MODIFICATION
A -- Recipient Epidemiology and Donor Evaluation Study III (REDS-III) – International Sites
- Notice Date
- 1/9/2015
- Notice Type
- Modification/Amendment
- 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
- HHS-NIH-NHLBI-RDSS-HB-15-11
- Point of Contact
- Allison M Cristman, Phone: 301-435-0359, Cheryl A Jennings, Phone: (301) 435-0347
- E-Mail Address
-
allison.cristman@nih.gov, cj19f@nih.gov
(allison.cristman@nih.gov, cj19f@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- NOTE: Amendment changes are underlined in the text below. This is a Research and Development (R & D) Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential R&D requirement. BACKGROUND The National Heart, Lung, and Blood Institute (NHLBI) is seeking three (3) International Sites (one each in Brazil, China, and South Africa) for an ongoing program - the Recipient Epidemiology and Donor Evaluation Study III (REDS-III). The objective of REDS-III is 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. The REDS-III program is comprised of one Central Laboratory, one Data Coordinating Center, four Domestic Hubs, and three International collaborative sites in Brazil, China, and South Africa. REDS-III contractors are currently completing Phase 2 of the contract, conducting several study protocols and compiling donor, recipient, and linked databases, and performing laboratory testing. The NHLBI anticipates that the three International collaborative sites in Brazil, China, and South Africa will be needed until March 14, 2020 to complete the development, review and approval of analyses, presentations and publications based on the research conducted in Phase 2, as well as closure of databases. MANDATORY QUALIFICATION CRITERIA Listed below are mandatory qualification criteria. The qualification criteria establish conditions that must be met at the time of receipt of capability statements by the Contracting Officer in order for your capability statement to be responsive. a.The offeror shall be a U.S. blood center, blood bank, or academic institution (henceforth referred to as a U.S. blood center) with an established collaborative program with a foreign blood center or blood bank in a low or middle income country where HIV/AIDS is prevalent. b.The U.S. blood center shall provide evidence of scientific collaborations with proposed foreign site investigator(s) that could include participating in research project(s) in the foreign country, publications, and/or conducting training programs in the foreign country. c.To ensure the statistical relevance of the resulting data, the U.S. blood center shall confirm that the proposed foreign blood collection sites located in a low or middle income country collect a total of at least 250,000 blood donations per year and that each of the sites collects a minimum of 25,000 annual blood donations. PROJECT REQUIREMENTS During the period from September 15, 2017 - March 14, 2020, each of the three International Sites (one each in Brazil, China, and South Africa) is expected to provide the necessary technical expertise and facilities to effectively perform the tasks and meet the requirements identified below: 1. The U.S. blood center shall manage the REDS-III international site's scope of work and study protocols and ensure transmission of complete and accurate scientific data from the foreign blood collection sites (subcontracts) to the REDS-III Data Coordinating Center (DCC), in accordance with procedures set forth in the protocols and Manuals of Procedures. 2. The U.S. blood center shall manage, through foreign subcontracts, the collection of a minimum of 250,000 blood donations annually from at least three collaborating and geographically dispersed 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. 3. The U.S. blood center Principal Investigator shall serve as a member of the REDS-III Oversight Committee. As a member of the Oversight Committee, actively participate in the review and approval of the REDS-III Domestic and International study portfolios as well as evaluate program progress to ensure that the overall objectives of the REDS-III program are being met. 4. The U.S. blood center and foreign investigators shall serve as members of the REDS-III country-specific International Steering Committee. Each of the REDS-III International Steering Committees will consist at a minimum of a chairperson (the U.S. blood center Principal Investigator of each international program), the NHLBI Contracting Officer, the NHLBI Contracting Officer's Representative(s), the Principal Investigator of the DCC, the Principal Investigator of the central laboratory, the U.S. blood center Co-Principal Investigator of each international program, and the country-specific Principal Investigator, Co-Principal Investigator, and Project Coordinator (or respective designees). As members of the country-specific International Steering Committee (and its subcommittees, as appropriate), serve as active participants in developing, reviewing, finalizing and prioritizing proposed country-specific epidemiology, survey, and laboratory studies; participate in the development of study forms, questionnaires, and Manual of Procedures by providing technical expertise in the areas of blood safety and availability and with specific issues pertaining to the conduct of blood safety and availability studies in the participating foreign country; oversee and ensure the progress of ongoing studies; develop, review and approve analyses, presentations, and publications; and report to the REDS-III Oversight Committee on research activities including progress of international study protocols. The final protocols must be approved by the REDS-III country-specific International Steering Committee and Oversight Committee before being approved in writing by the NHLBI Contracting Officer. 