data] and donor demographic data [age, race, gender, education, ethnicity, country of birth, history of transfusion] and study data from the central laboratory; monitor shipment of biological specimens from blood centers to the central laboratory); assure the quality of the study data submitted and stored; provide support and documentation for the OMB forms clearance process if necessary. 4) Train blood center staff in entry of data and completion of study forms. 5) Have primary responsibility to assure prompt accumulation, entry, and editing of study data (screening, baseline, periodic follow-up, special events); assume data will be collected from a minimum of between 120,000 and 160,000 blood donors per year. 6) Communicate with blood centers concerning missing, delayed, incomplete, or erroneous data. 7) Obtain and process laboratory test reports from the study?s central laboratory; coordinate compilation of data collected by central laboratory into a study database for subsequent statistical analysis; maintain a record of studies conducted, the number and types of samples used, and the results of analyses conducted by the central laboratory; compile and manage an inventory of specimens shipped and received by the central laboratory from the blood centers. 8) Prepare technical progress reports in order to monitor study progress, quality of data and blood center performance. 9) Interact with the Project Officer on issues relating to study design, study conduct, and data analysis. 10) Analyze all study data collected during REDS-II. Analytic and statistical capabilities needed shall include not only descriptive epidemiological analyses, but categorical and longitudinal data analyses, multivariate regression models, and analysis capabilities specific to case control studies, cohort studies, and complex survey designs. Analysis capabilities shall include the ability to model transfusion-transmitted risks using established models or by developing novel models and methods as necessary. For laboratory studies, sensitivity and specificity analysis may be needed where there may not be a gold standard. 11) Complete analysis of final study data for delivery in SAS format. 12) Assist in preparation of scientific reports for publication and presentation. 13) Develop, implement, and update an approved automated information system security plan. Small business firms having demonstrated experience in performing tasks 1-13 above are invited to submit capability statements (original and two copies). Capability statements must provide evidence of experience in performing the tasks described above and demonstrate the following: 1) Qualifications and availability of personnel with experience in the operation of a coordinating center for multi-center, multi-project epidemiologic, survey, and laboratory research in the areas of blood banking and transfusion medicine. 2) Design and conduct of multicenter surveys, and compilation of data sets using mail and web-based data collection methods; 3) Ready access to expertise in transfusion medicine and infectious disease; 4) Adequacy of organizational and administrative structure to participate in a multicenter epidemiologic, survey, and laboratory study; 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 five years with an approximate date of award August 31, 2004. 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.
- Record
- SN00341616-W 20030608/030606213242 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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