5. The U.S. blood center and foreign collection sites shall participate in, coordinate, and successfully conduct the REDS-III research protocols that have been approved by the REDS-III country-specific International Steering Committee. Performance shall be in accordance with study protocols. Provide strong, proactive leadership in coordinating efforts to ensure the successful conduct of all research protocols. Obtain all necessary administrative and regulatory clearances. Incorporate study protocols into foreign blood centers' operations as needed. Contact and enroll participants in study protocols, conduct blood record review, and conduct follow-up visits as required per study protocols. Collect and transmit all data to the DCC as required by each protocol. Collect, process, and ship biospecimens according to protocol specifications. Field all inquiries related to REDS-III research studies. Data shall be analyzed centrally by the REDS-III DCC. 6. The U.S. blood center shall oversee the management of a Centralized Data Collection Center (CCC). The CCC shall be responsible for obtaining and transmitting donor/donation and all study-specific data to the DCC. All foreign collections sites shall capture the same donor/donation data elements as defined by the International Steering Committee and described in the donor/donation database Manuals of Operations. The CCC shall also conduct quality-checks on the data. The CCC shall be responsible for collecting all foreign collection sites donor/donation data and study-specific data, transmitting the data to the DCC, and providing the necessary IT and data management expertise to: a. Prepare and provide data to the REDS-III DCC on all donors and donations collected by the participating foreign sites. These data shall be compiled in a cumulative donor/donation central database by the DCC. The foreign collection centers shall collect, prepare and provide data on a total of at least 250,000 donations annually with corresponding donor information. The donor/donation data will be compiled for a period of approximately 5 years (60 months). Demographic information on blood donors shall include date of birth, gender, race/ethnicity, level of education, country of birth, history of transfusion and geographical area of residence. Information on blood donor status (first-time versus repeat), donation type (e.g., community whole blood), donation date, and donation site shall be collected and provided to the REDS-III DCC. Screening and confirmatory test data shall include detailed results of all individual tests being performed and final screening and confirmatory test interpretations. The donation screening and confirmatory test data shall be transmitted to the REDS-III DCC with minimal delay from time of donation to receipt of confirmatory test results. This information shall be considered a deliverable to the DCC; b. Direct the foreign blood collection centers to provide a unique identification number for each donor with each donation record, allowing the donor to be followed longitudinally and for their individual donations to be identified in the data base. This unique donor identifier shall accompany each donation record transmitted to the coordinating center; c. Collect, enter, and transmit all study-specific data to the DCC. Data elements to be collected shall be protocol-specific and specified in the corresponding Manual of Operation. These data may be prospectively or retrospectively collected as delineated in the protocol. Data shall be entered by the CCC in a data management system as specified in the protocol, and transmitted to the DCC. This information shall be considered a deliverable to the DCC; d. Conduct quality-checks on the donor/donation data files provided by the participating foreign blood centers and on study-specific data. Data must not include identifying information such as donor's name, social security number, address, etc., but must include a unique study identification number (ID) for each donor with each donation record, allowing the donor to be longitudinally followed. The foreign blood centers should maintain the link between the unique study donor identification number and blood center identifier. The link between donor identification number and donor name shall be kept in a secured location by the research staff at the foreign blood centers. The identity of the blood donor shall be known only to the appropriate foreign blood center investigator, but not to the CCC, U.S blood center or REDS-III DCC staff; e. Provide data to the REDS-III DCC in an electronic format, as specified by the DCC, in a timely manner for compilation into databases and data sets. English versions of code books must accompany databases and data sets being provided to the DCC. This information shall be a deliverable to the DCC at specified intervals; and f. Implement procedures to maintain data security and confidentiality. 7. The U.S. blood center shall be responsible for translating all materials. Translate study materials (protocols including informed consents, questionnaires, and forms) and Manuals of Operations prepared in collaboration with the DCC to appropriate languages or dialects, or to English, as appropriate. Final protocols and Manuals of Operations must be approved in writing by the NHLBI REDS-III Contracting Officer's Representative(s). 8. The U.S. blood center shall oversee the collection, processing, testing, and storage of biospecimens by the foreign blood collection sites as required by study protocols. Samples shall be cataloged, tested, and stored according to protocols. The international sites shall be responsible for the conduct of all laboratory testing not being conducted in the U.S. which should represent the vast majority of required testing. Collection of specimens as part of laboratory-based research studies or epidemiologic investigations is permitted and can be established at the foreign blood centers or at a central location. However, large, labor-intensive repositories or population-based repositories (usually > 100,000 biospecimens) are not within the current scope of this program. Strict confidentiality of biospecimens, test results and related data shall be maintained by all REDS-III participants. 9. In collaboration with the REDS-III central laboratory and the DCC, the U.S. blood center shall oversee the shipment of specific biospecimens of research interest to the U.S. for laboratory testing which for technical or financial reasons is better accomplished at the central laboratory (or at another U.S. testing facility subcontracted by the central laboratory). 10. Participate in all committee and subcommittee meetings, conference calls, and organizational training sessions of which the international site Investigators and staff are members. 11. The U.S. blood center and foreign blood collection sites shall obtain all necessary governmental, administrative and regulatory approvals to ensure participation in and successful completion of all studies included in the REDS-III country-specific research portfolio. The U.S. blood center and foreign blood collection sites shall obtain all governmental, administrative and regulatory approvals necessary to 1) conduct the research program in the foreign country; 2) provide to the REDS-III DCC data from all blood collections, epidemiologic studies, laboratory studies, and surveys conducted under the contract; and 3) provide any required selected biospecimens to the REDS-III central laboratory and potentially the NHLBI Biological Specimen Repository in the U.S. OTHER IMPORTANT CONSIDERATIONS The Government intends to negotiate three (3) cost reimbursement task orders, each for the period of September 15, 2017 - March 14, 2020. CAPABILITY STATEMENT - HOW TO SUBMIT A RESPONSE Organizations that believe they possess the capabilities necessary to undertake this work should submit complete documentation of their capabilities to the Contracting Officer. The capabilities statement must specifically address each mandatory qualification criterion and project requirement separately. Additionally, the capability statement should include 1) the professional qualifications of scientists, medical experts, and technical personnel as it relates to the above outlined requirements; 2) a description of general and specific facilities and equipment available, including the software used analyze study data; 3) an outline of previous research projects that are similar to the project requirements in which the organization and proposed personnel have participated; and 4) any other information considered relevant to this program. The capability statement must not exceed 16 single-sided or 8 double-sided pages in length using a minimum 11-point font size. The Government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone numbers of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. All capability statements sent in response to this Sources Sought Notice must be submitted electronically (via email) to Allison Cristman, Contracting Officer at allison.cristman@nih.gov in either MS Word or Adobe Portable Document Format (PDF). All responses must be received by the specified due date and time in order to be considered. DISCLAIMER AND IMPORTANT NOTES This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. CONFIDENTIALITY No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
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